R Series ALS Operators Guide Rev V Dec 2018

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R Series

®

ALS

Operator’s Guide

9650-0912-01 Rev. V

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The issue date for the R Series Operator’s Guide ALS (REF 9650-0912-01 Rev. V) is December, 2018.

Copyright © 2018 ZOLL Medical Corporation. All rights reserved.

R Series, M Series, Pedi-padz, Pro-padz, Stat-padz, CodeNet, Real CPR Help, RescueNet, See-Thru CPR,

Code-Ready, SurePower, OneStep, Smart Alarms, Perfusion Performance Indicator, Defib Mentor, Rectilinear

Biphasic, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United

States and/or other countries.

Masimo is a registered trademark of Masimo Corporation in the United States and/or other countries.

All other trademarks are property of their respective owners.

Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA USA

01824-4105

ZOLL International Holding B.V.

Newtonweg 18

6662 PV ELST

The Netherlands

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Indication of Use

Indication of Use

Defibrillator Function

The R Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of

circulation as indicated by:

• Unconsciousness.

• Absence of breathing.

• Absence of pulse.

The R Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or

ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.

The R Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs

where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive

care are incorporated into a medically-approved patient care protocol.

The R Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients.

ECG Monitoring

The R Series system is indicated to evaluate the patient’s heart rate or ECG morphology via ECG monitoring. In

ECG monitoring mode, the feature is indicated for use by personnel who are qualified by training in the use of

the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency

medical training.

Real CPR Help

The R Series system is indicated to provide visual and audio feedback via the CPR Help feature, which is

designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended depth and rate

of 2 inches (5 cm) and 100 compressions per minute.

External Pacemaker

The R Series system is indicated for temporary external cardiac pacing in conscious or unconscious patients as

an alternative to endocardial stimulation. External Pacing is indicated for pediatric and adult patients.

SpO2 Monitoring

The R Series system is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation

(SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion

conditions for pediatric and neonatal patients in a hospital or prehospital environment.

EtCO2 Monitoring

The R Series system is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2)

and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia. EtCO2

Monitoring is indicated for in patients from newborn (neonate) to adult.

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Non-Invasive Blood Pressure Monitoring (NIBP)

The R Series system is indicated for the non-invasive measurement of arterial blood pressure for resting patients

in critical care and in-hospital transport. The NIBP feature is indicated to measure blood pressure for patients

from newborn (neonate) to adult.

CONTRAINDICATIONS

The R Series Semiautomatic Operation Contraindications for Use

The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implanted

pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the

basis for any treatment of patients with implanted pacemakers. Do not use the rhythm analysis function during

patient movement on a stretcher. A patient must be motionless during ECG analysis. Do not touch the patient

during analysis. Cease all movement of the stretcher prior to analyzing the ECG.

General Information

Federal (U.S.A.) law restricts this defibrillator to sale by or on the order of a physician.

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TABLE OF CONTENTS

Warnings........................................................................................................................... 1-14

Operator Safety ........................................................................................................ 1-16

Patient Safety ........................................................................................................... 1-17

Cautions............................................................................................................................ 1-18

Restarting the Defibrillator ................................................................................................ 1-18

FDA Tracking Requirements ............................................................................................. 1-19

Notification of Adverse Events .................................................................................. 1-19

Software License .............................................................................................................. 1-20

Service.............................................................................................................................. 1-20

The ZOLL Serial Number.................................................................................................. 1-22

Chapter 2

Product Overview

Defibrillator Controls and Indicators.................................................................................... 2-1

The Front Panel .......................................................................................................... 2-3

Display Screen ............................................................................................................ 2-5

Patient Cables and Connectors .................................................................................. 2-7

External Paddles ......................................................................................................... 2-9

Working with Menus.......................................................................................................... 2-11

Defib Mentor Mode (Optional) .................................................................................. 2-12

Common Tasks ................................................................................................................. 2-13

Replacing a Battery Pack ......................................................................................... 2-13

Adjusting Display Brightness .................................................................................... 2-13

Using Code Markers ................................................................................................. 2-14

Chapter 3

Manual Defibrillation

Emergency Defibrillation Procedure with Paddles .............................................................. 3-1

Determine the Patient’s Condition Following Local Medical Protocols ....................... 3-1

Begin CPR Following Local Medical Protocols. .......................................................... 3-2

1 Select DEFIB ........................................................................................................... 3-2

2 Charge Defibrillator .................................................................................................. 3-4

3 Deliver Shock ........................................................................................................... 3-5

Autoclavable External Paddles ........................................................................................... 3-5

Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes........................ 3-6

Determine the Patient’s Condition Following Local Medical Protocols ....................... 3-6

Begin CPR Following Medical Protocols .................................................................... 3-6

Prepare Patient ........................................................................................................... 3-6

1 Select DEFIB ........................................................................................................... 3-8

2 Charge Defibrillator .................................................................................................. 3-9

3 Deliver Shock ......................................................................................................... 3-10

Autoclavable Electrodes ................................................................................................... 3-10

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Chapter 4

Advisory Defibrillation

Advisory Defibrillation Procedure........................................................................................ 4-2

Determine the Patient’s Condition Following Local Medical Protocols ....................... 4-2

Begin CPR Following Local Medical Protocols ........................................................... 4-2

Prepare Patient ........................................................................................................... 4-2

1 Select DEFIB ........................................................................................................... 4-2

2 Press ANALYZE Button ........................................................................................... 4-3

3 Press SHOCK .......................................................................................................... 4-5

Advisory Function Messages .............................................................................................. 4-7

Warning Messages ............................................................................................................. 4-7

Chapter 5

Synchronized Cardioversion

Synchronized Cardioversion Procedure ............................................................................. 5-2

Determine the Patient’s Condition and Provide Care Following Local Medical

Protocols .................................................................................................................. 5-2

Prepare Patient ........................................................................................................... 5-2

1 Select DEFIB ........................................................................................................... 5-3

2 Charge Defibrillator .................................................................................................. 5-4

3 Deliver SHOCK ........................................................................................................ 5-5

Remote Synchronized Cardioversion Procedure................................................................ 5-5

Determine the Patient’s Condition and Provide Care Following Local Medical

Protocols .................................................................................................................. 5-6

Prepare Patient ........................................................................................................... 5-6

1 Select DEFIB ........................................................................................................... 5-6

2 Charge Defibrillator .................................................................................................. 5-7

3 Deliver SHOCK ........................................................................................................ 5-7

Chapter 6

Real CPR Help

Real CPR Help Field........................................................................................................... 6-2

Perfusion Performance Indicator (Optional/Adult Only) .............................................. 6-2

CPR Idle Time Display ................................................................................................ 6-2

CPR Rate and Depth Display ..................................................................................... 6-2

Compression Release Bar (Adult only) ....................................................................... 6-3

CPR Metronome ......................................................................................................... 6-3

Fully Release prompt .................................................................................................. 6-3

CPR Voice Prompts (Adult only) ......................................................................................... 6-4

Chest Compressions Bar Graph ......................................................................................... 6-4

Displaying the CPR Bar Graph ........................................................................................... 6-4

Chapter 7

See-Thru CPR (Optional)

Using See-Thru CPR .......................................................................................................... 7-2

Examples .................................................................................................................... 7-2

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TABLE OF CONTENTS

Chapter 8

Noninvasive Temporary Pacing (Optional)

Noninvasive Temporary Pacing .......................................................................................... 8-2

Determine Patient Condition and Provide Care Following Local Medical Protocols ... 8-2

Prepare the Patient ..................................................................................................... 8-2

1 Apply ECG Electrodes/Hands-Free Therapy Electrodes ......................................... 8-2

2 Turn Selector Switch to PACER .............................................................................. 8-3

3 Set Pacer Rate ........................................................................................................ 8-3

4 Set Pacer Output ..................................................................................................... 8-4

5 Determine Capture .................................................................................................. 8-5

6 Determine Optimum Threshold ................................................................................ 8-6

Special Pacing Applications ................................................................................................ 8-7

Standby Pacing ........................................................................................................... 8-7

Asynchronous Pacing ................................................................................................. 8-7

Pediatric Pacing .......................................................................................................... 8-8

Chapter 9

ECG Monitoring

Preparations ....................................................................................................................... 9-2

Electrode Placement........................................................................................................... 9-2

Monitoring Electrodes Attachment ...................................................................................... 9-3

Monitoring the Patient’s ECG ............................................................................................. 9-5

Set the Controls .......................................................................................................... 9-5

Implanted Pacemakers ....................................................................................................... 9-5

5-Lead Monitoring............................................................................................................... 9-7

Simultaneous 3-Lead Printing ..................................................................................... 9-7

See-Thru CPR Filter (Optional) .................................................................................. 9-7

Adding Traces to Be Displayed .................................................................................. 9-8

Printing the ECG on a Stripchart ........................................................................................ 9-8

Diagnostic Bandwidth ................................................................................................. 9-8

Alarms................................................................................................................................. 9-9

Setting Alarm Limits .................................................................................................... 9-9

Heart Rate Alarm Limits ............................................................................................ 9-10

Vital Sign Alarms ...................................................................................................... 9-10

Suspending and Silencing Alarms ............................................................................ 9-10

Smart Alarms ............................................................................................................ 9-11

Alarm Settings for Unattended Monitoring ................................................................ 9-12

Chapter 10

Event Records and Reports

Summary Report............................................................................................................... 10-1

Summary Report Formats ........................................................................................ 10-2

Printing the Entire Summary Report ......................................................................... 10-7

Printing a Partial Summary Report ........................................................................... 10-8

Full Disclosure Recording ................................................................................................. 10-8

Incident Logs .................................................................................................................... 10-8

Printing an Incident Log ............................................................................................ 10-8

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Erasing Summary Report and Full Disclosure .................................................................. 10-9

Manual Erasure ........................................................................................................ 10-9

Automatic Erasure .................................................................................................... 10-9

Formatting the Disk ................................................................................................... 10-9

Related Messages ............................................................................................................ 10-9

Chapter 11

File Transfer

Transferring Files to an External Device........................................................................... 11-1

Wi-Fi (Optional)................................................................................................................. 11-2

Installing or Removing a Compact Flash Card ................................................................. 11-2

Transferring a Full Disclosure File to a Compact Flash Card ........................................... 11-3

Transferring Device Check and Activity Log Files to a Compact Flash Card.................... 11-3

Transferring Files Through the USB Port (Optional) ......................................................... 11-4

Transferring Full Disclosure Files Through Wi-Fi (Optional) ............................................. 11-5

Transferring Device Check and Activity Log Files Through Wi-Fi (Optional) .................... 11-6

Related Wi-Fi Messages ........................................................................................... 11-7

Chapter 12

Maintenance

Routine Procedures .......................................................................................................... 12-2

Daily Visual Inspection .............................................................................................. 12-2

Code Readiness Test ............................................................................................... 12-3

Manual Defibrillator Testing............................................................................................... 12-3

Defibrillator Testing with Paddles ............................................................................. 12-4

Defibrillator Testing with Hands-Free Therapy Electrodes ....................................... 12-5

Pacer Testing ............................................................................................................ 12-5

Recorder Check ........................................................................................................ 12-6

Code Readiness Log ................................................................................................ 12-6

Setting Time and Date .............................................................................................. 12-8

Cleaning the R Series Unit ....................................................................................... 12-8

Loading Stripchart Paper .......................................................................................... 12-9

Cleaning the Print Head .......................................................................................... 12-10

Operator’s Checklist for R Series Product ............................................................. 12-11

Chapter 13

Troubleshooting

Code-Ready .............................................................................................................. 13-1

Monitor ...................................................................................................................... 13-2

Recorder ................................................................................................................... 13-3

Pacer ........................................................................................................................ 13-4

Defibrillator ................................................................................................................ 13-5

AC Charger ............................................................................................................... 13-7

CPR .......................................................................................................................... 13-7

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TABLE OF CONTENTS

Appendix A

Specifications

Defibrillator Specifications ..................................................................................................A-2

Battery Pack Specifications ........................................................................................A-7

IEC 60601-1-2 Specifications .............................................................................................A-7

Electromagnetic Emissions Declaration .....................................................................A-7

Electromagnetic Immunity Declaration (EID) ..............................................................A-8

Electromagnetic Immunity ..........................................................................................A-9

Recommended Separation Distances from RF Equipment for the R Series

Functions ................................................................................................................A-10

R Series Rectilinear Biphasic Waveform Characteristics ................................................. A-11

Clinical Trial Results for the Biphasic Waveform ..............................................................A-23

Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation

(VF) and Ventricular Tachycardia (VT) ...................................................................A-23

Pre-Clinical Study .....................................................................................................A-24

Published Clinical Data .............................................................................................A-25

Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation (AF) ...A-25

Synchronized Cardioversion of Atrial Fibrillation ......................................................A-27

ECG Rhythm Analysis Algorithm Accuracy .......................................................................A-28

Appendix B R Series Accessories

Appendix C Wi-Fi Radio Module Information

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Chapter 1

General Information

Product Description

The ZOLL® R Series® products combine a defibrillator, ECG display, advanced monitoring

capabilities, and Noninvasive Transcutaneous Pacing (NTP) with communication, data printing

and recording capabilities in a single lightweight portable instrument. The unit has been

designed for all resuscitation situations and its small, compact, lightweight design makes it

ideal for accompanying patients during in-hospital transport. The product is powered by AC

mains and an easily replaced battery pack that is quickly recharged in the device when it is

connected to AC mains. In addition, the unit’s battery may be recharged and tested using a

ZOLL SurePower™ Battery Charger.

The product is designed for use only in the hospital. All of its ruggedized features add to its

durability in hospital applications.

There are multiple models of the R Series defibrillator that can contain a variety of

functions. Your model may not contain all of the functions that are documented in this

manual. Those features that are not contained in all models are specified as optional.

The R Series is a versatile manual/advisory external defibrillator. When operating in the

manual configuration, the device operates as a conventional defibrillator where the device’s

charging and discharging are fully controlled by the operator. In advisory mode, some of the

features of the device are automated and a sophisticated algorithm is used to identify shockable

ECG rhythms (VF and wide complex VT >150 bpm) that should be treated by defibrillator

shock delivery. Depending on local protocols, the unit may be configured to automatically

analyze the ECG, charge the defibrillator (if appropriate), and prompt the operator to PRESS

SHOCK between periods of CPR.

The R Series unit assists caregivers during cardiopulmonary resuscitation (CPR) by evaluating

the rate and depth of chest compressions and providing feedback to the rescuer.

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CHAPTER 1 GENERAL INFORMATION

Real CPR Help® requires the use of OneStep™ CPR electrodes or OneStep Complete

electrodes. When using these pads, the displayed ECG waveforms can be adaptively filtered,

using the See-Thru CPR® feature, to reduce the artifact caused by chest compressions.

The R Series is a Code-Ready® defibrillator. It extends testing beyond shock delivery and

checks more than 40 measures of readiness, including the presence of the correct cables and

electrodes, the type of electrode, and other important electronic functions. The R Series also

verifies the condition and expiration date of OneStep electrodes. This code readiness testing

can occur automatically, without disconnecting electrodes or paddles, or requiring additional

equipment to test shock delivery. The system also provides a printed, or electronic log to alert

hospital personnel of any defibrillator functions or accessories that are compromised in

advance of a code.

Some R Series models include an optional transcutaneous pacemaker consisting of a pulse

generator and ECG sensing circuitry. The pacing option supports both demand and

asynchronous noninvasive pacing for adult, pediatric, or neonatal patients. OneStep Pacing

electrodes and OneStep Complete electrodes allow demand pacing and ECG monitoring

without separate ECG electrodes when the R Series is used with the OneStep Pacing cable.

Information regarding the unit’s operation, ECG, and other physiological waveforms are

displayed on a large 6.5 inch (16.5 cm) diagonal display which provides high contrast and

visibility under virtually all lighting conditions. Operating and warning messages are displayed

on the monitor, and the unit can also be configured with voice prompts to alert the user to unit

status. The R Series performs code readiness testing when the unit is OFF but connected to

AC power, when the defibrillator is initially turned on, and periodically during operation.

An annotating strip chart recorder is included to provide immediate documentation as well as

summary report functions about patient care and treatment.

A sophisticated data collection system, including summary report, printer, and multiple

communication ports is available for this unit. The stored data can be reviewed and archived on

a properly equipped personal computer using ZOLL CodeNet® Central software or ZOLL

RescueNet® Code Review software. R Series data files may be transferred to a PC using USB

or Compact Flash cards or Wi-Fi.

R Series products are intended for use in Manual mode by personnel certified by appropriate

federal, state, or local government authority to provide advanced life support care.

How to Use This Manual

The R Series Operator’s Guide provides information operators need for the safe and effective

use and care of the R Series products. It is important that all persons using this device read and

understand all the information contained within.

Please read thoroughly the safety considerations and warnings section.

Procedures for daily checkout and unit care are located in “Maintenance” on page 12-1.

This manual is supplemented by manual inserts for options available on the R Series. These

inserts contain additional warnings, precautions, and safety-related information.

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Operator’s Guide Updates

Operator’s Guide Updates

An issue or revision date for this manual is shown on the front cover. If more than three years

have elapsed since this date, contact ZOLL Medical Corporation to determine if additional

product information updates are available.

All users should carefully review each manual update to understand its significance and then

file it in its appropriate section within this manual for subsequent reference.

Product documentation is available through the ZOLL website at www.zoll.com. From the

Products menu, choose Product Manuals.

Unpacking

Carefully inspect each container for damage. If the shipping container or cushion material is

damaged, keep it until the contents have been checked for completeness and the instrument has

been checked for mechanical and electrical integrity. If the contents are incomplete, if there is

mechanical damage, or if the defibrillator does not pass its electrical self-test, U.S.A. customers

should call ZOLL Medical Corporation (1-800-348-9011). Customers outside of the U.S.A.

should contact the nearest ZOLL authorized representative. If the shipping container is

damaged, also notify the carrier.

Symbols Used on the Equipment

Any or all of the following symbols may be used in this manual or on this equipment:

Symbol

Description

Dangerous voltage.

MR unsafe: keep away from magnetic resonance imaging equipment

Attention, consult accompanying documents.

Fragile, handle with care.

Keep dry.

This end up.

Temperature limitation.

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CHAPTER 1 GENERAL INFORMATION

Symbol

Description

Conformité Européenne Complies with medical device directive 93/42/EEC.

Type B patient connection.

Type BF patient connection.

Type CF patient connection.

Defibrillator-proof type BF patient connection.

Defibrillator-proof type CF patient connection.

Fusible link.

Equipotentiality.

Alternating current (AC).

,I

2.

45

2%

)/.

Direct current (DC).

Contains lithium. Recycle or dispose of properly.

R EC Y C LE

,I )/.

Keep away from open flame and high heat.

Do not open, disassemble, or intentionally damage.

Do not crush.

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Symbols Used on the Equipment

Symbol

Description

Do not discard in trash. Recycle or dispose of properly.

Return to a collection site intended for waste electrical and electronic

equipment (WEEE). Do not dispose of in unsorted trash.

Date of manufacture.

Use by.

Latex-free.

Do not reuse.

Do not fold.

Not sterile.

Nonionizing electromagnetic radiation from Wi-Fi during data transfer.

Manufacturer.

Authorized representative in the European Community.

Serial Number.

Catalogue number.

Consult instructions for use.

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CHAPTER 1 GENERAL INFORMATION

Symbol

Description

Prescription only.

Maximum energy.

Test port.

Conventions

This guide uses the following conventions:

Within text, the names and labels for physical buttons and softkeys appear in boldface type (for

example, “Press the SHOCK button or the Code Marker softkey”).

This guide uses uppercase italics for audible prompts and for text messages displayed on the

screen (for example, CHECK PATIENT).

WARNING!

Warning statements alert you to conditions or actions that can result in personal injury

or death.

Caution

Caution statements alert you to conditions or actions that can result in damage to the unit.

Defibrillator Function

The R Series product contains a direct current (DC) defibrillator capable of delivering up to 200

joules. It may be used in synchronized mode to perform synchronized cardioversion using the

patient’s R-wave as a timing reference. The unit uses paddles or disposable, pregelled

electrodes for defibrillation.

Intended Use — Manual Operation

In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or

ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is

appropriate.

The advisory function should be used to confirm ventricular fibrillation or wide complex

ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three

conditions indicating lack of circulation (listed above).

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External Pacemaker (Optional)

Intended Use — ECG Monitoring

The unit is intended for use when ECG monitoring is indicated to evaluate the patient’s heart

rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by

personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or

advanced life support, or other physician-authorized emergency medical training.

Intended Use — Real CPR Help

The Real CPR Help function provides visual and audio feedback designed to encourage

rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 - 120

compressions per minute. Voice and visual prompts encourage a compression depth in

accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult

patients.

Defibrillator Complications

Inappropriate defibrillation or cardioversion of a patient (for example, with no malignant

arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias.

Defibrillation without proper application of electrodes or paddle electrolyte gel might be

ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or

hyperemia of the skin under the paddles, or electrodes often occurs; this effect is usually

enhanced along the perimeter of the paddles or electrodes. This reddening should diminish

substantially within 72 hours.

Defibrillator Output Energy

R Series defibrillators can deliver as much as 200 joules into a 50 ohm impedance. The energy

delivered through the chest wall, however, is determined by the patient’s transthoracic

impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of

10 to 12 kilograms (22 to 26.4 pounds) must be applied to each paddle in order to minimize this

impedance. If hands-free therapy electrodes are used, make sure that they are properly applied.

(Refer to the instructions on the electrode package).

External Pacemaker (Optional)

Some R Series products include an optional transcutaneous pacemaker consisting of a pulse

generator and ECG-sensing circuitry. Noninvasive transcutaneous pacing (NTP) is an

established and proven technique. This therapy is easily and rapidly applied in both emergency

and nonemergency situations when temporary cardiac stimulation is indicated.

The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is

continuously variable from 30 to 180 pulses per minute (ppm), by increments of 2.

The pacing output pulse is delivered to the heart via ZOLL hands-free defibrillation/pacing

electrodes placed on the patient’s back and the precordium.

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CHAPTER 1 GENERAL INFORMATION

The characteristics of the output pulse, together with the design and placement of the

electrodes, minimize cutaneous nerve stimulation, cardiac stimulation threshold currents, and

reduce discomfort due to skeletal muscle contraction.

The unique design of the R Series products allow clear viewing and interpretation of the

electrocardiogram on the display without offset or distortion during external pacing.

Proper operation of the device, together with correct electrode placement, is critical to

obtaining optimal results. Every operator must be thoroughly familiar with these operating

instructions.

Intended Use — Pacemaker

This product can be used for temporary external cardiac pacing in conscious or unconscious

patients as an alternative to endocardial stimulation.

The purposes of pacing include:

• Resuscitation from standstill or bradycardia of any etiology.

Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal

standstill, drug-induced standstill (due to procainamide, quinidine, digitalis, b-blockers,

verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography,

and other therapeutic or diagnostic procedures). It has also been used for temporary

acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer,

more reliable, and more rapidly applied in an emergency than endocardial or other

temporary electrodes.

• As a standby when standstill or bradycardia might be expected.

Noninvasive pacing can be useful as a standby when cardiac arrest or symptomatic

bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia,

or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants

or the introduction of transvenous therapy. In standby pacing applications, noninvasive

pacing might provide an alternative to transvenous therapy that avoids the risks of

displacement, infection, hemorrhage, embolization, perforation, phlebitis, and mechanical

or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial

pacing.

• Suppression of tachycardia.

Increased heart rates in response to external pacing often suppress ventricular ectopic

activity and might prevent tachycardia.

WARNING!

This device must not be connected to internal pacemaker electrodes.

Pacemaker Complications

Ventricular fibrillation does not respond to pacing and requires immediate defibrillation.

Therefore, the patient’s dysrhythmia must be determined immediately, so that you can employ

appropriate therapy. If the patient is in ventricular fibrillation and defibrillation is successful but

cardiac standstill (asystole) ensues, you should use the pacemaker.

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Intended Use — SpO2 Monitoring

Ventricular or supraventricular tachycardias can be interrupted with pacing, but in an

emergency or during circulatory collapse, synchronized cardioversion is faster and more

certain.

Pulseless electrical activity (PEA) can occur following prolonged cardiac arrest or in other

disease states with myocardial depression. Pacing might then produce ECG responses without

effective mechanical contractions, making other effective treatment necessary.

Pacing can evoke undesirable repetitive responses, tachycardia, or fibrillation in the presence of

generalized hypoxia, myocardial ischemia, cardiac drug toxicity, electrolyte imbalance, or

other cardiac diseases.

Pacing by any method tends to inhibit intrinsic rhythmicity. Abrupt cessation of pacing,

particularly at rapid rates, can cause ventricular standstill and should be avoided.

Noninvasive temporary pacing can cause discomfort of varying intensity, which occasionally

can be severe and preclude its continued use in conscious patients.

Similarly, unavoidable skeletal muscle contraction might be troublesome in very sick patients

and might limit continuous use to a few hours. Erythema or hyperemia of the skin under the

hands-free therapy electrodes often occurs; this effect is usually enhanced along the perimeter

of the electrode. This reddening should lessen substantially within 72 hours.

There have been reports of burns under the anterior electrode when pacing adult patients with

severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases

and periodic inspection of the underlying skin is advised.

There are reports of transient inhibition of spontaneous respiration in unconscious patients with

previously available units when the anterior electrode was placed too low on the abdomen.

WARNING!

