ZOLL R Series ALS Operator's Manual

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ALS Operator’s Guide

PPI

CPR

9650-0912-06 Rev. G

The issue date for the R Series Operator’s Guide ALS (REF 9650-0912-06 Rev. G) is May, 2016.

0123

ZOLL Medical Corporation

269 Mill Road Chelmsford, MA USA 01824-4105

ZOLL International Holding B.V.

Newtonweg 18 6662 PV ELST The Netherlands

Code-Ready, SurePower, OneStep, Smart Alarms, CPR Index, Defib Mentor, Rectilinear Biphasic, an d 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.

Table of Contents

Ch a p t e r 1 General Information

Product Description ............................................................................................................1-1

How to Use This Manual.....................................................................................................1-2

Operator’s Guide Updates..................................................................................................1-3

Unpacking...........................................................................................................................1-3

Symbols Used on the Equipment .......................................................................................1-3

Conventions........................................................................................................................1-6

Defibrillator Function...........................................................................................................1-6

Intended Use — Manual Operation ............................................................................1-6

Intended Use — ECG Monitoring ...............................................................................1-7

Intended Use — Real CPR Help ................................................................................1-7

Defibrillator Complications ..........................................................................................1-7

Defibrillator Output Energy .........................................................................................1-7

External Pacemaker (Optional)...........................................................................................1-8

Intended Use — Pacemaker .......................................................................................1-8

Pacemaker Complications ..........................................................................................1-9

Pediatric Pacing ........................................................................................................1-10

Intended Use — SpO Intended Use — EtCO

Intended Use — NIBP....................................................................................................... 1-11

ECG Monitoring................................................................................................................ 1-11

Recorder Function............................................................................................................ 1-11

Paddles and Electrodes....................................................................................................1-12

Batteries............................................................................................................................1-12

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

Safety Considerations.......................................................................................................1-13

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

Operator Safety ........................................................................................................1-15

Patient Safety ...........................................................................................................1-16

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

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

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

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

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

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

The ZOLL Serial Number..................................................................................................1-21

Monitoring ....................................................................................1-10

Monitoring...................................................................................1-10

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Ch a p t e r 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

Ch a p t e r 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 ...........................................................................................................3-7

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

3 Deliver Shock ...........................................................................................................3-9

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

Ch a p t e r 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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Ch a p t e r 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

CPR Index (Optional) ..................................................................................................6-2

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

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

Compression Release Bar (Adult only) ....................................................................... 6 -2

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

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

CPR Voice Prompts............................................................................................................6-3

Chest Compressions Waveform.........................................................................................6-3

Displaying the CPR Waveform...........................................................................................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

Ch a p t e r 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...............................................................................................................9-6

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

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

Adding Traces to Be Displayed ..................................................................................9-7

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

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

Alarms.................................................................................................................................9-8

Setting Alarm Limits ....................................................................................................9-8

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

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

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

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

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............................................................................................................10-9

Chapter 11 File Transfer

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

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

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

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

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

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

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

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

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

Chapter 12 Maintenance

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Chapter 13 Troubleshooting

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

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

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

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

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

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

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

EID for Life-Support Functions ...................................................................................A-9

Recommended Separation Distances from RF Equipment for the R Series

Life-Support Functions ...........................................................................................A-10

EID for Non–Life-Support Functions .........................................................................A-11

Recommended Separation Distances from RF Equipment for the R Series

Non–Life-Support Functions ...................................................................................A-12

R Series Rectilinear Biphasic Waveform Characteristics.................................................A-13

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Clinical Trial Results for the Biphasic Waveform ..............................................................A-25

Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation

(VF) and Ventricular Tachycardia (VT) ...................................................................A-25

Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation (AF) ...A-26

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

ECG Rhythm Analysis Algorithm Accuracy.......................................................................A-29

Appendix B R Series Accessories

Appendix C Wi-Fi Radio Module Information

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Product Description

The ZOLL® RSeries® products combine a defibrillator, ECG display, advanced monitoring capabilities, and Noninvasive T ranscutaneous 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, lig ht weight 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.

Chapter 1

General Information

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 1GENERAL 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

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 pa tients. 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 warn ing messages are displa yed 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.

feature, to reduce the artifact caused by chest compressions.

