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Zoll AED Pro Operator`s Guide

1. 9650 0350 01 Rev H This page intentionally left blank ZOLL AED Pro Operator s Guide
2. Operating time For a new fully charged battery pack at 20 C 170 defibrillator discharges at maximum energy 200 joules or 6 hours of continuous monitoring The CHANGE BATTERY warning appears after 115 maximum energy discharges Standby life 3 months before recharge or retest Disposable Sealed Lithium Manganese Dioxide Type Disposable sealed lithium manganese dioxide Weight 0 4 kg 0 9 Ib Nominal voltage 12V Operating time For a new fully charged battery pack at 20 C 300 defibrillator discharges at maximum energy 200 joules or 15 hours of continuous ECG monitoring The CHANGE BATTERY warning appears after 200 maximum energy discharges Standby life 5 years Rechargeable Lithium lon SurePower Battery Pack Type Rechargeable lithium ion Weight 0 77 kg 1 7 Ib Nominal voltage 10 8 V Recharge time 4 hours or less with SurePower Charger Station Operating time For a new fully charged battery pack at 20 C 400 defibrillator discharges at maximum energy 200 joules or 19 hours of continuous ECG monitoring The CHANGE BATTERY warning appears after 300 maximum energy discharges Standby life 3 months before recharge or retest 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 5 APPENDIX A SPECIFICATIONS Guidance and Manufacturer s Declaration Electromagnetic Emissions The ZOLL AED Pro device is intended for use in the electromagn
3. See Thru CPR See Thru CPR See Thru CPR enables the rescuer to see a close approximation of the patient s underlying ECG rhythm while performing CPR See Thru CPR is an optional feature that must be configured using the ZOLL Administration Software Chest compressions introduce CPR artifact into the ECG signal See Thru CPR uses a filter that relies on the correlation between CPR compressions as detected by the ZOLL CPR Depadz or CPR statepadz electrodes and the CPR artifact to remove much but not all of the artifact from the ECG signal Under some conditions residual noise after filtering can obscure the ECG rhythm requiring the rescuer to stop CPR to assess the ECG For example in the case of asystole or low amplitude PEA the residual artifact seen after filtering may look like fine ventricular fibrillation Because the filtered ECG signal may contain residual chest compression and or filtering artifacts a rescuer should always follow the standard protocol of stopping CPR to assess the patient s ECG rhythm before determining treatment Using See Thru CPR To use See Thru CPR e The AED Pro unit must be operating in Manual Mode e CPR Depadz or CPR statepadz electrodes must be attached to the unit e The AED Pro unit must be configured to use See Thru CPR using the ZOLL Administration Software When a rescue begins an AED Pro unit that has been configured to use See Thru CPR automatically starts filtering the CPR art
4. default e Check Circulation e Check Pulse Circulation Pulse Prompt Delay Sets the duration before the next prompt or disables this prompt e 2 seconds e 5 seconds e 7 seconds e 10 seconds default e 15 seconds e 20 seconds Press Treatment Shock Selects the wording for this and related prompts e Press Flashing Treatment Button e Press Flashing Shock Button default CPR CPR Monitoring When this option is checked On and CPR D paaz or CPR stat paaz are attached the unit performs CPR monitoring and prompts the rescuer e On default e Off No Shock CPR Period Sets the duration of the CPR period following a no shock result for the first analysis in a stack When you select Extended the device remains in the CPR state indefinitely and displays the ANALYZE softkey You must press the ANALYZE softkey to move to analysis e 30seconds e 60 seconds e 90 seconds e 120 seconds default e 150 seconds e 180 seconds es Extended Cycle through CPR When this option is checked On and pads are detached from the patient for more than one and one half minutes the unit prompts the rescuer to perform CPR e On default e Off www zoll com 9650 0350 01 Rev H Descriptions of AED Pro Configurable Settings Configurable Option Possible Values Post Shock CPR Period e 30 seconds Sets the duration of the CPR period following the e 60 seconds e 90 s
5. The unit displays MONITOR as the current mode and the SEMI AUTO softkey label appears 1 00 24 18 MONITOR 34 ECG X1 0 NN CHECK PATIENT SEMI AUTO Monitor the patient s ECG If it detects a shockable rhythm while monitoring the unit prompts you to check the patient and changes to semiautomatic mode To manually return to semiautomatic mode press and release the SEMI AUTO softkey 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 5 7 CHAPTER 5 ECG MONITORING MODE Messages in ECG Monitoring Mode The following voice prompts and text messages can occur while using the unit for ECG 5 8 monitoring Message Description CHECK PATIENT ECG monitoring detected a shockable rhythm or low heart rate Evaluate the status of the patient PLUG IN DEFIB CABLE The unit detected a shockable rhythm while monitoring the patient with ECG electrodes An ECG cable was plugged in but the unit is not configured for ECG monitoring Plug in the defibrillation cable CHECK ECG ELECTRODES Ensure that the ECG electrodes are properly attached to the patient and that the cable is plugged into the unit CHECK DEFIB PADS Ensure that the defibrillation electrode pads are properly attached to the patient and that the cable is plugged into the unit ATTACH DEFIB PADS TO PATIENT S BARE CHEST The unit does not detect attachment of the defibrillation electrode pads to the pa
6. Applying ECG Electrodes on page 5 4 Check for proper adhesion of the electrodes to the patient Arrange the cable and leads so that they do not pull on the electrodes or swing excessively Poor ECG signal level Replace the ECG electrodes and change their position on the patient Irregular heart rate Observe the patients ECG Verify that the irregular heart rate is not caused by noise low amplitude R waves extra systoles or arrhythmias Replace the ECG electrodes and change their position on the patient Message PLUG IN DEFIB CABLE ECG analysis detected a shockable rhythm Replace the ECG electrodes and cable with defibrillation pads to deliver therapy ECG data recording stops If the unit is turned off and then turned on again within 10 seconds ECG recording is interrupted www zoll com 9650 0350 01 Rev H Defibrillator Troubleshooting Defibrillator Troubleshooting Table 7 3 lists common issues with defibrillation and their associated corrective action Table 7 3 Defibrillator Issues Symptom Corrective Action Defibrillator does not charge The patient s ECG rhythm is not shockable because it is not either ventricular fibrillation VF or wide complex ventricular tachycardia VT or is VF with amplitude less than 100 uV semiautomatic mode only Verify the rhythm Confirm that the defibrillation cable is plugged in and the pads are attached to
7. the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable 1 kV I O Surge IEC 61000 4 5 1 kV differential mode 2 kV for common mode Not applicable Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ut gt 95 dip in Ut for 5 seconds Note Ut is the ac mains voltage prior to application of the test level Not applicable Not applicable Not applicable Not applicable Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide APPENDIX A SPECIFICATIONS Immunity Test IEC 60601 Compliance Electromagnetic Environment Test Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the AED Pro device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms 3 Vrms Recommended sepa
8. which changes to a green check within 10 seconds after the unit is turned on e The unit issues the voice and text message UNIT OK within 10 seconds if configured e The screen displays the shock count and the elapsed time Set the simulator to send a VF rhythm to the AED Pro unit After the sequence of patient assessment prompts verify that the unit does the following e Issues the voice and text prompt DON T TOUCH PATIENT ANALYZING e Analyzes the ECG rhythm e Issues the voice and text message SHOCK ADVISED e Charges the defibrillator e Issues the voice and text prompts DON T TOUCH PATIENT and PRESS FLASHING SHOCK BUTTON Verify that the AED Pro unit sounds the charge ready tone and that the Shock button flashes repeatedly Press the Shock button Verify that the simulator indicates that a shock was delivered and that the unit updates the displayed shock count Note The simulator can verify the unit s ability to deliver energy but cannot verify that the correct energy was delivered To verify the level of delivered energy use a defibrillator analyzer and universal adapter cable in place of the simulator Immediately after shock delivery change the simulator to send a normal sinus rhythm NSR to the AED Pro unit Verify that the AED Pro unit performs a new rhythm analysis resulting in the message NO SHOCK ADVISED followed by the voice and text prompt START CPR 9650 0350 01
9. a fully charged battery pack Before you begin Be sure the unit is turned off Be sure the battery pack to be installed is fully charged Do not use a rechargeable battery pack if the unit s standby period will exceed 90 days Procedure To install or replace a battery pack Step Action Notes 1 Pull the bottom edge of the battery compartment latch outward When released the latch slides upward 2 Pull the top edge of the latch toward you and then downward 3 Lift the edge of the battery compartment cover www zoll com 9650 0350 01 Rev H Installing a Battery Pack Step Action Notes Slide out the cover panel If a battery is installed remove it from the compartment by pressing the tab on the battery pack Align the tab of the new battery with the finger access area on the left side of the battery compartment then place the battery into the compartment The shape of the battery pack allows it to seat itself properly Press the edge of the battery pack until it clicks into place Slide the cover panel back into place and then lower the edge of the cover Raise the compartment latch and tilt the top edge toward the unit 10 Press the bottom edge of the latch toward the unit to lock the cover in place 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 2 3 CHAPTER 2 GETTING STARTED Important If yo
10. 60 bpm Bidirectional systoles Figure A4 59 60 bpm Response time to change in heart rate 80 to 120 bpm 4 seconds 80 to 40 bpm 4 seconds Time to alarm for tachycardia per EN 60601 2 27 2nd Ed 2005 Figure B1 206 bpm 1 mV 7 9 seconds 206 bpm 5 mV 8 7 seconds 206 bpm 2 mV 8 2 seconds Figure B2 195 bpm 2 mV 7 9 seconds 195 bpm 1 mV 7 1 seconds 195 bpm 4 mV 8 0 seconds ECG leads off sensing A DC current of lt 10 uA per lead wire is supplied to the patient Defibrillation electrodes leads off sensing 67 kHz square wave lt 1 mA Data Recording and Storage Type Nonvolatile memory Capacity 5 8 hours of ECG data and CPR data 20 minutes of audio recording and ECG data if Audio Recording Option is enabled Display Screen Display type Liquid crystal display LCD High resolution 320 pixels by 240 pixels Viewable area height width 2 27 in 3 02 in 5 76 cm 7 68 cm Sweep speed 25 mm s 5 Viewing time 2 96 seconds if CPR gauge displayed 3 2 seconds without CPR gauge www zoll com 9650 0350 01 Rev H Battery Pack Specifications Battery Pack Specifications Rechargeable Sealed Lead Acid Type Sealed lead acid Weight 1 kg 2 2 lb Nominal voltage 10V Recharge time 4 hours or less with ZOLL Base PowerCharger 4x4 ZOLL Base PowerCharger 1x1 ZOLL SurePower Charger Station
11. ECG electrode Keep the adhesive surface free of electrolyte gel WARNING Do not use electrodes if the gel is dried or damaged 5 4 www zoll com 9650 0350 01 Rev H Applying ECG Electrodes Step Action Apply the adhesive side of each ECG electrode firmly to the patient s skin pressing around the entire perimeter of the electrode Plug the ECG cable into the patient cable connector on the unit Note Arrange the ECG cable so that it does not pull on any of the electrodes 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 5 5 CHAPTER 5 ECG MONITORING MODE Monitoring the ECG Rhythm You can monitor a patient s ECG using standard ECG electrodes or defibrillation electrode pads Monitoring with ECG Electrodes When it detects an AED Pro ECG cable at startup the unit enters ECG monitoring mode if monitoring mode is enabled and displays the patient s ECG rhythm and heart rate Procedure To start and operate the unit in ECG monitoring mode Step Action Result 1 Be sure the AED Pro ECG cable is plugged into the unit the electrodes are snapped onto the cable and the electrodes are attached to the patient Press and release the On Off button to turn on the unit The unit starts up and the screen displays MONITOR as the current mode Allow the unit to monitor the patient s ECG If it detects a shockable rhythm while monitoring t
12. SEMIAUTOMATIC MODE Applying Defibrillation Electrode Pads WARNING WARNING To deliver defibrillation therapy to a patient you must use AED Pro compatible defibrillation electrode pads e ZOLL CPR Depadz adult patients includes CPR sensor e CPR statepadz adult patients includes CPR sensor e ZOLL statspadz II adult patients e ZOLL pedi padz II pediatric patients Defibrillation electrode pads connect to the AED Pro unit through the patient cable connector Preconnect a set of electrode pads so that they are ready for use in an emergency Do not open the sealed electrodes until immediately prior to use You can also use defibrillation electrode pads for ECG monitoring Before applying defibrillation electrode pads to the patient be sure to e Remove all clothing covering the patient s chest e Clip or shave any excessive hair to ensure proper adhesion of the pads e Use alcohol to wash away any oil or dirt at the electrode site e Dry any moisture at the electrode site Poor adherence or air pockets under the defibrillation electrode pads can lead to arcing skin burns or reduced energy delivery For proper placement of electrodes for defibrillation refer to the graphics on the electrode packaging Check the expiration date on the defibrillation electrode packaging Do not use expired pads This symbol on the electrode label is accompanied by the expiration date Note ZOLL electrodes contain no hazar
13. US Pre 2007 e US e EU e EU Southern Hemisphere Number of Shocks Sets the number of shocks in the shock sequence to 1 2 or 3 shocks e 1 Shock default e 2 Shocks e 3 Shocks www zoll com 9650 0350 01 Rev H Descriptions of AED Pro Configurable Settings Configurable Option Possible Values Shock Energy Level and Charging Adult First Shock Energy e 120 J default Sets the energy level in joules for the first shock for an 150J adult patient e 200J Adult Second Shock Energy e 120J Note This value cannot be less than the value e 150 J default selected for the first adult shock e 200 J Adult Third Shock Energy e 120J Note This value cannot be less than the value e 150J selected for the second adult shock e 200 J default Pediatric First Shock Energy e 50 J default Sets the energy level in joules for the first shock for a e 70J pediatric patient e 85J Pediatric Second Shock Energy e 50J Note This value cannot be less than the value e 70 J default selected for the first pediatric shock e 85J Pediatric Third Shock Energy e 50J Note This value cannot be less than the value e 70J selected for the second pediatric shock e 85 J default Enable Lay Rescuer e Off default When this option is checked On the unit issues the e On following voice and text prompts after completion of the power on self test and entry into clinical mode STAY CALM CA
14. algorithm as tested against the ZOLL ECG rhythm database The algorithm sequence takes approximately 9 seconds and proceeds as follows e Divides the ECG rhythm into 3 second segments e Filters and measures noise artifact and baseline wander e Measures baseline content waviness at the correct frequencies frequency domain analysis of signal e Measures QRS rate width and variability e Measures amplitude and temporal regularity autocorrelation of peaks and troughs e Determines if multiple 3 second segments are shockable and then prompts the operator to treat the patient Table A 4 Clinical Performance Results Adult Patients Rhythms Se Shockable 466 Sensitivity Coarse VF 403 gt 90 96 28 94 33 Rapid VT 63 gt 75 100 0 95 36 Nonshockable 2305 Specificity NSR 1659 gt 99 100 0 99 82 AF SB SVT heart block 604 gt 95 100 0 99 51 idioventricular PVCs Asystole 42 gt 95 100 0 93 12 Intermediate 68 Fine VF 50 Report only 92 00 82 62 Other VT 18 Report only 88 89 68 97 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 15 APPENDIX A SPECIFICATIONS A 16 Table A 5 Clinical Performance Results Pediatric Patients panels 90 One sided ize Performance Lower nun 9 second Performance Confidence records Limit Shockable Sensitivity 49 patients Coarse VF 42 100 42 42 93 1 Rapid VT 82 93 9 77 82 87 6 Nonshockable Specificity 155
15. either a shockable rhythm or a low heart rate DON T TOUCH PATIENT CHARGING The defibrillator is charging Do not touch the patient RELEASE SHOCK BUTTON The Shock button was pressed while the unit was charging Do not press the Shock button until the unit emits the charge ready tone and the button begins flashing RELEASE LEFT SOFTKEY A softkey was pressed for more than 10 seconds the of unit automatically switched to semiautomatic mode RELEASE RIGHT SOFTKEY Release the softkey www zoll com 9650 0350 01 Rev H Chapter 5 ECG Monitoring Mode You can use the AED Pro unit for short term monitoring of the patient s electrocardiogram ECG The AED Pro unit monitors lead II only Rescue protocol voice prompts are disabled in ECG monitoring mode This chapter contains the following sections e About ECG Monitoring on page 5 2 e ECG Electrode Placement on page 5 3 e Applying ECG Electrodes on page 5 4 e Monitoring the ECG Rhythm on page 5 6 e Messages in ECG Monitoring Mode on page 5 8 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 5 1 CHAPTER 5 ECG MONITORING MODE About ECG Monitoring WARNING For ECG monitoring you can use e Standard ECG electrodes with an AED Pro ECG cable e AED Pro compatible defibrillation electrode pads e L The AED Pro ECG cable is an applied type CF defibrillator proof device In ECG monitoring mode the sc
