R Series ALS Operators Guide Rev R

The issue date for the R Series Operator’s Guide ALS (REF 9650-0912-05 Rev. R) is September, 2023. Copyright © 2023 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, AutoPulse, 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. Einsteinweg 8A 6662 PW Elst Netherlands ZOLL Medical Switzerland AG Baarerstrasse 8 6300 Zug Switzerland

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Indication of Use

Indication of Use The R Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by: • Unconsciousness. • Absence of breathing. • Absence of pulse.

The R Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The R Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. The R Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients.

ECG Monitoring The R Series system is indicated to evaluate the patient’s heart rate or ECG morphology via ECG monitoring. In ECG monitoring mode, the feature is indicated for use by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.

Real CPR Help The R Series system is indicated to provide visual and audio feedback via the CPR Help feature, which is designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended depth and rate of 2 inches (5 cm) and 100 compressions per minute.

External Pacemaker The R Series system is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. External Pacing is indicated for pediatric and adult patients.

SpO2 Monitoring The R Series system is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.

EtCO2 Monitoring The R Series system is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia. EtCO2 Monitoring is indicated for in patients from newborn (neonate) to adult.

Non-Invasive Blood Pressure Monitoring (NIBP) The R Series system is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport. The NIBP feature is indicated to measure blood pressure for patients from newborn (neonate) to adult.

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CONTRAINDICATIONS The R Series Semiautomatic Operation Contraindications for Use The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implanted pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of patients with implanted pacemakers. Do not use the rhythm analysis function during patient movement on a stretcher. A patient must be motionless during ECG analysis. Do not touch the patient during analysis. Cease all movement of the stretcher prior to analyzing the ECG.

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

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Table of Contents Indication of Use ... iii ECG Monitoring ... iii Real CPR Help ... iii External Pacemaker ... iii SpO2 Monitoring ... iii EtCO2 Monitoring ... iii Non-Invasive Blood Pressure Monitoring (NIBP) ... iii CONTRAINDICATIONS ...iv General Information ...iv

Chapter 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 Purpose ... 1-7 Intended Use - Manual Operation ... 1-7 Intended Use - ECG Monitoring ... 1-7 Intended Use - Real CPR Help ... 1-8 Defibrillator Contraindications for Use ... 1-8 Defibrillator Complications ... 1-8 Defibrillator Output Energy ... 1-8 External Pacemaker (Optional)... 1-8 Intended Use - Pacemaker ... 1-9 Pacemaker Complications ... 1-9 Pediatric Pacing ... 1-10 Intended Use - SpO2 Monitoring ... 1-10 Intended Use - EtCO2 Monitoring... 1-11 Intended Use - NIBP... 1-11 ECG Monitoring ... 1-12 Recorder Function ... 1-12 Paddles and Electrodes ... 1-12 Batteries... 1-13 Code-Ready System... 1-14 Safety Considerations... 1-14 Warnings... 1-15 Operator Safety ... 1-17 Patient Safety ... 1-18 Cautions... 1-19

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TABLE OF CONTENTS Restarting the Defibrillator ... 1-19 FDA Tracking Requirements ... 1-19 Notification of Adverse Events ... 1-20 Software License ... 1-20 Service... 1-21 The ZOLL Serial Number... 1-22

Chapter 2

Product Overview

Defibrillator Controls and Indicators... 2-1 The Front Panel ... 2-3 Display Screen ... 2-5 Patient Cables and Connectors ... 2-7 External Paddles ... 2-9 Working with Menus... 2-11 Defib Mentor Mode (Optional) ... 2-12 Common Tasks ... 2-13 Replacing a Battery Pack ... 2-13 Adjusting Display Brightness ... 2-13 Using Code Markers ... 2-14