An annotating strip chart recorder is included to provide immediate documentation as well as summary report functions about patient care and treatment.

A sophisticated data collection system, including summary report, printer, and multiple communication ports is available for this unit. The stored data can be reviewed and archived on a properly equipped personal computer using ZOLL CodeNet RescueNet

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

or Compact Flash cards or Wi-Fi. R Series products are intended for use in Manual mode by personnel certified by appropriate

federal, state, or local government authority to provide advanc ed 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.

Central software or ZOLL

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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 n ot pass its electrical self-t est, 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.

Operator’s Guide Updates

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.

Attention, consult accompanying documents.

Fragile, handle with care.

Keep dry.

This end up.

Temperature limitation.

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

CHAPTER 1GENERAL INFORMATION

2%452.

,I)/.

RECYCLE

,I)/.

Symbol Description

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).

Contains lithium. Recycle or dispose of properly.

Keep away from open flame and high heat.

Do not open, disassemble, or intentionally damage.

Do not crush.

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

Symbol Description

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.

Symbols Used on the Equipment

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.

Prescription only.

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CHAPTER 1GENERAL INFORMATION

Symbol Description

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 de livering 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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In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronize d 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 defibril lat or, 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 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 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 adequat e amount of electrol yte 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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CHAPTER 1GENERAL INFORMATION

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), b y in crements 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 placeme nt, 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, d rug toxic ity, anesthesia, or surgery . It is also useful as a temporary treatment in patients awaiting pa cemaker 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 fibrillati on 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 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 ventricula r fibrillation and defibrilla tion 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 repetitiv e 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. Ab rupt 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 1GENERAL INFORMATION

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 33 lb. (15 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 (SpO

) 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.

Intended Use — EtCO2 Monitoring

The ZOLL R Series EtCO2 option with Respironics Novametrix techno log y i s ind ic ated for the continuous noninvasive monitoring of end tidal carbon d io xide (EtCO patients requiring ventilator support, in-hospital transport, or anesthesia.

) and respiration rate in

This option uses the CAPNOSTAT 5 Mainstream CO

sensor attached to an airway adapter that

connects to an endotrac heal tube, mask or disposable mouthpiece. The R Series EtCO

option is designed to monitor adult, pediatric, and neonatal patients.

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

• elevated oxygen levels

• nitrous oxide

• halogenated agents The R Series EtCO

compensation. Halogenated anesthetic agents alter CO monitor CO

option provides settings for high oxygen and/or nitrous oxide

readings, but the R Series unit will

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 EtCO CAPNOSTAT 5 Mainstream CO

option is intended for use only with the ZOLL/Respironics Novametrix

Sensor and mainstream airway adapters.

The R Series EtCO2 option can be used on adult patients (21 years of age and older) and on pediatric patients, as described in the following table:

Pediatric Subpopulation Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age

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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

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:

Intended Use — NIBP

• 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 evaluati on. Attach conventional ECG electrodes for diagnostic purposes.

• ECG size - 0.5, 1, 1.5, 2, 3 cm/mV

• 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.

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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 Ad visory 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 electrode s 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 Pacing electrodes, or OneStep Complete electrodes, MFE Pads,

Pediatric MFE Pads, stat-padz

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. For stat-padz II, this symbol does not appear; the expiration date appears on the lower

right corner of the label, below the lot number.

The R Series defibrillator reads and reports the expiration date for OneStep Pacing electrodes, OneStep CPR electrodes, and OneStep Complete electrodes. 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 pedi-padz patient’s exact age or weight.

II pediatric defibrillation electrodes. Do not delay therapy to determine the

, and ECG electrodes are disposable, single-use items.

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.

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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 Not lit The defibrillator is not connected to

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

accurately display run time.

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

and test the battery’ s capacity. For details, refer to the ZOLL SurePower defibri llator battery Operator’s Manual.

Code-Ready System

No battery is installed or a battery charging fault has been detected.

AC mains.