16. 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 DISARM softkey This guide uses uppercase italics for audible prompts and for text messages displayed on the screen for example DON T TOUCH PATIENT ANALYZING 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 vi www zoll com 9650 0350 01 Rev H Safety Considerations Safety Considerations AN General All operators should review these safety considerations before placing the AED Pro unit into service These operating instructions describe the functions and proper operation of the AED Pro unit This manual does not substitute for a formal training course Operators must obtain formal training from an appropriate authority before using this device for patient care Follow all recommended maintenance instructions If a problem occurs obtain service immediately Do not use the device until it has been inspected by appropriate personnel Do not disassemble the unit A shock hazard exists Refer all problems to authorized service personnel The AED Pro unit is capable of delivering 200 joules To completely deactivate the unit turn it off and remove the battery pack To manually disarm a charged
17. unit continues analyzing the patient s ECG guiding the rescuer to perform CPR or to deliver additional shocks if needed The unit also provides CPR monitoring if ZOLL CPR Dspadz or CPR statepadz defibrillation electrodes are attached CPR Depadz and CPR stat padz include a sensor to monitor the rescuer s chest compression rate and depth The compression data enables the unit to guide the rescuer to perform effective CPR The unit can be preconfigured to prompt the rescuer to perform a period of CPR before the first ECG analysis cycle begins For more information refer to Chapter 3 Semiautomatic Mode www zoll com 9650 0350 01 Rev H Manual Mode Defibrillation Manual Mode Defibrillation In manual mode the rescuer controls each step of defibrillation therapy The AED Pro unit displays patient ECG data and heart rate on the screen The rescuer uses this information to determine whether or not the patient has a shockable rhythm If the AED Pro unit is configured for semiautomatic mode defibrillation with ECG monitoring enabled and manual mode override and the ECG cable is not attached the AED Pro unit starts in semiautomatic mode at power up If the AED Pro unit is configured for manual mode defibrillation the AED Pro unit runs only in manual mode When a shock is deemed necessary the rescuer charges the defibrillator by pressing the CHARGE softkey to charge the unit to the preconfigured energy level Note Defibrilla
18. view the Continue CPR prompt or view it only es Audio and Text default e Text only Stop CPR Allows you to select whether you want to both hear and view the Stop CPR prompt or view it only es Audio and Text default e Text only 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide CONFIGURABLE SETTINGS Configurable Option Possible Values ECG Display ECG Waveform When this option is checked On the unit displays the patient s ECG rhythm On default Off Monitor BW Filter Cutoff 1 35 22 Hz default Selects the bandwidth filter to be used during ECG 0 7 30 Hz monitoring ECG Analysis During CPR Off default On When this option is checked On background ECG analysis begins after the start of a CPR period If a shockable rhythm is detected during a 12 second period in which CPR is not performed the unit prompts the rescuer to stop CPR and stand clear It then initiates ECG analysis When this option is not checked Off the unit does not perform ECG analysis during CPR periods Use Analysis After When the ECG Analysis During CPR option is checked On this option specifies the number of seconds to delay background ECG analysis after a no shock or post shock CPR period begins 0 seconds default 15 seconds 30 seconds 45 seconds 60 seconds 120 seconds 180 seconds See Thru CPR On When this option is
19. 2 7 to 16 5 90 confidence interval 1 01 to 15 3 1 Kerber RE et al Automated External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety Circ J Am Heart Assoc 1997 95 1677 1682 the task force suggests that to demonstrate superiority of an alternative waveform over standard waveforms the upper boundary of the 90 confidence interval of the difference between standard and alternative waveforms must be lt 0 ie alternative is greater than standard 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 13 APPENDIX A SPECIFICATIONS A 14 Successful defibrillation with Rectilinear Biphasic shocks was achieved with 58 less delivered current than with monophasic shocks 14 1 amperes versus 33 7 amperes p 0 0001 The difference in efficacy between the Rectilinear Biphasic and the monophasic shocks was greater in patients with high transthoracic impedance greater than 90 ohms The first shock first induction efficacy of biphasic shocks was 100 versus 63 for monophasic shocks for patients with high impedance p 0 02 95 confidence interval of the difference of 0 0217 to 0 759 and 90 confidence interval of the difference of 0 037 to 0 706 Monophasic Biphasic First shock efficacy 63 100 high impedance patients p value 0 02 95
20. 5 le ETC th Mee Ma hoa coca a EEN A MM Mme 1 6 A W ACCESSOMES a Bes Bava ones faranae satan HEED Wa 29 WE 1 7 The Front ETC TEE cscs Me esehevtesseucssosseveuseucevavssnsdvarteuedsavestanderersenserrsser eera A ibe 1 8 Display Screen ee E Ee 1 10 Chapter 2 Getting Started linstallingza Battery RACK ccccccccccceeeceneeeee sess RE i ME coe a irrien 2 2 CHANGE BATTERY Warning 9 Wee p reee iaei 2 4 Preparing the Unit for Clinical Use BBR Ait BRM cee edhabel ceeeesceeeeenssceeteeeaees 2 5 Performing a Self Test c cccccccces sees ee MERREE DEE 2 6 Automatic Self Test nun EE E aaa anae eeraa raian iara ae 2 6 EIVCHEN e EE 2 6 Preconnecting the Defibrillation Electrodes CGable AEN 2 7 EGE EE WEE E e een ee a a eia Aa 2 8 Chapter 3 Semiautomatic Mode Applying Defibrillation Electrode Pads i ccccccceeeceeeeececeeeeeeeeneeeeeeeeeeeeeseeeeeeeeneneeeeessiees 3 2 Applying Defibrillation Electrode Pads Adult CPR D paaZ ccccceecreeteneeeeees 3 3 Applying Defibrillation Electrode Pads Adult CPR stateDa0Z A 3 5 CPR Monitoring with CPR Depadz and CPR stat paaz cccccecccccceseeetenteeetsnees 3 6 Applying Defibrillation Electrode Pads Adult statspadZ lf 3 7 Applying Defibrillation Electrode Pads Infant Child pediepadZz lf 3 8 Semiautomatic Defibrillation EE EEN A nnet 3 9 Start MAP HE EE Ee 3 12 Messages in Semiautomatic Mode AAA 3 12 9650 03
21. 50 01 Rev H ZOLL AED Pro Operator s Guide i TABLE OF CONTENTS Chapter A Manual Mode About Manual Mode 4or 2 0 Rbsccsccccccceeeecccsccceessneceeececccenenenteeeeeseseene Maree Mua eeen het 4 2 Switching Be BETEN EEN A 0 If EE eas 4 3 Manual Defibrillation c ccceeeseenseeeseeeaeeeaeeaaaeaaaesaecaaeeaaecaeceaeceaeceeceeseceaeceeeeeeeeeeeeeeeees 4 4 SOS SOOT EE fe EN ON 4 5 Messages in Manual e oe ee er 4 10 Chapter 5 ECG Monitoring Mode tt EGG Monitoring EE I aaeeei rererere rea tarena E 5 2 ECG Electrode Placement ECKE 20000 Eiere eeaeee reer 5 3 Applying ECG Electrodes tr SE MME eee eee 5 4 Monitoring the ECG Rhythm e i 200 a eEEEEEEEEEEEEEEK EEN rete rere sess ee 5 6 Monitoring with ECG Electrodes Sitter cccccccesecceeesseseceeeseteneseenseeeeeeeeseeeess BEE 5 6 Monitoring with Defibrillation Electrodes 9 EEEEREEERREEEEEENEEREEEEEEERREEEEEEEEEEEEEN ue 5 7 Messages in ECG Monitoring MOG e ccccceesecceeeseeceeeeeeseneeeneseenenesesendipensseeeensiiines 5 8 Chapter6 Nonrescue Mode Entering Nonrescue Mode ai Wedd ccssessesceries ceesenescdtsantanastasessectiececes KEE eene eec A 6 2 BE ERs EE San eee ee 6 3 Device AIS ie EE MT EEN k 6 3 Pationt Chal Data 2 ccccscneseeetereeeesenee ees EE cee aea 6 3 Communicating with an External Device REENEN 6 4 Setting Up Data Communications with an IrDA Connection 0 ccccceeeeeeeeeeeeeeeeeeeee 6 4 D
22. 50 0350 01 Rev H Chapter 3 Semiautomatic Mode In semiautomatic mode the unit uses voice prompts and visual indicators to guide the rescuer through a resuscitation sequence that can include defibrillation and or cardiopulmonary resuscitation CPR AED models start up in semiautomatic mode unless an AED Pro ECG cable is connected to the unit For more information refer to Chapter 5 ECG Monitoring Mode After guiding the rescuer through patient assessment by issuing voice and text messages the unit issues the voice and text prompt DON T TOUCH PATIENT ANALYZING The unit then begins analysis of the patient s ECG to determine whether the rhythm is shockable or not and announces and displays the result SHOCK ADVISED or NO SHOCK ADVISED If defibrillation is needed ECG analysis ends and the unit charges to the preconfigured energy level When charged the unit emits a charge ready tone repeatedly flashes the Shock button and issues the voice and text prompt PRESS FLASHING SHOCK BUTTON After the rescuer presses the button to deliver therapy the unit resumes analysis and can guide the rescuer through an escalating series of three shocks if necessary This chapter contains the following sections e Applying Defibrillation Electrode Pads on page 3 2 e Semiautomatic Defibrillation on page 3 9 e Messages in Semiautomatic Mode on page 3 12 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 3 1 CHAPTER 3
23. 8900 0840 30 Electrodes w Ferrite 1 pair Airworthy Certified Airworthy stat padz II Adult Multi Function 8900 0841 30 Electrodes w Ferrite Case of 12 Airworthy Certified AED Pro ECG Cable AAMI Airworthy Certified 8000 0838 AED Pro A W non rechargeable lithium battery pack 8000 0860 30 Airworthy Certified 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 1 7 CHAPTER 1 PRODUCT OVERVIEW The Front Panel Figure 1 1 shows the front panel of the AED Pro unit Table 1 1 describes each of the unit s front panel features Patient cable connector Display screen Shock button Microphone optional On Off button indicator deii port Speaker Softkeys Battery compartment latch Battery compartment cover Figure 1 1 AED Pro Front Panel USB connector inside battery compartment Figure 1 2 USB Connector 1 8 www zoll com 9650 0350 01 Rev H 9650 0350 01 Rev H The Front Panel Table 1 1 AED Pro Front Panel Features Feature Description Shock button When the defibrillator is fully charged and ready the Shock button repeatedly flashes To deliver a shock press and hold the button On Off button To start the unit press this button and release it within 5 seconds To start the unit in nonrescue mode press and hold this button for more than 5 seconds To turn the unit off and place it in standby state press and hold this button for 1 second
24. D Pro Operator s Guide ix PREFACE Cautions A To prepare for an emergency keep the defibrillation electrode cable connected to the unit at all times even when the unit is not in use Use only high quality ECG electrodes ECG electrodes are for monitoring only you cannot use ECG electrodes for defibrillation Implanted pacemakers Do not place electrodes directly over an implanted pacemaker Implanted pacemakers might cause the heart rate meter or ECG rhythm analysis to count the pacemaker rate during incidents of cardiac arrest or other arrhythmia Carefully observe pacemaker patients 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 Do not sterilize the device or the ECG monitoring cable Do not immerse any part of the device into water Do not use ketones such as MEK or acetone on the device Avoid using abrasives including paper towels on the display screen and IrDA port Restarting the Device Certain events require a restart of the AED Pro unit after it shuts off encounters an error or becomes inoperative If such an event occurs always try to restore device operation as follows before seeking alternative methods of patient monitoring or treatment 1 Press and hold the On Off button for 1 second to turn the unit off 2 After the unit has shut down wait at least 3 seconds 3 Pr
25. EW Audio Recording When installed and enabled the Audio Recording Option allows the AED Pro unit to record up to 20 minutes of continuous audio and clinical event data during a rescue The AED Pro unit can record and store at least 5 8 hours of clinical event data when the Audio Recording Option is disabled The recorded audio data is synchronized to the clinical event data Note The AED Pro unit records up to 3 minutes of audio data prior to electrode placement The AED Pro unit can record and store data for only a single rescue when audio recording is enabled when the electrode pads are placed on the patient the unit deletes any stored data ECG Audio and Event data and begins recording data from the current rescue When you start the AED Pro unit in Non rescue Mode it does not delete stored rescue data www zoll com 9650 0350 01 Rev H Nonrescue Mode Nonrescue Mode The AED Pro unit provides the following functions in nonrescue mode e Data transfer e Device configuration The following sections briefly describe these functions For more information refer to Chapter 6 Nonrescue Mode Data Transfer The AED Pro unit includes nonvolatile memory which automatically records e Device history e Clinical data Stored information can be transferred to a remote device such as a computer through a USB device or an IrDA infrared wireless connection The clinical data format is compatible with ZOLL RescueN
26. Equipment on page xi e Intended Use on page xvi 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide v PREFACE How To Use This Guide The AED Pro Operator s Guide provides information that operators need for the safe and effective use and care of the AED Pro device Before operating this device be sure to read and understand all the information contained within This guide also describes device setup and maintenance procedures Separate chapters in this document describe use of the device in either semiautomatic or manual mode Manual Updates ZOLL Medical Corporation provides manual updates to inform customers of changes in device information and use Customers should carefully review each update to understand its significance and then file the update in its appropriate section within the manual for subsequent reference Product documentation is available through the ZOLL website at www zoll com From the Products menu choose Product Documentation Related Manuals In addition to this manual the following ZOLL publications provide information about this product and related products and accessories REF Title 9650 0054 01 ZOLL Base PowerCharger 4 Operator s Manual 9650 0120 01 ZOLL Base PowerCharger Operator s Manual 9651 0801 01 AED Pro Simulator Operator s Guide 9650 0535 01 SurePower Charger Station Operator s Guide 9650 0536 01 SurePower Battery Pack Guide Conventions This guide uses the
27. Figure A 6 Rectilinear Biphasic Waveforms at 50 Joules A 12 www zoll com 9650 0350 01 Rev H Clinical Trial Results for the M Series Biphasic Waveform Clinical Trial Results for the M Series Biphasic Waveform The efficacy of the ZOLL Rectilinear Biphasic waveform has been clinically verified during a study of defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT A feasibility study was performed initially for defibrillation of VF VT n 20 on two separate groups of patients to ensure waveform safety and energy selection Subsequently a separate multicenter randomized clinical trial was performed to verify the waveform s efficacy A description of this study is provided below The study was performed using ZOLL defibrillation systems consisting of ZOLL defibrillators the ZOLL Rectilinear Biphasic waveform and ZOLL defibrillation pads Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT Overview The defibrillation efficacy of the ZOLL Rectilinear Biphasic waveform was compared to a monophasic damped sine waveform in a prospective randomized multicenter study of patients undergoing ventricular defibrillation for VF VT during electrophysiological studies ICD implants and test A total of 194 patients were enrolled in the study Ten patients who did not satisfy all protocol criteria were excluded from the analysis leaving a study populatio
28. LL FOR HELP Jump to Analysis e On default When this option is checked On the unit immediately Off begins ECG analysis when pads are attached to the patient except during CPR periods Note The Start with CPR option if also checked On overrides this setting Unit OK s n When this option is checked On the unit issues the e Off default message Unit OK after a successful power on self test Clinical Protocol Voice Prompts Breathing e OFF default Allows you to select a check breathing prompt based Open Airway Check Breathing on the guidelines you want to follow Give Two Breaths e Open Airway Check Breathing When disabled Off these prompts are not issued e Give Two Breaths 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide C 3 CONFIGURABLE SETTINGS Configurable Option Possible Values Breathing Prompt Delay Sets the period over which the unit issues the check breathing prompts e 2 seconds e 4 seconds e 6 seconds default e 9 seconds e 15 seconds e 20 seconds Responsiveness Patient Selects the wording for this prompt e OFF default e Check Responsiveness e Check Patient Responsiveness Patient Prompt Delay Sets the duration before the next prompt or disables this prompt e 2 seconds e 4 seconds default e 6 seconds e 8 seconds Circulation Pulse Selects the wording for this and related prompts e OFF
29. NS metronome begins beeping Try to time each EE e compression with the metronome beep Ip SEH if unit SH ee See Check the on screen gauge to ensure that BE Se r default the compression depth is adequate promp y y e CONTINUE CPR 9 When the unit resumes ECG analysis return During ECG analysis keep the patient to step 3 motionless and do not touch the patient 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 3 11 CHAPTER 3 SEMIAUTOMATIC MODE Start with CPR Option Your AED Pro unit may be configured to start a rescue with a CPR period of 30 to 180 seconds that begins after you power on the AED Pro unit You can end this initial CPR period at any time by pressing the Analyze softkey When you press the Analyze softkey the AED Pro unit immediately begins analyzing the patient s ECG rhythm if the electrode pads are attached correctly The Analyze softkey appears only during the initial CPR period and does not appear during any subsequent CPR periods unless it is configured to do so and or the subsequent CPR intervals are set to Extended Messages in Semiautomatic Mode 3 12 During semiautomatic mode the unit can issue the following voice prompts and text messages The unit issues each voice prompt only once but the equivalent message remains on the screen until you take action time expires or the device status changes Message Description UNIT OK The unit successfully passed th