Chapter 3

Manual Defibrillation

Emergency Defibrillation Procedure with Paddles ... 3-1 Determine the Patient’s Condition Following Local Medical Protocols ... 3-1 Begin CPR Following Local Medical Protocols. ... 3-2 1 Select DEFIB ... 3-2 2 Charge Defibrillator ... 3-4 3 Deliver Shock ... 3-5 Autoclavable External Paddles ... 3-6 Emergency Defibrillation Procedure with Hands-Free Therapy Electrodes... 3-6 Determine the Patient’s Condition Following Local Medical Protocols ... 3-6 Begin CPR Following Medical Protocols ... 3-6 Prepare Patient ... 3-6 1 Select DEFIB ... 3-8 2 Charge Defibrillator ... 3-9 3 Deliver Shock ... 3-10 Autoclavable Electrodes ... 3-10

Chapter 4

Advisory Defibrillation

Advisory Defibrillation Procedure... 4-2 Determine the Patient’s Condition Following Local Medical Protocols ... 4-2 Begin CPR Following Local Medical Protocols ... 4-2 Prepare Patient ... 4-2 1 Select DEFIB ... 4-2 2 Press ANALYZE Button ... 4-3 3 Press SHOCK ... 4-5 ii

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Advisory Function Messages ... 4-6 Warning Messages ... 4-7

Chapter 5

Synchronized Cardioversion

Synchronized Cardioversion Procedure ... 5-2 Determine the Patient’s Condition and Provide Care Following Local Medical Protocols ... 5-2 Prepare Patient ... 5-2 1 Select DEFIB ... 5-3 2 Charge Defibrillator ... 5-4 3 Deliver SHOCK ... 5-5 Remote Synchronized Cardioversion Procedure... 5-5 Determine the Patient’s Condition and Provide Care Following Local Medical Protocols ... 5-6 Prepare Patient ... 5-6 1 Select DEFIB ... 5-6 2 Charge Defibrillator ... 5-7 3 Deliver SHOCK ... 5-7

Chapter 6

Real CPR Help

Real CPR Help Field... 6-2 Perfusion Performance Indicator (Optional/Adult Only) ... 6-2 CPR Idle Time Display ... 6-2 CPR Rate and Depth Display ... 6-2 Compression Release Bar (Adult only) ... 6-3 CPR Metronome ... 6-3 Fully Release prompt ... 6-4 CPR Voice Prompts (Adult only) ... 6-4 Chest Compressions Bar Graph ... 6-4 Displaying the CPR Bar Graph ... 6-4

Chapter 7

See-Thru CPR (Optional)

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

Chapter 8

Noninvasive Temporary Pacing (Optional)

Noninvasive Temporary Pacing ... 8-2 Determine Patient Condition and Provide Care Following Local Medical Protocols ... 8-2 Prepare the Patient ... 8-2 1 Apply ECG Electrodes/Hands-Free Therapy Electrodes ... 8-2 2 Turn Selector Switch to PACER ... 8-3 3 Set Pacer Rate ... 8-3 4 Set Pacer Output ... 8-4 5 Determine Capture ... 8-5 6 Determine Optimum Threshold ... 8-6 9650-0912-05 Rev. R

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TABLE OF CONTENTS Special Pacing Applications ... 8-7 Standby Pacing ... 8-7 Asynchronous (Fixed) Pacing ... 8-7 Pediatric Pacing ... 8-8

Chapter 9

ECG Monitoring

Preparations ... 9-2 Electrode Placement... 9-2 Monitoring Electrodes Attachment ... 9-3 Monitoring the Patient’s ECG ... 9-5 Set the Controls ... 9-5 Implanted Pacemakers ... 9-5 5-Lead Monitoring... 9-7 Simultaneous 3-Lead Printing ... 9-7 See-Thru CPR Filter (Optional) ... 9-7 Adding Traces to Be Displayed ... 9-8 Printing the ECG on a Stripchart ... 9-8 Diagnostic Bandwidth ... 9-8 Alarms... 9-9 Setting Alarm Limits ... 9-9 Heart Rate Alarm Limits ... 9-10 Vital Sign Alarms ... 9-10 Suspending and Silencing Alarms ... 9-10 Smart Alarms ... 9-11 Alarm Settings for Unattended Monitoring ... 9-12

Chapter 10

Event Records and Reports

Summary Report... 10-1 Summary Report Formats ... 10-2 Printing the Entire Summary Report ... 10-8 Printing a Partial Summary Report ... 10-9 Full Disclosure Recording ... 10-9 Incident Logs ... 10-9 Printing an Incident Log ... 10-9 Erasing Summary Report and Full Disclosure ... 10-10 Manual Erasure ... 10-10 Automatic Erasure ... 10-10 Formatting the Disk ... 10-10 Related Messages ... 10-11

Chapter 11

File Transfer

Transferring Files to an External Device... 11-1 Wi-Fi (Optional)... 11-2 Installing or Removing a Compact Flash Card ... 11-2 Transferring a Full Disclosure File to a Compact Flash Card ... 11-3 iv

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Transferring Device Check and Activity Log Files to a Compact Flash Card... 11-3 Transferring Files Through the USB Port (Optional) ... 11-4 Transferring Full Disclosure Files Through Wi-Fi (Optional) ... 11-5 Transferring Device Check and Activity Log Files Through Wi-Fi (Optional) ... 11-6 Related Wi-Fi Messages ... 11-8

Chapter 12

Maintenance

Routine Procedures ... 12-2 Daily Visual Inspection ... 12-2 Code Readiness Test ... 12-3 Manual Defibrillator Testing... 12-3 Defibrillator Testing with Paddles ... 12-4 Defibrillator Testing with Hands-Free Therapy Electrodes ... 12-5 Pacer Testing ... 12-5 Recorder Check ... 12-6 Code Readiness Log ... 12-6 Setting Time and Date ... 12-8 Cleaning the R Series Unit ... 12-8 Loading Stripchart Paper ... 12-9 Cleaning the Print Head ... 12-10 Operator’s Checklist for R Series Product ... 12-11

Chapter 13

Troubleshooting

Code-Ready ... 13-1 Monitor ... 13-2 Recorder ... 13-3 Pacer ... 13-4 Defibrillator ... 13-5 AC Charger ... 13-7 CPR ... 13-8

Appendix A

Specifications

Defibrillator Specifications ...A-2 Battery Pack Specifications ...A-6 IEC 60601-1-2 Specifications ...A-7 Electromagnetic Emissions Declaration ...A-7 Electromagnetic Immunity Declaration (EID) ...A-8 Electromagnetic Immunity ...A-9 Recommended Separation Distances from RF Equipment for the R Series Functions ...A-11 R Series Rectilinear Biphasic Waveform Characteristics ...A-12 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 Pre-Clinical Study ...A-25 Published Clinical Data ...A-26 9650-0912-05 Rev. R

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TABLE OF CONTENTS Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation (AF) ...A-26 Synchronized Cardioversion of Atrial Fibrillation ...A-28 ECG Rhythm Analysis Algorithm Accuracy ...A-29

Appendix B R Series Accessories Appendix C Wi-Fi Radio Module Information

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Chapter 1 General Information Product Description The ZOLL® R Series® products combine a defibrillator, ECG display, advanced monitoring capabilities, and Noninvasive Transcutaneous Pacing (NTP) with communication, data printing and recording capabilities in a single lightweight portable instrument. The unit has been designed for all resuscitation situations and its small, compact, lightweight design makes it ideal for accompanying patients during transport. The product is powered by AC mains and an easily replaced battery pack that is quickly recharged in the device when it is connected to AC mains. In addition, the unit’s battery may be recharged and tested using a ZOLL SurePower™ Battery Charger. The product is designed for use in the hospital. All of its ruggedized features add to its durability in hospital applications. There are multiple models of the R Series defibrillator that can contain a variety of functions. Your model may not contain all of the functions that are documented in this manual. Those features that are not contained in all models are specified as optional. The R Series is a versatile manual/advisory external defibrillator. When operating in the manual configuration, the device operates as a conventional defibrillator where the device’s charging and discharging are fully controlled by the operator. In advisory mode, some of the features of the device are automated and a sophisticated algorithm is used to identify shockable ECG rhythms (VF and wide complex VT >150 bpm) that should be treated by defibrillator shock delivery. Depending on local protocols, the unit may be configured to automatically analyze the ECG, charge the defibrillator (if appropriate), and prompt the operator to PRESS SHOCK between periods of CPR. The R Series unit assists caregivers during cardiopulmonary resuscitation (CPR) by evaluating the rate and depth of chest compressions and providing feedback to the rescuer.

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CHAPTER 1 GENERAL INFORMATION Real CPR Help® requires the use of OneStep™ CPR electrodes or OneStep Complete electrodes. When using these pads, the displayed ECG waveforms can be adaptively filtered, using the See-Thru CPR® feature, to reduce the artifact caused by chest compressions. The R Series is a Code-Ready® defibrillator. It extends testing beyond shock delivery and checks more than 40 measures of readiness, including the presence of the correct cables and electrodes, the type of electrode, and other important electronic functions. The R Series also verifies the condition and expiration date of OneStep electrodes. This code readiness testing can occur automatically, without disconnecting electrodes or paddles, or requiring additional equipment to test shock delivery. The system also provides a printed, or electronic log to alert hospital personnel of any defibrillator functions or accessories that are compromised in advance of a code. Some R Series models include an optional transcutaneous pacemaker consisting of a pulse generator and ECG sensing circuitry. The pacing option supports both synchronous (demand) and asynchronous (fixed) noninvasive pacing for adult, pediatric, or neonatal patients. OneStep Pacing electrodes and OneStep Complete electrodes allow demand pacing and ECG monitoring without separate ECG electrodes when the R Series is used with the OneStep Pacing cable. Information regarding the unit’s operation, ECG, and other physiological waveforms are displayed on a large 6.5 inch (16.5 cm) diagonal display which provides high contrast and visibility under virtually all lighting conditions. Operating and warning messages are displayed on the monitor, and the unit can also be configured with voice prompts to alert the user to unit status. The R Series performs code readiness testing when the unit is OFF but connected to AC power, when the defibrillator is initially turned on, and periodically during operation. An annotating strip chart recorder is included to provide immediate documentation as well as summary report functions about patient care and treatment. A sophisticated data collection system, including summary report, printer, and multiple communication ports is available for this unit. The stored data can be reviewed and archived on a properly equipped personal computer using ZOLL RescueNet® software. R Series data files may be transferred to a PC using USB, Compact Flash cards or Wi-Fi. R Series products are intended for use in Manual mode by personnel certified by appropriate federal, state, or local government authority to provide advanced life support care.

How to Use This Manual The R Series Operator’s Guide provides information operators need for the safe and effective use and care of the R Series products. It is important that all persons using this device read and understand all the information contained within. Please read thoroughly the safety considerations and warnings section. Procedures for daily checkout and unit care are located in “Maintenance” on page 12-1. This manual is supplemented by manual inserts for options available on the R Series. These inserts contain additional warnings, precautions, and safety-related information.

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Operator’s Guide Updates

Operator’s Guide Updates An issue or revision date for this manual is shown on the front cover. If more than three years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available. All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference. Product documentation is available through the ZOLL website at www.zoll.com. From the Products menu, choose Product Manuals.

Unpacking Carefully inspect each container for damage. If the shipping container or cushion material is damaged, keep it until the contents have been checked for completeness and the instrument has been checked for mechanical and electrical integrity. If the contents are incomplete, if there is mechanical damage, or if the defibrillator does not pass its electrical self-test, U.S.A. customers should call ZOLL Medical Corporation (1-800-348-9011). Customers outside of the U.S.A. should contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify the carrier.

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

Description Dangerous voltage.

MR unsafe: keep away from magnetic resonance imaging equipment

Attention, consult accompanying documents.

Fragile, handle with care.

Keep dry.

This end up.

Temperature limitation.

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CHAPTER 1 GENERAL INFORMATION Symbol

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

Type B patient connection.

Type BF patient connection.

Type CF patient connection.

Defibrillator-proof type BF patient connection.

Defibrillator-proof type CF patient connection.

Fusible link.

Equipotentiality.

Alternating current (AC).

,I

2.

45

2%

)/.

Direct current (DC).

Contains lithium. Recycle or dispose of properly.

R EC Y C LE

,I )/.

