R Series Plus and BLS Operators Guide Rev N Feb 2019.pdf
Page 1
R Series
®
PLUS
R Series
®
BLS
Operator’s Guide
9650-0904-05 Rev. N
Page 2
The issue date for the R Series Operator’s Guide BLS/Plus (REF 9650-0904-05 Rev. N) 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 1
General Information
Product Description ............................................................................................................ 1-1
R Series Model Features .................................................................................................... 1-3
How to Use This Manual..................................................................................................... 1-4
Operator’s Guide Updates .................................................................................................. 1-4
Unpacking........................................................................................................................... 1-4
Symbols Used on the Equipment ....................................................................................... 1-4
Conventions ........................................................................................................................ 1-7
Defibrillator Function ........................................................................................................... 1-7
Intended Use — Manual Operation ............................................................................ 1-8
Intended Use — Semiautomatic Operation (AED) ..................................................... 1-8
Intended Use — ECG Monitoring ............................................................................... 1-8
Intended Use — Real CPR Help ................................................................................ 1-9
Semiautomatic Operation Contraindications for Use .................................................. 1-9
Defibrillator Complications .......................................................................................... 1-9
Defibrillator Output Energy ......................................................................................... 1-9
External Pacemaker (Optional)........................................................................................... 1-9
Intended Use — Pacemaker ..................................................................................... 1-10
Pacemaker Complications ........................................................................................ 1-11
Pediatric Pacing ........................................................................................................ 1-11
Intended Use — SpO2 Monitoring .................................................................................... 1-11
Intended Use — EtCO2 Monitoring................................................................................... 1-12
Intended Use — NIBP....................................................................................................... 1-13
ECG Monitoring ................................................................................................................ 1-13
Recorder Function (Manual Mode Only)........................................................................... 1-14
Paddles and Electrodes .................................................................................................... 1-14
Batteries............................................................................................................................ 1-15
Code-Ready System......................................................................................................... 1-15
Safety Considerations....................................................................................................... 1-15
Warnings........................................................................................................................... 1-16
Operator Safety ........................................................................................................ 1-18
Patient Safety ........................................................................................................... 1-19
Cautions............................................................................................................................ 1-20
Restarting the Defibrillator ................................................................................................ 1-20
FDA Tracking Requirements ............................................................................................. 1-20
Notification of Adverse Events .................................................................................. 1-21
Software License .............................................................................................................. 1-21
Service.............................................................................................................................. 1-22
The ZOLL Serial Number.................................................................................................. 1-23
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TABLE OF CONTENTS
Chapter 2
Product Overview
Defibrillator Controls and Indicators.................................................................................... 2-1
The Front Panel .......................................................................................................... 2-3
Display Screen ............................................................................................................ 2-6
Patient Cables and Connectors .................................................................................. 2-8
External Paddles (Manual Mode Only) ..................................................................... 2-10
Working with Menus (Manual Mode Only) ........................................................................ 2-12
Common Tasks ................................................................................................................. 2-13
Replacing a Battery Pack ......................................................................................... 2-13
Adjusting Display Brightness (Manual Mode Only) ................................................... 2-14
Using Code Markers (Manual Mode Only) ............................................................... 2-14
Chapter 3
Automated External Defibrillator (AED) Operation
AED Operation.................................................................................................................... 3-2
Determine Patient Condition Following Medical Protocols ......................................... 3-2
Begin CPR Following Medical Protocols .................................................................... 3-2
Prepare Patient ........................................................................................................... 3-2
1 Select ON ................................................................................................................ 3-4
2 Analyze .................................................................................................................... 3-5
3 Press SHOCK .......................................................................................................... 3-6
Operating Messages ................................................................................................... 3-8
Audio and Display Messages ..................................................................................... 3-8
Switching to Manual Mode Operation ............................................................................... 3-10
Chapter 4
Manual Defibrillation
Emergency Defibrillation Procedure with Paddles .............................................................. 4-1
Determine the Patient’s Condition Following Local Medical Protocols ....................... 4-1
Begin CPR Following Local Medical Protocols ........................................................... 4-2
1 Select ON ................................................................................................................ 4-2