30. OPERATOR S GUIDE This page intentionally left blank 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide xviii Chapter 1 Product Overview The AED Pro device provides the following clinical modes e Semiautomatic defibrillation with CPR monitoring e Manual defibrillation e ECG monitoring To guide the operator through rescue protocols the AED Pro unit issues instructions through text messages displayed on its screen and by voice prompts played through a speaker This chapter introduces the AED Pro unit and contains the following sections e Defibrillation on page 1 2 e Semiautomatic Mode Defibrillation and CPR Monitoring on page 1 2 e Manual Mode Defibrillation on page 1 3 e ECG Monitoring on page 1 3 e Audio Recording on page 1 4 e Nonrescue Mode on page 1 5 e Standby State on page 1 5 e Automatic Shutoff on page 1 5 e Accessories on page 1 6 e The Front Panel on page 1 8 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 1 1 CHAPTER 1 PRODUCT OVERVIEW Defibrillation The AED Pro unit uses the ZOLL Rectilinear Biphasic waveform and ZOLL single use defibrillation electrode pads for defibrillation Escalating energy levels for the first three shocks are preconfigured into the unit for adult and pediatric patients The unit selects the appropriate levels by detecting the type of defibrillation electrode pads in use After the first three shoc
31. Pro Operator s Guide XV PREFACE Intended Use The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia for ECG monitoring and for CPR monitoring of patients The CPR monitoring function provides a metronome 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 of at least 2 inches 5 cm for adult patients Indications for Use Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by e Unconsciousness e Absence of breathing and e Absence of pulse and other signs of circulation When the victim is less than 8 years old or weighs less than 55 Ib 25 kg use ZOLL pedi padz II pediatric defibrillation electrodes Do not delay therapy to determine the patient s exact age or weight The device is also intended for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology Contraindications for Use Defibrillation Never use the AED Pro unit for defibrillation when the patient e Is conscious e Is breathing or e Has a detectable pulse or other sign of circulation CPR Monitoring The CPR monitoring function is not intended for use on patients under 8 years of age Intended Users xvi In semiautomatic mode the AED Pro unit is i
32. RABLE SETTINGS Descriptions of AED Pro Configurable Settings Configurable Option Possible Values General Settings Self test Interval Sets the period of time between automated self tests in standby state es 1 day default e 2days es 3days es 4days e 5days e 6days e 7days Line Frequency Selects the AC power frequency to be filtered during ECG monitoring e 60 Hz default es 50Hz Power Down Delay Sets the time interval after which the unit powers off if no patient connection is detected e 5 minutes e 10 minutes default e 15 minutes e 20 minutes e 30 minutes Audio Volume e High default Sets the volume level for voice messages and tones e Medium e Low Number of Patient Records oO Sets the number of patients for whom information will Oo 2 be stored in nonvolatile flash memory e 3 e 4 default Audio Recording Enabled Enables the use of the Audio Recording Option requires the installation of an internal microphone when the AED Pro unit is manufactured Note You must set the Number of Patient Records to 1 before you can enable the Audio Recording Option e Disabled default e Enabled Monthly Test When checked On the unit performs a monthly full energy self test 120 joules e On default e Off Daylight Savings Allows the AED Pro s 24 hour clock to automatically adjust for Daylight Savings Time e Manual default e
33. Ready indicator Shows the status of the unit based on its last self test A green check indicates the unit is ready for use H 8 A red X indicates the unit is not ready for use IrDA port Provides a way to connect the unit to an external device for transferring patient data unit status information or configuration information Speaker Issues voice prompts and alerts Battery compartment Holds the battery pack Battery compartment latch Provides access to the battery compartment Softkeys Directly below the display two unlabeled buttons control various functions depending on the operating mode Labels for the softkeys appear at the bottom of the display above each softkey to indicate its function Patient cable connector Used for plugging in defibrillation electrodes or an AED Pro ECG cable D This connector is a defibrillator proof type BF patient connection USB connector Allows you to download patient data to a USB device Microphone optional Allows the AED Pro Unit to record audio rescue data Only AED Pro units that have been ordered with the Audio Recording Option have a microphone installed ZOLL AED Pro Operator s Guide 1 9 CHAPTER 1 PRODUCT OVERVIEW Display Screen The display screen shows the following items depending on the activity in progress Elapsed time Shows the total time in hours minutes and seconds since the unit wa
34. Rev H ZOLL AED Pro Operator s Guide 7 7 CHAPTER 7 TROUBLESHOOTING AND MAINTENANCE Step Action 10 Activate the simulator s CPR function 11 Verify that the metronome begins to beep Verify that the AED Pro unit issues the following voice and text prompts within 60 seconds unless CPR monitoring is disabled on the unit PUSH HARDER GOOD COMPRESSIONS Verify that the chest compression gauge functions properly 12 After approximately 2 minutes of CPR verify that the unit issues the voice and text prompt STOP CPR 13 Verify that the AED Pro unit begins a new ECG analysis 14 Turn off the AED Pro unit and the simulator 15 Verify that the Ready indicator displays a green check before disconnecting the simulator and attaching defibrillation electrode pads For instructions on placing the unit back into service refer to Preparing the Unit for Clinical Use on page 2 5 www zoll com 9650 0350 01 Rev H Appendix A specifications This appendix describes the specifications for the AED Pro unit and contains the following sections e Device Specifications on page A 2 e Battery Pack Specifications on page A 5 e Guidance and Manufacturer s Declaration Electromagnetic Emissions on page A 6 e Rectilinear Biphasic Waveform Characteristics on page A 10 e Clinical Trial Results for the M Series Biphasic Waveform on page A 13 e ECG Analysis Algorith
35. S FLASHING SHOCK BUTTON 3 10 www zoll com 9650 0350 01 Rev H Semiautomatic Defibrillation Step Action Result WARNING You have 30 seconds to perform the following step otherwise the defibrillator automatically disarms itself During the final 10 seconds the charge ready tone sounds intermittently to indicate that time is expiring Before discharging the defibrillator warn everyone to STAND CLEAR Verify that no one is touching the patient the bed rails or any other potential pathway for electrical current 6 Press and hold the Shock button until The unit delivers the shock and updates treatment is delivered the shock count Depending on the number of shocks that have been delivered the unit either resumes ECG analysis or prompts you to perform CPR 7 Does the unit resume ECG analysis When the unit resumes ECG analysis it If NO continue with step 8 displays the message If YES return to step 3 DON T TOUCH PATIENT ANALYZING 8 Follow the prompts to perform CPR until The unit displays the message directed to stop START CPR At the end of the defined CPR period the unit displays the message STOP CPR Note If CPR D paaz or CPR statepaaz are attached the unit also monitors the rate and depth of chest compressions and can issue these related voice and text prompts CPR D paaz or CPR stat padz only After e PUSH HARDER the first few chest compressions the e GOOD COMPRESSIO
36. Shock button and issues voice and text messages so that you can verify the visual and auditory output functions In addition the screen shows information about the unit s hardware and software www zoll com 9650 0350 01 Rev H Preconnecting the Defibrillation Electrodes Cable Preconnecting the Defibrillation Electrodes Cable WARNING To prepare for an emergency keep the defibrillation electrodes cable connected to the unit at all times a WARNING Do not reuse defibrillation electrodes WARNING The AED Pro unit supports both adult and pediatric electrode pads The device adjusts defibrillation energy to adult or pediatric levels depending on the type of electrodes connected to it Always use electrode pads that are appropriate for the patient Do not use adult defibrillation electrode pads or CPR Depadz on patients under 8 years of age The electrode packaging allows you to connect the cable to the unit while the pads remain in a sealed envelope e To prepare for future emergencies after each use connect a new package of electrodes by plugging the electrode cable into patient cable connector e To ensure that the electrodes are fresh and ready to use in an emergency regularly check the electrode expiration date on the preconnected electrode pack e Replace expired electrodes e After completing its power on self test the unit issues a voice and text message to indicate the type of electrode
37. ZOLL AED Proe AED Proe Aw Operator s Guide An issue date and revision level for this guide appear on the title page If more than three years have elapsed since this date contact ZOLL Medical Corporation to determine if additional product information updates are available ZOLL AED Pro AED Plus CPR D padz stat padz pedie padz RescueNet Real CPR Help See Thru CPR and M Series are registered trademarks of ZOLL Medical Corporation PowerCharger Rectilinear Biphasic and SurePower are trademarks of ZOLL Medical Corporation All other trademarks and registered trademarks are property of their respective owners Copyright 2011 ZOLL Medical Corporation All rights reserved Table of Contents Chapter 1 Product Overview DSTO eu eu EEN EEN BEE 1 2 pefprillation Modes ccccccrscrsersssensssrrsegMliee ssessrnsssegatttltacherecsecessesseeasserseacesessoneeueres 1 2 Semiautomatic Mode Defibrillation and CPR Monitoring 1 2 Manual Mode Defibrillation cccccccccecsesseceeeeenseeeceeneceesenseeeetaneseeesaneaseetetsnseseetsneseeta 1 3 EUG Mortitoring llie eee ff 7 EE 1 3 AUGIGSRECOPING EEN EN e TEE 1 4 Nonrescue Mode ue vunn EE SEENEN eh soesssseserssrerssserrensesereseeesrenes callie 1 5 RECH CITE ce EEN EEN ED 1 5 Device Configuration e h 2 spo eaaeo iernat inerat rannen nnne nananet annee eneee ER 1 5 lee ET EEN e E WEEN 1 5 Automatic SHUtOPT A NNNNEKRRNER EE aa Ean ENN nan 1
38. ablished While in the USB menu if no softkeys are pressed and there is no IrDA connection established the unit powers off after 30 seconds Setting the Date and Time To set the current date and time in the AED Pro make sure that you are in Nonrescue Mode by holding down the On Off button for 5 seconds see page 6 2 Press the SET TIME softkey The unit then prompts you to set the year month day hour minute and second To advance to each subsequent screen press the gt softkey e SET YEAR Press the softkey to advance to the desired year using numbers 2000 through 2037 Press the softkey to advance to the next screen e SET MONTH Press the softkey to advance to the desired month using numbers 01 through 12 e SET DAY Press the softkey to advance to the desired day using numbers 01 through 31 e SET HOUR The AED Pro has a 24 hour clock Press the softkey to advance to the desired hour using numbers 01 through 24 e SET MINUTE Press the softkey to advance to the desired minute using numbers 00 through 59 e SET SECOND Press the softkey to advance to the desired second using numbers 00 through 59 Note You cannot go backwards when scrolling through the numbers If you go past the number you want keep pressing the softkey until it resets to the desired number The unit then displays the selected date and time To save changes press the softkey The text message SAVING DATA appears To cancel cha
39. alysis NO SHOCK ADVISED ECG analysis did not detect a shockable rhythm SHOCK ADVISED ECG analysis detected a shockable rhythm that requires therapy www zoll com 9650 0350 01 Rev H Semiautomatic Defibrillation Message Description DON T TOUCH PATIENT The unit is analyzing the patient s ECG charging the defibrillator or holding a charge Do not touch the patient PRESS FLASHING SHOCK After detecting a shockable rhythm the unit is charged to the BUTTON preselected energy level Within 30 seconds press the Shock button to deliver a shock to the patient RELEASE SHOCK BUTTON The Shock button was depressed too soon Wait until the unit issues the prompt PRESS FLASHING SHOCK BUTTON CHECK DEFIB PADS The defibrillation electrode pads became disconnected Check the pads to ensure that they are properly applied to the patient and verify that the cable is undamaged and plugged into the unit RELEASE LEFT SOFTKEY A softkey was pressed for more than 10 seconds Release the softkey or RELEASE RIGHT SOFTKEY ANALYSIS HALTED KEEP ECG rhythm analysis halted due to excessive ECG signal PATIENT STILL artifact Stop CPR and keep the patient as motionless as possible SHOCK DELIVERED A shock was delivered to the patient NO SHOCK DELIVERED No shock was delivered to the patient because the rescuer failed to press the Shock button or an error condition was detected STAY CALM Relax as much as po
40. arge time is less than 10 seconds Charge hold time Semiautomatic mode 30 seconds Manual mode 60 seconds Energy display Display screen shows selected energy level manual mode only Charge controls Semiautomatic mode Automated Manual mode Softkey www zoll com 9650 0350 01 Rev H Device Specifications Defibrillation electrode pads ZOLL single use pre gelled electrode pads e CPR D paaz includes CPR sensor e CPR stat paaz includes CPR sensor Adult statepaaz Il Pediatric pedi paaz Il Built in defibrillator self test Verifies proper charging and discharging of the defibrillator Defibrillation advisory Evaluates electrode attachment and patient ECG to determine if defibrillation is needed Shockable arrhythmia e Ventricular fibrillation VF with amplitude greater than 100 pV e Wide complex ventricular tachycardia VT Adult greater than 150 beats per minute Pediatric greater than 200 beats per minute Valid patient impedance range 10Q to 3009 CPR Monitoring Compression depth 0 75 to 3 inches 0 25 inches 1 9 to 7 6 cm 0 6 cm Compression rate 50 to 150 compressions per minute ECG Monitoring Input protection Fully defibrillation protected Implanted pacemaker pulses detected The AED Pro does not reject implanted pacemaker pulses Bandwidth 1 4 to 22 Hz with defibrillation electrode cable 1 4 to 22 Hz d
41. ator in his her upper right chest angle the electrode slightly to avoid placing it over the device Ensure that the CPR sensor remains over the lower half of the breastbone 4 Grasp the round electrode at the bottom and peel it from the plastic liner Apply the electrode so it lines up with the bottom of the pectoral muscle on a male patient as shown in the diagram For female patients place the electrode under the breast Note A more lateral placement increases the likelihood that more of the heart musculature will be within the current 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 3 5 CHAPTER 3 SEMIAUTOMATIC MODE CPR Monitoring with CPR D padz and CPR stat paaz ZOLL CPR Depadz and CPR statepadz electrodes include a sensor that detects the rate and depth of chest compressions When the electrodes are properly positioned on the patient the sensor lies between the rescuer s hands and the patient s lower sternum While the rescuer performs chest compressions the sensor detects the rate and depth and sends the information to the AED Pro unit If the unit does not detect chest compressions during a CPR period it periodically issues the voice and text prompt CONTINUE CPR if configured to do so ZOLL CPR Depadz and CPR statspadz electrodes can be connected to other ZOLL defibrillators and defibrillation can be administered through other ZOLL defibrillators The CPR function however does not operate wit
42. aveform Characteristics c ccccceseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseneeeeeeeas A 10 Clinical Trial Results for the M Series Biphasic Waveform cccceeseeeeeeeseeteeeeeeeneeees A 13 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT ccc ccccccscneeeeggyeeserseneeeeereesesenee Meeeeneeseees A 13 ECG Analysis Algorithm ACCUraCy 22 sgittttee eeseecceereaggeili ho ceeeeesecceeeenseceneenssenenseees A 15 Appendix B Rechargeable Battery Packs Managing Rechargeable Battery Packs 2 0 cesiceccceeeeeeedecseeeeeeeeeeeeeeeseseneeeeeseeeeeneeeeeeees B 2 Recharging and Testing Battery Packs digeecf eccccceedeteeeeesceeeeeeeeeseeeeeeeeeeeneeseeeeneeeeendiens B 2 Achieving Optimal Performance with Rechargeable Batteries nnnnnnnn0nnnnnnnnnneennrn nnee ne B 3 Appendix C Configurable Settings Descriptions of AED Pro Configurable Gettmgs C 2 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide iii TABLE OF CONTENTS iv www zoll com 9650 0350 01 Rev H Preface The AED Pro and AED Pro A W from ZOLL Medical Corporation is a portable automated external defibrillator AED intended for use by trained rescuers to provide emergency defibrillation and to monitor patient ECG during treatment This Preface contains the following sections e How To Use This Guide on page vi e Safety Considerations on page vii e
43. c pediepadz Il electrodes 8900 0810 01 Smart Ready ECG electrodes 3 ECG electrodes pouch 200 8900 0003 pouches 600 electrodes AED Pro ECG cable AAMI 8000 0838 IEC 8000 0839 Defibrillation analyzer universal adapter cable 8000 0804 01 Rechargeable PD 4410 battery pack Standard 8004 0009 Smart 8004 0103 01 8004 0104 01 Disposable sealed lithium manganese dioxide battery pack 8000 0860 01 AED Pro carry bags Soft carry case Molded vinyl case with spare battery compartment Hard case with foam cut outs 8000 0810 01 8000 0832 01 8000 0875 32 IrDA adapter for personal computer USB RS 232 8000 0815 8000 0816 AED Pro simulator 8000 0829 01 See Thru CPR simulator 8009 0751 01 AED Pro ZOLL Administration Software ZAS CD 9658 0800 01 RescueNet Code Review Standard software for Windows installation CD and Getting Started Guide 8000 0608 01 AED Pro Service Manual 9650 0309 01 AED Pro Simulator Manual 9651 0801 01 SurePower Charger Station 8050 0030 01 SurePower Battery Pack 8019 0535 01 www zoll com 9650 0350 01 Rev H Accessories A W Accessories The following accessories are also available for the AED Pro A W Item REF CPR D padz one piece defibrillation and CPR 8900 0800 01 System Adult Electrode Airworthy Certified Airworthy statepadz II Adult Multi Function
