LIFEPAK 500 ® Automated External Defibrillator Operating Instructions
OPERATING INSTRUCTIONS LIFEPAK® 500 Automated External Defibrillator
IMPORTANT This instrument is to be used by authorized personnel only. Responsibility for Information It is the responsibility of our customers to ensure that the appropriate person(s) within their organization have access to this information, including general safety information provided in Section 1. Revision History These operating instructions describe LIFEPAK 500 devices with the monophasic defibrillation waveform (software version 5.
TABLE OF CONTENTS Preface About Defibrillation .......................................................................................................................... x Operator Considerations ................................................................................................................. x Indications for Use ...........................................................................................................................
3 Using the LIFEPAK 500 AED Warnings and Cautions ................................................................................................................ 3-2 Preparing the AED for Operation.................................................................................................. 3-2 AED Operation ............................................................................................................................. 3-3 AED Prompts.......................................................
LIST OF FIGURES Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 LIFEPAK 500 AED controls, indicators, and connectors ...................................................... 2-2 Accessories for the LIFEPAK 500 AED................................................................................. 2-4 Battery installation ................................................................................................................. 2-5 Setup transfer connections.........................................
LIST OF TABLES Table 2-1 Table 2-2 Table 2-3 Table 2-4 Table 2-5 Controls, Indicators, and Connectors ...................................................................................... 2-2 Accessories for the LIFEPAK 500 AED ................................................................................... 2-4 MODEM PHONE NUMBER Dial String Characters .................................................................... 2-7 MODEM SELECTION Numbers.......................................................
Preface PREFACE About Defibrillation Operator Considerations Indications for Use Features of the LIFEPAK 500 Automated External Defibrillator Text Conventions Declaration of Conformity LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Preface ABOUT DEFIBRILLATION Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias. A direct current defibrillator applies a brief, high-energy pulse of electricity to the heart muscle. The LIFEPAK® 500 automated external defibrillator (AED) delivers this energy through disposable defibrillation electrodes applied to the patient's chest. Defibrillation is only one aspect of the medical care required to resuscitate a patient with a shockable ECG rhythm.
Preface Preface FEATURES OF THE LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR The optional and configurable features of the LIFEPAK 500 AED are designed to meet a variety of protocol needs. Authorized operators of this AED should always use the AED in accordance with local protocols. Defibrillation Waveform The LIFEPAK 500 AED is available with one of two defibrillation waveforms: monophasic or biphasic. For a description of each defibrillation waveform, refer to page 5-14 and page 5-17.
Preface Data Management The LIFEPAK 500 AED digitally records patient data, including ECG rhythm and delivered shocks. A digital audio recording of scene activity is available as an option. Recorded data may be transferred by direct connection to a printer or computer or by a modem to a remote computer. Three optional, Microsoft® Windows®-compatible data management software programs are available. The Data Transfer 500™ program transfers, stores, and prints AED reports.
Preface Preface DECLARATION OF CONFORMITY according to EN 45014 Manufacturer’s Name: Medtronic Physio-Control Corp. Manufacturer’s Address: 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706 USA declares that the CE-marked product Product Name: LIFEPAK® 500 automated external defibrillator Model Number: 3005400 (monophasic) 3011790 (biphasic) complies with 93/42/EEC (Medical Device Directive) Class Ilb, conformity assessed per Annex II.
Preface DECLARATION OF CONFORMITY Ault, Incorporated 7300 Boone Avenue North Minneapolis, MN 55428-1028 U.S.A.
1 1-0 1-0 SAFETY INFORMATION 1 Safety Information This section provides important information to help you operate the LIFEPAK 500 automated external defibrillator (AED). Familiarize yourself with all of these terms, warnings, and symbols. Terms General Warnings and Cautions Symbols LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Safety Information TERMS The following terms are used either in this manual or on the LIFEPAK 500 AED: Danger: Immediate hazards that will result in serious personal injury or death. Warning: Hazards or unsafe practices that could result in serious personal injury or death. Caution: Hazards or unsafe practices that could result in minor personal injury, product damage, or property damage. GENERAL WARNINGS AND CAUTIONS The following section provides general warning and caution statements.
Safety Information WARNINGS! Possible improper device performance. Using other manufacturers’ cables, electrodes, or batteries may cause the device to perform improperly and invalidates the safety agency certification. Use only the accessories specified in these Operating Instructions. Safety risk and possible equipment damage. Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials.
Safety Information Pb Rechargeable battery: recycle battery Battery Charger: green LED indicates power is on Battery Charger: battery is charging; amber LED indicates fast charge, green LED indicates trickle charge Indoor use only Safety Class II equipment (reinforced insulation) Data Cable: to printer Data Cable: to PC Data Cable: to modem IOIOIO Setup transfer cable LOT Lot code Expiration date REF Reorder number Do not reuse - single use only 0123 Mark of conformity according to the European M
2 2-0 2-0 GETTING READY This section provides a basic orientation to the LIFEPAK 500 automated external defibrillator (AED) and describes how to prepare the AED for use. LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Getting Ready UNPACKING AND INITIAL INSPECTION Remove the LIFEPAK 500 AED from the shipping container. Examine the AED and accessories for any sign of damage during shipping. Make sure that all the required supplies and accessories, including electrodes and batteries, are present. Save the shipping container and foam inserts for use in reshipping the AED. CONTROLS, INDICATORS, AND CONNECTORS Figure 2-1 and Table 2-1 provide an overview of the LIFEPAK 500 AED controls, indicators, and connectors.
Getting Ready 3 4 Orange SHOCK button delivers energy. The LED flashes to prompt the operator to press SHOCK when the AED is fully charged.
Getting Ready 18 15 20 16 21 19 22 17 Figure 2-2 Accessories for the LIFEPAK 500 AED Table 2-2 Accessories for the LIFEPAK 500 AED 15 LIFEPAK 500 nonrechargeable lithium battery pak Provides power for the LIFEPAK 500 AED. 16 LIFEPAK 500 rechargeable SLA battery pak Provides power for the LIFEPAK 500 AED. The SLA (Sealed Lead-Acid) battery pak is recharged by the battery charger listed below. 17 QUIK-COMBO electrodes Allow delivery of therapy to the patient.
Getting Ready ABOUT BATTERIES Use either of the following battery types to power the LIFEPAK 500 AED: • LIFEPAK 500 rechargeable sealed lead-acid (SLA) battery pak • LIFEPAK 500 nonrechargeable lithium sulfur dioxide (LiSO2) battery pak • LIFEPAK 500 nonrechargeable lithium manganese dioxide (LiMnO2) battery pak To save battery life if the LIFEPAK 500 AED is accidentally turned on or left on, the AED has a battery conservation feature.
Getting Ready Low Battery Detection Whenever the LIFEPAK 500 AED is turned on after it has been off for at least 60 seconds, it takes about 10 seconds to complete a self-test and to indicate a low or replace battery condition. The AED monitors the battery power level and indicates when the battery should be replaced: Indicator illuminates on the device key panel and appears on the Readiness Display and the LOW BATTERY message displays on the LCD; battery is low.
Getting Ready DEFINING SETUP OPTIONS The following paragraphs describe the setup options that define some of the operating features for the LIFEPAK 500 AED. The user should become thoroughly familiar with the operating features particular to their LIFEPAK 500 AED. Device ID The DEVICE ID option assigns a unique identifier that is printed at the top of each report. Up to 20 characters with any combination of displayable characters can be used.
Getting Ready Number Modem Type 5 US Robotics Courier V.Everything US Robotics 56K Fax Modem (Sportster) * You must specify the modem initialization string in the MODEM INIT STRING option. Note: The selection of commercially available modems changes rapidly. For more information or assistance regarding compatible modems, contact Medtronic Physio-Control Technical Support. In the USA call 1-800-442-1142. Outside the USA, contact your local Medtronic Physio-Control representative.
Getting Ready Display Energy The DISPLAY ENERGY option determines whether or not the energy of the last shock is displayed during use. The factory default setting is ON. Auto Analyze The AUTO ANALYZE options are OFF, 1, or 2. AUTO ANALYZE OFF: The operator must press ANALYZE to start every analysis. AUTO ANALYZE 1: The second and third rhythm analyses of each three-shock set start automatically without requiring the operator to press ANALYZE.
Getting Ready CPSS during CPR The CPSS DURING CPR option determines whether or not Continuous Patient Surveillance System (CPSS) is active during CPR Time. The factory default setting is OFF. If the CPSS DURING CPR option is ON, the AED “watches” for potentially shockable ECG rhythms (e.g., refibrillation) throughout CPR Time. When CPSS detects a potentially shockable ECG rhythm, the AED prompts PUSH ANALYZE, and CPR is temporarily interrupted while the user stays clear of the patient during the analysis.
Getting Ready Incident ID An INCIDENT ID number can be entered prior to transferring patient data to a computer through a modem. You can use up to 20 characters with any combination of displayable characters. The factory default setting is OFF. Audio Alert The AUDIO ALERT option determines whether or not an audible tone sounds when the automatic self-test detects a low battery condition or a condition that requires service. The factory default setting is OFF.
Getting Ready CHANGING SETUP OPTIONS To change the setup options: 1 Make sure the LIFEPAK 500 AED power is off for at least 60 seconds and that nothing is connected to the AED. buttons. Then, 2 If the LIFEPAK 500 AED has an ANALYZE button, hold down the ANALYZE, ▲, and until the SETUP MODE message appears. press ON/OFF. Do not release ANALYZE, ▲, and If the LIFEPAK 500 AED does not have an ANALYZE button, hold down the blank “menu” button (located between the ON/OFF and SHOCK buttons), ▲, and buttons.
Getting Ready 8 Press ANALYZE (or blank “menu” button) to advance to the ENERGY SEQUENCE screen. If the AED has a monophasic defibrillation waveform, the following screen appears: ENERGY SEQUENCE #2-300 • Press the ▲ button to change the energy selection (choices are 200 and 300 joules). Note: Pressing ▲ after the highest energy setting will display the lowest possible energy setting.
Getting Ready 13 Press ANALYZE (or blank “menu” button) to advance to the CPR TIME 2 screen: CPR TIME 2 60 SEC • Press the ▲ button to change the setting (choices are 0, 15, 30, 45, 60, 90, 120, 180, and 999). 14 Press ANALYZE (or blank “menu” button) to advance to the PULSE PROMPT screen. (This screen appears only on AEDs distributed in the English language): PULSE PROMPT 2 • Press the ▲ button to change the setting (choices are 1 or 2).
Getting Ready 21 Press ANALYZE (or blank “menu” button) to advance to the AUDIO ALERT screen. (This screen appears only on AEDs distributed in the English language): AUDIO ALERT OFF • Press the ▲ button to change the setting (choices are ON/OFF). 22 Press ANALYZE (or blank “menu” button) to advance to the TRANSFER SETUP screen: TRANSFER SETUP TO SEND PUSH • To transfer the setup to another AED, refer to Transferring Setup to Another LIFEPAK 500 AED, which follows.
Getting Ready 3 Turn on the receiving AED and wait for CONNECT ELECTRODES message to appear. 4 Push the " button on the original AED to send the setup to the receiving AED. During setup transfer, the original AED displays the SENDING message. The receiving AED displays a blank screen. After the original AED successfully transfers the setup, it displays the SEND COMPLETE message. The receiving AED turns itself off, turns itself back on, and then displays the CONNECT ELECTRODES message.
3 Using the LIFEPAK 500 AED 3 3-0 3-0 USING THE LIFEPAK 500 AED This section describes how to use the LIFEPAK 500 automated external defibrillator (AED) for ECG analysis and defibrillation. The actual clinical procedures that you use may vary according to your local protocol.
Using the LIFEPAK 500 AED WARNINGS AND CAUTIONS WARNINGS! Shock hazard. This defibrillator delivers up to 360 joules of electrical energy. When discharging the defibrillator, do not touch the disposable therapy electrodes. Shock hazard. If a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person.
Using the LIFEPAK 500 AED To prepare for ECG analysis and defibrillation: 1 Verify that the patient is in cardiac arrest (the patient is unconscious, not breathing normally and shows no signs of circulation, e.g., no pulse, and/or no coughing, no movement). 2 Press ON/OFF to turn on the AED (the green LED will light). The CONNECT ELECTRODES message and voice prompt will occur until the patient is connected to the AED.
Using the LIFEPAK 500 AED WARNING! Possible interference with implanted electrical device. Defibrillation may cause implanted electrical devices to malfunction. Place therapy electrodes away from implanted devices if possible. Check implanted device function after defibrillation. Patients with Implanted Pacemakers If possible, place defibrillation electrodes away from the internal pacemaker generator. Treat this patient like any other patient requiring emergency care.
Using the LIFEPAK 500 AED 3 Using the LIFEPAK 500 AED WARNING! Possible misinterpretation of data. Do not analyze in a moving vehicle. Motion artifact may affect the ECG signal resulting in an inappropriate shock or no shock advised message. Motion detection may delay analysis. Stop vehicle and stand clear of patient during analysis. Possible misinterpretation of data. Do not move the AED during analysis.
Using the LIFEPAK 500 AED Subsequent Analysis Cycles If the option AUTO ANALYZE 1 or 2 is selected, the AED automatically analyzes the patient’s ECG rhythm after Shock #1 is delivered. If the AUTO ANALYZE option is off, the AED displays PUSH ANALYZE after Shock #1. (You will also hear the PUSH ANALYZE voice prompt and see the ANALYZE LED flash.) You must press ANALYZE to begin the analysis. The second analysis and shock sequence is the same as that described for Shock #1.
Using the LIFEPAK 500 AED At the beginning of CPR TIME, the AED first displays one of the following message sequences, depending on the PULSE PROMPT selected in Setup: 10:52 10:52 CHECK FOR PULSE or CHECK FOR SIGNS 10:52 OF CIRCULATION You will hear the corresponding voice prompt. The AED then alternately displays two messages.
Using the LIFEPAK 500 AED After CPR Time After CPR TIME, the AED displays one of the following message sequences, depending on the PULSE PROMPT selected in Setup: 10:52 10:52 CHECK FOR PULSE or CHECK FOR SIGNS 10:52 OF CIRCULATION You will hear the corresponding voice prompt.
Using the LIFEPAK 500 AED If the AED is configured with MOTION DETECTION OFF, the ECG analysis proceeds uninhibited by the presence of motion. There is no motion detected verbal or text prompt if motion is present during ECG analysis. Continuous Patient Surveillance System — Check Patient Alert The Continuous Patient Surveillance System (CPSS) is active immediately after the AED is turned on when the patient is connected, and after CPR time.
Using the LIFEPAK 500 AED PATIENT CARE TRANSFER TO A DIFFERENT DEVICE To transfer patient care between devices equipped with identical therapy cable connectors: 1 Turn off the device connected to the patient. 2 Leave the defibrillation electrodes on the patient; disconnect the electrodes from the therapy cable or the device. 3 Connect the therapy electrodes to the next device.
4 4-0 4-0 DATA MANAGEMENT 4 Data Management This section describes how to store and transfer LIFEPAK 500 automated external defibrillator (AED) data to a computer or a modem. Topics include: Overview of Data Storage and Retrieval Sending Data to a Computer by Modem Sending Data to a Computer by Direct Connection Sending Data to a Printer LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Data Management OVERVIEW OF DATA STORAGE AND RETRIEVAL Every time you use the LIFEPAK 500 AED on a patient, data is stored digitally inside the AED. This data allows post-incident review for quality control, training, and research purposes. Print or transfer this data as soon as possible to save the information. The following paragraphs describe how the LIFEPAK 500 AED stores and retrieves data.
Data Management The AED stores all data for the Current Patient (B). However, the AED only retains the Event Log and CODE SUMMARY data for the Previous Patient (A). Information Stored When Creating a New Patient Record When the AED creates a new patient record, the following occurs: • The AED stores all data for the newest patient record, Patient C (refer to Figure 4-3). Patient C is now the Current Patient. • The AED deletes the ECG and audio recording data for Patient B.
Data Management Overview of Data Retrieval There are three ways you can retrieve data from the LIFEPAK 500 AED: • Send the data to a computer by modem. • Send the data to a computer by direct connection. • Send the data to a printer. The AED does not delete data after it is transferred. Data is only deleted when new patient records are created. Table 4-1 describes the stored data and how you can retrieve it.
Data Management Required Resources at Destination Site Modem that supports the Hayes AT command set Personal Computer: – QUIK-VIEW 500 data review program or CODE-STAT Suite data management system – Microsoft Windows 3.1 or later for Data Transfer 500, and for QUIK-VIEW 500 if audio review is not needed. Microsoft Windows 95 for QUIK-VIEW 500 if audio review is needed – Microsoft Windows 95 or Windows NT 4.0 for CODE-STAT Suite 3.
Data Management 7 After a few seconds, you will see the message: TO SEND PUSH " • Press " to send the Current Patient. • Press ! to send the Previous Patient. • Press both " and ! to send the Current and Previous Patients. 8 If the incident ID option is ON and an Incident ID has not already been entered for the Current or Previous Patient, you will see the message: ENTER CURRENT [ or PREVIOUS] ID? YES • Press ANALYZE (or the blank “menu” button) to answer YES; or • Press ! to change to NO.
Data Management SENDING DATA TO A COMPUTER BY DIRECT CONNECTION These paragraphs describe the resources, equipment connections, and procedures required to send AED data to a computer by direct connection. Required Resources Table 4-3 summarizes the resources required to send data to a computer by direct connection.
Data Management 3 Turn off the AED and prepare it for the next patient use. Troubleshooting During Data Transfer If you cannot transfer data, refer to the application program operating instructions for troubleshooting information. SENDING DATA TO A PRINTER These paragraphs describe the resources, equipment connections, and procedures required to print AED data on a printer. Required Resources Table 4-4 summarizes the resources required to print AED data.
Data Management After the AED successfully completes the data transfer, it displays the SEND COMPLETE message. 6 Check that the LOW BATTERY indicator is not displayed. 7 Disconnect the Printer Cable. 8 Turn off the AED and prepare it for the next patient use. Troubleshooting During Printing If the data does not print, refer to Table 6-3 on page 6-4 for troubleshooting tips.
Data Management Event Log Report Patient ID No: Patient Name: Age Sex: Race: Software REV: 3005360-000 REV. 4.4 Configuration: 000000000 Incident ID No: Incident Date: 15MAY98 Operator ID No: Device Type: LIFEPAK 500 Device Serial No: 00001203 Device ID: RFD#6 25mm/SEC, 1.
Data Management CODE SUMMARY Report Incident ID No: Incident Date: 15MAY98 Operator ID No: Device Type: LIFEPAK 500 Device Serial No: 00001203 Device ID: RFD#6 25mm/sec, 1.0 cm/mV Patient ID No: Patient Name: Age: Sex: Race: Software REV: 3005360-000 REV.4.
Data Management CODE SUMMARY Report Incident ID No: Incident Date: 15MAY98 09:48:38 09:48:38 SEGMENT 1 ANALYSIS 2 09:48:44 NO SHOCK ADVISED 09:50:11 NONSHOCKABLE Patient ID No: Patient Name: 09:48:41 SEGMENT 2 NONSHOCKABLE CHECK PATIENT 09:50:11 CHECK PATIENT 09:50:13 09:50:13 SEGMENT 1 ANALYSIS 3 09:50:19 SHOCK ADVISED 09:50:44 CHARGE REMOVED SHOCKABLE 09:50:16 SEGMENT 2 SHOCKABLE PAGE 2 Figure 4-9 Example of CODE SUMMARY Report (cont.
Data Management CODE SUMMARY Report Incident ID No: Incident Date: 15MAY98 Patient ID No: Patient Name: ANALYSIS 4 SHOCKABLE 09:50:51 SEGMENT 3 NONSHOCKABLE 09:50:54 09:51:58 NO SHOCK ADVISED ANALYSIS 5 09:50:48 SEGMENT 2 NONSHOCKABLE 4 Data Management 09:50:45 09:50:48 SEGMENT 1 END OF REPORT PAGE 3 Figure 4-10 Example of CODE SUMMARY Report (cont.) LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Data Management Test Log Report Device Type: LIFEPAK 500 Device Serial No: 00001203 Device ID: RFD#6 Software REV: 3005360-000 REV .4.
5 5-0 5-0 MAINTENANCE This section describes how to perform operator-level maintenance and testing on the LIFEPAK 500 automated external defibrillator (AED). For troubleshooting information, refer to page 6-2. Topics in this section include: LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Maintenance MAINTENANCE AND TESTING SCHEDULING The LIFEPAK 500 AED performs an automatic self test every 24 hours. If the automatic self test detects a low battery condition or a condition that requires service, the monophasic AED activates an alarm; AEDs with a readiness display will change the indicators on the display and will not activate an alarm unless AUDIO ALERT is configured ON. It is important to place the AED where the alarm is likely to be heard and to periodically inspect the AED.
Maintenance Instruction Inspect for AEDs without a Readiness Display: With the battery installed, BATTERY OK press ON/OFF to turn on the SELF-TEST xx.xx message. AED. Illumination and display of each LED, all indicators, and all LCD segments. BATTERY LOW or REPLACE BATTERY SELF-TEST xx.xx Recommended Corrective Action None needed. Contact authorized service personnel to repair or replace parts. Replace the battery immediately. message. Service indicator or CALL SERVICE message.
Maintenance TESTING This section describes the AED automatic self tests and the test load test. If testing indicates a problem, refer to Troubleshooting on page 6-2. If you cannot correct the problem, remove the AED from active service and contact authorized service personnel. The AED stores the results of autotests and the external test load test in a Test Log. For information about retrieving Test Log data, refer to page 4-4.
Maintenance Note: If the battery has been adequately charged to deliver therapy, you will see OK on the Readiness Display and the BATTERY OK message on the LCD during the self-test. If the battery is low, you will see a battery indicator on the Readiness Display, an illuminated battery indicator on the device key panel, and the LOW BATTERY message on the LCD.
Maintenance External Test Load Test The external test load test checks the AED charging circuits and the operator’s response during a typical ECG analysis and charging cycle. During this test, the AED charges for a low energy test shock. The usual messages and audio prompts are provided. To perform the test load test: 1 Make sure that the AED is turned off. 2 Connect the Physio-Control test load to the cable connector on the AED.
Maintenance BATTERY MAINTENANCE The LIFEPAK 500 AED can be powered by two types of batteries: • LIFEPAK 500 nonrechargeable lithium sulfur dioxide (LiSO2) or lithium manganese dioxide (LiMnO2) battery pak • LIFEPAK 500 rechargeable sealed lead-acid (SLA) battery pak Note: Unless stated otherwise, references to nonrechargeable lithium apply to both LiSO2 and LiMnO2 battery technologies. Either type of battery may be installed.
Maintenance Capacity 100% 80% 60% 40% Low battery indicator on 20% New 1 2 3 4 5 Years Energy consumed by the device auto tests & battery self discharge Figure 5-2 Energy available to use to operate the device LiSO2 battery capacity over 5 years while installed in a LIFEPAK 500 AED at 20°C (68°F) A new lithium battery pak has a shelf life of 5 years if stored at the proper temperature. Although a lithium battery may be stored for up to 5 years, it self-discharges over time.
Maintenance Discharging Nonrechargeable Batteries Before disposing of lithium battery paks, make sure that they are fully discharged. To discharge a lithium battery pak, follow this procedure: 1 Place the battery pak with the label side up on a firm, flat surface such as a table top or floor.
Maintenance Capacity 100% 80% 60% 40% Low battery indicator on 20% New 2 1 3 Months Energy consumed by the device auto tests & battery self discharge Energy available to use to operate the device Figure 5-3 SLA battery capacity while installed in a LIFEPAK 500 AED for 3 months without recharging at 20°C (68°F) To properly maintain SLA battery paks: • Recharge after each use or once a month, whichever comes first. Maintain a battery recharge record.
Maintenance CAUTIONS! Possible battery damage. Recharge the battery until the battery charger charge LED is green. Undercharging can cause battery damage. Possible battery damage. Charging batteries outside the temperature range of 15° to 35°C (59° to 95°F) may cause improper charging and shorten battery life. Possible battery damage. Electrical connection between battery contacts can blow an internal fuse and permanently disable the battery.
Maintenance ELECTRODE STORAGE For information about defibrillation electrode storage, refer to the operating instructions for the FAST-PATCH and QUIK-COMBO electrodes. SERVICE AND REPAIR WARNING! Shock hazard. Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair.
Maintenance SUPPLIES, ACCESSORIES, AND TRAINING TOOLS Table 5-3 lists supplies, accessories, and training tools for the LIFEPAK 500 AED. For information about ordering, contact your local Medtronic Physio-Control representative. In the USA, call 1.800.442.1142.
Maintenance SPECIFICATIONS Table 5-4 lists the specifications for the LIFEPAK 500 AED (monophasic and biphasic). Table 5-5 lists the specifications for the LIFEPAK 500 AED Battery Charger. Table 5-4 LIFEPAK 500 AED Specifications1 AED Input ECG via QUIK-COMBO or FAST-PATCH disposable electrodes. Standard placement: anterior-lateral. Alternate placement: anterior-posterior. Electrical Protection Input protected against high voltage defibrillator pulses per IEC 60601/ EN 60601.
Maintenance Service Indicator Service icon. Displayed Messages Messages prompt user through complete operating sequence. Audible Tones Coded tones assist user through device operation and alert operator of display messages. Voice Prompts Prompt user through complete operation sequence. EVENT DOCUMENTATION Type Internal digital memory. Memory Capacity 20 minutes audio recording (optional).
Maintenance Shock MIL-STD-810E, Method 516.4, Procedure 1 (40 g, 6–9 ms pulse, 1/2 sine each axis). Vibration Monophasic version: MIL-STD-810E, Method 514.4, Category 10 Biphasic version: MIL-STD-810E, Method 514.4, Helicopter - Category 6 (3.75 Grms) and Ground Mobile - Category 8 (3.15 Grms). RTCA D0 160C, Table 8-2 Fixed Wing - Turbojet Engine Classification C’ (Fuselage). Test level per Figure 8-5 C’. One hour in each of three axes.
Maintenance Depth 29.5 cm (11.6 in) including handle. Weight 2.7 6kg (6.1 lb) without battery or electrodes (monophasic) 2.41 kg (5.3 lb) without battery or electrodes (biphasic). Defibrillation protected, type BF patient connection.
Maintenance Table 5-5 LIFEPAK 500 AED Battery Charger Specifications GENERAL Safety Classification Class II (double insulation), IEC 60601/EN 60601, 5.1 Input 100–240V 0.7–0.4A 50/60 Hz Output 9.9Vdc for 10 hours, 9.
Maintenance Ventricular Tachycardia Seventy-two episodes of ventricular tachycardia (VT), induced in 62 patients, were treated with randomized shocks. High rates of conversion were observed with biphasic and monophasic shocks. Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested.
6 Troubleshooting 6 6-0 6-0 TROUBLESHOOTING This section describes how to troubleshoot LIFEPAK 500 automated external defibrillator (AED) operating problems. This section also describes screen messages, voice prompts, and event types.
Troubleshooting TROUBLESHOOTING DURING PATIENT CARE Table 6-1 Troubleshooting During Patient Care Observation Possible Cause Corrective Action 1 CONNECT ELECTRODES message appears. Inadequate connection to AED. • Check for complete insertion of connector to AED. Electrode does not adhere properly to the patient. • Press electrodes firmly on patient’s skin. • Clean, shave, and dry the patient’s skin as recommended. Electrodes are dry, damaged, or • Replace the electrodes. out-of-date.
Troubleshooting Possible Cause Corrective Action SHOCK button not pressed within 15 seconds. • Press SHOCK within 15 seconds after the PUSH TO SHOCK message appears. 9 Displayed time is incorrect. Time is incorrectly set in the AED. • Change the AED time setting. 10 Date printed on report is incorrect. Date is incorrectly set in the AED. • Change the AED date setting. 11 Displayed messages are faint or flicker. Low battery power. Out of Temperature Range. • Replace the battery immediately.
Troubleshooting Observation Possible Cause Corrective Action 4 LOW BATTERY message or indicators appear on Readiness Display and key panel. Low battery. • If using AED, continue to use and replace battery at earliest convenience. Approximately 20% of battery energy remains. • If AED not is use, replace the battery immediately. 5 REPLACE Very low battery. • Replace battery immediately. BATTERY voice prompt or indicator on key panel flashes.
Troubleshooting Possible Cause Corrective Action Receiving AED failed to receive transmission. • Turn the receiving AED off and on with the Setup Transfer Cable connected. Table 6-5 LIFEPAK 500 AED Screen Messages Screen Message Description ANALYZING NOW The AED is analyzing the patient ECG rhythm. ASYSTOLE The AED has analyzed the patient’s ECG and detected persistent asystole. ASYSTOLE DETECTOR Setup mode message for asystole time option.
Troubleshooting Screen Message Description REPLACE BATTERY The battery voltage is very low. SELF-TEST XX.XX The self-test is being performed and software version xx.xx is installed. SEND COMPLETE The AED successfully transferred data. SENDING The AED is transferring the setup to another AED. SENDING XX% COMPLETE The AED is transferring data by modem or to a printer. The transfer is xx% complete. SETUP MODE nnnnnnnnnnnnnnnnnnn The AED is in the setup mode.
Troubleshooting 6 Troubleshooting Voice Prompt Description STAND CLEAR Move away and do not touch patient. STAND CLEAR, PUSH TO SHOCK The AED is fully charged and ready to provide therapy. This is the AED prompt to move everyone away from the patient, then press SHOCK to discharge.
A A-0 A-0 This section describes the basic function of the Shock Advisory System (SAS). LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
Shock Advisory System OVERVIEW OF THE SHOCK ADVISORY SYSTEM The Shock Advisory System (SAS) is an ECG analysis system built into the LIFEPAK 500 AED that advises the operator if it detects a shockable or nonshockable rhythm. This system makes it possible for individuals not trained to interpret ECG rhythms to provide potentially-lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia.
Shock Advisory System Table A-1 LIFEPAK 500 AED SAS Performance Table for Adult ECGs Rhythm Class Intermediate: fine VF ECG Test1 Sample Size Performance Goal2, 3 Observed Performance Sensitivity or Specificity [LCL]4 29 Report only 86.2% [74.3%] sensitivity 1. From Medtronic Physio-Control ECG database. Each sample is run 10 times asynchronously. Association for the Advancement of Medical Instrumentation. DF39-1993 Standard for Automatic External Defibrillators and Remote-Control Defibrillators.
Shock Advisory System Control of Shock Therapy Operator Control of Shock Therapy The Shock Advisory System causes the AED to charge automatically when it detects the presence of a shockable rhythm. When a shock is advised, the operator remains in control of when the shock is delivered.
B B-0 B-0 LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
® LIFEPAK 500 automated external defibrillator OPERATOR’S CHECKLIST Unit Serial No.: Location: Instruction This is a suggested checklist for inspecting and checking this device on a daily basis and after each use. You may also consult JAMA, August 22/29, 1990, Vol. 264, No. 8, Table 3 for the Defibrillator Working Group's automated defibrillator checklist. This form may be reproduced. Recommended Corrective Action Date Initials Insert a ✔ in the box after completing each instruction.
