R Series ALS Operators Guide Rev M Feb 2019

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R Series

®

ALS

Operator’s Guide

9650-0912-05 Rev. M

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The issue date for the R Series Operator’s Guide ALS (REF 9650-0912-05 Rev. M) is February, 2019.

Copyright © 2019 ZOLL Medical Corporation. All rights reserved.

R Series, M Series, CPR-D-padz, Pedi-padz, Pro-padz, Stat-padz, 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.

ZOLL Medical Corporation

269 Mill Road

Chelmsford, MA USA

01824-4105

ZOLL International Holding B.V.

Newtonweg 18

6662 PV ELST

The Netherlands

0123

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TABLE OF CONTENTS

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

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

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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

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

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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

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

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

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

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

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

Chapter 11

File Transfer

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

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

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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 ........................................................................................... 11-8

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

Appendix A

Specifications

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

Battery Pack Specifications ........................................................................................A-6

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-11

R Series Rectilinear Biphasic Waveform Characteristics .................................................A-12

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Clinical Trial Results for the Biphasic Waveform ..............................................................A-24

Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation

(VF) and Ventricular Tachycardia (VT) ...................................................................A-24

Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation

(AF) ........................................................................................................................A-25

Synchronized Cardioversion of Atrial Fibrillation ......................................................A-26

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 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 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 RescueNet® 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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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

Use of the R Series products in the manual mode for defibrillation is indicated on victims of

cardiac arrest where there is apparent lack of circulation as indicated by:

• Unconsciousness.

• Absence of breathing.

• Absence of pulse.

This product should be used only by qualified medical personnel for converting ventricular

fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable

of producing hemodynamically significant heart beats.

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Defibrillator Function

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).

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 Contraindications for Use

There are no known contraindications for the use of the defibrillator.

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).

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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.

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.

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External Pacemaker (Optional)

• 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 Contraindications for Use

There are no known contraindications for the use of the pacemaker.

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.

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.

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CHAPTER 1 GENERAL INFORMATION

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 or

pre-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.

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

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.

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Intended Use — NIBP

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:

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

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CHAPTER 1 GENERAL INFORMATION

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.

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.”

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Batteries

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:

When the indicator is:

It means:

Steady yellow

Battery is charging

Steady green

Battery is charged

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.

Note:

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

accurately display run time.

Note:

The battery must be charged before first use.

• 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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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.

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Warnings

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

Appendix A of this manual.

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.

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, 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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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:

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