44. checked On See Thru CPR is Off default enabled for the AED Pro see page 4 5 for information on using See Thru CPR Archive ECG AF Data On When this option is checked On the See Thru CPR Off default adaptive filter information will be saved Monitoring ECG Monitoring Modes On default When this option is checked On the unit switches to Off ECG monitoring mode when an ECG cable is attached or when the left softkey is pressed and held for at least 5 seconds in semiautomatic mode When this option is not checked Off the unit does not support ECG monitoring mode If an ECG cable is attached the unit prompts the rescuer to plug ina defibrillation cable Display Heart Rate On default Off When this option is checked On the unit displays the patient heart rate in manual mode www zoll com 9650 0350 01 Rev H Descriptions of AED Pro Configurable Settings Configurable Option Possible Values Low Heart Rate Limit e 0 In manual or ECG monitoring mode the unit issues the 30 default prompt CHECK PATIENT if the patient heart rate falls e 35 below this number of beats per minute e 45 e 50 e 55 e 60 e 65 e 75 e 80 e 85 e 90 e 100 Patient Impedance Archive Patient Impedance e On default Enables or disables the archiving of patient impedance Off data 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide C 9 AED PRO OPERATOR S GUIDE
45. ck Pulse If no Pulse Start with CPR Period is enabled the AED Pro issues CPR one of the voice and text prompts shown in the e Open Airway Check Breathing Possible Values column Check Circulation If No Circulation Start CPR e Start CPR default e Start Compressions e If no Pulse Start Compressions e If no Circulation Start Compressions 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide C 5 CONFIGURABLE SETTINGS Configurable Option Possible Values Continue CPR When you select one of the prompts in the Possible Values column that prompt will be repeated once every 10 seconds default during the CPR period if compression stops while in the e OFF default e If no Circulation Continue CPR e If no Pulse Continue CPR e Continue CPR e Continue Compressions CPR state e If no Pulse Continue fe Compressions When this option is set to Off no prompts willbe no Circulation Continue supe Compressions Post Shock CPR Period Start CPR At the beginning of the CPR period after the ECG analysis the AED Pro issues one of the voice and text prompts shown in the Possible Values column e Open Airway Check Breathing Check Pulse If no Pulse Start CPR e Open Airway Check Breathing Check Circulation If No Circulation Start CPR e Start CPR default e Start Compressions e If no Pulse Start Compressions e If no Circulation Start Compressions Continue CPR Wh
46. confidence interval 0 0217 to 0 759 90 confidence interval 0 037 to 0 706 A single patient required a second biphasic shock at 150 joules to achieve 100 efficacy versus six patients for whom monophasic shocks of up to 360 joules were required for 100 total defibrillation efficacy Conclusion The data demonstrate the equivalent efficacy of low energy Rectilinear Biphasic shocks compared to standard high energy monophasic shocks for transthoracic defibrillation for all patients at the 95 confidence level The data also demonstrate the superior efficacy of low energy Rectilinear Biphasic shocks compared to standard high energy monophasic shocks in patients with high transthoracic impedance at the 90 confidence level There were no unsafe outcomes or adverse events due to the use of Rectilinear Biphasic waveform www zoll com 9650 0350 01 Rev H ECG Analysis Algorithm Accuracy ECG Analysis Algorithm Accuracy Sensitivity and specificity are expressions of ECG analysis algorithm performance when compared to ECG interpretation by a clinician or expert Sensitivity refers to the algorithm s ability to correctly identify shockable rhythms as a percentage of the total number of shockable rhythms Specificity refers to the algorithm s ability to correctly identify nonshockable rhythms as a percentage of the total number of nonshockable rhythms The data in Table A 4 and Table A 5 summarize the accuracy of the ECG analysis
47. d and ready for use ZOLL can provide battery pack status labels for this purpose or you can use labels or methods of your own DO change the battery pack as soon as the message CHANGE BATTERY appears The battery warning ultimately leads to shutdown of the unit As a battery ages its remaining operating time between the warning and shutdown progressively diminishes Older battery packs might provide very little run time after the warning and might fail unexpectedly Always replace a battery with a fully charged battery as soon as the battery warning appears DO test rechargeable battery packs regularly Your organization must determine and implement an appropriate testing schedule for rechargeable battery packs Conformance to this schedule is crucial for identifying battery packs that have reached end of life and should be removed from use Battery packs subjected to repeated short discharge and charge cycles might lose capacity quickly and so should be tested more frequently DO exchange battery packs regularly Exchange battery packs once every shift or once every day depending on their use DO exercise or test battery packs every 90 days or sooner as they age 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide B 3 APPENDIX B RECHARGEABLE BATTERY PACKS DA DO NOT store battery packs in a discharged or depleted state When you remove a rechargeable battery from the unit immediately place it in a charger or test well Id
48. ddress contact name and contact phone number 2 Part number model number and serial number of the device 3 Disposition of the device 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 ZOLL Medical Corporation Attn Tracking Coordinator 269 Mill Road Chelmsford MA 01824 4105 Fax 978 421 0025 Tel 978 421 9655 Notification of Adverse Events xiv Under the Safe Medical Devices Act SMDA health care providers are responsible for reporting to ZOLL Medical Corporation and possibly to the FDA the occurrence 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 malfunctions This information is required to ensure that ZOLL Medical Corporation provides only the highest quality products www zoll com 9650 0350 01 Rev H Equipment Contacting Technical Service The AED Pro unit is calibrated at the factory and does not require periodic recalibration or adjustment If a unit requires service contact the ZOLL Technical Service Department Telephone 1 800 348 9011 with
49. deliver a shock to the patient 4 4 Before you begin Prepare the patient as described in Applying Defibrillation Electrode Pads on page 3 2 Procedure To manually defibrillate the patient Step Action Result 1 Press the CHARGE softkey to begin charging the defibrillator If you need to disarm the defibrillator before it reaches full charge press the DISARM softkey The unit displays the message DON T TOUCH PATIENT CHARGING The CHARGE softkey label changes to DISARM The charge ready tone indicates that the defibrillator is charged and ready The Shock button flashes repeatedly WARNING You have 60 seconds to perform the following step otherwise the defibrillator automatically disarms itself During the final 10 seconds the charge ready tone sounds intermittently to indicate that time is expiring Before discharging the defibrillator warn everyone to STAND CLEAR Verify that no one is touching the patient the bed rails or any other potential pathway for electrical current 2 Press and hold the Shock button until The unit delivers the shock to the patient treatments gevergd The unit updates the shock count and shows the energy level for the next shock XXX J SELECTED Or to disarm the defibrillator press the DISARM softkey 3 Continue evaluating the patient If additional shocks are needed repeat this procedure www zoll com 9650 0350 01 Rev H
50. ditional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular or cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the AED Pro unit is used exceeds the applicable RF compliance level above the AED Pro unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the AED Pro unit Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m www zoll com 9650 0350 01 Rev H Guidance and Manufacturer s Declaration Electromagnetic Emissions Recommended separation distances between portable and mobile RF communications equipment and the AED Pro unit The AED Pro unit is intended for use in an environment in which radiated RF disturbances are controlled The customer or operator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AED Pro unit as recommended below according to the maximum outpu
51. dous materials and may be disposed of in general trash unless contaminated with pathogens Use appropriate precautions when disposing of contaminated electrodes www zoll com 9650 0350 01 Rev H Applying Defibrillation Electrode Pads Applying Defibrillation Electrode Pads Adult CPR D padz WARNING ZOLL CPR Depadz are for adult patients only do not use them on patients under 8 years of age To apply CPR Depadz defibrillation electrodes Step Action 1 Tear open the electrode package and unfold the electrodes 2 Using the cross hairs on the CPR sensor to guide you place the sensor on the middle of the patient s breastbone between the nipples 3 Hold the CPR sensor in place with your right hand and use your left hand to pull the number 2 tab and peel the protective backing from the electrode Note If the patient has an implanted pacemaker or defibrillator in his her upper right chest angle the electrode slightly to avoid placing it over the device Ensure that the CPR sensor remains over the lower half of the breastbone Press the electrode from the center of the chest outward to push out air from beneath the pad and to make sure the pad adheres properly to the patient s skin 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 3 3 CHAPTER 3 SEMIAUTOMATIC MODE Step Action 4 Hold the CPR sensor in place with your left hand and use your right hand to pull
52. ds into this chart the rhythm changes to asystole which could easily be mistaken for coarse VF When the CPR filter turns on the CPR compression ripples are still obvious making the rhythm look like Fine VF Asystole y Raw ECG Filtered ECG CPR 10 12 Asystole e Raw ECG 12 5 mm sec 5 mm mV Figure 3 www zoll com 9650 0350 01 Rev H See Thru CPR Figure 4 shows a patient with an organized rhythm where See Thru CPR effectively filters out artifact created by CPR Raw ECG Filtered ECG CPR 0 00 Raw ECG Filtered ECG CPR 0 12 Raw ECG Filtered ECG CPR 0 24 SinusRhythm Raw ECG j Filtered ECG CPR 0 12 Raw ECG y Filtered ECG CPR Raw ECG Filtered ECG CPR 0 36 12 5 mm sec 5 mm mV Figure 4 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 4 9 CHAPTER 4 MANUAL MODE Messages in Manual Mode 4 10 During manual mode the following messages can be displayed Message Description PLUG IN CABLE The unit started up without an electrode cable plugged in Plug the cable into the unit CHECK DEFIB PADS The defibrillation electrode pads became disconnected Check the pads to ensure that they are properly applied to the patient and verify that the cable is undamaged and plugged into the unit CHECK PATIENT Evaluate the status of the patient The unit detected
53. e the AED Pro unit analyzes the patient s ECG rhythm to determine whether it is shockable or not If a shock is needed follow the text and voice prompts to defibrillate the patient WARNING During ECG analysis do not touch or move the patient If conveying the patient in a vehicle or stretcher cease all patient movement After an ECG analysis resulting in delivery of a shock or after any no shock advised result the unit initiates a period of CPR Note Ifthe AED Pro unit is configured to use a two or three shock sequence the unit initiates a period of CPR after two episodes of ECG analysis and shock two shock sequence or three successive episodes of ECG analysis and shock three shock sequence or after a no shock advised result In semiautomatic mode the screen shows the shock count elapsed time ECG size ECG rhythm and text messages If CPR Depadz or CPR stat padz are attached to the patient the screen includes a chest compression gauge that shows the depth of each chest compression as detected by the CPR sensor 02 04 45 ECG X1 5 GOOD COMPRESSIONS shockable rhythm and the defibrillator is charged and ready but will not bring the The rhythm recognition detector continues analyzing the ECG after detecting a L unit into a state where defibrillation is prohibited 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 3 9 CHAPTER 3 SEMIAUTOMATIC MODE Before you begin Be sure the defibri
54. e power on self test UNIT FAILED The unit failed the power on self test and is not usable for patient care CHANGE BATTERY The self test detected a low energy condition that is insufficient for patient care Replace the battery pack immediately ADULT PADS The unit detected the specified type of electrode pads and PEDIATRIC PADS adjusted defibrillation energy settings accordingly PLUG IN CABLE The unit started up without an electrode cable plugged in Plug the cable into the unit ATTACH DEFIB PADS TO The unit does not detect attachment of the defibrillation PATIENT S BARE CHEST electrode pads to the patient Check the cable for damage Make sure that the pads are properly applied to the patient If this message continues check the electrode sites to ensure that they are clean dry and free of excess hair Check the expiration date on the electrode package CHECK PATIENT Check the patient for responsiveness or consciousness by gently shaking the patient and shouting Are you all right CHECK PULSE Check the patient for a pulse or other signs of circulation such as normal breathing movement or coughing START CPR Indicates the beginning of a CPR period Begin CPR STOP CPR Indicates the end of the CPR period Discontinue CPR DON T TOUCH PATIENT Indicates the beginning of an ECG analysis period Make sure ANALYZING everyone stands clear of the patient Keep the patient motionless during ECG an
55. econds delivery of one or more shocks e 120 seconds default e 150 seconds e 180 seconds When you select Extended the device remains in the CPR state indefinitely and displays the ANALYZE softkey You must press the ANALYZE softkey to move f e Extended to analysis Start with CPR Semiautomatic Mode only e On When this option is checked On before beginning e Off default ECG analysis the unit prompts the rescuer to check the patient s pulse and perform a period of CPR if no pulse is detected Start with CPR Period 30 seconds Sets the duration of the CPR period associated with the 60 seconds Start with CPR option e 90 seconds es 120 seconds default e 150 seconds e 180 seconds e Extended When you select Extended the device remains in the CPR state indefinately and displays the ANALYZE softkey You must press the ANALYZE softkey to move to analysis Analyze Key e On Enables or disables the ANALYZE softkey during the e Off default Post Shock and Post No Shock CPR periods If the ANALYZE softkey is enabled it appears during both the Post Shock and Post No Shock CPR periods Fully Release e On When checked On this text prompt reminds the e Off default rescuer to lift the hands off the chest during CPR to allow full recoil CPR Prompts Start with CPR Period Start CPR e Open Airway Check Breathing At the beginning of the first CPR period if Start Che
56. efault with AED Pro ECG cable 0 7 to 30 Hz as a configurable option ECG lead Lead II ECG amplitude range 5 mV Heart rate range 30 to 300 beats per minute Heart rate accuracy 5 beats per minute Heart rate resolution 1 beat per minute Heart rate alert e Configurable low heart rate limit in the range 30 to 100 beats per minute e Off Heart rate alarm Voice and text prompt indicates activated deactivated status Tachycardia 250 bpm Bradycardia 30 bpm 100 bpm user selectable Tall T wave rejection lt 9 mm ECG scale at x1 lt 0 9 mV 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 3 APPENDIX A SPECIFICATIONS A 4 Heart rate averaging The AED Pro averages the interval between the last 5 detected beats On startup the AED Pro averages the rate between detected beats once two beats are detected until a full 5 beats have been received The rate is updated every beat After this condition is met the meter is updated every beat with an average of the last 5 beats If a period of time greater than 5 seconds elapses without a beat detected the heart rate meter reports a rate of 0 bpm which is repeated every 5 seconds Accuracy and response time to irregular rhythm per EN 60601 2 27 2nd Ed 2005 Ventricular Bigeminy Figure A1 40 bpm Slow alternating ventricular bigeminy Figure A2 55 65 bpm Rapid alternating ventricular bigeminy Figure A3 59
57. efibrillation electrode pads SS Ensure that no one is touching the patient and that the patient is motionless during ECG analysis Message Contact ZOLL Technical Service 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide CHAPTER 7 TROUBLESHOOTING AND MAINTENANCE Cleaning the Unit After each use clean and disinfect the unit and ECG cables with a soft damp cloth using any of the following cleaning agents e Soap and water e Chlorine bleach solution 30 milliliters per liter of water e 90 isopropyl alcohol The AED Pro unit and its accessories are chemically resistant to most common cleaning solutions and noncaustic detergents Refer to the Cautions on page x 7 6 www zoll com 9650 0350 01 Rev H Optional Maintenance for Technical Professionals Optional Maintenance for Technical Professionals The AED Pro is calibrated at the factory and requires no testing other than the self tests it performs Qualified professionals who want to perform additional tests can use the following procedure Required equipment e AED Pro simulator or equivalent Before you begin Be sure the unit and the simulator tester are turned off Procedure To test the unit Step Action 1 Connect the AED Pro simulator to the unit s patient cable connector 2 Power on the simulator and the AED Pro unit Verify that all of the following occur e The Ready indicator initially displays a red X