This device must not be connected to internal pacemaker electrodes.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 55 lb. (25 kg) or less using ZOLL

pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes),

particularly in neonates, can cause burns. Periodic inspection of the underlying skin is

recommended.

Intended Use — SpO2 Monitoring

The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of

oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen

saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult

patients, and no motion conditions for pediatric and neonatal patients in a hospital environment.

SpO2 Contraindications for Use

See the R Series Pulse Oximetry (SpO2) insert (ZOLL part number 9650-0901-01) for

disclosures of any contraindications for use of the pulse oximeter monitoring feature.

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CHAPTER 1 GENERAL INFORMATION

Intended Use — EtCO2 Monitoring

The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the

continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in

patients requiring ventilator support, in-hospital transport, or anesthesia. The R Series EtCO2

option with Respironics Novametrix technology supports two methods for continuous

measurement of end tidal carbon dioxide (EtCO2) and respiration rate.

The first method uses the CAPNOSTAT 5 Mainstream CO2 sensor attached to an airway adapter

that connects to an endotracheal tube, mask or disposable mouthpiece.

The second method uses the LoFlo CO2 module to monitor both non-intubated and intubated

patients using specially designed sampling cannulas and airway adapters.

The R Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients.

The following substances can influence CO2 measurements made with the CAPNOSTAT 5 CO2

mainstream sensor or the LoFlo sidestream module:

• elevated oxygen levels

• nitrous oxide

• halogenated agents

The R Series EtCO2 option provides settings for high oxygen and/or nitrous oxide

compensation. Halogenated anesthetic agents alter CO2 readings, but the R Series unit will

monitor CO2 within specifications when these agents are present at normal clinical levels. The

presence of Desflurane in the exhaled breath beyond normal values (5%) may positively bias

measured carbon dioxide values by up to an additional 3 mmHg.

The R Series EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix

CAPNOSTAT 5 Mainstream CO2 Sensor and mainstream airway adapters, the LoFlo CO2

Module, nasal and nasal/oral sampling cannula sets, and sidestream on-airway adapters.

The R Series EtCO2 option can be used on adult patients (21 years of age and older) and on

pediatric patients, as described in the following table:

Pediatric Subpopulation

Approximate Age Range

Newborn (neonate)

Birth to 1 month of age

Infant

1 month to 2 years of age

Child

2 to 12 years of age

Adolescent

12-21 years of age

EtCO2 Contraindications for Use

See the R Series End Tidal Carbon Dioxide (EtCO2) insert (ZOLL part number 9650-0915-01)

for disclosures of any contraindications for use of the EtCO2 monitoring feature.

Intended Use — NIBP

The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial

blood pressure for resting patients in critical care and in-hospital transport.

The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of

age and older) and for pediatric patients, as described in the following table:

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ECG Monitoring

Pediatric Subpopulation

Approximate Age Range

Newborn (neonate)

Birth to 1 month of age

Infant

1 month to 2 years of age

Child

2 to 12 years of age

Adolescent

12-21 years of age

NIBP Contraindications for Use

See the R Series Non-Invasive Blood Pressure (NIBP) insert (ZOLL part number

9650-0914-01) for disclosures of any contraindications for use of the NIBP monitoring feature.

ECG Monitoring

The patient’s ECG is monitored by connecting the patient to the unit via a 3- or 5-lead patient

cable, hands-free therapy electrodes, or through paddles. Five seconds of ECG is presented on

the display along with the following information:

• averaged heart rate, derived by measuring R to R intervals

• lead selection - I, II, III, aVR, aVL, aVF, V (with ECG cable), PADDLES or PADS, P1, P2,

P3 (when using OneStep Pacing cable with OneStep Complete electrodes).

P1, P2, and P3 are non-standard ECG leads derived from electrodes within particular

OneStep electrodes. While ECG signals acquired from these leads are appropriate for

rhythm assessment and determining electrical capture during pacing, they should not be

used for ECG morphological evaluation. Attach conventional ECG electrodes for diagnostic

purposes.

• ECG size relative scale factor - x0.5, x1, x1.5, x2, x3

• other operational prompts, messages, and diagnostic codes

Monitoring or diagnostic ECG bandwidth is selectable.

Recorder Function

The strip recorder is provided to document events. The strip recorder normally operates in the

delay mode (6 seconds) to ensure the capture of ECG information immediately preceding

critical events. The recorder may be activated manually by pressing the RECORDER button.

It is activated automatically whenever a defibrillation SHOCK is delivered, a heart rate alarm

occurs, or the rhythm analysis function is activated. The strip recorder may also be configured

not to print during these events.

Paddles and Electrodes

The R Series will defibrillate, cardiovert, and monitor ECG using either defibrillation paddles

or hands-free therapy electrodes.

The pacer version of the R Series will pace using ZOLL hands-free therapy electrodes.

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CHAPTER 1 GENERAL INFORMATION

ENERGY SELECT, CHARGE and SHOCK controls are located on the paddles and front

panel. When using hands-free therapy electrodes, you must use the controls on the front panel

of the unit. To switch between paddles and hands-free therapy electrodes, remove the OneStep

cable from the apex paddle and connect the hands-free therapy electrodes to the cable.

The Advisory function cannot be activated unless hands-free therapy electrodes are attached to

the OneStep cable and used as the ECG monitoring lead.

The R Series can monitor the patient’s ECG while pacing without the need for a separate ECG

cable and ECG electrodes. This also allows demand pacing when separate ECG electrodes are

either not connected, or unavailable. OneStep pacing capability requires the OneStep Pacing

cable along with OneStep Pacing electrodes, or OneStep Complete electrodes.

Note:

The ZOLL OneStep electrodes, MFE Pads, Pediatric MFE Pads, Stat-padz®, and ECG

electrodes are disposable, single-use items.

You should always check the expiration date on the electrode packaging. Do not use expired

electrodes, which might result in false patient impedance readings and affect the level of

delivered energy, or cause burns.

This symbol on the electrode package is accompanied by the expiration date.

The R Series defibrillator reads and reports the expiration date for all OneStep electrodes

(except for OneStep Basic). When these electrodes exceed their expiration date, the Code

Readiness indicator will change to a red “X.”

Note:

ZOLL electrodes contain no hazardous materials and may be disposed of in general

trash unless contaminated with pathogens. Use appropriate precautions when

disposing of contaminated electrodes.

When the patient is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pediatric

defibrillation electrodes. Do not delay therapy to determine the patient’s exact age or weight.

Batteries

R Series products use an easily replaced rechargeable lithium-ion battery pack (the ZOLL

SurePower battery pack). A new, fully charged battery pack typically delivers more than 5

hours of ECG monitoring. Use of other functions (such as the defibrillator, printer, or

pacemaker) reduces this time.

When a LOW BATTERY message appears on the display and the unit emits two beeps in

conjunction with the displayed message, the battery must be replaced and recharged.

You can charge the battery by either of the following methods:

• Internal charging — plug the R Series into an AC power supply to automatically begin

charging the installed battery pack. The front panel battery indicator operates as follows:

1–12

When the indicator is:

It means:

Steady yellow

Battery is charging

Steady green

Battery is charged

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Code-Ready System

Note:

When the indicator is:

It means:

Alternating yellow and

green

No battery is installed or a battery

charging fault has been detected.

Not lit

The defibrillator is not connected to

AC mains.

Upon power up, it takes approximately 45 seconds for the LEDs on the battery to

accurately display run time.

• External charging — use the ZOLL SurePower Battery Charger to charge the battery pack

and test the battery’s capacity. For details, refer to the ZOLL SurePower defibrillator battery

Operator’s Manual.

Code-Ready System

The R Series defibrillator’s Code-Ready system tests the defibrillator whenever the unit is

turned on, periodically during operation, whenever manual testing is initiated by the operator,

and automatically, at pre-configured intervals.

The code readiness indicator on the front panel shows the result of the most recent readiness

check. Also, OneStep Pacing, CPR or Complete electrodes provide an interface that

communicates the electrode’s expiration date and condition to the defibrillator.

The Defib Test Log stores the results for as many as 1000 defibrillator tests in internal memory.

Each log entry shows the time and date of the defibrillator test. The Defib Test Log can be

printed on the stripchart or transferred to a personal computer for printing and archiving.

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CHAPTER 1 GENERAL INFORMATION

Safety Considerations

All operators should review these safety considerations before using the R Series.

R Series products are high-energy defibrillators capable of delivering 200 joules. To completely

deactivate the unit, turn the Mode Selector to OFF.

To manually disarm a charged (or charging) defibrillator, do one of the following:

• Turn the Mode Selector to OFF, MONITOR, or PACER.

• Change the selected defibrillator energy.

For safety, the R Series unit automatically disarms if left charged for more than either 60 or 120

seconds (user configurable) if the SHOCK button is not pressed.

Warnings

General

Federal (U.S.A.) law restricts this defibrillator to use by or on the order of a physician.

Only appropriately trained, skilled personnel who are familiar with equipment operation should

perform emergency defibrillation. The prescribing physician should determine what training,

such as Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) certification, is

appropriate.

Only skilled personnel trained in Advanced Cardiac Life Support (ACLS) and who are familiar

with equipment operation should perform synchronized cardioversion. The precise cardiac

arrhythmia must be determined before attempting defibrillation.

These operating instructions describe the functions and proper operation of the R Series

products. They are not a substitute for a formal patient care training course. Operators should

obtain formal training from an appropriate authority before using this defibrillator for patient

care.

Proper operation of the unit and correct electrode placement is critical to obtaining optimal

results. Operators must be thoroughly familiar with proper device operation.

The use of external pacing/defibrillation electrodes or adapter devices from sources other than

ZOLL is not recommended. ZOLL makes no representations or warranties regarding the

performance or effectiveness of its products when used with pacing/defibrillation electrodes or

adapter devices from other sources. Defibrillator failures attributable to the use of pacing/

defibrillation electrodes or adapters not manufactured by ZOLL might void ZOLL’s warranty.

Do not disassemble the unit. A shock hazard exists. Refer all problems to authorized service

personnel.

Follow all recommended maintenance instructions. If a problem occurs, obtain service

immediately. Do not use the defibrillator until it has been inspected by appropriate personnel.

The R Series unit might not perform to specifications when stored at the upper or lower

extreme limits of storage temperature and then immediately put into use.

Avoid using the R Series adjacent to, or stacked on, other equipment. If unavoidable, verify that

the R Series operates normally in this configuration before clinical use.

The R Series should be installed and put into service according to the EMC information in

Appendix A of this manual.

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Warnings

Assess the Wi-Fi performance for the possibility of RFI in your environment of use.

If multiple devices are transmitting simultaneously to the same access point, Wi-Fi data transfer

will be slowed down. If the access point is too overloaded, data transmission failures can occur.

The use of accessories, transducers, and cables other than those specified in this manual and

related R Series option manual inserts may result in increased emissions or decreased immunity

of the R Series.

Do not use or place the unit in service if the Code Readiness indicator (at the upper right of the

front panel) displays a red “X”.

Carefully route patient cables to avoid tripping over them, or inadvertently pulling the unit onto

the patient.

Always inspect the unit for damage if it has been dropped.

To avoid risk of electric shock, this equipment must only be connected to a supply mains with

protective earth.

Do not modify this equipment without authorization from the manufacturer.

Ensure that the unit is always positioned so as to allow unobstructed access to and detachment

of the power cord from the unit to AC mains.

MR Unsafe: Keep the R Series defibrillator away from magnetic resonance imaging (MRI)

equipment.

ECG Analysis, Defibrillating, Pacing and CPR

Prior to attempting synchronized cardioversion, ensure the ECG signal quality is good and that

sync markers are displayed above each QRS complex.

Do not use the unit in advisory mode during patient movement. A patient must be motionless

during ECG rhythm analysis. Do not touch the patient during analysis. If transporting the

patient in the hospital, cease all movement before beginning ECG analysis.

ECG rhythm analysis does not warn of patient asystole, which is not a shockable rhythm.

The ECG rhythm analysis function might not reliably identify ventricular fibrillation in the

presence of an implanted pacemaker. Inspection of the electrocardiogram and clinical evidence

of cardiopulmonary arrest should be the basis for any treatment of patients with an implanted

pacemaker.

Implanted pacemakers might cause the heart rate meter to count the pacemaker rate during

incidents of cardiac arrest or other arrhythmias. Dedicated pacemaker detection circuitry may

not detect all implanted pacemaker spikes. Check the patient's pulse; do not rely solely on heart

rate meters. Patient history and physical examination are important factors in determining the

presence of an implanted pacemaker. Pacemaker patients should be carefully observed.

Do not place electrodes directly over an implanted pacemaker.

The R Series unit detects ECG electrical signals only. It does not detect a pulse (effective

circulatory perfusion). Always verify pulse and heart rate by physical assessment of the patient.

Never assume that the display of a nonzero heart rate means that the patient has a pulse.

To avoid possible damage to the R Series unit, turn off pacing before defibrillating the patient

with a second defibrillator.

Do not use the unit’s ECG-out signal as a synchronization pulse for another defibrillator or

cardioverter.

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CHAPTER 1 GENERAL INFORMATION

Place the patient on a firm surface before performing CPR.

Battery

Do not operate the unit without a battery. Always have a source of available backup power for

all anticipated use environments. A fully charged spare battery or ready access to AC mains

power from a local wall outlet can provide this backup power.

Test battery packs regularly. A battery that does not pass the ZOLL charger’s capacity test

might cause the R Series unit to shut down unexpectedly.

When the warning LOW BATTERY appears, plug the R Series unit into a power source or install

a fully charged battery pack. When the warning REPLACE BATTERY appears, immediately

replace the battery pack with a fully charged pack or plug the R Series unit into a power source,

as unit shut down due to a low battery condition is imminent.

If mistreated, a battery pack might explode. Do not disassemble a battery pack or dispose of it

in fire.

Operator Safety

Do not use R series products in the presence of oxygen-rich atmospheres, flammable

anesthetics, or other flammable agents (such as gasoline). Using the unit in such environments

might cause an explosion.

Do not use the unit near or within standing water. Electrical safety might be compromised when

the defibrillator is wet.

Never discharge the unit with the defibrillation electrodes or paddles shorted together or in

open air.

Do not discharge the defibrillator except as indicated in the instructions. Discharge the

defibrillator only when defibrillation electrodes or paddles are properly applied to the patient.

To avoid risk of electrical shock, do not touch the gelled area of the hands-free therapy

electrodes during pacing or defibrillation.

To avoid risk of electrical shock, do not allow electrolyte gel to accumulate on hands or paddle

handles.

To avoid risk of electrical shock, do not allow patient connectors to contact other conductive

parts, including earth.

For defibrillation using paddles, use only high-conductivity electrolyte gel specified for such

use by the manufacturer.

When using paddles for defibrillation, use your thumbs to operate the SHOCK buttons. Doing

so avoids inadvertent shock to the operator and unintentional depression of an ENERGY

SELECT button, which causes the defibrillator to disarm. Keep your hands and fingers away

from the paddle plates.

The use of accessory equipment that does not comply with the equivalent safety requirements

of the R Series defibrillator could reduce the level of safety of the combined system. When

choosing accessory equipment, consider the following:

• Use of the accessory in the patient vicinity.

• Evidence that the safety certification of the accessory has been performed in accordance

with the appropriate IEC (EN) 60601-1 and/or IEC (EN) 60601-1-1 harmonized national

standards.

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Warnings

Always check that the equipment functions properly and is in proper condition before use.

Disconnect all electro-medical equipment that is not defibrillation-protected from the patient

prior to defibrillation.

Before discharging the defibrillator, warn everyone to STAND CLEAR of the patient.

Do not touch the bed, patient, or any equipment connected to the patient during defibrillation.

A severe shock can result. To avoid hazardous pathways for the defibrillation current, do not

allow exposed portions of the patient's body to touch any metal objects, such as a bed frame.

When the R Series is performing a Code Readiness test, as indicated on the display, do not

touch the connected paddles, electrodes, or OneStep cable connector.

Patient Safety

This equipment should be connected to only one patient at a time.

Use only OneStep Pediatric electrodes to defibrillate patients under 8 years of age in Advisory

modes. Use of adult electrodes, or pediatric electrodes other than OneStep Pediatric electrodes,

can result in the delivery of excessive energy doses.

Neonatal and pediatric defibrillation energy level settings should be based on site-specific

clinical protocols.

To ensure patient safety, connect the R Series only to equipment with galvanically isolated

circuits.

Use only high-quality ECG electrodes. ECG electrodes are for rhythm acquisition only; you

cannot use ECG electrodes for defibrillation or pacing.

Do not use therapy or ECG electrodes if the gel is dried, separated, torn or split from the foil;

patient burns may result from using such electrodes. Poor adherence and/or air pockets under

therapy electrodes can cause arcing and skin burns.

Check the expiration date on the electrode packaging. Do not use electrodes after their

expiration date.

Excessive body hair or wet, diaphoretic skin can inhibit electrode coupling to the skin. Clip

excess hair and dry any moisture from the area where an electrode is to be attached.

Therapy electrodes should be replaced periodically during continuous pacing. Consult

electrode directions for proper replacement instructions.

Prolonged pacing (more than 30 minutes), particularly in neonates or adults with severely

restricted blood flow, may cause burns. Periodically inspect the skin under the electrodes.

Carefully route the patient cables to reduce the possibility of patient entanglement or

strangulation.

To avoid electrosurgery burns at monitoring sites, ensure proper connection of the

electrosurgery return circuit so that a return path cannot be made through monitoring electrodes

or probes.

During electrosurgery, observe the following guidelines to minimize electrosurgery unit (ESU)

interference and provide maximum operator and patient safety:

•

9650-0912-01 Rev. V

Keep all patient monitoring cables away from earth ground, ESU knives, and ESU

return wires.

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CHAPTER 1 GENERAL INFORMATION

•

Use electrosurgical grounding pads with the largest practical contact area.

Always ensure proper application of the electrosurgical return electrode to the patient.

Check electrical leakage levels before use. Leakage current may be excessive if more than one

monitor or other piece of equipment is connected to the patient.

Do not use the ZOLL OneStep Pacing cable (REF 1009-0913-02) or the ZOLL Multi-Function

Cable (REF 1009-0913-03) in a 220/240 VAC 60Hz power environment. Patient leakage

current may be excessive.

Do not place the unit in contact with a patient. Burns may result.

Cautions

If the unit is to be stored longer than 90 days, remove the battery pack.

Do not sterilize the defibrillator, or its accessories unless the accessories are labelled as

sterilizable.

Do not immerse any part of the defibrillator in water.

Do not use ketones (such as acetone or MEK) on the defibrillator.

Avoid using abrasives (including paper towels) on the display window.

To protect the unit from damage during defibrillation, for accurate ECG information, and to

protect against noise and other interference, use only internal current-limiting ECG cables

specified or supplied by ZOLL.

For continued safety and EMI performance, use only the line cord supplied by ZOLL.

Dispose of battery packs in accordance with national, regional and local regulations. Battery

packs should be shipped to a reclamation facility for recovery of metal and plastic compounds

as the proper method of waste management.

Restarting the Defibrillator

Certain events require the R Series products to be restarted after they shut off or become

inoperative (for example, when the battery runs down and the unit shuts off).

In such a case, always try to restore defibrillator operation as follows:

1. Turn the Mode Selector to OFF.

2. If necessary, replace a depleted battery with a fully charged pack, or connect the defibrillator

to AC mains.

3. Turn the Mode Selector to the desired operating mode to restart the unit.

This sequence is necessary to restart the defibrillator and can also be used to clear some fault

messages when immediate use of the defibrillator is required.

If restarted after a shutdown period of 10 seconds or more, the unit restores all settings (such as

ECG lead, ECG size, and alarm state and limits) to their power-up default values. After

restoring device operation, you might need to reinstate previously selected, non-default

settings.

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FDA Tracking Requirements

FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners

of this defibrillator must notify ZOLL Medical Corporation if this product is

• received

• lost, stolen, or destroyed

• donated, resold, or otherwise distributed to a different organization

If any such event occurs, contact ZOLL Medical Corporation in writing with the following

information:

1. Originator's organization – Company name, address, contact name, and contact phone

number

2. Model number, and serial number of the defibrillator

3. Disposition of the defibrillator (for example, received, lost, stolen, destroyed, distributed to

another organization), new location and/or organization (if known and different from

originator’s organization) – company name, address, contact name, and contact phone

number

4. Date when the change took effect

Please address the information to:

ZOLL Medical Corporation

Attn: Tracking Coordinator

269 Mill Road

Chelmsford, MA 01824-4105

Fax:

(978) 421-0025

Telephone: (978) 421-9655

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act

(SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence

of certain events.

These events, described in 21 CFR Part 803, include device-related death and serious injury or

illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation

requests to be notified of device failures or malfunctions. This information is required to ensure

that ZOLL Medical Corporation provides only the highest quality products.

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CHAPTER 1 GENERAL INFORMATION

Software License

Note:

Read this Operator’s Guide and License agreement carefully before operating any of

the R Series products.

Software incorporated into the system is protected by copyright laws and international

copyright treaties as well as other intellectual property laws and treaties. This software is

licensed, not sold. By taking delivery of and using this system, the Purchaser signifies

agreement to and acceptance of the following terms and conditions:

1. Grant of License: In consideration of payment of the software license fee which is part of

the price paid for this product ZOLL Medical Corporation grants the Purchaser a

non-exclusive license, without right to sublicense, to use the system software in object-code

form only.

2. Ownership of Software/Firmware: Title to, ownership of and all rights and interests in the

system software and all copies thereof remain at all times vested in the manufacturer, and

Licensors to ZOLL Medical Corporation and they do not pass to purchaser.

3. Assignment: Purchaser agrees not to assign, sublicense or otherwise transfer or share its

rights under the license without the express written permission of ZOLL Medical

Corporation.

4. Use Restrictions: As the Purchaser, you may physically transfer the products from one

location to another provided that the software/firmware is not copied. You may not disclose,

publish, translate, release or distribute copies of the software/firmware to others. You may

not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble or

create derivative works based on the software/firmware.

NO IMPLIED LICENSE

Possession or purchase of this device does not convey any express or implied license to use the

device with replacement parts which would, alone, or in combination with this device, fall

within the scope of one or more of the patents relating to this device.

Service

The R Series does not require periodic recalibration or adjustment. Appropriately trained and

qualified personnel should, however, perform periodic tests of the defibrillator to verify proper

operation.

If a unit requires service, contact the ZOLL Technical Service Department.

For customers In the U.S.A.

For customers outside the U.S.A.

Telephone:

1-800-348-9011

1-978-421-9655

Call the nearest authorized ZOLL Medical Corporation

representative.

Fax:

1-978-421-0010

To locate an authorized service center, contact the

International Sales Department at

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Telephone: 1-978-421-9655

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Service

When requesting service, please provide the following information to the service

representative:

• Unit serial number

• Description of the problem

• Department using the equipment and name of the person to contact

• Purchase order to allow tracking of loan equipment

• Purchase order for a unit with an expired warranty

• Sample ECG or other stripcharts demonstrating the problem (if available and applicable),

less any confidential patient information.

Returning a unit for service

Before sending a unit to the ZOLL Technical Service Department for repair, obtain a service

request (SR) number from the service representative.

Remove the battery pack from the unit. Pack the unit with its cables and battery in the original

containers (if available) or equivalent packaging. Be sure the assigned service request number

appears on each package.

For customers

Return the unit to

In the U.S.A.

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Attention: Technical Service Department (SR number)

Telephone: 1-800-348-9011

In Canada

ZOLL Medical Canada Inc.

1750 Sismet Road, Unit #1

Mississauga, ON L4W 1R6

Attention: Technical Service Department (SR number)

Telephone: 1-866-442-1011

In other locations

The nearest authorized ZOLL Medical Corporation representative.

To locate an authorized service center, contact the International Sales

Department at

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA 01824-4105

Telephone: 1-978-421-9655

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CHAPTER 1 GENERAL INFORMATION

The ZOLL Serial Number

Each ZOLL product displays a serial number that contains information about that product.

From left to right, ZOLL serial numbers are structured as follows:

• A two-character product code

• A three-character date-of-manufacture code

• A product serial number of six or more alphanumeric characters

The product code for the R Series defibrillator is AF.

The first two characters of the date-of-manufacture code give the last two digits of the year (for

example, “06” appears for products manufactured in 2006). The last character of the

date-of-manufacture code gives the month in which the product was manufactured. The month

appears in the form of a single alphanumeric character: “A” for January, “B” for February, “C”

for March, and so on through “L” for December.

The product serial number is a unique set of alphanumeric characters that ZOLL assigns to each

individual unit.

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Chapter 2

Product Overview

Defibrillator Controls and Indicators

1

SHOCK

LEAD

ANALYZE

CHARGE

SIZE

ALARM

SUSPEND

ENERGY

SELECT

RECORDER

MONITOR

DEFIB

OFF

PACER

OUTPUT

mA

4:1

RATE

ppm

2

3

3

4

9

Front

Left

Right

7

56

8

15

11

10

?

Top

Rear

SpO2

13 14

12

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CHAPTER 2 PRODUCT OVERVIEW

Table 2-1.

2–2

R Series Unit Features

Item

Description

1

Front panel

Includes the display screen and primary controls.

2

Handle

Integrated carrying handle.

3

External paddle well

Holds paddles when not in use. Allows defib self-test when

paddles are stowed in their respective wells.

4

Beeper

Emits R-wave detection beeps, defib charge Ready tones, and

alarm tones.

5

USB host connector

(Optional)

(Reserved for future use — do not connect to any equipment.)