C B-0 B-0 Appendixes APPENDIX C FAST-PATCH DEFIBRILLATION CABLE INSTRUCTIONS FOR USE LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
FAST-PATCH® defibrillation cable for LIFEPAK® 500 automated external defibrillator Instructions for Use Introduction Cable Attachment To use FAST-PATCH disposable defibrillation/ ECG electrodes, the LIFEPAK 500 automated external defibrillator (AED) requires this FAST-PATCH defibrillation cable (see Figure 1). A lanyard is provided to help prevent loss of the defibrillation cable. (3.5 ft) To attach the lanyard: 1 Loop the lanyard around the AED connectorend of the cable (see Figure 2).
FAST-PATCH® defibrillation cable for LIFEPAK® 500 automated external defibrillator Instructions for Use (continued) Connecting to FAST-PATCH defibrillation/ECG electrodes Properly connect the defibrillation cable to the electrodes to help ensure energy delivery (see Figure 4). • Attach the cable to the electrode post before attaching electrodes to the patient. • Support the electrode post under the electrode when attaching the cable to the electrode.
D C-0 C-0 LIFEPAK 500 Automated External Defibrillator Operating Instructions ©1996–2003 Medtronic Physio-Control Corp.
QUIK-COMBO™ defibrillation cable for LIFEPAK® 500 automated external defibrillator Instructions for Use Introduction If using standard QUIK-COMBO pacing/ defibrillation/ECG electrodes (PN 806086) with the LIFEPAK 500 automated external defibrillator (AED), use the QUIK-COMBO defibrillation cable (PN 3011215) for additional length (see Figure 1). A. B.
QUIK-COMBO™ defibrillation cable for LIFEPAK® 500 automated external defibrillator Instructions for Use (continued) Cleaning and Testing Ordering Information To clean the QUIK-COMBO defibrillation cable, wipe the surface with any one of the following: Contact your local Medtronic Physio-Control sales or service office to order parts. In the USA, call the Medtronic Physio-Control PARTSLINE at 1.800.442.1142.
INDEX Overview of data storage and retrieval, 4-2 Preparing for use, 3-2 Printing reports, 4-8 Procedure for analysis and defibrillation, 3-3 Screen message definitions, 6-5 Service and repair guidelines, 5-12 Setup options, 2-7 Audio recording, 2-10 Auto analyze, 2-9 CPR time, 2-13 Device Configuration code, 2-12 Device ID, 2-7 Energy sequence, 2-12 How to change the options, 2-12 Modem phone number, 2-7 Modem selection, 2-7 Specifications, 5-14 Storage recommendations, 5-15 Supplies and accessories, 5-13
Index Battery charger, General description, 2-4 Battery maintenance, 5-7 Nonrechargeable battery pak, 5-7 Rechargeable Battery Pak, 5-9 C Cable Connector Types of possible connections, 2-3 Call service message, 5-3 Carrying case, General description, 2-4 Cautions Definition, 1-2 General caution, 1-3 Charging battery, 5-11, 5-14 Cleaning the AED, 5-3 Clock Changing the time and date, 2-6 Transferring setup information, 2-15 Code for device configuration, 2-12 CODE SUMMARY Report Description, 4-9 Example, 4-
Index Preparing the AED for use, 3-2 Previous Patient Record, Definition, 4-2 Printed reports, Examples, 4-9 Printer Connection, 4-8 Type required, 4-8 Printer cable Connection, 4-8 General description, 2-4 Printing reports, 4-8 Procedure for analysis and defibrillation, 3-3 PULSE PROMPT screen, 2-14 PULSE PROMPT setup option, 2-9 Pushbutton descriptions, 2-2 N No shock advised response, 3-6 Nonrechargeable battery pak Discharging, 5-9 Disposing, 5-9 General description, 2-4 Maintenance, 5-7 R Rechargeab
Index Daily auto test, 5-5 Extended auto test, 5-5 Self test at power-on, 5-4 Service indicator and message, 5-5 Test load test, 5-4, 5-6 Text conventions, xii Time/date setting, 2-6 Transfer setup feature.
Medtronic Physio-Control 11811 Willows Road Northeast Post Office Box 97006 Redmond, WA 98073-9706 USA Telephone: 425.867.4000 Toll Free (USA only): 800.442.1142 Fax: 425.867.4121 Internet: www.physiocontrol.com www.medtronic.com Medtronic Europe S.A. Medtronic Physio-Control Rte. du Molliau 31 Case postale 84 1131 Tolochenaz Switzerland Telephone: 41.21.802.7000 Fax: 41.21.802.