58. ems Number of shocks Elapsed time Heart rate and delivered heartbeat symbol Current mode ECG size Ea Mio e Shock symbol g 1 en 1 4 ECG X0 5 oe Allan A und M kant marker Chest compression depth gauge with L CPR D padz only Text prompts 150 J SELECTED and messages ECG rhythm Left softkey I CHARGE J Right softkey label location label location Figure 1 3 AED Pro Display Screen Elements 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 1 11 AED PRO OPERATOR S GUIDE 9650 0350 01 Rev H This page intentionally left blank ZOLL AED Pro Operator s Guide Chapter 2 Getting Started This chapter describes some common tasks that you must do to get the AED Pro unit ready to use and contains the following sections e Installing a Battery Pack on page 2 2 e Preparing the Unit for Clinical Use on page 2 5 e Performing a Self Test on page 2 6 Preconnecting the Defibrillation Electrodes Cable on page 2 7 e Messages on page 2 8 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide CHAPTER 2 GETTING STARTED Installing a Battery Pack WARNING The AED Pro unit accepts the following types of battery packs e Rechargeable PD 4410 series battery packs e Disposable sealed lithium manganese dioxide battery packs e SurePower rechargeable lithium ion battery packs When the unit displays the message CHANGE BATTERY immediately replace the battery with
59. en you select one of the prompts in the Possible Values column that prompt will be repeated once every 10 seconds default during the CPR period if compression stops while in the e OFF default e If no Circulation Continue CPR e If no Pulse Continue CPR e Continue CPR e Continue Compressions CPR state e If no Pulse Continue e ee Compressions When this option is set to Off no prompts willbe no Circulation Continue Issue Compressions Post No Shock CPR Period Start CPR At the beginning of the CPR period after the ECG analysis the AED Pro issues one of the voice and text prompts shown in the Possible Values column www zoll com e Open Airway Check Breathing Check Pulse If no Pulse Start CPR e Open Airway Check Breathing Check Circulation If No Circulation Start CPR e Start CPR default e Start Compressions e If no Pulse Start Compressions e If no Circulation Start Compressions 9650 0350 01 Rev H Descriptions of AED Pro Configurable Settings Configurable Option Start CPR At the beginning of the first CPR period if Start with CPR Period is enabled the AED Pro issues one of the voice and text prompts shown in the Possible Values column Possible Values e Open Airway Check Breathing Check Pulse If no Pulse Start CPR e Open Airway Check Breathing Check Circulation If No Circulation Start CPR e Start CPR default e Start Compressions e If no Pu
60. erator s Guide xi PREFACE Symbol Description e L Defibrillator proof type CF equipment Contains lead Recycle or dispose of properly RECYCLE Pb Contains lithium Recycle or dispose of properly RECYCLE Li ION Keep away from open flame and high heat Do not open disassemble or intentionally damage Do not crush Nonrechargeable battery Do not discard in trash Recycle or dispose of properly Date of manufacture Use by Latex free Do not reuse gon Teo oo e xii www zoll com 9650 0350 01 Rev H Equipment Symbol Description D Do not fold Not sterile Ko A Nonionizing electromagnetic radiation Manufacturer Authorized representative in the European Community Echt Serial Number AJ AU Se Catalogue number Consult instructions for use 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide xiii PREFACE FDA Tracking Requirements U S Federal Law 21 CFR 821 requires the tracking of defibrillators Under this law owners of this device must notify ZOLL Medical Corporation if this product is e received e lost stolen or destroyed e 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 a
61. ess and release the On Off button to restart the unit www zoll com 9650 0350 01 Rev H Equipment Equipment Before unpacking the AED Pro unit carefully inspect each shipping container for damage If the container or cushioning material is damaged keep it until you have checked the contents for completeness and the unit has been tested for mechanical and electrical integrity Examine the unit for any signs of damage that might have occurred during shipping Review the shipping list to ensure that you received all ordered items If the contents are incomplete if there is mechanical damage or if the device does not pass its electrical self test as indicated by a red X in the Ready indicator after battery installation contact the ZOLL Technical Service Department or the nearest ZOLL authorized representative If the shipping container is damaged notify the carrier also Symbols Used on the Equipment The following symbols might appear in this document or on the AED Pro unit battery packs electrodes or shipping materials Symbol Description Dangerous voltage Attention consult accompanying documents a Fragile handle with care d geg Keep dry a This end up D Temperature limitation CE Conformit Europ enne Complies with medical device directive 93 42 EEC JE Defibrillator proof type BF equipment 9650 0350 01 Rev H ZOLL AED Pro Op
62. et Code Review software which can be used to review and analyze the patient data The unit retains the device history and clinical data even when powered off or when the battery pack is removed Clinical data is erased only when the device is powered on and electrodes are attached to a new patient If configured to do so the unit can store data for more than one patient Device Configuration The AED Pro unit provides configurable settings that can be used to tailor the device for local rescue protocols and procedures Using the ZOLL Administration Software on a personal computer you can view or modify the unit s configuration Standby State When the unit is turned off with a good battery installed the unit enters standby state While in standby the unit periodically starts up automatically to perform a self test and then returns to standby The Ready indicator shows the result of the self test The frequency of self tests while the unit is in standby state is a configurable setting Automatic Shutoff The unit automatically powers off if no patient connection is detected within 10 minutes configurable 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 1 5 CHAPTER 1 PRODUCT OVERVIEW Accessories The following related accessories and equipment are available Item REF Adult CPR D paaz electrodes 8900 0800 01 Adult CPR stat padz electrodes 8900 0400 Adult statepadz II electrodes 8900 0801 01 Pediatri
63. etic environment specified below The customer or operator should ensure that the device is used in such an environment Table A 1 EMC Specifications SE Electromagnetic Environment Emissions Test Compliance S Guidance RF emissions Group 1 The ZOLL AED Pro unit uses RF energy CISPR 11 for its internal function only Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emission Not applicable IEC 61000 3 2 Voltage fluctuations Not applicable flicker emission IEC 61000 3 3 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document A 6 www zoll com 9650 0350 01 Rev H Guidance and Manufacturer s Declaration Electromagnetic Emissions Electromagnetic Immunity Declaration EID The ZOLL AED Pro device is intended for use in the electromagnetic environment specified below The customer or operator should ensure that the device is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material
64. evice You can also download patient data to a portable USB device for use with RescueNet Code Review software Press and hold the On Off button on the AED Pro unit for at least 5 seconds to enter nonrescue mode see page 6 2 Attach a USB device to the port inside the battery compartment then press the USB softkey The unit issues the voice and text message USB DEVICE CONNECTED Press the New softkey to download all new patient data since the last download Press the All softkey to download all patient data on the unit The unit issues the voice and text message DOWNLOADING DATA If there is no USB device attached or if the unit fails to establish a connection with the USB device the unit issues the command INSERT USB DEVICE 6 4 www zoll com 9650 0350 01 Rev H Setting the Date and Time q WARNING Do not connect the AED Pro to a PC or other device via the USB port while the unit s electrodes are still connected to the patient When the AED Pro has finished downloading data it issues the prompt DATA DOWNLOAD COMPLETE and then immediately powers off To ensure that the unit has finished writing to the device wait 5 seconds or until the unit powers off before removing the device from the unit You can now plug your USB device into a PC for use with the RescueNet Code Review software Note While in Nonrescue Mode the AED Pro allows you to download data to a USB device at any time with or without an IrDA connection est
65. external IrDA device USB DEVICE CONNECTED The unit recognizes that an external USB device has been connected USB DEVICE FULL The attached USB device is full and cannot receive data INSERT USB DEVICE Prompts you to insert a USB device into the USB port located inside the battery compartment NO DATA There is no new patient data to download to the USB device www zoll com 9650 0350 01 Rev H Chapter 7 Troubleshooting and Maintenance To ensure that the AED Pro unit is functioning properly and is ready for use in an emergency general maintenance procedures should be performed before putting the unit into service and after each clinical use This chapter contains the following sections e General Troubleshooting on page 7 2 e ECG Monitoring Troubleshooting on page 7 4 e Defibrillator Troubleshooting on page 7 5 e Cleaning the Unit on page 7 6 e Optional Maintenance for Technical Professionals on page 7 7 If trouble persists after consulting this chapter contact the appropriate technical personnel or ZOLL Technical Service Department 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 7 1 CHAPTER 7 TROUBLESHOOTING AND MAINTENANCE General Troubleshooting Table 7 1 lists general issues with the unit and their associated corrective action Table 7 1 General Issues Symptom Corrective Action Unit beeps or displays a red X while turned off Turn the unit on Foll
66. fficult for a rescuer to discern this rhythm during CPR compressions When the CPR filter turns on the Fine VF rhythm becomes more obvious Raw ECG Filtered ECG CPR 0 00 L Raw ECG Filtered ECG CPR 0 12 Raw ECG Filtered ECG CR 0 24 4 6 FineVF Raw ECG Filtered ECG CPR 10 24 FineVF Raw ECG 12 5 mm sec 5 mm mV Figure 1 www zoll com 9650 0350 01 Rev H See Thru CPR Figure 2 shows a patient in VF which during compressions is slightly more difficult to discern When viewing this ECG it is possible to view the underlying rhythm as the filter is able to reject all of the CPR artifact Coarse VF Raw ECG Raw ECG Filtered ECG Filtered ECG CPR CPR 0 00 0 12 Coarse VF Raw ECG Raw ECG Filtered ECG Filtered ECG CPR CPR 0 12 Coarse VF Raw ECG Raw ECG Filtered ECG Filtered ECG CPR CPR 12 5 mm sec 5 mm mV Figure 2 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 4 7 CHAPTER 4 Raw ECG Filtered ECG CPR l 0 00 Raw ECG Filtered ECG CPR Raw ECG Filtered ECG CPR 0 24 4 8 MANUAL MODE Figure 3 shows a patient in PEA which could easily be mistaken for Fine VF because enough of the compression artifact leaks through to distort this signal When the CPR filter turns on the PEA is still not obvious because of the left over ripples from the CPR signal About 14 secon
67. h any device other than the ZOLL AED Pro or the ZOLL AED Plus Chest compression rate With CPR Depadz and CPR statepadz the unit provides a metronome function to encourage rescuers to perform chest compressions at the AHA ERC recommended rate of 100 compressions per minute When CPR is indicated the metronome begins to beep after detecting the first few chest compressions The metronome continues at rates described below until a few seconds after the rescuer halts compressions or until the recommended CPR period ends 2 minutes for AHA and ERC protocols The metronome beeps 100 times per minute to encourage the rescuer to increase the rate of chest compressions to achieve the recommended rate of 100 cpm During the CPR period if the rescuer stops chest compressions the metronome stops within a few seconds If chest compressions resume the metronome starts again The metronome is disabled whenever CPR should not be performed for example during ECG analyses and defibrillation shock sequences Chest compression depth With CPR Depadz and CPR stat padz the unit provides visual indicators and voice prompts to encourage a chest compression depth of at least 2 inches 5 cm for adult patients The screen displays a gauge which shows the depth of chest compressions Compression depth is correct when the bar extends downward between the lower two lines which represent 2 0 and 2 4 inches 5 to 6 cm When the detected compressi
68. he Open field type x setup exe where x is the letter of the CD ROM drive that contains the ZAS CD 3 Click OK Follow the on screen instructions to complete the installation www zoll com 9650 0350 01 Rev H ZOLL Administration Software RescueNet Code Review Software To analyze incident information transferred from the AED Pro unit to a personal computer use RescueNet Code Review software With this software you can e Transfer patient data from the AED Pro unit to a personal computer e Access and review patient case data e Add or modify patient information e View an animated ECG e Annotate the ECG e Print ECG stripcharts and case reports For more information refer to the RescueNet Code Review User s Guide 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 6 7 CHAPTER 6 NONRESCUE MODE Messages in Nonrescue Mode The unit can display the following messages when exchanging data Message COMMUNICATIONS ESTABLISHED Description The unit successfully contacted an external IrDA device DATA DOWNLOAD COMPLETE Data transfer was successful DATA DOWNLOAD FAILED Data transfer halted because the external device detected an error or the operator canceled transmission through the communication program Check the communications package or utility on the external device for the source of the error NON RESCUE MODE The unit is operating in nonrescue mode and connected to an
69. he unit issues the voice and text prompts CHECK PATIENT PLUG IN DEFIB CABLE The latter message remains on screen until defibrillation pads are attached If the detected heart rate is lower than the configured minimum heart rate limit the unit issues the voice and text prompt CHECK PATIENT This message remains on screen as long as the patient s heart rate is below the limit If prompted check the patient If prompted to plug in defibrillation cable replace the ECG electrodes and cable with defibrillation electrode pads If it detects defibrillation pads the unit changes to semiautomatic mode For more information refer to Chapter 3 Semiautomatic Mode 5 6 www zoll com 9650 0350 01 Rev H Monitoring with Defibrillation Electrodes Monitoring the ECG Rhythm With defibrillation electrodes in use you can change from semiautomatic mode to ECG monitoring mode If the unit detects a shockable rhythm while in ECG monitoring mode and defibrillation electrodes are in use the unit prompts you to check the patient and then changes to semiautomatic mode For more information refer to Chapter 3 Semiautomatic Mode Before you begin Attach defibrillation electrode pads to the patient refer to Chapter 3 Procedure To change from semiautomatic to ECG monitoring mode Step Action Result 1 Press and hold the left unlabeled softkey for at least 5 seconds
70. ice and text message least 5 seconds UNIT OK If using an IrDA connection make sure the connection is established before starting the AED Pro unit Refer to Setting Up Data Communications with an IrDA Connection on page 6 4 6 2 www zoll com 9650 0350 01 Rev H Data Storage Data Storage The AED Pro unit stores device history and patient clinical data in nonvolatile memory The unit retains the device history and clinical data even when powered off or when the battery pack is removed Clinical data is erased only when the device is powered on and electrodes are attached to a new patient If configured to do so the unit can store data for more than one patient Device History The AED Pro unit keeps a log of its status information including Unit model name Device serial number Hardware revision number Application software and boot code revision numbers Language file version number Total shocks delivered Battery life status percentage of charge remaining Ready indicator status Elapsed time since installation of the battery Date and results of last self test Error log To view device history use ZOLL Administration Software Patient Clinical Data During clinical mode the device stores the following with date and time notation Electrode attachment Electrode type CPR Depadz CPR statepadz statspadz II or pedi padz IT defibrillation pads or AED Pro ECG cable Results of ECG ana
71. ifact after detecting the first 3 to 6 chest compressions The filtered ECG is displayed along with the CPR FLTR message on the top left of the LCD screen See Thru CPR filtering continues as long as the CPR Depadz or CPR stat padz electrodes detect compressions When no compressions are detected filtering stops unfiltered ECG signals are displayed and the unit removes the CPR FLTR message from the LCD screen When compressions resume filtering automatically restarts after 3 to 6 chest compressions WARNINGS e The See Thru CPR filter works only when the AED Pro defibrillator is operating in Manual Mode e The See Thru CPR filter does not remove all CPR artifact Always stop CPR to verify the patient s ECG rhythm before making treatment decisions e The See Thru CPR filter does not operate during ECG rhythm analyses Always stop chest compressions during ECG rhythm analyses to avoid incorrect results caused by the presence of CPR artifact 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 4 5 CHAPTER 4 MANUAL MODE Examples The following examples show the effects of See Thru CPR filtering on ECG signals contaminated with CPR artifact Each example includes ECG signal with CPR artifact ECG signal after the See Thru CPR filter has removed CPR artifact Indication of the period during which See Thru CPR is active CPR signal to show when CPR activity occurred Figure 1 shows a patient in Fine VF It is di
