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Philips Agilent Heartstream XL Defibrillator

1. X 13 8 Tie emma Array Printer eebe 13 9 leprae ui P 13 10 SPOOZ Pulse Duel ees 13 11 IT TEA eege 13 11 Environmental e 13 12 Symbol EE mt 13 14 Clinical Performance Summary Eugene cta Dad ani ehe eed Se ebegEe 13 19 Methods e H 13 19 D oj M C natiusee 13 19 eui MET 13 20 Safety ConstderationS E 13 21 Electromagnetic Compatibility sisceiecsscscpcasisiesnesastaveesascsnatasdennaesanshavanstouateasashavenvassenenessnnes 13 25 Reducing Electromagnetic Interference Lees etes tei etti ten ta RH dU ege eeu La 13 26 Restrictions Tor USE AH EiS 13 27 Mimunty Leye tT 13 27 xiv 1 Introduction The M4735A Heartstream XL Defibrillator Monitor is designed to meet your resuscitation and monitoring needs This guide provides instructions for safe and proper operation set up configuration and care of your M4735A Heartstream XL Defibrillator Monitor In this chapter you ll find general information that you should become famil iar with before using the defibrillator monitor M4735A Heartstream XL Defibrillator Monitor 1 1 Overview Overview The M4735A Heartstream XL Defibrillator Monitor is a lightweight porta ble semi automatic external defibrillator It offers two modes of operation for defibrillation e Automated
2. If the Heartstream XL is off for more than two minutes and turned on with no new event the data is saved The Continued Use feature allows you to change batteries or shut the Heart stream XL off briefly for 2 minutes or less while preserving the current patient record Events recorded after the power interruption are appended to the patient record Continued use also preserves alarm settings Storing Retrieving amp Printing Printing the Internal Event Summary Printing the Internal Event Summary To print the internal Event Summary press Summary To stop printing before the complete summary is printed press again or press Ca The Event Summary includes the following information in the order listed e aheader with a place for you to write in the patient s name and the operator s name e a directory list of events that occurred during the incident and the time of their occurrence e ECG strips of the events in the directory list where relevant Figure 9 2 shows the beginning of an Event Summary Figure 9 2 Event Summary Patient Device On 12 41 00 AED Mode 12 41 00 Operator Pads On 12 41 01 Leads On 12 41 03 Device On 03Jan00 12 41 00 Analyzing 12 41 03 Shock Advised 12 41 11 Last Event 03 Jan 00 01 09 04 Sheek 1 12 41 17 Analyzing 12 41 24 Total Shocks 2 Shock Advised 12 41 31 Incident 0000045 Shock 2 12 41 38 Serial Number 123456789 Manual Mode 12 41 42 M4735A Heartstream XL Defibrillator
3. Tel 800 548 8833 Canada Eastern Region Central amp Western Regions Tel 800 361 9790 Tel 800 268 1221 Other International Areas Australia France Tel 131147 Tel 0803 35 34 33 Germany Italy Tel 0130 4730 Tel 0292 122999 Netherlands United Kingdom Tel 0 20 547 6333 Tel 44 344 36633 Belgium Tel 32 2 778 35 31 Troubleshooting 13 Specifications amp Safety This section provides e Specifications for the Heartstream XL e Symbol definitions for symbols appearing on the Heartstream XL e Clinical Performance Summary data e Safety related information e Electromagnetic compatibility information M4735A Heartstream XL Defibrillator Monitor 13 1 Specifications Specifications Defibrillator Waveform Biphasic Truncated Exponential Waveform parameters adjusted as a function of patient impedance Shock Delivery Via multi function defib electrode pads or paddles Delivered Energy Accuracy Delivered Energy LIN Load p rigen Accuracy 25 150 ar Cea maf EIE L3 a wa 104 EE EES l 26 2 382 TEN 65 4 73 1 75 0 72 8 15 100 93 5 104 7 107 2 104 4 15 140 3 156 8 161 0 166 6 156 m 1er Le 99s aas 2088 1s Charge Time Less than 3 seconds to 200 Joules with a new fully charged M3516A SLA battery pack at 25 C Less than 15 seconds to 200 Joules when powered by AC with n
4. A medical device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC with and without the appropriate accessories has been performed according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 The EMC standards describe tests for both emitted and received interference Emission tests deal with interference generated by the device being tested Radio frequency RF interference from nearby transmitting devices may degrade performance of the M4735A Heartstream XL Defihrillator Monitor Electromagnetic compatibility with surrounding devices should be assessed prior to using the detihrillator 13 M4735A Heartstream XL Defibrillator Monitor 13 25 Electromagnetic Compatibility Reducing Electromagnetic Interference The M4735A Heartstream XL Defibrillator Monitor and associated accessories are susceptible to interference from other RF energy sources and continuous repetitive power line bursts Examples of other sources of RF interference are medical devices cellular products information technology equipment and radio television transmission Should interference be encountered as demonstrated by artifact on the ECG or dramatic variations in SpO2 values attempt to locate the source Assess s the interference intermittent or constant Does the interference occur only in ce
5. Lead Heart Rate and Heart Rate alarm limits Storing Retrieving amp Printing Events Recorded Table 9 1 Event Information Event Types Related Information Stored SpO Violation SpO2 value and SpO2 alarm limit Mark ECG waveform with annotation A Epi Atro Lido or Other Print Strip ECG waveform Sync Sync on Sync off Sync pace marker Pacing Pacer start Pacer stop Pacer settings M4735A Heartstream XL Defibrillator Monitor 9 5 Creating a Patient Record Creating a Patient Record The Heartstream XL creates an Event Summary patient record for each new patient Each record is assigned a unique incident number The Heartstream XL keeps the Event Summary in its internal memory until you begin caring for a new patient It assumes the following Table 9 2 Power Status and Patient Records If Then Power is off for more than 2 minutes The Heartstream XL assumes you are and a new event is recorded caring for a new patient The last inter nal Event Summary is deleted a new Event Summary is started and a new incident record is created Power is off less than 2 minutes The Heartstream XL assumes you are continuing to care for the same patient Additional events are appended to the Event Summary the annotation Con tinued Use is printed on the Event Summary provided it wasn t printed prior to turning the Heartstream XL off and or patient contact was never made
6. e Agilent M4735A e Heartstream XL Defibrillator Monitor User s Guide ov Agilent Technologies e ut Agilent Technologies z v a a User s Guide M4735A Heartstream XL Defibrillator Monitor Notice About This Edition Edition 1 Printed in the USA Publication number M4735 91900 The information in this guide applies to the M4735A Heartstream XL release A 00 This information is subject to change without notice Agilent Technologies shall not be liable for errors contained herein or for inci dental or consequential damages in con nection with the furnishing performance or use of this material Edition History Edition 1 September 2000 Copyright Copyright 2000 Agilent Technologies Inc 3000 Minuteman Road Andover MA USA 01810 1099 978 687 1501 This document may not be photocopied reproduced or translated to another lan guage without prior written consent of Agilent Technologies SMART Biphasic is a registered trademark of Agilent Technologies iv Use of supplies or accessories other than those recommended by Agilent Technologies may compromise product performance THIS PRODUCT IS NOT INTENDED FOR HOME USE IN THE U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN Medical Device Directive The M4735A Heartstream XL Defibril lator Monitor complies with the requirements of the Medical Device Directive 93 42 EEC and carries the Ce 01
7. A new Event Summary begins when patient contact is made Getting Started Using a Data Card Optional Using a Data Card Optional If you would like to collect patient information on a Data Card the card must be inserted into the Heartstream XL before e the device is turned on and e the incident has begun The recommended practice is to use one Data Card per patient Once a Data Card fills recording stops a second Data Card may not be inserted for the current incident Data cards hold up to two hours of patient information Multiple incidents can be recorded on a single Data Card Each incident is assigned a unique incident number NOTE Patient data from a Data Card may be downloaded to a CodeRunner Web data management system CodeRunner Web also allows you to erase patient data from a Data Card allowing the card to be reused for another patient NOTE It s recommended that you use a designated data card to configure one or more defibrillator monitor M4735A Heartstream Defibrillator Monitor 2 13 Using a Data Card Optional Inserting a Data Card To insert a Data Card 1 Make sure the Heartstream XL is powered off 2 Press up on the release latch to open the door to the Data Card compart ment 3 Ifa Data Card is already in the compartment press the black button to the left of the card to eject the card see Figure 2 9 Then pull the card out 4 With the yellow label facing up and the A p
8. Applying Monitoring Elec trodes on page 4 4 Turn the Energy Select knob to Manual On Remove paddles from pockets by simultaneously pulling out and up Apply conductive material NOTE WARNING 74 Do not apply conductive matter by rubbing paddles together Improper usage will result in a Paddles On event that will be registered in the Event Sum mary and may cause paddle damage 5 Apply paddles Press Sync On Use SUE to select the best lead that displays a large QRS complex See Selecting the Lead on page 4 7 Artifact introduced by paddle movement may resemble an R wave and trigger a defibrillation shock When performing synchronized cardioversion pads are sug gested Performing Synchronized Cardioversion Delivering a Synchronized Shock Delivering a Synchronized Shock Once you are properly prepared to perform synchronized cardioversion per form the following steps Press C o located below the Sync On Off display to enable Sync Mode The message SYNC appears on the display 2 Usethe gain control Cl to adjust the ECG size so that the marker dot appears only with each R wave 3 Select the desired energy level Press CHARGE or the yellow charge button located on the Apex paddle Wait until the current charge has reached the energy level selected and you hear a continuous charge done tone Figure 7 1 Charging in Sync Mode Shocks 0 00 00 8 M4735A Heartstream XL Defibrill
9. If no selection is made the event is marked with justa A Figure 9 1 Annotations NOTE n Australia and the U K EPI is replaced by ADRN adrenaline The marked event is stored in the Event Summary If the printer is configured to Print on Mark an ECG strip prints when is pressed If the printer is configured to 6 second delay the strip is 9 seconds and includes 6 seconds pre ceding the event and 3 seconds following the event If No Delay is configured a 3 second ECG strip prints in real time To stop printing before the entire strip is printed press Cas M4735A Heartstream XL Defibrillator Monitor 9 3 Events Recorded 9 4 Events Recorded The following events and related information are stored in the Event Sum mary Table 9 1 Event Information Event Types Power Change Related Information Stored Power on Power off Continued use Battery low Pads Change Pads on Pads off AED Mode Analysis Analyzing Analysis Stopped Artifact Detected Cannot Analyze Shock Advised No Shock Advised Mode Change AED Mode or Manual Mode Rhythm Monitoring Check Patient Pause Resume Charging ECG waveform Energy charged to Shock ECG waveform Shock Delivered energy Peak current and Patient impedance Shock Failed No Shock Delivered Disarm ECG waveform ECG Monitoring Leads on off Lead change Gain change Heart Rate Alarm Violation
10. reducing its life and capacity Refer to the charging procedures provided in the operating instructions for the Battery Charger Kit Maintaining the Heartstream XL CAUTION WARNING Battery Maintenance Battery Capacity A new fully charged M3516A battery operating at room temperature 25 C provides 100 minutes of monitoring or more than 50 200 joule charge shock 1 1 cycles Battery Life Expectancy Life expectancy of a battery depends on the frequency and duration of use When properly maintained and stored the life expectancy of a battery is about 1 5 years For more aggressive use models life expectancy may be less The date of manufacture is located at the bottom of the battery s back label Storing Batteries Batteries should be used regularly and rotated to distribute the use evenly When storing batteries make sure that the battery terminals do not come in contact with metallic objects Batteries should not be stored without charging for more than one month if installed in the defibrillator or more than three months if not installed in the defibrillator Storage at temperatures between 15 C 59 F and 30 C 86 F is recommended to maximize life expectancy Storing at temperatures above 40 C 104 F for extended periods of time will significantly reduce a battery s life expectancy Discarding Batteries Batteries should be discarded if there are visual signs of damage or if they fai
11. 10 9 Pacemakers AED therapy 1 5 heart rate alarm 4 6 Pacing 8 1 defibrillation 8 6 defined 1 6 8 1 demand v fixed mode 8 2 8 4 8 6 ECG monitoring 8 2 events recorded 9 4 function buttons 2 5 indications for use 1 7 messages 12 3 preparation 8 3 procedure 8 4 selecting leads 8 3 8 7 specifications 13 7 system messages 8 7 troubleshooting 8 5 8 7 12 6 Pads applying 3 6 13 14 cleaning 11 13 ECG monitoring 4 1 4 7 events recorded 9 3 safety precautions 13 troubleshooting 3 18 12 3 12 5 Index Pads Cable Off message 3 18 12 3 Pads cables cleaning 11 13 connecting 10 2 ordering 11 18 See also Cables Pads Off message 3 18 4 7 12 3 Paper See Printer paper Patient information See Data Card Pausing AED Mode 3 12 3 15 settings 10 11 Pediatric care 1 5 Post 10 11 Post Shock CPR Timer 3 17 10 11 Power supply checking 11 5 events recorded 9 3 interruption of power 9 5 overview 2 9 specifications 13 2 troubleshooting 12 7 See also Batteries xxxiii Index Precautions 13 asystole 1 6 batteries 11 8 defibrillation current shock 3 10 ECG analysis 3 9 electrodes 4 2 electromagnetic compatibility 16 heart rate alarms 4 6 8 2 pacemakers 1 5 4 6 rhythm monitoring 3 14 safety symbols 10 sensors 5 5 5 9 SpO2 alarm 5 8 SpO2 monitoring 5 1 Print strip contents 5 controls 2 2 events recorded 9 4 settings 10 8 See also Event Summary Printer checking 11 5 cleaning p
12. 2 Enabling Manual vor 6 2 Defibrillating in Manual Mode 25 ccs ete ttnd eo Pug ea uade ua ea Ropa m dece ufus ide unde 6 3 Using External Paddles eee desi stai ben dieu ides io tae nnd deep r a e Eaa a 6 3 Using Multifunction Defib Electrode Pads 125 2 Lnd rri rer aperi poeta Edge 6 5 Defibrillation ie iio eT p tenes 6 6 1 Select ENETEY de ace 6 6 2s Charg NUR T M 6 7 Dec DOCK qp 6 8 Entering AED Mde PCR 6 9 Performing Synchronized Cardioversion Using Multifunction Defib Electrode Pads veisscictecscesaceugiacsvceaccsstictacesecnpnceetetecteaemvanien 7 2 Using 3 or 3 wire ECG LeddS CT 7 3 Using Ext rnal Paddles e 1 4 Delivering a Synchronized Shock tege ege 7 5 Using External ECG Monitors sssssssessesesesesesesseeesssessressersseetssresstesseeeseeessseessresseneseesseeetstts 7 7 Delivering Additional Synchronized Shocks esee 7 7 Disablme Syp Mode P HM 7 7 Contents Pacing Optional ET Operational Controls M 8 2 Demand Mode Versus Fixed Mode trier ttt ipee beoe EHE Sena a Ue REESEN 8 2 Monitoring Darm EE 8 3 Pre Per for Pacino RM sdeeeg aS E E R EEO N E 8 3 Performing Pacis M A D A TA 8 5 EE e 8 8 Defibrillating During Paci
13. 94 W x 7 2 D 61 7mm x 23 9mm x 182mm Weight 1 4 Ib 0 65 kg Charge Time Approximately 14 5 hours to 100 Approximately 3 hours to 90 indicated by LED on front panel Capacity 100 minutes ECG monitoring or 50 full energy discharges or 75 minutes ECG monitoring while pacing with a new fully charged battery at room temperature 25 C Battery Indicators LOW BATTERY message appears on display when at least 10 minutes of monitoring time and 5 maximum energy discharges remain with a new battery at room temperature 25 C Battery Storage Should not be stored above 40 C for extended periods of time Charger Output Unit can be operated using only AC Power with no battery installed Specifications amp Safety Specifications Thermal Array Printer Continuous Real Time Strip User starts and stops the strip The strip prints the selected ECG lead with the following data Header 1 Date Time Heart Rate the SPO2 Value if available and the text Delayed if printing has been configured for Delayed Mode Prints every 12 seconds Header 2 Current mode AED Manual Lead Gain filter setting the text Sync if Sync has been enabled and Pacer Settings consisting of the Pacer Mode Rate and Current if presently pacing the patient Prints every 12 sec onds with Header 1 Header 3 Changes in Mode Gain Lead Sync and Pacer Settings Footer Drug Annotations HR SpO2 limits on a Limit Alarm the
14. Cables ECG electrodes See Electrodes ECG Fault message 12 2 ECG Filter Settings 10 13 ECG monitoring 4 1 controls 2 3 electrodes 4 2 10 9 events recorded 9 3 heart rate alarm 4 6 leads 4 5 settings 10 9 10 10 10 13 signal quality 4 8 size 4 7 specifications 13 4 synchronized cardioversion 7 1 troubleshooting 4 7 Electrode pads See Pads Electrodes applying 4 2 checking 11 2 cleaning 11 13 ordering 11 18 placing 3 5 4 3 settings 10 9 Electromagnetic compatibility EMC 16 Environmental specifications 13 9 safety precautions 14 15 Erratic spiking 1 5 European 10 11 F Index European Protocol 10 11 Event Summary 9 1 events recorded 9 3 information included 9 6 interruption of power 9 5 marking events 9 2 printing 9 6 9 8 specifications 13 8 Failure message 8 7 H Heart rate alarm disabling 4 7 events recorded 9 3 interruption of power 9 5 pacing 8 2 settings 4 6 specifications 13 4 See also ECG monitoring xxxi Index Heartstream XL 1 2 assessment of 1 4 cleaning 11 11 configuring 10 6 controls 2 2 operational checks 11 2 11 3 safety precautions 14 specifications 13 2 13 8 symbols 13 10 training materials 1 8 training required 1 4 troubleshooting 12 7 HR alarm See Heart rate alarm Hypothermia pacing 1 7 SpO2 monitoring 5 1 Incident number See Event Summary Incident Timer 2 6 Incompatible Data Card message 12 6 Indications for use AED
15. Electrodes M3501A Multi function Defib Adult Electrodes AAMI M3502A Multi function Defib Adult Electrodes IEC M3503A Multi function Defib Pediatric Electrodes IEC M3504A Multi function Defib Pediatric Electrodes AAMI DP2 Heartstream Defibrillation Pads 2 Pack DP6 Heartstream Defibrillation Pads 5 Pack Paper 11 14 Maintaining the Heartstream XL Supplies amp Accessories Tahle 11 3 Upgrades Supplies and Accessories Part Number Description 40457C 50 mm Strip Chart Thermal Paper 1 box 10 rolls 40457D 50 mm Strip Chart Thermal Paper 1 box 80 rolls External Paddles PCI Sterilizable M4745A Sterilizable External Paddles M4746A External Paddles with PCI M17898 Adult Adapter clips onto external paddle Pads Cables M3507A Agilent Pad Connector Cable M3508A Heartstream Pad Connector Cable 05 10200 Heartstream Pads Adapter DP2 E DP6 use with M3507A M4735A Heartstream XL Defibrillator Monitor 11 15 Supplies amp Accessories Tahle 11 3 Upgrades Supplies and Accessories Part Number Description ECG Cables M1500A 3 lead ECG Trunk Cable AAMI M1605A 3 lead ECG Lead Set with Snaps AAMI M1510A 3 lead ECG Trunk Cable IEC M1615A 3 lead ECG Lead Set IEC M1520A 5 lead ECG Trunk Cable AAMI M1625A 5 lead ECG Lead Set with Snaps AAMI M1530A 5 lead ECG Trunk Cable IEC M1635A 5 lead ECG Lea
16. Monitor 9 7 Printing the Internal Event Summary The Event Summary also includes waveforms and the appropriate annotation for each of the following events Tahle 9 3 Event Summary Information Event Shock Advised Waveform Information Stored 11 seconds of ECG just prior to the message Shock Advised No Shock Advised 11 seconds of ECG just prior to the message No Shock Advised Cannot Analyze 11 seconds of ECG just prior to the message Cannot Analyze Shock Delivered 11 seconds 3 seconds prior to the shock plus 8 seconds after the shock strip 3 pressed 11 seconds 3 seconds prior to C Strip gt being pressed plus 8 seconds after C Strip is pressed pressed 11 seconds 3 seconds prior to being pressed plus 8 seconds after C Mark y is pressed Heart Rate or SpO Alarm 11 seconds 3 seconds prior to the alarm plus 8 seconds after the alarm 9 8 Storing Retrieving amp Printing Printing Events Printing Events The Heartstream XL can be configured to print automatically when certain events occur The table below lists these events and the length of the strip printed depending on whether the printer is configured to print real time or with a 6 second delay Table 9 4 Configurations for Length of Printed Strips Real Time Delayed Event j Strip Length Strip Length Defibrillator charges continuous 6 seconds just
17. Shift System Check Report Using External Paddles Shift System Check 8 Jan 1999 13 52 17 M4735A Serial Number 00000001 Last Checked 25 Nov 00 1 25 30 Pass Qty Check List Current Tests Pass General System Test Pass ___ Defibrillator Inspection ECG Test Pass ____ Cables Connectors Backup Power Test Pass Paddles Pads SpO2 Test Pass ___ Monitoring Electrodes Data Card Test 2 07 h mm remaining Charged Batteries Defib Test Pass External Paddles AC Power Cord Pacer Test Not tested Printer Paper _ Data Card ___ Ancillary Supplies SpO2 Sensor WARNING Be sure to safely discharge external paddles M4735A Heartstream XL Defibrillator Monitor 11 3 Operational Checks Using Pads To perform the Shift System Check using multifunction defib electrode pads 1 2 Turn the Heartstream XL off Connect the M1781A 50 ohm test load to the pads patient cable instead of pads If a Data Card is routinely used insert a Data Card into the Heartstream XL Unplug the AC power cord Insert a charged battery While pressing Ca turn the Energy Select knob to AED On to start the test Follow the prompts on the display to proceed with the test If the message Service Unit appears do not use the device and call for service The test takes less than a minute to complete When it is done a report is printed as shown in Figure 11 2 Figure 11 2 Shift System Check Report Using Pads Shift System Check 8 Jan
18. Therapy eene 1 6 Noninvasive Pacing Therapy Optional eese nennen nnn 1 7 liie sio E T RR 1 7 crude n fM 1 7 SpO2 Monitoring Optional geet 1 7 Dira o stor ER EE 1 8 ContraindicationS eebe e aaia 1 8 Safety Ee MN P 1 8 Documentation and Training eessen 1 9 vii Contents Getting Started G tting Ga DIT E T 2 2 Basic Orientation t 2 2 M n al Mod Controls t Tm 2 5 Display Buttons PR D a a i a a a aaga 2 6 Display Layout C M 2 7 Connecting EEN eege 2 9 oserting the Battery ECT 2 10 Remove the Battery MER eR NEEE E TEE IT E NES 2 11 Low Battery risa es 2 12 Using a Data Card Optional E 2 13 Inserting a Data Card ee eean a aaa ae 2 14 DOS ADIAC E Data Cand e n 2 15 Defibrillating in AED Mode DVL VIC AF 3 3 Defibrillation using the default configuration sese 3 4 Defibrillation with a modified configuration eee 3 5 Preparation geheegt E E 3 6 Kieler seanna a E AE Musis UM es a D nse Em EEE cs 3 7 Automatic Re analysis On E M 3 13 Automati Re analysis E 3 13 Eemer Eu qe dE 3 14 M on
19. XL 2 Plug the cable into the external monitor ECG Output jack and plug the input end of the cable into the ECG Input plug on the Heartstream XL Delivering Additional Synchronized Shocks If additional synchronized shocks are indicated make sure Sync Mode is still enabled and repeat steps 2 5 In its default configuration the Heartstream XL remains in Sync Mode after a shock is delivered as indicated by the message Sync on the display The Heartstream XL can be configured to exit Sync Mode after each shock is delivered Disabling Sync Mode To disable Sync Mode press C located below the Sync display The message Sync is no longer displayed Sync Mode is also disabled when you exit Manual Mode M4735A Heartstream XL Defibrillator Monitor 7 7 Disabling Sync Mode 7 8 Performing Synchronized Cardioversion 8 Pacing Optional Noninvasive transcutaneous pacing is a Manual Mode function that is used to deliver paced pulses to the heart Paced pulses are delivered through multi function defib electrode pads that are applied to the patient s bare chest This chapter explains the pacing option available with the Heartstream XL and describes how to perform pacing M4735A Heartstream XL Defibrillator Monitor 8 1 Pacing Operational Controls E Pacing Operational Controls In Manual Mode the following pacing operational controls are displayed on the handle of the Heartstream XL Figure 8 1 Pacing Controls Manual
20. a reliable indicator of energy delivery or device performance Introduction Defibrillation Therapy Indications for AED Therapy An AED is to be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are e Unresponsive e Not breathing e Pulseless Contraindications for AED Therapy An AED is not to be used on patients that exhibit one or any combination of the following e Responsiveness e Spontaneous breathing e Palpable pulse Precautions for AED Therapy The AED algorithm is not designed to handle erratic spiking problems caused by a properly or improperly functioning pacemaker In patients with cardiac pacemakers the M4735A Heartstream XL Defibrillator Monitor may have reduced sensitivity and not detect all shockable rhythms NOTE The AED algorithm is not intended for children under 8 years of age For chil dren older than 8 years the American Heart Association recommends that standard operating procedures for AEDs be followed American Heart Asso ciation Textbook of Advanced Cardiac Life Support Dallas Texas AHA 1997 M4735A Heartstream XL Defibrillator Monitor 1 5 Defibrillation Therapy Indications for Manual Defibrillation Therapy Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients who are pulseless and unresponsive The SMART Biphasic waveform utilized in the M4735A Hearts
21. accessory malfunction 13 Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation Electric shock hazards exist internally Do not remove assembly screws Refer servicing to qualified personnel M4735A Heartstream XL Defibrillator Monitor 13 23 Safety Considerations CAUTION This device has not been evaluated for use with electrosurgery equipment NOTE This device and accessories are not intended for home use CAUTION Do not discharge the defibrillator with the paddles shorted together WARNING Properly dispose of or recycle depleted batteries according to local regulations Do not puncture disassemble or incinerate batteries WARNING Where the integrity of the external protective earth conductor is in douht the device shall be operated from its internal power source NOTE For operation in the U S the attachment plug must be the proper NEMA type for connection to the alternative voltage CAUTION Be aware of patient cables including ECG monitoring equipment when used with high frequency surgical equipment WARNING To hreak connection with main power remove plug from wall outlet 13 24 Specifications amp Safety WARNING Electromagnetic Compatibility Electromagnetic Compatibility When using the M4735A Heartstream XL Defibrillator Monitor electromagnetic compatibility with surrounding devices should be assessed
22. and patient skin burns during defibrillation and may divert current away from the heart During defibrillation air pockets between the skin and multifunction defib electrode pads may cause patient skin burns To help prevent air pockets make sure the pads completely adhere to the skin Do not use dried out pads do not open pads package until just prior to use Never touch the patient or any equipment connected to the patient including the hed or gurney during defihrillation Never operate the Heartstream XL in standing water Do not immerse or pour fluids on any portion of the Heartstream XL Do not use the Heartstream XL in a flammable or oxygen rich atmosphere This can cause an explosion hazard Specifications amp Safety WARNING Safety Considerations Avoid connecting the patient to several devices at once Leakage current limits may be exceeded Do not use a second defibrillator on the patient while pacing with the Heartstream XL NOTE WARNING WARNING WARNING WARNING The Heartstream XL can be operated with only AC line power only 12v M3516A SLA Battery or AC power and M3516A SLA battery simultaneously Avoid contact between the patient and conductive fluids and or metal objects such as the gurney Contact with metal objects could cause unintentional current pathways Operating the Heartstream XL or its accessories in conditions outside the environmental specifications can result in device or
23. configured to on a QRS beeper identifies each QRS complex detected Heart rate alarms and meters function with internal and external pacemakers hut they can he unreliable Observe the patient closely if pacemakers are used The HR alarm may be configured to alert you when the heart rate is outside the specified limits Limit choices are listed in Table 4 5 HR Alarm Limit Choices Table 4 5 HR Alarm Limit Choices Alarm If Under Or Over 30 100 60 140 90 160 120 200 To set a HR alarm cycle through the limit choices by pressing HR ALARM until the desired limits are shown The then appears next to the heart rate value to indicated that the HR alarm is set Heart rate alarms are temporarily suspended in AED Mode during ECG analysis or when PAUSE is pressed for the duration of the paused period Heart rate alarms are also suspended while charging for defibrillation and delivering a shock M4735A Heartstream XL Defibrillator Monitor 4 0 Disabling the HR Alarm Disabling the HR Alarm If the heart rate is outside the HR alarm limits an alarm sounds To disable the alarm press HR ALARM amp appears to indicate that the alarm is disabled Adjusting the ECG Size To increase or decrease the size of the ECG press A or W on the gain con trol Glo Preset ECG sizes are x 25 x 5 x1 0 x2 0 and x4 0 The default setting at power on is x1 0 Adjusting the ECG Volume To increase or decrea
24. defib electrode pads connections If in demand mode pacing will not start if there is a problem with the ECG monitoring electrodes connections In either case if a problem occurs a system message is displayed NOTE The pacing window remains on as long as the pacing function is enabled M4735A Heartstream XL Defibrillator Monitor 8 7 Changing Pacing Modes Changing Pacing Modes If paced pulses are being delivered you must stop pacing before changing the pacing mode For example ce to stop pacing Press to change the Mode Adjust the rate if needed Press CD to resume pacing Adjust the output as needed to obtain capture Press St dE ae ho Defibrillating During Pacing If the patient must be defibrillated during pacing follow the procedure for defibrillating in Manual Mode on page 6 1 Pacing is automatically turned off when you charge the defibrillator and the pacing dialogue box is removed from the display After a shock pacing remains off To resume pacing refer to Performing Pacing on page 8 5 When you resume settings selected prior to defibrillation rate mode and output remain the same Pacing Optional Troubleshooting Troubleshooting The table below lists the pacing related system and momentary messages that you may encounter when using the pacing function Table 8 1 Pacing System Messages Message Possible Cause Corrective Action Leads Off e The s
25. e Mild soap and water e Chlorine bleach 3 in water e Quaternary ammonium compounds such as Lysol 10 in water When cleaning be sure to avoid pouring fluids on the device and do not allow fluids to penetrate the exterior surfaces of the device Use of a soft cloth is recommended for cleaning the display to prevent scratching CAUTION 11 12 The Heartstream XL may not be autoclaved ultrasonically cleaned or immersed Do not use abrasive cleaners or strong solvents such as acetone or acetone based cleaners Cleaning the Printer Printhead If the printout has light or varying density printing clean the printhead to remove any buildup of paper residue To clean the printhead 1 Slide the printer door to the right until the paper roller pops up 2 Pullup on the plastic removal tab to remove the roll of paper 3 Clean the printhead surface above the brush with a cotton swab dipped in rubbing alcohol 4 Replace the roll of paper see Loading Printer Paper on page 11 10 Maintaining the Heartstream XL Cleaning Instructions Cleaning Paddles Pads Electrodes amp Cables Defibrillation pads and monitoring electrodes are single use and do not require cleaning 1 1 The paddles paddles cable and pads patient cable may be cleaned with e Alcohol free hand soap e 2 gluteraldehyde solution such as Cidex e Sodium hypochlorite chlorine bleach solution 10 in water e Quaternary ammonium compoun
26. mode 1 5 Manual Mode 1 6 pacing 1 7 SpO2 monitoring 1 7 INOP Alerts 7 xxxii Key Inactive message 3 18 8 7 12 6 Leads formation 4 3 Lead Select setting 10 10 selecting 4 5 7 1 8 3 troubleshooting 4 7 8 7 12 2 Leads Off message 4 7 8 7 12 2 Loading printer paper 11 9 settings from Data Card 10 15 Low Battery message 12 2 Maintenance batteries 11 7 cleaning 11 11 operational checks 11 2 supplies and accessories 11 17 Manual Mode 6 1 controls 2 2 2 4 current charge 6 4 defibrillation process 6 4 delivering shock 6 5 display 2 5 2 8 ECG monitoring 4 1 enabling 2 5 6 2 energy setting 6 4 Events Summary 9 2 indications for use 1 6 overview 1 2 preparation 6 3 returning to AED Mode 6 6 settings 10 9 specifications 13 2 SpO2 monitoring 5 1 training required 1 4 Marking events 9 2 See also Event Summary Messages defined 2 7 list of 12 2 Momentary messages 2 7 list of 12 5 Monitoring See ECG monitoring Monitoring electrodes See Electrodes Monitoring Rhythm See Rhythm Monitoring Multifunction defib electrode pads See Pads Nellcor sensors 5 3 No Data Card Present message 12 6 No Pads message 12 3 No Shock Advised Timer 3 17 10 11 No Shock Delivered message 3 18 12 5 Non Pulsatile message 5 10 12 4 Noninvasive transcutaneous pacing See Pacing Operational checks 11 2 Output Low message 8 7 Oxygen saturation See SpO2 monitoring Pace Pulse Markers
27. movement nail polish and excessive ambient light Safety Considerations General warnings and cautions that apply to use of the M4735A Heartstream XL Defibrillator Monitor are provided in Chapter 13 Additional warnings and cautions specific to a particular feature are provided in the appropriate section of this guide Introduction Documentation and Training Documentation and Training Documentation for the M4735A Heartstream XL Defibrillator Monitor includes e M4735A Heartstream XL Defibrillator Monitor User Guide e M4735A Heartstream XL Defibrillator Monitor Quick Reference Card and e About Sealed Lead Acid Batteries an application note on battery maintenance Training tools available for use with the M4735A Heartstream XL include e Using the M4735A Heartstream XL Defibrillator Monitor a work book e Heartstream XL User Training CD ROM optional For additional online documentation and training please visit our website www agilent com healthcare heart Available online training materials include e AED Application Note e SpO2 Concept Guide e Pacing Application Note M4735A Heartstream XL Defibrillator Monitor 1 9 Documentation and Training 1 10 Introduction 2 Getting Started Congratulations on purchasing your Heartstream XL This chapter will give you a quick tour of your new defibrillator monitor s controls and display The Heartstream XL ships complete with paddles and the cables necessary f
28. of the Pause time in sec onds when PAUSE is pressed and the time since the last shock is less than or equal to the Shock Series Timer setting typically at the com pletion of a shock series 30 60 120 180 NSA Timer Appears only when European Protocol is on Defines the duration of the Pause time in sec onds when must is pressed Also defines the time since the last shock is greater than the Shock Series Timer setting when No Shock Advised 30 60 120 180 f European Protocol is set to Off the Pause Timer is used during the Pause state and appears as a configurable parameter If European Protocol is set to On either the Post Shock CPR Timer or the NSA Timer are used during the Pause state and appear as configurable parameters in place of Pause Timer NOTE ured to either Off or 210 If European Protocol is set to On the setting for the Shock Series Timer must be Post Shock CPR Timer NSA Timer Also the Shock Series Timer can not be config M4735A Heartstream XL Defibrillator Monitor 10 11 10 Configuring the Heartstream XL Table 10 3 Manual Settings Parameter Description Choices Sync After Shock Determines if the Sync function stays on On Off after a synchronized shock is delivered Display Shock Determines if the number of shocks On Off Counter delivered appears on the display during an event Display Incident Determines if the elap
29. or Fixed Rate Refractory Period 340 msec 30 to 80 ppm 240 msec 90 to 180 ppm Specifications amp Safety Specifications SpO2 Pulse Oximetry Accuracy with M1191A sensor 1 standard deviation 70 to 100 2 5 M1192A sensor 1 standard deviation 70 to 100 2 5 M1194A sensor 1 standard deviation 70 to 100 4 0 NELLCOR sensors standard deviation 80 to 100 3 0 Resolution 1 Sp02 Alarm Limits Three preset low alarm limits 90 85 and 80 INOP Alerts Triggered by disconnected sensor noisy signal light interfer ence or low signal non pulsatile Event Storage Internal Event Summary The internal Event Summary stores up to 300 events and up to 50 waveforms 13 Events can be marked with a Mark symbol and if configured for drug annota tion the following labels can be added Epinephrine Adrenaline in U K amp Australia Atropine Lidocaine or Other The Summary key on the front panel is used to print the internal Event Sum mary M4735A Heartstream XL Defibrillator Monitor 13 11 Specifications Data Card Event Summary The Data Card stores continuous ECG wave forms and events on a Type II PCMCIA card SanDisk SDP3B 8MB ATA FlashDisk One 8MB card can store approximately 2 hours of continuous ECG waveforms and events General Dimensions 19 0 cm H x 37 6 cm W x 34 6 cm L 7 5 in x 14 8 in x 13 7 in Weight Standard Configuration weighs 6 5 kg 14 3 Ibs includ
30. selected energy level before readjusting ss the selected energy level M4735A Heartstream XL Defibrillator Monitor 6 7 Defibrillating in Manual Mode 3 Shock Confirm that a shock is still indicated Make sure no one is touching the patient or anything connected to the patient Call out loudly and clearly Stand Clear If using pads paddles press SHOCK to deliver a shock to the patient If using external paddles simultaneously press the shock buttons located on the paddle s until the shock is delivered Figure 6 6 Manual Mode Shock Display SpO2 132A Pads 86 I Pulse 130 PF F Zi W I MW V f UN V Li Shocks 00 15 02 SYNC DISARM Tc due Tse To disarm the defibrillator press DISARM If SHOCK or the shock buttons are not pressed within 30 seconds the defibrillator disarms automatically If additional shocks are indicated repeat the defibrillation process WARNING Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation 6 8 Defibrillating in Manual Mode Entering AED Mode Entering AED Mode To enter AED Mode from Manual Mode simply turn the Energy Select knob from Manual On to AED On ECG and or SpO2 monitoring are defaulted enabled in AED Mode If these settings are still active the alarms set in Manual Mode remain active when you switch to AED Mode M4735A Heartstream X
31. site should be free of vibration and excessive motion Power cables should be kept away from the sensor cable and connec tor M4735A Heartstream XL Defibrillator Monitor 5 3 Selecting a Sensor Selecting a Sensor Table 5 1 shows the SpO gt sensors that may be used with the Heartstream XL Table 5 1 Approved Sensors Sensor Type Patient Patient Size Ideal Site MI1191A Reusable Adult 50kg Finger M1192A Reusable Small adult 15 50 kg Finger Pediatric M1194A Reusable Pediatric gt 40 kg Fleshy part Adult of ear M1903A B Disposable Pediatric 10 50 kg Toe Finger Nellcor D 20 NOTE 5 4 To use Nellcor sensors you must connect the M1943A Nellcor Adaptor patient cable to the Heartstream XL See Connecting the SpO2 Patient Cable on page 10 5 Monitoring SpO2 Selecting a Sensor The most important factor when selecting a sensor is the position of the light emitting diodes in relation to the photodetector when a sensor is applied the diodes and the photodetector must be opposite each other Sensors are designed for patients within a specific weight range and for specific sites Be sure to e Select a sensor appropriate for the patient s weight e Select a sensor site with adequate perfusion e Avoid application to sites with edematous tissue Reusable Sensors Reusable sensors may be reused on different patients after they have been cleaned and disinfected s
32. the biphasic AEDs there was a single energy output of 150J for all shocks For monophasic AEDs the shock sequence was 200 200 360J Defibrillation was defined as termination of VF for at least five seconds without regard to hemodynamic factors Results Randomization to the use of monophasic or SMART Biphasic automatic external defibrillators AEDs was done in 338 SCAs from four emergency medical service systems VF was observed as the first monitored rhythm in 115 patients The biphasic and monophasic groups for these 115 patients were similar in terms of age sex weight primary structural heart disease cause or location of arrest and bystanders witnessing the arrest or performing CPR The 150J SMART Biphasic waveform defibrillated 98 of VF patients in the first series of three shocks or less compared with 69 of patients treated with monophasic waveform shocks Outcomes are summarized in Clinical SummaryTable 13 4 M4735A Heartstream XL Defibrillator Monitor 13 19 Clinical Performance Summary Table 13 4 Clinical Summary Biphasic Patients Monophasic Patients P Value Number Percent Number Percent chi square Defibrillation Efficacy Single shock only 52 54 96 36 61 59 0 0001 2 shocks 52 54 9696 39 61 64 0 0001 3 shocks 53 54 9896 42 61 69 0 001 Patients Defibrillated 54 54 10096 49 58 84 0 003 Return of Spontaneous 41 54 76 33 61 54 0 01 Circulation Surviv
33. the main configuration menu to return all settings to their default settings Although there is no visi ble change in the display default settings are restored M4735A Heartstream XL Defibrillator Monitor 10 13 Configuring the Heartstream XL Saving Settings to a Data Card Configuration settings may be saved to a Data Card and used to load the same configuration into other Heartstream XLs or to restore the configuration if necessary To save the configuration 1 Make sure a Data Card is in the Heartstream XL before you turn the defibrillator monitor on 2 Select Save Settings to Data Card from the main configuration menu 3 Press SAVE inresponse to the question Save Settings to Data Card The Heartstream XL saves the configuration settings to the Data Card and returns to the main configuration menu NOTE 10 14 To avoid possible confusion designate one Data Card as the Configuration Card and label it clearly Keep this card physically separate from cards used for storing patient data Loading Settings from a Data Card To load configuration settings 1 Make sure a Data Card is in the Heartstream XL before you turn the defibrillator monitor on 2 Select Load Settings from Data Card from the main configuration menu 3 Press LOAD in response to the question Load Settings from Data Card The Heartstream XL loads the configuration settings from the Data Card and returns to the main configuratio
34. 0 shock of a new shock series rather than the 210 Off next shock of the current shock series Device Initiated Initiates ECG analysis when the Heartstream On Off Analysis XL is turned on in AED Mode for new use Automatic Initiates ECG analysis in between shocks On Off Re analysis within a shock series Rhythm Monitoring Monitors the ECG for potentially shockable On Off rhythms when the Heartstream XL is not ana lyzing defibrillating or paused Lead Select Turns on ECG monitoring via ECG Leads On Off Sp02 Turns on SpO2 monitoring Only listed as a On Off configurable item if the SpO option was pur chased Check Patient Defines how often in seconds the Check 30 45 60 90 Timer Patient prompt is repeated when Rhythm Mon Off Setting Up and Configuring the Heartstream XL Configuring the Heartstream XL Tahle 10 2 AED Settings Parameter Pause Timer Description Defines the duration of the pause time in sec onds when PAUSE is pressed when European Protocol is set to Off Appears only when European Protocol is configured off Pause Timer is the default Setting Choices 30 60 120 180 European Protocol Modifies Pause state prompts and replaces the Pause Timer with either the Post Shock CPR Timer or the NSA Timer depending on the event preceding the Pause state Off On Post Shock CPR Timer Appears only when European Protocol is on Defines the duration
35. 11 3 to verify that the Heartstream XL is functioning properly and to ensure that necessary supplies and accessories are present and ready for use Every Month Check expiration dates on multifunction defib electrode pads and monitoring electrodes every month Replace them if the expiration date has passed Every Three Months Perform a Battery Capacity Test on each battery every three months to ensure that your batteries meet the specifications for safe and effective use 11 2 Maintaining the Heartstream XL Operational Checks Using External Paddles To perform the Shift System Check using external paddles 1 Turn the Heartstream XL off If routinely used insert a Data Card into the Heartstream XL 2 3 Unplug the AC power cord 4 Inserta charged battery 5 While pressing Cas turn the Energy Select knob to Manual On to start the test NOTE If the paddles are in the holders and the message Place Paddles in Pockets appears adjust the paddles to improve contact Poor contact may be due to due to clinical use e g oxidation or residue on either the connectors or pad dles If the message continues to appear contact a certified technician 6 Follow the prompts on the display to proceed with the test If the message Service Unit appears do not use the device and call for service The test takes less than a minute to complete When it is done a report is printed as shown in Figure 11 1 Figure 11 1
36. 12 8 XXXVI E Edition 1 M4735 91900 Copyright 2000 Agilent Technologies Inc Printed in the U S A September 2000
37. 1999 13 52 17 SN 00000001 Current Tests Pass Qty Check List General System Test Pass Defibrillator Inspection ECG Test Pass ___ Cables Connectors Backup Power Test Pass ___ Defibrillation Pads Paddles Data Card Test Pass Monitoring Electrodes Defib Test Pass ____ Charged Batteries Pacer Test Pass ___ AC Power Cord Printer Paper Data Card ___ Ancillary Supplies ___ Pads Maintaining the Heartstream XL Operational Checks The Shift System Check report lists the results of the test and additional checks that you should do Perform each of these checks and record the results The guidelines for completing the checks are as follows 11 Defibrillator Inspection make sure the Heartstream XL is clean clear of objects on top and has no visible signs of damage Paddles Cables Connectors make sure there are no cracks broken wires or other visible signs of damage Make sure the connectors engage securely Battery make sure e a charged battery is in the Heartstream XL e another battery is charged or being charged e the batteries have no visible signs of damage AC Power 1 Make sure a battery is in the Heartstream XL 2 Plug the power cord into a power outlet and connect it to the Heart stream XL 3 Verify that the power and charging indicators on the front of the defibrillator monitor are lit 4 Remove the battery from the Heartstream XL and verify that the charging indicator on the f
38. 23 mark accordingly Authorized EU representative Agilent Technologies Deutschland GmbH Herrenbergerstr 130 D 71034 Boeblingen Germany Fax 49 703 1 14 2346 Warning Radio frequency RF interference from nearby transmitting devices may degrade the performance of the M4735A Heartstream XL Defibrillator Monitor Electromagnetic compatibil ity with surrounding devices should be assessed prior to using the defibrillator monitor Index This guide uses the following conventions WARNING Warning statements describe conditions or actions that can result inpersonal injury or loss of life CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of data NOTE Notes contain additional information on usage TEXT represents messages that appear on the display Softkey represents softkey labels that appear on the display above or below the button to which they correspond vi Contents Introduction OVETVIEW 1 2 Tntended Use c H 1 4 Dye Tiler Aton Th tapy EE 1 4 Indications for AED ER 1 5 Contraindications for AED tem ete eee geseent eege 1 5 Indications for Manual Defibrillation Therapy eee 1 6 Contraindications for Manual Defibrillation Therapy eee 1 6 Precautions for Manual Defibrillation
39. 3 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 4 Turn the Energy Select knob to Manual On M4735A Heartstream XL Defibrillator Monitor 8 3 Preparing for Pacing In addition for demand mode pacing 1 Apply monitoring electrodes See Applying Monitoring Electrodes on page 4 4 2 Use stp to select the best lead with an easily detectable R wave See Selecting the Lead on page 4 7 If you do not select a lead i e pads is the selected ECG source Lead is automatically selected when the pacing function is turned on NOTE 8 4 If pacing for long periods of time new monitoring electrodes and multifunc tion defib electrode pads may need to be applied periodically Refer to the manufacturer s documentation for recommendations regarding frequency Pacing Optional Performing Pacing Performing Pacing To use pacing perform the following steps 1 Press Pacer The green LED next to lights up and a dialogue box appears on the display Figure 8 2 Pacing with ECG Monitoring Electrodes Display LEAD SpO2 v 78 A Lead Uu Pacer Stop Demand Mode 7 A Shocks 0 ppm som 00 00 8 SYNC CHARGE diir Lee OOOO The Pacer Stop message indicates that the pacing function is on but paced pulses are not being delivered The pacer turns on in the mode last used 2 Verify that the dot markers appears near the middle of the QRS complexes of th
40. A A aN A V VN wee A If Needed Press PAUSE And Begin CPR Shocks 1 00 00 50 If CPR is needed press PAUSE While paused the Pause Timer indicates the elapsed time and the total duration of the pause state in seconds The Pause Timer is configurable to meet your local CPR protocol needs Rhythm SpO and heart rate monitoring alarms are suspended for the duration of the pause NOTE If your Heartstream XL is configured to support the European Resuscitation Council Guidelines for Resuscitation refer to the ERC Protocol section on page 3 18 for details Defibrillating in AED Mode Pausing for CPR Figure 3 12 Pause Display HR LEAD SpO2 ALARM SELECT ON OFF v1204 Pads Mw Vw v My Paused 3 l Shocks 3 Timer 21 60 00 01 40 Elapse Time Total Pause Duration The pause state ends when the Pause Timer reaches the preconfigured pause state duration or if you press RESUME or ANALYZE At the completion of the pause state the defibrillation process begins again If instructed press ANALYZE If you do not press PAUSE the Heartstream XL begins monitoring the ECG rhythm provided Rhythm Monitoring is on You may initiate ECG analysis at any time by pressing ANALYZE M4735A Heartstream XL Defibrillator Monitor 3 15 Monitoring Rhythm WARNING 3 16 Monitoring Rhythm When the Heartstream XL is not analyzing defibrillating or paused Rhythm Monitoring alerts you
41. External Defibrillation AED Mode e Manual Mode Both modes incorporate a low energy SMART Biphasic waveform for defibrillation In AED Mode the M4735A Heartstream XL Defibrillator Monitor analyzes the patient s ECG and advises you whether or not to deliver a shock Voice prompts guide you through the defibrillation process by providing instruc tions and patient information Voice prompts are reinforced by messages that appear on the display In Manual Mode the M4735A Heartstream XL Defibrillator Monitor turns control of the defibrillation process over to you You analyze the patient s ECG and select the energy setting for defibrillation if necessary Manual Mode also allows you to perform synchronized cardioversion and offers noninvasive pacing optional Defibrillation is performed through attached paddles or multifunction defib electrode pads Monitoring is available in AED and Manual Mode through pads 3 lead ECG monitoring electrodes or optional 5 lead ECG monitoring electrodes Optional pulse oximetry SpO5 monitoring is also available in AED and Manual Modes While monitoring ECG or SpO you may set heart rate and or SpO alarms to alert you when these parameters are outside the defined limits Introduction Overview The M4735A Heartstream XL Defibrillator Monitor automatically stores crit ical events in its internal memory such as shocks and alarm violations Addi tional events of interest may also be marked for stora
42. L Defibrillator Monitor 6 9 Entering AED Mode 6 10 Defibrillating in Manual Mode 7 Performing Synchronized Cardioversion Synchronized cardioversion is a Manual Mode function that allows you to synchronize the defibrillator shock with the R wave of the ECG being moni tored There are three ways to monitor ECG for synchronized cardioversion e multifunction defib electrode pads e 3 or 5 lead monitoring electrodes or e external paddles attached to the M4735A Heartstream XL You may also use an external Agilent or Hewlett Packard ECG monitor while performing synchronized cardioversion When selecting a lead choose the best lead that displays a large QRS com plex The synchronized shock is delivered through the mulifunction defib electrode pads or external paddles regardless of the lead being monitored This chapter describes how to perform synchronized cardioversion with the Heartstream XL NOTE See chapter 4 Monitoring the ECG for information on how to apply elec trodes and select a lead M4735A Heartstream XL Defibrillator Monitor 7 1 Using Multifunction Defib Electrode Pads 7 2 Using Multifunction Defib Electrode Pads To prepare for synchronized cardioversion using multifunction defib electrode pads perform the following steps l If needed insert a Data Card as described in Using a Data Card Optional on 2 13 Apply monitoring electrodes if desired See Applying Monitoring E
43. Mode only Demand Mode Versus Fixed Mode The Heartstream XL can deliver paced pulses in either demand or fixed mode In demand mode the pacer only delivers paced pulses when the patient s heart rate is lower than the selected pacing rate In fixed mode the pacer delivers paced pulses at the selected rate 8 2 Pacing Optional Monitoring During Pacing Monitoring During Pacing Multifunction defib electrode pads cannot be used to monitor the ECG and deliver paced pulses simultaneously When pacing in demand or fixed mode you must monitor the patient through either 3 or 5 lead monitoring elec trodes The Heartstream XL uses the R wave detection from this monitoring source to determine if a paced pulse should be delivered WARNING Use demand mode pacing whenever possihle Use fixed mode pacing when motion artifact or other ECG noise makes R wave detection unreliable WARNING Heart rate meters and alarms function during pacing but they can be unreliable o Observe the patient closely while pacing Do not rely on heart rate alarms or the indicated heart rate as a measure of the patient s perfusion status Preparing for Pacing To prepare for pacing perform the following steps 1 Apply multifunction defib electrode pads as directed on the package Use either the anterior apex or anterior posterior placement as appropriate Connect the pads to the patient cable See Figure 6 3
44. Results of Analysis in AED Mode No Shock Advised Shock Advised or Cannot Ana lyze Charging to xxx J Shock Delivered No Shock Delivered Disarm Bat tery Low 13 Symbols Mark Triangle for presses of the Mark key an Alarm Bell Alarm Limit Violations Lightning Bolt Shock Delivered followed by b for bipha sic Vertical Stripe Boundaries Pacer Sync Tick Marks Event Printing Mark key automatically documents ECG and events during defibrillation episodes The Mark key can annotate the event with one of the following labels Epinephrine Adrenaline Atropine Lidocaine and Other M4735A Heartstream XL Defibrillator Monitor 13 9 Specifications 13 10 Auto Printing The printer can be configured to automatically print on Mark Charge Shock and Alarm Delayed Printing The printer can be configured to run real time or with a 6 second delay Reports The following can be printed Event Summary Configuration Extended Self Test System Log Battery Capacity Test Shift System Check Speed 25 mm s with an accuracy of 5 Amplitude Accuracy 10 or 50 uV whichever is greater Paper Size 50 mm by 30 m 100 ft Noninvasive Pacing Waveform Monophasic Truncated Exponential Current Pulse Amplitude 10 mA to 200 mA 5 mA resolution accuracy 10 mA to 50mA 5mA 50mA 200mA 10 Pulse Width 20 ms with accuracy 0 5 ms Rate 30 ppm to 180 ppm 10 ppm increments accuracy 1 5 Modes Demand
45. TeSt P 11 6 Battery EE TE 11 7 Recharging Batteries T ai ais 11 8 GE Ee E 11 9 lura gdBidsiscucui M 11 9 Storing Batteries M I 11 9 Docatdme Dalle FE s postes Dedi ie eege 11 9 Loading Printer Paper serenissimi 11 10 Cleaning Instr ctionsS NIRE c 11 12 Cleaning the Heartstream XL eege ra P PIRE dn t de Dra ula eR eU 11 12 leaning he Printer Printhead uie pa REC hc br na ved edu ae e CU eG 11 12 Cleaning Paddles Pads Electrodes amp Cables seen 11 13 Supplies amp ACCESSOMES P 11 14 Disposing of the Heartstream AX Luise once anne dnstseddeddupotaatigenedaastaniddeasdasccdeibiesdedasendvedss 11 17 xiii Contents Troubleshooting System SGA egener 12 2 Mom ntary M ssa g s Mmm 12 5 Troubl sh oting bet a aae aE e e E TEE ATAN ERES 12 7 Calling E E 12 8 United e P 12 8 Canada c 12 8 Other International Areas uei eei tet nee eto ebbe toe ocu SES bons Ra Losada Ede 12 8 Specifications amp Safety Specifications MM EREDA 13 2 Defibrillatt eC M S 13 2 ECG nva pa C 13 5 HR 13 7 Display eT T 13 8 lc Cr
46. The Heartstream XL can be used for short or long term ECG monitoring The ECG monitoring function allows you to monitor through e multi function defib electrode pads or e 3 or 5 lead ECG monitoring electrodes as configured When the Heartstream XL is turned on the ECG acquired is shown on the dis play ECG monitoring allows you to continue to monitor through the pads or to select a lead from an alternate ECG source 3 or 5 lead ECG monitoring also displays the heart rate HR and allows you to set HR alarms ECG monitoring is always active in Manual Mode In AED Mode ECG monitoring is only active if Lead Select is configured to on the default is on Plug the 3 or 5 lead ECG patient cable into the connector marked ECG as shown in Figure 4 1 A new fully charged battery provides approximately 100 minutes of continu ous monitoring Monitoring the ECG Connecting the ECG Patient Cable n M Connecting the ECG Patient Cable To connect a 3 or 5 lead ECG patient cable 1 Align the keyed patient cable connector with the slot on the ECG receptacle as shown in Figure 4 1 2 Push the patient cable firmly into the ECG receptacle until the white por tion is no longer visible Figure 4 1 ECG Patient Cable Connector Receptacle a a d To disconnect the ECG patient cable gently pull the white patient cable connector out of the ECG receptacle M4735A Heartstream XL Defibrillator Monitor 4 3 Applying M
47. age 5 11 SpO2 Light Interf message 5 11 SpO2 Low Signal message 5 10 SpO2 monitoring 5 1 cable connection 5 6 controls 2 3 defined 1 7 5 1 discontinuing 5 9 events recorded 9 4 inaccuracies 1 7 indications for use 1 7 noisy signal 5 10 procedure 5 7 process 5 2 sensors applying 5 5 sensors caring for 5 9 11 13 settings 10 10 specifications 13 7 troubleshooting 5 10 12 4 SpO2 Noisy Signal message 5 10 SpO2 Sensor Fail message 5 11 Stop message 8 7 Stop Pacer message 12 6 Strip See Print strip Index Supplies checking 11 4 ordering 11 17 Symbols list of 10 Sync After Shock setting 10 12 Sync control 2 5 Synchronized cardioversion 7 1 delivering shock 7 2 disabling Sync Mode 7 4 enabling 2 5 indications for use 1 6 preparation 7 2 selecting leads 7 1 synchronizer specifications 13 2 System Failure Service Unit message 12 3 System messages 2 7 list of 12 2 System tests See Maintenance Telephone assistance 12 8 Test load ordering 11 19 Thermal Array Printer See Printer Time 10 8 12 7 XXXV Index Training materials 1 8 Training required 1 4 13 Troubleshooting 12 1 AED Mode 3 18 Data Card 12 6 display 12 7 ECG monitoring 4 7 pacing 8 5 8 7 12 3 12 6 SpO2 monitoring 5 10 12 4 time and date 12 7 U User messages 2 7 V Ventricular fibrillation manual defibrillation 1 6 pacing 1 7 Ventricular tachycardia 1 6 W Warnings See Precautions Web site
48. al to Hospital 33 54 6190 31 61 51 0 27 Admission Survival to Hospital 15 54 2896 19 61 3196 0 69 Discharge CPC 1 Good 13 15 8796 10 19 53 0 04 Conclusion The 150J SMART Biphasic waveform defibrillated at higher rates than 200 360J monophasic waveforms resulting in more patients achieving return of spontaneous circulation ROSC p 0 01 EMS system outcomes of survival discharge were not significantly different statistically However patients resuscitated with the lower energy SMART Biphasic waveform were more likely to have good cerebral performance CPC cerebral performance cate gory p 0 04 13 20 Specifications amp Safety Safety Considerations Safety Considerations The following general warnings and cautions apply to use of the Heartstream XL Additional warning and cautions specific to a particular feature are provided in the appropriate section WARNING The Heartstream XL is not intended to be deployed in settings or situations that promote use by untrained personnel Operation hy untrained personnel can result in injury or death WARNING Remain attentive to the patient during the delivery of therapy Delay in delivering a shock may result in a rhythm that was analyzed as shockable converting spontaneously to non shockable and could result in inappropriate delivery of a shock WARNING Use only the multifunction defib electrode pads hattery and accesso
49. arge Prints a continuous strip during charging Printing continues until a shock is deliv ered the device is disarmed or is pressed On Off Print on Shock Prints a 12 second strip when a shock is delivered On Off Print on Alarm Prints a 6 second strip during alarms On Off Printer Delay Captures what you just saw All printed strips including those generated by an event mark charge shock or alarm include an additional 6 seconds of infor mation the 6 seconds of information that occurred just prior to printing being initi ated 6 Sec Delay No Delay Pace Pulse Markers Shows pace pulse markers on the ECG displayed if an internal pacemaker is detected Leads amp Pads Leads Only ECG Lead Cable Selects the monitoring electrodes source 3 lead 5 lead ORS Beeper Provides an audible beep with each QRS complex detected On Off M4735A Heartstream XL Defibrillator Monitor Configuring the Heartstream XL 10 10 Tahle 10 2 AED Settings itoring detects a potentially shockable rhythm xs Setting Parameter Description Choices AED Shock Series Defines the maximum number of shocks to 2 3 4 deliver before prompting Check Patient Check Pulse If Needed Begin CPR Shock Series Timer Defines the number of seconds that must pass 30 60 90 before the next shock is considered the first 120 150 18
50. ator Monitor 7 5 Delivering a Synchronized Shock If desired you may increase or decrease the selected energy level after pressing CHARGE by moving the Energy Select knob until the desired energy level is displayed The defibrillator charges to the modified energy level automatically Wait until the current charge reaches the selected energy level before proceeding 5 Make sure no one is touching the patient or anything connected to the patient Call out clearly and loudly Stand Clear Then press SHOCK If you are using external paddles deliver the shock by pressing and simulta neously holding the orange keys on both external paddles NOTE It is important to continue to hold SHOCK or the buttons down until the shock is delivered The defibrillator shocks with the next detected R wave WARNING Defihrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation 7 6 Performing Synchronized Cardioversion Using External ECG Monitors Using External ECG Monitors When the patient is already connected to the bedside monitoring equipment there is an external monitoring cable which plugs into the ECG Output jack of the bedside monitor and connects to the M4735A Heartstream XL ECG Input for monitoring To use an external monitor with the Heartstream XL perform the following steps 1 Select Lead I or Lead II on the Heartstream
51. brillator automatically disarms within 30 seconds if you do not press SHOCK 3 12 Defibrillating in AED Mode Defibrillating Delivery of the shock is confirmed by the message Shock Delivered and the shock counter is updated Figure 3 10 Shock Delivered Display um steer owore ALARM _ SELECT ON OFF 712 0 a Pads n D n A UM IW WV V ux nu WA tuli d Shock Delivered d Shocks 1 00 00 40 Automatic Re analysis On If Automatic Re analysis is on the Heartstream XL analyzes the ECG fol lowing delivery of the shock You are prompted to press SHOCK if an addi tional shock is advised This cycle repeats until the rhythm converts or a shock series is complete A shock series may be configured to 2 3 or 4 shocks Automatic Re analysis Off If Automatic Re analysis is off the Heartstream XL monitors the ECG for potentially shockable rhythms provided Rhythm Monitoring is on and prompts you to press ANALYZE if one is detected You can initiate analysis without being prompted by pressing ANALYZE M4735A Heartstream XL Defibrillator Monitor 3 13 Pausing for CPR Pausing for CPR The Heartstream XL prompts you to Check Patient Check Pulse at the completion of a shock series or when no shock is advised This default configuration will allow eight seconds to check the pulse then prompts you as follows Figure 3 11 Press Pause Display HR LEAD SpO2 ALARM SELECT ON OFF v1204 Pads fi A n a bal up A
52. cond beep to alert you Table 12 2 lists momentary messages Table 12 2 Momentary Messages Message Attach Pads Possible Cause The multifunction defib electrode pads are not making proper contact with the patient Corrective Action Check the pads are applied to the patient as directed on the pads package Replace the pads if the prompt continues Defib Disarmed e The pads connection is compromised e The mode is changed from Manual to AED while the defibrillator is charged e SHOCK or shock buttons are not pressed within 30 seconds of the defibrillator being charged e DISARM is pressed Check the pads are applied to the patient properly If a shock is indicated deliver the shock before changing modes To deliver a shock press SHOCK or shock buttons on paddles within 30 seconds of the defibrillator being charged No Shock Delivered Patient impedance is too high Make sure the pads are applied properly Replace the pads if necessary Check Printer Printer paper is absent or jammed the printer door is not closed properly Reload printer paper Make sure the door is closed properly M4735A Heartstream XL Defibrillator Monitor System Messages Table 12 2 Continued Momentary Messages Message Data Card Full Possible Cause e The incident is more than 2 hours in duration causing the Data Card to fill e Anempty Data Card was
53. consist of an energy select knob and a set of softkeys that perform the function displayed as a label above each button These controls assist in both AED and Manual Mode defibrillation Audiovisual Controls Adjusts the size of the ECG waveform displayed printed and stored Pressing A and W simultaneously generates a 1 mV calibration pulse Adjusts the volume of voice prompts and the QRS beeper To completely turn the QRS beeper off it must be changed from the configu ration menu Monitoring Controls Monitoring controls consist of a set of softkeys that perform monitoring functionality These functions are displayed in the softkey label below each button Monitoring softkeys also control heart rate and SpO alarms and selection of the ECG source to monitor Getting Started Getting Acquainted Print Controls Print controls perform the function shown above each button The print controls from are Prints ECG data defibrillation events and marked events real time or with a 6 second delay as configured Press to start printing press again to stop printing Prints the Event Summary See Storing Retrieving amp Printing Summary for more information Printing may be stopped by pressing the Summary or Strip button Inserts a time stamped annotation in the Event Summary May be configured to print an annotated ECG strip when pressed Manual Mode Controls Manual Mode controls provide access to manual d
54. d Set with Snaps IEC Sync Cable M1783A 12 pin Sync Cable Monitoring Electrodes M2202A High Tack Foam ECG Electrodes 5 electrodes pouch 300 electrodes case 11 16 Maintaining the Heartstream XL Disposing of the Heartstream XL Tahle 11 3 Upgrades Supplies and Accessories Part Number Description SpO Cables Sensors MI1191A Adult Reusable SpO Sensor M1192A Pediatric Reusable SpO Sensor M1194A Adult Pediatric Ear Clip Reusable SpO Sensor M1943A Nellcor SpO Sensor Adapter Cable Data Card M3510A Data Card Battery M3516A Sealed Lead Acid Battery M4747A Battery Charger Kit Test Load MI1781A 50 ohm defibrillator test load User Training CD ROM M4735 9 1000 User Training CD ROM Kit Disposing of the Heartstream XL Prior to disposing of the Heartstream XL remove the battery Then dispose of the device and its accessories in accordance with local regulations WARNING Disposal of the device with the battery inserted presents a potential shock hazard M4735A Heartstream XL Defibrillator Monitor 11 17 Disposing of the Heartstream XL 11 18 Maintaining the Heartstream XL 12 Troubleshooting If the Heartstream XL detects an error or potential problem during use it dis plays a system or momentary message These messages are often accompa nied by a voice prompt This chapter describes the messages and what you should do in response In addition thi
55. ds such as Lysol e Isopropyl alcohol CAUTION The paddles and paddles cable may not be ultrasonically cleaned or immersed Nor may they be autoclaved or steam sterilized The ECG cable may be cleaned by wiping it with any of the following e 2 gluteraldehyde solution such as Cidex e Alcohol free hand soap e Chlorine bleach 100ml I CAUTION Do not ultrasonically clean immerse autoclave or steam sterilize the pads or ECG cable Do not clean the ECG cable with alcohol Alcohol can cause the plastic to become brittle and may cause the cable to fail prematurely To clean the SpO sensor and cable follow the manufacturer s instructions NOTE For information about paddle sterilization procedures see the M4741 91000 Agilent Technologies Sterilizable Paddles Owner s Guide M4735A Heartstream XL Defibrillator Monitor 11 13 Supplies amp Accessories Supplies amp Accessories Approved supplies and accessories for the Heartstream XL are listed in 1 To order e Inthe USA call 1 800 225 0230 e Outside the USA contact your local Agilent Technologies Sales Office your authorized Agilent Technologies Dealer or Distributor or visit our Medical Supplies website at www healthcare agi lent com mpgsupplies Tahle 11 3 Upgrades Supplies and Accessories Part Number Description Upgrades M4738A Pacing Upgrade M4739A SpO Upgrade Defibrillation Pads
56. e ECG If the dot markers do not appear or are in the wrong location adjust the ECG size or select another lead See Monitoring the ECG in Chapter 4 M4735A Heartstream XL Defibrillator Monitor 8 5 Performing Pacing 8 6 3 Press to change to fixed mode if in demand mode or if R wave detection is unreliable The pacing dialogue box displays the current mode To switch back to demand mode press again Adjust the rate to the desired number of paced pulses per minute ppm Press up A or down VW on Rate ij to increase or decrease the number of paced pulses per minute To start pacing press Clar 3 The message Pacing indicates that paced pulses are being delivered in the selected mode at the rate and output level displayed Figure 8 3 Pacing with Pads Display LEAD SpO2 wv 78 A Pads Pacer Stop Demand Mode Shocks 0 70ppm 30mA uns ee ST ON OFF Pacing Optional Performing Pacing 6 Increase the output until cardiac capture occurs Press A on to increase the output in increments of 10 mA 7 Decrease the output to the lowest level that still maintains capture Press W on to decrease the output in increments of 5 mA 8 Press to stop pacing 9 Press to exit the pacing function The green LED next to the but ton goes out indicating pacing is no longer active NOTE If pacing using pads pacing will not start if there is a problem with the multi function
57. e it can be influenced by movement and artifact The symbol indicates no alarm is set Below the SpO value is the pulse rate derived from the pulse oximetry Monitoring SpO2 Setting Alarms Setting Alarms An alarm may be set to alert you if the SpO value falls below a specified lower limit Lower limit alarm choices are INI no alarm 90 85 or 80 The defaulted high limit is 100 and cannot be changed Press Sp ALARM repeat edly to cycle through the choices Stop when the desired choice is displayed AA appears in three seconds indicating that the selected alarm is active To review the alarm limit press Sp0 ALARM WARNING Sp0 alarms are temporarily suspended in AED Mode during ECG analysis or when PAUSE is pressed for the duration of the paused period Sp0 alarms are also sus pended while charging for defibrillation and delivering a shock Responding to an Alarm When the SpO value falls below the alarm limit a continuous tone alerts you and the SpO value is displayed in inverse video Figure 5 4 Sp0 Alarm Triggered LEAD O SpO2 v 7 8 fm Pu ir A Pulse 78 a Pe fee M E 1 Monitoring Rhythm Shocks 3 00 00 49 Press Sp0 ALARM to turn off the alarm Refer to Setting Alarms if subse quent alarms are desired M4735A Heartstream XL Defibrillator Monitor 5 9 Discontinuing SpO2 Monitoring Discontinuing SpO Monitoring To shut off SpO monitoring press p02 ON OFF once Nothing
58. e symbols that appear on the Heartstream XL ship ping carton Tahle 13 3 Shipping Carton Symhols Symbol Definition a Atmospheric pressure range Temperature range Relative humidity range Recyclable paper product Fragile t t Right side up i E Do not get wet M4735A Heartstream XL Defibrillator Monitor 13 17 Symbol Definitions 13 18 Tahle 13 3 Shipping Carton Symhols Symbol 2 Definition Shelf life fa Long term storage conditions Short term transport storage Specifications amp Safety Clinical Performance Summary Clinical Performance Summary An international multicenter prospective randomized clinical study was conducted to assess the effectiveness of the SMART Biphasic waveform in out of hospital sudden cardiac arrests SCAs as compared to monophasic waveforms The primary objective of the study was to compare the percent of patients with ventricular fibrillation VF as the initial monitored rhythm that were defibrillated in the first series of three shocks or less This section summarizes the methods and results of this study Methods Victims of out of hospital SCA were prospectively enrolled in four emer gency medical service EMS systems Responders used either 150 SMART Biphasic AEDs or 200 360J monophasic waveform AEDs A sequence of up to three defibrillation shocks were delivered For
59. eartstream XL Defibrillator Monitor 10 1 Connecting Disconnecting Patient Cables EEE Connecting Disconnecting Patient Cables This section describes how to connect and disconnect the e Pads Paddles Patient Cable e ECG Patient Cable 3 or 5 lead e SpO2 Patient Cable 10 2 Setting Up and Configuring the Heartstream XL Connecting Disconnecting Patient Cables Pads Paddles Patient Cable To connect external paddles to the defibrillator 1 Align the white arrow on the patient cable with the white arrow on the defibrillator s cable connector as shown in Figure 10 1 2 Insert the cable into the connector Push until you hear it click in place Figure 10 1 Attaching the Patient Cable for Pads and External Paddles M4735A Heartstream XL Defibrillator Monitor 10 3 Connecting Disconnecting Patient Cables To disconnect the patient cable from the defibrillator Rotate the green locking mechanism on the cable in the direction of the green arrow clockwise until it stops as shown in Figure 10 2 2 Hold the locking mechanism in this position as you pull the cable out Figure 10 2 Disconnecting the Pads Paddles Patient Cable 10 4 Setting Up and Configuring the Heartstream XL Connecting Disconnecting Patient Cables SpO Patient Cable To connect the SpO patient cable 1 Hold the connector with the flat side facing away from the Heartstream XL as shown in Figure 10 3 2 Insert the connector into the
60. ed Paddle Fault NO PADDLES CONNECTED message and dashed line appear on the display if paddles become disconnected Pad Fault PADS OFF message and dashed line appear on the display if a pad becomes disconnected Heart Rate Display Digital readout on display from 15 to 300 bpm with an accuracy of 10 Heart Rate Alarms Configurable pairs of low and high heart rate alarm lim its 30 to 100 60 to 140 90 to 160 and 120 to 200 bpm Hands Free Defibrillation Patient Cable Length 7 ft 2 13 m ECG Cable Length 12 ft 3 7 m Common Mode Rejection Greater than 90 dB measured per AAMI standard for cardiac monitors EC 13 M4735A Heartstream XL Defibrillator Monitor 13 5 Specifications ECG Size 2 5 5 10 20 40 mm mV Frequency Response AC Line Filter 60 Hz or 50 Hz Pads ECG for Display Monitor 15 40 Hz or EMS 1 30 Hz Pads ECG for Printer Monitor 15 40 Hz or EMS 1 30 Hz Leads ECG for Display Monitor 15 40 Hz or EMS 1 30 Hz Leads ECG for Printer Diagnostic 05 150 Hz or EMS 1 30 Hz or Monitor 15 40 Hz Patient Isolation defibrillation proof ECG Type CF SpO2 Type CF Defib Type BF 13 6 Specifications amp Safety Specifications ECG Analysis Performance ECG TEST RHYTHM CLASS SAMPLE SIZE NOMINAL SPECIFICATIONS Shockable Rhythm 600 Meets AAMI DF39 requirement and AHA recommenda ventricular fibrillation tion sensitivity gt 90 for adu
61. ed for a Paddles Pads Lead I Lead II Lead III 3 lead ECG cable Paddles Pads Lead I Lead II Lead III 5 lead ECG cable aVR aVL aVF V lead To select a lead to monitor cycle through the choices by pressing EE until the desired lead is displayed Figure 4 4 ECG Monitoring Display in AED Mode LEAD SpO2 v 78 A Led Im p P P IR E ES Monitoring Rhythm Shocks 3 00 00 49 NOTE To change to a different V Lead move the electrode rather than pressing the Lead Select softkey M4735A Heartstream XL Defibrillator Monitor 4 7 Selecting the Lead 4 8 Figure 4 5 ECG Monitoring Display in Manual Mode 78 a Pads hix A ee Si SS ap c 87J Shocks 0 Sync 00 00 08 Y mam The message Leads Off is displayed in the System Message area accompanied by a beep when a lead is disconnected or the electrodes have poor patient con tact A dashed line on the display indicates that there is no ECG signal as shown in Figure 4 6 Figure 4 6 Leads Off Display in AED Mode SpO2 IHR ALARM LEAD P pmaramw setter ovom 4 A Leadil Shocks 0 00 00 08 Monitoring the ECG WARNING WARNING Setting the Heart Rate Alarm Setting the Heart Rate Alarm The computed heart rate the number of detected QRS complexes per minute is displayed below the HR ALARM softkey next to the amp The heart rate repre sents the number of QRS complexes detected in a minute If
62. ee the manufacturer s instructions supplied with the sensor Disposable Sensors Disposable sensors should be used only once and then discarded They can be relocated to a different application site on the patient if the first location does not give the desired results Disposable sensors must not be reused on differ ent patients M4735A Heartstream XL Defibrillator Monitor 5 5 Applying the Sensor Applying the Sensor Follow the manufacturer s directions for applying and using the sensor mak ing sure to observe any warnings or cautions For the best results e Make sure the sensor is dry e Ifthe patient is moving secure the sensor cable loosely to the patient e Avoid excessive pressure at the sensor site ensure that circulation is not obstructed e Keep power cables away from the sensor cable and connection e Avoid placing the sensor in an environment with bright lights if nec essary cover the sensor with opaque material e Avoid placing the sensor on any extremity with an arterial catheter blood pressure cuff or intravascular venous infusion line WARNING Failure to apply the sensor properly may reduce the accuracy of the Sp0 measur ment WARNING Inspect the sensor application site at least every two hours for changes in skin qual ity correct optical alignment and proper sensor application If skin quality is com promised change the sensor site More frequent checking may he required due to an individua
63. efib electrodes pads are properly connected If either connection is compro mised you are prompted to fix the problem 25 Analysis begins automatically there is no need to press ANALYZE Once analysis is complete the Heartstream XL tells you Shock Advised or No Shock Advised G5 If a shock is advised press SHOCK After the first shock is delivered the Heartstream XL automatically begins analyzing the ECG and the process repeats until a shock series is complete or no shock is advised At this point you are prompted to check the patient Defibrillating in AED Mode Overview Defibrillation with a modified configuration Chapter 10 details the configurable parameters for AED Mode Three param eters significantly impact the defibrillation process They are Device Initiated Analysis initiates ECG analysis when the Heartstream XL is first turned on The default configuration setting is On If you choose to set this parameter to Off you need to press ANALYZE to initiate analysis in step 2 of the defibrillation process Automatic Re analysis initiates ECG analysis in between shocks within a shock series The default configuration setting is On If you choose to set this parameter to Off you need to press ANALYZE to initiate analysis in between shocks within a shock series i e after the first and second shock of a three shock series Rhythm Monitoring monitors the ECG for potentially shockable rhythms when the Heart
64. efibrillation and synchronized cardioversion and optional pacing functionality Figure 2 3 Manual Mode Controls Energy Select Knob and Pacing Controls Energy Select P Jm O Cran M4735A Heartstream Defibrillator Monitor 2 5 Getting Acquainted Display Buttons Energy Can enable both Manual Mode and AED Mode The AED Select On position activates AED Mode Manual On enables Knob Manual Mode synchronized cardioversion and pacing optional Button below the display far left that enables synchronized cardioversion when first pressed in Manual Mode disables synchronized cardioversion when pressed again Activates the pacing function buttons as indicated by the green LED allowing you to use the buttons below to define pacing rate mode and current output Also turns off the Pacer function when pressed a second time Adjusts the pacing rate Starts pacing Delivers pacer pulses when first pressed stops pacing when pressed again Selects Demand or Fixed Mode for pacing Adjusts the current output for pacing NOTE 2 6 Synchronized cardioversion and pacing controls only function when Manual Mode is enabled Getting Started Getting Acquainted Display Layout The following figures show the layout of the display in e AED Mode with ECG and SpO2 monitoring capabilities enabled e AED Mode with ECG and SpO2 monitoring capabilities disabled e Manual Mode NOTE ECG and SpO2 monitor
65. elected monitoring e Check that the monitoring lead is not making proper electrodes are properly contact with the patient applied e Pacing was attempted in e Check that the monitoring demand mode without cable and electrodes are monitoring electrodes properly connected attached Pacer Failure The pacing system is not Remove the device from active functioning use and call for service Pacer Output High patient impedance is Check that the pads are applied Low resulting in the delivering less properly current to the patient than specified in the output current setting Stop Pacer W Stop pacing before changing e pressed While the pacing mode paced pulses are being deliv ered Key Inactive Make sure Manual Mode is r SE the other active before pressing pacing function keys is pressed when Manual Mode is or one of the other not active pacing function keys M4735A Heartstream XL Defibrillator Monitor 8 9 Troubleshooting 8 10 Pacing Optional 9 Storing Retrieving amp Printing This chapter describes how the Heartstream XL creates an Event Summary or patient record for later retrieval and printing Marking events for storage in the Event Summary and printing individual events as they occur are also dis cussed M4735A Heartstream XL Defibrillator Monitor 9 1 Overview 9 2 Overview The Heartstream XL automatically creates an Event Summary for each patient The Eve
66. eliv ered the duration is equal to the Post Shock CPR Timer configuration set ting the default setting is 60 seconds e when no shock was advised the duration is equal to the NSA Timer configuration setting where NSA is an acronym for No Shock Advised the default setting is 180 seconds M4735A Heartstream XL Defibrillator Monitor 3 19 Troubleshooting 3 20 Troubleshooting When the Heartstream XL detects a problem it provides display and or voice prompts to guide you to resolution The table below lists the prompts you may encounter in AED Mode the cause and the suggested corrective action Prompts related to the battery and Data Card are discussed in Chapter 12 Tahle 3 1 Trouhleshooting in AED Mode Prompt Possible Cause Corrective Action Pads Off e The multifunction defib elec Check that the pads are applied display trode pads are not properly to the patient s bare chest as or applied to the patient directed on the pads package Apply Pads Replace the pads if the prompt voice continues Pads Cable e The pads cable is not connected Check that the defibrillation Off to the defibrillator pads connector is locked in display place or Apply Pads voice Artifact e Patient motion interferes with Attempt to eliminate patient Detected analysis motion Avoid analyzing while Do Not transporting or performing CPR Touch Move suspected devices away Patient e Electrical sources are causing f
67. ge These events can be printed as they occur or as part of an Event Summary The M4735A Heart stream XL Defibrillator Monitor also enables you to store data and events on an optional Data Card for downloading to CodeRunner Web Data Manage ment Systems The versatile M4735A Heartstream XL Defibrillator Monitor is highly con figurable to better meet the needs of diverse users The messages and softkeys vary depending on how the M4735A Heartstream XL Defibrillator Monitor is configured Be sure to familiarize yourself with your configuration before using the M4735A Heartstream XL Defibrillator Monitor see Configuring the Heartstream XL on page 10 7 The M4735A Heartstream XL Defibrillator Monitor is powered by AC power and a rechargable sealed lead acid SLA battery which allows the defibrilla tor to charge to 200 joules in less than three seconds Proper care of your bat teries will ensure that they have the energy required to operate the M4735A Heartstream XL Defibrillator Monitor and to deliver the appropriate therapy See Battery Maintenance on page 11 7 Similarly performing the speci fied operational checks will ensure that the M4735A Heartstream XL Defibrillator Monitor is functioning properly and ready for use See Opera tional Checks on page 11 2 M4735A Heartstream XL Defibrillator Monitor 1 3 Intended Use Intended Use The M4735A Heartstream XL Defibrillator Monitor is for use in the hospital by
68. ib electrode pads applied to the patient s bare chest Indications Noninvasive pacing is one method of treating patients with symptomatic bradycardia It can also be helpful in patients with asystole if performed early Contraindications Noninvasive pacing is contraindicated in the treatment of ventricular fibrilla tion Noninvasive pacing in the presence of severe hypothermia may be con traindicated SpO Monitoring Optional A pulse oximeter is a noninvasive device that indicates the oxygen saturation SpO of arterial blood This measurement is obtained through a probe that directs red and near infrared light through arterial beds Hemoglobin absorbs these lights differently when it is bound with oxygen Pulse oximetry mea sures this difference and translates the measurement into a saturation percent age that is displayed as an SpO reading M4735A Heartstream XL Defibrillator Monitor 1 7 Safety Considerations Indications SpO monitoring is indicated for use when it is beneficial to assess a patient s oxygen saturation level Contraindications There are no known contraindications for SpO2 NOTE 1 8 Readings should be carefully considered in the presence of certain circum stances Inaccuracies may result from the use of pulse oximeters in the pres ence of certain circumstances such as hemoglobin saturated with compounds other than oxygen such as carbon monoxide hypothermia hypovolemia patient
69. ibrillator Monitor System Messages Table 12 1 System Messages Continued Message Sp02 Cable Off Description The SpO cable is not connected to the device Corrective Action Attach the SpO cable to the Heartstream XL Sp02 Light Interf The level of ambient light is so high that the sensor cannot obtain an SpO reading or the sensor or cable is damaged e Cover the sensor with an opaque material e Check the sensor for damage try another sensor Non Pulsatile The patient s pulse is absent or too weak to be detected e Check that the sensor is applied prop erly Make sure the sensor site has a pulse Relocate the sensor to a site with improved circulation e Try another sensor Sp02 Low Signal SpO signal is too low to give an accurate reading Check the sensor is applied properly Try another sensor type Sp02 Noisy Signal Excessive patient movement electrical interference or optical interference is e Minimize patient movement or apply the sensor to a site with less present movement e Secure the sensor cable loosely to the patient e Reduce sources of electrical or optical interference Sp02 Sensor Fail The SpO transducer is broken Try another sensor 12 4 Troubleshooting Momentary Messages System Messages Momentary messages are temporary and only appear on the display for a few seconds Each message is accompanied by a three se
70. ically Figure 3 7 Analyzing Display HR LEAD SpO2 ALARM SELECT ON OFF v1204 Pads As D i foal in l un V v V JUN M il r i d dn Ad Vu Analyzing Do Not Touch Patient Shocks 0 00 00 08 Ts TT ANALYSIS Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis Defibrillating in AED Mode Defibrillating If a shockable rhythm is detected as indicated by the message Shock Advised analysis stops and the Heartstream XL automatically charges to 150J Charg ing is accompanied by an intermittent charge tone Figure 3 8 Charging Display ALARM SELECT ON OFF v1204 Pads V ARI A Charging to 150 97J Shocks 0 00 00 10 M4735A Heartstream XL Defibrillator Monitor 3 11 Defibrillating 3 If shock advised press SHOCK Once charging is complete the charge tone becomes continuous Make sure no one is touching the patient or anything connected to the patient Call out clearly and loudly Stand Clear Then press SHOCK to deliver a shock to the patient Figure 3 9 Press SHOCK Display HR LEAD SpO2 ALARM SELECT ON OFF v1204 Pads n lin n nli Ann a n rn uU vi ACA A A V ow pd i WA T U VV fa Uu Stand Clear Press SHOCK 150J Shocks 0 WARNING Defihrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation The defi
71. information on printing storing and retrieving patient information acquired while monitoring see Chapter 9 WARNING Do not rely solely on Sp0 readings assess the patient at all times Sp02 readings may be inaccurate in the presence of significant levels of carhoxyhemoglobin or methomoglobin in patients with restricted blood flow to the extremities such as those in severe shock or hypothermia or in the presence of excessive motion 5 2 Monitoring SpO2 Understanding Pulse Oximetry Understanding Pulse Oximetry A pulse oximetry sensor sends light through patient tissue to a receiver on the other side of the sensor As Figure 5 1 shows light emitting diodes transmit red and infrared light through peripheral areas of the body such as a finger Figure 5 1 Pulse Oximetry Sensor Light Emitting Diodes Photodetector A photodector positioned opposite the light emitting diodes compares light absorption before and after pulsation The amount of light getting through reflects the blood flow in the arterioles This measurement of light absorption during pulsation is translated into an oxygen saturation percentage and an SpO value is displayed For accurate SpO measurements the following conditions must apply The patient must have perfusion in that extremity The light emitter and the photodetector must be directly opposite each other All of the light from the emitter must pass through the patient s tissue The sensor
72. ing battery full roll of paper and external paddles Environmental Temperature 0 C to 55 C operating 20 to 70 C storage e Charging the battery at temperatures above 35 C may degrade bat tery life e Storing the battery for extended periods at temperatures above 40 C will reduce battery capacity and degrade battery life Humidity Up to 95 Relative Humidity e Printer paper may jam if paper is wet e Thermal Printer may be damaged if wet paper is allowed to dry while in contact with printer elements 13 12 Specifications amp Safety Specifications Altitude Operating up to 15 000 ft Storage up to 15 000 ft Shock Agilent Technologies Section 760 Class B1 Drop Test 200 G s 3 msec pulse Vibration Agilent Technologies Section 759 Class B1 Vibration Water Resistance Meets IEC 601 2 4 IPXO EMC Meets EN 60601 1 2 Safety Meets IEC 601 1 EN 60601 1 UL 2601 1 CAN CSA C22 2 No 601 1 Other Considerations Equipment not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Mode of Operation Continuous AC Line Powered 100 240 VAC 50 60 Hz 1 5 A Class 1 Battery Powered 12 V Rechargeable SLA M4735A Heartstream XL Defibrillator Monitor 13 13 Symbol Definitions 13 14 Symbol Definitions The following table lists the meaning of each symbol shown on the Heartstream XL and the M3516A battery Table 13 1 Defibrillator and Battery S
73. ing capabilities for AED Mode may be enabled and disabled independently in the configuration Figure 2 4 AED Mode Display Layout ECG and SpO Enabled Lead Displayed SpO value HR ALARM SELECT er o OFF He Heart Rate 9 132 4 Lead II SpO alarm HR Alarm Pleth Bar System Message Pulse ra Pulse Rate Momentary Message f 1 i ECG gt j Pal nl UU NM NN vy Ln ey yq ECG Gain User Message 114J Current Charge Shocks 0 Shocks Delivered 00 15 02 Incident Timer Defibrillation PAUSE ANALYZE Soft Keys Op PAUSE The Incident Timer shows the elapsed time since the Heartstream XL was turned on provided patient contact was established If the Heartstream XL is powered on after being off for less than two minutes the Incident Timer resumes where it left off If power is off for more than two minutes the Inci dent Timer resets to zero 00 00 00 If an Event Summary is printed the inci dent timer will be set to zero the next time the unit is turned on M4735A Heartstream Defibrillator Monitor 2 7 Getting Acquainted Figure 2 5 AED Mode Display Layout ECG and SpO disabled System Message Momentary Message n n li i ECG gt ilia nnl a AAA aN ECG Gain d U VV n V Vd LU Vi Vu d A VV User Message 150J Current Charge Shocks 0 Shocks Delivered 00 15 02 Incident Timer Defibrillation PAUSE ANALYZE EN ei User messages accompany voice prompts to guide you thr
74. ito ng KC t 3 16 lg iB vor 3 18 icol diee 3 20 viii Contents Monitoring the ECG EE M n 4 2 Connecting the ECG Patient Cable iiio ete Side 4 3 Applying Monitoring Electrodes eessen eege 4 4 El ctrode Placem nt PE a E a 4 5 Selecting EE 4 7 Setting the Heart Rate A DIEBUS e octo rtp eiectus osi eH eite ax Sep edi NOE une ce qdE 4 9 Disabling the HR Alarm se ase cence chine oh 4 10 Adjusting th ECG SALE n 4 10 Adjusting the ECG Volume e m 4 10 Troubleshooting TE 4 11 Monitoring SpO2 ee LE e HER 5 2 Und rstanding Pulse OXIMEtry tegen act ud taque tuse Latin enkei asise aisiak 5 3 Selecting Eis iiio im M 5 4 RGSS SSMS M 5 5 Rice ci iori ro s T ai 5 5 Applying the Sensor rescos arenai 5 6 Connecting the Sensor Cable RR EE EEE T AA EE econ 5 7 hear mar EE 5 8 Setting AX TALIS eee cedet dtc oi aa resanni irte ii an oeiia Teede t Dau cansa Ei 5 9 screen EP Nan TP c ieia 5 9 Discontinung SpO2 Monitori 24222 diii meii ien aan i urat emi rta e ud tees eet 5 10 Caring Tor DU or c EE P A a EEA aA 5 10 Troubleshooting EE 5 11 Contents Defibrillating in Manual Mode M n al Mode Display a aE 6
75. l the Battery Capacity Test Batteries should be discarded in an environmentally safe manner Properly dispose of batteries according to local regulations Do not disassemhle puncture or incinerate batteries Be careful not to short the hattery terminals because this could result in a fire hazard M4735A Heartstream XL Defibrillator Monitor 11 9 Loading Printer Paper EN Loading Printer Paper To load printer paper 1 Slide the printer door to the right until the paper roller pops up 2 If there is an empty or low paper roll in the printer pull up on the plastic removal tab to remove the roll Figure 11 3 Opening the Printer 11 10 Maintaining the Heartstream XL Loading Printer Paper 3 Place a new roll of printer paper 40457C D into the printer paper well positioning the roll so that the end of the roll is on the top and the grid faces down Be sure to push the roll down so that it is firmly seated in the paper well 11 4 Pullthe end of the paper past the paper roll 5 Slide the printer door to the right and hold it open Press the roller down over the paper and release the door Figure 11 4 Loading Paper M4735A Heartstream XL Defibrillator Monitor 11 11 Cleaning Instructions Cleaning Instructions Cleaning the Heartstream XL The following cleaning products may be used to clean the exterior surfaces of the Heartstream XL as well as the battery and data card e Isopropyl alcohol 70 in water
76. l patient s condition 5 6 Monitoring SpO2 Connecting the Sensor Cable Connecting the Sensor Cable To connect a sensor cable 1 Hold the connector with the flat side up so that the part number is visible 2 Insert the connector into the receptacle and push until the blue portion of the connector is no longer visible Figure 5 2 Connecting the Sensor Cable 3 X M4735A Heartstream XL Defibrillator Monitor 5 7 Monitoring 5 8 Monitoring To monitor SpO 1 Ifthe Heartstream XL is not on turn the Energy Select knob to AED On or Manual On 2 Apply the appropriate sensor to the patient 3 Make sure the sensor cable is connected to the Heartstream XL 4 Press Sp0 0N OFF to turn on SpO monitoring A dashed line is displayed under Sp0 ALARM while the oxygen saturation is measured and an SpO value is calculated In a few seconds the SpO value is displayed in place of the dashed line As the patient s oxygen saturation changes the SpO value is updated continuously Figure 5 3 Sp0 Monitoring Display in AED Mode LEAD SpO2 SpO2 475 amp Pads 98 IS Pulse 78 prn P ER IL m re Monitoring Rhythm Shocks 3 00 00 49 To the right of the SpO value a pleth bar and SpO alarm indicator are dis played The pleth bar should be observed for fluctuation It is an indication of pulsation detected by the sensor The pleth bar should not be used as the sole indicator of pulsation becaus
77. lec trodes on page 4 4 Turn Energy Select knob to Manual On Apply multifunction defib electrode pads to the patient as directed on the package Use either the anterior apex or anterior posterior placement as appropriate Connect the pads to the patient cable See Figure 6 3 Press the Sync On Off button to turn synchronized cardioversion func tionality on Use tpe to select the best lead that displays a large QRS complex See Selecting the Lead on page 4 7 Performing Synchronized Cardioversion Using 3 or 5 wire ECG Leads Using 3 or 5 wire ECG Leads To prepare for synchronized cardioversion using 3 or 5 wire ECG leads perform the following steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 2 Apply monitoring electrodes if desired See Applying Monitoring Elec trodes on page 4 4 Turn Energy Select knob to Manual On Connect the ECG cable to the Heartstream XL See Figure 6 3 Press Sync On Use HAD to select the best lead that displays a large QRS complex See Selecting the Lead on page 4 7 D Mm x ko M4735A Heartstream XL Defibrillator Monitor 7 3 Using External Paddles Using External Paddles To prepare for synchronized cardioversion using external paddles perform the following steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 Apply monitoring electrodes if desired See
78. lt defibrillation Shockable Rhythm 300 Meets AAMI DF39 requirement and AHA recommenda ventricular tachycardia tion sensitivity gt 75 for adult defibrillation Non Shockable Rhythm 250 Meets AAMI DF39 requirement specificity gt 95 and Normal Sinus Rhythm AHA recommendation specificity gt 99 for adult defibrillation Non Shockable Rhythm 500 Meets AAMI DF39 requirement and AHA recommenda Asystole tion specificity gt 95 for adult defibrillation Non Shockable Rhythm 600 Meets AAMI DF39 requirement and AHA recommenda All other non shockable tion specificity gt 95 for adult defibrillation rhythms a From Agilent Technologies ECG rhythm databases b American Heart Association AHA AED Task Force Subcommittee on AED Safety amp Efficacy Automatic External Defibrillators for Public Access Use Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporation of New Waveforms and Enhancing Safety American Heart Association AHA AED Task Force Subcommittee on AED Safety amp Efficacy Circulation 1997 95 1677 1682 M4735A Heartstream XL Defibrillator Monitor 13 7 Specifications Display Size 115 mm x 86 mm Type EL Electroluminescent Resolution 320 x 240 pixels Sweep Speed 29 mm s nominal stationary trace sweeping erase bar Viewing Time 4 seconds Battery Type 2 Ah 12V rechargeable Sealed Lead Acid Dimensions 2 4 H x 0
79. lutions Table 12 3 Troubleshooting Tips Situation Cause Possible Solution The Heartstream XL There is no power e Insert a fully charged battery does not turn on e Attach AC Power cord There is a dashed ECG data is not being acquired e Check the patient cable is connected line on the display e Check the pads paddles or electrodes instead of an ECG are properly applied e Check that the desired lead is selected The Heartstream XL e The battery is low e Change the battery does not appear to be e There is a system failure e Take the device out of use and call for functioning properly service The displayed time is The time was not correctly set in the con Set the time in the General Settings menu incorrect figuration of the Configuration Mode The printed date is The date was not correctly set in the con Set the time in the General Settings menu incorrect figuration of the Configuration Mode The Heartstream XL Corrupt data card may prevent the unit Take the Data Card out replace it with will not power on from powering on new Data Card if possible Then attempt to turn the Heartstream XL on M4735A Heartstream XL Defibrillator Monitor 12 7 Calling for Service Calling for Service For telephone assistance call the Response Center nearest to you or visit our website at www healthcare agilent com mpgcsd United States of America Medical Response Center
80. motion or apply sen sor to site with less movement Secure the sensor cable loosely to the patient Reduce sources of electrical RFI or optical interference M4735A Heartstream XL Defibrillator Monitor Troubleshooting 5 12 Table 5 2 Troubleshooting when Monitoring Sntt Problem or Message Possible Cause Corrective Action ken Sp0 Light Interf e The level of ambient Cover sensor with an light is so high that the opaque material sensor cannot obtain an Check sensor for dam SpO reading age try another sen Sensor or cable is dam SOT aged Sp0 Cable Off The SpO cable is not Attach the cable to the connected to the device Heartstream XL Sp0 Sensor Fail e The transducer is bro Apply a new trans ducer Monitoring SpO2 6 Defibrillating in Manual Mode In Manual Mode you analyze the ECG decide if defibrillation is indicated select the energy level charge the device and deliver the shock The defibril lation process is under your control There are no voice prompts However system and momentary messages provide relevant information throughout the process It is important to be attentive to these messages This chapter describes how to defibrillate using Manual Mode For Manual Mode features such as synchronized cardioversion and pacing see Chapter 7 Performing Synchronized Cardioversion and Chapter 8 Pacing Optional For information on st
81. n Manual Mode using external paddles per form the following steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 2 Turn the Energy Select knob to Manual On 3 Remove paddles by simultaneously pulling them up and out of the holders M4735A Heartstream XL Defibrillator Monitor 6 3 Defibrillating in Manual Mode 4 Apply conductive matter NOTE Do apply conductive matter by rubbing paddles together Improper usage will result in a Paddles On event that will be registered in the Event Summary and may damage paddles 5 Apply paddles to patient s chest using the anterior apex placement NOTE To optimize patient contact adjust paddle pressure and placement Once proper contact has been made the patient contact indicator PCI located on the Sternum paddle will show a green LED See Figure 6 2 Figure 6 2 Patient Contact Indicator on Sternum Paddle Ca s Patient Contact Indicator E 1 1 kal 6 4 Defibrillating in Manual Mode Defibrillating in Manual Mode Using Multifunction Defib Electrode Pads In preparation for defibrillation in Manual Mode using pads perform the fol lowing steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 2 Turn the Energy Select knob to Manual On 3 If you are using multifunction electrode pads apply as directed on the package Use either the anterior apex or ante
82. n menu Printing Settings To print the configuration settings select Print All Settings from the main config uration menu Setting Up and Configuring the Heartstream XL 11 Maintaining the Heartstream XL This chapter describes how to care for your Heartstream XL Defibrillator Monitor and its accessories including operational checks battery maintenance procedures instructions on loading printer paper cleaning instructions a list of approved supplies and accessories and instructions for disposal of the device The operational checks described must be performed at the specified intervals in order to help prevent and detect electrical and mechanical problems The battery maintenance procedures specified must be strictly adhered to in order to ensure that your batteries have the energy required to operate the defibrilla tor and deliver the appropriate therapy M4735A Heartstream XL Defibrillator Monitor 11 1 Operational Checks Operational Checks The following operational checks are intended to quickly verify the viability of the Heartstream XL Perform these checks regularly at the intervals speci fied along with visual inspection of the device and all cables controls acces sories and supplies Also regularly check expiration dates of all supplies such as multifunction defib electrode pads and monitoring electrodes Every Shift Perform a Shift System Check every shift see Using External Paddles on page
83. ng 11 4 cleaning 11 13 connecting 2 2 3 6 ECG 10 3 ordering 11 18 Pads 3 6 10 2 SpO2 5 6 5 11 10 4 Cal Pulse 2 3 Check Patient Timer setting 10 11 Check Printer message 12 5 Cleaning Heartstream XL 11 11 pads electrodes amp cables 11 13 power modules 11 12 printer printhead 11 12 CodeRunner Web 2 11 9 1 Configuration 10 6 accessing menu 10 6 AED Mode 3 4 Automatic Re analysis 3 4 default 10 14 Device Initiated Analysis 3 4 ECG filters 10 13 heart rate alarm 4 6 list of configurable items 10 7 modifying 10 14 printing settings 10 15 Rhythm Monitoring 3 4 3 14 saving and loading from Data Card 10 15 Configuration Lost message 12 2 Continued Use feature 9 5 Controls 2 2 CPR 3 12 D Data Card 2 11 downloading and erasing information 9 1 inserting and removing 2 11 ordering 11 19 saving and loading settings 10 15 specifications 13 8 troubleshooting 12 2 12 6 Date 10 8 12 7 Default settings See Configuration Defib Disarmed message 12 5 Defib electrode pads See Pads Defibrillation 1 2 AED Mode 3 3 3 6 defined 1 4 Manual Mode 6 4 pacing 8 6 Defibrillation controls 2 3 Defibrillator See Heartstream XL Device Initiated Analysis settings 3 4 10 10 E Display AED Mode 2 7 controls 2 2 layout 2 5 Manual Mode 2 8 specifications 13 5 troubleshooting 12 7 ECG analysis See Analysis ECG cables cleaning 11 13 connecting 10 3 ordering 11 18 See also
84. ng D 8 8 erte 8 9 Storing Retrieving amp Printing isi Jr 9 2 Markin sh soir MN RE 9 3 loc sg M 9 4 Cr ating a Patient RECOTA M isata 9 6 Printing the Internal Event Summary AERCH 9 7 PANOS EE 9 9 xi Contents Setting Up and Configuring the Heartstream XL xii Connec ng Disconnecung Patient Cables iiis deerit tions ta ttr etn tss ortas to tuo Regg isa 10 2 Pads Paddles Patient Cable 1i E reb ERE EID ten Ma Mp PME P eme UE UNS 10 3 SpO2 Patient Cable er ieaie 10 5 ECG P tient Cable M taei a aE aS aaa E AE Ea 10 6 Contigutme the Heartstream XL uiui occi airnn E EE EE Ea 10 7 Accessing the Configuration Menu E 10 7 Configurable Parameters eene tc betonte eege nib iisi iiai iaaii 10 8 Modifying th Configuration uui rund erae edat en rasta un dia du Posen ip sata EIER 10 13 Returning to the Default Configuration eese nennen 10 13 paving Settings toa Data COE Ee 10 14 Loading Settings from a Data Card ME 10 14 PUTS 3 s T HU re ERE 10 14 Contents Maintaining the Heartstream XL Operational e 11 2 loce MN Ea 11 2 is gl vri M c M 11 2 Every Three Months 22dascsteteetantentdenn eegene 11 2 Using External Paddles PP 11 3 Usine Pads ee E TRES 11 4 Battery Capacity
85. nitoring Active SpO and heart rate alarms are also restored M4735A Heartstream XL Defibrillator Monitor 3 17 ERC Protocol ERC Protocol The Heartstream XL can be configured to support the European Resuscitation Council ERC Guidelines for Resuscitation If European Protocol is configured to On the defibrillation process described in this chapter is the same with the exception of how the Pause state functions see Pausing for CPR on 3 14 As described you can enter a Pause state e at the completion of a shock series or e when no shock is advised In both cases the ERC protocol prompts you to Check Patient Then it prompts you as follows Figure 3 15 Check Patient Message f A A li d al V Ww IV N V vro MAR UM If Needed Press PAUSE And Begin CPR Shocks 1 00 00 50 pause Lee NOTE Using the ERC protocol you are not prompted or given time to check the patient s pulse Defibrillating in AED Mode ERC Protocol If CPR is needed press PAUSE While paused a timer indicates the elapsed time and the total duration of the Pause state as shown Figure 3 16 Display in Paused State nd Y VAR IM UV Paused Elapsed Time V Y Total Pause Duration Timer 35 60 Shocks 3 in Seconds 00 01 40 The total pause duration depends on the event preceding the Pause state If you entered the Pause state e at the completion of a shock series or shortly after a shock is d
86. not open the electrode pack age until immediately prior to use Relocate or turn off equip ment that may be causing RFI M4735A Heartstream XL Defibrillator Monitor Troubleshooting 4 12 Situation Cause Solution QRS Volume No sound Adjust the volume Too low Check configurations Too loud QRS beeper inau The QRS beeper is con Check that the QRS dible or beeps do figured to Off beeper is configured to not occur with The amplitude of the On each QRS com plex QRS complex is too small to detect Adjust the volume Adjust the size of the ECG Monitoring the ECG 5 Monitoring SpO This chapter will provide information about e how pulse oximetry works e selecting and applying the correct sensor e monitoring Sp e discontinuing SpO M4735A Heartstream XL Defibrillator Monitor 5 1 Introduction Introduction Pulse oximetry is a noninvasive method of continuously measuring oxygen saturation SpO in arterial blood The resultant SpO reading indicates the percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen SpO monitoring is one of the tools available to assist in assess ing a patient s cardiac and respiratory systems This chapter explains how pulse oximetry works and describes how to use the Heartstream XL to moni tor Sp SpO monitoring is always available both in AED and Manual Mode if the option is purchased For
87. not inserted for the incident causing the Data Card to fill sooner Corrective Action e None A new Data Card can not be inserted during an incident e Use one Data Card per incident patient to decrease the chance of the card filling Data Card Interrupted The Data Card is removed during an inci dent e None The Data Card can not be re inserted during an incident e Do not remove the Data Card during an incident Data Card Not In Service The Data Card is inserted while the Heart stream XL is on None A Data Card must be inserted prior to turning the Heartstream XL on for the current patient Incompatible Data Card A Data Card other than the M3510A is inserted Use only M3510A Data Cards No Data Card Present A Data Card is not in the Heartstream XL Turn the Heartstream XL off and insert a Data Card prior to the first event for the patient Key Inactive The key pressed is currently inactive i e Use the appropriate mode for the key CPacer is inactive in AED Mode Stop Pacer Stop pacing before changing the pacing Mode is pressed while pacing pulses are being delivered mode Attach Cable Patient cable is not properly attached to Heartstream XL Check cable connections 12 6 Troubleshooting Troubleshooting Tips Troubleshooting Tips Table 12 3 lists some situations that you may encounter their possible causes and a few suggested so
88. nt Summary is stored in both internal memory and on a Data Card if one is used The Heartstream XL s internal Event Summary stores e upto 300 events pieces of critical information and e 50 ECG strips at 11 seconds each Events include things such as charging shocks and alarm violations You also trigger an event each time you press Mark 3 or C Strip 5 Storage on a Data Card is limited only by available space on the card In addi tion to storing all of the events that occur a continuous copy of the displayed ECG and Patient Contact Impedance are stored You can print the internal Event Summary at any time You can also configure your Heartstream XL to print individual events automatically as they occur Finally you can activate printing of individual events and patient information at any time by pressing Cas To print an Event Summary stored on the Data Card the information must first be downloaded to the Agilent Technologies CodeRunner Web data man agement system Refer to the CodeRunner Web User s Guide for download instructions Storing Retrieving amp Printing Marking Events Marking Events The button allows you to annotate the ECG strip at the point in time the button is pressed In AED Mode when monitoring is disabled the event is marked with a A In Manual Mode or when monitoring is enabled in AED Mode you can use the softkeys to select the annotation from the choices dis played See Figure 9 1
89. o battery installed Patient Impedance Range e Minimum 10 25 Ohm depending upon energy level e Maximum 180 Ohm Specifications amp Safety Specifications Manual Mode Manual Output Energy Delivered 2 3 5 7 10 20 30 50 70 100 150 200 Joules Controls Manual AED On Energy Select knob Charge Disarm Shock ECG Lead Select SpO2 On Off SpO2 Alarm HR Alarm Sync On Off Pacer Pacer Start Stop Pacer Rate Pacer Current Pacer Mode ECG Gain Volume Strip Summary Mark Indicators EL display for ECG waveform and text prompts Audio alerts QRS Beeper Charging tones for sync and asychronous modes AC Power LED Battery Charging LED Sync LED Pacer LED Armed Indicators Charge done tone and available energy indicated on display Energy Selection Front panel rotary knob Charge Control Front panel 2 key or buttons on paddles Shock Control Front panel 3 key or buttons on paddles 13 Synchronizer SYNC message appears on the monitor and is annotated on the printer if printing while in Sync mode An audible beep sounds with each detected R wave while a tick mark on the monitor and printed strip indicate the discharge points Synchronizer delay is less than 60 msec from peak R wave to peak current of the defibrillation discharge M4735A Heartstream XL Defibrillator Monitor 13 3 Specifications AED Mode AED Energy Profile Fixed energy 150 Joules AED Shock Series 2 3 or 4 shocks per se
90. odes 5 lead patient cable The V C lead of the 5 lead cable can be placed in any of the precordial lead positions V1 C1 through V6 C6 shown in Figure 4 3 Figure 4 2 Limb Lead Electrode Placement Table 4 2 3 Lead ECG Lead Formation AHA Labels IEC Labels RA Right Arm R Right LA Left Arm L Left RL Right Leg N Negative LL Left Leg F Foot Not used for 3 lead Lead reference I LA RA LL II LL RA LA III LL LA RA M4735A Heartstream XL Defibrillator Monitor 4 5 Applying Monitoring Electrodes Figure 4 3 Precordial Lead Electrode Placement Tahle 4 3 5 Lead ECG Lead Formation Location forth intercostal space at right sternal margin V2 C2 forth intercostal space at left sternal margin V3 C3 midway between V2 C2 and V4 C4 V4 C4 fifth intercostal space at left midclavicular line V5 C5 same level as V4 C4 on anterior axillary line V6 C6 same level as V4 C4 at left mid axillary line Lead Lead Formation I LA RA II LL RA III LL LA VR LA LL i RA 2 aVF RA LA LL 2 VL RA LL LA 2 V RA LA LL VIC 4 6 Monitoring the ECG Selecting the Lead Selecting the Lead Available monitoring leads depend upon how your device is configured Table 4 4 Lead Select Choices Lead Select Choices ace If Configur
91. ointing towards the Heart stream XL slide the Data Card into the compartment Be sure the card is seated securely within the compartment 5 Close the Data Card compartment door Make sure that you hear a click indicating that the door is latched shut Figure 2 9 Inserting a Data Card e 2 14 Getting Started Using a Data Card Optional Removing a Data Card To remove the Data Card press the black eject button see Figure 2 9 and pull the Data Card from the compartment Figure 2 10 Removing the Data Card M4735A Heartstream Defibrillator Monitor 2 15 Using a Data Card Optional 2 16 Getting Started 3 Defibrillating in AED Mode The Heartstream XL s AED Mode is designed to guide you through standard treatment algorithms for cardiac arrest including those provided by the Amer ican Heart Association and the European Resuscitation Council Configura tion choices allow you to customize AED Mode to better follow a specific treatment algorithm and to meet the unique needs of your life saving team This chapter describes how to use the Heartstream XL to defibrillate in AED Mode It explains the prompts that guide you through the defibrillation pro cess and describes how prompts vary depending upon the disposition of the patient and the configuration of your device For information on storing retrieving and printing patient information acquired in AED Mode see Chapter 9 M4735A Heartstream XL Defibrillator M
92. onitor 3 1 Figure 3 1 AED Mode Overview If Patient is e Unresponsive e Not Breathing e Pulseless Attach Pads Insert Data Card Optional Rotate Energy Select Knob to AED On If Instructed r Press ANALYZE Shock No Shock Advised Advised Press SHOCK gt Check Patient at completion of shock series within a shock series No Pulse Pulse P ress MEME Ventilate Do CPR Y Y 3 2 if Rhythm Monitoring on Defibrillating in AED Mode Overview Overview An overview of the AED Mode defibrillation process is shown in Figure 3 1 The process begins only after you have e assessed that the patient is unresponsive not breathing and pulseless e turned the Energy Select knob to AED On e prepared for defibrillation by attaching pads and cables and e inserting a Data Card if desired M4735A Heartstream XL Defibrillator Monitor 3 3 Overview 3 4 The defibrillation process is dependent upon the configuration of your Heart stream XL as described in the following paragraphs Defibrillation using the default configuration In its default configuration the defibrillation process is Turn the Energy Select knob to AED On Figure 3 2 Energy Select Knob Energy Select AED On Manual On The Heartstream XL checks to see if the pads patient cable and multifunction d
93. onitoring Electrodes Applying Monitoring Electrodes Proper application and placement of electrodes is essential for reliable moni toring Good contact between the electrode and the skin reduces the effects of motion artifact and signal interference Be sure that the electrodes do not come in contact with other conductive materials WARNING especially when connecting or disconnecting the electrodes to from the patient To apply electrodes 1 Identify the appropriate electrode sites See Figure 4 2 and Figure 4 3 2 Shave the electrode sites if necessary 3 Clean and abrade the skin at the electrode sites 4 Dry the skin at the electrode sites 5 Opena new package of M2202A Radio Translucent Monitoring Electrodes verify that the Use Before date has not passed 6 Apply the electrodes by peeling them one at a time from the protective backing and sticking them firmly to the patient s skin Press around the entire edge of each electrode to ensure that they are secure 7 Snap the lead wires onto the electrodes Make sure the lead wires do not pull on the electrodes NOTE If monitoring for long periods of time new monitoring electrodes and multi function defib electrode pads may need to be changed periodically Refer to the manufacturer s documentation for how often 4 4 Monitoring the ECG Electrode Placement Figure 4 2 shows typical electrode placement for the limb leads of a 3 or Applying Monitoring Electr
94. or easy operation This chapter will help you get your Heartstream XL up and running by following a few easy steps including e Connecting to AC Power e Inserting the battery e Inserting the optional Data Card if desired NOTE To connect cables to the Heartstream XL refer to Setting Up and Configur ing the Heartstream XL in chapter 10 M4735A Heartstream XL Defibrillator Monitor 2 1 Getting Acquainted Getting Acquainted This section provides an overview of the Heartstream XL controls connec tions and display layout A review of control functionality is also provided Basic Orientation Review the figure for a general layout of the controls where the patient cables connect and where to insert the battery and Data Card Figure 2 1 Basic Orientation Front Mark AC Power a Batt Charge Con Coe OLOR Print Strip TE SL Event Summary Volume ECG Size Pacer Rate Mode Energy Select Knob Start Stop Output Ee Battery Patient Cable diii Data Card 2 2 Getting Started Getting Acquainted Printer ECG Connector SpO Connector ECG Input Jack AC Power NOTE If your Heartstream XL does not have the SpO or Pacing option disregard these controls and the related information described in this section M4735A Heartstream Defibrillator Monitor 2 3 Getting Acquainted 2 4 Defibrillation Controls Defibrillation controls
95. oring retrieving and printing patient information acquired in Manual Mode see Chapter 9 Storing Retrieving and Printing M4735A Heartstream XL Defibrillator Monitor 6 1 Manual Mode Display Manual Mode Display The following figure Figure 6 1 identifies the major elements for the Manual Mode display Unlike the AED Mode display Manual Mode gives you access to synchronized cardioversion and self selected energy levels Figure 6 1 Manual Mode Display LEAD SpO2 Sp02 HRALARM SELECT ON OFF ALARM Sp0 gt Val Heart Rate Y I 32 ih Pads SEH Br Heart Rate Alarm T Pulse Rate Current Lead IW a ECG Gain ECG Waveform l y hA f WW SR vu U NOVY N Sync Shocks 0 00 15 02 Elapsed Time SYNC CHARGE SHOCK Shock Softke Charge Disarm PER Shock Counter Enabling Manual Mode To enable Manual Mode turn the Energy Select knob to Manual On 6 2 Defibrillating in Manual Mode Defibrillating in Manual Mode Defibrillating in Manual Mode This section will explain how to prepare for and perform asynchronous defibrillation in Manual Mode using multifunction defib electrode pads and paddles NOTE In Manual Mode defibrillation is always performed through paddles or pads However during defibrillation you may choose to monitor leads acquired through an alternate ECG source 3 or 5 lead monitoring electrodes Using External Paddles In preparation for defibrillation i
96. ough the defibrilla tion process System and Momentary Messages e alert you to conditions that require your attention e provide status information or e offer recommendations A System Message remains on the display until the condition that generated the message no longer exists A Momentary Message is temporary and appears on the display for a minimum of 3 seconds For a list of system and momentary messages see Chapter 12 2 8 Getting Started Connecting to Power Figure 2 6 Manual Mode Display Layout Lead Displayed SpO value LEAD PO2 SPO2 HR ALARM SELECT o OFF ALARM SpO alarm Heart Rate gt gt Je 132 4 MLE HR Alarm Pleth Bar System Message Pulse 130 Pulse Rate Momentary Message j d n ECG gt jl Malin nnl a A i ECG Gain V di V VU RA n T uu M y i uu U T il H i t 114J Current Charge S nc Shocks 0 Shocks Delivered y 00 15 02 Incident Timer Sync Display Defibrillation SYNC Softkeys ON OFF Connecting to Power The Heartstream XL is powered by AC Power and the M35164 battery Prior to inserting the battery make sure that the battery is charged and has been properly maintained See Battery Maintenance on page 11 7 It is recommended that a second charged battery be available at all times NOTE The Heartstream XL will take longer to charge to the desired energy level when using only AC Power and without the battery 2 9 M4735A Heartstream Defibrillator Monito
97. prior to charging plus continuous printing throughout the charge duration Shock Delivered 12 seconds 6 seconds just prior to shock plus 12 seconds after shock Shock Failed 6 seconds 6 seconds just prior to the message No Shock Delivered plus 6 seconds after the message Defibrillator disarmed 6 seconds 6 seconds just prior to disarm plus 6 seconds after disarm SpO2 or Heart Rate 6 seconds 6 seconds just prior to alarm viola Alarm Violation tion plus 6 seconds after alarm violation 6 seconds 6 seconds just prior to marking plus a pressed 6 seconds after button pressed M4735A Heartstream XL Defibrillator Monitor 9 9 Printing Events NOTE 9 10 Printing is configured independently for each of these events You can stop the printing before it has printed the entire strip by pressing Causa To print additional events that you observe in the course of caring for your patient press CSuip An ECG strip will print continuously until you press C Strip 2 a second time to stop printing If the printer is configured to have a 6 second delay the print out contains an additional 6 seconds of the ECG that occurred just prior to pressing Ca Storing Retrieving amp Printing 10 Setting Up and Configuring the Heartstream XL This chapter describes how to set up and configure your Heartstream XL Chapter 10 covers e Connecting Patient Cables e Configuring the Heartstream XL M4735A H
98. qualified medical personnel trained in the operation of the device and qual ified by training in basic life support advanced cardiac life support or defibrillation It must be used by or on the order of a physician When operating as a semi automatic external defibrillator in AED Mode the M4735A Heartstream XL Defibrillator Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED When operating as a defibrillator monitor in Manual Mode the M4735A Heartstream XL Defibrillator Monitor is suitable for use by emergency medi cal personnel trained in advanced cardiac life support Defibrillation Therapy Defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias The M4735A Heartstream XL Defibrillator Monitor provides this therapy through the application of a brief biphasic pulse of electricity to the cardiac muscle This electrical energy is transferred through attached paddles or disposable multifunction defib electrode pads applied to the patient s bare chest NOTE Successful resuscitation is dependent on many variables specific to the patient s physiological state and the circumstances surrounding the patient event Failure to have a successful patient outcome is not a reliable indicator of defibrillator monitor performance The presence or absence of a muscular response to the transfer of energy during electrical therapy is not
99. r Connecting to Power Inserting the Battery To insert the battery slide it into the battery receptacle as shown in Figure 2 7 Then push the battery in until you hear an audible click Figure 2 7 Inserting the Battery Getting Started Connecting to Power Removing the Battery To remove the battery from the Heartstream XL press the black battery eject button and pull the battery out as shown in Figure 2 8 Figure 2 8 Removing the Battery e M4735A Heartstream Defibrillator Monitor Connecting to Power 2 12 Low Battery Warning The message Low Battery is displayed when the battery is low and needs recharging This message indicates that the battery has sufficient remaining capacity to provide only about ten minutes of monitoring time and five shocks before the Heartstream XL shuts off Replace the battery or get access to AC power as soon as possible If the power is off for less than 2 minutes while you change the battery the Heartstream XL assumes that you are continuing to treat the same patient provided patient contact was established and the Event Summary was not printed prior to turning the power off It continues to store data on the Data Card if being used and append events to the existing Event Summary Alarms set prior to the power loss remain active If power remains off for more than 2 minutes the Heartstream XL assumes you are treating a different patient and assigns a new incident number
100. re softkeys are assigned numbers as shown in Figure 10 5 Figure 10 5 Softkey Numbers D Gb OD CD CD OD QD M4735A Heartstream XL Defibrillator Monitor 10 7 Configuring the Heartstream XL 10 8 To turn the Heartstream XL on in Configuration Mode 1 Ifthe device is already on turn the Energy Select knob to Off 2 While holding down softkeys 4 amp 5 turn the Energy Select knob to AED On The configuration menu appears as shown in Figure 10 6 The menu lists the categories of settings that may be configured Figure 10 6 Configuration Menu AED Settings Manual Settings ECG Filter Settings Save Settings to Data Card Load Settings from Data Card Print All Settings urn O o Exit Configuration Configurable Parameters The following tables show the configurable parameters for each category of settings A description of each parameter is provided along with the possible choices Default settings are in bold Setting Up and Configuring the Heartstream XL Configuring the Heartstream XL Tahle 10 1 General Settings Parameter Date dd mmm yyyy Description Current date where dd is the day mmm is the month and yyyy is the year Setting Choices any valid date Time hh mm Current time where hh is the hour and mm is the minutes Time is based on a 24 hour clock any valid time Print on Mark Prints a 3 second strip when is pressed On Off Print on Ch
101. receptacle and push until the blue portion of the connector is no longer visible Figure 10 3 Connecting the SpO Patient Cable To disconnect the SpO patient cable gently pull the connector out of the SpO receptacle M4735A Heartstream XL Defibrillator Monitor 10 5 Connecting Disconnecting Patient Cables 10 6 ECG Patient Cable To connect a 3 or 5 lead ECG patient cable l Align the keyed patient cable connector with the slot on the ECG receptacle as shown in Figure 10 4 2 Push the patient cable firmly into the ECG receptacle until the white por tion is no longer visible Figure 10 4 ECG Patient Cable Connector Receptacle To disconnect the ECG patient cable gently pull the white patient cable connector out of the ECG receptacle Setting Up and Configuring the Heartstream XL Configuring the Heartstream XL Configuring the Heartstream XL Configuration options allow you to customize the Heartstream XL to best meet your needs This section describes e how to access the configuration menu e configurable items and their setting options e how to change the configuration e how to save the configuration to a Data Card e how to load the configuration from a Data Card e how to print the configuration Accessing the Configuration Menu There is a special combination of softkeys that when pressed simultaneously turn the Heartstream XL on in Configuration Mode For the purposes of executing this procedu
102. ries Shock Series Timer off 30 60 90 120 150 180 or 210 seconds Text and Voice Prompts Extensive text audible messages guide user through protocol AED Controls On Off Pause Resume Analyze Stop Analysis Shock Lead Select SpO2 On Off SpO2 Alarms HR Alarms ECG Gain Vol ume Strip Summary Mark Indicators EL display for ECG waveform and text prompts Audio alerts Voice Prompts QRS Beeper Charging Tone Charge Done Tone Printer AC Power LED Battery Charging LED Armed Indicators Charge Done Tone Available Energy indicated on display Voice Message Patient Analysis Per protocol evaluates patient ECG and signal quality to determine if a shock is appropriate and evaluates connection impedance for proper defibrillation pad contact Shockable Rhythms Ventricular Fibrillation with amplitude gt 100 uV and wide complex ventricular tachycardia with rates greater than 150 bpm Sensitivity and Specificity Meets AAMI guidelines Specifications amp Safety Specifications ECG Monitoring Inputs Single channel ECG may be viewed on display and printed Pads ECG is obtained through 2 multifunction defibrillation electrode pads Lead I II or III is obtained through the 3 lead ECG cable and separate monitoring electrodes With a 5 lead cable lead aVR aVL aVF or V can also be obtained Lead Fault LEADS OFF message and dashed line appear on the display if an electrode or lead wire becomes disconnect
103. ries listed in Outside the USA contact your local Agilent Technologies Sales Office your authorized Agilent Technologies Dealer or Distributor or visit our Medical Supplies website at www healthcare agilent com mpgsupplies on page 11 14 Substitu tions may cause the Heartstream XL to function improperly WARNING Use multifunction defib electrode pads prior to their expiration date Discard pads after use Do not reuse pads Do not use for more than 8 hours of continuous pacing WARNING In AED Mode the multifunction defib electrode pads must be in the anterior apex oO ______ position as shown on the packaging The Heartstream XL was not designed to assess data acquired from pads in an anterior posterior position WARNING Use only 3 wire AC power cords with 3 pronged grounded plugs WARNING Keep hands and feet clear of paddle electrode edges Use your thumbs to depress the shock buttons on the paddle handle M4735A Heartstream XL Defibrillator Monitor 13 21 Safety Considerations CAUTION WARNING WARNING WARNING WARNING WARNING 13 22 Conductive parts of electrodes and associated connectors for applied parts including the neutral electrode should not contact other conductive parts including earth Do not allow multifunction defib electrode pads to touch each other or to touch other ECG monitoring electrodes lead wires dressings etc Contact with metal objects may cause electrical arcing
104. rinthead 11 12 specifications 13 5 XXXIV Printer paper loading 11 9 ordering 11 17 specifications 13 9 troubleshooting 12 5 Printing controls 2 3 Event Summary 9 6 events automatically 9 8 settings 10 15 Pulse checking 3 12 5 10 Pulse oximetry defined 1 7 5 1 described 5 2 specifications 13 7 See also SpO2 monitoring Q QRS beeper 4 6 adjusting 2 2 settings 10 9 troubleshooting 4 8 R Radio frequency RF interference 16 Re analysis 3 4 3 11 Recording events See Event Summary S RF interference 16 Rhythm Monitoring 3 4 3 14 AED Mode 3 8 configuring 3 14 10 10 events recorded 9 3 Safety precautions See Precautions Saving settings to Data Card 10 15 Semi Automatic External Defibrillation See AED Mode Sensors 5 3 applying 5 5 caring for 5 9 cleaning 11 13 ordering 11 18 selecting 5 3 troubleshooting 5 11 12 4 Service 12 8 Settings See Configuration Shipping carton symbols 12 Shock AED Mode 3 9 events recorded 9 3 settings 10 10 troubleshooting 3 18 12 5 Shock Series Timer 10 10 Softkeys 2 3 See also Controls Specifications AED Mode 13 3 batteries 13 6 defibrillator 13 2 display 13 5 ECG monitoring 13 4 environmental 13 9 Event Summary 13 8 Heartstream XL 13 8 Manual Mode 13 2 pacing 13 7 power supply 13 2 printer 13 5 SpO2 monitoring 13 7 SpO2 alarm 5 8 specifications 13 7 SpO2 cable cleaning 11 13 connecting 10 4 ordering 11 18 SpO2 Cable Off mess
105. rior posterior electrode placement as appropriate 4 Connect the pads to the pads patient cable as shown in Figure 6 3 Figure 6 3 Connecting Pads to the Patient Cahle M4735A Heartstream XL Defibrillator Monitor 6 5 Defibrillating in Manual Mode Defibrillation Procedure Once you have prepared to defibrillate in Manual Mode perform the follow ing steps 1 Select Energy To select the energy setting move the Energy Select knob to the desired energy level as shown in Figure 6 4 Energy choices range from 2 to 200 joules with the suggested level for adults being 150 joules Figure 6 4 Energy Select Knob Energy Select so D 100 ao A T Tq LI 2 D Mion emm SE 1c 6 6 Defibrillating in Manual Mode Defibrillating in Manual Mode 2 Charge Press CHARGE or charge button on paddles As the defibrillator charges the current charge is displayed above the shock counter if configured on as shown in Figure 6 5 A charging tone beeps until the desired energy level is reached at which point you ll hear a continuous charge tone Figure 6 5 Charging Display rr LEAD Spo2 1 32 Pads 861 Pulse 130 d SYNC You may increase or decrease the selected energy level after pressing the CHARGE button Simply move the Energy Select knob to desired energy level as before The defibrillator charges to the selected energy level automatically WARNING Wait until the current charge reaches the
106. rom the defibrillator when pos interference sible Shock Shock key not pressed within 30 Press within 30 seconds of Canceled seconds prompt Defibrillating in AED Mode Tahle 3 1 Trouhleshooting in AED Mode Troubleshooting Possible Cause Pads are not properly connected to the patient Corrective Action Check pads connection Prompt No Shock e Delivered Key D Inactive e e The key pressed only functions in Manual Mode The key pressed does not func tion during analysis or charging The key pressed does not func tion while in a pause state Turn the Energy Select knob to Manual on prior to pressing the key Wait for analysis or charging to complete prior to pressing the key Press RESUME prior to pressing the key M4735A Heartstream XL Defibrillator Monitor 3 21 Troubleshooting 3 22 Defibrillating in AED Mode 4 Monitoring the ECG This chapter will provide information about e applying monitoring electrodes e selecting the correct lead e setting and disabling the heart rate HR alarm and e adjusting the ECG size For information on how to apply multifunction defib electrode pads follow the directions on the pads packaging NOTE For information on storing and retrieving and printing patient information acquired while monitoring see Chapter 9 M4735A Heartstream XL Defibrillator Monitor 4 1 Overview 4 2 Overview
107. ront of the defibrillator monitor is no longer lit Replace the battery Printer make sure the printer e has sufficient paper e prints properly M4735A Heartstream XL Defibrillator Monitor 11 5 Operational Checks Battery Capacity Test To perform a Battery Capacity Test Turn the Heartstream XL off 2 Labelthe Heartstream XL to indicate to others that testing is in progress and the battery may not be used 3 Insert a charged battery 4 Ifan AC power cord is connected unplug it While pressing Cat 5 turn the Energy Select knob to AED On to start the test 5 Allow the test to proceed to completion The test takes approximately three hours and is complete when test results print out and the device turns itself off 6 Review the test results and take the appropriate action as follows Tahle 11 1 Battery Capacity Test Results If Then Elapsed Time gt 85 minutes 1 The battery passed the test and 2 Record pass CT and the date on Low Battery Time gt 10 minutes the bottom of the battery 3 Recharge the battery before use Elapsed Time 85 minutes 1 The battery failed the test or 2 Record fail CT and the date on Low Battery Time 10 minutes the bottom of the battery 3 Discard the battery appropriately Maintaining the Heartstream XL Battery Maintenance Battery Maintenance The Heartstream XL uses the M3516A Battery Pack It is a rechargeable sealed lead acid battery Batte
108. rtain locations Does the interference occur only when in close proximity to certain medical devices Does the SpO2 value change dramatically when the AC line cord is unplugged Once the source is located attempt to attenuate the EMC coupling path by distancing the defibrillator from the source as much as possible If assistance is needed call your local service representative 13 26 Specifications amp Safety Electromagnetic Compatibility Restrictions for Use Artifact on the ECG caused by electromagnetic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment Immunity Level The EMC standards state that manufacturers of patient coupled equipment must specify immunity levels for their systems It is recognized that the Heartstream XL defibrillator monitor is designed to receive and amplify low level signals in the same bandwidth as the interference Immunity is defined in the standard as the ability of a system to perform without degradation in the presence of an electromagnetic disturbance Degradation in ECG quality is a qualitative assessment which can be subjective Caution should therefore be taken in comparing immunity levels of different devices The criteria used for degradation is not specified by the standard and may vary with the manufacturer 13 NOTE For additional information about compliance with the EMC s
109. ry maintenance begins when you receive a new battery and continues throughout the life of the battery Detailed information on battery care is provided in the application note About Sealed Lead Acid Batteries that came with your Heartstream XL Table 11 2 lists battery maintenance activities and when they should be per formed Tahle 11 2 Battery Maintenance Activities Activity When to Perform Perform a visual inspection Daily as part of the Shift System Check Charge the battery After each use or if the message Low Battery is displayed Perform a Battery Capacity Test At the time of purchase and every three months thereafter Store the battery appropriately When not in use M4735A Heartstream XL Defibrillator Monitor 11 7 11 Battery Maintenance Recharging Batteries You may charge batteries while they are in either the Heartstream XL or the optional M4747A Battery Charger Kit If the battery is being charged while in the defibrillator monitor with the Heartstream XL powered off a discharged battery will typically be 90 charged after 3 hours at 25 C as indicated by the Batt Charge LED on the front panel turning from amber to green After the LED turns green the battery will typically be fully recharged after an additional 12 hours at 25 C CAUTION The battery should be fully charged whenever possible Repeated charges to just the 90 level will degrade the battery
110. s chapter provides general troubleshoot ing tips and information on calling for service 12 NOTE For instructions for repair or for further technical information refer to the M4735 90900 Heartstream XL Service Manual M4735A Heartstream XL Defibrillator Monitor 12 1 System Messages Table 12 1 System Messages System Messages System messages remain on the display until the specified action is taken or no longer relevant Each new message displayed is accompanied by three beeps to alert you Table 12 1 lists system messages Message Configuration Lost Description The configuration is reset to the default settings Corrective Action Reconfigure the Heartstream XL Check to see if the battery is properly charged Replace the battery If the message persists call for service Data Card Disabled The Data Card is not in use because it is full incompatible absent or inserted after the Heartstream XL was turned on If possible turn the Heartstream XL off for more than 2 minutes insert an empty compatible Data Card and turn the device on You may also enter configuration mode and turn the machine off then on again ECG Fault The ECG data acquisition system failed and data is unavailable from the 3 or 5 wire monitoring electrodes Remove the device from active use and call for service Low Battery The battery has sufficient capacity remaining to provide onl
111. se the volume of voice prompts and or alarms press A or W on the volume control Cas NOTE 4 10 Note When using the Heartstream XL during a new event the ECG volume is set at the default volume level However if the unit is turned off and then back on within 2 minutes continued use the volume settings will remain where you left them when the unit was turned off Monitoring the ECG Troubleshooting Troubleshooting Table 4 6 provides troubleshooting tips for ECG Monitoring Tahle 4 6 Troubleshooting when Monitoring the ECG Situation Leads Off message or dashed line Cause e The monitoring elec trodes are not applied or are not making proper contact with the patient e The monitoring cable is not connected Solution Check that the monitoring electrodes are properly applied Check that the monitoring cable is properly con nected Pads Off message e The pads are not mak ing proper contact with the patient Check that the pads are properly applied Poor ECG signal quality e The monitoring elec trodes are not making proper contact with the patient e The monitoring elec trodes are outdated or dried out e Radio frequency inter ference RFI is causing artifact Check that the monitoring electrodes are properly applied If necessary pre pare the patient s skin and apply new electrodes Check the date code on the electrodes Do
112. sed time appears on On Off Timer the display during an event Table 10 4 ECG Filter Settings Item Description Setting Choices AC Line Filter Selects the setting used to filter out 60 Hz 50 Hz AC line noise Pads ECG for Selects the display filter frequency Monitor 15 40Hz Display for the therapy cable attached EMS 1 30 Hz Pads ECG for Selects the printer filter frequency Monitor 15 40Hz Printer for the therapy cable attached EMS 1 30 Hz Leads ECG for Selects the display filter frequency Monitor 15 40Hz Display for the monitoring electrodes ECG EMS 1 30 Hz Leads ECG for Selects the printer filter frequency Diag 05 150 Hz Printer for the monitoring electrodes ECG EMS 1 30 Hz Monitor 15 40 Hz 10 12 Setting Up and Configuring the Heartstream XL Configuring the Heartstream XL Modifying the Configuration To modify the configuration from the main menu 1 Use the softkeys A and W to highlight the desired category of settings Press ENTER Use the softkeys to highlight the item you want to change Press CHANGE Use the softkeys to select the desired setting o ot oan Press SAVE to save the change To exit without making the change press CANCEL 7 Press MAIN to return to the main menu To make additional changes repeat steps 1 7 Returning to the Default Configuration Press A and W on Ef simultaneously while in
113. should appear below the Sp0 ALARM softkey Figure 5 5 Sp0 Monitoring Off LEAD SpO2 78 A Pads LAL ahs Monitoring Rhythm Shocks 3 00 00 49 Caring for Sensors Refer to the manufacturers instructions for care and cleaning of sensors To get the best results from your SpO reusable sensors always handle the sensor and cable with care and protect them from sharp objects The sensor sleeve houses a sensitive electronic device that can be damaged Harsh treatment of sensors will drastically reduce their lifetime WARNING Do not use a damaged sensor or one with exposed electrical circuits 5 10 Monitoring SpO2 Troubleshooting Troubleshooting The table below lists system messages that you may encounter when monitoring SpO gt Table 5 2 Troubleshooting when Monitoring Sp0 Problem or Message Non Pulsatile Possible Cause Pulse absent or too weak to be detected Corrective Action Check the sensor is applied properly Make sure the sensor site has a pulse Relocate the sensor to a site with improved circulation Try another sensor type Make sure nail polish is not present Sp0 Low Signal SpO signal is too low to give an accurate read ing Check the sensor is applied properly Try another sensor type Sp0 Noisy Signal Excessive patient move ment electrical interfer ence RF interference or optical interference Minimize patient
114. stream XL is not analyzing defibrillating or paused The default setting is On If you choose to set this parameter to Off the Heartstream XL will not look for potentially shockable rhythms during these idle times Idle times also include e power on when Device Initiated Analysis is off e in between shocks within a shock series when Auto Re analysis is off If Rhythm Monitoring is off you need to observe the patient during idle times and determine when to press ANALYZE The following sections describe the defibrillation process in detail They also describe what happens at the completion of a shock series and if a shockable rhythm is not detected M4735A Heartstream XL Defibrillator Monitor 3 5 Preparation Preparation If the patient is e unresponsive e not breathing e pulseless Then 1 Apply multifunction defib electrode pads to the patient as directed on the package Use the anterior apex electrode placement 2 Connect the pads to the pads patient cable as shown in Figure 3 3 3 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 Figure 3 3 Connecting Pads to the Patient Cable 3 6 Defibrillating in AED Mode Defibrillating Defibrillating Follow the voice and screen prompts as they guide you through the following steps 1 Turn the Energy Select knob to AED On In this first step of the defibrillation process the Heartstream XL checks to see if the pads pa
115. tandards please see the Declaration of Conformity Statement available at http www healthcare agilent com mpg reginfo conformity html M4735A Heartstream XL Defibrillator Monitor 13 27 Electromagnetic Compatibility 13 28 Specifications amp Safety A Accessories arranging 10 5 checking 11 4 ordering 11 17 13 AED Mode 3 1 configuring 3 4 10 9 CPR 3 12 defibrillation process 3 6 display 2 5 2 7 ECG monitoring 4 1 enabling from Manual Mode 6 6 events recorded 9 3 Events Summary 9 2 indications for use 1 5 overview 1 2 3 2 3 3 pausing 3 12 3 15 preparation 3 5 re analysis 3 11 rhythm monitoring 3 14 specifications 13 3 SpO2 monitoring 5 1 training required 1 4 troubleshooting 3 18 Alarms heart rate 4 6 8 2 interruption of power 9 5 SpO2 monitoring 5 8 symbols 11 Analysis 3 8 AED Mode 3 8 re analysis 3 11 settings 3 4 Arrhythmias 1 6 Artifact Detected message 3 18 Asynchronous defibrillation 1 6 Asystole 1 6 pacing 1 7 Attach Pads message 12 5 Audiovisual controls 2 2 2 3 Automatic Re analysis 3 11 setting 3 4 10 10 Index Batteries 1 3 2 9 charging 11 7 checking 11 5 inserting and removing 2 9 maintenance 11 7 operational checks 11 2 ordering 11 19 specifications 11 8 13 6 storing and discarding 11 8 symbols 10 troubleshooting 12 2 See also Power supply Battery Capacity Test 11 6 Battery charger 11 19 Bradycardia 1 7 xxix Index Cables checki
116. tient cable and the pads are connected If they are it pro ceeds to step 2 If the pads patient cable is not properly attached you are prompted to Connect Pads Cable Figure 3 4 Connect Pads Cable Display Shocks 0 00 00 02 M4735A Heartstream XL Defibrillator Monitor Defibrillating Once the cable is connected the Heartstream XL will ensure the pads have adequate contact with the patient s skin Contact quality is measured by monitoring the electrical impedance between the two pads If the pads have not been applied or are not making proper contact with the patient you are prompted to Apply Pads and Check Connections Figure 3 5 Apply Pads Display Shocks 0 00 00 03 3 8 Defibrillating in AED Mode Defibrillating 2 If instructed press ANALYZE If device initiated analysis is off the Heartstream XL monitors the rhythm provided Rhythm Monitoring is on The Heartstream XL prompts you to press ANALYZE if a potentially shockable rhythm is detected Figure 3 6 Press ANALYZE Display SELECT ON OFF v120 n n i T JA WAV WH Zus MN Press Analyze Shocks 0 00 15 02 NOTE ECG Analysis is always performed through multifunction defib electrode pads Analysis can not be performed through monitoring electrodes M4735A Heartstream XL Defibrillator Monitor 3 9 Defibrillating WARNING If device initiated analysis is on you do not need to press ANALYZE ECG analysis begins automat
117. to potentially shockable rhythms provided Rhythm Monitoring is set to the default configuration 0n The message Monitoring Rhythm appears on the display to let you know this feature is active and remains on the display for the duration of the monitoring Figure 3 13 Monitoring Rhythm Display D nix n h i a fA a you wy Du uU Vu L VM y A E cu Monitoring Rhythm d Shocks 3 00 00 49 The recommended configuration setting for Rhythm Monitoring is On If Rhythm Monitoring is off you are not alerted when a patient s rhythm changes from non shockable to shockable as in refibrillation or an initially nonshockable rhythm that converts to a shockable rhythm Defibrillating in AED Mode Monitoring Rhythm If Rhythm Monitoring detects a shockable rhythm you are prompted as fol lows Figure 3 14 Shockable Rhythm no UN WAV MU AR A Check Patient If No Pulse Press ANALYZE Shocks 3 00 00 55 Ui This prompt is repeated periodically as configured until ANALYZE or PAUSE is pressed If you press ANALYZE the defibrillation process starts again If you press PAUSE rhythm monitoring is suspended for the duration of the pause PAUSE is used when administering CPR as noted earlier It may also be useful when performing medical procedures or encountering artifact during patient transport Active SpO2 and heart rate alarms are suspended during the pause duration as well Press RESUME to restore rhythm mo
118. tream XL Defibrillator Monitor has undergone clinical testing in adults These trials support the waveform s effectiveness for defibrillation of ventricular tach yarrhythmias at the 150J In manual mode operation the M4735A Heartstream XL Defibrillator Moni tor incorporates some user selectable lower energy levels that were not used in the clinical trials There are currently no clinical studies related to the use of the SMART Biphasic waveform in pediatric applications or in direct defibrillation of the heart during open chest surgery Contraindications for Manual Defibrillation Therapy Asynchronous defibrillation therapy is contraindicated in patients that exhibit one or any combination of the following e Responsiveness e Spontaneous breathing e Palpable pulse Precautions for Manual Defibrillation Therapy Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and completely eliminate any chance of recovery Asystole should not be routinely shocked Introduction Noninvasive Pacing Therapy Optional Noninvasive Pacing Therapy Optional The M4735A Heartstream XL Defibrillator Monitor provides noninvasive transcutaneous pacing by delivering a monophasic electrical stimulus to the heart This stimulus is intended to cause cardiac depolarization and myocar dial contraction The medical care provider selects the stimulus current and rate settings The energy is delivered through multifunction def
119. y about ten min utes of monitoring time and 5 shocks before the Heartstream XL shuts off e Replace the battery with a fully charged battery e Plugin AC power 12 2 Troubleshooting Table 12 1 System Messages Continued System Messages with the patient Message Description Corrective Action Leads Off e The monitoring electrodes are not e Check the monitoring electrodes are applied properly applied e The monitoring electrodes are not e Check the monitoring cable is prop making proper contact with the erly connected patient e The monitoring cable is not con nected No Pads The multifunction defib electrode pads Check the pads cable connection are not properly connected to the Heart stream XL Pads Cable Off The pads cable is not connected to the Check pads connector is locked in place defibrillator Pads Off The pads are not making proper contact Make sure the pads are properly applied to the patient Pacer Failure The pacing system is not functioning Remove the device from active use and call for service Pacer Output Low High patient impedance is resulting in the pacer delivering less current to the patient than specified in the output current set ting Check the pads are applied properly No Paddles Connected The paddles are not properly connected to the Heartstream XL Check that external paddles are con nected M4735A Heartstream XL Def
120. ymbols Symbol Definition Defibrillation Shock Attention See operating instructions in user s guide ASE Input E Meets IEC type BF leakage current requirements and is defibrilla tor protected Patient Applied Part is isolated and defib proof suitable for direct patient contact except the heart or major arteries Meets IEC type CF leakage current requirements and is defibrilla tor protected Patient Applied Part is isolated and defib proof suitable for direct patient contact including the heart and major arteries Alarms are active Alarms are inactive 3 ch T i t1 Recyclable material Specifications amp Safety Table 13 1 Defibrillator and Battery Symbols Symbol Definitions Symbol A Definition Biphasic energy is being used xi Must be recycled or disposed of properly Unlock A Audio Speaker Protective earth ground Alternating current Dangerous voltage M4735A Heartstream XL Defibrillator Monitor 13 15 Symbol Definitions Table 13 2 Abbreviations and Acronyms on Definition AC Alternating Current AED Automated External Defibrillator ECG Electrocardiogram Sp Pulse oximetry Batt Battery ECG Out Monitoring Signal from Defibrillator 13 16 Specifications amp Safety Symbol Definitions The following table lists th

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