The R Series defibrillator’s Code-Ready system tests the defibrillator whenever the unit is turned on, periodically during operat ion, 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 ma ny as 1000 de fibrillator tests i n 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 Seri es. R Series products are high-energy defibril lators 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 Seri es unit automatically disarms if left ch arg ed for more than eith er 60 or 120 seconds (user configurable) if the SHOCK button is not pressed.

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CHAPTER 1GENERAL INFORMATION

Warnings

General

Federal (U.S.A.) law restricts this defibrillator to use by or on the order of a physician. Only appropriately trained, skilled person nel who are familiar wi th equipment opera tion should

perform emergency defibrillation. The prescribing physician should determine what training, such as Advanced Cardiac Life Su pp ort (A CLS) 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 defi brillation.

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.

A void 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 poin t, W i-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 t o avoid tripp ing over the m, or inadverte ntly pulling the unit on to the patient.

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

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Warnings

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.

Place the patient on a firm surface before performing CPR.

Battery

Do not operate the unit without a battery. Keep a fully charged spare battery pack with the defibrillator at all times.

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 char ged 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.

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CHAPTER 1GENERAL INFORMATION

Do not use the unit near or with in 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.

T o 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 electro lyte gel specified for such use by the manufacturer.

When using paddles for defibrillation, use yo ur th umb s to operat e th e 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. 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.

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Warnings

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 electro de co up ling 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 wi th 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.

T o 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:

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

return wires.

• Use electrosurgical grounding pads with the largest practical contact area.

Always ensure proper application of the electrosurgical return electrode to the patient. Check electrical leakage levels before use. Leakage current may be excessive if more than one

monitor or other piece of equipment is connected to the patient. Do not use the ZOLL OneStep Pacing cable (REF 1009-0913-02) or the ZOLL Multi-Function

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

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CHAPTER 1GENERAL INFORMATION

Cautions

If the unit is to be stored longer than 90 days, remove the battery pack. Do not sterilize the defibrillator, or its accessories unless the accessories are labelled as

sterilizable. Do not immerse any part of the defibrillator in water. Do not use ketones (such as acetone or MEK) on the defibrillator. Avoid using abrasives (including paper towels) on the display window. Grounding reliability can be achieved only when the equipment is connected to a receptacle

marked “HOSPIT AL ONLY,” “HOSPITAL GRADE,” or equivalent. If the grounding integrity of the line cord or AC receptacle is questionable, operate the defibrillator using battery power only.

To protect the unit from damage during defibrillation, for accurate ECG inform ation, and to protect against noise and other interference, use only internal current-limiting ECG cables specified or supplied by ZOLL.

For continued safety and EMI performance, use only the line cord supplied by ZOLL. Dispose of battery packs in accordance with national, regional and local regulations. Battery

packs should be shipped to a reclamation facility for recovery of metal and plastic compounds as the proper method of waste management.

Restarting the Defibrillator

Certain events require the R Series products to be restarted after they shut off or become inoperative (for example, when the battery runs down and the unit shuts off).

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

1. Turn the Mode Selector to OFF.

2. If necessary , replace a depleted battery with a fully charge d pack, or connect the de fibrillator

to AC mains.

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

This sequence is necessary to restart the defibrillator and can also be used to clear some fault messages when immediate use of the defibrillator is required.

If restarted after a shutdown period of 10 second s or more, the unit restores all se ttings (su ch as ECG lead, ECG size, and alarm state and limits) to their power-up default values. After restoring device operation, you might need to reinstate previously selected, non-default settings.

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FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners of this defibrillator must notify ZOLL Medical Corporation if this product is

• received

• lost, stolen, or destroyed

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

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

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

number

2. Model number, and serial number of the defibrillator

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

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

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

number

4. Date when the change took effect

Please address the information to:

FDA Tracking Requirements

ZOLL Medical Corporation Attn: Tracking Coordinat or 269 Mill Road Chelmsford, MA 01824-4105

Fax: (978) 421-0025 Telephone: (978) 421-9655

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrenc e of certain events.

These events, described in 21 CFR Part 803, include device-related death and serious injury or illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation requests to be notified of device failures or malf unctions. This informatio n is required to ensure that ZOLL Medical Corporation provides only the highest quality products.

9650-0912-06 Rev. G ZOLL R Series Operator’s Guide 1–19

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ZOLL R Series ALS Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual