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HEARTSTART XL - Philips

1. M4735A HeartStart XL Defibrillator Monitor 10 1 Connecting Disconnecting Patient Cables ees Connecting Disconnecting Patient Cables This section describes how to connect and disconnect the e Pads cable and Paddle Cables to the Patient Cable connector e SpO Patient Cable to the SpO connector e ECG Patient Cable 3 or 5 lead to the ECG connector 10 2 Setting Up and Configuring the HeartStart XL Connecting Disconnecting Patient Cables Connecting Cables to the Patient Cable Connector You connect the pads and internal external paddles to the HeartStart XL using the patient cable connector on the defibrillator An adapter cable is required for switchless paddles The patient cable connector on the HeartStart XL is used to connect e Pads patient cable for use with multifunction defib electrode pads e External paddles e Switchless internal paddles adapter cable e Switched internal paddles To connect any of these cables to the defibrillator 1 Align the white pointer on the cable with the white arrow on the defibril lator s patient cable connector as shown in Figure 10 1 2 Insert the cable into the patient cable connector Push until you hear it click in place Figure 10 1 Attaching Cables to the Patient Cable Connector Pointer Patient cable connector M4735A HeartStart XL Defibrillator Monitor 10 3 Connecting Disconnecting Patient Cables To disconnect the cable from the defibrillator 1 Ro
2. e Reconfigure the HeartStart XL e Check to see if the battery is properly charged e Replace the battery e Ifthe 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 HeartStart XL was turned on If possible turn the HeartStart 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 multifunc tion defib electrode pads or both Remove the device from active use and call for service Low Battery The battery has sufficient capacity remaining to provide only about ten min utes of monitoring time and 5 shocks before the HeartStart XL shuts off e Replace the battery with a fully charged battery e Plug in AC power 12 2 Troubleshooting Table 12 1 System Messages Continued System Messages mum energy delivered is limited to 50J 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 no
3. on page 2 14 Turn the Energy Select knob to Manual On 3 Ifyou are using multifunction electrode pads apply as directed on the package Use either the anterior anterior or anterior 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 Cable 5 Connect the patient cable to the patient cable connector on the defibrilla tor as follows a Align the white pointer on the cable with the white arrow on the defibrillator s patient cable connector as shown in Figure 6 4 b Insert the cable into the patient cable connector Push until you hear it click in place M4735A HeartStart XL Defibrillator Monitor 6 5 Defibrillating in Manual Mode Using Switched Internal Paddles In preparation for defibrillation in Manual Mode using switched internal pad dles perform the following steps 1 Ifneeded insert a Data Card as described in Using a Data Card Optional on page 2 14 Turn the Energy Select knob to Manual On 3 Align the white pointer on the patient cable with the white arrow on the defibrillator s patient cable connector as shown in Figure 6 4 4 Insert the cable into the patient cable connector Push until you hear it click in place Figure 6 4 Attaching the paddles cable to the Patient Cable Connector Pointer Patient cable connector 660 Defibrillating in Manual Mode De
4. PHILIPS HEARTSTART XL HEARTSTART XL INSTRUCTIONS FOR USE a n es M4735A HeartStart XL Defibrillator Monitor PHILIPS Notice About This Edition Edition 7 Printed in the USA Publication number M4735 91900 The information in this guide applies to the M4735A HeartStart XL release Main 20 and earlier This information is subject to change without notice Philips shall not be liable for errors con tained herein or for incidental or conse quential damages in connection with the furnishing performance or use of this material Edition History Edition 1 September 2000 Edition 2 May 2001 Edition 3 June 2002 Edition 4 September 2002 Edition 4 1 February 2003 Edition 5 August 2004 Edition 6 May 2005 Edition 7 April 2006 Copyright Copyright 2006 Koninklijke Philips Electronics N V All rights are reserved Reproduction in whole or in part is prohibited without the prior written consent of the copy right holder SMART Biphasic is a registered trademark of Philips Use of supplies or accessories other than those recommended by Philips may compromise product performance ii 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 HeartStart XL Defibrilla tor Monitor complies with the require ments of the Medical Device Directive 93 42 EEC and c
5. The Event Summary is stored in both internal memory and on a Data Card if one is used The HeartStart XL s internal Event Summary stores e up to 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 Qar or Gstrip 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 HeartStart 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 German To print an Event Summary stored on the Data Card the information must first be downloaded to the HeartStart Event Review Data Management sys tem Refer to the HeartStart Event Review Instructions for Use 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
6. especially when connecting or disconnecting the electrodes to or 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 or clip hair if necessary 3 Clean and abrade the skin at the electrode sites 4 Dry the skin at the electrode sites 5 Open a new package of monitoring electrodes verify that the Use Before date has not passed 6 Snap the lead wires onto the electrodes 7 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 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 to replace the monitoring electrodes or defib pads 4 4 Monitoring the ECG Applying Monitoring Electrodes Electrode Placement Figure 4 2 shows typical electrode placement for the limb leads of a 3 or 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 1 3 Lead ECG Lead Formation AHA Labels TEC Labels RA Right Arm R Right
7. level in each frequency range Interference may occur in the vicinity of equipment marked with the following sym bol K 13 43 Emissions and Immunity 13 44 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromag netic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HeartStart XL is used exceeds the applicable RF compliance level above the HeartStart XL should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartSTart XL gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Specifications amp Safety Emissions and Immunity Recommended Separation Distances The HeartStart XL is intended for use in an electromagnetic environment
8. 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 Recyclable material Specifications amp Safety Symbol Definitions Table 13 1 Defibrillator and Battery Symbols Continued Symbol Definition Biphasic energy is being used b Must be recycled or disposed of properly Unlock PX Audio Speaker ps Protective earth ground Alternating current Dangerous voltage M4735A HeartStart XL Defibrillator Monitor 13 17 Symbol Definitions 13 18 Table 13 2 Abbreviations and Acronyms pate ag Definition AC Alternating Current AED Automated External Defibrillator ECG Electrocardiogram SpO Pulse oximetry Batt Battery ECG Out Monitoring Signal from Defibrillator Specifications amp Safety Symbol Definitions The following table lists the symbols that may appear on the HeartStart XL shipping carton Table 13 3 Shipping Carton Symbols Symbol Definition aco Atmospheric pressure range BA ox on Y Temperature range Relative humidity range R
9. 4J 50 46 7 50 52 3 53 5 52 1 15 70 65 4 70 73 1 75 0 72 9 15 100 93 5 100 104 7 107 2 104 4 15 150 140 3 150 156 8 161 0 156 5 15 200 187 200 209 3 214 6 208 6 15 Specifications amp Safety Specifications Charge Time e Less than 3 seconds to 200 Joules with a new fully charged M3516A SLA battery pack at 25 C e Less than 15 seconds when operating without a battery using AC power alone at 90 100 rated mains voltage e Less than 15 seconds with a new fully charged M3516A SLA battery pack at 25 C depleted by up to 15 200 Joule discharges e Less than 25 seconds from initial power on with a new fully charged M3516A SLA battery pack at 25 C depleted by up to 15 200 Joule discharges e Less than 25 seconds from initial power on when operating without a battery using AC power alone at 90 100 rated mains voltage e Less than 30 seconds from initiation of rhythm analysis AED Mode with a new fully charged M3516A SLA battery pack at 25 C depleted by up to 15 200 Joule discharges e Less than 30 seconds from initiation of rhythm analysis AED Mode when operating without a battery using AC power alone at 90 100 rated mains voltage e Less than 40 seconds from initial power on AED Mode with a new fully charged M3516A SLA battery pack at 25 C depleted by up to 15 200 Joule discharges e Less than 40 seconds from initial power on AED Mod
10. Figure 11 4 Loading Paper 11 14 Maintaining the HeartStart XL Cleaning Instructions Use the following recommendations to clean the HeartStart XL and its associ 1 1 ated cables paddles etc Cleaning the HeartStart XL Cleaning Instructions You may use the following cleaning products to clean the exterior surfaces of the HeartStart XL as well as the battery and Data Card e Isopropyl alcohol 70 in water 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 Do not autoclave ultrasonically clean or immerse the HeartStart XL 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 2 3 Slide the printer door to the right until the paper roller pops up Pull up on the plastic removal tab to remove the roll of paper Clean the printhead surface above the brush with a cotton swab dipped in rubbing alcohol Replace the roll of paper see Loading Printer Paper on page 11 13 M4735A Hear
11. Good 13 15 87 10 19 53 0 04 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 Specifications amp Safety Clinical Performance Summary Cardioversion Clinical Performance Summary Cardioversion An international multicenter prospective double blinded randomized clini cal trial was conducted to assess the effectiveness of the SMART Biphasic waveform in treatment of atrial fibrillation AF as compared to monophasic waveforms The primary objective of the study was to determine the required energy for cardioversion of AF using the SMART Biphasic waveform as compared with a monophasic damped sine waveform This section summarizes the methods and results of this study Methods Patients enrolled for this study were adults scheduled for elective cardiover sion of AF at one of 11 clinical sites Clinicians used both a defibrillator deliv ering the SMART Biphasic waveform and one delivering a monophasic waveform A sequence of up to five shocks was administered four with the initial defibrillator and a fifth cross over s
12. LEAD SpO2 SpO2 HR ALARM SELECT ON OFF ALARM 98 Pulse 78 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 because 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 SpO WARNING 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 no alarm 90 85 or 80 The defaulted high limit is 100 and cannot be changed Press Sp0 ALARM repeat edly to cycle through the choices Stop when the desired choice is displayed A appears in three seconds indicating that the selected alarm is active To review the alarm limit press Sp0 ALARM Sp0 alarms are temporarily suspended in AED Mode during ECG analysis or when PAUSE is pressed for the duration of the paused period SpO alarms are also suspended while the unit is charging for defibrillation and delivering a shock Responding to an Alarm When the SpO gt 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 Trig
13. NOTE The pacing window remains on as long as the pacing function is enabled CAUTION If you are using the pacing function with battery power and the Low Battery message appears plug the device into AC power When the device powers back up pacing is no longer activated Press Cacer to re activate the pac ing function M4735A HeartStart XL Defibrillator Monitor 8 7 Changing Pacing Modes 8 8 Changing Pacing Modes If paced pulses are being delivered you must stop pacing before changing the pacing mode For example 1 Press to stop pacing Press to change the Mode 2 3 Adjust the rate if needed 4 Press gat gt to resume pacing 5 Adjust the output as needed to obtain capture 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 Table 8 1 lists the pacing related system and momentary messages that you may encounter when using the pacing function Table 8 1 Pacing System Messages Message Leads Off Pacer Failure Pos
14. SELECT ON OFF Monitoring Rhythm Shocks 3 00 00 49 WARNING 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 deteriorates to a shockable rhythm M4735A HeartStart XL Defibrillator Monitor 3 17 Monitoring Rhythm If Rhythm Monitoring detects a shockable rhythm you are prompted as fol lows Figure 3 15 Shockable Rhythm HR ALARM LEAD SpO02 SELECT ON OFF 120m Pads Check Patient If No Pulse Press ANALYZE Shocks 3 00 00 55 e OO 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 SpO gt and heart rate alarms are suspended during the pause duration as well Press RESUME to restore Rhythm Monitoring Active SpO and heart rate alarms are also restored Defibrillating in AED Mode ERC Protocol ERC Protocol The HeartStart XL can be configured to support the European Resuscitation Council ERC Guidelines for Resuscitation 2005 If European Protocol
15. SpO Type CF Defib Type BF Other Considerations The HeartStart XL is suitable for use in the presence of electrosurgery Burn hazard protection is provided via a 1K current limiting resistor contained in each ECG lead wire M4735A HeartStart XL Defibrillator Monitor 13 7 Specifications ECG Analysis Performance ECG TEST Rhythm Class SAMPLE Nominal Specifications SIZE Shockable Rhythm 600 Meets AAMI DF39 requirement and AHA recommenda ventricular fibrillation tion sensitivity gt 90 for adult 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 Philips Medical Systems 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
16. When the HeartStart XL detects a problem it provides display and or voice prompts to guide you to resolution Table 3 1 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 Table 3 1 Troubleshooting 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 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 from the defibrillator when pos interference sible Shock e Shock key not pressed within 30 Press within 30 seconds of Canceled seconds prompt M4735A HeartStart XL Defibrillator Monitor 3 21 Troubleshooting 3 22 Table 3 1 Troubleshooting in AED Mode Continued Prompt Possible Cause Corrective Action No Shock Poor skin contact pads are not Check pads conne
17. 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 Discard batteries if there are visual signs of damage or if they fail the Battery Capacity Test Discard batteries in an environmentally safe manner Properly dispose of batteries according to local regulations Do not disassemble puncture or incinerate batteries Be careful not to short the battery terminals because this could result in a fire hazard Maintaining the HeartStart XL Loading Printer Paper Loading Printer Paper To load printer paper 1 1 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 M4735A HeartStart XL Defibrillator Monitor 11 13 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 Pull the 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
18. gt 95 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 lt 95 minutes 1 The battery failed the test or 2 Record fail CT and the date on Low Battery Time lt 10 minutes the bottom of the battery 3 Discard the battery appropriately M4735A HeartStart XL Defibrillator Monitor 11 11 Battery Maintenance CAUTION WARNING 11 12 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 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 Do not store batteries for more than one month without charging them if the batteries are installed in the defibrillator Do not store batteries for more than three months without charging them if the batteries are not installed in the
19. used for storing patient data Loading Settings from a Data Card To load configuration settings 1 Make sure a Data Card is in the HeartStart 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 HeartStart XL loads the configuration settings from the Data Card and returns to the main configuration menu Printing Settings To print the configuration settings select Print All Settings from the main config uration menu Setting Up and Configuring the HeartStart XL 11 Maintaining the HeartStart XL This chapter describes how to care for your HeartStart 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 You must perform the operational checks described at the specified intervals in order to help prevent and detect electrical and mechanical problems You must adhere to the battery maintenance procedures specified in order to ensure that your batteries have the energy required to operate the defibrillator and deliver the appropriate therapy M4735A HeartStart XL Defibrillator Monitor Operational Checks Operational Checks The following operational checks are inten
20. 41 01 12 41 03 12 41 03 12 41 11 12 41 17 12 41 24 12 41 31 12 41 38 12 41 42 9 7 Printing the Internal Event Summary The Event Summary also includes waveforms and the appropriate annotation for each of the following events Table 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 pressed 11 seconds 3 seconds prior to being pressed plus 8 seconds after is pressed pressed 11 seconds 3 seconds prior to being pressed plus 8 seconds after 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 HeartStart 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 z Strip Length Strip Length
21. 7 6 Performing Synchronized Cardioversion 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 Make sure no one is touching the patient or anything connected to the patient Call out clearly and loudly Stand Clear Press and hold SHOCK If you are using external paddles press and hold the orange buttons on both paddles The shock will be delivered when the next R wave is detected NOTE It is important to continue to hold SHOCK or the paddle buttons until the WARNING shock is delivered The defibrillator shocks with the next detected R wave Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation M4735A HeartStart XL Defibrillator Monitor 7 7 Delivering Additional Synchronized Shocks Delivering Additional Synchronized Shocks If additional synchronized shocks are indicated perform the following steps 1 Make sure Sync Mode is still enabled as indicated by the message Sync on the display 2 Repeat steps 2 6 under Delivering a Synchronized Shock In its default configuration the HeartStart XL remains in
22. Action Attach Pads The multifunction defib electrode pads e Check that the pads are applied to are not making proper contact with the the patient as directed on the patient pads package e Replace the pads if the prompt continues Attach Leads An attempt was made to begin pacing in Attach leads to patient Demand Mode without ECG leads attached to the patient Attach Paddles An attempt was made to charge the defib Connect paddles in Manual Mode with no paddles connected Select Leads An attempt was made to activate Syn Use leads for ECG chronized Cardioversion with paddles connected and selected as the ECG input With no leads connected the user con Use leads for ECG nected paddles and selected them as the ECG input then connected the leads Defib Disarmed e The pads connection is compromised e Check that the pads are applied to the e The mode is changed from Manual to patient properly AED while the defibrillator is e Ifashock is indicated deliver the charged shock before changing modes e SHOCK or shock buttons are not e To deliver a shock press SHOCK pressed within 30 seconds of the or shock buttons on paddles within defibrillator being charged 30 seconds of the defibrillator being e DISARM is pressed charged M4735A HeartStart XL Defibrillator Monitor 12 5 Momentary Messages Table 12 2 Momentary Messages Continued Message No Shock Delivered Possible Cause Po
23. CPR protocol needs Rhythm SpO and heart rate monitoring alarms are suspended for the duration of the pause NOTE If your HeartStart XL is configured to support the European Resuscitation Council Guidelines for Resuscitation refer to the ERC Protocol section on page 3 19 for details M4735A HeartStart XL Defibrillator Monitor 3 15 Pausing for CPR Figure 3 13 Pause Display HR ALARM LEAD SpO2 SELECT ON OFF Paused Elapsed Time i Total Pause Duration ocks 3 V sh Timer 21 120 00 01 40 Pane age 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 HeartStart XL begins monitoring the ECG rhythm provided Rhythm Monitoring is on You may initiate ECG analysis at any time by pressing ANALYZE 3 16 Defibrillating in AED Mode Monitoring Rhythm Monitoring Rhythm When the HeartStart XL is not analyzing defibrillating or paused Rhythm Monitoring alerts you to potentially shockable rhythms provided Rhythm Monitoring is set to the default configuration On 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 14 Monitoring Rhythm Display HR ALARM LEAD SpO2
24. Defibrillator charges continuous 6 seconds just 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 pressed 6 seconds after button pressed M4735A HeartStart XL Defibrillator Monitor 9 9 Printing Events Printing is configured independently for each of these events You can stop the printing before it has printed the entire strip by pressing Qr To print additional events that you observe in the course of caring for your patient press Crip NOTE An ECG strip will print continuously until you press 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 C 9 10 Storing Retrieving amp Printing 10 Setting Up and Configuring the HeartStart XL This chapter describes how to set up and configure your HeartStart XL Chapter 10 covers e Connecting Patient Cables e Configuring the HeartStart XL
25. E NAASE EES 10 8 M difying th Config ratiot ssseresscsneirsenk ninin a EA g a 10 15 Returning to the Default Configuration 00 0 0 ceccecceesceesceeeseceeeceeeeeeseceseeneeeeeseeeaeens 10 15 Saving Settings toa Data Card swcesssissessavabescsecwstasbsseaddualunssesadinasesesnasecubannd i 10 16 Loading Settings from a Data Card sc cccocscsssecssensoncenssnsnessunceecamsnssnassesasanensnesncdvandentones 10 16 Printing Settings secsinarosnn ai A EREE E SEAE EREA EEE ARSi 10 16 Maintaining the HeartStart XL Op r tional Checks ososan Ea E EE REEE EEEE ETE 11 2 B fore Yoy BEZIN sacussvenddesnscnenvanredsonvanesuestensevunaesecsedueneduostusasstaandpesseaianasumvesnciuesspucantoes 11 2 viii Contents Every Shift se sacossasedess neretto ra E REEE E R RAR 11 3 Every Month sesers eresie iret er E EE sumoetcestvoveddobepiadetdcenteseenctesnuenRecierenstdluceee 11 3 Using External Paddles cgeccacssacuesanaccvaarexennsnneacssiacexatuanavacwnaceceeatereacieeuvexencanctemeatneunies 11 4 Using Pads uc sinciateds caters vai raavin innr E REE TERE EERE E eRe 11 5 Using Internal Paddles lt 5 cect accnesenessiareecwncenes as veestextescxsescensicosedseansasescataneoreumivensueacireers 11 7 Battery Maintenance xxcanssiscindetaseassectecn seas tbccnedatcnnpdaavccensetnccapissadesatabbeassaphacdeeietadaneosanicauntions 11 8 Recharging Batteries 3nacsecniscnyd aiaeeiiee ie a R E E EEE A RAT R REA 11 9 Battery Capacity Testees nresiiarepreei nann E S E E E
26. ECG can be monitored through pads 3 lead 1 II HT or 5 lead I I I aVR aVL aVF or V Default is Lead II 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 mon itoring 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 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 To disconnect the ECG patient cable gently pull the white patient cable connector out of the ECG receptacle M4735A HeartStart XL Defibrillator Monitor 4 3 Applying Monitoring 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 WARNING Be sure that the electrodes do not come in contact with other conductive materials
27. EREE Ri 11 9 Battery Cap ity cremene ier ERS E AS 11 12 Battery Life Expectancy ss sssessseessesersseesseesrssresstestestesseesesrsstessesrtssressessrssresresseent 11 12 Storing Batt ri s sisirin nrii e rianan E EREE dace a Rede ein 11 12 Discarding Batteries cscs crease nscuses eaaccsusvancesuancesaneantsseresetacesseantacananssaceractixarsumrnceusesetarere 11 12 Loading Printer Papet srren eE E ER RRE 11 13 Cleaning InStr ctiohS esiis e E E E ORERE R RS 11 15 Cleaning the HeartStart XE ernen E E E EE aaia 11 15 Cleaning the Printer Printhead sciccascuiainpadendecaseniganseboatatestuhgexieieedesaisanadatetantaexosenteeaeens 11 15 Cleaning Defib Pads amp Monitoring Electrodes sss sssssssssnssessesssssressersessesseesresressee 11 16 Cleaning the External and Internal Paddles eccccccecceeeeeeceeeeceeeeeeeeeseecsseenseenees 11 16 Cleaning the Pads Cable scriescene innana Eea eA i EEEE EE SEERE 11 17 Cleaning the ECG Cable sessionaris eaa a A E EE EOE 11 17 Cleaning the SpO2 sensor and cable jy sccccssuncavsnevecensteatsamndeeeuieededuyiaceisnnleanaeneni 11 17 Supplies amp Accessories 2a cracenccessecsadveaccnanceaessicsetey vxanzrscuscn eh aeesunrasedeenstermcasieesen a avcerexstarers 11 18 Disposing of the HeartStart XE ccicaiscsuccsccascsddeesedbatecaasiiuaxnadonievasauiaeusstonnoaty ES 11 23 Troubleshooting System M SSAgES sccisscnsassiocnaaupdeasensartocicnssshanbagatecavataiundachdducapadaaneteatscedusshadusseabanccergnano
28. Maintaining the HeartStart XL Disposing of the HeartStart XL Disposing of the HeartStart XL Prior to disposing of the HeartStart XL remove the battery Then dispose of 1 1 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 HeartStart XL Defibrillator Monitor 11 23 12 Troubleshooting If the HeartStart 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 this chapter provides general troubleshoot ing tips and information on calling for service 12 NOTE For repair instructions or for additional technical information refer to the M4735 90900 HeartStart XL Service Manual M4735A HeartStart 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 Attach Pads Cable Description The pads cable is not properly attached to the device Corrective Action Check the cable connections Configuration Lost The configuration is reset to the default settings
29. Sync Mode after a shock is delivered The HeartStart XL can also be configured to exit Sync Mode after each shock is delivered Disabling Sync Mode To disable Sync Mode press located below the display The mes sage Sync is no longer displayed Sync Mode is also disabled when you exit Manual 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 HeartStart XL and describes how to perform pacing M4735A HeartStart XL Defibrillator Monitor 8 1 Pacing Operational Controls SEE Pacing Operational Controls In Manual Mode the following pacing operational controls are displayed on the handle of the HeartStart XL Figure 8 1 Pacing Controls Manual Mode only o CoD Demand Mode Versus Fixed Mode The HeartStart 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 electrodes pads cannot be used to monitor the ECG and
30. XL Configuring the HeartStart XL Configuring the HeartStart XL Configuration options allow you to customize the HeartStart XL to best meet your needs This section describes how to access the configuration menu configurable items and their setting options how to change the configuration how to save the configuration to a Data Card how to load the configuration from a Data Card how to print the configuration Accessing the Configuration Menu There is a special combination of softkeys that when pressed simultaneously turn the HeartStart XL on in Configuration Mode For the purposes of executing this procedure softkeys are assigned numbers as shown in Figure 10 5 Figure 10 5 Softkey Numbers M4735A HeartStart XL Defibrillator Monitor 10 7 Configuring the HeartStart XL To turn the HeartStart 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 Off To Exit Configuration Configurable Parameters The following tables show the configurable parameters for each category of settings A description of ea
31. a time 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 Use only the multifunction defib electrode pads battery and accessories listed in Outside the USA contact your local Philips Medical Systems Sales Office your authorized Philips Medical Systems Dealer or Distributor or visit our website at www medical philips com ems and follow the Supplies link on page 11 18 Substi tutions may cause the HeartStart XL to function improperly 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 In AED Mode the multifunction defib electrode pads must be in the anterior anterior position as shown on the packaging The HeartStart XL was not designed to assess data acquired from pads in an anterior posterior position Use only 3 wire AC power cords with 3 pronged grounded plugs Specifications amp Safety Safety Considerations WARNING Keep hands and feet clear of paddle electrode edges Use your thumbs to depress the shock buttons on the paddle handle CAUTION Conductive parts of electrodes and associated connectors for applied parts including the neutral electrode should not contact other conductive parts including
32. 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 HR ALARM LEAD SpO02 SELECT ON OFF Pads Shocks 0 00 00 03 M4735A HeartStart XL Defibrillator Monitor 3 9 Defibrillating 2 If instructed press ANALYZE If device initiated analysis is off the HeartStart XL monitors the rhythm provided Rhythm Monitoring is on The HeartStart XL prompts you to press ANALYZE if a potentially shockable rhythm is detected Figure 3 6 Press ANALYZE Display HR ALARM LEAD SpO02 SELECT ON OFF Press Analyze Shocks 0 00 00 08 NOTE ECG Analysis is always performed through multifunction defib electrode pads Analysis can not be performed through monitoring electrodes Defibrillating in AED Mode Defibrillating If device initiated analysis is on you do not need to press ANALYZE ECG analysis begins automatically Figure 3 7 Analyzing Display HR ALARM LEAD Spo2 SELECT ON OFF 1204 Pads Analyzing Do Not Touch Patient Shocks 0 00 00 08 STOP ANALYSIS WARNING Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis M4735A HeartStart XL Defibrillator Monitor Defibrillating 3 I
33. assigns a new incident number A new Event Summary begins when patient contact is made 2 12 Getting Started Continued Use Continued Use Once a patient event is started the Continued Use feature is activated This feature facilitates continued care of the same patient by retaining settings and the patient record when the HeartStart XL is powered off for less than 2 min utes such as to change a battery or transition between AED and Manual Modes When power is restored within the 2 minute time period the Heart Start XL retains the most recent settings including e Alarms e ECG lead displayed e Incident time e QRS and voice prompt volumes including muting of the QRS if set e ECG gain e Patient record in the event summary and on the data card if used new data is appended to the record NOTE Sync Mode remains active if power is disrupted in Manual Mode for less than 2 minutes However Sync is disabled when AED Mode is activated and remains disabled even if you return to Manual Mode M4735A HeartStart XL Defibrillator Monitor 2 13 Using a Data Card Optional Using a Data Card Optional Use of a Data Card is optional the defibrillator will power up without a Data Card inserted If you would like to collect patient information on a Data Card the card must be inserted into the HeartStart XL before the device is turned on CAUTION Inserting or removing the data card while the defibrillator is
34. can annotate the event with one of the following labels Epinephrine Adrenaline Atropine Lidocaine and Other M4735A HeartStart XL Defibrillator Monitor 13 11 Specifications 13 12 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 or Fixed Rate Refractory Period 340 msec 30 to 80 ppm 240 msec 90 to 180 ppm Specifications amp Safety SpO Pulse Oximetry Range SpO gt 0 to 100 Pulse Rate 30 to 300 bpm Accuracy with M1191A sensor 1 standard deviation 70 to 100 M1192A sensor standard deviation 70 to 100 M1194A sensor 1 standard deviation 70 to 100 M1131A sensor 1 standard deviation 70 to 100 M1903B sensor 1 standard deviation 70 to 100 M1904
35. deeply it is discharged before recharging Therefore some general guidelines for performing the Battery Capacity Test are as follows Peon Average Usage Battery Capacity Test g g Every 6 months Infrequent use for short duration Every 3 months Frequent use or for longer duration Infrequent use is less than once per day Short duration is lt 15 shocks or lt 30 minutes of monitoring or lt 6 shocks and 20 minutes of monitoring You should perform a Battery Capacity Test any time you are concerned about the battery s performance You may choose to perform the Battery Capacity Test less frequently if your storage and usage procedures ensure another charged battery is always available To perform a Battery Capacity Test CT 1 Turn the HeartStart XL off 2 Labelthe HeartStart 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 Ca turn the Energy Select knob to AED On to start the test 11 10 Maintaining the HeartStart XL Battery Maintenance 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 Table 11 2 Battery Capacity Test Results If Then Elapsed Time
36. deliver paced pulses simultaneously The HeartStart XL always uses the 3 or 5 lead ECG cable and monitoring electrodes as the source of ECG during pacing In demand mode ECG electrodes must be used because the HeartStart XL uses the R wave detection from this monitoring source to determine if a paced pulse should be delivered In fixed mode ECG electrodes may or may not be used however an ECG will only be displayed if ECG monitoring electrodes are used WARNING Use demand mode pacing whenever possible Use fixed mode pacing when motion artifact or other ECG noise makes R wave detection unreliable WARNING Heart rate displays and alarms function during pacing but they can be unreliable 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 WARNING When pacing in demand mode the ECG cable must be directly connected from the ee patient to the HeartStart XL 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 anterior or anterior posterior placement as appropriate Connect the pads to the patient cable See Figure 6 3 3 Ifneeded insert a Data Card as described in Using a Data Card Optional on 2 14 4 Turn the Energy Select knob to Manual On M4735A HeartStart XL Defibrillator Monitor 8 3 Prep
37. earth WARNING 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 and patient skin burns during defibrillation and may divert current away from the heart WARNING 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 13 until just prior to use WARNING Never touch the patient or any equipment connected to the patient including the bed or gurney during defibrillation WARNING Never operate the HeartStart XL in standing water Do not immerse or pour fluids on any portion of the HeartStart XL WARNING Do not use the HeartStart XL in a flammable or oxygen rich atmosphere This can cause an explosion hazard M4735A HeartStart XL Defibrillator Monitor 13 29 Safety Considerations WARNING 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 HeartStart XL NOTE WARNING WARNING WARNING WARNING 13 30 The HeartStart 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 pati
38. external paddles in Manual Mode 6 3 using switched internal paddles in Manual Mode 6 6 using switchless internal paddles in Manual Mode 6 8 Pads applying 3 9 13 28 13 29 cleaning 11 16 11 17 ECG monitoring 4 2 4 12 events recorded 9 4 safety precautions 13 28 troubleshooting 3 21 12 3 12 5 using in Manual Mode 6 5 Pads Cable Off message 3 21 12 3 Pads cables See Cables Pads Off message 3 21 4 12 12 3 Paper See Printer paper Patient information See Data Card Pausing AED Mode 3 15 3 18 settings 10 12 Post 10 12 Post Shock CPR Timer 3 20 10 12 Power modules electromagnetic compatibility 13 32 13 35 Power supply events recorded 9 4 interruption of power 9 6 overview 2 9 troubleshooting 12 7 See also Batteries Precautions 13 28 asystole 1 6 batteries 11 12 defibrillation current shock 3 14 ECG analysis 3 11 electrodes 4 4 electromagnetic compatibility 13 32 13 35 heart rate alarms 4 10 8 3 pacemakers 1 5 4 10 rhythm monitoring 3 17 safety symbols 13 16 sensors 5 6 5 10 SpO2 alarm 5 9 SpO2 monitoring 5 2 Print strip events recorded 9 5 settings 10 9 See also Event Summary Printer checking 11 6 cleaning printhead 11 15 Printer paper loading 11 13 ordering 11 19 troubleshooting 12 6 Printing controls 2 5 Event Summary 9 7 events automatically 9 9 settings 10 16 Pulse checking 3 15 5 11 Pulse oximetry defined 1 7 5 2 described 5 3 See also SpO2 monitor
39. in which radiated RF disturbances are controlled The customer or the user of the HeartStart XL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip ment transmitters and the HeartStart XL as recommended below according to the maximum output power of the communications equipment Table 13 10 Recommended Separation Distances Separation Distance According to Frequency of Transmitter m Rated Maximum Output 150 KHZ to 800 MHz 800 MHz to 2 5 GHz Power of Transmitter d 1 2 JP d 2 34 P W 0 01 0 1m 0 2m 0 1 0 4m 0 7m 1 1 2 m 2 3 m 10 4m 7m 100 12 m 23 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter s manufacturer At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people M4735A HeartStart XL Defibrillator Monitor 13 45 Index AC Power Module See Power modules Accessories ordering 11 18 13 28 AED Mode 3 1 configuring 3 5 CPR 3 15 defibrillation process 3 8 display 2 7 2 8 ECG monitor
40. 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 pointing towards the Heart Start 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 Eject Button M4735A HeartStart XL Defibrillator Monitor 2 15 Using a Data Card Optional 2 16 Removing a Data Card To remove the Data Card 1 Make sure the HeartStart XL is turned off wait 2 seconds 2 Press the black eject button see Figure 2 10 3 Pull the Data Card from the compartment Figure 2 10 Removing the Data Card Eject Button Getting Started 3 Defibrillating in AED Mode The HeartStart 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 HeartStart XL to defibrillate in AED Mode It explains the prompts that guide you through the defibrillation pro cess and describes how pr
41. on can corrupt the Data Card and prevent the unit from powering on again If this occurs see Table 12 3 Troubleshooting Tips 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 because the device will only allow the use of one Data Card per incident Data Cards hold a minimum of two hours of patient information Multiple incidents can be recorded on a single Data Card Each incident is assigned a unique incident number Patient data from a HeartStart XL compatible Data Card may be downloaded to a HeartStart Event Review Data Management system HeartStart Event Review also allows you to erase patient data from a Data Card allowing the card to be reused for another patient It s recommended that you use a designated Data Card to configure one or more defibrillators monitors CAUTION 2 14 Use only a HeartStart XL compatible Data Card see Chapter 11 for a listing These cards are specifically formatted to work with your Philips defibrillator Generic cards or other types of cards such as modem cards will not work and may cause the defibrillator to malfunction Getting Started Using a Data Card Optional Inserting a Data Card To insert a Data Card 1 Make sure the HeartStart XL is turned off 2 Press up on the release latch to open the door to the Data Card compart ment 3 Ifa Data Card
42. option is purchased For 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 Sp0 readings may be inaccurate in the presence of significant levels of carboxyhemoglobin or methemoglobin 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 SpO 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 e The patient must have perfusion in that extremity e The light emitter and the photodetector must be directly opposite each other e All of the light from the emitter must pass through th
43. other visible signs of damage Make sure the connectors engage securely Battery make sure e a charged battery is in the HeartStart 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 HeartStart XL 2 Plug the power cord into a power outlet and connect it to the HeartStart XL 3 Verify that the power and charging indicators on the front of the defibrillator monitor are lit 4 Remove the battery from the HeartStart XL and verify that the charging indicator on the front of the defibrillator monitor is no longer lit Replace the battery Audio verify there is an audible tone when the HeartStart XL is turned on Printer make sure the printer e has sufficient paper e prints properly 11 6 Maintaining the HeartStart XL NOTE WARNING WARNING Operational Checks Using Internal Paddles Since internal paddles are sterilized testing them prior to use requires a differ ent procedure than the usual Shift System Check Follow the steps below to 1 1 verify performance of either switched or switchless internal paddles See the Sterilizable Defibrillator Paddles Instructions for Use for sterilization recommendations 1 Use your institution s approved sterile defibrillator paddle test device to perform this test Connect the internal paddles to the defibrillator Turn the Energy Select knob to Manual and select 2
44. population M4735A HeartStart XL Defibrillator Monitor 13 25 Clinical Performance Summary Internal Defibrillation 13 26 Clinical Performance Summary Internal Defibrillation Overview A study was conducted during the first half of 2002 to assess the effectiveness of the HeartStart XL biphasic for use in intra thoracic application as com pared to a control biphasic waveform This appendix summarizes the methods and results of the study Methods Twelve swine each weighing approximately 30 kg were anesthetized and intubated A sternotomy was performed to expose the heart VF was induced electrically by 60 Hz current via a pacemaker catheter in the right ventricle After 15 seconds of VF a defibrillating shock was applied using hand held 2 inch diameter surgical electrode paddles applied directly to the epicar dium Shock energies of 2 5 10 20 and 30 J were used in random order At least 4 shocks at each energy level were administered for 4 separate VF epi sodes to derive a success data point at that energy Success was defined as conversion of fibrillating rhythm to non fibrillating rhythm five seconds after the shock Specifications amp Safety Results Clinical Performance Summary Internal Defibrillation The results showed that the average impedance was about 40 ohms in this study which is similar to the human impedance data encountered in direct heart defibrillation The efficacy results of the H
45. 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 volume of voice prompts and the QRS beeper At the lowest setting the QRS beeper is muted The voice prompts and other alert tones cannot be muted Adjusts the size of the ECG waveform displayed printed and stored Pressing A and W simultaneously generates a 1 mV calibration pulse NOTE 2 4 To permanently turn the QRS beeper off use the General settings in Configuration mode See Chapter 10 Setting Up and Configuring the Heart Start XL 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 on each button The print controls from are gt FF Prints ECG data defibrillation events and marked events C strip real time or with a 6 second delay as configured Press to start printing press again to stop printing Gonna Prints the Event Summary See Storing Retrieving amp Print ing for more information Printing may be stopped by pressing the Summary or Strip button Inserts a time stamp
46. sriisisiian a R E E 4 5 Using External ECG Monitors scccsuccossssesanendveGunraasctupnasaaltoncauutabsntaseusssscseiepaniusssaieiieunias 4 7 Selecting the L ddo nire orn ena E E EAE E A AAEE 4 8 Setting the Heart Rate Alarm xsscssansipeasedescsesnetisaidesaomnstentennnesuasiouaseiensseseunsdssuteusediseawinedsesvens 4 10 Disabling the RATA aiprsstisien toxacesencnccnstuceneantaceacescacuxeeaaneaeeswen ta neacenavaceraseeeencanrieeeare omens 4 11 Adju tin th EGG SIZE srira a E EE EARE R ERNE IREE 4 11 Adjusting QRS Beeper and Voice Prompt Volume cccccecceesseceteceeeeeeeeeeseecsaeeneensees 4 11 Troubleshooting srie eied teo ne oea a iadi E e E EAEE a EIEEE 4 12 Monitoring SpO2 TAD EOU CULO i EEEE EA 5 2 Understanding Pulse Oximetry sssssssseeseesesseesseserssessessrssesstsstsstesseestesrsstesesrssressessrssres 5 3 Selecting a SINS AI crer eczinec op ctrcaaccs estes Svea cans edad aeaee EAER T aTa a EEE A EE E AOE ESER EErEE EEES isi 5 4 Reusable SENSO eae eee nero ee E ene eee ee eer 5 5 Disposable SEUSONS sedrer en eae E EEE EEE AEAN EE EEE EDE 5 5 Applying th SCMNOT renerne Ee a aR EAER A EA ERE 5 6 vi Contents Connecting the Sensor Cable secin a EEEE ERAT ERA ESATE aaant 5 7 MOomitornine sressiessiee r teniseri roK E E E ERE EER E EE EE E E E a E 5 8 Setting Alarms sereset nue env EE ee EAE E aca E E EE E RE 5 9 R sponding to a Alarm cases oc aaca Sse omauaste dua ia i E TE E eee eS 5 9 Discontinuin
47. sterilize the pads cable Cleaning the ECG Cable 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 100m1 1 CAUTION Do not ultrasonically clean immerse autoclave or steam sterilize the 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 Cleaning the SpO sensor and cable To clean the SpO sensor and cable follow the manufacturer s instructions M4735A HeartStart XL Defibrillator Monitor 11 17 Supplies amp Accessories 11 18 Supplies amp Accessories Approved supplies and accessories for the HeartStart XL are listed in Table 11 3 To order e Inthe USA call 1 800 225 0230 pads electrodes cables paper etc e Outside the USA contact your local Philips Medical Systems Sales Office your authorized Philips Medical Systems Dealer or Distribu tor or visit our website at www medical philips com cms and follow the Supplies link Table 11 3 Upgrades Supplies and Accessories Part Number Description Upgrades M4738A Pacing Upgrade M4739A SpO Upgrade Defibrillation Pads Pads Cables and Test Load white twist lock connector M3501A Multifunction Adult defib pads AAMI M3502A Multifunction Adult defib pads IEC M3503A Multifunction Pe
48. the battery appropriately When not in use Maintaining the HeartStart XL Battery Maintenance Recharging Batteries You may charge batteries while they are in either the HeartStart XL or the optional M4747A Battery Charger Kit If the battery is being charged while in the defibrillator monitor with the HeartStart XL powered off a discharged battery will typically be 90 charged after 3 hours at 25 C This is 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 reducing its life and capacity Refer to the charging procedures provided in the operating instructions for the Battery Charger Kit Battery Capacity Test As sealed lead acid batteries age due to usage and storage conditions their capacity to store and deliver energy diminishes The Battery Capacity Test provides a quantitative measure of battery capacity Performing a Battery Capacity Test periodically over the life of the battery gives you an indication of how that battery is aging and what level of performance it is capable of delivering M4735A HeartStart XL Defibrillator Monitor 11 9 Battery Maintenance A battery s capacity is most affected by the duration of use and how
49. 0 8 modifying 10 15 printing settings 10 16 Rhythm Monitoring 3 5 3 17 saving and loading from Data Card 10 16 Configuration Lost message 12 2 Continued Use feature 9 6 CPR 3 15 Data Card 2 14 downloading and erasing information 9 2 inserting and removing 2 15 ordering 11 21 saving and loading settings 10 16 troubleshooting 12 2 12 6 Date 10 8 12 8 DC Power Module See Power modules Default settings See Configuration Defib Disarmed message 12 5 Defib electrode pads See Pads Defibrillation 1 2 AED Mode 3 4 3 8 defined 1 4 Manual Mode 6 9 pacing 8 8 Defibrillation controls 2 4 Index Defibrillator See HeartStart XL Device Initiated Analysis settings 3 5 10 11 Display AED Mode 2 7 layout 2 6 troubleshooting 12 8 ECG analysis See Analysis ECG cables cleaning 11 17 connecting 10 6 ordering 11 21 See also Cables ECG electrodes See Electrodes ECG Fault message 12 2 ECG Filter Settings 10 13 ECG monitoring 4 2 electrodes 4 4 10 9 events recorded 9 4 heart rate alarm 4 10 leads 4 8 settings 10 9 10 13 signal quality 4 12 size 4 11 synchronized cardioversion 7 2 troubleshooting 4 12 Index Electrode pads See Pads Electrodes applying 4 4 checking 11 3 cleaning 11 16 11 17 ordering 11 21 placing 3 6 4 5 settings 10 9 Electromagnetic compatibility EMC 13 32 13 35 Environmental specifications safety precautions 13 30 Erratic spiking 1 5 Event Review 2 14 9 2 Event Su
50. 7D 50 mm Strip Chart Thermal Paper 1 box 80 rolls M4735A HeartStart XL Defibrillator Monitor 11 19 Supplies amp Accessories Table 11 3 Upgrades Supplies and Accessories Continued Part Number Description External Paddles M4745A Sterilizable External Paddles with PCI M4746A External Paddles with PCI M1789A Replacement Adult Paddle Electrode clips onto external pad dle Internal Paddles Switched Switchless M1741A 7 5 cm Switchless Internal Paddles M1742A 6 0 cm Switchless Internal Paddles M1743A 4 5 cm Switchless Internal Paddles M1744A 2 8 cm Switchless Internal Paddles M4741A 7 5 cm Switched Internal Paddles M4742A 6 0 cm Switched Internal Paddles M4743A 4 5 cm Switched Internal Paddles M4744A 2 8 cm Switched Internal Paddles M4740A Internal Paddles Adapter Cable 989803127121 Large Disposable Switched 989803127131 Medium Disposable Switched 989803127141 Small Disposable Switched 989803127151 Large Disposable Switchless 989803127161 Medium Disposable Switchless 989803127171 Small Disposable Switchless 11 20 Maintaining the HeartStart XL Supplies amp Accessories Table 11 3 Upgrades Supplies and Accessories Continued Part Number Description ECG Cables M1500A 3 lead ECG Trunk Cable AAMI MI1510A 3 lead ECG Trunk Cable IEC M1520A 5 le
51. A HeartStart XL Defibrillator Monitor 2 9 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 2 10 Getting Started Connecting to Power Removing the Battery To remove the battery from the HeartStart XL press the black battery eject button and pull the battery out as shown in Figure 2 8 Figure 2 8 Removing the Battery M4735A HeartStart XL Defibrillator Monitor 2 11 Connecting to Power 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 HeartStart 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 HeartStart XL assumes that you are continuing to treat the same patient pro vided 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 HeartStart XL assumes you are treating a different patient and
52. AN OR 7 Recyclable paper product Fragile Right side up Do not get wet M4735A HeartStart XL Defibrillator Monitor 13 19 Symbol Definitions 13 20 Table 13 3 Shipping Carton Symbols Continued Symbol Definition Shelf life Long term storage conditions Fu Short term transport storage Specifications amp Safety Clinical Performance Summary Defibrillation Clinical Performance Summary Defibrillation 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 150J SMART Biphasic AEDs or 200 360J monophasic waveform AEDs A sequence of up to three defibrillation shocks were delivered For 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
53. Adjust the rate to the desired number of paced pulses per minute ppm Press up A or down W on to increase or decrease the number of paced pulses per minute M4735A HeartStart XL Defibrillator Monitor 8 5 Performing Pacing 4 To start pacing press Ga The message Pacing indicates that paced pulses are being delivered in the selected mode at the rate and output level displayed If fixed pacing is desired or R wave detection is unreliable press to change to fixed mode To switch back to demand mode press again Figure 8 3 Pacing with Pads Display LEAD Sp02 HR ALARM SELECT ON OFF feel 78 Lead I Pacer Stop Demand Mode Shocks 0 TOppm 30mA 00 00 8 8 6 Pacing Optional Performing Pacing Increase the output until cardiac capture occurs Press A on Cup to increase the output in increments of 10 mA Decrease the output to the lowest level that still maintains capture Press W on lt lt to decrease the output in increments of 5 mA Press Gar to stop pacing Press to exit the pacing function The green LED next to the but ton goes out indicating pacing is no longer active NOTE Pacing will not start if there is a problem with the multifunction defib elec trode 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
54. 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 Specifications amp Safety Specifications Display Type EL Electroluminescent Size 115 mm x 86 mm Resolution 320 x 240 pixels Sweep Speed 29 mm s nominal stationary trace sweeping erase bar Viewing Time 4 seconds OR Type LCD TFT Color Liquid Crystal Display Size 111 4 mm x 83 5 mm Resolution 320 x 240 pixels Sweep Speed 29 mm s nominal stationary trace sweeping erase bar 1 2 Viewing Time 4 seconds The presence of display information on the primary label located on the bot tom of the device indicates that the HeartStart XL contains an LCD display M4735A HeartStart XL Defibrillator Monitor 13 9 Specifications 13 10 Battery Type 2 Ah 12V rechargeable Sealed Lead Acid Dimensions 2 4 H x 0 94 W x 7 2 D 61 7mm x 23 9mm x 182mm Weight 1 4 lb 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 r
55. B sensor 1 standard deviation 70 to 100 Specifications 3 0 3 0 3 0 Pulse Rate Accuracy 2 or 1 bpm whichever is greater Wavelength Range 500 to 1000 nm Emitted Light Energy lt to 15 mW Display Update Interval lt 60 seconds Resolution 1 2 5 2 5 4 0 Sp0 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 Alarm delay lt 10 seconds M4735A HeartStart XL Defibrillator Monitor 13 13 Specifications 13 14 Event Storage Internal Event Summary The internal Event Summary stores up to 300 events and up to 50 waveforms 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 Data Card Event Summary One Data Card can store a minimum of 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 6 0 kg 13 2 Ibs including battery and one roll of paper 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 batt
56. ED Mode Preparation NOTE Impedance is the resistance between the defibrillator s pads or paddles that the defibrillator must overcome to deliver an effective discharge of energy The degree of impedance differs from patient to patient and is affected by sev eral factors including the presence of chest hair moisture and lotions or pow ders on the skin The low energy SMART Biphasic waveform is an impedance compensating waveform that is designed to be effective across a wide range of patients However if you receive a No Shock Delivered message check that the patient s skin has been washed and dried and that any chest hair has been clipped If the message persists change the pads and or the pads cable M4735A HeartStart XL Defibrillator Monitor 3 7 3 8 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 HeartStart XL checks to see if the pads patient 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 HR ALARM LEAD SpO2 SELECT ON OFF w Pads Shocks 0 00 00 02 Defibrillating in AED Mode Defibrillating Once the cable is connected the HeartStart XL will ensure the pads have
57. EE E RE 13 37 Guidance and Manufacturer s Declaration ccceccceesceeseeesseceeeceseeeeeeeeseecesecneensaes 13 38 Recommended Separation Distances lt iassauccvssendenenusvestsssenndacasunecensieysacaessvelecessunedecaiies 13 45 1 Introduction The M4735A HeartStart 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 HeartStart XL Defibrillator Monitor In this chapter you ll find general information that you should become famil iar with before using the defibrillator monitor M4735A HeartStart XL Defibrillator Monitor 1 1 Overview 1 2 Overview The M4735A HeartStart XL Defibrillator Monitor is a lightweight portable semi automatic external defibrillator It offers two modes of operation for defibrillation e Automated External Defibrillation AED Mode e Manual Mode Both modes incorporate a low energy SMART Biphasic waveform for defibrillation In AED Mode the M4735A HeartStart 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 HeartStart XL Defibrillator Monitor turns con trol of the defibrillation proc
58. Energy choices range from 2 to 200 joules with the suggested level for adults being 150 joules Figure 6 5 Energy Select Knob Energy Select 70 30 Oe ED Q 20 200 2 Manual On amm or Vao AED On M4735A HeartStart XL Defibrillator Monitor 6 9 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 6 A charging tone beeps until the desired energy level is reached at which point you II hear a continuous charge tone Figure 6 6 Charging Display LEAD SpO2 Sp02 HRALARM SELECT ON OFF ALARM V132 Pads 861 Pulse 130 47J Shocks 0 00 15 02 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 selected energy level before readjusting the selected energy level 6 10 Defibrillating in Manual Mode Defibrillating in Manual Mode 3 Shock Confirm that a shock is still indicated and that the current charge has reached the selected energy level Make sure no one is touching the patient or anything connected to the patient Call out loudly and clearly Stand Clear If using pads or switchless internal p
59. Figure 9 1 If no selection is made the event is marked with justa A Figure 9 1 Annotations ATRO LIDO OTHER Shocks 0 NOTE In 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 E 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 stip M4735A HeartStart XL Defibrillator Monitor 9 3 Events Recorded 9 4 Events Recorded The following events and related information are stored in the Event Summary Table 9 1 Event Information Event Types Related Information Stored Power Change 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 Heart Rate Alarm Violat
