ZOLL aed pro Operator'S Manual Download Page 26

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HAPTER

RODUCT

VERVIEW

1–6

www.zoll.com

9650-0350-01 Rev. J

Accessories

The following related accessories and equipment are available.

Item

REF

Adult CPR-D•padz electrodes

8900-0800-01

Adult CPR stat•padz electrodes

8900-0400

Adult stat•padz

II electrodes

8900-0801-01

Pediatric pedi•padz

II electrodes

8900-0810-01

ECG electrodes: 3 ECG electrodes/pouch (200
pouches / 600 electrodes)

8900-0003

AED Pro ECG cable

AAMI

IEC

8000-0838
8000-0839

Defibrillation analyzer (universal) adapter cable

8000-0804-01

Rechargeable PD 4410 battery pack

Standard

Smart

Smart Ready

8004-0009
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

Summary of Contents for aed pro

Page 1: ...AED Pro AED Pro A W Operator s Guide 9650 0350 01 Rev J...

Page 2: ...reserved AED Plus AED Pro CPR D padz M Series pedi padz PowerCharger Real CPR Help Rectilinear Biphasic RescueNet See Thru CPR stat padz SurePower and ZOLL are trademarks or registered trademarks of Z...

Page 3: ...Pack 2 2 CHANGE BATTERY Warning 2 4 Preparing the Unit for Clinical Use 2 5 Performing a Self Test 2 6 Automatic Self Tests 2 6 Manual Self Test 2 6 Preconnecting the Defibrillation Electrodes Cable...

Page 4: ...ing Nonrescue Mode 6 2 Data Storage 6 3 Device History 6 3 Patient Clinical Data 6 3 Communicating with an External Device 6 4 Setting Up Data Communications with an IrDA Connection 6 4 Downloading Da...

Page 5: ...ults for the M Series Biphasic Waveform A 13 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT A 13 ECG Analysis Algorithm Accuracy...

Page 6: ...TABLE OF CONTENTS iv www zoll com 9650 0350 01 Rev J...

Page 7: ...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...

Page 8: ...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 acce...

Page 9: ...lts 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 Cor...

Page 10: ...ged 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...

Page 11: ...ver assume that the display of a nonzero heart rate means that the patient has a pulse ECG rhythm analysis does not warn of patient asystole which is not a shockable rhythm Do not connect the AED Pro...

Page 12: ...e meters Patient history and physical examination are important factors in determining the presence of an implanted pacemaker Cautions Do not sterilize the device or the ECG monitoring cable Do not im...

Page 13: ...e 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 Dep...

Page 14: ...thium Recycle or dispose of properly 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 dis...

Page 15: ...ED Pro Operator s Guide xiii Do not fold Not sterile Nonionizing electromagnetic radiation Manufacturer Authorized representative in the European Community Serial Number Catalogue number Consult instr...

Page 16: ...cation 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 inform...

Page 17: ...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 con...

Page 18: ...termine 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 Defibril...

Page 19: ...fibrillation 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 oft...

Page 20: ...AED PRO OPERATOR S GUIDE 9650 0350 01 Rev J ZOLL AED Pro Operator s Guide xviii This page intentionally left blank...

Page 21: ...ructions 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 Defibrillation on page...

Page 22: ...o 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 i...

Page 23: ...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...

Page 24: ...dio 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...

Page 25: ...d 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 mor...

Page 26: ...k Standard Smart Smart Ready 8004 0009 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 b...

Page 27: ...tem Adult Electrode Airworthy Certified 8900 0800 01 Airworthy stat padz II Adult Multi Function Electrodes w Ferrite 1 pair Airworthy Certified 8900 0840 30 Airworthy stat padz II Adult Multi Functio...

Page 28: ...cribes each of the unit s front panel features Figure 1 1 AED Pro Front Panel Figure 1 2 USB Connector On Off button Ready indicator Display screen Shock button Patient cable connector Softkeys Batter...

Page 29: ...des 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...

Page 30: ...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 D padz are connected The bar...

Page 31: ...3 AED Pro Display Screen Elements 00 03 45 1 142 MANUAL CHARGE ECG X0 5 150 J SELECTED Elapsed time Heart rate and heartbeat symbol ECG rhythm Text prompts and messages Number of shocks delivered Che...

Page 32: ...AED PRO OPERATOR S GUIDE 9650 0350 01 Rev J ZOLL AED Pro Operator s Guide 1 12 This page intentionally left blank...

Page 33: ...common tasks that you must do to get the AED Pro unit ready to use and contains the following sections Installing a Battery Pack on page 2 2 Preparing the Unit for Clinical Use on page 2 5 Performing...

Page 34: ...ely replace the battery with 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 WARNING Do not use a rechargeable ba...

Page 35: ...e of the battery compartment then place the battery into the compartment The shape of the battery pack allows it to seat itself properly 7 Press the edge of the battery pack until it clicks into place...

Page 36: ...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 shutdo...

Page 37: ...bent pins 4 Install a fully charged battery pack that is appropriate for your application 5 Ensure that you have an adequate supply of defibrillation and ECG electrodes 6 Verify that the defibrillatio...

Page 38: ...hed Audio circuitry Verifies that the audio output circuitry is functional Display Verifies that the visual indicators are functional Automatic Self Tests The unit performs a self test whenever it is...

Page 39: ...remain in a sealed envelope To prepare for future emergencies after each use connect a new package of electrodes by plugging the electrode cable into patient cable connector To ensure that the electr...

Page 40: ...The self test detected a low energy condition that is insufficient for patient care Replace the battery pack immediately ADULT PADS PEDIATRIC PADS The unit detected the specified type of electrode pad...

Page 41: ...T 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 defibrilla...

Page 42: ...g Before applying defibrillation electrode pads to the patient be sure to Remove all clothing covering the patient s chest Clip or shave any excessive hair to ensure proper adhesion of the pads Use al...

Page 43: ...u 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 protec...

Page 44: ...ss 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...

Page 45: ...d 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...

Page 46: ...t 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 t...

Page 47: ...re electrode from its backing material and place it on the patient s upper right chest as shown 3 Place your hand on the electrode edge Using your other hand gently roll the electrode onto the patient...

Page 48: ...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 o...

Page 49: ...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...

Page 50: ...e 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 3 Allow the unit to analyze...

Page 51: ...n to step 3 When the unit resumes ECG analysis it displays the message DON T TOUCH PATIENT ANALYZING 8 Follow the prompts to perform CPR until directed to stop CPR D padz or CPR stat padz only After t...

Page 52: ...hat is insufficient for patient care Replace the battery pack immediately ADULT PADS PEDIATRIC PADS The unit detected the specified type of electrode pads and adjusted defibrillation energy settings a...

Page 53: ...ECG signal 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 r...

Page 54: ...CHAPTER 3 SEMIAUTOMATIC MODE 3 14 www zoll com 9650 0350 01 Rev J...

Page 55: ...scuer 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 mo...

Page 56: ...e 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 C...

Page 57: ...e information refer to Chapter 3 Procedure To override semiautomatic mode and begin manual mode To return to semiautomatic mode after manual override turn the unit off and then back on again Step Acti...

Page 58: ...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 other...

Page 59: ...ee Thru CPR To use See Thru CPR The AED Pro unit must be operating in Manual Mode CPR D padz or CPR stat padz electrodes must be attached to the unit The AED Pro unit must be configured to use See Thr...

Page 60: ...which See Thru CPR is active CPR signal to show when CPR activity occurred Figure 1 shows a patient in Fine VF It is difficult for a rescuer to discern this rhythm during CPR compressions When the CPR...

Page 61: ...ing this ECG it is possible to view the underlying rhythm as the filter is able to reject all of the CPR artifact Figure 2 CoarseVF 0 00 0 12 Raw ECG Raw ECG Filtered ECG Filtered ECG CPR CPR CoarseVF...

Page 62: ...e CPR signal About 14 seconds 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 mak...

Page 63: ...effectively filters out artifact created by CPR Figure 4 SinusRhythm 0 00 0 12 Raw ECG Raw ECG Filtered ECG Filtered ECG CPR CPR Filter ON SinusRhythm 0 12 0 24 Raw ECG Raw ECG Filtered ECG Filtered E...

Page 64: ...verify that the cable is undamaged and plugged into the unit CHECK PATIENT Evaluate the status of the patient The unit detected either a shockable rhythm or a low heart rate DON T TOUCH PATIENT CHARG...

Page 65: ...ectrocardiogram 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 About ECG Monitoring on page 5...

Page 66: ...ctrode pads are in use the label SEMI AUTO appears above the right softkey WARNING An implanted pacemaker might cause the heart rate meter or ECG rhythm analysis to count the pacemaker rate during inc...

Page 67: ...al 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 T...

Page 68: ...t 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 pa...

Page 69: ...he adhesive side of each ECG electrode firmly to the patient s skin pressing around the entire perimeter of the electrode 6 Plug the ECG cable into the patient cable connector on the unit Note Arrange...

Page 70: ...ton to turn on the unit The unit starts up and the screen displays MONITOR as the current mode 3 Allow the unit to monitor the patient s ECG If it detects a shockable rhythm while monitoring the unit...

Page 71: ...hapter 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 P...

Page 72: ...ng 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 ar...

Page 73: ...sistant 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...

Page 74: ...er to Setting Up Data Communications with an IrDA Connection on page 6 4 Step Action Result 1 If the unit is on press and hold the On Off button for 1 second to turn off the unit Wait until the messag...

Page 75: ...cation 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 installa...

Page 76: ...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...

Page 77: ...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 softk...

Page 78: ...u 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 trans...

Page 79: ...unit to a personal computer use RescueNet Code Review software With this software you can Transfer patient data from the AED Pro unit to a personal computer Access and review patient case data Add or...

Page 80: ...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 operati...

Page 81: ...putting the unit into service and after each clinical use This chapter contains the following sections General Troubleshooting on page 7 2 ECG Monitoring Troubleshooting on page 7 4 Defibrillator Trou...

Page 82: ...hutdown 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 resolv...

Page 83: ...le is connected but the unit is not configured for ECG monitoring Check the cable and replace if necessary Message RELEASE LEFT SOFTKEY or RELEASE RIGHT SOFTKEY A softkey was pressed for more than 10...

Page 84: ...ectrodes properly prepare the patient s skin refer to 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 pul...

Page 85: ...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...

Page 86: ...unit and ECG cables with a soft damp cloth using any of the following cleaning agents Soap and water Chlorine bleach solution 30 milliliters per liter of water 90 isopropyl alcohol The AED Pro unit an...

Page 87: ...simulator to send a VF rhythm to the AED Pro unit 5 After the sequence of patient assessment prompts verify that the unit does the following Issues the voice and text prompt DON T TOUCH PATIENT ANALY...

Page 88: ...e 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 min...

Page 89: ...ns the following sections Device Specifications on page A 2 Battery Pack Specifications on page A 5 Guidance and Manufacturer s Declaration Electromagnetic Emissions on page A 6 Rectilinear Biphasic W...

Page 90: ...sing 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 ing...

Page 91: ...nge 10 to 300 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...

Page 92: ...igeminy Figure A3 59 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...

Page 93: ...anganese Dioxide Type Disposable sealed lithium manganese dioxide Weight 0 4 kg 0 9 lb Nominal voltage 12 V Operating time For a new fully charged battery pack at 20 C 300 defibrillator discharges at...

Page 94: ...lectromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The ZOLL AED Pro unit uses RF energy for its internal function only Therefore its RF emissions are very low and are not likely to caus...

Page 95: ...tive 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...

Page 96: ...61000 4 3 10 V m 80 MHz to 2 5 GHz 10 V m d 1 20 80 MHz to 800 MHz d 2 30 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manu...

Page 97: ...00 12 00 23 00 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be determined using the equation applicable to the frequency of the...

Page 98: ...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 Table A 2 Rectilinear Biphasi...

Page 99: ...linear Biphasic Waveforms at 150 Joules Figure A 3 Rectilinear Biphasic Waveforms at 120 Joules 25 50 75 100 125 150 175 30 25 20 15 10 5 0 5 10 15 20 25 30 35 0 2 4 6 8 10 12 14 16 18 20 A ms 25 20 1...

Page 100: ...ar Biphasic Waveforms at 70 Joules Figure A 6 Rectilinear Biphasic Waveforms at 50 Joules 20 15 10 5 0 5 10 15 20 25 0 2 4 6 8 10 12 14 16 18 20 25 50 75 100 125 150 175 ms A 20 15 10 5 0 5 10 15 20 2...

Page 101: ...l 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 signific...

Page 102: ...uired 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 Th...

Page 103: ...ately 9 seconds and proceeds as follows Divides the ECG rhythm into 3 second segments Filters and measures noise artifact and baseline wander Measures baseline content waviness at the correct frequenc...

Page 104: ...nn 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 Table A 5 Clinical Performance Results...

Page 105: ...ut 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 Achieving...

Page 106: ...tive 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...

Page 107: ...re not Establish a system for visually indicating whether a battery pack requires charging or is charged and ready for use ZOLL can provide battery pack status labels for this purpose or you can use l...

Page 108: ...ss 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 testin...

Page 109: ...ings 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 compute...

Page 110: ...tones High default Medium Low Number of Patient Records Sets the number of patients for whom information will be stored in nonvolatile flash memory 1 2 3 4 default Audio Recording Enabled Enables the...

Page 111: ...rgy Note This value cannot be less than the value selected for the second pediatric shock 50 J 70 J 85 J default Enable Lay Rescuer When this option is checked On the unit issues the following voice a...

Page 112: ...default 15 seconds 20 seconds Press Treatment Shock Selects the wording for this and related prompts Press Flashing Treatment Button Press Flashing Shock Button default CPR CPR Monitoring When this op...

Page 113: ...definately and displays the ANALYZE softkey You must press the ANALYZE softkey to move to analysis 30 seconds 60 seconds 90 seconds 120 seconds default 150 seconds 180 seconds Extended Analyze Key Ena...

Page 114: ...CPR Start CPR default Start Compressions If no Pulse Start Compressions If no Circulation Start Compressions Continue CPR When you select one of the prompts in the Possible Values column that prompt...

Page 115: ...tinue Compressions If no Circulation Continue Compressions Delays Continue CPR Delay Allows you to set the inverval between Continue CPR prompts 5 seconds 10 seconds default 15 seconds Push Harder Del...

Page 116: ...o 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 When this option is...

Page 117: ...ECG monitoring mode the unit issues the prompt CHECK PATIENT if the patient heart rate falls below this number of beats per minute 0 30 default 35 45 50 55 60 65 75 80 85 90 100 Patient Impedance Arch...

Page 118: ...AED PRO OPERATOR S GUIDE 9650 0350 01 Rev J ZOLL AED Pro Operator s Guide C 10 This page intentionally left blank...

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