R Series ALS Operators Guide Rev M

The issue date for the R Series Operator’s Guide ALS (REF 9650-0912-05 Rev. M) is February, 2019. Copyright © 2019 ZOLL Medical Corporation. All rights reserved. R Series, M Series, CPR-D-padz, Pedi-padz, Pro-padz, Stat-padz, Real CPR Help, RescueNet, See-Thru CPR, Code-Ready, SurePower, OneStep, Smart Alarms, Perfusion Performance Indicator, Defib Mentor, Rectilinear Biphasic, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Masimo is a registered trademark of Masimo Corporation in the United States and/or other countries. All other trademarks are property of their respective owners. ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

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Table of Contents 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 Use - Manual Operation ... 1-6 Intended Use - ECG Monitoring ... 1-7 Intended Use - Real CPR Help ... 1-7 Defibrillator Contraindications for Use ... 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 - SpO2 Monitoring ... 1-10 Intended Use - EtCO2 Monitoring... 1-10 Intended Use - NIBP... 1-11 ECG Monitoring ... 1-11 Recorder Function ... 1-12 Paddles and Electrodes ... 1-12 Batteries... 1-13 Code-Ready System... 1-13 Safety Considerations... 1-14 Warnings... 1-14 Operator Safety ... 1-16 Patient Safety ... 1-17 Cautions... 1-18 Restarting the Defibrillator ... 1-18 FDA Tracking Requirements ... 1-19 Notification of Adverse Events ... 1-19 Software License ... 1-20 Service... 1-20 The ZOLL Serial Number... 1-21

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TABLE OF CONTENTS

Chapter 2

Product Overview

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

Chapter 3

Manual Defibrillation

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

Chapter 4

Advisory Defibrillation

Advisory Defibrillation Procedure... 4-2 Determine the Patient’s Condition Following Local Medical Protocols ... 4-2 Begin CPR Following Local Medical Protocols ... 4-2 Prepare Patient ... 4-2 1 Select DEFIB ... 4-2 2 Press ANALYZE Button ... 4-3 3 Press SHOCK ... 4-5 Advisory Function Messages ... 4-7 Warning Messages ... 4-7

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Chapter 5

Synchronized Cardioversion

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

Chapter 6

Real CPR Help

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

Chapter 7

See-Thru CPR (Optional)

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

Chapter 8

Noninvasive Temporary Pacing (Optional)

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

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

Chapter 9

ECG Monitoring

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

Chapter 10

Event Records and Reports

Summary Report... 10-1 Summary Report Formats ... 10-2 Printing the Entire Summary Report ... 10-7 Printing a Partial Summary Report ... 10-8 Full Disclosure Recording ... 10-8 Incident Logs ... 10-8 Printing an Incident Log ... 10-8 Erasing Summary Report and Full Disclosure ... 10-9 Manual Erasure ... 10-9 Automatic Erasure ... 10-9 Formatting the Disk ... 10-9 Related Messages ... 10-10

Chapter 11

File Transfer

Transferring Files to an External Device... 11-1 Wi-Fi (Optional)... 11-2

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Installing or Removing a Compact Flash Card ... 11-2 Transferring a Full Disclosure File to a Compact Flash Card ... 11-3 Transferring Device Check and Activity Log Files to a Compact Flash Card... 11-3 Transferring Files Through the USB Port (Optional) ... 11-4 Transferring Full Disclosure Files Through Wi-Fi (Optional) ... 11-5 Transferring Device Check and Activity Log Files Through Wi-Fi (Optional) ... 11-6 Related Wi-Fi Messages ... 11-8

Chapter 12

Maintenance

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

Chapter 13

Troubleshooting

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

Appendix A

Specifications

Defibrillator Specifications ...A-2 Battery Pack Specifications ...A-6 IEC 60601-1-2 Specifications ...A-7 Electromagnetic Emissions Declaration ...A-7 Electromagnetic Immunity Declaration (EID) ...A-8 Electromagnetic Immunity ...A-9 Recommended Separation Distances from RF Equipment for the R Series Functions ...A-11 R Series Rectilinear Biphasic Waveform Characteristics ...A-12

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TABLE OF CONTENTS Clinical Trial Results for the Biphasic Waveform ...A-24 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation (VF) and Ventricular Tachycardia (VT) ...A-24 Randomized Multi-Center Clinical trial for Cardioversion of Atrial Fibrillation (AF) ...A-25 Synchronized Cardioversion of Atrial Fibrillation ...A-26 ECG Rhythm Analysis Algorithm Accuracy ...A-28

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

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

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

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

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Operator’s Guide Updates

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

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

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

Description Dangerous voltage.