6

USB device connector

For connecting the R Series defibrillator to a USB device. For

details, refer to “Event Records and Reports” on page 10-1.

7

Data card slot

Holds a compact flash card for copying data stored in the

device’s internal memory. Accepts a CF memory card or a

WiFi card.

8

Defibrillator test port

When not using OneStep electrodes or paddles, connect the

patient end of a OneStep cable to this port to allow device

checks.

9

Speaker

Issues voice prompts.

10

Paper Compartment

Holds the paper for the stripchart printer.

11

RELEASE button

Allows access to the paper compartment.

12

Battery compartment

Holds a rechargeable lithium ion battery pack.

13

Grounding post

Earth-grounded terminal provided for the convenient

connection of biomedical test equipment requiring an

equipotential ground. This terminal has no clinical function and

should not be used for electrical safety purposes.

14

AC mains connector

For connecting the device to an AC power source.

15

Patient connectors

For details, refer to “Patient Cables and Connectors” on

page 2-7.

www.zoll.com

9650-0912-01 Rev. V

Page 35

Defibrillator Controls and Indicators

The Front Panel

The front panel of the R Series device includes the display screen, softkeys, battery indicator,

AC power indicator, Code Readiness indicator, SHOCK button, and control panel. The control

panel configuration varies slightly depending on the model. See Figure 2-1.

Battery

indicator

Display screen

AC power

indicator

Code

Readiness

indicator

3

SHOCK

2

LEAD

ANALYZE

CHARGE

SIZE

ALARM

SUSPEND

1

RECORDER

ENERGY

SELECT

MONITOR

DEFIB

OFF

Mode Selector

PACER

OUTPUT

mA

NIBP Button

(optional)

Figure 2-1.

4:1

RATE

ppm

Six softkeys

R Series Front Panel

Table 2-2 describes the controls and indicators that appear on the front panel.

Table 2-2.

R Series Controls and Indicators

Control or Indicator

Description

Display screen

Shows therapeutic settings, physiological waveforms, and other

information for each monitored parameter, messages, time, and softkey

labels.

Battery indicator

Indicates battery status:

Steady yellow:

Steady green:

Alternating yellow and green:

Battery is charging.

Battery is charged.

No battery is installed, or there is a

battery charging fault.

Indicator for AC power

Illuminated when the unit is plugged into an alternating current (AC)

power source.

Code Readiness

indicator

Shows the status of the unit, based on its most recent Readiness check:

9650-0912-01 Rev. V

• A green ““ indicates the unit is ready for therapeutic use.

• A red “X” indicates the unit’s Readiness is compromised an that it

may not be ready for therapeutic use.

ZOLL R Series Operator’s Guide

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CHAPTER 2 PRODUCT OVERVIEW

Table 2-2.

R Series Controls and Indicators (continued)

Control or Indicator

Description

Mode Selector

Selects the mode of operation (available options depend on model):

•

•

•

•

OFF — Unit is powered off.

MONITOR — Physiological monitoring (ECG and other options)

DEFIB — Manual or advisory defibrillation

PACER — Noninvasive external pacing

ENERGY SELECT

Buttons

Two sets of up-down arrow buttons control the selection of defibrillator

energy, one set located on the front panel and the other located on the

sternum paddle.

CHARGE Button

Charges the defibrillator to the selected energy. In addition to the

CHARGE button on the front panel, there is one located on the apex

paddle handle.

SHOCK Button

The front panel SHOCK button is only active when using OneStep

electrodes, hands-free therapy electrodes (see “R Series Accessories”

on page B-1 for a list), external autoclavable paddles, or internal

defibrillation paddles without a discharge button. The SHOCK button

illuminates when the device is charged and ready.

To discharge the defibrillator when using paddles (internal or external)

with discharge buttons, press and hold the SHOCK buttons on the

paddles.

2–4

ANALYZE Button

Initiates ECG analysis to determine whether or not a shockable rhythm

is present.

LEAD Button

Selects the ECG source for display and printing. Pressing this button

sequentially selects ECG signals derived from each of the following lead

configurations: I, II, III, aVR, aVL, aVF, PADDLES, or PADS, P1, P2, and

P3 (when using OneStep Pacing electrodes, or OneStep Complete

electrodes with OneStep Pacing cable) for display. The PADS or

PADDLES lead setting is automatically selected when the defibrillator

powers up in DEFIB or MONITOR mode with either hands-free therapy

electrodes or paddles attached to the OneStep cable. Lead II or P3

(OneStep Pacing) is automatically selected when the R Series is

powered up in PACER mode. Pads or Paddles monitoring is not

available in PACER mode.

SIZE Button

Selects the relative amplitude scale factor for the displayed ECG

waveform. Available scale factors are x0.5, x1, x1.5, x2 and x3

ALARM SUSPEND

Button

Activates, deactivates or audibly suspends all alarm functions. A bell

symbol () appears on the display when alarms are enabled. When

alarms are either audibly or permanently disabled, an “X” appears

across the bell (  ) symbol.

RECORDER Button

Starts or stops the stripchart recorder. You can switch the unit to

diagnostic ECG bandwidth (0.05 - 150Hz) by pressing and holding the

RECORDER button. Diagnostic bandwidth is maintained as long as the

RECORDER button is held down. When the RECORDER button is

released, the unit reverts to standard monitoring bandwidth.

PACER OUTPUT mA

(optional)

When pacing is selected, this control sets the amount of current

delivered. The selected current setting is indicated on the display.

PACER RATE ppm

(optional)

When pacing is selected, this control sets the rate (pulses per minute) at

which the pacemaker will operate. The selected pace rate setting is

indicated on the display.

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9650-0912-01 Rev. V

Page 37

Defibrillator Controls and Indicators

Table 2-2.

R Series Controls and Indicators (continued)

Control or Indicator

Description

4:1 Button

(optional)

This button is used to determine a patient’s underlying ECG rhythm.

While depressed, this button causes pacing stimuli to be delivered at ¼

of the indicated ppm setting. When the button is released, normal

pacing resumes.

NIBP Button

(optional)

Allows you to start single, auto, or STAT non-invasive blood pressure

measurements as described in the option insert Non-Invasive Blood

Pressure (part number 9650-0914-01). Your unit has this button only if

you ordered this configuration.

Softkeys

Six unlabeled buttons located directly below the display control different

functions depending on the operating mode of the unit.

Labels for the softkeys appear at the bottom of the display directly

above each softkey to indicate its function.

Charge Indicator Light

(not shown)

Located on the apex paddle, this light turns on when the defibrillator is

charged and ready.

Display Screen

The front panel includes a color display which shows:

• The elapsed time (since the unit was turned on).

• The ECG trace, selected lead, size, heartbeat indicator, and alarm status.

• The selected energy, charging status, and delivered energy for defibrillation and

synchronized cardioversion.

• The output current and stimulus rate for pacing.

• The measured SpO2 percent saturation, signal strength, plethsymographic trace (if

•

•

•

•

•

•

applicable), and alarm status indicators for optional SpO2 monitoring.

Non-invasive blood pressure (NIBP) readings: diastolic, systolic, and mean, plus alarm

status indicators (optional; refer to the insert Non-Invasive Blood Pressure (NIBP), part

number 9650-0914-01).

The patient’s carbon dioxide level, respiration rate and capnogram (if applicable), and alarm

status indicators for CO2 monitoring (optional; refer to the insert End Tidal Carbon Dioxide

(EtCO2), part number 9650-0915-01).

Messages and prompts.

Labels above the softkeys (appropriate to the context).

Perfusion Performance Indicator™ and Release Bar.

CPR Rate and Depth.

Figure 2-2 shows the layout of parameter values, waveforms, system data, and softkey labels.

9650-0912-01 Rev. V

ZOLL R Series Operator’s Guide

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Page 38

CHAPTER 2 PRODUCT OVERVIEW

ECG

Rate and Depth Indicators

CPR

Idle

Time

SpO2 values and

alarm indicator

(optional)

SpO2%

NIBP values and

alarm indicator

(optional)

NIBP

120

80

Elapsed time

Softkey labels

CPR ECG

I

x1

IDLE

0:00

Depth

Rate

99

Ɔ

PPI

72

mmHg

CO2

RR

35

13

11:24

Options

Heart rate

(beats per minute)

Messages

Trace 1

I

100

CO2 values and

alarm indicator

(optional)

• size

• selected lead

Perfusion

Performance Indicator • alarm indicator

• heartbeat indicator

mmHg

Trace 2

II

Trace 3

III

Mode/Messages

CPR 1:51

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

Figure 2-2. R Series Display Screen (shown with optional SpO2, NIBP and CO2

monitoring)

Color coding

To differentiate information for various parameters, the unit displays each type of information

in a specific user-configurable color.

Messages

During operation, a fault or error message is displayed when a fault is detected. If this occurs,

turn the unit off and then on and recheck operation. If the fault persists, contact your authorized

ZOLL agent as described on page 1-21.

2–6

www.zoll.com

9650-0912-01 Rev. V

Page 39

Defibrillator Controls and Indicators

Patient Cables and Connectors

The back of the unit includes a set of connectors for patient cables.

Sync In/

Marker Out/

ECG Out

Figure 2-3.

NIBP

(optional)

EtCO2

(optional)

ECG

SpO2

(optional)

OneStep

Cable

Patient Cable Connectors

Connector

Description

OneStep Cable

For connecting paddles or ZOLL hands-free therapy and pacing

electrodes using either OneStep or OneStep Pacing cables.

ECG

For connecting 3- or 5-lead ECG cable or OneStep Pacing cable’s

ECG cable.

Sync In / Marker Out / ECG

x1000

Connector for

NIBP

(Optional) For connecting blood pressure cuff cable.

EtCO2

(Optional) For connecting CO2 monitor cable.

SpO2

(Optional) For connecting pulse oximeter cable.

• An incoming defibrillator synchronization signal from an

external patient monitor.

• Output of R wave marker to an external patient monitor.

• ECG signal output for use with other equipment such as patient

monitors and radio telemetry equipment (1 V/cm of displayed

ECG signal).

OneStep Cables

The R Series ships with either a OneStep, or OneStep Pacing cable.

The OneStep Pacing cable has an additional connector that plugs into the rear panel ECG

connector. This cable is used with OneStep Pacing electrodes or OneStep Complete electrodes

for external pacing and ECG monitoring. Alternatively, you can disconnect the OneStep Pacing

cable from the ECG connector and use a 3- or 5-lead ECG cable.

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Page 40

CHAPTER 2 PRODUCT OVERVIEW

ECG Connector

OneStep Pacing Cable

OneStep Cable

Figure 2-4.

OneStep Cables

OneStep Cable Manager (Optional)

As an option, the OneStep Cable Manager is available to store and organize cables.

OneStep Cable

Manager

Cable Caddy

Figure 2-5.

2–8

The R Series with the Optional OneStep Cable Manager (Side View)

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9650-0912-01 Rev. V

Page 41

Defibrillator Controls and Indicators

Power Cord

The AC power cord is used to operate the R Series unit when battery power is not being used.

An additional extension cord is available for use when the cable organizer accessory is attached

to the unit. The extension cord plugs into the main AC power cord as shown below.

External Paddles

Paddles are defibrillation-proof Type BF equipment.

The external paddles on the R Series device are used for defibrillation and synchronized

cardioversion.

Caution

You cannot use paddles for ECG analysis or pacing.

Defibrillation paddles can be used for ECG monitoring when it is not practical to apply ECG

electrodes. Press the LEAD button to select PADDLES as the ECG source.

The paddles are stowed in wells on either side of the unit. To release the paddles, grasp the

handles and then press down on the latch button above each paddle.

9650-0912-01 Rev. V

RELEASE

RELEASE

RE

RELE

LEAS

ASEE

Figure 2-6.

Releasing the Paddles

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Page 42

CHAPTER 2 PRODUCT OVERVIEW

Attach the OneStep cable from the R Series unit to the connector at the base of the apex paddle.

1. Align OneStep cable as shown.

Figure 2-7.

2. Insert OneStep cable into APEX paddle.

Attaching the OneStep Cable to the APEX Paddle

OneStep cable connected

to APEX paddle

Figure 2-8.

OneStep Cable Connected to APEX Paddle

If you need to detach the OneStep cable from the APEX paddles, push the RELEASE button

(see Figure 2-9) in the direction of the arrow and unplug the OneStep cable.

Refer to Chapter 3, "Manual Defibrillation" before using paddles for defibrillation. The paddles

include controls for selecting defibrillation energy, charging, delivering a shock, and turning

the stripchart recorder on and off.

RECORDER

Button

ENERGY

SELECT

Buttons

SHOCK

Buttons

CHARGE

Button

Charge Ready

Indicator

Connector

and RELEASE

button for

OneStep cable

Sternum Paddle

Figure 2-9.

2–10

Apex Paddle

External Paddles

www.zoll.com

9650-0912-01 Rev. V

Page 43

Working with Menus

Pediatric-size electrodes are built into the paddle assembly beneath the standard electrode

plates. The user must manually adjust energy settings to pediatric levels consistent with their

institution’s protocols.

PEDI button

To expose the pediatric plate, press the PEDI button at

the top of the paddle, then slide the Adult plate upward.

Before replacing the Adult plate, be sure to clean the

pediatric plate and surrounding area thoroughly.

Slide the Adult plate onto the paddle until it locks into

place.

Figure 2-10.

Note:

Pediatric Plate

The R Series defibrillator also supports ZOLL autoclavable internal handles for use

during open chest defibrillation procedures.

Working with Menus

For some functions, the screen shows a menu of options with related softkeys for navigating

through the menus and making selections and entries.

Depth

Rate

99

NIBP mmHg

------CO2

RR

mmHg

----Next

Param

Figure 2-11.

CPR

IDLE

0:00

SpO2%

ECG

x1

PADS

Ɔ

PPI

72

ALARM SET

Parameter

ECG HR

SpO2

EtCO2

RESP RATE

ENABLE

DISABLE

ENABLE

ENABLE

NIBP SYS

NIBP DIA

NIBP MEAN

ENABLE

ENABLE

ENABLE

Prev

Param

State

Next

Field

Low

30

85

25

5

90

50

60

Change

Value

High

150

100

55

120

160

110

130

Return

Example Display Screen

On the display, highlighting indicates the currently selected item, that is, the item or value you

are working with.

9650-0912-01 Rev. V

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Page 44

CHAPTER 2 PRODUCT OVERVIEW

The following table summarizes some of the more common softkeys.

Softkey

Action

Next Item

Next Field

Moves the highlighting down to the next item in a vertical list.

Prev Item

Moves the highlighting up to the previous item in a vertical list.

Next Digit

Moves the highlighting to the right in a series of letters or digits.

Prev Digit

Moves the highlighting to the left in a series of letters or digits.

Inc

Inc Digit

Increases the highlighted value or digit.

(For example, changes 2 to 3 or B to C).

Dec

Dec Digit

Decreases the highlighted value or digit.

(For example, changes 2 to 1 or B to A).

Newer

Moves the highlighting to the adjacent item with the more recent date or time.

Older

Moves the highlighting to the adjacent item with the older date or time.

Enter

Accepts the settings with the values currently shown.

Return

Displays the previous menu.

Next Param

Moves the highlighting to the next parameter.

Prev Param

Moves the highlighting to the previous parameter.

Change Value

Changes the value of the selected parameter.

Defib Mentor Mode (Optional)

Defib Mentor™ mode is a nonclinical tutorial mode available when the Mode Selector is

turned to MONITOR. When in this mode, the device displays a brief description of each front

panel control’s function when that control is activated.

Note:

Do not run the Defib Mentor mode with a patient connected to the R Series unit.

To access Defib Mentor mode:

1. Turn the Mode Selector to MONITOR.

2. Press the Options softkey.

3. Press MORE.

Additional options appear.

4. Press Mentor.

5. Press Confirm Mentor Mode.

The unit is now in Defib Mentor Mode, a non-clinical operating mode.

6. Activate a front panel control (except the Mode Selector or the Exit Mentor softkey).

A brief description of that control’s function appears on the screen.

To exit Mentor mode, press the Exit Mentor softkey or turn the Mode Selector to OFF,

DEFIB, or PACER.

Note:

2–12

After 60 seconds of non use in the Mentor mode, the R Series returns to MONITOR

mode.

www.zoll.com

9650-0912-01 Rev. V

Page 45

Common Tasks

Common Tasks

Follow the instructions in the subsequent sections for:

• “Replacing a Battery Pack” on page 2-13.

• “Adjusting Display Brightness” on page 2-13.

• “Using Code Markers” on page 2-14.

Replacing a Battery Pack

3P/

3P/

To remove a battery pack, press the tab on the end of the battery pack inward, and lift the

battery pack out of the compartment.

?

?

Figure 2-12.

Removing a Battery Pack

To install a battery pack:

3P/

3P/

1. Place the end of the battery pack opposite the tab into the end of the compartment closest to

the front of the unit.

2. Lower the tabbed end of the battery pack into the compartment and press down on the tabbed

end until it locks into place.

?

?

Figure 2-13.

Installing a Battery Pack

Adjusting Display Brightness

To adjust brightness:

1. Press the Options softkey.

9650-0912-01 Rev. V

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Page 46

CHAPTER 2 PRODUCT OVERVIEW

2. Press the High Bright or Low Bright softkey to select high and low brightness.

Note:

Brightness level affects battery run time. Selecting high bright will cause the battery

charge to be depleted at a faster rate than when selecting low bright.

Using Code Markers

Pressing the CODE MARKER softkey causes the unit to display a preconfigured list of

clinical actions. Pressing the softkey associated with a particular action causes that action, and

6 seconds of ECG, to be recorded along with a date and time stamp in the Summary Report

memory. You can supplement an event summary by manually adding code markers which

itemize drugs or treatments administered to the patient.

Up to six Code Markers can be displayed on the screen at one time.

CPR

Figure 2-14.

Intubate

EPI

LIDO

Narcan

MORE

Code Markers

The right-most softkey is labeled MORE when there are more than six items on the code

marker list. Press the MORE softkey to see the next set of Code Markers displayed above the

softkeys.

Separate code marker lists are maintained for DEFIB, MONITOR, and PACER modes, thereby

enabling the display of appropriate code markers for each particular protocol. (For information

on configuring these code marker lists, refer to the R Series Configuration Guide.)

The code markers are removed from the display after 10 seconds. If no Code Marker softkey

has been pressed during that time, a “default” event mark is stored in Summary Report

memory.

2–14

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9650-0912-01 Rev. V

Page 47

Chapter 3

Manual Defibrillation

Paddles are a defibrillation-protected Type BF patient connection.

ECG leads are a defibrillation-protected Type CF patient connection.

Emergency Defibrillation Procedure with Paddles

WARNING!

To avoid risk of electrical shock, do not allow electrolyte gel to accumulate on hands or

paddle handles.

When defibrillating with paddles, use your thumbs to operate the SHOCK buttons in

order to avoid inadvertent operator shock. No portion of the hands should be near the

paddle plates.

Determine the Patient’s Condition Following Local Medical Protocols

Verify:

• Unconsciousness.

• Absence of breathing.

• Absence of pulse.

9650-0912-01 Rev. V

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Page 48

CHAPTER 3 MANUAL DEFIBRILLATION

Begin CPR Following Local Medical Protocols.

Request additional assistance.

1 Select DEFIB

Turn the Mode Selector to DEFIB. The unit automatically defaults to 120 joules or the

preconfigured first shock energy selection.

1

RECORDER

MONITOR

DEFIB

OFF

PACER

Note:

Defibrillator PADDLES are selected as the ECG source when the instrument is turned

to MONITOR or DEFIB with paddles connected to the OneStep cable.

Energy Select

Look at the Display and verify the energy is appropriate. Unless internal handles are connected

to the OneStep cable, the default energy selections for adult patients are:

• Shock 1 - 120 joules

• Shock 2 - 150 joules

• Shock 3 - 200 joules

If medical protocol allows, you may select a different energy level using the up and down arrow

buttons. One pair is located on the front panel of the unit; the other pair is located on the

sternum paddle.

3

SHOCK

2

ANALYZE

CHARGE

or

or

1

Note:

3–2

ENERGY

SELECT

Neonatal and pediatric defibrillator energy levels should be selected based on sitespecific protocols.

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9650-0912-01 Rev. V

Page 49

Emergency Defibrillation Procedure with Paddles

The selected energy level is shown as DEFIB XXXJ SEL. on the display.

ECG

DEFIB 120J SEL.

00:01

Options

Code

Marker

Param

Report

Data

Alarms

Sync

On/Off

If you have configured Shocks 1, 2, and 3 to escalating energy levels (see the R Series

Configuration Guide for instructions), the R Series automatically sets the energy to the

preconfigured Energy Level: Shock 1, 2, 3 setting at power-up and after each of the first two

shocks. The ENERGY INCREMENTED message will be displayed after Shocks 1 and 2 are

delivered. Manually changing the energy level outside the preprogrammed sequence and

delivering a shock disables the automatic escalation function.

Prepare Paddles

Release the paddles, apply a liberal amount of electrolyte gel to the electrode surface of each

paddle, and rub the electrode surfaces together to evenly distribute the applied gel. (You can

substitute electrode gel patches for the gel.)

Apply Paddles to Chest

Apply the paddles firmly to the anterior wall of the chest. Place the sternum paddle to the right

of the patient’s sternum (patient’s right), just below the clavicle.

Place the apex paddle on the chest wall, just below and to the left of the patient’s left nipple,

along the anterior-axillary line.

Sternum

Apex

Rub the paddles against the skin to maximize the paddle-to-patient contact.

9650-0912-01 Rev. V

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Page 50

CHAPTER 3 MANUAL DEFIBRILLATION

WARNING!

Do not permit gel to accumulate between the paddle electrodes on the chest wall (gel

bridge). This could cause burns and reduce the amount of energy delivered to the heart.

If using defibrillator gel pads, make sure that the size of the pad is large enough to cover

the entire paddle electrode area.

The paddles may be used for ECG monitoring in emergency situations when time does not

allow connection of standard ECG monitoring electrodes.

If an ECG cable and ECG electrodes are in use, press the LEAD button to select the desired

ECG lead.

2 Charge Defibrillator

Press the CHARGE button on the apex handle or on the front panel.

3

SHOCK

2

ANALYZE

CHARGE

1

RE

RELE

LEAS

ASEE

or

ENERGY

SELECT

If both SHOCK buttons on the paddles are depressed when the CHARGE button is activated,

the unit does not charge and a RELEASE SHOCK BUTTON message appears on the display.

To increase or decrease the selected energy after you have pressed the CHARGE button, use

the defibrillator ENERGY SELECT buttons on either the sternum paddle or the defibrillator

front panel.

Caution

Changing the selected energy while the unit is charging or charged causes the defibrillator to

disarm itself. Press the CHARGE button again to charge the unit to the newly selected energy

level.

After charging to the selected energy, the charge indicator on the apex paddle lights. A

distinctive charge ready tone sounds, and the message DEFIB XXXJ READY is displayed. The

defibrillator is now ready to discharge.

3–4

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9650-0912-01 Rev. V

Page 51

Autoclavable External Paddles

3 Deliver Shock

WARNING!

Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator

discharge.

Do not touch the bed, patient, or any equipment connected to the patient during

defibrillation. A severe shock can result. Do not allow exposed portions of the patient’s

body to come into contact with metal objects, such as a bed frame, as unwanted

pathways for defibrillation current may result.

Apply a force of 10 - 12 kilograms (22 - 26.4 pounds) to each paddle in order to minimize

patient impedance and achieve optimal results.

Using your thumbs, simultaneously press and hold both SHOCK buttons (one on each paddle)

until energy is delivered to the patient.

Caution

Use only thumbs to depress the SHOCK buttons. Failure to do so could result in the inadvertent

depression of the ENERGY SELECT buttons, causing the defibrillator to disarm itself.

Once the energy is delivered, the display simultaneously shows XXXJ DELIVERED and DEFIB

XXXJ SEL. After approximately 5 seconds, the XXXJ DELIVERED message disappears, and

the DEFIB XXXJ SEL. message remains to indicate the selected energy level.

Note:

If the defibrillator is not discharged within 60 seconds after reaching the selected

energy level, the unit automatically disarms itself.

During the 10 seconds prior to disarming, the charge ready tone beeps intermittently. The

charge ready tone then stops, the charge indicator light goes off, and the monitor message

changes to DEFIB XXXJ SEL. Press the CHARGE button to recharge the unit.

Autoclavable External Paddles

ZOLL Autoclavable External Paddles are available for use with manually operated ZOLL

defibrillators when sterile conditions must be maintained during defibrillation.

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Page 52

CHAPTER 3 MANUAL DEFIBRILLATION

Emergency Defibrillation Procedure with Hands-Free

Therapy Electrodes

ZOLL hands-free therapy electrodes are a defibrillation-protected Type BF patient

connection.

ECG leads are a defibrillation-protected Type CF patient connection.

Determine the Patient’s Condition Following Local Medical Protocols

Verify:

• Unconsciousness.

• Absence of breathing.

• Absence of pulse.

Begin CPR Following Medical Protocols

Request additional assistance.

Prepare Patient

Remove all clothing covering the patient’s chest. Dry chest if necessary. If the patient has

excessive chest hair, clip or shave it to ensure proper adhesion of the electrodes.

Attach hands-free therapy electrodes according to instructions on the electrode packaging.

Ensure that the therapy electrodes are making good contact with the patient’s skin and are not

covering any part of the ECG electrodes.