72. in standby state Press and release the On Off button to turn on the unit and initiate a power on self test The message UNIT OK indicates that the battery pack and electrodes are properly installed and that the unit is ready for service The message UNIT FAILED indicates that the unit is not ready for service Verify that the unit correctly detects the type of electrodes that are attached with the message ADULT PADS or PEDIATRIC PADS 10 Press and hold the On Off button for 1 second to turn off the unit 11 Wait 2 minutes Verify that the Ready indicator displays a green check and that the unit does not beep 12 Place the unit into service While the unit is in service periodically check the Ready indicator to ensure that it displays a green check and inspect the unit for physical damage 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 2 5 CHAPTER 2 GETTING STARTED Performing a Self Test The AED Pro unit performs automatic or manual self tests to verify its integrity and readiness for emergency use These tests verify the following e Battery energy Verifies that the battery energy is sufficient for at least 2 hours of continuous monitoring and ten shocks at maximum energy e Defibrillation electrodes connection Verifies that defibrillation electrodes are properly preconnected to the unit e ECG circuitry Verifies that the ECG signal acquisition and processing elect
73. in the U S A only 1 978 421 9655 Fax 1 978 421 0010 When requesting service please provide the following information to the service representative e Unit serial number e Description of the problem e Department using the equipment and name of the person to contact e Purchase order to allow tracking of loan equipment e Purchase order for a unit with an expired warranty Returning a unit for service Before sending a unit to the ZOLL Technical Service Department for repair obtain a service request SR number from the service representative Remove the battery pack from the unit Pack the unit with its cables in the original containers if available or equivalent packaging Be sure the assigned service request number appears on each package For customers Return the unit to ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Attention Technical Service Department SR number Telephone 1 800 348 9011 ZOLL Medical Canada Inc 1750 Sismet Road Unit 1 Mississauga Ontario LAN 1R6 Attention Technical Service Department SR number Telephone 1 866 442 1011 In the U S A In Canada The nearest authorized ZOLL Medical Corporation representative To locate an authorized service center contact the International Sales Department at In other locations ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Telephone 1 978 421 9655 9650 0350 01 Rev H ZOLL AED
74. ing Optimal Performance with Rechargeable Batteries on page B 3 For specifications refer to Battery Pack Specifications on page A 5 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide APPENDIX B RECHARGEABLE BATTERY PACKS Managing Rechargeable Battery Packs Rechargeable battery packs require a full recharge after each use Avoid using a battery pack that is not fully recharged WARNING Regular use of a partially charged battery pack without a full recharge between uses results in permanently reduced capacity and early failure of the battery pack Many factors contribute to the loss of battery capacity including the frequency of use the number of battery packs available for operations and the pattern of discharging and recharging battery packs Because of this ZOLL recommends that operators schedule a preventive routine for replacing and discarding used battery packs Base your replacement schedule for rechargeable battery packs on anticipated use patterns battery pack testing results and experience with the device in actual operation When stored and not in use a battery pack can lose 2 to 3 of its energy per month ZOLL recommends purchasing new batteries every eighteen months or sooner Recharging and Testing Battery Packs ZOLL battery packs are designed to be charged in ZOLL chargers ZOLL recommends that you always have a ZOLL auxiliary battery charger available for charging spare battery packs and fo
75. ks all subsequent shocks are delivered at the same energy as the third shock The factory default energy levels in joules are as follows First shock Second shock Third shock Adult 120 150 200 Pediatric 50 70 85 For more information refer to Appendix C Configurable Settings Defibrillation Modes The AED Pro unit can be manufactured to run in one of three defibrillation modes e Semiautomatic Mode Defibrillation with CPR Monitoring e Manual Mode Defibrillation e Semiautomatic Mode Defibrillation with CPR Monitoring and Manual Mode Override Semiautomatic Mode Defibrillation and CPR Monitoring When the AED Pro unit is configured to run in semiautomatic mode or semiautomatic mode with manual mode override the unit starts up in semiautomatic mode unless an AED Pro ECG cable is attached to the unit In semiautomatic mode the unit analyzes the patient s ECG through the defibrillation electrode pads attached to the patient If the unit detects a shockable rhythm it automatically charges to the appropriate preconfigured energy level Once the defibrillator is fully charged the Shock button begins flashing The unit also emits a charge ready tone and directs the rescuer to press the Shock button to deliver therapy In semiautomatic mode the rescuer must deliver the shock within 30 seconds of full charge otherwise the defibrillator automatically disarms itself and the unit resumes ECG analysis After delivering a shock the
76. l Placement R red RA white Patient s right midclavicular line directly below clavicle 3 lead configuration L yellow LA black Patient s left midclavicular IEC line directly below clavicle F green LL red Between sixth and seventh intercostal space on the patient s left midclavicular line 3 lead configuration AHA a International Electrotechnical Commission b American Heart Association 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 5 3 CHAPTER 5 ECG MONITORING MODE Applying ECG Electrodes Proper application and placement of electrodes is essential for ECG monitoring Good contact between the electrode and the skin minimizes motion artifact and signal interference ZOLL recommends the use of high quality Ag AgCl silver silver chloride ECG electrodes Before you begin Check the electrodes to ensure they are free from damage and are not past the expiration date on the packaging Procedure To apply ECG electrodes to the patient Step Action 1 Identify the appropriate sites for electrode placement refer to ECG Electrode Placement on page 5 3 Clean and abrade the patient s skin to remove the outer layer of dead tissue Ensure that the skin at the electrode site is dry Snap the leads onto each electrode Check for good contact between the electrode and the lead termination Peel the protective backing from the
77. lace battery pack as soon unit is powered on CHANGE BATTERY as possible Dead battery Ready indicator shows a Replace battery pack ree If the red X remains contact ZOLL Technical Service 2 4 www zoll com 9650 0350 01 Rev H Preparing the Unit for Clinical Use Preparing the Unit for Clinical Use The following setup and checkout procedures should be performed before placing the unit into service and after each clinical use Before you begin You need the following items e A fully charged battery e Defibrillation electrode pads Procedure To prepare an AED Pro unit for clinical use Step Action 1 Inspect all external surfaces of the unit to ensure that they are clean with no fluid spills and free from structural damage such as cracks and broken or missing parts Inspect the patient cable connector to ensure that the pins are not broken bent or missing Inspect all cables Replace any item that is cut or frayed or that has bent pins Install a fully charged battery pack that is appropriate for your application Ensure that you have an adequate supply of defibrillation and ECG electrodes Verify that the defibrillation electrodes have not expired and are not close to expiration Follow the instructions provided with the defibrillation electrodes to preconnect them to the patient cable connector Note If electrodes are not preconnected the unit will fail its next self test
78. le battery packs lose some of their charge and might suffer damage to charge capacity if left in a discharged state DO NOT assume that a shift check of the unit verifies adequate battery pack run time Test the unit daily to verify its readiness for use This test however does not verify adequate charge state or capacity of the battery pack and might leave the unit with inadequate run time If the message CHANGE BATTERY appears during testing replace the battery pack immediately If the removed battery pack is rechargeable recharge it immediately DO NOT charge battery packs at temperature extremes Charge battery packs at or near normal room temperature 15 C to 35 C or 59 F to 95 F DO NOT remove a partially charged battery pack from the battery charger Always fully charge a battery pack before returning it to use If you must use a partially charged battery pack be sure to fully charge the pack before its next use www zoll com 9650 0350 01 Rev H Appendix C Configurable Settings This appendix describes the configurable settings for the AED Pro unit To configure the AED Pro device use ZOLL Administration Software ZAS installed on a Windows based personal computer After you establish an IrDA connection between the computer and the AED Pro unit you can modify the configuration settings on the unit or load a saved configuration and send it to the unit 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide C 1 CONFIGU
79. llation cable is plugged into the unit Procedure To defibrillate the patient in semiautomatic mode Step Action Result 1 Press and release the On Off button to turn on the unit On successful completion of the power on self test the unit indicates the type of attached electrodes If the defibrillation pads are not attached to the patient the unit issues the voice and text prompt ATTACH DEFIB PADS TO PATIENT S BARE CHEST If prompted apply defibrillation electrode pads to the patient Refer to Applying Defibrillation Electrode Pads on page 3 2 When the pads are properly attached to the patient the unit issues the voice and text message DON T TOUCH PATIENT ANALYZING and then begins ECG analysis Allow the unit to analyze the patient s ECG The unit determines whether or not the patient has a shockable rhythm and then displays and voices its recommendation SHOCK ADVISED or NO SHOCK ADVISED After ECG analysis which message appears If SHOCK ADVISED continue with step 5 If NO SHOCK ADVISED go to step 8 If a shock is needed the defibrillator automatically begins charging If a shock is not needed the unit prompts you to perform CPR Wait for the defibrillator to charge When fully charged the unit emits a charge ready tone repeatedly flashes the Shock button and issues the voice and text prompts DON T TOUCH PATIENT PRES
80. lse Start Compressions e If no Circulation Start Compressions Continue CPR When you select one of the prompts in the Possible Values column that prompt will be repeated once every 10 seconds default during the CPR period if compression stops while in the e OFF default e If no Circulation Continue CPR e If no Pulse Continue CPR e Continue CPR e Continue Compressions CPR state e If no Pulse Continue i Senn i Compressions When this option is set to Off no prompts willbe no Circulation Continue SR Compressions Delays Continue CPR Delay Allows you to set the inverval between Continue CPR prompts e 5seconds e 10 seconds default e 15 seconds Push Harder Delay Allows you to set the inverval between Push Harder prompts es 15 seconds default e 20 seconds e 30 seconds Audio and Text Prompts Start CPR Allows you to select whether you want to both hear and view the START CPR prompt or view it only e Audio and Text default e Text only Push Harder Allows you to select whether you want to both hear and view the Push Harder prompt or view it only e Audio and Text default e Text only e OFF Good Compressions Allows you to select whether you want to both hear and view the Good Compressions prompt or view it only es Audio and Text default e Text only e OFF Continue CPR Allows you to select whether you want to both hear and
81. lysis Continuous ECG data Number of shocks delivered Energy delivered Patient impedance Voice prompts CPR data depth and rate of chest compressions To view and analyze patient clinical data use ZOLL RescueNet Code Review software 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 6 3 CHAPTER 6 NONRESCUE MODE Communicating with an External Device For many nonrescue operations such as data transfer or device configuration the AED Pro unit must establish a connection with an external device Setting Up Data Communications with an IrDA Connection You can transfer data from an AED Pro unit to an external device through an IrDA infrared wireless connection The AED Pro unit has an IrDA port on its right side near the Ready indicator The external device such as a personal computer or personal digital assistant must have an IrDA port as well For IrDA adapters refer to Accessories on page 1 6 For best transmission results the IrDA ports must be facing each other with a clear 10 to 18 inch line of sight between devices Start the ZOLL Administration Software or RescueNet Code Review software on the computer Press and hold the On Off button on the AED Pro unit for at least 5 seconds to enter nonrescue mode see page 6 2 The AED Pro unit establishes contact with the computer within 5 seconds and issues the voice and text message COMMUNICATIONS ESTABLISHED otherwise it shuts down Downloading Data to a USB D
82. m Accuracy on page A 15 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 1 APPENDIX A SPECIFICATIONS Device Specifications General Size height width length 3 ins 9 24 in 9 4 in 7 62 cm 23 47 cm 23 88 cm Weight 5 19 lb 2 35 kg without battery pack 5 97 Ib 2 70 kg with nonrechargeable battery pack Power Battery pack Device classification Class II and internally powered per EN 60601 1 Design standards Meets applicable requirements of UL 2601 AAMI DF80 IEC 60601 2 4 EN 60601 1 IEC 60601 1 2 Patient safety All patient connections are electrically isolated Environmental Temperature Operating 0 C to 50 C Storage and shipping 30 C to 70 C Humidity 10 to 95 relative humidity noncondensing Vibration MIL STD 810F Integrity Test for Helicopters Shock IEC 60068 2 27 100G Altitude Height 300 to 15 000 ft 91 to 4573 m Pressure 768 to 429 mmHg 1024 to 572 millibars Particle and water ingress IEC 60529 IP 55 Drop test 1 5 m per IEC 68 2 32 Defibrillator Waveform ZOLL Rectilinear Biphasic waveform Energy selection Configurable preset energy levels for adult and pediatric patients in three shock stacks Charge time Less than 10 seconds with a new fully charged battery with depleted battery packs the charge time is longer For the fifteenth discharge at maximum energy 200 joules the ch
83. n air www zoll com 9650 0350 01 Rev H Safety Considerations Electrical shock Before defibrillation be sure to disconnect from the patient all electromedical equipment that is not defibrillation protected Keep electrodes away from all other equipment attached to the patient and from metal objects in contact with the patient During defibrillation do not touch the bed the patient conductive material or any equipment connected to the patient 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 Accessory equipment The use of accessory equipment that does not comply with the equivalent safety requirements of the AED Pro device could reduce the level of safety of the resulting system When selecting accessory equipment consider the following e Use of the accessory in the patient vicinity e 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 Patient Safety AN The AED Pro unit detects ECG electrical signals only and 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 ECG rhythm analysis does
84. n of 184 Objectives The primary goal of this study was to compare the first shock efficacy of the 120 J Rectilinear Biphasic waveform with a 200 J monophasic waveform The secondary goal was to compare all shock three consecutive 120 150 and 170 joules efficacy of the Rectilinear Biphasic waveform with that of a monophasic waveform three consecutive 200 300 and 360 joules A significance level of p 0 05 or less was considered statistically significant using Fischer s Exact test Also differences between the two waveforms were considered statistically significant when the customary 95 or AHA recommended 90 confidence interval between the two waveforms was greater than 0 Results The study population of 184 patients had a mean age of 63414 years Of these 143 patients were male 98 patients were in the biphasic group ventricular fibrillation flutter n 80 ventricular tachycardia n 18 and 86 patients were in the monophasic group ventricular fibrillation flutter n 76 ventricular tachycardia n 10 There were no adverse events or injuries related to the study The first shock first induction efficacy of biphasic shocks at 120 J was 99 versus 93 for monophasic shocks at 200 J p 0 0517 95 confidence interval of the difference of 2 7 to 16 5 and 90 confidence interval of the difference of 1 01 to 15 3 Monophasic Biphasic First shock efficacy 93 99 p value 0 0517 95 confidence interval
85. n page 4 2 e Switching to Manual Mode on page 4 3 e Manual Defibrillation on page 4 4 e See Thru CPR on page 4 5 e Messages in Manual Mode on page 4 10 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 4 1 CHAPTER 4 MANUAL MODE About Manual Mode WARNING 4 2 In manual mode you must evaluate the patient s rhythm to determine whether or not it is shockable If a shock is required you manually charge the defibrillator to the preselected energy level Once the defibrillator is fully charged the Shock button begins flashing The unit also emits a charge ready tone to indicate that the defibrillator is ready to deliver a shock The tone is continuous for the first 50 seconds and then sounds intermittently for 10 seconds more Press the Shock button to deliver therapy If you do not deliver a shock within this 60 second period the defibrillator automatically disarms itself To recharge the defibrillator you must press the CHARGE softkey again During shock delivery do not touch the patient or any other equipment connected to the patient A severe shock can result To avoid unwanted pathways for defibrillation current do not allow exposed portions of the patient s body to touch metal objects such as a bed frame In manual mode the screen shows the shock count elapsed time mode MANUAL heart rate heartbeat symbol ECG size ECG rhythm text messages and the label CHARGE or DISARM above the lef