MR unsafe: keep away from magnetic resonance imaging equipment

Attention, consult accompanying documents.

Fragile, handle with care.

Keep dry.

This end up.

Temperature limitation.

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CHAPTER 1 GENERAL INFORMATION Symbol

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

Type B patient connection.

Type BF patient connection.

Type CF patient connection.

Defibrillator-proof type BF patient connection.

Defibrillator-proof type CF patient connection.

Fusible link.

Equipotentiality.

Alternating current (AC).

,I

2.

45

2%

)/.

Direct current (DC).

Contains lithium. Recycle or dispose of properly.

R EC Y C LE

,I )/.

Keep away from open flame and high heat.

Do not open, disassemble, or intentionally damage.

Do not crush.

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Symbols Used on the Equipment Symbol

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

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

Date of manufacture.

Use by.

Latex-free.

Do not reuse.

Do not fold.

Not sterile.

Nonionizing electromagnetic radiation from Wi-Fi during data transfer.

Manufacturer.

Authorized representative in the European Community.

Serial Number.

Catalogue number.

Consult instructions for use.

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CHAPTER 1 GENERAL INFORMATION Symbol

Description Prescription only.

Maximum energy.

Test port.

Conventions This guide uses the following conventions: Within text, the names and labels for physical buttons and softkeys appear in boldface type (for example, “Press the SHOCK button or the Code Marker softkey”). This guide uses uppercase italics for audible prompts and for text messages displayed on the screen (for example, CHECK PATIENT).

WARNING!

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

Caution

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

Defibrillator Function The R Series product contains a direct current (DC) defibrillator capable of delivering up to 200 joules. It may be used in synchronized mode to perform synchronized cardioversion using the patient’s R-wave as a timing reference. The unit uses paddles or disposable, pregelled electrodes for defibrillation.

Intended Use - Manual Operation 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. 1–6

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Defibrillator Function In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).

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

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

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

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

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

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

Intended Use - Pacemaker This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: • Resuscitation from standstill or bradycardia of any etiology.

Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug-induced standstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes. • As a standby when standstill or bradycardia might be expected.

Noninvasive pacing can be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia, or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing might provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis, and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.

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External Pacemaker (Optional) • Suppression of tachycardia.

Increased heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia. WARNING!

This device must not be connected to internal pacemaker electrodes.

Pacemaker Contraindications for Use There are no known contraindications for the use of the pacemaker.

Pacemaker Complications Ventricular fibrillation does not respond to pacing and requires immediate defibrillation. Therefore, the patient’s dysrhythmia must be determined immediately, so that you can employ appropriate therapy. If the patient is in ventricular fibrillation and defibrillation is successful but cardiac standstill (asystole) ensues, you should use the pacemaker. Ventricular or supraventricular tachycardias can be interrupted with pacing, but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain. Pulseless electrical activity (PEA) can occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing might then produce ECG responses without effective mechanical contractions, making other effective treatment necessary. Pacing can evoke undesirable repetitive responses, tachycardia, or fibrillation in the presence of generalized hypoxia, myocardial ischemia, cardiac drug toxicity, electrolyte imbalance, or other cardiac diseases. Pacing by any method tends to inhibit intrinsic rhythmicity. Abrupt cessation of pacing, particularly at rapid rates, can cause ventricular standstill and should be avoided. Noninvasive temporary pacing can cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients. Similarly, unavoidable skeletal muscle contraction might be troublesome in very sick patients and might limit continuous use to a few hours. Erythema or hyperemia of the skin under the hands-free therapy electrodes often occurs; this effect is usually enhanced along the perimeter of the electrode. This reddening should lessen substantially within 72 hours. There have been reports of burns under the anterior electrode when pacing adult patients with severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised. There are reports of transient inhibition of spontaneous respiration in unconscious patients with previously available units when the anterior electrode was placed too low on the abdomen.

WARNING!

This device must not be connected to internal pacemaker electrodes.

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Pediatric Pacing Pacing can be performed on pediatric patients weighing 55 lb. (25 kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), particularly in neonates, can cause burns. Periodic inspection of the underlying skin is recommended.

Intended Use - SpO2 Monitoring The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or pre-hospital environment.