Connect the hands-free therapy electrodes to the OneStep cable if not preconnected.

When connecting a OneStep electrode to the OneStep cable, push the two connectors together

until the latch clicks, as shown.

Latch

3–6

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Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes

When disconnecting the OneStep electrode and OneStep cable, press down the latch with your

thumb as shown.

Latch

If defibrillation electrodes are not making good contact with the patient’s skin, the unit issues

the messages CHECK PADS and POOR PAD CONTACT and does not allow delivery of energy.

If a short circuit exists between the electrodes, the unit issues the message DEFIB PAD SHORT.

Therapy Electrode Application

WARNING!

Poor adherence and/or air under the therapy electrodes can lead to the possibility of

arcing and skin burns.

1. Apply one edge of the pad securely to the patient.

2. Roll the pad smoothly from the applied edge to the other, being careful not to trap any air

pockets between the gel and skin.

Pad

Note:

WARNING!

Skin

If it is not possible to place the “BACK” electrode on the patient’s back, place the

electrodes in the standard apex-sternum positions. Effective defibrillation results, but

pacing will usually be less effective.

Application of adult electrodes to a pediatric patient will result in the automatic

selection of adult energy levels. If needed, manually adjust the energy settings based on

site-specific protocols.

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CHAPTER 3 MANUAL DEFIBRILLATION

1 Select DEFIB

Turn the Mode Selector to DEFIB. The unit automatically defaults to 120 joules or the

preconfigured first shock energy selection.

1

RECORDER

MONITOR

DEFIB

OFF

PACER

PADS are selected as the ECG source when the instrument is turned to MONITOR or DEFIB

and paddles are not connected to the OneStep cable. You may select any of the other ECG leads

by pressing the front panel LEAD button.

Energy Select

Look at the display, and verify the selected energy is appropriate. The default energy selections

for adult patients are:

• Shock 1 - 120 joules

• Shock 2 - 150 joules

• Shock 3 - 200 joules

When used with OneStep Pediatric electrodes, the default energy selections are:

• Shock 1 - 50 joules

• Shock 2 - 70 joules

• Shock 3 - 85 joules

WARNING!

When used with other pediatric defibrillation electrodes, defibrillator energies must be

set manually based on site-specific institutional protocols for pediatric defibrillation.

After the third shock, all subsequent shocks are delivered at the same energy as the third shock

in both Adult and Pediatric modes.

If medical protocol allows, you may select a different energy level using the ENERGY

SELECT buttons on the front panel.

3

SHOCK

2

ANALYZE

1

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CHARGE

ENERGY

SELECT

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Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes

The selected energy level is shown as DEFIB XXXJ SEL. on the display.

ECG

DEFIB 120J SEL.

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

If you have configured Shocks 1, 2, and 3 to escalating energy levels (see the R Series

Configuration Guide for instructions), the R Series automatically sets the energy to the

preconfigured Energy Level: Shock 1, 2, 3 setting at power-up and after each of the first two

shocks. The ENERGY INCREMENTED message will be displayed after Shocks 1 and 2 are

delivered. Manually changing the energy level outside the preprogrammed sequence and

delivering a shock disables this function.

2 Charge Defibrillator

Press the CHARGE button on the front panel.

3

SHOCK

2

ANALYZE

1

CHARGE

ENERGY

SELECT

To increase or decrease the selected energy after you have pressed the CHARGE button, use

the defibrillator ENERGY SELECT buttons.

Caution

Changing the selected energy while the unit is charging or charged causes the defibrillator to

disarm itself. Press the CHARGE button again to charge the unit.

After charging to the selected energy, the SHOCK button on the front panel lights. A

distinctive charge ready tone sounds and the DEFIB XXXJ READY is displayed. The

defibrillator is now ready to discharge.

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3 Deliver Shock

WARNING!

Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator

discharge.

Do not touch the bed, patient, or any equipment connected to the patient during

defibrillation. A severe shock can result. Do not allow exposed portions of the patient’s

body to come into contact with metal objects, such as a bed frame, as unwanted

pathways for defibrillation current may result.

Press and hold the SHOCK button until energy is delivered to the patient.

3

SHOCK

2

ANALYZE

1

Note:

CHARGE

ENERGY

SELECT

If the defibrillator is not discharged within 60 seconds after reaching the selected

energy level, the unit automatically disarms itself.

During the 10 seconds prior to disarming, the charge ready tone beeps intermittently. The

charge ready tone then stops, the SHOCK button light goes off, and the monitor message

changes to DEFIB XXXJ SEL. Press the CHARGE button to recharge the unit.

Once the energy is delivered, the display simultaneously shows XXXJ DELIVERED and DEFIB

XXXJ SEL. After approximately 5 seconds, the XXXJ DELIVERED message disappears and the

DEFIB XXXJ SEL. message remains to indicate the selected energy level.

Autoclavable Electrodes

ZOLL Autoclavable Internal Handles are designed for use with a manually operated ZOLL

defibrillator to defibrillate the heart during open chest procedures. Two types of Autoclavable

Internal Handles are available:

• Molded Autoclavable Internal handles with integrated electrode spoons

• Autoclavable Internal Handles with removable internal defibrillation electrodes

When these internal handles are used, the R Series defibrillator can operate only in Manual

mode even if the unit supports Advisory mode. When an internal handle set is connected to the

R Series, it automatically limits energy output to a maximum of 50 joules.

For step-by-step procedures for open chest defibrillation as well as important cleaning and

sterilization information, refer to the Autoclavable Internal Handle and Electrode Operator’s

Guide.

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Chapter 4

Advisory Defibrillation

ZOLL hands-free therapy electrodes are a defibrillation-protected Type BF patient

connection.

When the Mode Selector is turned to DEFIB and hands-free therapy electrodes are used, the

R Series can identify shockable rhythms using its built in ECG analysis capability. You must

read the advisory messages, charge the defibrillator to the preconfigured or user-selected

energy level (if automatic charge is disabled), and deliver treatment to the patient when

required by protocol and patient condition.

The advisory function can be activated only when:

• Hands-free therapy electrodes are connected and selected as the ECG source.

• Hands-free therapy electrodes are properly connected to the patient.

• The Mode Selector is turned to DEFIB.

WARNING!

Use only pediatric electrodes to defibrillate patients under 8 years of age in Advisory

mode. Use of adult electrodes with pediatric patients can result in the delivery of

excessive energy doses.

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CHAPTER 4 ADVISORY DEFIBRILLATION

Advisory Defibrillation Procedure

Determine the Patient’s Condition Following Local Medical Protocols

Verify:

• Unconsciousness.

• Absence of breathing.

• Absence of pulse.

Begin CPR Following Local Medical Protocols

Request additional assistance.

Prepare Patient

Remove all clothing covering the patient’s chest. Dry chest if necessary. If the patient has

excessive chest hair, clip or shave it to ensure proper adhesion of the electrodes.

Attach hands-free therapy electrodes according to instructions on the electrode packaging and

as described in “Therapy Electrode Application” on page 3-7.

Ensure that the electrodes are making good contact with the patient’s skin and are not covering

any part of the ECG electrodes.

If therapy electrodes are not making good contact with the patient’s skin, the unit issues the

messages CHECK PADS and POOR PAD CONTACT and does not allow delivery of energy. If a

short circuit exists between the electrodes, the unit issues the message DEFIB PAD SHORT.

1 Select DEFIB

Turn the Mode Selector to DEFIB. The unit displays DEFIB 120J SEL on the monitor.

RECORDER

1

MONITOR

DEFIB

OFF

PACER

Energy Select

The default energy selections for adult patients are:

• Shock 1 - 120 joules

• Shock 2 - 150 joules

• Shock 3 - 200 joules

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Advisory Defibrillation Procedure

When used with OneStep Pediatric electrodes, the default energy selections for pediatric

patients are:

• Shock 1 - 50 joules

• Shock 2 - 70 joules

• Shock 3 - 85 joules

WARNING!

Use only OneStep Pediatric electrodes to defibrillate patients under 8 years of age in

Advisory mode. Use of adult electrodes, or pediatric electrodes other than OneStep

Pediatric electrodes, can result in the delivery of excessive energy doses.

After the third shock, all subsequent shocks are delivered at the same energy as the third shock

in both Adult and Pediatric modes.

If medical protocols allow, you may select a different energy level using the energy select up

and down arrow buttons on the front panel. The new energy setting displays on the monitor.

ECG

DEFIB 120J SEL.

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

If you have configured SHOCK 1, 2, and 3 to escalating energy levels, and then you manually

change the energy level outside preconfigured SHOCK 1, 2, 3 sequence and deliver a shock, it

disables the automatic energy escalation. See the Energy Level: Shock 1, 2, 3 section of the

R Series Configuration Guide for more details.

2 Press ANALYZE Button

WARNING!

Keep patient motionless during ECG analysis. Do not touch the patient during analysis.

Cease all movement via stretcher before analyzing the ECG.

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CHAPTER 4 ADVISORY DEFIBRILLATION

Press the ANALYZE button to begin the analysis of the patient’s ECG rhythm and to determine

if a shockable rhythm is present.

ECG

ANALYZING ECG

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

An ANALYZING ECG message is displayed for 6 to 12 seconds while the patient’s ECG is

analyzed. Once the analysis is completed, the unit indicates whether or not a shock is advised.

The analysis normally consists of three consecutive 3-second ECG rhythm analyses. If at least

two of the three analyses determine that the patient has a shockable rhythm, the unit

automatically charges to the preconfigured energy level and prompts the operator to shock the

patient. If two or more of the three 3-second ECG analyses do not detect a shockable rhythm,

the unit alerts the operator that no shock is advised.

WARNING!

ECG rhythm analysis does not warn of patient asystole, which is not a shockable

rhythm.

NO SHOCK ADV.

ECG

DEFIB 120J SEL.

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

When a nonshockable rhythm is detected, the unit displays a NO SHOCK ADV. message.

Follow the local protocols to continue CPR or other life support, and re-analyze the ECG at

appropriate intervals.

Note:

When a nonshockable rhythm is detected, the R Series does not prevent the user from

manually defibrillating the patient.

When a shockable rhythm is detected (ventricular fibrillation or wide-complex tachycardia

with heart rate > 150), one of the following occur:

• Units with the automatic charge option enabled automatically charge to the preconfigured or

user selected energy setting.

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Advisory Defibrillation Procedure

• Units with the automatic charge option disabled will alternately display the messages

SHOCK ADVISED and PRESS CHARGE. Press the CHARGE button.

Regardless of the analysis result, the user can control the defibrillator manually. For example,

the user can defibrillate the patient even if the advisory function issues a NO SHOCK ADV.

message.

SHOCK ADVISED

ECG

DEFIB 120J SEL.

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

3 Press SHOCK

WARNING!

Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator

discharge.

Do not touch the bed, patient, or any equipment connected to the patient during

defibrillation. A severe shock can result. Do not allow exposed portions of the patient’s

body to come in contact with metal objects, such as a bed frame, as unwanted pathways

for defibrillation current may result.

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CHAPTER 4 ADVISORY DEFIBRILLATION

Once the unit is charged to the selected energy, the SHOCK button illuminates and the PRESS

SHOCK message is displayed. Simultaneously, the monitor displays the energy level to which

the defibrillator is charged, DEFIB XXXJ READY.

Note:

Rhythm analysis does not continue after the defibrillator is charged and ready once a

decision to shock has been made. The R Series unit will not automatically disarm the

defibrillator if the patient’s rhythm reverts to a non-shockable rhythm before the shock

has been delivered.

PRESS SHOCK

ECG

DEFIB 120J READY

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

A continuous tone sounds for 50 seconds, followed by an intermittent beeping for 10

seconds.You must deliver the shock within this 60 second interval, or the defibrillator will

disarm itself.

Press and hold the illuminated SHOCK button on the front panel until energy is delivered to

the patient. An XXXJ DELIVERED message appears on the display for approximately 5

seconds.

Watch the patient or ECG response to verify that the shock has been delivered.

After the energy has been delivered to the patient, the display returns to DEFIB XXX J SEL.

Perform CPR

Begin chest compressions and rescue breathing per local protocol.

Repeat Analysis

Press the ANALYZE button to restart an ECG analysis and determine if additional shocks are

required.

Note:

Reanalysis of the ECG rhythm is inhibited for 3 seconds after each shock.

Continue Patient Care

Continue patient care according to medical protocols.

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Advisory Function Messages

Advisory Function Messages

SELECT DEFIB MODE

Displayed if the ANALYZE button is pressed, but the unit is not in the DEFIB mode. Turn the

Mode Selector to DEFIB to enable the defibrillator and advisory capability.

SELECT PADS

Displayed if the ANALYZE button is pressed while the device is operating in any ECG lead

other than “PADS.” Press the LEAD button until “PADS” is selected.

REMOVE SYNC

Displayed if the ANALYZE button is pressed while the device is in Sync mode. Turn off Sync

mode by pressing the Sync On/Off softkey. Press the ANALYZE button again to initiate ECG

rhythm analysis.

Warning Messages

Warning messages prompt the operator to check the patient, the unit, the electrodes and/or

connections.

NOISY ECG / RETRY ANALYSIS

A NOISY ECG message alternating with a RETRY ANALYSIS message is displayed for 5

seconds when the unit detects a noisy ECG signal during ECG analysis. Check and adjust

electrode placement and cable connections to help eliminate the noise source. Keep patient

motionless during ECG analysis. Press the ANALYZE button again to begin ECG analysis.

CHECK PATIENT

The unit has detected a shockable rhythm during continuous background ECG analysis

(i.e., Smart Alarms™). The prompt is given only when the heart rate alarms are enabled and the

unit detects a shockable rhythm. The screen message persists as long as a shockable rhythm is

being detected. Press the ANALYZE button to begin ECG analysis.

Note:

This CHECK PATIENT analysis function operates continuously when heart rate

alarms are enabled and does not require pressing the ANALYZE button for operation.

CHECK PADS / POOR PAD CONTACT

The therapy electrodes are not properly attached to the patient, or the cable connections have

become loose.

Check that the therapy electrodes are making good contact with the patient’s skin and that all

cables are securely connected. This voice prompt will not sound if the therapy electrodes were

not previously connected to the patient.

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Chapter 5

Synchronized Cardioversion

Paddles are a defibrillation-protected Type BF patient connection.

ECG leads are a defibrillation-protected Type CF patient connection.

WARNING!

Only skilled personnel trained in Advanced Cardiac Life Support and familiar with

equipment operation should perform synchronized cardioversion. The precise cardiac

arrhythmia must be determined before attempting defibrillation or cardioversion.

Before attempting synchronized cardioversion, ensure that ECG signal quality is

sufficient to minimize the risk of synchronizing on artifact.

Certain arrhythmias, such as ventricular tachycardia, atrial fibrillation, and atrial flutter,

require synchronizing the defibrillator discharge with the ECG R-wave to avoid the induction

of ventricular fibrillation. In this case, a synchronizing (Sync) circuit within the defibrillator

detects the patient’s R-waves. When the SHOCK button (or buttons, if using paddles) is

pressed and held, the unit discharges with the next detected R-wave, thus avoiding the

vulnerable T-wave segment of the cardiac cycle.

When in the Sync mode, the unit displays markers () above the ECG trace to indicate the

points in the cardiac cycle (R waves) where discharge can occur.

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CHAPTER 5 SYNCHRONIZED CARDIOVERSION

Marker indicates each detected

R wave during synchronization

Verify that markers are clearly visible on the monitor and their location is appropriate and

consistent from beat to beat. If necessary, use the LEAD and SIZE buttons to establish settings

that yield the most consistent Sync marker pattern.

The Sync On/Off softkey may be highlighted for clearer visibility, if desired. This is off by

default. Refer to the R Series Configuration Guide for instructions on how to turn on the

highlighting.

00:01

Options

Param

Code

Marker

Report

Data

Alarms

Sync

On/Off

The synchronized cardioversion procedure for ZOLL hands-free therapy electrodes is identical

to that for paddles with the exception of the SHOCK button location.

The R Series defibrillator supports two types of synchronized cardioversion:

• Synchronized Cardioversion — The R Series monitors the patient’s ECG and

synchronizes shock delivery with this ECG source. For instructions, refer to “Synchronized

Cardioversion Procedure” below.

• Remote Synchronized Cardioversion — An external device (such as a patient monitor)

monitors the patient’s ECG and provides a synchronization pulse to the R Series’ Sync

In/Marker Out connector. The R Series synchronizes shock delivery with these external

pulses.

Note:

When using the Remote Sync function, the procedure and displayed information are

different. Make sure to follow the instructions for Remote Synchronized Cardioversion

on page 5-5.

Synchronized Cardioversion Procedure

Determine the Patient’s Condition and Provide Care Following Local

Medical Protocols

Prepare Patient

Remove all clothing covering the patient’s chest. Dry chest if necessary. If the patient has

excessive chest hair, clip or shave it to ensure proper adhesion of the electrodes.

Attach ECG electrodes as described in“Monitoring Electrodes Attachment” on page 9-3.

A standard ECG cable and ECG electrodes are recommended for use during cardioversion.

Hands-free therapy electrodes may be used as an ECG source. Signal quality will be equal to

that of standard leads except immediately following a discharge when there may be more noise

due to muscle tremors, especially if an electrode is not in complete contact with the skin.

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Synchronized Cardioversion Procedure

Attach hands-free therapy electrodes according to instructions on the electrode packaging and

as described in “Therapy Electrode Application” on page 3-7.

Ensure that the therapy electrodes are making good contact with the patient’s skin and are not

covering any part of any other electrodes.

Connect the hands-free therapy electrodes to the OneStep cable if not preconnected.

If therapy electrodes are not making good contact with the patient’s skin, the unit issues the

messages CHECK PADS and POOR PAD CONTACT and does not allow delivery of energy. If a

short circuit exists between the electrodes, the unit issues the message DEFIB PAD SHORT.

An ECG LEAD OFF condition prevents synchronized discharge if leads are selected as the

ECG source. This condition does not prevent the use of the defibrillator; it simply prevents use

in a synchronized manner.

If paddles are being used for synchronized cardioversion, refer to “Emergency Defibrillation

Procedure with Paddles” on page 3-1 for preparing paddles, applying paddles, charging the

defibrillator, and delivering a shock. Note, however, that synchronized discharge with paddles

as an ECG source is discouraged since the artifact induced by moving the paddles may

resemble an R-wave and trigger defibrillator discharge at the wrong time.

1 Select DEFIB

Turn the Mode Selector to DEFIB. Select the desired energy using the up and down arrow keys

on the front panel (or sternum paddle if using paddles).

3

SHOCK

2

ANALYZE

1

CHARGE

ENERGY

SELECT

DEFIB

Press the Sync On/Off softkey

Your system will be in Sync mode once you press the Sync On/Off softkey if your R Series is

not configured to support Remote Sync. However, if your R Series is configured to support

Remote Sync, pressing the Sync On/Off softkey will cause two other softkeys to be displayed:

Remote Sync and Sync. Press the Sync softkey to enter Sync mode.

The selected energy level is displayed on the monitor.

A Sync marker () appears on the monitor above each detected R-wave to indicate where

discharge will occur.

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Verify that the markers are clearly visible on the monitor and their location is appropriate and

consistent from beat to beat. If necessary, use the LEAD and SIZE buttons to establish settings

that yield the best display.

A SYNC XXXJ SEL. message appears on the display. If DEFIB XXXJ SEL. appears, press the

Sync On/Off softkey. (If your unit supports Remote Sync, you must also press the Sync

softkey.) Two quick beeps sound.

ECG

SYNC 120J SEL.

00:01

Options

Param

Code

Marker

Report

Data

Sync

On/Off

Alarms

Unless otherwise configured, the unit automatically exits Sync mode after each shock and when

the Mode Selector is moved to MONITOR, PACER or OFF.

To reactivate Sync mode, press the Sync On/Off softkey again. (If your unit supports Remote

Sync, press the Sync softkey again.) Changing the selected energy levels does not cause the

unit to leave Sync mode.

Note that the unit can be configured to stay in Sync mode after defibrillation, if desired. Refer

to the R Series Configuration Guide for instructions.

2 Charge Defibrillator

Press the CHARGE button on the front panel or on the apex paddle handle.

3

SHOCK

2

ANALYZE

CHARGE

1

RE

RELE

LEAS

ASEE

or

ENERGY

SELECT

To abort charging and increase or decrease the selected energy after the CHARGE button has

been pressed, use the ENERGY SELECT buttons on either the defibrillator front panel or the

sternum paddle. Press the CHARGE button again to charge the unit to the newly selected

energy level.

After charging the unit to the selected energy, either the front panel SHOCK button or the

APEX paddle charge indicator illuminates. A distinctive audible tone sounds and the SYNC

XXXJ READY message is displayed.

The defibrillator is now ready to deliver therapy.

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Remote Synchronized Cardioversion Procedure

3 Deliver SHOCK

WARNING!

Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator

discharge.

Verify that no one is in contact with the patient, monitoring cable or leads, bed rails, or

any other potential current pathways.

Verify that the ECG waveform is stable and that Sync markers appear over each R-wave.

Press and hold the illuminated SHOCK button on the front panel, (or simultaneously press and

hold both paddle SHOCK buttons) until energy is delivered to the patient. The defibrillator will

discharge with the next detected R wave.

Note:

If the defibrillator is not discharged within 60 seconds after reaching the selected

energy level, the unit automatically disarms itself. During the ten seconds prior to this

internal disarm, the charge ready tone beeps intermittently. The charge ready tone then

stops, and the defibrillator remains in Sync mode.

Once the energy is delivered, the display simultaneously shows XXXJ DELIVERED and DEFIB

XXXJ SEL. After approximately 5 seconds, the XXXJ DELIVERED message disappears and the

DEFIB XXXJ SEL. message remains to indicate the selected energy level.

If additional countershocks are necessary, readjust the energy level as necessary, press the

Sync On/Off softkey, followed by the Sync softkey (if your unit supports Remote Sync), and

repeat. Note that SYNC XXXJ SEL must be displayed prior to pressing the CHARGE button.

If the ANALYZE button is pressed while the unit is in Sync mode, the unit displays the

REMOVE SYNC message and does not allow ECG rhythm analysis until the unit is taken out of

Sync mode.

Remote Synchronized Cardioversion Procedure

The R Series may be configured to receive defibrillation synchronization pulses from a remote

ECG monitoring device. See the R Series Configuration Manual. Be sure that the remote

device is connected to the Sync In/Marker Out connector on the R Series unit. The remote

device must have a Sync out connector and a cable must be provided to connect the two

devices. Ensure the remote device conforms with the Sync In/Marker Out specifications

(described in Appendix A, “Defibrillator Specifications”).

WARNING!

A lethal arrhythmia may be induced through improper synchronization. Qualified

personnel within the hospital should verify synchronization delay for the entire remote

monitor and defibrillator system prior to clinical use. Synchronization delay for the

system as a whole must not exceed 60 msec.

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CHAPTER 5 SYNCHRONIZED CARDIOVERSION

Determine the Patient’s Condition and Provide Care Following Local

Medical Protocols

Prepare Patient

Prepare the patient as described in “Prepare Patient” on page 5-2.

Follow the instructions provided with the external monitoring device to prepare the patient for

ECG monitoring and synchronization with a separate defibrillator.

1 Select DEFIB

Turn the Mode Selector to DEFIB.

Select the desired energy using the up and down arrow keys on the front panel (or sternum

paddle if using paddles).

3

SHOCK

2

ANALYZE

1

CHARGE

ENERGY

SELECT

DEFIB

Press Sync On/Off softkey, then press the Remote Sync Softkey

The selected energy level is displayed on the monitor.

The words “REMOTE SYNC” are displayed in place of the ECG trace, and a REMOTE SYNC

XXXJ SEL. message appears on the display.

The ECG heartbeat indicator will flash with each synchronization pulse received from the

remote monitoring device.

Unless otherwise configured, the unit automatically exits Sync mode after each shock, and if

the Mode Selector is moved to MONITOR, PACER or OFF.

Press the Sync On/Off, Remote Sync softkey sequence again to reactivate Remote Sync mode.

Changing the selected energy levels does not cause the unit to leave Remote Sync mode.

View the ECG trace on the remote device’s display. Verify that Sync markers appear with each

R-wave. The Sync markers will appear as described in the remote device’s user manual.

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Remote Synchronized Cardioversion Procedure

WARNING!

Verify the ECG waveform is stable and that a Sync marker appears only with R-waves.

If Sync markers are not present on the remote device display, or do not appear to be

nearly simultaneous with each R-wave, do not proceed with synchronized

cardioversion.

2 Charge Defibrillator

Press the CHARGE button on the front panel or, if using paddles, on the apex paddle handle.

3

SHOCK

2

ANALYZE

CHARGE

1

RE

RELE

LEAS

ASEE

or

ENERGY

SELECT

To abort charging and increase or decrease the selected energy after the CHARGE button has

been pressed, use the ENERGY SELECT buttons on either the defibrillator front panel or the

sternum paddle. Press the CHARGE button again to charge the unit.

After charging the unit to the selected energy, either the front panel SHOCK button or, the apex

paddle charge indicator illuminates. A distinctive audible tone sounds and the energy ready

REMOTE SYNC XXXJ READY message is displayed.

The defibrillator is now ready to deliver therapy.

3 Deliver SHOCK

WARNING!

Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator

discharge.

Verify that no one is in contact with the patient, monitoring cable or leads, bed rails, or

any other potential current pathways.