86. nges and revert to the previously set date and time press the X softkey 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 6 5 CHAPTER 6 NONRESCUE MODE While in the SET TIME menu if no softkeys are presssed and there is no IrDA connection established the unit powers off after 30 seconds Device Configuration The AED Pro unit provides configurable settings to suit the needs of your organization and its medical protocols Before putting the unit into service for the first time the administrator should inspect the factory settings and make any required adjustments Operators cannot adjust these settings while the unit is in clinical use For more information refer to Appendix C Configurable Settings ZOLL Administration Software ZOLL Administration Software ZAS helps you perform software maintenance tasks when the AED Pro unit is communicating with a personal computer Using ZAS you can transfer data from the AED Pro unit to a computer From the computer you can transmit the data to a network or print the data to a local printer For instructions on using ZAS refer to its online help Installing ZOLL Administration Software 6 6 To install ZOLL Administration Software insert the ZOLL Administration Software CD into a CD ROM drive on the computer The installation program starts automatically If the installation program does not start do the following 1 From the Windows Start menu select Run 2 In t
87. not warn of patient asystole which is not a shockable rhythm Do not connect the AED Pro to a PC or other device via the USB port while the unit s electrodes are still connected to the patient Disconnect the AED Pro from the patient before performing defibrillation with another defibrillator If the AED Pro shuts down or malfunctions during defibrillation of the patient with a different defibrillator turn the AED Pro unit off and then back on and continue normal use Check electrical leakage levels before use Leakage current might be excessive if more than one monitor or other piece of equipment is connected to the patient Do not use this equipment in the presence of electrosurgery Defibrillation pads and ECG electrodes Check the expiration date on the electrode packaging Do not use electrodes that have passed their expiration date Do not use defibrillation pads or ECG electrodes if the gel is dried or damaged patient burns or poor quality ECG signals might result from using such electrodes Poor adherence or air pockets under defibrillation pads can cause arcing skin burns or reduced energy delivery To minimize burning apply freshly opened and undamaged defibrillation pads to clean and dry skin Excessive body hair or wet diaphoretic skin can inhibit electrode pad coupling contact with the skin Clip excess hair and dry any moisture from the area where an electrode pad is to be attached 9650 0350 01 Rev H ZOLL AE
88. ntended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient In manual mode the AED Pro unit is intended to be used only by qualified medical personnel trained in Advanced Life Support skills In ECG monitoring mode the AED Pro unit is intended to be used by personnel who are qualified by training in the use of the AED Pro device basic life and or advanced life support or other physician authorized emergency medical training www zoll com 9650 0350 01 Rev H Defibrillator Precautions Inappropriate defibrillation of a patient for example with no malignant arrhythmia can precipitate ventricular fibrillation asystole or other dangerous types of arrhythmia Without proper application of electrode pads defibrillation might be ineffective and cause burns particularly when repeated shocks are necessary Erythema or hyperemia of the skin under the defibrillation pads often occurs This reddening effect often enhanced along the perimeter of the pad should diminish substantially within 72 hours Defibrillator output energy The AED Pro unit 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 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide xvii AED PRO
89. on depth is consistently less than 2 inches 5 cm the unit issues the voice and text prompt PUSH HARDER If the rescuer responds by increasing compression depth to 2 inches 5 cm or more the unit issues the voice and text message GOOD COMPRESSIONS The AED Pro unit can be configured to display the FULLY RELEASE text prompt to remind the rescuer to lift the hands off the chest during CPR By default this text prompt is not enabled www zoll com 9650 0350 01 Rev H Applying Defibrillation Electrode Pads Applying Defibrillation Electrode Pads Adult statepaaz Il WARNING under 8 years of age To apply statepadz I defibrillation electrode pads ZOLL statepadz I electrodes are for adult patients only do not use them on patients Step Action 1 Tear open the electrode package and unfold the inner package to expose the electrodes Remove the square electrode from its backing material and place it on the patient s upper right chest as shown Place your hand on the electrode edge Using your other hand gently roll the electrode onto the patient s chest pushing out air from beneath the electrode as you go Remove the round electrode from its backing material and place it on the patient s lower left chest as shown For female patients place the electrode under the patient s left breast Place your hand on the electrode s edge Using your other hand roll the electrode onto the pa
90. or charging defibrillator do one of the following e Turn the unit off for at least 3 seconds e Press the DISARM softkey manual mode only For safety the AED Pro unit automatically disarms a fully charged defibrillator after 60 seconds in manual mode or 30 seconds in semiautomatic mode if the Shock button is not pressed Federal U S A law restricts this device to use by or on the order of a physician Proper operation of the unit and correct electrode placement are critical to obtaining optimal results Operators must be thoroughly familiar with proper device operation The use of external defibrillation electrodes or adapter devices from sources other than ZOLL is not recommended ZOLL Medical Corporation makes no representations or warranties regarding the performance or effectiveness of its products when used with defibrillation electrodes or adapter devices from other sources Device failures attributable to the use of defibrillation electrodes or adapters not manufactured by ZOLL might void the warranty on the ZOLL equipment This device is protected against interference from radio frequency emissions typical of the two way radios and cellular phones digital and analog used in emergency service or public safety activities You should assess the device s performance in your typical operating environment to determine the likelihood of radio frequency interference RFI from high power sources Radio frequency interference can cau
91. ow the prompts to resolve the problem If the unit continues to fail take it out of service and contact ZOLL Technical Service Ready indicator shows a red X while the device is powered on Turn the unit off and then on again Follow the prompts to resolve the problem If the unit continues to fail take it out of service and contact ZOLL Technical Service Power on self test failed Follow the prompts to resolve the problem If the unit continues to fail take it out of service and contact ZOLL Technical Service Unexpected shutdown in clinical mode Note In clinical mode the unit automatically powers off if it does not detect a patient connection within 10 minutes configurable Turn the unit on Follow the prompts to resolve the problem If the unit continues to fail take it out of service and contact ZOLL Technical Service Unexpected shutdown in nonrescue mode Note The unit automatically powers off if an established IrDA connection is lost Press and hold the On Off button for at least 5 seconds Follow the prompts to resolve the problem If the unit still is not ready for use take it out of service Contact ZOLL Technical Service Message Replace the battery pack with a fully charged battery CHANGE BATTERY pack as soon as possible Message Ensure that the electrode cable is properly connected PLUG IN CABLE to the unit Remove the cable and check for bent or b
92. ownloading Data to a USB Device UR Seef Me ceeeeeeseneceeeeseeeeeees 6 4 Setting the Dae and Tume eseu vun EE 200 errete i raer ae irene 6 5 DWeyice Configuration 2 0 c2 c ees pM daearen rnirar rennan 6 6 ZOLL Administration Software BE Seege 28 Saceesaseceeseeseeeeesseeseeenesnceeees 6 6 Installing ZOLL Administration Software Ae 6 6 RescueNet Code Review Software AEN 6 7 Messages in Nonrescue Mode Auen eege var Ste hese sndeuctnseetebesdsdecncadensnnndvennenshnenets 6 8 Chapter 7 Troubleshooting and Maintenance General Troubleshooting 4 00 rc SRB ecesecceeesaseeeeeceeceeeeseeeneesecseeeeeseseneeeeseeneeneneee en 7 2 ECG Monitoring Trordlegl RAO tig cis ccconsis Me seceatusessivedserendanveonmndunxcntexensbenbeareeoe Rsanveecaaragaas 7 4 ul elle EL wi 1 le EEN v WEEN EE 7 5 Eer Au lr ME EEN S 20 A 7 6 Optional Maintenance for Technical Professionals sseesonneseesnneeenneersenreserrnnrerrnnennene 7 7 Appendix A Specifications Device Specifications 2 ccccc cccresecceeeesseeeees seen sen EE nn cenecceeeeessseenessenees A 2 ii www zoll com 9650 0350 01 Rev H Battery Pack Gpechficatiobes A SseERRRRREEEESEEEEEEEERREEENEENNEeeee eene unn EE aa A 5 Guidance and Manufacturer s Declaration Electromagnetic Emissions A 6 Electromagnetic Immunity Declaration EID eeeseeeeeceeeeeegedbeeee cael eeeeseeateetee A 7 Rectilinear Biphasic W
93. patients NSR 208 100 208 208 98 6 AF SB SVT heart block 348 99 4 346 348 98 2 idioventricular PVCs Asystole 29 100 29 29 90 2 Intermediate 16 patients Fine VF 0 Report only Other VT 40 Report only 90 36 40 78 6 a 161 of the 348 abnormal rhythm records were SVT 72 patients The SVT heart rates ranged from 152 to 302 beats per minute Arrhythmia performance is reported according to the article Kerber RE Becker LB Bourland JD Cummins RO Hallstrom AP Michos MB Nichol G Ornato JP Thies WH White RD Zuckerman BD Automated External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety Circ J Am Heart Assoc 1997 95 1677 1682 References Young KD Lewis RJ What is confidence Part 2 Detailed definition and determination of confidence intervals Ann Emerg Med September 1997 30 311 318 Beyer WH Percentage Points F Distribution Table CRC Standard Mathematical Tables 28th ed Boca Raton Fla CRC Press 1981 573 www zoll com 9650 0350 01 Rev H Appendix B Rechargeable Battery Packs This appendix provides information about using rechargeable battery packs with the AED Pro unit and contains the following sections Managing Rechargeable Battery Packs on page B 2 Recharging and Testing Battery Packs on page B 2 Achiev
94. performing CPR place the patient on a firm surface Battery care Keep a fully charged spare battery pack with the device at all times When the unit displays the message CHANGE BATTERY immediately replace the battery pack with a fully charged one Regular use of a partially charged battery pack without fully recharging it between uses might permanently reduce the battery s capacity and result in early failure Regularly test rechargeable battery packs A rechargeable battery pack that does not pass its test could fail without warning Do not disassemble a battery pack or dispose of it in fire Do not try to recharge a nonrechargeable battery pack If mistreated a battery pack might explode Dispose of battery packs in accordance with federal state 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 Operator Safety viii AN Do not use the unit near oxygen rich atmospheres flammable anesthetics or other flammable agents such as gasoline Do not use the unit within standing water Before discharging the defibrillator warn everyone to stand clear of the patient Do not discharge the defibrillator except as indicated in the instructions Discharge the defibrillator only when defibrillation pads are properly attached to the patient Never discharge the unit with the defibrillation pads shorted together or in ope
95. r routine testing of battery packs WARNING Test battery packs regularly A battery that does not pass its test might shut down unexpectedly For information on using battery chargers refer to the ZOLL Base PowerCharger manuals listed in Related Manuals on page vi B 2 www zoll com 9650 0350 01 Rev H Achieving Optimal Performance with Rechargeable Batteries Achieving Optimal Performance with Rechargeable Batteries To ensure the longest life from rechargeable battery packs follow these general practices DO carry a fully charged spare battery pack at all times DO charge battery packs completely Whenever a battery pack exchange is required install a fully charged battery pack Use of partially charged battery packs might result in very short run time and unexpected shutdown If you use a partially charged battery pack fully charge that battery pack before using it again Repeated use after partial charging quickly diminishes the battery pack s capacity thereby shortening its life If you must frequently use partially charged battery packs your organization should assess whether enough battery packs are available to fully support typical rescue activity DO implement a means of indicating the charge status of battery packs It is important to visually distinguish battery packs that are charged from those that are not Establish a system for visually indicating whether a battery pack requires charging or is charge
96. ration distance Oh IEC 61000 4 6 150 kHz to 80 MHz in meters outside ISM bands d 1 17 VP outside ISM bands 10 Vrms 10 Vrms 150 kHz to 80 MHz d 1 20 VP within ISM bands in ISM bandsa Radiated RF 10 V m 10 V m d 1 20 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 30 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol wn A Notes At 80 MHz and 800 MHz the higher frequency range applies 1 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a b The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile or portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an ad
97. reen shows the shock count elapsed time mode MONITOR heart rate heartbeat symbol ECG size ECG rhythm and text messages If defibrillation electrode pads are in use the label SEMI AUTO appears above the right softkey 24 ce eu ECG X1 0 SSES CHECK PATIENT An implanted pacemaker might cause the heart rate meter or ECG rhythm analysis to count the pacemaker rate during incidents of cardiac arrest or other arrhythmia Carefully observe pacemaker patients Check the patient s pulse do not rely solely on the heart rate meter Patient history and physical examination are important in determining the presence of an implanted pacemaker 5 2 www zoll com 9650 0350 01 Rev H ECG Electrode Placement ECG Electrode Placement Before applying ECG electrodes be sure to e Remove all clothing covering the patient s chest e Clip or shave any excessive hair to ensure proper adhesion of the electrodes e Use alcohol to wash away any oil or dirt at the electrode site e Dry any moisture at the electrode site Some skin abrasion is necessary to remove the top layer of dead skin cells and expose moist living cells for better electrical contact Proper skin preparation reduces baseline wander and noise and provides a noise free signal more quickly after electrode application Place ECG electrodes on the patient s chest as shown in Table 5 1 Table 5 1 ECG Electrode Labeling and Placement IEC Label AHA Labe
98. roken pins Replace the electrode cable Message Release the Shock button Wait until the unit issues the RELEASE SHOCK BUTTON prompt PRESS FLASHING SHOCK BUTTON before pressing the button www zoll com 9650 0350 01 Rev H Table 7 1 General Issues continued General Troubleshooting Symptom Corrective Action Message Note This prompt appears if an ECG cable is PLUG IN DEFIB CABLE connected but the unit is not configured for ECG monitoring Check the cable and replace if necessary Message A softkey was pressed for more than 10 seconds the RELEASE LEFT SOFTKEY unit automatically switched to semiautomatic mode or Release the softkey RELEASE RIGHT SOFTKEY 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 7 3 CHAPTER 7 TROUBLESHOOTING AND MAINTENANCE ECG Monitoring Troubleshooting Table 7 2 lists common issues with ECG monitoring and their associated corrective action Table 7 2 ECG Monitoring Issues Symptom Corrective Action Messages Ensure that the ECG cable is connected to each CHECK ECG ELECTRODES electrode and to the unit ATTACH ECG ELECTRODES Ensure that the ECG electrodes are making good contact with the patient and are not dried out Replace the ECG electrodes Replace the ECG cable Noisy ECG artifact or wandering baseline Turn off nearby two way radios and cell phones Before attaching electrodes properly prepare the patient s skin refer to
99. ronics are functional e Defibrillator charge and discharge circuitry Verifies that the defibrillator electronics are functional and can charge and discharge at 2 joules e Microprocessor hardware and software Verifies the proper function of the microprocessor electronics and the integrity of the software e CPR circuitry and sensor Verifies that the CPR monitoring and compression depth detection are functional when CPR Depadz or CPR statepadz are attached e Audio circuitry Verifies that the audio output circuitry is functional e Display Verifies that the visual indicators are functional After the successful completion of the self test the Ready indicator displays a green check indicating that the unit is ready for use 10 If the Ready indicator displays a red X after a self test the unit is not H ready for use and might be defective Remove the unit from service and consult the Troubleshooting chapter of this guide Automatic Self Tests The unit performs a self test whenever it is turned on or a battery pack is installed or at periodic intervals while in standby state The interval for automatic self tests in standby state is a configurable setting the default interval is one day For more information refer to Appendix C Configurable Settings Manual Self Test You can manually initiate a self test by pressing and holding the On Off button for 5 seconds The unit illuminates the
