ZOLL AED 3, Administrator'S Manual

Page 1: ...Administrator s Guide 9650 000752 01 Rev D...

Page 2: ...CPR Uni padz CPR D padz Pedi padz Real CPR Help Rectilinear Biphasic RescueNet Stat padz ZOLL and ZOLL AED 3 are trademarks or registered trademarks of ZOLL Medical Corporation in the United States an...

Page 3: ...is 4 Transferring Files Using a USB Flash Drive 4 Wi Fi Communication 4 ZOLL AED 3 Operation 5 Operating Controls and Indicators 5 Graphical Display Area 6 AED Management Mode 6 Rescue Mode 7 Audio Pr...

Page 4: ...bility Guidance 36 Rectilinear Biphasic Waveform Characteristics 40 ECG Analysis Algorithm Accuracy 45 Clinical Performance Results 46 Wireless Output Guidance and Manufacturer s Declaration 48 RF Tra...

Page 5: ...the following sections Chapter 1 Overview describes a general product overview of the ZOLL AED 3 defibrillator Chapter 2 Data Transfer provides instructions on how to transfer data that is stored on t...

Page 6: ...21 CFR 821 requires the tracking of defibrillators As an owner of this defibrillator you have the responsibility under this law to notify ZOLL Medical Corporation if this product has been received lo...

Page 7: ...ment or the nearest ZOLL sales office or distributor Telephone 1 978 421 9655 Toll free 1 800 348 9011 Fax 1 978 421 0010 Email techsupport zoll com Have the following information available for the Te...

Page 8: ...fice or authorized distributor For a list of ZOLL offices please visit http www zoll com contact worldwide locations Software Licensing Statement Certain software components referred to herein as Open...

Page 9: ...rillation pads The defibrillation pads include an intelligent CPR sensor that allows the AED to monitor chest compressions and provide feedback during CPR This guide contains instructions for all ZOLL...

Page 10: ...ng modes AED Management Mode and Rescue Mode In AED Management Mode the icons on the touch screen allow you to change configuration settings and upload clinical archives device history and configurati...

Page 11: ...tor is compatible with the following adult and child defibrillation pads CPR Uni padz for adults and children CPR D padz for adults only CPR Stat padz for adults only Stat padz II for adults only Pedi...

Page 12: ...t Code Review software or view online with ZOLL RescueNet Case Review requires ZOLL Online account and ZOLL AED 3 device to transmit clinical event data over Wi Fi Device history A log of device statu...

Page 13: ...est and is ready for use A blank window indicates that the AED has failed its self test and is not ready for use Speaker Provides audio prompts and metronome beeps that direct rescuers on what to do d...

Page 14: ...tment Contains a connection for a USB flash drive when importing or exporting files to or from the AED Battery Compartment Holds the battery pack used to power the AED Carrying Handle The strap design...

Page 15: ...plays the depth of chest compressions measured while the rescuer is performing CPR Indicator lines are displayed in the bar graph at 5 and 6 centimeters of compression depth and provide reference poin...

Page 16: ...hythm optional Displays the current ECG waveform User Prompt Displays a visual message on the screen while simultaneously issuing an audio prompt Event Elapsed Time Indicates the amount of time that h...

Page 17: ...s been changed PLUG IN PADS CABLE Ensure that the defibrillation cable is properly connected to the ZOLL AED 3 defibrillation connector ATTACH CORRECT DEFIB PADS Pads that are connected to the AED are...

Page 18: ...DS TO PATIENT S BARE CHEST Attach defibrillation pads to the patient s bare chest ATTACH PADS TO CHILD S BACK AND CHEST Attach defibrillation pads to child s bare back and chest as shown DON T TOUCH P...

Page 19: ...pt may also be issued if Real CPR Help fails to detect chest compressions at least 2 centimeters deep ANALYSIS HALTED KEEP PATIENT STILL ECG rhythm analysis has been halted due to excessive ECG signal...

Page 20: ...12 ZOLL AED 3 Administrator s Guide 9650 000752 01 Rev D...

Page 21: ...n settings using a USB flash drive This allows you to quickly and easily update software or copy a configuration to multiple AEDs In order to transfer data the ZOLL AED 3 defibrillator must be in AED...

Page 22: ...ing ECG audio BLS model and clinical event data When the AED is configured to store two cases and a clinical event is detected in rescue mode the AED deletes the oldest of the two previously stored ca...

Page 23: ...the Device Configuration icon to enter AED Management mode 2 If you are transferring data Using a wireless connection go to step 3 Using a USB flash drive insert the flash drive into the USB connecto...

Page 24: ...ng Case Review Software Case Review software is a cloud based clinical data management and quality reporting system that is hosted in ZOLL Online Using its Wi Fi capability the ZOLL AED 3 can be confi...

Page 25: ...drive into the USB connector on the back of the AED 2 Press and hold the On Off button for more than 5 seconds Once the USB flash drive has been detected the USB device icon appears in the status bar...

Page 26: ...HIS PROCESS THIS MAY TAKE UP TO 5 MINUTES DO NOT POWER OFF DURING THIS TIME Root Certificates Select a root certificate s Press OK When the AED has finished transferring data it issues the prompt SELE...

Page 27: ...again THE REQUESTED FILE IS CORRUPTED UNABLE TO IMPORT The AED cannot import the file from the USB flash drive Verify that the file is valid and try the import operation again THE REQUESTED FILE CANNO...

Page 28: ...mended Action UPON COMPLETION OF THE SOFTWARE UPGRADE THE SYSTEM WILL RESTART THE SCREEN WILL GO BLANK DURING THIS PROCESS THIS MAY TAKE UP TO 5 MINUTES DO NOT POWER OFF DURING THIS TIME AED is perfor...

Page 29: ...an be performed on the AED This section of the guide contains information about functions that are performed with each self test as well as procedures for maintaining the ZOLL AED 3 device Self Tests...

Page 30: ...iration dates ECG Circuitry Tests that the ECG signal acquisition and processing electronics are functional Defibrillator Charge and Discharge Circuitry Verifies that the device s defibrillator electr...

Page 31: ...st Automatic Monthly Test Battery Capacity Defibrillation Pads Connection Defibrillation Pads Battery Expiration ECG Circuitry Defibrillator Charge and Discharge Circuitry 2 Joule Charge Discharge Tes...

Page 32: ...chlorine bleach and water mixture 30 ml liter water to clean the defibrillator except on the contacts and connectors NOTE Wipe down the defibrillator with water after using any cleaning solution Chlo...

Page 33: ...UNIT OK voice prompt and displays the message within 5 seconds after power up The AED displays the number of shocks in the bottom left of the screen and the event elapsed time since power up in the bo...

Page 34: ...the event elapsed time since power up in the bottom right of the LCD screen 3 Using the simulator input a VF rhythm to the AED Verify that after the AED proceeds through its sequence of victim assess...

Page 35: ...window no green check indicating that the battery is at low capacity or that the ZOLL AED 3 defibrillator has failed other self tests Table 5 Battery Conditions Battery Icon Condition Indications Corr...

Page 36: ...28 ZOLL AED 3 Administrator s Guide 9650 000752 01 Rev D...

Page 37: ...does not help you resolve the problem call the ZOLL Technical Service Department for assistance For contact information refer to page v Troubleshooting the AED The following table lists issues that m...

Page 38: ...button for at least 5 seconds to perform a self test Verify that a green check appears in the status indicator window If the AED continues to beep remove it from service and contact ZOLL Technical Ser...

Page 39: ...chnical Service ATTACH CORRECT DEFIB PADS Attach one of the following compatible defibrillation pads to the AED CPR Uni padz CPR D padz CPR Stat padz Pedi Padz II child pads Stat padz II If the messag...

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Page 41: ...60601 1 Design Standards Meets applicable requirements of EN 60601 1 IEC 60601 1 11 EN 60601 2 4 Environment Operating Temperature 32 to 122 F 0 to 50 C Storage Temperature 22 to 158 F 30 to 70 C Humi...

Page 42: ...from power on to AED charged and ready to shock at 200J 36 seconds Electrodes CPR Uni padz CPR D padz CPR Stat padz Stat padz II or Pedi padz II Built in Defibrillator Self Test Included verifies prop...

Page 43: ...perating Time Clinical Mode Typical new battery running at an ambient temperature of 20 C to 25 C 68 F to 77 F can provide 140 defibrillator discharges at maximum energy 200 joules or 6 hours of conti...

Page 44: ...Electromagnetic environment guidance RF emissions CISPR11 Group 1 The AED uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer...

Page 45: ...ot applicable Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30...

Page 46: ...OTE 2 At 80 MHz the higher frequency range applies NOTE 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects...

Page 47: ...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 d in metres m can be determined using the e...

Page 48: ...charged into 25 ohm load Discharged into 50 ohm load Discharged into 100 ohm load Discharged into 125 ohm load First Phase Maximum Initial Current 32 A 26 A 21 A 17 A First Phase Average Current 28 A...

Page 49: ...rrents voltages and essentially the same mechanisms for controlling defibrillation waveshape the AED Pro and ZOLL AED 3 defibrillation waveforms are considered substantially equivalent Figures 1 throu...

Page 50: ...s the duration in milliseconds ms Figure 1 Rectilinear Biphasic Waveforms at 200 Joules Figure 2 Rectilinear Biphasic Waveforms at 150 Joules 25 50 75 100 125 150 175 30 25 20 15 10 5 0 5 10 15 20 25...

Page 51: ...ctilinear Biphasic Waveforms at 120 Joules Figure 4 Rectilinear Biphasic Waveforms at 85 Joules 20 15 10 5 0 5 10 15 20 25 30 0 2 4 6 8 10 12 14 16 18 20 ms A 25 50 75 100 125 150 175 20 15 10 5 0 5 1...

Page 52: ...5 Rectilinear Biphasic Waveforms at 70 Joules Figure 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 15 10 5 0 5 10...

Page 53: ...the accuracy of the ECG analysis algorithm as tested against ZOLL s ECG Rhythm Database The algorithm sequence takes approximately six to nine seconds and proceeds as follows Divides the ECG rhythm i...

Page 54: ...ty Coarse VF Rapid VT 536 80 90 75 99 98 99 94 Non shockable Specificity NSR AF SB SVT Heart block idioventricular PVCs Asystole 2210 819 115 99 95 95 99 99 99 99 99 97 Intermediate Fine VF Other VT 6...

Page 55: ...arrest that has been incorrectly classified as non shockable Table 11 Rhythm Recognition Detector Categories Pediatric Patients A true positive 121 is a correct classification of a shockable rhythm A...

Page 56: ...peration The user is cautioned to maintain 20 cm 8 inches of space from the product to ensure compliance with FCC requirements Canada Industry Canada IC Notices Contains Model ConnectCardTM for i MX28...

Page 57: ...ecified in this appendix may result in increased emissions or decreased immunity of the ZOLL AED 3 defibrillator Accessory REF Defibrillation Pads CPR Uni padz 8900 000260 CPR D padz 8900 0800 01 CPR...

Page 58: ...66 Strobe for Standard Surface Wall Cabinet 8000 001259 Strobe for Semi Fully recessed Wall Cabinet 8000 001267 Wall Signs ILCOR Flush Wall Sign AED 8000 001260 ILCOR 3D Wall Sign AED 8000 001261 ILCO...

Page 59: ...e are two levels of configuration settings user and supervisor The supervisor settings are indicated by the Supervisor Access icon You need a pass code to access these advanced settings the default pa...

Page 60: ...pre attached to the patient these prompts are not issued ON OFF default CPR Depth Measure Units Note This setting is also available to the Supervisor user Allows you to set the CPR depth measurement...

Page 61: ...antic including the east coast of Brazil Azores UTC Western Europe Central Europe Namibia Algeria Eastern Europe Egypt Lebanon Syria Kaliningrad Iraq Moscow Arabia Iran Samara Afghanistan Western Asia...

Page 62: ...ecording ZOLL AED 3 BLS model only Enables audio recording during Rescue Mode ON OFF default Device Display ZOLL AED 3 BLS model only Allows you to select information displayed on the LCD screen durin...

Page 63: ...new Device History Configuration Import Files You can download files from a USB flash drive to the AED Configuration System Software Root Certificates Supervisor Setting Description Values Adult Energ...

Page 64: ...tart with CPR Period Sets the duration of the Start with CPR period once defibrillation pads are attached to the patient Off 30 seconds 60 seconds default 90 seconds 120 seconds 150 seconds 180 second...

Page 65: ...tificate in your documentation folder for instructions on how to register for AED Program Management You can also automatically configure the Wi Fi settings for the AED by downloading a configuration...

Page 66: ...e applicable information in the following fields Network SSID Press the wireless button to the right of this field to search for available wireless networks Select a network from the list and press OK...

Page 67: ...y in the Network Settings window Go to step 5 to enter the static information 5 You can either keep all of the displayed default settings and press OK or you can enter information in the following fie...

Page 68: ...account 8 Press OK to save the Server settings 9 Press the Profile Settings icon and enter information in the following fields in the Profile Settings window Network SSID Use the alpha numeric keypad...

Page 69: ...and enter the applicable information in the following fields Network SSID Press the wireless button to the right of this field to search for available wireless networks Select a network from the list...

Page 70: ...x xxx xxx where xxx 000 255 Press OK Gateway IP Address Use the numeric keypad to enter your Gateway IP address format is xxx xxx xxx xxx where xxx 000 255 Press OK Subnet Mask Use the numeric keypad...

Page 71: ...rity See the table below for the next step based on the method you selected 10 Press OK to save the Profile settings 11 Press the Test Wi Fi button in the Device History Wi Fi window to test the serve...

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