2 Charge Defibrillator .................................................................................................. 4-4
3 Deliver Shock ........................................................................................................... 4-5
Autoclavable External Paddles ........................................................................................... 4-5
Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes........................ 4-6
Determine the Patient’s Condition Following Local Medical Protocols ....................... 4-6
Begin CPR Following Medical Protocols .................................................................... 4-6
Prepare Patient ........................................................................................................... 4-6
1 Select ON ................................................................................................................ 4-8
2 Charge Defibrillator .................................................................................................. 4-9
3 Deliver Shock ......................................................................................................... 4-10
Autoclavable Electrodes ................................................................................................... 4-10
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Chapter 5
Advisory Defibrillation
Advisory Defibrillation Procedure........................................................................................ 5-2
Determine the Patient’s Condition Following Local Medical Protocols ....................... 5-2
Begin CPR Following Local Medical Protocols ........................................................... 5-2
Prepare Patient ........................................................................................................... 5-2
1 Select ON ................................................................................................................ 5-2
2 Press ANALYZE Button ........................................................................................... 5-4
3 Press SHOCK .......................................................................................................... 5-5
Advisory Function Messages .............................................................................................. 5-7
Warning Messages ............................................................................................................. 5-7
Chapter 6
Synchronized Cardioversion
Synchronized Cardioversion Procedure ............................................................................. 6-2
Determine the Patient’s Condition and Provide Care Following Local Medical
Protocols .................................................................................................................. 6-2
Prepare Patient ........................................................................................................... 6-2
1 Select ON ................................................................................................................ 6-3
2 Charge Defibrillator .................................................................................................. 6-4
3 Deliver SHOCK ........................................................................................................ 6-5
Remote Synchronized Cardioversion Procedure................................................................ 6-5
Determine the Patient’s Condition and Provide Care Following Local Medical
Protocols .................................................................................................................. 6-6
Prepare Patient ........................................................................................................... 6-6
1 Select ON ................................................................................................................ 6-6
2 Charge Defibrillator .................................................................................................. 6-7
3 Deliver SHOCK ........................................................................................................ 6-7
Chapter 7
Real CPR Help
Real CPR Help Field........................................................................................................... 7-2
Perfusion Performance Indicator (R Series Plus/Adult Only) ..................................... 7-2
CPR Idle Time Display ................................................................................................ 7-2
CPR Rate and Depth Display ..................................................................................... 7-2
Compression Release Bar (R Series Plus/Adult only) ................................................ 7-3
CPR Metronome ......................................................................................................... 7-3
Fully Release prompt .................................................................................................. 7-4
CPR Voice Prompts (R Series Plus/Adult only) .................................................................. 7-4
Chest Compressions Bar Graph (Manual Mode Only) ....................................................... 7-4
Displaying the CPR Bar Graph (Manual Mode Only) ......................................................... 7-4
Chapter 8
See-Thru CPR (R Series Plus Only)
Using See-Thru CPR (R Series Plus Only) ........................................................................ 8-2
Examples .................................................................................................................... 8-2
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Chapter 9
Noninvasive Temporary Pacing (Optional)
Noninvasive Temporary Pacing .......................................................................................... 9-2
Determine Patient Condition and Provide Care Following Local Medical Protocols ... 9-2
Prepare the Patient ..................................................................................................... 9-2
1 Apply ECG Electrodes/Hands-Free Therapy Electrodes ......................................... 9-2
1 Select ON ................................................................................................................ 9-3
2 Turn Mode Selector to PACER ................................................................................ 9-4
3 Set Pacer Rate ........................................................................................................ 9-4
4 Set Pacer Output ..................................................................................................... 9-5
5 Determine Capture .................................................................................................. 9-5
6 Determine Optimum Threshold ................................................................................ 9-6
Special Pacing Applications ................................................................................................ 9-8
Standby Pacing ........................................................................................................... 9-8
Asynchronous Pacing ................................................................................................. 9-8
1 Select ON ................................................................................................................ 9-9
2 Turn Mode Selector to PACER ................................................................................ 9-9
Press the Async Pacing On/Off softkey .................................................................... 9-10
Pediatric Pacing ........................................................................................................ 9-10
Chapter 10
ECG Monitoring
Preparations ..................................................................................................................... 10-2
Electrode Placement......................................................................................................... 10-2
Monitoring Electrodes Attachment .................................................................................... 10-3