100. s turned on The counter resets to 00 00 00 after 23 hours 59 minutes and 59 seconds or when the unit is turned off ECG size Shows the amplitude scale for the displayed ECG in centimeters per millivolt cm mV The device adjusts the scale automatically The ECG scale marker always indicates the size of a 1 mV peak to peak signal Heart rate and heartbeat symbol Manual and ECG monitoring modes only Shows the current heart rate in beats per minute The symbol flashes with each detected heartbeat Chest compression depth gauge Shows the depth of chest compression during CPR when ZOLL CPR Depadz are connected The bar extends downward as the depth of compression increases with scale marks representing 0 2 0 inches and 2 4 inches Softkey labels Labels for the softkeys appear at the bottom of the display directly above each softkey to indicate its function Text prompts and messages In semiautomatic mode text prompts guide the rescuer In all modes messages alert the operator about problem conditions ECG rhythm Displays the patient s ECG Shock symbol and number of shocks delivered Shows the number of shocks delivered since the unit was powered on Current mode Displays MANUAL in manual mode or MONITOR in ECG monitoring mode No mode label appears in semiautomatic mode www zoll com 9650 0350 01 Rev H The Front Panel Figure 1 3 shows the layout of the screen and the location of the above it
101. s that are connected ADULT PADS or PEDIATRIC PADS Verify that the connected electrodes are appropriate for the patient If necessary replace the connected electrodes with appropriate ones If the electrode cable is not properly connected to the unit the unit issues the voice and text prompt PLUG IN CABLE If the electrodes are not properly attached to the patient the unit issues the voice and text prompt CHECK DEFIB PADS or ATTACH DEFIB PADS TO PATIENT S BARE CHEST 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 2 7 CHAPTER 2 GETTING STARTED Messages While preparing the AED Pro unit for use the following messages can be seen and or heard Message Description UNIT OK The unit successfully passed its power on self test UNIT FAILED The unit failed its power on self test and is not usable for patient care CHANGE BATTERY The self test detected a low energy condition that is insufficient for patient care Replace the battery pack immediately ADULT PADS The unit detected the specified type of electrode pads PEDIATRIC PADS and adjusted defibrillation energy settings accordingly PLUG IN CABLE The unit started up without an electrode cable plugged in Plug the cable into the unit NON RESCUE MODE The device is operating in nonrescue mode and an IrDA connection is established POWERING OFF The On Off button was pressed and held for 1 second to turn the unit off www zoll com 96
102. se shifts in the monitor baseline trace compression changes to brightness of the display or transient spikes on the screen The AED Pro unit might not perform to specifications when stored at the upper or lower extreme limits of storage temperature and then immediately put into use Do not use or stack the unit with other equipment If the unit is used or stacked with other electrical equipment verify proper operation before using it Do not use or place the unit in service if it beeps while turned off The use of accessories or cables other than those specified in this manual may result in increased emissions or decreased immunity of the AED Pro 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide vii PREFACE Do not use or place the unit in service if the Ready indicator at the upper right of the front panel shows a red X Defibrillation Emergency defibrillation should be performed only by appropriately trained skilled personnel who are familiar with the operation of the equipment The prescribing physician should determine what training such as Advanced Cardiac Life Support ACLS or Basic Life Support BLS certification is appropriate for operating this device ECG analysis A patient must be motionless during ECG analysis Do not touch the patient during analysis Cease all patient movement by stretcher or vehicle before beginning ECG analysis in semiautomatic mode Cardiopulmonary resuscitation CPR Before
103. situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 9 APPENDIX A SPECIFICATIONS Rectilinear Biphasic Waveform Characteristics A 10 The following table shows the characteristics of the Rectilinear Biphasic waveform when discharged into 25 ohm 50 ohm 100 ohm and 125 ohm loads at the maximum energy setting of 200 joules Table A 2 Rectilinear Biphasic Waveform Characteristics 200 J discharged into 250 509 1009 1250 First phase Maximum initial current 32 A 26 A 21A 17A Average current 28 A 22 A 16A 13A Duration 6 ms 6 ms 6 ms 6 ms Interphase duration 200 us 200 us 200 us 200 us between first and second phases Second phase Initial current 33 A 19A 12A 11A Average current 21A 14A 11A 10A Duration 4 ms 4 ms 4 ms 4 ms Table A 3 Delivered Energy at Each Defibrillator Setting into a Range of Loads Selected Energy Load 50 J 70 J 85 J 120 J 150 J 200 J 250 40 J 61J 66 J 95 J 111 J 146 J 50Q 51J 80 J 85 J 124 J 144 J 183 J 75Q 64J 89 J 111 148 J 172 J 204 J 100Q 62 J 86 J 108 J 147 J 171 J 201 J 1250 63 J 89 J 110 J 137 J 160 J 184 J 150Q 67 J 93 J 116 J 127 J 148 J 168 J 1750 61J 86 J 107 J 119 J 138 J 155 J Accuracy 15 15 15 15 15 15 The AED Pro Rectilinear Biphasic wa
104. ssible and focus on the rescue effort CALL FOR HELP Activate the local emergency medical services EMS system or ask a bystander to do it for you OPEN AIRWAY Place the patient in the supine position and perform a head tilt chin lift or jaw thrust to open the patient s airway CHECK BREATHING Look listen or feel for signs of breathing or airflow from the patient s lungs GIVE TWO BREATHS If the patient is not breathing give two rescue breaths CONTINUE CPR Optional prompt Perform CPR until directed to stop PUSH HARDER With CPR D padz and CPR statepadz only Apply more force so that chest compressions are at least 2 inches 5 cm deep Observe the compression indicator on the display screen GOOD COMPRESSIONS With CPR D padz and CPR stat paaz only The unit detected proper chest compression depth during CPR 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide CHAPTER 3 SEMIAUTOMATIC MODE 3 14 www zoll com 9650 0350 01 Rev H Chapter 4 Manual Mode In manual mode the AED Pro unit displays the patient s ECG while the rescuer evaluates the rhythm to determine if a shock is needed The rescuer can charge the unit to a preselected energy level Once the defibrillator is fully charged the rescuer presses the Shock button to deliver therapy Note Manual mode is not available on AED only models This chapter contain s the following sections e About Manual Mode o
105. t power of the communications equipment Separation distance in meters m according to frequency of transmitter Rated maximum 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz to output power of outside ISM bands in ISM bands 800 MHz 2 5 GHz transmitter in watts W din d H P d 42 p det dP 0 01 0 17 0 12 0 12 0 23 0 1 0 37 0 38 0 38 0 73 1 1 17 1 20 1 20 2 3 10 3 69 3 79 3 79 7 27 100 11 70 12 00 12 00 23 00 For transmitters rated at a maximum output power not listed above the recommended separation distance din meters can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile or portable communications equipment could cause interference if it is inadvertently brought into patient areas 4 These guidelines may not apply in all
106. t softkey Ti oe ECG X1 5 MIM wn Aw 150 J SELECTED CHARGE www zoll com 9650 0350 01 Rev H Switching to Manual Mode Switching to Manual Mode When the unit is operating in semiautomatic mode you can override the automated functions and switch to manual operation Changing modes does not affect the preselected energy level Before you begin Be sure the defibrillation electrode pads are properly attached to the patient and are plugged into the unit For more information refer to Chapter 3 Procedure To override semiautomatic mode and begin manual mode Step Action Result 1 Press and hold both unlabeled softkeys simultaneously for at least 3 seconds The MANUAL and SEMI AUTO softkey labels appear To change to manual mode press the MANUAL softkey Or to remain in semiautomatic mode press the SEMI AUTO softkey Note If you do not press either softkey within 10 seconds the unit reverts to semiautomatic mode The unit changes to manual mode and displays the CHARGE softkey label To return to semiautomatic mode after manual override turn the unit off and then back on again 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 4 3 CHAPTER 4 MANUAL MODE Manual Defibrillation With manual defibrillation you must evaluate the ECG rhythm to determine whether or not it is shockable If a shock is needed you manually charge the defibrillator and then
107. the number 3 tab and peel the protective backing from the electrode Press the electrode from the center of the abdomen outward to push out air from beneath the pad and to make sure the pad adheres properly to the patient s skin If the patient is large or there is a need to place the electrode under a breast you can detach the lower pad at the perforation and extend it for effective positioning Place the pad slightly to the patient s left and below the patient s left breast www zoll com 9650 0350 01 Rev H Applying Defibrillation Electrode Pads Applying Defibrillation Electrode Pads Adult CPR statepaaz WARNING ZOLL CPR statepadz are for adult patients only do not use them on patients under 8 years of age To apply CPR statepadz defibrillation electrodes Step Action 1 Tear open the electrode package and expose the electrodes Grasp the square electrode at the bottom with the attached sensor and peel from the plastic liner 2 Place the CPR sensor on the sternum lining up the cross hairs with the patient s nipple line and center of the sternum Place the electrode in the mid clavicular line below the patient s right clavicle as shown in the diagram Avoid any contact between the nipple and gel treatment area 3 Gently roll the electrode onto the chest pushing any air out from beneath the electrode Note Ifthe patient has an implanted pacemaker or defibrill
108. the patient Install a fully charged battery pack Defibrillator takes more than 15 seconds to charge Install a fully charged battery pack Energy does not discharge when the Shock button is pressed A fully charged defibrillator automatically disarms itself after 60 seconds in manual mode or 30 seconds in semiautomatic mode Charge the defibrillator again and deliver the shock while the charge ready tone sounds The Shock button was pressed before the unit was fully charged Wait for the charge ready tone and a flashing Shock button before pressing and holding the Shock button No apparent energy delivery to patient Under certain circumstances a patient might not display a physical reaction when energy is delivered Replace the electrodes if they are dried out or expired Ensure that the electrodes are making proper contact with the patient s skin Test the defibrillator Refer to Optional Maintenance for Technical Professionals on page 7 7 If the message CHECK DEFIB PADS appears check and correct the attachment or position of the electrodes DEFIB MAINTENANCE REQUIRED Message Ensure that the defibrillation electrode pads are making CHECK DEFIB PADS proper skin contact and that patient does not have excessive hair beneath electrodes If message persists change the defibrillation cable Message Check for proper application and adhesion of the ANALYSIS HALTED KEEP PATIENT d
109. tient Attach defibrillation pads to the patient www zoll com 9650 0350 01 Rev H Chapter 6 Nonrescue Mode For the AED Pro device Nonrescue Mode includes e Managing device history and clinical data e Configuring the device The unit includes nonvolatile memory for storing device status and clinical event information You can retrieve stored data using a personal computer or personal digital assistant with ZOLL RescueNet Code Review software through a USB device or an IrDA connection with the AED Pro unit You can configure an AED Pro device using a personal computer with ZOLL Administration Software ZAS through an IrDA connection with the unit This chapter contains the following sections e Entering Nonrescue Mode on page 6 2 e Data Storage on page 6 3 e Communicating with an External Device on page 6 4 e Setting the Date and Time on page 6 5 e Device Configuration on page 6 6 e ZOLL Administration Software on page 6 6 e Messages in Nonrescue Mode on page 6 8 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 6 1 CHAPTER 6 NONRESCUE MODE Entering Nonrescue Mode To place the AED Pro unit in Nonrescue Mode Step Action Result 1 If the unit is on press and hold the On Off The unit powers off button for 1 second to turn off the unit Wait until the message POWERING OFF disappears 2 Press and hold the On Off button for at The unit issues the vo
110. tient s skin pushing out air from beneath the electrode as you go Follow the AED Pro prompts 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide CHAPTER 3 SEMIAUTOMATIC MODE Applying Defibrillation Electrode Pads Infant Child pediepaaz Il WARNING ZOLL pediepadz IT electrodes are for pediatric patients only these pads provide defibrillation energy levels that might be inadequate for adult patients Procedure To apply pediepadz II defibrillation electrode pads Step Action 1 Tear open the electrode package and unfold the inner package to expose the electrodes 2 Remove the round electrode from its backing material 3 Position the electrode on the patient s chest as shown Place your hand on the electrode edge Using your other hand gently roll the electrode onto the patient s chest pushing out air from beneath the electrode as you go 4 Roll the patient onto his her chest 5 Remove the square electrode from its backing material 6 Position the electrode on the patient s back as shown Place your hand on the electrode s edge Using your other hand roll the electrode onto the patient s skin pushing out air from beneath the electrode as you go 7 Roll the patient onto his her back and follow the AED Pro prompts 9650 0350 01 Rev H www zoll com Semiautomatic Defibrillation Semiautomatic Defibrillation In semiautomatic mod
111. tion energy levels are preconfigured and cannot be changed during clinical use Once the defibrillator is fully charged the Shock button begins flashing The unit also emits a charge ready tone continuously for the first 50 seconds and then intermittently for the final 10 seconds The rescuer must deliver the shock within this 60 second period otherwise the defibrillator automatically disarms itself To recharge the unit the rescuer must press the CHARGE softkey again For more information refer to Chapter 4 Manual Mode ECG Monitoring The optional ECG monitoring mode provides ECG rhythm and heart rate display as well as performing background ECG analysis to detect shockable rhythms If the AED Pro unit detects a shockable rhythm during monitoring it immediately alerts the rescuer through displayed and voiced prompts if defibrillation pads are attached the unit automatically switches to semiautomatic mode For ECG monitoring you can use e AED Pro compatible defibrillation electrode pads e Standard ECG electrodes with an AED Pro ECG cable While ECG electrodes not defibrillation electrode pads are connected to the unit the only available mode is ECG monitoring All ECG monitoring is performed in the lead II configuration The operator cannot select another lead For more information refer to Chapter 5 ECG Monitoring Mode 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide 1 3 CHAPTER 1 PRODUCT OVERVI
112. u change the battery while the unit is in clinical use that is with a cable connected the unit automatically powers on in nonrescue mode and then shuts down Press and release the On Off button to restart the unit CHANGE BATTERY Warning When the unit detects a low energy condition it issues the voice and text prompt CHANGE BATTERY once every minute Depending on the age and condition of the battery the remaining operating time of the unit might be extremely limited The warning message continues until the device shuts down WARNING To ensure the availability of adequate power during an emergency keep a fully charged spare battery pack with the device at all times Whenever the unit issues the prompt CHANGE BATTERY immediately replace the used battery pack with a fully charged one to ensure continuous operation and to avoid unexpected device shutdown After removing a depleted rechargeable battery pack from the unit recharge the pack as soon as possible Battery Condition Indications Correction Low energy detected during Message Replace battery pack power on self test CHANGE BATTERY Low energy or other self test Ready indicator shows a Replace battery pack failure while the unit is red X Unit beeps once every C heck or replace powered off standby minute for 30 minutes preconnected electrodes If the red X remains contact ZOLL Technical Service Low energy detected while the Message Rep
113. veform employs the same first and second phase timing similar first and second phase currents voltages and essentially the same mechanisms for controlling defibrillation waveshape as the ZOLL M Series The ZOLL M Series and AED Pro defibrillation waveforms are considered substantially equivalent Figures A 1 through A 6 show the Rectilinear Biphasic waveforms that are produced when the AED Pro defibrillator is discharged into loads of 25 50 75 100 125 150 and 175 ohms at each energy setting 200 150 120 85 70 and 50 joules The vertical axis shows the current in amperes A the horizontal axis shows the duration in milliseconds ms www zoll com 9650 0350 01 Rev H Rectilinear Biphasic Waveform Characteristics Figure A 1 Rectilinear Biphasic Waveforms at 200 Joules 30 N o o N 25 NNT E o en NO 20 20 25 Figure A 3 Rectilinear Biphasic Waveforms at 120 Joules 9650 0350 01 Rev H ZOLL AED Pro Operator s Guide A 11 APPENDIX A SPECIFICATIONS

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