Keep away from open flame and high heat.

Do not open, disassemble, or intentionally damage.

Do not crush.

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Symbols Used on the Equipment Symbol

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

Return to a collection site intended for waste electrical and electronic equipment (WEEE). Do not dispose of in unsorted trash.

Date of manufacture.

Use by.

Latex-free.

Do not reuse.

Do not fold.

Not sterile.

Nonionizing electromagnetic radiation from Wi-Fi during data transfer.

Manufacturer.

Authorized representative in the European Community.

Serial Number.

Catalogue number.

Consult instructions for use.

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CHAPTER 1 GENERAL INFORMATION Symbol

Description Prescription only.

Maximum energy.

Test port.

UDI

MD

Indicates a carrier that contains Unique Device Identifier information.

Indicates the item is a medical device.

Indicates the entity importing the medical device into the locale.

Indicates the authorized representative in Switzerland.

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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Defibrillator Function

Intended Purpose The intended purpose of the R Series products is for qualified medical professionals to use the device to help adult, pediatric, and neonatal patients experiencing symptoms of sudden cardiac arrest. The R Series devices are portable defibrillators that combine defibrillation and external pacing with the following monitoring capabilities: ECG, EtCO2, SpO2, non-invasive blood pressure, and Real CPR Help, when using compatible electrodes and sensors. The R Series devices have optional features that can be configured to meet the needs of a particular application and can be configured to operate in manual, advisory, or AED modes. In advisory and AED modes, some the device’s features are automated and an ECG detection algorithm is used to analyze a patient’s presenting rhythm and determine the appropriateness of defibrillation shock. Units may be configured to automatically charge, analyze, recharge, and prompt the operator to PRESS SHOCK, depending on local protocols. The unit is switched from AED mode to manual mode for advanced cardiac life support use by pressing the appropriate key on the front panel. When operating in manual configuration, the device operates as a conventional defibrillator where the device’s charging and discharging is fully controlled by the operator. In manual mode, the device may also be used to perform synchronized cardioversion using the patient’s R-wave as a timing reference.

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 - 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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Intended Use - Real CPR Help The Real CPR Help function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 - 120 compressions per minute. Voice and visual prompts encourage a compression depth in accordance with AHA and/or ERC recommendations of 2 inches (5 cm) minimum for adult patients.

Defibrillator Contraindications for Use There are no known contraindications for the use of the defibrillator.

Defibrillator Complications Inappropriate defibrillation or cardioversion of a patient (for example, with no malignant arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias. Defibrillation without proper application of electrodes or paddle electrolyte gel might be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles, or electrodes often occurs; this effect is usually enhanced along the perimeter of the paddles or electrodes. This reddening should diminish substantially within 72 hours.

Defibrillator Output Energy R Series defibrillators can deliver as much as 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patient’s transthoracic impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of 10 to 12 kilograms (22 to 26.4 pounds) must be applied to each paddle in order to minimize this impedance. If hands-free therapy electrodes are used, make sure that they are properly applied. (Refer to the instructions on the electrode package).

External Pacemaker (Optional) Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG-sensing circuitry. Noninvasive transcutaneous pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and nonemergency situations when temporary cardiac stimulation is indicated. The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm), by increments of 2. The pacing output pulse is delivered to the heart via ZOLL hands-free defibrillation/pacing electrodes placed on the patient’s back and the precordium. The characteristics of the output pulse, together with the design and placement of the electrodes, minimize cutaneous nerve stimulation, cardiac stimulation threshold currents, and reduce discomfort due to skeletal muscle contraction. The unique design of the R Series products allow clear viewing and interpretation of the electrocardiogram on the display without offset or distortion during external pacing. 1–8

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External Pacemaker (Optional) 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.

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. 9650-0912-05 Rev. R

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CHAPTER 1 GENERAL INFORMATION 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 saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or pre-hospital environment.

SpO2 Contraindications for Use See the R Series Pulse Oximetry (SpO2) insert (ZOLL part number 9650-0901-01) for disclosures of any contraindications for use of the pulse oximeter monitoring feature.

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