Monitoring the Patient’s ECG ........................................................................................... 10-4
Set the Controls ........................................................................................................ 10-4
Implanted Pacemakers ..................................................................................................... 10-5
5-Lead Monitoring............................................................................................................. 10-7
Simultaneous 3-Lead Printing ................................................................................... 10-7
See-Thru CPR Filter (R Series Plus Only) ................................................................ 10-7
Adding Traces to Be Displayed ................................................................................ 10-8
Printing the ECG on a Stripchart ...................................................................................... 10-8
Diagnostic Bandwidth ............................................................................................... 10-8
Alarms............................................................................................................................... 10-9
Setting Alarm Limits .................................................................................................. 10-9
Heart Rate Alarm Limits .......................................................................................... 10-10
Vital Sign Alarms .................................................................................................... 10-10
Suspending and Silencing Alarms .......................................................................... 10-10
Smart Alarms .......................................................................................................... 10-11
Alarm Settings for Unattended Monitoring .............................................................. 10-12
Chapter 11
Event Records and Reports
Summary Report............................................................................................................... 11-1
Summary Report Formats ........................................................................................ 11-2
Printing the Entire Summary Report ......................................................................... 11-7
Printing a Partial Summary Report ........................................................................... 11-8
Full Disclosure Recording ................................................................................................. 11-8
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Incident Logs .................................................................................................................... 11-8
Printing an Incident Log ............................................................................................ 11-8
Erasing Summary Report and Full Disclosure .................................................................. 11-9
Manual Erasure ........................................................................................................ 11-9
Automatic Erasure .................................................................................................... 11-9
Formatting the Disk ................................................................................................... 11-9
Related Messages .......................................................................................................... 11-10
Chapter 12
File Transfer
Transferring Files to an External Device........................................................................... 12-1
Wi-Fi (Optional)................................................................................................................. 12-2
Installing or Removing a Compact Flash Card ................................................................. 12-2
Transferring a Full Disclosure File to a Compact
Flash Card ...................................................................................................................... 12-3
Transferring Device Check and Activity Log Files to a Compact Flash Card.................... 12-4
Transferring Files Through the USB Port (R Series Plus Only) ........................................ 12-4
Transferring Full Disclosure Files Through Wi-Fi (R Series Plus Only) ............................ 12-5
Transferring Device Check and Activity Log Files Through Wi-Fi (R Series Plus Only) ... 12-6
Related Wi-Fi Messages ........................................................................................... 12-8
Chapter 13
Maintenance
Routine Procedures .......................................................................................................... 13-2
Daily Visual Inspection .............................................................................................. 13-2
Code Readiness Test ............................................................................................... 13-3
Manual Defibrillator Testing............................................................................................... 13-3
Defibrillator Testing with Paddles ............................................................................. 13-4
Defibrillator Testing with Hands-Free Therapy Electrodes ....................................... 13-5
Pacer Testing ............................................................................................................ 13-6
Recorder Check ........................................................................................................ 13-6
Code Readiness Log ................................................................................................ 13-7
Setting Time and Date .............................................................................................. 13-8
Cleaning the R Series Unit ....................................................................................... 13-9
Loading Stripchart Paper ........................................................................................ 13-10
Cleaning the Print Head .......................................................................................... 13-11
Operator’s Checklist for R Series Product ............................................................. 13-12
Chapter 14
Troubleshooting
Code-Ready .............................................................................................................. 14-1
Monitor ...................................................................................................................... 14-2
Recorder ................................................................................................................... 14-4
Pacer ........................................................................................................................ 14-4
Defibrillator ................................................................................................................ 14-5
AC Charger ............................................................................................................... 14-8
CPR .......................................................................................................................... 14-8
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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-11
R Series Rectilinear Biphasic Waveform Characteristics .................................................A-12
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.
The R Series comes in both R Series Plus and R Series BLS models. This guide
documents all the features that are available in both models. Both models can also have
the additional optional features of Pacing and SpO2.
The BLS model does not contain all of the functions that are included in the Plus
model. The features that only apply to the Plus model are documented as R Series Plus
Only within the manual, and optional features are documented as Optional.
Refer to the table on page 1-3 for a listing of features that are available in the R Series
defibrillator models.