Press and hold the illuminated SHOCK button on the front panel, or simultaneously press and

hold both paddle SHOCK buttons until energy is delivered. The defibrillator will discharge

with the next remote synchronization pulse.

Note:

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If the defibrillator is not discharged within 60 seconds after reaching the selected

energy level, the unit automatically disarms itself. During the ten seconds prior to this

internal disarm, the charge ready tone beeps intermittently. The charge ready tone then

stops and the defibrillator remains in Remote Sync mode.

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CHAPTER 5 SYNCHRONIZED CARDIOVERSION

Once the energy is delivered, the display simultaneously shows XXXJ DELIVERED and DEFIB

XXXJ SEL. After approximately 5 seconds, the XXXJ DELIVERED message disappears and the

DEFIB XXXJ SEL. message remains to indicate the selected energy level.

If additional countershocks are necessary, readjust the energy level as necessary, press the

Sync On/Off, and then the Remote Sync softkeys and repeat. Note that REMOTE SYNC XXXJ

SEL must be displayed prior to pressing the CHARGE button.

If the ANALYZE button is pressed while the unit is in Remote Sync mode, the unit displays the

REMOVE SYNC message and disallows ECG rhythm analysis until the unit is taken out of Sync

mode.

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Chapter 6

Real CPR Help

Real CPR Help is defibrillation-proof Type BF equipment.

WARNING!

The Real CPR Help function is fully functional only when using adult CPR electrodes.

Do not use Adult CPR electrodes with patients under 8 years of age.

WARNING!

Use only Pediatric CPR electrodes with patients under 8 years of age. The use of

Pediatric CPR electrodes enables the R Series unit to display Idle Time and

Compression Rate and Depth measurements. Pediatric CPR electrodes do not enable

Real CPR voice prompts or any visual indication of ineffective CPR.

When used with OneStep CPR electrodes or OneStep Complete electrodes, the R Series unit

can provide rescuers with feedback about the quality of CPR they are delivering to their

patients. The way in which feedback is provided varies with respect to the operational mode

and user configuration, but is derived from compression rate and depth measurements.

When applied according to package instructions, ZOLL OneStep CPR and OneStep Complete

electrodes provide a chest compression sensor that is located between the rescuer’s hands and

the patient’s lower sternum. This sensor monitors the rate and depth of chest compressions and

sends this information to the R Series unit for processing and display.

The R Series defibrillator uses this information to provide feedback to the rescuer in one or

more of the following forms:

• Perfusion Performance Indicator

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CHAPTER 6 REAL CPR HELP

• CPR Idle Time Display

• CPR Rate Metronome

• Voice prompts

• Chest Compressions Waveform display

• FULLY RELEASE display prompt (if configured)

Real CPR Help Field

Whenever OneStep CPR, or OneStep Complete electrodes are connected to the R Series

defibrillator, the unit illuminates the Real CPR Help field in the upper center portion of the

display. This field includes the indicators described in the next sections.

Perfusion Performance Indicator (Optional/Adult Only)

This diamond shaped figure provides a quick, overall indicator of how well the rescuer's

combined rate and depth of chest compressions match the AHA/ERC recommendations for

adult CPR.

Before chest compressions begin (and after each shock), the Perfusion Performance Indicator is

displayed as a hollow outline. This index starts to fill from the center out as compressions

begin, and becomes fully filled when consistent chest compression depth exceeding 1.5 or 2

inches, depending on the configuration, and rate exceeding 100 compressions per minute (cpm)

are simultaneously achieved. Should the chest compression rate or depth begin to fall below the

AHA/ERC recommended levels, the PPI will only partially fill to indicate the need for more

vigorous efforts. Following the cessation of compressions, the PPI’s fill level gradually

decreases until a hollow outline is displayed after a short period of time.

When complete filling of the Perfusion Performance Indicator has not been achieved due to

diminished compression rate or depth, and the CPR Dashboard is configured Off, the R Series

will display the words RATE and/or DEPTH to assist the rescuer in determining whether chest

compression rate or depth should be increased. When an appropriate rate or depth has been

achieved, 100 cpm and 1.5 or 2 inches, respectively, one or both of these words will disappear

from the display.

This feature is unavailable while using Pediatric CPR electrodes.

CPR Idle Time Display

This display indicates the elapsed time in minutes and seconds since the last detected chest

compression. When compressions are being delivered, this time display will be blanked. Three

seconds following the cessation of compressions, the display will illuminate and show the

elapsed time since the last detected compression. If no compressions have been delivered for

more than 20 minutes, dashes (---) will be displayed in this time field.

CPR Rate and Depth Display

If the CPR Dashboard is configured On and the CPR Idle Time is not displayed, the Rate and

Depth values are displayed in the default color; the same values are highlighted and change

color if they are not within the AHA-recommended range of below 100 or over 120

compressions per minute. This feature is unavailable while using Pediatric CPR electrodes.

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Real CPR Help Field

Compression Release Bar (Adult only)

If the CPR Dashboard is configured On, the Compression Release Bar shows the release of the

chest compression by the rescuer. When the release of the chest is properly administered

(quickly and completely released), the bar will fill all the way to the top.

This feature is unavailable while using Pediatric CPR electrodes.

CPR Dashboard

CPR

Depth Rate

Perfusion

Performance Indicator

1.8 120

(in)

(cpm)

Depth and Rate Indicators

Release

PPI

Compression Release Bar

CPR Metronome

The R Series unit includes a CPR metronome feature that can be used to encourage rescuers to

perform chest compressions at the AHA/ERC recommended rate of 100 - 120 compressions per

minute. This feature can be configured.

When activated, the metronome beeps at the AHA/ERC recommended rate to provide a

compression rhythm for rescuers to follow. The metronome is silent when no chest

compressions are being detected by CPR-equipped hands-free therapy electrodes.

When Manual and Advisory modes are configured to “Yes,” the metronome only beeps when

chest compressions are detected and their rate falls below the AHA/ERC recommended levels.

When compressions are being performed at 100 compressions per minute or higher, the

metronome is silent. Should the detected compression rate fall below this level, the metronome

will begin beeping until recommended compression rates are consistently achieved over several

compression cycles. The metronome stops beeping approximately 2 seconds after the last chest

compression is detected.

When Manual and Advisory modes are configured to “Continuous,” the metronome beeps as

long as compressions are detected, even when they are being performed at 100 compressions

per minute or higher. The metronome stops beeping approximately 2 seconds after the last chest

compression is detected.

Fully Release prompt

The R Series unit can be configured to display the text prompt FULLY RELEASE, which

reminds rescuers to lift (fully release) their hands from the patient’s chest during compressions

to allow full recoil.

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CHAPTER 6 REAL CPR HELP

By default, the FULLY RELEASE text prompt is not enabled.

This feature is unavailable while using Pediatric CPR electrodes.

CPR Voice Prompts (Adult only)

The R Series unit can be configured to issue voice prompts related to the depth of chest

compressions as feedback to rescuers performing CPR. Two voice prompts are available for

this purpose:

• Push Harder

• Good Compressions

When chest compressions are detected but their depth is consistently less than 1.5 or 2 inches

(3.8 or 5 cm), depending on the configuration, the defibrillator will issue the prompt “Push

Harder” every 15 seconds. If the rescuer responds by increasing compression depth to more

than 1.5 or 2 inches (3.8 or 5 cm), depending on the configuration, on a consistent basis, the

unit will issue a “Good Compressions” prompt.

See the R Series Configuration Guide for information on enabling/disabling CPR voice

prompts.

CPR Voice prompts are unavailable while using Pediatric CPR electrodes.

Chest Compressions Bar Graph

The R Series unit can display a CPR compression bar graph computed from the CPR sensor

signals. This bar graph, representing depth of compression, is presented on a displacement scale

with a reference marker at 1.5 or 2.0 inches, depending on the configuration. When the full

width of the trace is visible, the unit displays a minimum of 12 seconds of compression data.

Displaying the CPR Bar Graph

To display the CPR displacement bar graph in the Trace 2 or 3 position:

1. Press the Options softkey, then press Traces.

2. Press either the Trace 2 or Trace 3 softkey.

3. Press CPR.

Note:

6–4

The CPR softkey appears only when OneStep CPR or OneStep Complete electrodes

are in use.

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Chapter 7

See-Thru CPR (Optional)

WARNING!

The See-Thru CPR filter works only when the R Series defibrillator is monitoring CPR.

The See-Thru CPR filter stops if:

— The unit is in pace mode.

— Patient impedance is invalid.

— OneStep CPR electrodes or OneStep Complete electrodes are no longer detected.

The See-Thru CPR filter will not remove all CPR artifact. Always stop CPR to verify

the patient’s ECG rhythm before making treatment decisions.

The See-Thru CPR filter does not operate during ECG rhythm analysis. Always stop

chest compressions during ECG rhythm analysis to avoid incorrect results caused by

the presence of CPR artifact.

Diagnostic bandwidth is never applied to the See-Thru CPR waveform.

See-Thru CPR enables the rescuer to see a close approximation of the patient’s underlying ECG

rhythm while performing CPR. See-Thru CPR is available if the R Series is monitoring CPR.

Chest compressions introduce CPR artifact into the ECG signal. See-Thru CPR uses a filter

that relies on the correlation between CPR compressions, as detected by the ZOLL Onestep

CPR or OneStep Complete electrodes, and the CPR artifact to remove much, but not all, of the

artifact from the ECG signal. Under some conditions, residual noise after filtering can obscure

the ECG rhythm, requiring the rescuer to stop CPR to assess the ECG. For example, in the case

of asystole or low amplitude PEA, the residual artifact seen after filtering may look like fine

ventricular fibrillation.

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CHAPTER 7 SEE-THRU CPR (OPTIONAL)

Because the filtered ECG signal may contain residual chest compression and/or filtering

artifacts, a rescuer should always follow the standard procedure of stopping CPR to assess the

patient’s ECG rhythm before determining treatment.

Using See-Thru CPR

To use See-Thru CPR

• The R Series unit must be monitoring CPR.

• OneStep CPR or OneStep Complete electrodes must be attached to the unit.

When chest compressions begin, the R Series unit automatically starts filtering the CPR artifact

after detecting the first 3 to 6 compressions.

The filtered ECG, with the label “FIL,” may be displayed on the second or third trace (by

selecting FILT ECG in the Trace2 or Trace3 menu). See-Thru CPR filtering continues as long

as the OneStep CPR or OneStep Complete electrodes detect compressions and patient

impedance is valid. When no compressions are detected or one of the conditions noted above

occurs, See-Thru CPR filtering stops, and unfiltered ECG signals are displayed. When

compressions resume, filtering automatically restarts after 3 to 6 chest compressions.

Note:

There is a delay of approximately 1/16 second between the See-Thru CPR waveform

and the Trace 1 ECG waveform.

If configured to display the CPR Dashboard, the R Series unit can also be configured to display

the filtered ECG in Trace1. When the unit is configured to display the filtered ECG in Trace1,

the softkey Disable Filt ECG appears, which you can press to disable display of the filtered

ECG in Trace1 and replace it with the unfiltered ECG. When the unit displays the unfiltered

ECG in Trace1, the softkey Enable Filt ECG appears, which can redisplay the filtered ECG in

Trace1.

Examples

The following examples show the effects of See-Thru CPR filtering on ECG signals

contaminated with CPR artifacts.

Each example includes:

• ECG signal with CPR artifact.

• ECG signal after the See-Thru CPR filter has removed CPR artifact.

• Indication of the period during which See-Thru CPR is active.

• CPR signal to show when CPR activity occurred.

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Using See-Thru CPR

The following figure shows a patient in Fine VF. It is difficult for a rescuer to discern this

rhythm during CPR compressions. When the CPR filter turns on, the Fine VF rhythm becomes

more obvious.

FineVF

Raw ECG

Raw ECG

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:00

CPR

0:12

FineVF

Raw ECG

Raw ECG

•

| Filter OFF

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:12

CPR

0:24

FineVF

Raw ECG

Raw ECG

•

| Filter OFF

Filtered ECG

Filtered ECG

CPR

CPR

0:24

0:36

12.5 mm/sec, 5 mm/mV

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CHAPTER 7 SEE-THRU CPR (OPTIONAL)

The following figure shows a patient in VF, which, during compressions, is slightly more

difficult to discern. When viewing this ECG, it is possible to view the underlying rhythm as the

filter is able to reject all of the CPR artifact.

CoarseVF

Raw ECG

Raw ECG

Filtered ECG

Filtered ECG

CPR

0:00

CPR

0:12

CoarseVF

Raw ECG

Raw ECG

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:12

CPR

0:24

CoarseVF

Raw ECG

Raw ECG

•

| Filter OFF

Filtered ECG

Filtered ECG

CPR

CPR

0:24

0:36

12.5 mm/sec, 5 mm/mV

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Using See-Thru CPR

The following figure shows a patient in PEA, which could easily be mistaken for Fine VF

because enough of the compression artifact leaks through to distort this signal. When the CPR

filter turns on, the PEA is still not obvious because of the left over ripples from the CPR signal.

About 14 seconds into this chart, the rhythm changes to asystole, which could easily be

mistaken for coarse VF. When the CPR filter turns on, the CPR compression ripples are still

obvious, making the rhythm look like Fine VF.

Asystole

Raw ECG

Raw ECG

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:00

CPR

0:12

Asystole

Raw ECG

Raw ECG

•

| Filter OFF

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:12

CPR

0:24

Asystole

Raw ECG

Raw ECG

•

| Filter OFF

Filtered ECG

Filtered ECG

CPR

CPR

0:24

0:36

12.5 mm/sec, 5 mm/mV

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CHAPTER 7 SEE-THRU CPR (OPTIONAL)

The following figure shows a patient with an organized rhythm where See-Thru CPR

effectively filters out artifact created by CPR.

SinusRhythm

Raw ECG

Raw ECG

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:00

CPR

0:12

SinusRhythm

Raw ECG

Raw ECG

•

| Filter OFF

•

| Filter ON

Filtered ECG

Filtered ECG

CPR

0:12

CPR

0:24

SinusRhythm

Raw ECG

Raw ECG

•

| Filter OFF

Filtered ECG

Filtered ECG

CPR

CPR

0:24

0:36

12.5 mm/sec, 5 mm/mV

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Chapter 8

Noninvasive Temporary Pacing

(Optional)

When ZOLL hands-free therapy electrodes are used, the patient connection is

considered to be defibrillation-protected Type BF.

ECG leads are a defibrillation-protected Type CF patient connection.

WARNING!

To avoid risk of electrical shock, do not touch the gelled area of the hands-free therapy

electrodes while pacing.

Therapy electrodes should be replaced periodically. Consult electrode directions for

specific recommendations.

Prolonged pacing (in excess of 30 minutes), particularly in neonates or adults with

severely restricted blood flow, may cause burns. Periodic inspection of the underlying

skin is recommended.

If the unit was NOT turned off and less than 10 minutes have elapsed since the pacing

mode was last used, reactivating the pacer mode causes pacing to resume immediately

at the previously selected mA and ppm settings.

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CHAPTER 8 NONINVASIVE TEMPORARY PACING (OPTIONAL)

Noninvasive Temporary Pacing

R Series defibrillators with the pacer option contain a VVI demand pacemaker – a safe and

effective design for Noninvasive Temporary Pacemakers.

Proper demand pacing requires a reliable, high quality surface ECG signal. For best results:

• Apply both standard ECG monitoring electrodes and hands-free pacing therapy electrodes

(such as, OneStep electrodes or Stat-padz) to the patient,

or

• Use OneStep Pacing electrodes, or OneStep Complete electrodes. These hands-free therapy

pads include both ECG monitoring and pacing/defibrillation electrodes in a single pad

assembly. They provide reliable ECG monitoring without the need to use separate ECG

leads. With these electrodes you must also use the OneStep Pacing cable.

Determine Patient Condition and Provide Care Following Local

Medical Protocols.

Prepare the Patient

Remove all clothing covering the patient’s chest. Dry chest if necessary. If the patient has

excessive chest hair, clip it to ensure proper adhesion of the electrodes.

1 Apply ECG Electrodes/Hands-Free Therapy Electrodes

The R Series supports two electrode configurations for pacing:

• OneStep Pacing Configuration

Simultaneous ECG monitoring and pacing can be performed with a single set of therapy

electrodes when using OneStep Pacing electrodes or OneStep Complete electrodes along

with a OneStep Pacing cable. The OneStep Pacing cable must be connected to both the MFC

and ECG connectors of the R Series unit. Attach OneStep electrodes according to

instructions on the electrode packaging. Then connect the electrodes to the OneStep Pacing

cable.

• Separate ECG Electrodes and Hands-free Therapy Electrodes Configuration

Apply ECG electrodes, attach lead wires, and connect the ECG cable to the R Series rear

panel (see page 9-3 for instructions on attaching ECG electrodes to the patient). Attach

hands-free therapy electrodes according to instructions on the electrode packaging. Connect

these therapy electrodes to the OneStep cable.

Therapy Electrode Application

WARNING!

Poor adherence and/or air under the therapy electrodes can lead to the possibility of

arcing and skin burns.

1. Apply one edge of the pad securely to the patient.

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Noninvasive Temporary Pacing

2. Roll the pad smoothly from the applied edge to the other, being careful not to trap any air

pockets between the gel and skin.

Pad

Skin

3. Ensure that hands-free therapy electrodes are making good contact with the patient’s skin and

are not covering any part of any other ECG electrodes.

4. If using OneStep Pacing electrodes or OneStep Complete electrodes, select ECG lead P1, P2,

or P3; otherwise, select an appropriate ECG lead. Adjust ECG size for a clean, well-defined

ECG signal.

5. Verify proper R-wave detection. The heart-shaped symbol flashes with each R-wave when

proper detection is taking place. Adjust ECG size for a clean, well-defined ECG signal.

Note:

When the OneStep Pacing electrode configuration is used and the unit is switched to

PACER mode, P3 is automatically selected as the ECG source. When separate ECG

electrodes and hands-free therapy electrodes are used, Lead II is automatically selected

as the ECG source.

While ECG signals acquired from P1, P2 or P3 are appropriate for ECG rhythm assessment and

determining electrical capture during pacing, they should not be used for diagnostic purposes.

Conventional ECG electrodes and cable should be used for this purpose.

2 Turn Selector Switch to PACER

RECORDER

MONITOR

1

DEFIB

OFF

PACER

Set the Pacer Output to 0 mA

If the unit has just been turned on, the PACER OUTPUT is automatically set to 0 mA.

3 Set Pacer Rate

Set the PACER RATE to a value 10-20 ppm higher than the patient’s intrinsic heart rate. If no

intrinsic rate exists, use 100 ppm.

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CHAPTER 8 NONINVASIVE TEMPORARY PACING (OPTIONAL)

The pacer rate increments or decrements by a value of 2 ppm on the display when the knob is

turned.

OFF

PACER

OUTPUT

mA

4:1

RATE

ppm

Observe the pacing stimulus marker on the display or stripchart (

well-positioned in diastole.

) and verify that it is

Pacing Stimuli

4 Set Pacer Output

Increase PACER OUTPUT until stimulation is effective (capture); the output mA value is

displayed. The pacer output increments and decrements by a value of 2 mA on the display

when the knob is turned.

OFF

PACER

OUTPUT

mA

Note:

4:1

RATE

ppm

When the unit is switched out of PACER mode into DEFIB or MONITOR mode and

then switched back to PACER mode, within 10 seconds the pacer settings remain

unchanged.

If the unit is turned off for more than 10 seconds, the pacer’s power up default settings are

restored.

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Noninvasive Temporary Pacing

5 Determine Capture

It is important to recognize when pacing stimulation has produced a ventricular response

(capture). Determination of capture must be assessed both electrically and mechanically in

order to ensure appropriate circulatory support of the patient.

Electrical capture is determined by the presence of a widened QRS complex, the loss of any

underlying intrinsic rhythm, and the appearance of an extended, and sometimes enlarged,

T-wave.

Ventricular response is normally characterized by suppression of the intrinsic QRS complex.

WARNING!

Determination of electrical capture should only be performed by viewing the ECG trace

on the R Series display with its ECG connection directly attached to the patient. Use of

other ECG monitoring devices might provide misleading information due to the

presence of pacer artifacts.

Mechanical capture is assessed by palpation of the peripheral pulse.

To avoid mistaking muscular response to pacing stimuli for arterial pulsations, use ONLY the

following locations for palpating pulse during pacing:

• femoral artery

• right brachial or radial artery

Effective pacing

The following ECG traces illustrate typical examples of effective pacing.

Large T wave

Negative R wave

Pacer Markers

Widened, positive QRS,

(which looks like an

ectopic beat).

Inverted T wave/ absence of P waves

Pacer Markers

Changing ECG leads and size can sometimes be helpful in determining capture.

Note:

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The shape and size of the paced ECG waveforms can vary depending on the ECG lead

configuration chosen; variation from patient to patient can be expected.

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CHAPTER 8 NONINVASIVE TEMPORARY PACING (OPTIONAL)

6 Determine Optimum Threshold

The ideal pacer current is the lowest value that maintains capture — usually about 10% above

threshold. Typical threshold currents range from 40 to 80 mA. Location of the hands-free

therapy or OneStep therapy electrodes affects the current required to obtain ventricular capture.

Typically the lowest threshold is obtained when the position of the electrodes provides the most

direct current pathway through the heart while avoiding large chest muscles. Lower stimulation

currents produce less skeletal muscle contraction and are better tolerated.

4:1 Mode

OFF

PACER

OUTPUT

mA

4:1

RATE

ppm

Pressing and holding the 4:1 button temporarily withholds pacing stimuli, thereby allowing you

to observe the patient’s underlying ECG rhythm and morphology.

When depressed, this button causes pacing stimuli to be delivered at ¼ of the indicated ppm

setting.

Pace Fault

If the unit is attempting to deliver pacing therapy and one of the following conditions occur, the

messages CHECK PADS and POOR PAD CONTACT are alternately displayed on the screen

and an audible alarm sounds:

• The OneStep cable is not connected to the device.

• The cable is defective.

• Therapy pads are not connected to the OneStep cable.

• The therapy pads are not making good skin contact.

The alarm will continue to sound until proper connections between the patient and pacer are

achieved and the leftmost softkey (Clear Pace Alarm) is pressed.

CHECK PADS

ECG

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PACE

00:01

50 mA

70 PPM

Clear

Pace

Alarm

8–6

Async

Pacing

On/Off

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Special Pacing Applications

Special Pacing Applications

Noninvasive Temporary Pacing can be performed in the Cardiac Catheterization Lab either for

emergency pacing or standby pacing. For pacing in X-ray and fluoroscopic applications, ZOLL

Pro-padz® radiolucent hands-free therapy electrodes may be used.

Noninvasive Temporary Pacing can be performed in the Operating Room using ZOLL

Pro-padz sterile hands-free therapy electrodes.

Caution

Under certain conditions, it may not be possible to properly monitor or pace while

electrosurgical apparatus is operating. Interference caused by use of electrosurgical apparatus

may result in a CHECK PADS or LEADS OFF message. If a CHECK PADS message is present,

the unit will not deliver energy. Observe the device carefully for evidence of proper operation.

Standby Pacing

For certain patients at risk of developing symptomatic bradycardia, it may be advisable to use

the unit in standby mode. When used in standby mode, the unit automatically provides pacing

stimuli whenever the patient’s heart rate drops below the pacer rate setting. Patient’s ECG must

be monitored using one of the two electrode configurations described on page 8-2. To use the

device in standby mode:

1. Establish effective pacing (see instructions on previous pages). Note the mA output at

capture and run an ECG stripchart to document ECG morphology during capture.

2. Set the mA output 10% higher than the minimum mA output necessary to effect consistent

ventricular capture.

3. Turn the pacing rate (ppm) below the patient’s heart rate. This suppresses pacing unless the

patient’s own rate drops below the pacer rate setting. The pacing rate should be set at a level

sufficient to ensure adequate cardiac output.

4. Check the threshold periodically.

Asynchronous Pacing

If ECG electrodes are not available or there is some circumstance that prevents or interferes

with the surface ECG, the R Series delivers pacemaker pulses asynchronously.

Asynchronous pacing should be performed only in an emergency when no alternative is

available. To pace asynchronously:

Turn the Mode Selector to PACER.

Press the Async Pacing On/Off softkey.

Note:

If the pacer output is set to 8 mA or higher, pacing stimuli begin immediately at the set

rate.

The display shows “ASYNC PACE” to indicate that asynchronous pacing has been activated.

The annotation “ASYNC PACE” is also printed on the stripchart when activated by the

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CHAPTER 8 NONINVASIVE TEMPORARY PACING (OPTIONAL)

RECORDER button, and printed on the corresponding summary report. To return to demand

pacing, press the Async Pacing On/Off softkey again. The display returns to “PACE.”

ASYNC PACE

00:01

Options

50 mA

Param

70 PPM

Code

Marker

Report

Data

Alarms

Async

Pacing

On/Off

Pace stimuli are also delivered asynchronously whenever there is an ECG LEAD OFF

condition. Due to the lead off condition, no ECG waveforms will be displayed when pacing by

this method. Use other means to determine capture such as checking the patient’s pulse.

When asynchronously pacing with an ECG LEAD OFF condition, the rate and mA should be

set at the known capture level or high enough (100mA) to presume capture.

Pediatric Pacing

Noninvasive pacing of pediatric patients is performed in an identical manner to adult pacing.

Smaller size pediatric therapy electrodes are available for patients weighing less than

55 lbs/25 kg. Continuous pacing of neonates can cause skin burns. If it is necessary to pace for

more than 30 minutes, periodic inspection of the underlying skin is strongly advised. Carefully

follow all instructions on electrode packaging.

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Chapter 9

ECG Monitoring

ECG leads are a defibrillation-protected Type CF patient connection.

The R Series products can be used for either short- or long-term ECG monitoring.

R Series products have built-in circuitry to prevent damage to their ECG monitoring circuits

during defibrillation. Monitoring electrodes, however, can become polarized during

defibrillator discharge, causing the ECG trace to briefly disappear from the screen.

High-quality silver/silver chloride (Ag/AgCl) electrodes minimize this effect. Circuitry in the

unit returns the ECG trace to the display within a few seconds.

You can monitor a patient’s ECG using an ECG patient cable, hands-free therapy electrodes, or

through standard defibrillation paddles.

During ECG monitoring, the R Series displays the following information:

• Five seconds of ECG waveforms

• Heart Rate

• Heartbeat indicator

• ECG source lead (I, II, III, aVR, aVL, aVF, or V with ECG cable; PADS, or PADDLES)

• ECG size relative scale factor - x0.5, x1, x1.5, x2, x3

• Alarm indicator

Whenever more than one waveform is displayed, the selected ECG lead appears as the

uppermost trace (unless the unit is configured for Filtered ECG).

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CHAPTER 9 ECG MONITORING

Caution

ECG electrodes embedded in OneStep Pacing and Complete resuscitation pads produce

non-standard ECG monitoring lead vectors, designated P1, P2 and P3. While ECG signals

acquired from these leads are appropriate for ECG rhythm assessment and determining

electrical capture during pacing, they should not be used for ECG morphological

evaluations. Attach conventional ECG electrodes for diagnostic purposes.

Note:

Under certain clinical circumstances, the R Series heart rate counting system may

respond to narrow, high-amplitude spikes in the ECG signal (e.g., 10 msec duration, 1

mV peak-to-peak amplitude) leading to miscounting of the patient’s heart rate. Do not

rely on heart rate meters if the ECG waveform contains narrow, high-amplitude spikes.

If there is a question about the accuracy of heart rate counting, verify the patient’s heart

rate by taking his/her pulse.

Preparations

Proper application and placement of electrodes is essential for high quality ECG monitoring.

Good contact between the electrode and skin minimizes motion artifact and signal interference.

Remove all clothing covering the patient’s chest. Dry chest if necessary. If the patient has

excessive chest hair, clip or shave it to ensure proper adhesion of the electrodes.

Electrode Placement

Depending upon local usage, the ECG leads are marked either RA, LA, LL, RL, and V or R, L,

F, N and C. The following table shows the markings and color codes for the different lead sets.

IEC Color

Coding

AHA Color

Coding

Placement of Electrodes

R/Red Electrode RA/White

Electrode

Place near patient’s right mid-clavicular line, directly below

clavicle.

L/Yellow

Electrode

LA/Black

Electrode

Place near patient’s left mid-clavicular line, directly below

clavicle.

F/Green

Electrode

LL/Red

Electrode

Place between 6th and 7th intercostal space on patient’s left

mid-clavicular line.

N/Black*

Electrode

RL/Green*

Electrode

Place between 6th and 7th intercostal space on patient’s right

mid-clavicular line.

C/White*

Electrode

V/Brown*

Electrode

Single movable chest electrode.

* Not used for 3-lead monitoring

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Monitoring Electrodes Attachment

3-lead configuration

RA

5-lead wire configuration

RA

LA

LA

V

RL

LL

3-lead set

3-lead cable

LL

5-lead cable

Note:

Lead sets and lead cables are different accessories and are not interchangeable. For

5-lead monitoring, use a 5-lead cable.

Note:

3-lead cables are available with and without Electro Surgical Unit noise suppression. If

the R Series unit is being used in the presence of an ESU, ablation device, or any other

high electromagnetic noise emitting source, ZOLL recommends using the R Series

3-Lead ECG Cable, ESU Filtered (PN: 9500-000693) specifically designed to limit

ESU artifact when monitoring heart rates.

Monitoring Electrodes Attachment

Attach snap-on leads to electrodes and check for good contact between the electrode and the

lead termination.

If you are using a 3-lead set, connect the end of the 3-lead set to a OneStep Pacing cable.

OneStep Pacing cable

3-lead set

connection complete

Peel the protective backing from the ECG electrode. Be careful to keep adhesive surface free of

electrolyte gel.

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CHAPTER 9 ECG MONITORING

Caution

Only use electrodes that are well within the expiration date indicated on the package.

Apply the ECG electrodes firmly to the patient’s skin, pressing around the entire perimeter of

the electrodes.

Plug the patient cable connector into the black ECG input connector (located on the rear panel

of the instrument).

If you are using a 3-lead set that is connected to a OneStep Pacing cable, plug the red

connector into the red OneStep cable input connector on the device, and plug the

connector (that is black inside) into the black ECG input connector on the device.

?

?

Note:

OneStep Pacing cable

(connected to a 3-lead set)

Caution

3-lead or 5-lead cable

To avoid electrosurgery burns at monitoring sites, ensure proper connection of the electrosurgery

return circuit so that the return paths cannot be made through monitoring electrodes or probes.

During electrosurgery, observe the following guidelines to minimize ESU interference and

provide maximum user and patient safety:

• Keep all patient monitoring cables away from earth ground, ESU knives, and ESU return

wires.

• Use electrosurgical grounding pads with the largest practical contact area.

Always assure proper application of the electrosurgical return electrode to the patient.

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Monitoring the Patient’s ECG

Monitoring the Patient’s ECG

Set the Controls

Set the Mode Selector to MONITOR, then press the LEAD button until the desired lead

configuration is selected. The selected lead is indicated at upper right of the display.

LEAD

SIZE

ALARM

SUSPEND

RECORDER

MONITOR

OFF

If the unit displays the ECG LEAD OFF, POOR LEAD CONTACT, or CHECK PADS message,

inspect the ECG electrodes or therapy electrodes, lead wires, and cables for proper connections.

If heart rate alarms are enabled with paddles selected, the unit displays the messages SELECT

LIMB LEADS and VF ALARMS OFF. If you see these messages, select limb or precordial leads.

If you want to change the size of the displayed ECG waveform, press the SIZE button until the

desired waveform size is displayed. Options are 0.5, 1, 1.5, 2, and 3 times the normal

size.

If you want to shut off the heart rate beeper, press the Options, then the QRS VOL OFF

softkeys. To turn it back on, press the QRS VOL ON softkey.

WARNING!

Implanted pacemakers may cause the heart rate meter to count pacemaker pulses

during incidents of cardiac arrest or other arrhythmias. Pacemaker patients should be

carefully observed. Check the patient's pulse; do not rely solely on heart rate meters.

Dedicated pacemaker detection circuitry may not detect all implanted pacemaker

spikes; patient history and physical exam are important in determining the presence of

an implanted pacemaker.

Implanted Pacemakers

The R Series device can be configured to detect pacemaker signals from a patient with an

implanted pacemaker and indicate their presence on the display. When pacer pulses are

detected, the device displays a 5mm, vertical, solid line on the ECG trace.

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CHAPTER 9 ECG MONITORING

CPR

IDLE

0:00

SpO2%

x1

PADS

Depth

Rate

99

ECG

Ɔ

PPI

72

Pace Marker

NIBP mmHg

----ECG

--CO2

RR

mmHg

----MONITOR

Options

Param

Code

Marker

Report

Data

Alarms

Test

Log

To disable detection of pacemaker spikes:

1. Press the Param softkey.

2. Press ECG.

3. Press Disable Pacer Detect.

The Pacer Off icon (

) appears in the ECG field to indicate that detection and rejection of

implanted pacemaker pulses by the heart rate detector is disabled. Do not disable the implanted

pacemaker detector when monitoring patients known or suspected to have an implanted pacer.

Disabling pacemaker pulse detection under these conditions can result in erroneously counting

pacemaker pulses as R-waves leading to the display of inaccurate heart rates.

CPR

IDLE

0:00

SpO2%

PADS

Depth

Rate

99

ECG

x1

Ɔ

PPI

75

NIBP mmHg

----ECG

--CO2

RR

Pacer Off icon

mmHg

----MONITOR

Options

Param

Code

Marker

Report

Data

Alarms

Test

Log

To re-enable detection of pacemaker spikes:

1. Press the Param softkey.

2. Press ECG.

3. Press Enable Pacer Detect.

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5-Lead Monitoring

5-Lead Monitoring

You can perform 5-lead ECG monitoring with the appropriate ECG patient cable. The 5-lead

cable allows you to monitor the following ECG leads:

• I, II, III

• aVR, aVL, aVF

• V1

Changing from 3-Lead Monitoring

To change from 3-lead to 5-lead monitoring, simply disconnect the 3-Lead ECG patient cable

(or OneStep Pacing cable ECG connector) and connect the 5-lead ECG cable. Refer to the

beginning of this section for appropriate preparations (i.e., placing electrodes, attaching

electrodes, setting the controls, etc.).

If any ECG lead becomes disconnected during monitoring, an ECG LEAD OFF message

appears on the display.

Changing from 5-Lead ECG Monitoring

To change from 5-lead monitoring to 3-lead monitoring, you must power off the unit for at least

10 seconds, remove the 5-lead cable, connect the 3-lead cable, then power on the unit again. If

you fail to shut the unit off for at least 10 seconds, the unit displays the ECG LEAD OFF

message after you disconnect the 5-lead wire cable, even if leads from a 3 lead ECG cable are

properly attached to the patient.

Simultaneous 3-Lead Printing

The R Series unit can display and print three simultaneous ECG leads when using a 5 lead

cable and an ECG lead is selected as the signal source (not PADS or PADDLES).

Note:

This feature does not work with a 3 lead cable.

To display and print 3 simultaneous leads:

1. Press the Options softkey, then press the Traces softkey.

2. Press 3 Leads.

Leads belong to two groups: limb leads (I, II and III) and augmented leads (aVR, aVL, and

aVF). The selected lead is always displayed and printed in the Trace 1 uppermost position. The

other two leads are displayed in the Trace 2 and 3 positions. For example, if aVL is the selected

Trace 1 lead, the Trace 2 and 3 positions display aVR, and aVF respectively.

3 ECG leads will also be printed (when an ECG lead is selected) if the “Print 3 Leads When

Leads are Sel.” configuration option is set to YES. Refer to the R Series Configuration Guide

for instructions.

See-Thru CPR Filter (Optional)

When OneStep CPR electrodes or OneStep Complete electrodes are in use, the R Series unit

allows simultaneous display and printing of the selected ECG lead and the same ECG lead with

CPR filtering applied. The CPR filter uses signals from the electrode’s CPR sensor to help

reduce artifact in the ECG signal caused by mechanical compressions of the chest, thereby

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CHAPTER 9 ECG MONITORING

providing a clearer view of the ECG during periods of CPR. For more detailed information on

this feature, see Chapter 7, "See-Thru CPR (Optional)".

To apply the See-Thru CPR Filter to the selected ECG lead and display it:

1. Press the Options softkey, then press the Traces softkey.

2. Press the Trace 2 or Trace 3 softkey.

3. Press Filt ECG.

If Display Filtered ECG in Trace1 is configured, the unit displays the filtered ECG in Trace1.

You can then switch between filtered and unfiltered ECG using the Enable/Disable Filt ECG

softkey. With the unfiltered ECG displayed in Trace1, the user of the R Series unit can also

enable the display of the filtered ECG in Trace2 or Trace3.

Adding Traces to Be Displayed

The screen can display up to three traces simultaneously. The trace for the selected ECG lead

always appears in the Trace 1 uppermost position.

If optional physiological monitoring parameters are installed in the unit, the operator can select

applicable traces to appear in the second or third position.

To select the display for the second or third trace:

1. Press the Options softkey, then press Traces.

2. Press Trace 2 or Trace 3 to select the position.

3. Press the softkey for the parameter or other waveform to display in the selected position (or

Off to clear that position).

Note:

Trace 3 is not available while the unit is in Pacer mode.

Printing the ECG on a Stripchart

The stripchart recorder documents the ECG trace with a 6 second delay at all times. To start the

stripchart recorder, press the RECORDER button. The stripchart recorder runs continuously

until you press the button again.

Each time the strip chart recorder is started, the time, date, ECG lead, size, and heart rate are

printed on the top part of the paper. If the unit is pacing, the output current is also printed.

Note:

Check the paper supply at the beginning of each shift and after each use to ensure

adequate recording capability. A colored stripe on the paper means that the paper

supply is low.

A CHECK RECORDER message appears on the display when the stripchart recorder is

activated without paper. The stripchart recorder automatically shuts off when there is no paper.

After loading new paper, press the RECORDER button to start the strip chart recorder.

Diagnostic Bandwidth

When using an ECG cable for monitoring, you can switch the unit to diagnostic bandwidth

(0.05-150 Hz) by pressing and holding the RECORDER button depressed. Diagnostic

bandwidth is maintained and printing continues as long as the RECORDER button is held

down. The unit reverts to standard monitoring bandwidth when you release the RECORDER

button.

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Alarms

Alarms

Setting Alarm Limits

Unless configured otherwise, heart rate alarms are preset at 30 bpm (bradycardia) and 150 bpm

(tachycardia). Refer to the R Series Configuration Guide for details on setting power-up alarm

limits.

To set alarm parameters:

1. Press the Alarms softkey to view the Alarm Set screen and softkeys.

Depth

Rate

99

NIBP mmHg

------CO2

RR

CPR

IDLE

0:00

SpO2%

mmHg

----Next

Param

ECG

x1

PADS

Ɔ

PPI

72

ALARM SET

Parameter

ECG HR

SpO2

EtCO2

RESP RATE

Low

30

85

25

5

High

ENABLE

DISABLE

ENABLE

ENABLE

NIBP SYS

NIBP DIA

NIBP MEAN

ENABLE

ENABLE

ENABLE

90

50

60

160

110

130

Prev

Param

State

Next

Field

Change

Value

150

100

55

120

Each setting includes the alarm state

(ENABLE, DISABLE, or AUTO) and

the low and high limit of the

acceptable range of values.

Return

2. Press the Next Param or Prev Param softkey.

This scrolls the highlighted area among the different available vital signs.

If you want to change the state of the highlighted vital sign:

a. Press the Change Value softkey.

b. Press the Inc > or Dec < softkey to change the state value.

c. Press the Enter softkey.

The State field can be set to three possible values, Enable, Disable, or Auto.

• Disable permanently turns off alarm processing for the selected physiological parameter.

• Enable causes alarm processing to operate whenever alarms are activated via the front

panel ALARM key.

• Selecting AUTO sets the lower and upper alarm limits to 80% and 120% of the patient’s

currently measured heart rate, if valid measurements are present for the vital sign when

the Enter softkey is pressed. (Refer to appropriate Operator’s Guide parameter insert(s)

for percentages associated with other parameters).

3. Press the Next Field softkey to move to the Low or High field for the highlighted vital sign;

repeat steps 2a through 2c to change the Low or High value.

Note:

To recalculate the Low and High limits for any parameter when these limits have

previously been set using the AUTO State, follow the procedure above to select AUTO

again, and then press the Enter softkey. The unit automatically resets the Low and

High limits based upon the currently measured value of the selected physiological

parameter.

4. Press the Return softkey to set all values and return to normal operating mode.

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CHAPTER 9 ECG MONITORING

Heart Rate Alarm Limits

The heart rate is displayed in the upper right-hand corner of the screen.

Unless configured otherwise, heart rate alarms are preset at 30 bpm (bradycardia) and 150 bpm

(tachycardia). The low heart rate alarm limit range is 20 bpm to 100 bpm.

When the unit is monitoring a patient’s heart rate via ECG, the range for the high heart rate

alarm limit is 60 to 280 bpm with a default setting of 150 bpm. When the unit is monitoring a

patient’s pulse rate via pulse oximetry (SpO2), however, the unit automatically lowers the upper

limit for the high heart rate alarm to 235 bpm. The unit restores the original high heart rate

alarm limit when ECG monitoring resumes.

Vital Sign Alarms

Each vital sign has associated high and low alarm limits. You can set alarm limits for patient

heart rate and other optional monitoring parameters such as pulse oximetry (SpO2),

non-invasive blood pressure (NIBP), or end-tidal carbon dioxide monitoring (EtCO2), if

available.

The R Series unit has three levels of alarms:

• High Priority — Reflects physiological parameters that are out of bounds. When these

alerts occur, the unit emits an audio tone at 2.86 KHz, highlights the alarming parameter,

and flashes the associated alarm bell.

• Medium Priority — Reflects equipment- related, user correctable faults such as LEAD

OFF. The unit emits a two beep audio tone and displays a message for a timed period.

• Low Priority — Informational message only; the unit emits a two beep audio tone and

displays a message for a timed period.

Suspending and Silencing Alarms

When a high priority alarm occurs, the unit emits a continuous alarm tone, highlights the value

of the alarming parameter on the display, and flashes the bell icon associated with that

parameter.

You can either suspend the alarm tone for 90 seconds or you can silence the alarm tone.

Suspending Alarm Tones

To suspend an alarm tone for 90 seconds, press and release the ALARM SUSPEND

button in less than 1 second. The alarms tone stops, the unit displays an “X” across

the alarm’s flashing bell icon, and the value for the alarming parameter remains

highlighted. (If you press the ALARM SUSPEND button again, alarm processing is

reactivated.)

After 90 seconds, if the physiological parameter remains at a value that triggers the alarm, the

unit sounds the alarm tone again.

If the alarm condition clears (the physiological parameter returns to a value within

range) after you suspend the alarm tone, the unit resets the alarm and displays the bell

icon (no flashing, no “X”). The alarm parameter displays normally (no highlighting).

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Alarms

If a second, different alarm occurs after you suspend an alarm tone, you can suspend the alarm

tone for that second parameter by pressing and releasing the ALARM SUSPEND button again.

The unit behaves the same as described above for the first alarm. Suspending a second alarm

does not alter the timing or processing of the previously suspended alarm.

Silencing Alarm Tones

To silence the alarm tone, press and hold down the ALARM SUSPEND button for

between 1 and 3 seconds. The alarm tone stops, the unit displays the alarm’s bell icon

in inverse video with an “X” across it, and the value of the alarm parameter remains

highlighted. (If you press the ALARM SUSPEND button again, alarm processing is

reactivated.)

The alarm tone will not sound again as long as the physiological parameter’s value remains out

of range.

If the alarm condition clears (the physiological parameter returns to a value within

range) after you silence the alarm tone, the unit resets the alarm and displays the bell

icon (no inverse video, no “X”). The alarm parameter value displays normally (no

highlighting).

After the unit resets an alarm, should the physiological parameter again go out of range, it will

trigger the alarm.

Activating and Deactivating Alarm Processing

To deactivate all alarms on the R Series unit, press and hold down the ALARM

SUSPEND button for 3 seconds or longer. The bell icons for all alarms will have an

“X” through them to indicate that the alarms are deactivated. Alarm parameter values

display normally (no highlighting).

To reactivate the alarms, press and release the ALARM SUSPEND button in less than 1

second.

Smart Alarms

In DEFIB or MONITOR mode, ECG/heart rate alarm capabilities are enhanced with the

defibrillation advisory feature called Smart Alarms. When alarms are operating, this feature

triggers an audible alarm and displays the message CHECK PATIENT whenever the unit detects

ventricular fibrillation or wide complex ventricular tachycardias. This message appears on the

display and the stripchart recorder print out.

If alarms are operating in PACER mode, the unit displays VF ALARMS OFF, indicating that the

Smart Alarms feature has been disabled.

The Smart Alarms feature is always disabled when augmented leads (aVR, aVL, aVF), V-leads,

or PADDLES are selected for ECG monitoring. The messages VF ALARMS OFF and SELECT

LIMB LEADS are alternately displayed when alarms are activated and augmented leads or

V-leads are selected. These messages are displayed only the first time you select the augmented

or V-leads. They are not redisplayed as you cycle through the lead selection.

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CHAPTER 9 ECG MONITORING

Alarm Settings for Unattended Monitoring

Alarms for all monitored parameters should be activated whenever a patient is left unattended.

Alarm limits should be intentionally set to levels appropriate for detecting relevant changes in

the patient’s condition. Leaving alarm settings at their default levels or setting them to the

extremes of their ranges may defeat the utility of the alarms even when they are activated.

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Chapter 10

Event Records and Reports

The R Series defibrillator records important event information during operation. You can

retrieve this information in various forms:

• Summary Report — Summary report allows you to store and later retrieve important ECG

and event information. You can print summary report information in various formats. For

more information about Summary Report and how to print a report, refer to the Summary

Report section below.

• Full Disclosure Recording — Full Disclosure waveforms along with event information are

stored and may be reviewed using ZOLL CodeNet Central software. For information about

Full Disclosure Recording, refer to “Full Disclosure Recording” on page 10-8.

• Incident Log — The Incident log is an abbreviated list of all major events recorded in

Summary Report. For more information about the Incident log and how to print it, refer to

“Printing an Incident Log” on page 10-8.

Summary Report

The R Series defibrillator automatically records defibrillation and cardioversion events,

PACER mode information, heart rate alarms, and segments of ECG when the recorder is

activated. Associated event information including device control settings, time, and date are

also recorded.

The following events trigger Summary Report to automatically record information:

• Power is turned on.

• Stripchart recorder is turned on.

• Defibrillator shock is administered.

• Code markers entered.

• ECG rhythm analysis is initiated.

• VF alarm is triggered.

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CHAPTER 10 EVENT RECORDS AND REPORTS

• Parameter alarm is triggered.

• Mode Selector is turned to PACER.

Note:

Diagnostic bandwidth recordings are not included in Summary Report.

The unit stores and prints summary information in chronological order. The memory allocated

for summary data can hold up to 350 defibrillation or 350 recorder-activated events. All event

data remains in memory and is accessible until data is manually erased or until the

preconfigured time interval has elapsed. (The time interval is specified in the Set Report Restart

Delay parameter; see the R Series Configuration Manual for more information). A new patient

record is automatically created when the unit has been turned off for a configurable time period

of 5 minutes to 72 hours. When all memory for code summary is used, the unit issues the

message REPORT FULL.

To continue recording the code event after the memory has been filled or to prepare the unit for

a new code, the operator can erase the stored records. (Refer to “Erasing Summary Report and

Full Disclosure” on page 10-9.)

Summary Report Formats

This section describes the information included with each type of summary report record.

Each summary report begins with an overview of all events currently stored in memory

including:

• Date and time

• Report start time (either when the unit was turned on or, if data was manually erased, when

•

•

•

•

•

subsequent recording began)

Time of the last recorded event

Total number of shocks delivered

Cumulative pacing time

Device ID

System serial number

Space is provided for patient name and comments. On the last event recorded, the unit prints

“SUMMARY COMPLETE” on the bottom left of the stripchart.

Figure 10-1.

10–2

Summary Report

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Summary Report

Defibrillation Event Format

The summary report function records 6 seconds of pre-shock and 9 seconds of post-shock

patient ECG data. Also recorded are joules selected, joules delivered, Sync if active (includes

Sync markers), ECG lead, ECG size, patient current, defib impedance, actual time and date.

The date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds

before the event.

Figure 10-2.

Defibrillation Event Format (Pre-Shock)

Figure 10-3.

Defibrillation Event Format (Post Shock)

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CHAPTER 10 EVENT RECORDS AND REPORTS

Pacer Mode Selected Format

The summary report function records 6 seconds of pre-pace patient ECG data. Also recorded

are the ECG lead, ECG size, patient's heart rate, pace rate, pace current, time and date. The

date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before

the event.

Figure 10-4.

Pacer Mode Selected Format

After establishing a paced rhythm, turning the recorder on briefly records the paced rhythm for

later reports. If Async pace is active, the annotation ASYNC PACE is also recorded and printed.

The date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds

before the event.

Figure 10-5.

10–4

Pacer Mode Selected Format (Asynchronous Pacing)

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Summary Report

Heart Rate Alarm Activated Format

The summary report function records 6 seconds of pre-alarm patient ECG. Also recorded are

the ECG lead, ECG size, patient's heart rate, actual event time, and date. The date/time printed

on the top of the strip corresponds to the ECG data occurring 6 seconds before the event. If the

pacer is on during this event, the pacing rate and pacing current are also recorded.

Figure 10-6.

Heart Rate Alarm Activated Format

VF Alarm Activated Format

The summary report function records 18 seconds of patient ECG data associated with each VF

alarm. Also recorded are the ECG lead, ECG size, actual event time, the number of noise

events, and the message CHECK PATIENT. The date/time printed on the top of the strip

corresponds to the ECG data occurring 6 seconds before the event.

Figure 10-7.

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CHAPTER 10 EVENT RECORDS AND REPORTS

Recorder On Format

The summary report function records 6 seconds of patient ECG prior to turning on the recorder.

Also recorded are the ECG lead, ECG size, patient's heart rate, actual event time, and date. The

date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before

the event. If the pacer is on during this event, the pacing rate and current are also recorded. If

Async pace is active, the annotation ASYNC PACE is recorded.

Figure 10-8.

Recorder On Format

Analyze Format

The summary report function records six seconds of pre analysis ECG, 12 seconds of ECG

recorded during the analysis and the annotation SHOCK ADVISED or NO SHOCK ADVISED.

The date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds

before the analysis was started.

The analysis normally consists of three consecutive 3-second ECG rhythm analyses. Each

segment is represented at the top of the strip with either an asterisk (*) for shockable, or a dash

(-) for non shockable. The unit automatically charges to the preconfigured energy level upon

detection of the first shockable segment. If at least two of the three analyses determine that the

patient has a shockable rhythm, the unit will prompt the operator to shock the patient. If two or

more of the three 3-second ECG analyses do not detect a shockable rhythm, the unit alerts the

operator that no shock is advised.

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Summary Report

Note:

If the first two segments are shockable, only two asterisks appear on the stripchart, and

the third segment is not analyzed.

Figure 10-9.

Analyze Format

In addition, the ECG rhythm analysis report can include the following annotations:

Annotation

Description

POOR PAD CONTACT

The hands-free therapy electrodes are improperly connected.

ANALYSIS HALTED

A fault condition occurred, or the operator pressed the ANALYZE

button again.

NOISY ECG

Excessive noise was detected.

SHOCK ADVISED

A shockable rhythm was detected.

NO SHOCK ADV.

No shockable rhythm was detected.

Printing the Entire Summary Report

To print all summary report data:

1. Press the Report Data softkey, then press Print Chart.

2. Press the Print All softkey.

The unit prints all stored code events and code markers in chronological order beginning

with the oldest entry. If the stripchart recorder is on or the defibrillator is charged, summary

report printing is disabled. To stop printing a report, press the RECORDER button or turn

off the unit. You can print an unlimited number of copies of the report by repeating this

procedure.

Note:

Summary report printing is interrupted when a, ECG analysis is in progress, or the

defibrillator is charging or charged. Also, if a summary report is printing and you press

the Report softkey to print another type of report (such as the log report), the device

stops printing the summary report and begins printing the selected report.

If the recorder is out of paper when the Report Data softkey and a corresponding print

softkey are pressed, a CHECK RECORDER message appears on the display. Load paper and

press the Report Data softkey again to select the report to print.

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Printing a Partial Summary Report

To print a partial summary report:

1. Press the Report Data softkey, then press Print Chart.

2. Press the Print Range softkey.

3. Use the First Event, Prev. Event, Next Event and Last Event softkeys to locate the event

from which printing will start (all subsequent events are also printed).

4. Press the Print softkey.

The unit prints all records from the selected item to the most recent.

Note:

The overview information (such as the number of shocks delivered) covers all stored

summary data, not just the selected range.

Full Disclosure Recording

Along with event information captured in Summary Report, R Series also records the full

disclosure CPR sensor and parameter waveforms. The full disclosure recording on the unit can

accommodate at least 6 hours of data.

Full disclosure recordings are erased at the same times as Summary Reports.

Incident Logs

An incident log is an abbreviated list of all major events recorded in summary report. You can

print an incident log that includes the following events and their time of occurrence.

• Unit powered on.

• Defibrillation advisory message issued (for example, CHECK PATIENT or SHOCK

ADVISED)

• Shock delivered (and energy level)

• PACER mode selected

• Alarm triggered

• Stripchart printing started

• Code marker entered

In addition, the incident log lists the following:

• System serial number

• Device identification number

• Report start time (when the summary data was last erased)

• Time of the last recorded event

• Total number of shocks delivered

• Total cumulative pacing time

Printing an Incident Log

To print an incident log, press the Report Data softkey, then press the Print Log softkey.

The log is printed on the stripchart, starting with the oldest entry.

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Erasing Summary Report and Full Disclosure

Erasing Summary Report and Full Disclosure

Summary information can be erased either manually or automatically.

Manual Erasure

You can manually erase summary records and full disclosure data from memory in preparation

for collecting data for a new patient.

Note:

When the event summary memory and full disclosure memory are filled, data

recording stops. You must erase the records to continue recording.

Make sure to print out any important summary records currently in memory. Transfer important

full disclosure records to ZOLL CodeNet Central.

To manually erase stored data:

1. Press the Report Data softkey.

2. Press the Erase softkey, then the Erase Report softkey. To erase all reports stored in the unit,

press Erase All.

Automatic Erasure

Automatic erasure of summary report and full disclosure data occurs if the R Series unit has

been turned off for a user-configurable period of 5 minutes to 72 hours.

Formatting the Disk

The R Series uses an internal flash memory disk that stores the data in files similar in structure

to those on a personal computer hard drive. Like a personal computer, there may be rare

occasions when the internal disk requires formatting. For example, this may occur if all power

(battery and ac) is removed while erasing a report. Under such a circumstance, the message

DISK FORMAT REQ. will be displayed. Perform the following steps to format the flash

memory disk. All patient data will be erased during this procedure. If possible, print out any

important summary records currently in memory and transfer important full disclosure records

to ZOLL CodeNet Central.

1. Press the Report Data softkey.

2. Press the Erase softkey, then the Format Disk softkey.

3. When you are ready, press the Confirm Format softkey.

The messages FORMATTING DISK and DO NOT POWER OFF will be displayed while the

disk is formatting. This procedure may take several minutes to complete.

Related Messages

Message

Description

CHECK RECORDER

The paper supply in the stripchart printer is exhausted.

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10–10

Message

Description

DISK FORMAT REQ.

The internal flash memory disk file system has been

corrupted. Follow the procedure in the previous section,

“Formatting the Disk.”

DO NOT POWER OFF

Do not remove power (both battery and AC) while the

unit is erasing reports or formatting the disk.

ERASING REPORT

The unit is erasing the selected report data.

FORMATTING DISK

The internal flash memory disk is being formatted.

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Chapter 11

File Transfer

This chapter describes procedures for transferring files from the R Series defibrillator to an

external system, such as a personal computer or handheld device. It also explains how to

remove, install and erase a Compact Flash card.

Transferring Files to an External Device

You can transfer the following files from the R Series defibrillator to an external device:

• Device check, activity log, and full disclosure waveforms

• Defibrillator test information

The unit includes the following data transfer features:

• 802.11 Wi-Fi (optional)

• USB device connector (optional)

• Compact flash card slot

To retrieve and review event files, you need one of the following software packages installed on

the receiving equipment:

• ZOLL CodeNet Central software

• ZOLL RescueNet Code Review software

To retrieve and review maintenance files, you need ZOLL Defib Dashboard software installed

on the receiving equipment.

R Series defibrillators use the Microsoft Windows file structure for stored records. Files can be

transferred to a properly equipped Windows-based personal computer or handheld device. With

CodeNet Central software, the personal computer allows the user to access the files for review.

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CHAPTER 11 FILE TRANSFER

If configured, the unit can display a reminder to transfer files while in clinical mode. When

turned off, the unit displays the message TURN UNIT ON AND ENTER DATA TRANSFER

MODE TO TRANSFER REPORT for 15 seconds. This is turned off by default; see the R Series

Configuration Guide to change this setting.

Wi-Fi (Optional)

The R Series has an optional Wireless Ethernet function that transfers data files using the IEEE

802.11 protocol (Wi-Fi). This includes a ZOLL R Series Data COMM Card or ZOLL R Series

Data COMM II card, and a protective guard that must be installed on the unit. See R Series

Data COMM Instructions for Use and Wi-Fi Guard Installation (Part number 9652-000395) or

R Series Data COMM II Instructions for Use and Wi-Fi Guard Installation (Part number

9652-000405) for instructions on how to install the Wi-Fi Guard.

Do not clean the Wi-Fi Data COMM or Data COMM II Card with isopropyl alcohol.

All file transfer operations are terminated when the defibrillator is switched to either Defib

mode or Pacing mode, or powered off.

Installing or Removing a Compact Flash Card

Before you begin, check the card and its connector to ensure that they are clean and

undamaged.

To install a compact flash card:

1. Insert the card, with its label side up, into the front slot on the lower left side of the unit.

You can install a compact flash card while the unit is operating or while it is turned off.

2. Slide the card into the slot until it is firmly seated.

Figure 11-1.

11–2

Inserting Compact Flash Card

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Transferring a Full Disclosure File to a Compact Flash Card

To remove a compact flash card:

Press the release button and pull the card out of the slot.

Figure 11-2.

Removing a Compact Flash Card

Transferring a Full Disclosure File to a Compact Flash

Card

Make sure that a compact flash card is installed in the slot on the left side of the device.

To transfer data to a compact flash card:

1. Turn the Mode Selector to MONITOR.

2. Press the Report Data softkey.

3. Press the Transfer Mode softkey.

4. Press the Report to Card softkey.

The message TRANSFERRING DATA is displayed. All data is transferred to the installed CF

data card.

Note:

Do not remove the CF card while files are transferring. Corruption may result on the

data card.

When all files are transferred, the message DATA TRANSFERRED is displayed. You can now

remove the CF card from the R Series unit.

To exit Data Transfer mode, press the Exit Transfer softkey.

Transferring Device Check and Activity Log Files to a

Compact Flash Card

Make sure that a compact flash card is installed in the slot on the left side of the device.

To copy the Code Readiness Log to a CF card:

1. Turn the mode selector to MONITOR.

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CHAPTER 11 FILE TRANSFER

2. Press the Report Data softkey.

3. Press the Transfer Mode softkey.

4. Press the More softkey.

5. Press the Defib History to Card softkey.

The message TRANSFERRING DATA is displayed. All data is transferred to the installed CF

data card.

Note:

Do not remove the CF card while files are transferring. Corruption may result on the

data card.

When all files are transferred, the message DATA TRANSFERRED is displayed. You can now

remove the CF card from the R Series unit.

To exit the Data Transfer mode, press the Return softkey and then the Exit Transfer softkey.

Transferring Files Through the USB Port (Optional)

Before you begin, connect a USB cable from the Windows external device with USB host

capability (for example, a Window PC), to the R Series defibrillator USB device port.

USB Host Port

(Future Use)

Figure 11-3.

USB Device Port

USB Ports

To transfer data through the USB port:

1. Turn the Mode Selector to MONITOR.

2. Press the Report Data softkey.

3. Press the Transfer Mode softkey.

4. Press the More softkey.

5. Press the Enable USB softkey.

The R Series is now in USB Transfer Mode.

6. Initiate data transfer using ZOLL CodeNet Central.

To exit USB Transfer mode, press the Disable USB softkey or switch the Mode Selector to

DEFIB, PACER or OFF.

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Transferring Full Disclosure Files Through Wi-Fi (Optional)

Transferring Full Disclosure Files Through Wi-Fi

(Optional)

Before you begin, ensure the Wi-Fi card is properly seated with the name R Series

Data COMM or Data COMM II facing up in the compact flash slot. Make sure that the Wi-Fi

guard has been attached.

To transfer data through Wi-Fi:

1. Turn the Mode Selector to MONITOR.

2. Press the Report Data softkey.

3. Press the Transfer Mode softkey.

4. Press the Report to Wi-Fi softkey.

5. The Enter Report ID screen will appear, and you will be prompted to enter a unique report

ID. Use the arrow keys to select the desired characters, then press the Enter Char softkey.

Pressing the ... key will change the table to a different set of characters, including upper case

letters. To cancel and return to the previous screen, use the arrow keys and select Cancel.

Enter Report ID

Pat230

a

b

c

d

e

f

g h

i

j

k

m

n

o

p

q

r

s

u

v

w x

y

z

0

1

2

3 4 5 6 7

8

;

,

@

.

+

-

:

t

_ ?

'

"

l

9

Cancel

Del

...

DATA TRANSFER MODE

Enter

Char

Note:

Send

Report

Enable Report ID must be enabled in System Configuration mode for the report screen

to appear (See the R Series Configuration Guide). If Enable Report ID is set to No,

then the screen will not be displayed and the report will be sent immediately.

6. To send the report, press the Send Report softkey. The R Series is now in Wi-Fi Transfer

Mode and a status text message box appears in the middle of the screen and describes the

status of the file being sent. When the full disclosure file is transferred, the messages

TRANSFER COMPLETE and Full Disclosure Was Sent are displayed.

TRANSFER COMPLETE

Full Disclosure Was Sent

DATA TRANSFER MODE

Erase

Report

Return

7. To erase the report, press the Erase Report softkey. To keep the report and return to the

Transfer Mode screen, press the Return softkey.

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CHAPTER 11 FILE TRANSFER

Note:

If you are out of the range of an access point, the data will not be transferred and the

message Wi-Fi Network Not Found is displayed. Press the Return softkey to return to

the previous menu and try again.

TRANSFER FAILED

Wi-Fi Network Not Found

Contact Network Administrator

DATA TRANSFER MODE

Return

To exit Wi-Fi/DataTransfer Mode, press the Return softkey and then the Exit Transfer

softkey or switch the Mode Selector to OFF.

Transferring Device Check and Activity Log Files

Through Wi-Fi (Optional)

Before you begin, ensure the Wi-Fi card is properly seated with the name R Series

Data COMM or Data COMM II facing up in the compact flash slot. Make sure that the Wi-Fi

guard has been attached.

To transfer data through Wi-Fi:

1. Turn the Mode Selector to MONITOR.

2. Press the Report Data softkey.

3. Press the Transfer Mode softkey.

4. Press the More softkey.

5. Press the Defib History to Wi-Fi softkey.

The R Series is now in Wi-Fi Transfer Mode and a status text message box appears in the

middle of the screen and describes the status of the files being sent. When the files are

transferred, the messages TRANSFER COMPLETE, Device Check Was Sent, and Activity

Log Was Sent are displayed.

Note:

If you are out of the range of an access point, the data will not be transferred and the

message Wi-Fi Network Not Found is displayed.

To exit Wi-Fi/DataTransfer Mode, press the Return softkey and then the Exit Transfer

softkey or switch the Mode Selector to OFF.

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Transferring Device Check and Activity Log Files Through Wi-Fi (Optional)

Related Wi-Fi Messages

Informational Message

Description

INITIALIZING NETWORK

A transfer has been initiated.

CONNECTING TO THE NETWORK

The association with the host network is being

established.

CONNECTING TO SERVER

The unit is connecting to a remote system.

TRANSFER IN PROGRESS

The data transfer is in progress.

WAITING FOR SERVER RESPONSE

The unit is waiting for the final acknowledgment from

a remote system.

TRANSFER COMPLETE

XX Was Sent

The data transfer is complete (and lists the file type

that was sent).

XX=file type (Full Disclosure, Activity

Log, or Device check)

Error Message

Description/Action

TRANSFER FAILED

Wi-Fi Card Not Detected

Verify Installation of Wi-Fi Card

The transfer failed because no Wi-Fi card is installed

in the CF slot, or the card was ejected from the slot

during transmission.

Action: Make sure that the correct Wi-Fi card is

properly installed in the unit.

TRANSFER FAILED

Wi-fi Card Not Configured

Contact Network Administrator

The Wi-Fi card’s configuration data is corrupt or blank.

TRANSFER FAILED

Invalid Wi-Fi configuration

Error Number: N

Contact Network Administrator

The transfer failed because the Wi-Fi configuration

was illegal. N indicates one of following error codes:

Action: Verify the configuration settings on the Wi-Fi

card. Contact the Network Administrator for

assistance.

N = 1: Local Static IP settings

Action:

1) If running in Static IP mode, make sure that the

relevant static IP addresses are not 0.0.0.0.

2) Make sure the subnet mask is in the correct format.

N = 2: Server Static IP address

Action: With DNS set to No, make sure that the IP

addresses for the Full Disclosure Server and Defib

History Server are not 0.0.0.0.

N = 3: Server Name

Action: With DNS set to Yes, make sure that valid

names exist for the Full Disclosure Server and the

Defib History Server.

N = 4: DNS IP address

Action: With DHCP set to No and DNS set to Yes,

make sure that the DNS IP Address is not 0.0.0.0.

N = 5: SSID

Action: Make sure that there is at least one valid

SSID for each desired mode (infrastructure and data

management server).

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N = 6: Missing required configuration data for Network

Profile 1 with Enterprise Authentication selected

(Data COMM II only)

Action: Check the following:

If Authentication Protocol is set to PEAP, make sure

that the following are configured:

• User Identity

• User Password

If Authentication Protocol is set to TLS, make sure

that the following are configured:

• User Identity

• Private Key Password

• Client Certificate

N = 7: Missing required configuration data for Network

Profile 2 with Enterprise Authentication selected

(Data COMM II only)

Action: Same as above.

N = 8: The Defib Upload Server's Username /

Password are blank within the Full Disclosure and

Defib History server configuration items

Data COMM II only)

Action:

If Full Disclosure Transfer Mode is set to Server, make

sure that the Username (Full Disclosure) and

Password (Full Disclosure) entries are valid.

If Defib History Transfer Mode is set to Manual,

Automatic, or Both, make sure that the Username

(Defib History) and Password (Defib History) entries

are valid.

N = 9: Missing required certificate file for Network

Profile 1 with Enterprise Authentication selected

(Data COMM II only)

Action:

If Authentication Protocol is set to PEAP, make sure

that a root certificate has been added (if not using the

default ZOLL root certificate).

If Authentication Protocol set to TLS, make sure that a

root certificate has been added (if not using the

default ZOLL root certificate) and that the correct

client certificate has been configured.

N = 10: Missing required certificate file for Network

Profile 2 with Enterprise Authentication selected

(Data COMM II only)

Action: Same as above.

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Transferring Device Check and Activity Log Files Through Wi-Fi (Optional)

TRANSFER FAILED

Network Error: General

Errror Number: NNNN

Contact Network Administrator

The transfer failed because of a general network

Wi-Fi error. NNNN may indicate one of the following

error codes:

N = 7004

N = 7010

N = 7011

N = 7015

N = 7016

Action: Install another Data COMM card.

N = 7500

N = 7501

N = 7502

N = 7503

N = 7504

N = 7505

N = 7506

N = 7507

Action: Install another Data COMM II card.

N = 7017

Action: Make sure that the Defib Upload Server is

running, is operational, and can be reached on the

network.

TRANSFER FAILED

Network Error: Unknown [-7002]

Action: Make sure that no illegal characters are used

for the SSID names.

TRANSFER FAILED

Wi-Fi Card Failure

Error Number: -7009

Contact Network Administrator

The Wi-Fi card’s configuration data is corrupt or

cannot be read. (Data COMM only)

TRANSFER FAILED

Wi-Fi Network Not Found

Contact Network Administrator

The R Series could not associate with a Wi-Fi

network.

Action:

Install another Data COMM card. Contact the Network

Administrator for assistance.

Action:

1) Make sure that the configuration values for the

SSID names are correct.

2) Make sure that the R Series unit is within range of

the wireless server.

3) Contact the Network Administrator for assistance.

TRANSFER FAILED

Could Not Connect To Server

Contact Network Administrator

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The R Series could not communicate with the

DefibUpload Server.

Action:

1) Make sure that the DefibUpload Server is running,

is operational, and can be reached on the network.

2) If WEP is enabled, make sure that the WEP keys

on the R Series and Access Point match (value and

slot location).

3) Make sure that the server port is correct.

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CHAPTER 11 FILE TRANSFER

TRANSFER FAILED

Network Error: DHCP

Contact Network Administrator

The DHCP request has failed.

TRANSFER FAILED

Network Error: DNS

Contact Network Administrator

The DNS request has failed.

TRANSFER FAILED

Full Disclosure Service Not Available

Contact Network Administrator

The option to accept full disclosure files is not enabled

on the server.

TRANSFER FAILED

Defib History Service Not Available

Contact Network Administrator

The option to accept Defib History files is not enabled

on the server.

TRANSFER FAILED

Server Rejection

Contact Network Administrator

The server rejected the unit’s request.

TRANSFER FAILED

Unsupported Wi-Fi Card

Verify Installation of Wi-Fi Card

The card installed in the CF slot is not an R Series

Data COMM or Data COMM II card.

TRANSFER FAILED

Unsupported Wi-Fi Card

Update Wi-Fi Card

The card installed in the CF slot is an incorrect

version. (Data COMM II only)

TRANSFER FAILED

Authentication Error

The encryption passphrase/key is incorrect.

TRANSFER FAILED

Invalid Certificate

Contact Network Administrator

Could not associate to an SSID using WPA/WPA2

Enterprise security because one or more of the

certificates is invalid or expired. (Data COMM II only)

Action:

1) If WEP is enabled, make sure that the WEP keys

on the R Series and Access Point match (value and

slot location).

2) Make sure that the DHCP server is operational.

Action:

1) Make sure that the DNS server is running,

operational, and properly configured.

2) Make sure that the R Series configuration values

pertaining to the server names (Full Disclosure and

Defib History) are correct.

Action: Contact the Network Administrator for

assistance.

Action: Contact the Network Administrator for

assistance.

Action: Contact the Network Administrator for

assistance.

Action: Make sure that the correct Wi-Fi card is

properly installed in the unit.

Action: Install a Data COMM II card that is the latest

version.

Action: Contact the Network Administrator for

assistance.

Action: Contact the Network Administrator for

assistance.

TRANSFER FAILED

Invalid Credentials

Contact Network Administrator

Could not associate to an SSID using WPA/WPA2

Enterprise security because one or more of the

credentials were invalid. (Data COMM II only)

Action: Contact the Network Administrator for

assistance.

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Chapter 12

Maintenance

Defibrillator equipment must be maintained to be ready for immediate use. The defibrillator

should be tested daily. The R Series defibrillator gives you two readiness testing options:

• Automatic

• Manual

Note:

Both automatic and manual test results are automatically recorded to internal memory.

Maintenance Frequency

Visual Inspection

Once per day, inspect Code Readiness indicator.

Code Readiness Test

(Automatic)

Once per day, unless configured Off, in which case, perform manual

defibrillator testing daily.

Manual Defibrillator

Testing

Once per week; daily if Code Readiness Test is configured Off.

When the R Series device ships from ZOLL, the Code Readiness indicator may show a red

“X.” A manual readiness test should be performed (in addition to other site-specific tests such

as HiPot and Leakage) prior to putting the device into service. Follow the procedure on page

12-3, and verify that the Code Readiness indicator displays a green “.”

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CHAPTER 12 MAINTENANCE

Routine Procedures

Daily Visual Inspection

Equipment

Ensure that the unit is clean (with no fluid spills) and free of visible damage.

Inspect all cables, cords, and connectors for good condition (no cuts, fraying or bent pins).

Check that the paddle surfaces are clean and free of electrolyte gel and other contaminants.

Supplies and Accessories

Verify the presence, proper condition and quantity of all disposable supplies (such as ECG

monitoring electrodes, electrode gel, stripchart paper, alcohol swabs, razors, and

antiperspirant).

Ensure that two sets of ZOLL therapy pads are available in sealed packages. Check the

expiration date on all ZOLL therapy pad packages.

Batteries/External Power Supply

Check that a fully charged battery pack is installed in the unit.

Check that a fully charged spare battery pack accompanies the unit, or that the unit has ready

access to a local AC mains power outlet.

Code Readiness Status

Look at the /x Code Readiness indicator on the R Series defibrillator. If the Code Readiness

indicator displays a red “X” the unit is not ready for therapeutic use.

Should the automatic Code Readiness test fail, the R Series unit sets its Code Readiness

indicator to a red “X”. If the failed unit is connected to AC power, it will also display a Code

Readiness status report highlighting the defibrillator functions or accessories that are

compromised. If the failed unit is not connected to AC power, only the red “X” will display.

Connect the unit to AC power. Turn the unit to MONITOR mode, then press the Test Log

softkey to determine the problem. Readiness test reports can be displayed and printed as

described in “Code Readiness Log” on page 12-6.

Take corrective actions (for example, replace electrodes), or remove the unit from service, and

consult “Troubleshooting” on page 13-1.

While a red “X” indicates the unit is not ready for therapeutic use, the device will not prevent a

user from attempting to deliver therapy. An example of a condition in which therapy delivery

may still be possible is when expired electrodes are connected to the device.

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Manual Defibrillator Testing

Code Readiness Test

The R Series defibrillator performs Code Readiness tests automatically to verify its integrity

and readiness for emergency use. These tests verify the following:

• Battery — Verifies that the battery state of charge is sufficient for at least one hour of

continuous monitoring and ten shocks at maximum energy.

• Therapy Electrodes— Verifies that OneStep Pacing, CPR, or Complete electrodes are

attached to the unit and have not expired.

Note:

The Code Readiness system automatically verifies the integrity of the specific

electrodes listed above. Other electrodes (including members of the OneStep family)

should be verified manually for connection, condition, and expiration date.

• ECG circuitry — Verifies that the ECG signal acquisition and processing electronics are

functional.

• Defibrillator charge and discharge circuitry — Verifies that the defibrillator electronics are

functional and can charge and discharge at 30 joules through the patient cable and into

paddles, OneStep electrodes, or the Test Port.

• Microprocessor hardware and software — Verifies the proper function of the

microprocessor electronics and the integrity of software.

• CPR circuitry and sensor — Verifies that the Real CPR Help circuits are functional (when

OneStep CPR or Complete electrodes are attached).

To prepare for Code Readiness tests, do the following:

1. Connect the R Series to AC mains.

2. Do one of the following:

• Connect unopened OneStep electrodes to the OneStep cable,

(Unopened OneStep electrodes act as a test port. The test port capability no longer

functions once the electrode package is opened and electrodes are deployed.)

• Connect the OneStep cable to paddles, and seat the paddles in the paddle wells,

(Verify adult paddles are installed and pushed all the way into the paddle wells.)

or

• Connect the OneStep cable to the test port.

After the successful completion of the readiness check, the Code Readiness indicator displays a

green check, indicating that the unit is ready for therapeutic use. If configured, the R Series will

print a test record following automatic test completion.

The unit performs an automatic device check, if configured to do so, once per day at the

configured time. For information, refer to the R Series Configuration Guide.

Manual Defibrillator Testing

The following test performs:

•

•

•

•

Power-on sequence check.

SHOCK button and delivered energy check.

Pacer check.

Recorder check.

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CHAPTER 12 MAINTENANCE

If a LOW BATTERY message appears during testing, the battery is close to depletion and should

be replaced or recharged.

Before you begin

1. Connect the R Series to AC mains.

2. Do one of the following:

• Connect unopened OneStep electrodes to the OneStep cable,

(Unopened OneStep electrodes act as a test port. The test port capability no longer

functions once the electrode package is opened and electrodes are deployed.)

• Connect the OneStep cable to paddles, and seat the paddles in the paddle wells,

(Verify adult paddles are installed and pushed all the way into the paddle wells.)

or

• Connect the OneStep cable to the test port.

Follow the instructions in either the next section, “Procedure for Testing with Paddles,” or in

“Defibrillator Testing with Hands-Free Therapy Electrodes” on page 12-5.

Defibrillator Testing with Paddles

WARNING!

When performing this check, use your thumbs to operate the SHOCK buttons in order

to avoid inadvertent shock. No portion of the hand should be near the paddle electrode

plates.

To test the manual defibrillation function using paddles:

1. Turn the unit off for at least 10 seconds.

2. Turn the Mode Selector to DEFIB.

The unit emits a four-beep tone indicating successful completion of the power-on self-test.

The ECG source is PADDLES, and ECG size is X1. “DEFIB 120J SEL” appears on the

display. The ECG trace appears as a solid line while the paddles are seated in the paddle

wells.

3. Press the ENERGY SELECT buttons to set the energy to 30 joules.

4. Press the CHARGE button on the apex handle.

5. When the charge-ready tone sounds, press the ENERGY SELECT buttons to change the

selected energy to 20 joules.

The defibrillator will disarm itself.

6. Press the ENERGY SELECT buttons to reset the energy to 30 joules.

Note:

For testing, the unit discharges the defibrillator only if the energy is set to 30 joules.

7. Press the CHARGE button.

When the charge-ready tone sounds, the message DEFIB 30J READY appears.

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Manual Defibrillator Testing

8. Press paddles firmly into their wells and using your thumbs, simultaneously press and hold

the SHOCK buttons (one on each paddle) until the shock is delivered.

The unit displays the message 30J TEST OK and prints a stripchart indicating 30J TEST OK

and the delivered energy.

If the message 30J TEST FAILED appears, contact appropriate technical personnel or the

ZOLL Technical Service Department.

Defibrillator Testing with Hands-Free Therapy Electrodes

To test the manual defibrillation function using hands-free therapy electrodes:

1. Turn the unit off for at least 10 seconds.

2. Turn the Mode Selector to DEFIB.

The unit emits a four-beep tone indicating successful completion of the power-on self-test.

The ECG source is PADS, and ECG size is X1. “DEFIB 120J SEL,” and DEFIB PAD

SHORT appear on the display. The ECG trace appears as a solid line while the OneStep

cable is connected to either the Test Port or OneStep electrodes.

3. Press the ENERGY SELECT buttons to set the energy to 30 joules.

4. Press the CHARGE button on the front panel.

5. When the charge-ready tone sounds, press the ENERGY SELECT buttons to set the energy

to 20 joules.

The defibrillator will disarm itself.

6. Press the ENERGY SELECT buttons to reset the energy to 30 joules

Note:

For testing, the unit discharges the defibrillator only if the energy is set to 30 joules.

7. Press the CHARGE button on the front panel.

8. When the Ready tone sounds, press the SHOCK button on the front panel until the shock is

delivered.

The unit displays the message 30J TEST OK and prints a stripchart indicating 30J TEST OK

and the delivered energy.

If the message 30J TEST FAILED appears, contact appropriate technical personnel or the

ZOLL Technical Service Department.

Pacer Testing

1. Turn the Mode Selector to PACER.

2. Turn the PACER RATE control to 150 ppm, then press the RECORDER button.

) occur approximately every

On the stripchart, verify that pacing stimulus markers (

centimeter (10 small divisions or 2 large divisions).

3. Press and hold the 4:1 button.

The frequency of the pacing stimulus markers decreases, occurring approximately every 4

centimeters (40 small divisions or 8 large divisions).

4. Turn the PACER OUTPUT control to 0 mA.

There should be no CHECK PADS or POOR PAD CONTACT messages.

5. Disconnect the OneStep cable from the test port or OneStep electrodes, and slowly turn the

PACER OUTPUT control to 16 mA or more.

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CHAPTER 12 MAINTENANCE

The messages CHECK PADS and POOR PAD CONTACT appear alternately. The pace alarm

sounds, and the Clear Pace Alarm softkey flashes.

6. Reconnect the OneStep cable, and press the Clear Pace Alarm softkey.

The messages CHECK PADS and POOR PAD CONTACT disappear, and the alarm tone

stops.

Recorder Check

1. Check the printer for an adequate supply of paper, then press the RECORDER button.

2. Press and hold the SIZE button for at least 2 seconds.

A calibration pulse of 1 mV appears on the display while the button is held. The amplitude

of the calibration pulse is independent of the SIZE setting.

3. Inspect the recorder waveform for uniformity and darkness.

4. Inspect for uniformity of annotated characters and completeness of words.

5. Check the printer speed by verifying that the resulting waveform is:

• 2.5 mm ±0.5 mm wide

• 10 mm ±1.0 mm high

Code Readiness Log

Each automatic and manual defibrillation test result is stored in internal non-volatile memory,

the Code Log. A total of 1000 Code Readiness test records can be stored in internal memory.

When the Code Readiness Log is full, the oldest records are erased on a first-in-first-out (FIFO)

basis.

The Code Readiness Log can be transferred to an external computing device (see “Transferring

Files to an External Device” on page 11-1).

If configured, the R Series prints a Code Readiness Test Report following the completion of

each automatic defibrillator test.

To print the Code Readiness Log:

1. In MONITOR mode, press the Report Data softkey, then the Test Log softkey.

A menu appears with the print options.

2. To print a specific test, use the Prev Test and Next Test softkeys to select the test, then press

Print Test, or press Print Test Log to print the log of all of the tests.

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Manual Defibrillator Testing

Code Readiness Test Log

Date: 10 NOV 06 00:01:03 Battery: OK

30J Self Test: OK

Type: Automatic

OneStep Cable: OK

Defib: OK

Pace: OK

ECG: OK

AC Power: Connected

Print

Test Log

Print

Test

Prev

Test

Next

Test

Figure 12-1.

Code Readiness Test Log Print Display

Figure 12-2.

Code Readiness Test Log

Figure 12-3.

Code Readiness Test Report

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CHAPTER 12 MAINTENANCE

Setting Time and Date

To set the unit’s time and date:

1. Set the Mode Selector to MONITOR.

2. Press the Options softkey.

3. Press More.

4. Press Set Clock.

The month field will be highlighted.

Set Time

Oct

Prev

Field

Figure 12-4.

14, 06

Inc

Value

16

Dec

Value

:

Next

Field

37

Enter

and

Return

Set Time Screen

5. Press the Inc Value or Dec Value softkeys to select the appropriate month.

6. Press the Next Field softkey to set the selected month, and move the highlight to the next

field (day).

7. Repeat steps 5 and 6 to set the correct day, year, hours, and minutes values.

Note:

The last field does not automatically scroll (wrap) to the beginning. You must press the

Prev Field softkey to enter the values for the previous field. If you need to make

corrections, press the Prev Field softkey to move the highlight to the field previously

entered.

8. Press the Enter and Return softkey to set all values and return to normal monitoring mode.

Note:

The R Series unit may be configured to synchronize the time automatically with a data

server in the Wi-Fi Data Transfer configuration settings. See the R Series

Configuration Guide for more information.

Cleaning the R Series Unit

R Series products and accessories are chemically resistant to most common cleaning solutions

and noncaustic detergents. The following cleaning solutions are approved:

• 90% isopropyl alcohol (except on adapters, patient cable and Wi-Fi Data COMM Card)

• Soap and water

• Chlorine bleach solution of 30 milliliters per liter of water (except on Sync In/Marker Out

connector, battery compartment pins and Wi-Fi cards)

ZOLL recommends cleaning the device, paddles, and cables with a soft damp cloth using the

approved cleaning agents. The external printer parts should be cleaned with a damp, soft cloth

only.

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Manual Defibrillator Testing

Do not immerse any part of the defibrillator (or its accessories) in water. Do not use ketones

(such as acetone or MEK) on the defibrillator. Do not sterilize the defibrillator. Avoid using

abrasives (including paper towels) on the display window.

Take special care to clean the defibrillation paddles after each use. The buildup of gel can

interfere with ECG monitoring through the paddles, can adversely effect energy delivery and

may reduce operator safety. Keep the paddle handles clean as well.

Loading Stripchart Paper

The unit displays the message CHECK RECORDER when the printer is activated without paper

or if the supply runs out during printing.

Use ZOLL stripchart paper (Part number 8000-0300).

To load paper into the stripchart printer:

1. Press the release button and allow the printer door to open, then remove any paper.

3P/

?

Figure 12-5.

Opening the Printer Door

2. Refer to the illustration inside of the paper compartment for proper paper orientation, and

place a new pad of stripchart paper in the tray.

Note:

Paper feeds from the top of the stack with gridlines facing down.

3. Pull enough paper off the pad so that paper extends out of the unit when the printer cover is

closed.

4. Close the printer cover by pressing down lightly on the edge of the cover next to the release

button. Be sure the cover is flush with the top of the device.

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CHAPTER 12 MAINTENANCE

3P/

3P/

Figure 12-6.

Inserting the Paper and Closing Printer Door

After the paper is loaded, press the RECORDER button to resume printing.

Note:

To ensure you have loaded the paper properly, check to make sure the arrows printed

on the red, grid side of the paper point upward.

Cleaning the Print Head

To clean the recorder print head, perform the following steps:

1. Press the release button, and allow the printer door to open (see Figure 12-5); then remove

any paper.

2. Locate the printhead along the front floor of the printer compartment, just below the release

button.

3. Gently wipe the printhead with a cotton swab moistened with isopropyl alcohol, and dry any

residual alcohol with another dry cotton swab.

3P/

3P/

Figure 12-7.

Cleaning the Print Head

4. Place the paper back into the unit and close the cover (see Figure 12-6).

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Operator’s Checklist for R Series Product

Recommended checks and procedures to be performed

daily or weekly, depending on Automatic Test

configuration.

1. Condition

Date

______________________________________________

Location ____________________________________________

Unit Serial Number ___________________________________

Remarks

Unit clean, no spills, clear of objects on top, case intact

2. Hands-free Therapy electrodes

1 set preconnected / 1 spare

3. Paddles

Paddles clean, not pitted

Release from housing easily

4. Inspect cables for cracks, broken wires, connector

A ECG electrode cable, connector

B Defibrillator paddle cables

C OneStep cable, connector

D Other patient cables

5. Batteries/External power supply

A Fully charged battery in unit

B Fully charged spare battery available, or ready access to local AC mains

6. Disposable supplies

A Defib gel or gel patches

B Hands-free therapy electrodes in sealed packages — 2 sets

C ECG electrodes

D Recorder paper

E Alcohol wipes

F Razors

7. Operational checks

A Power On Sequence

Turn unit to MONITOR, 4-beep tone heard

“MONITOR” message on display

ECG size X 1

“PADDLES” or ‘PADS” as lead selected

B Paddles

Paddles in holder: Set defib energy level to 30 joules, press paddles firmly into the side

wells, and simultaneously press and hold both defib discharge buttons; “30J TEST OK”

message on Recorder.

C Defibrillator

OneStep cable connected to test connector, or OneStep electrodes. Set defib energy

level to 30 joules, press SHOCK button; “30J TEST OK” message on Recorder

D Pacer Operation (If installed)

OneStep cable not connected to Test Connector or OneStep electrodes

Turn to PACER, set pacer rate to 150 ppm, press RECORDER button

Pacer pulses occur ever 2 large divisions (10 small divisions)

Press 4:1 button, pulses occur every 8 large divisions

Set PACER OUTPUT to 0 mA, no CHECK PADS message

Set PACER OUTPUT to 16 mA, CHECK PADS message and alarm

Reconnect OneStep cable to test connector, or OneStep electrodes. Press Clear Pace

Alarm softkey; CHECK PADS message disappears and Pace alarm stops.

E Recorder

Press RECORDER button; Recorder runs. Press again; Recorder stops.

Inspect Recorder printing

8. Please check the appropriate box after each use of this checklist.

No action required

Minor problem(s) corrected

Disposable supplies replaced

Major problem(s) identified — UNIT OUT OF SERVICE

Signature

______________________

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CHAPTER 12 MAINTENANCE

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Chapter 13

Troubleshooting

The troubleshooting information provided in this chapter is intended for use by nontechnical

medical personnel during device operation. This chapter answers many of the common

problems or questions that may arise during operation.

If trouble persists after consulting this guide, contact the appropriate technical personnel or

ZOLL Technical Service Department. Refer to the R Series Service Manual for more detailed

troubleshooting information.

Code-Ready

Symptom

Recommended Action

1. Code Readiness indicator displays Turn the unit on. Print Code Readiness log as described on

a red “X” while unit is turned off.

page 12-6. Follow messages and prompts to resolve the

problem.

2. Code Readiness indicator displays Turn the unit off and then on again. Follow messages and

a red “X” while unit is powered on. prompts to resolve the problem.

Perform a Manual Defibrillator test as described in “Manual

Defibrillator Testing” on page 12-3.

If the unit continues to fail, take it out of service and contact

ZOLL Technical Service.

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CHAPTER 13 TROUBLESHOOTING

Symptom

Recommended Action

3. Pad Expired; Replace Pads

Check the expiration date on OneStep electrodes, and

replace them if they are expired.

4. Poor Pad Condition; Replace

Pads

OneStep electrode condition sensor indicates that the

electrode gel has dried or aged beyond its specifications.

The electrodes may no longer provide optimal therapy.

Replace therapy electrodes. (If emergency defibrillation is

required and spare hands-free therapy electrodes or

paddles are not immediately available, it may be advisable

to use the pads in question rather than delay therapy.)

Symptom

Recommended Action

Monitor

1. Unit does not turn on or unexpect- • Check that battery pack is properly installed.

edly shuts off.

• Verify the unit is plugged into AC power.

• Replace battery pack with a fully charged battery pack.

2. X FAULT XX message

• A fault has been detected.

• Attempt to clear the X FAULT XX message by turning

the Mode Selector to OFF for more than 10 seconds,

then back to the desired operating mode.

Note: Some settings (e.g. alarm settings, lead selection,

ECG size) may need to be restored.

3. SET CLOCK message

• Set time and date information.

• Verify that the internal lithium battery has been replaced

within the last 5 years. Contact ZOLL Technical Service

Department for assistance

4. ECG LEAD OFF message

• Check that ECG cable or OneStep Pacing cable is

connected to patient and instrument.

• Check that ECG electrodes or OneStep Pacing or

Complete electrodes are making good contact and are

not dried out.

• If changing from 5-lead ECG patient cable to 3-lead

ECG patient cable, remove the 5 lead cable then turn

unit OFF for at least 10 seconds.

• Replace ECG cable or OneStep cable.

5. POOR LEAD CONTACT message • Check that ECG cable or OneStep Pacing cable is

connected to patient and instrument.

• Check that ECG electrodes or OneStep Pacing or

Complete electrodes are making good contact and are

not dried out.

• If changing from 5-lead ECG patient cable to 3-lead

ECG patient cable, remove the 5 lead cable then turn

unit OFF for at least 10 seconds.

• Replace ECG cable or OneStep cable.

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Recorder

Symptom

Recommended Action

6. Noisy ECG, artifact, wandering

baseline

• Consider 1 – 21Hz filter bandwidth (see R Series

Configuration Manual).

• Prepare the patient’s skin prior to electrode attachment.

• Check for proper adhesion of electrodes to patient.

• Reduce or eliminate ECG artifact due to electrode or

patient cable movement. Route cables so that they don’t

pull on electrodes or swing excessively.

• Ensure patient is motionless.

• Check for possible excessive radio frequency

interference.

7. Poor ECG signal amplitude,

calibration pulse normal

• Select another lead.

• Apply new electrodes using different placement.

8. Inconsistent QRS beep or heart

rate

• Select another lead.

• Alter ECG electrode placement.

9. Sync marker is absent or

inconsistent with QRS waveform

on display and recorder

•

•

•

•

•

Ensure device is in Sync mode.

Ensure that device in NOT in Remote Sync mode.

Change ECG lead selection.

Alter ECG electrode placement.

Paper too narrow. It should be 90 mm wide.

10. No ECG trace or dashed line on

display

• Device is in Remote Sync mode. Press the

Sync On/Off softkey to exit Remote Sync mode.

Symptom

Recommended Action

1. CHECK RECORDER message

• Recorder out of paper.

• Remove paper, check paper type, check recorder for

paper jam, and reload paper.

• Recorder door is open.

• Paper is loaded upside down.

2. Recorder makes stuttering sound

when activated.

• Check recorder for paper jam.

3. Light or poor quality printing

• Ensure correct paper is in use.

• Ensure paper is installed grid side against recorder print

head.

• Recorder print head requires cleaning.

Recorder

4. Summary Report will not print

• 15 seconds have not elapsed since one of the events

when Report/Print Chart softkeys

that trigger Summary Report to record have occurred.

are activated.

Wait 15 seconds, then try again.

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CHAPTER 13 TROUBLESHOOTING

Pacer

Symptom

Recommended Action

1. CHECK PADS message

• Ensure therapy electrodes are connected to the

OneStep cable.

• Ensure electrode gel is not dry. Replace therapy

electrodes if necessary.

• Ensure good electrode-to-patient contact.

• Check integrity of OneStep cable by plugging into test

connector. CHECK PADS should disappear.

• Ensure electrosurgical apparatus is not active.

2. No stimulus marker (

) is

present on the ECG trace.

• Ensure unit is in PACER mode.

• Ensure PACER RATE (ppm) is set greater than patient

heart rate.

3. No ventricular capture beat

appears after stimulus marker on

ECG display.

• Check patient’s pulse.

• Increase output current.

• Ensure therapy electrodes are making good contact

with the patient.

• Select different ECG Lead configuration.

• Review therapy electrode placement.

4. Patient on “Standby” pacing gets

paced intermittently.

• Ensure proper ECG electrode or OneStep Pacing/

Complete electrode connection and placement. If ECG

lead wire comes off, pacer will automatically pace

asynchronously.

• Check ECG cable for damage.

• Patient R-to-R interval varying. Pace rate close to

patient’s heart rate.

• Verify rate is set appropriately.

5. Heart rate display reads 0 with

proper pacing capture displayed

on ECG trace.

• Check patient’s pulse.

• Select different ECG Lead configuration.

6. Bedside/Central Station/Telemetry None, the patient monitor ECG inputs are overloaded by

ECG display becomes erratic

pacer signals. ECG can only be monitored by the R Series

when pacing.

or pacing device while pacing.

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Defibrillator

Defibrillator

Symptom

Recommended Action

1. Excessive artifact detected when

using paddles as ECG source.

•

•

•

•

•

•

•

Ensure “PADDLES” is selected.

Firmly press paddles against patient skin.

Use gel on paddles.

Clean paddle surface.

Check and clean between adult and pediatric plate.

Check cable for damage.

Use ECG electrodes.

2. Defibrillator will not charge (energy • Ensure that SHOCK button(s) on paddles or front panel

level does not increment on

are not stuck on.

display).

• Replace the battery pack.

3. Charge time to 200 J exceeds

10 seconds.

• Typical in a low battery condition (up to 20 seconds)

• Plug device into AC power.

• Install fully charged battery pack.

4. Energy does not discharge when

the SHOCK button(s) is pressed.

• 60 seconds have elapsed in manual mode since initial

charge ready. Energy was internally discharged.

• Device is in Sync mode or Remote Sync mode and no

QRS complex is detected.

• Energy internally discharged because energy selection

was changed during charge or after the device was

ready.

• Unit was not completely charged when SHOCK

button(s) were pressed. Wait for DEFIB XXXJ READY

message and ready tone.

• Press and hold SHOCK button(s) until energy is

delivered to the patient.

• Pads or paddles not making good contact with patient.

5. Unable to SHOCK when in Sync

mode

• Ensure SYNC XXXJ SEL is displayed on monitor.

• Make sure ECG signals are displayed.

• Check for Sync markers (arrow above R wave). If not

present, change lead selection, or electrode placement.

• Press and hold SHOCK button(s) until energy is

delivered to the patient.

• Alter ECG electrode placement.

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CHAPTER 13 TROUBLESHOOTING

13–6

Symptom

Recommended Action

6. Unable to SHOCK when in

Remote Sync mode

• Ensure REMOTE SYNC is displayed in place of the

ECG waveform and that REMOTE SYNC XXXJ SEL. is

displayed.

• Ensure that a remote device conforming with the Sync

In/Marker Out specifications in Appendix A is properly

connected.

• Ensure that Sync markers appear with each R-wave on

the remote device’s display. If Sync markers are not

present on the remote device’s display or do not appear

to be nearly simultaneous with each R-wave, do not

proceed with synchronized cardioversion.

• Press and hold SHOCK button(s) until energy is

delivered to the patient.

7. No apparent energy delivery to

patient

• Under certain circumstances, some patients will not

show a physical reaction when energy is delivered.

• Perform defibrillator self-test.

• Check for CHECK PADS and POOR PAD CONTACT

messages alternating on the monitor.

• If hands-free therapy electrodes are used, ensure

proper placement and contact.

• Review the discharge stripchart for Joules/current

delivered.

8. CHECK PADS or ATTACH PADS

message

• Verify proper OneStep cable / hands-free therapy

electrode connection by disconnecting and

reconnecting the OneStep cable and hands-free therapy

electrodes.

• Ensure proper contact of hands-free therapy electrodes

and that the patient does not have excessive hair

beneath the electrodes.

• OneStep cable is defective. If message persists,

disconnect OneStep cable from therapy pads, and plug

cable into test connector. CHECK PADS or

ATTACH PADS should change to DEFIB PAD SHORT

(Manual mode only).

• Try using paddles to defibrillate.

• Ensure electrosurgical apparatus is not active.

9. SELECT PADS message

• ECG Analysis will operate only when hands-free

therapy electrodes are attached to the patient.

• Disconnect paddle, and connect hands-free therapy

electrodes for use in Advisory defibrillation.

• Activate manual mode to use Paddles.

10. NOISY ECG

RETRY ANALYSIS message

• Check for proper application and adhesion of handsfree therapy electrodes.

• Check to make sure that nobody is touching the patient

and that the patient is motionless.

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AC Charger

Symptom

Recommended Action

11. No 30J TEST OK message is

displayed when performing a

manual defibrillator self-test.

• Check to make sure unit is set to 30 joules.

• If testing with OneStep electrodes, make sure that the

OneStep cable patient connector is firmly inserted into

the electrode connector. Ensure the OneStep electrode

package is sealed.

• If testing with the Test Port, make sure the OneStep

cable is firmly inserted into the Test Port.

• If testing with paddles, make sure to press the paddles

firmly into the paddle wells while discharging.

12. DEFIB MAINT. REQ. message

• Contact ZOLL Technical Service Department.

AC Charger

Symptom

Recommended Action

1. The Battery indicator is alternately

illuminating green and yellow.

•

•

•

•

Verify battery is installed.

Turn unit ON to identify the fault condition.

Replace battery pack with a fully charged battery pack.

If problem persists, replace battery pack, unplug device

from AC mains for more than 10 seconds and plug

device back into AC mains.

2. LOW BATTERY message appears • Verify that the AC Power Indicator is illuminated.

on monitor when unit is plugged

• If not, check AC power cord connection at the wall outlet

into AC mains.

and at the rear of the device.

• Replace battery pack with a fully charged battery pack.

• Unplug device from AC mains, and plug device back

into AC mains.

• Verify AC mains is working properly.

3. Neither the Battery, nor AC Power

indicator is illuminated when the

device is plugged into AC mains.

• Unplug device from AC mains, and plug device back

into AC mains.

• Verify AC mains is working properly.

CHECK CPR PUCK message is

displayed.

• No action is required. This is an informational message

to indicate that default calibration values are being used

for the CPR puck. The CPR values will be within the

specification.

CPR

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Appendix A

Specifications

This section describes the specifications for the R Series Defibrillator as well as the ECG

rhythm analysis algorithm.

•

•

•

•

•

•

“Defibrillator Specifications” on page A-2

“Battery Pack Specifications” on page A-7

“IEC 60601-1-2 Specifications” on page A-7

“R Series Rectilinear Biphasic Waveform Characteristics” on page A-11

“Clinical Trial Results for the Biphasic Waveform” on page A-23

“ECG Rhythm Analysis Algorithm Accuracy” on page A-28

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APPENDIX A SPECIFICATIONS

Defibrillator Specifications

General

Size (height • width

• length)

8.2 in. • 10.5 in. • 12.5 in. with handle or 10.0 in. without handle

20.8 cm • 26.7 cm • 31.7 cm with handle or 25.4 cm without handle

Weight

13.6 lb (6.17 kg) with OneStep cable and battery pack

15.2 lb (6.89 kg) with paddles

Power (for R Series

ALS, BLS and Plus

models)

Battery: Rechargeable lithium ion battery pack

Device

classification

Class I and internally powered per EN 60601-1.

Design standards

Meets or exceeds applicable requirements of:

AC Power Requirements: 100-120 Vrms, 50/60 Hz

220-240 Vrms, 50 Hz