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

Intended Use - EtCO2 Monitoring The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia. The R Series EtCO2 option with Respironics Novametrix technology supports two methods for continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate. The first method uses the CAPNOSTAT 5 Mainstream CO2 sensor attached to an airway adapter that connects to an endotracheal tube, mask or disposable mouthpiece. The second method uses the LoFlo CO2 module to monitor both non-intubated and intubated patients using specially designed sampling cannulas and airway adapters. The R Series EtCO2 option is designed to monitor adult, pediatric, and neonatal patients. The following substances can influence CO2 measurements made with the CAPNOSTAT 5 CO2 sensor or the LoFlo sidestream module: • elevated oxygen levels • nitrous oxide • halogenated agents The R Series EtCO2 option provides settings for high oxygen and/or nitrous oxide compensation. Halogenated anesthetic agents alter CO2 readings, but the R Series unit will monitor CO2 within specifications when these agents are present at normal clinical levels. The presence of Desflurane in the exhaled breath beyond normal values (5%) may positively bias measured carbon dioxide values by up to an additional 3 mmHg. The R Series EtCO2 option is intended for use only with the ZOLL/Respironics Novametrix CAPNOSTAT 5 Mainstream CO2 Sensor and mainstream airway adapters, the LoFlo CO2 Module, nasal and nasal/oral sampling cannula sets, and sidestream on-airway adapters. 1–10

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

Approximate Age Range

Newborn (neonate)

Birth to 1 month of age

Infant

1 month to 2 years of age

Child

2 to 12 years of age

Adolescent

12-21 years of age

EtCO2 Contraindications for Use See the R Series End Tidal Carbon Dioxide (EtCO2) insert (ZOLL part number 9650-0915-01) for disclosures of any contraindications for use of the EtCO2 monitoring feature.

Intended Use - NIBP The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport. The R Series NIBP option is designed to measure blood pressure for adult patients (21 years of age and older) and for pediatric patients, as described in the following table: Pediatric Subpopulation

Approximate Age Range

Newborn (neonate)

Birth to 1 month of age

Infant

1 month to 2 years of age

Child

2 to 12 years of age

Adolescent

12-21 years of age

NIBP Contraindications for Use See the R Series Non-Invasive Blood Pressure (NIBP) insert (ZOLL part number 9650-0914-01) for disclosures of any contraindications for use of the NIBP monitoring feature.

ECG Monitoring The patient’s ECG is monitored by connecting the patient to the unit via a 3- or 5-lead patient cable, hands-free therapy electrodes, or through paddles. Five seconds of ECG is presented on the display along with the following information: • averaged heart rate, derived by measuring R to R intervals • lead selection - I, II, III, aVR, aVL, aVF, V (with ECG cable), PADDLES or PADS, P1, P2,

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

P1, P2, and P3 are non-standard ECG leads derived from electrodes within particular OneStep electrodes. While ECG signals acquired from these leads are appropriate for rhythm assessment and determining electrical capture during pacing, they should not be

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CHAPTER 1 GENERAL INFORMATION used for ECG morphological evaluation. Attach conventional ECG electrodes for diagnostic purposes. • ECG size relative scale factor - x0.5, x1, x1.5, x2, x3 • other operational prompts, messages, and diagnostic codes

Monitoring or diagnostic ECG bandwidth is selectable.

Recorder Function The strip recorder is provided to document events. The strip recorder normally operates in the delay mode (6 seconds) to ensure the capture of ECG information immediately preceding critical events. The recorder may be activated manually by pressing the RECORDER button. It is activated automatically whenever a defibrillation SHOCK is delivered, a heart rate alarm occurs, or the rhythm analysis function is activated. The strip recorder may also be configured not to print during these events.

Paddles and Electrodes The R Series will defibrillate, cardiovert, and monitor ECG using either defibrillation paddles or hands-free therapy electrodes. The pacer version of the R Series will pace using ZOLL hands-free therapy electrodes. ENERGY SELECT, CHARGE and SHOCK controls are located on the paddles and front panel. When using hands-free therapy electrodes, you must use the controls on the front panel of the unit. To switch between paddles and hands-free therapy electrodes, remove the OneStep cable from the apex paddle and connect the hands-free therapy electrodes to the cable. The Advisory function cannot be activated unless hands-free therapy electrodes are attached to the OneStep cable and used as the ECG monitoring lead. The R Series can monitor the patient’s ECG while pacing without the need for a separate ECG cable and ECG electrodes. This also allows demand pacing when separate ECG electrodes are either not connected, or unavailable. OneStep pacing capability requires the OneStep Pacing cable along with OneStep Pacing electrodes, or OneStep Complete electrodes. Note:

The ZOLL OneStep electrodes, MFE Pads, Pediatric MFE Pads, Stat-padz®, and ECG electrodes are disposable, single-use items.

You should always check the expiration date on the electrode packaging. Do not use expired electrodes, which might result in false patient impedance readings and affect the level of delivered energy, or cause burns.

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

The R Series defibrillator reads and reports the expiration date for all OneStep electrodes (except for OneStep Basic). When these electrodes exceed their expiration date, the Code Readiness indicator will change to a red “X.”

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