The R Series is a versatile external defibrillator. The device powers up in AED mode
automatically. Depending on local protocols, the device may start prompting the operator to
PERFORM CPR or the device may start analyzing ECG automatically, prompt the operator to
STAND CLEAR, charge the defibrillator (if appropriate), and prompt the operator to PRESS
SHOCK in between periods of CPR. The device can be switched to Manual mode after power
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CHAPTER 1 GENERAL INFORMATION
up. 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.
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 in Manual mode.
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, Compact Flash cards or Wi-Fi.
R Series products are intended for use in either AED mode or Manual mode by personnel
certified by appropriate federal, state, or local government authority to provide advanced life
support care.
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R Series Model Features
R Series Model Features
The following features are available in the R Series Plus and R Series BLS models. Pacing and
SpO2 monitoring are additional options that may be purchased separately.
Feature
BLS Model
Real CPR Help
Plus Model
See-Thru CPR
Perfusion Performance Indicator™
OneStep system
OneStep cable
OneStep ECG leads cable
(3-lead set)
OneStep Cable Manager
Code Readiness testing system
Integrated hands free electrode
mounting
Rectilinear Biphasic Waveform
Universal operating system
Defib activity log
Corrective voice prompts
5.8 Ah rechargeable lithium-ion
battery
3 lead ECG cable
90mm strip chart writer
Integrated AC power
Built-in test port
Compact Flash card slot
USB device port
Wi-Fi communication software
EtCO2
NIBP
Optional Items Available in Both Models
Pacing
SpO2
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CHAPTER 1 GENERAL INFORMATION
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 13-1.
This manual is supplemented by manual inserts for options available on the R Series. These
inserts contain additional warnings, precautions, and safety-related information.
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.
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Symbols Used on the Equipment
Symbol
Description
Fragile, handle with care.
Keep dry.
This end up.
Temperature limitation.
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).
Direct current (DC).
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CHAPTER 1 GENERAL INFORMATION
2.
,I
Description
45
2%
)/.
Symbol
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.
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.
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Conventions
Symbol
Description
Authorized representative in the European Community.
Serial Number.
Catalogue number.
Consult instructions for use.
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.
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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.
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 — Semiautomatic Operation (AED)
R Series products are designed for use by emergency care personnel who have completed
training and certification requirements applicable to the use of a defibrillator where the device
operator controls delivery of shocks to the patient.
They are specifically designed 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.
Use of the R Series in the Semiautomatic 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.
Specifications for the ECG rhythm analysis function are provided in the section, “ECG Rhythm
Analysis Algorithm Accuracy” on page A-27.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use
ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient’s exact age
or weight.
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.
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External Pacemaker (Optional)
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.
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 or in an
ambulance or other conveyance. A patient must be motionless during ECG analysis. Do not
touch the patient during analysis. Cease all movement of the stretcher or vehicle prior to
analyzing the ECG. If you are using the R Series in an emergency vehicle, bring the vehicle to a
halt before activating the analysis function.
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.
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CHAPTER 1 GENERAL INFORMATION
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.
• Suppression of tachycardia.
Increased heart rates in response to external pacing often suppress ventricular ectopic
activity and might prevent tachycardia.
WARNING!
This device can only be used for external pacing of patients and cannot be used for
internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator.
Pacemaker Contraindications for Use
There are no known contraindications for the use of the pacemaker.
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Intended Use — SpO2 Monitoring
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 can only be used for external pacing of patients and cannot be used for
internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator.
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
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CHAPTER 1 GENERAL INFORMATION
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.
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.
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:
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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
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Intended Use — NIBP
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
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.
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CHAPTER 1 GENERAL INFORMATION
Recorder Function (Manual Mode Only)
The strip recorder is provided to document events in Manual mode. 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
In AED mode, the R Series will defibrillate, cardiovert, and monitor ECG using only
hands-free therapy electrodes. In Manual mode, 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.”
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.
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Batteries
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.
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:
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CHAPTER 1 GENERAL INFORMATION
• In AED mode, Turn the Mode Selector to OFF.
• In Manual mode, turn the Mode Selector to OFF or PACER, or change the selected
defibrillator energy.
For safety, in Manual mode, 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; in AED
mode, the R Series unit automatically disarms if left charged for more than 30 seconds.
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.
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.
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Warnings
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 AED mode or 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.
Place the patient on a firm surface before performing CPR.
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