60. Joules Place the paddles on the test device Press CHARGE Press the Shock button on the right handle switched paddles or on the defibrillator switchless paddles 7 Observe the test device ON i Pe OO bo 8 Follow the test device requirements for completion of the test Refer to your institution s policy and procedure for testing internal paddles Do not use or test the defibrillator in a flammable atmosphere for example oxygen tents or other areas of concentrated flammable anesthetics Be sure to safely discharge internal paddles M4735A HeartStart XL Defibrillator Monitor 11 7 Battery Maintenance Battery Maintenance The HeartStart XL uses the M3516A Battery Pack It is a rechargeable sealed lead acid battery Battery maintenance begins when you receive a new battery and continues throughout the life of the battery Detailed information on bat tery care is provided in the application note About Sealed Lead Acid Batter ies that came with your HeartStart XL Table 11 1 lists battery maintenance activities and when they should be performed Table 11 1 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 Periodically as appropriate for your institution see Battery Capacity Test Store
61. LA Left Arm L Left RL Right Leg N Negative LL Left Leg F Foot Not used for 3 lead M4735A HeartStart XL Defibrillator Monitor Lead Reference I LA RA LL II LL RA LA HI LL LA RA 4 5 Applying Monitoring Electrodes Figure 4 3 Precordial Lead Electrode Placement Lead Location vil Cl 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 Table 4 2 5 Lead ECG Lead Formation Lead Lead Formation I LA RA II LL RA Il LL LA LA LL aVR RAL eee 2 F RA LA aV ipo MALA 2 aVL RA LL LA 2 V RA LA LL VIC a ae mE S Monitoring the ECG Applying Monitoring Electrodes Using External ECG Monitors An external Philips Agilent or Hewlett Packard branded monitor can be connected to the HeartStart XL for the purposes of sending or receiving an ECG signal between the two devices A sync cable is used to make this con nection To send an ECG signal from An external monitor to the HeartStart XL 1 Plug one end of the sync cable into the ECG Out connector on the exter nal monitor 2 Plug the other end of the sync cable into the ECG Conne
62. Manual On or AED On to start the test 7 Follow the prompts on the display to proceed with the test If the message Service Unit appears check the information in Table 12 2 and Table 12 3 If the message continues to appear do not use the device and call for service 8 Reconnect the HeartStart XL to AC power OY a NS 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 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 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 Be sure to safely discharge external paddles Maintaining the HeartStart XL Operational Checks Using Pads To perform the Shift System Check using multifunction defib electrode pads 1 Turn the HeartStart XL off 11 2 Connect a 50 ohm test load to the pads patient cable instead of pads 3 Ifa Data Card is routinely used insert a Data Card into the HeartStart XL 4 Unplug the AC power cord 5 Insert a char
63. YSTEM FAILURE CYCLE POWER or DEFIB FAILURE CYCLE POWER The Data Card is corrupt Remove this unit from clinical use and call for service If this occurs during routine testing e Remove this unit from clinical use and call for service e If pacing continue pacing while print ing a continuous ECG strip until it is safe to discontinue pacing e Turn the Energy Select Knob to the Off position Remove the Data Card Insert a new Data Card if available Turn on the device If the unit does not turn on normally it cannot be used e Remove this unit from clinical use and call for service There is a dashed line on the display ECG data is not being acquired e Check the patient cable is connected e Check the pads paddles or electrodes instead of an ECG are properly applied e Check that the desired lead is selected The HeartStart XL does e The battery is low e Change the battery not appear to be func e There is a system failure e Take the device out of use and call for tioning 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 incorrect The date was not correctly set in the con figuration Set the time in the General Settings menu of the Configuration Mode 12 8 Troubleshooting Troubleshooting Tips T
64. able and mobile frequency communications equipment can affect the per formance of medical equipment See Table 13 10 for the minimum recommended sep aration distance between RF communications equipment and the HeartStart XL M4735A HeartStart XL Defibrillator Monitor 13 35 Electromagnetic Compatibility 13 36 Reducing Electromagnetic Interference The M4735A HeartStart XL Defibrillator Monitor and associated accessories may be susceptible to interference from other RF energy sources and continu ous repetitive power line bursts Examples of other sources of RF interfer ence are medical devices cellular products information technology equipment and radio television transmission Should interference be encoun tered as demonstrated by artifact on the ECG or dramatic variations in SpO values attempt to locate the source Assess e Is the interference intermittent or constant e Does the interference occur only in certain locations e Does the interference occur only when in close proximity to certain medical devices e Does the SpO 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 Restrictions for Use Artifact on the ECG caused by electromagnetic interference should be evalu ated by a physician or physician autho
65. able 12 3 Troubleshooting Tips Continued Situation Cause Possible Solution The message Service Unit Someone touched the controls on the Check that the test is set up correctly or Failure is displayed or HeartStart XL during a Shift System Make sure that an unexpected Not Check e paper is in the printer Tested result is dis e the test load is attached played during a Shift e a Data Card with enough space is System Check inserted into the device e acharged battery is inserted into the device Run the Shift System Check again ensur ing that no one touches any of the controls on the defibrillator while the test is run ning M4735A HeartStart XL Defibrillator Monitor 12 9 Calling for Service 12 10 Calling for Service For telephone assistance call the Response Center nearest to you or visit our website at www medical philips com cms and follow the link for services North America Canada 800 323 2280 United States of America 800 722 9377 Latin America Medical Response Center 954 835 2600 Europe European International Sales 800 323 2280 Austria 01 25125 333 Belgium 02 778 3531 Finland 09 615 80 400 France 0803 35 34 33 Germany 01805 47 50 00 Italy 0800 825087 Netherlands 040 278 7630 Switzerland 0800 80 3000 German 0800 80 3001 French United Kingdom 07002 43258472 Troubl
66. ad ECG Trunk Cable AAMI M1530A 5 lead ECG Trunk Cable IEC Sync Cable M1783A 12 pin Sync Cable Monitoring Electrodes M2202A High Tack Foam ECG Electrodes 5 electrodes pouch 300 electrodes case SpO Cables Sensors MI191A Adult Reusable SpO Sensor length 2m M1192A Pediatric Reusable SpO Sensor M1131A Adult Pediatric Disposable SpO Sensor length 45cm M1194A Adult Pediatric Ear Clip Reusable SpO Sensor M1903B Disposable SpO Sensor Pediatric Finger Available outside the U S only M1904B Disposable SpO Sensor Adult Finger Available outside the U S only M1941A SpO 2 meter extension cable M1943A Nellcor SpO Sensor Adapter Cable length 1 1m Data Card 989803147711 Data Card M4735A HeartStart XL Defibrillator Monitor 11 21 Supplies amp Accessories 11 22 Table 11 3 Upgrades Supplies and Accessories Continued Part Number Description Battery M3516A Sealed Lead Acid Battery M4747A Battery Charger Kit M3506A Battery charger adapter Battery Chargers 989803135291 Cadex C7200 Battery Charger holds 2 XL batteries 989803135321 Cadex C7400 Battery Charger holds 4 XL batteries 989803135341 Cadex C7400 Battery Charger holds 2 XL and 2 MRx batteries Accessory Pouch M4751A Accessory pouch Extension Cable M4748A Adapter extension cable User Training CD ROM M4735 91000 User Training CD ROM Kit
67. adausdersd ENES eSa EESE 1 7 SpO2 Monitoring Optional sses nerdaseccizensasiasntins Sara EEEE E EEE E EANES 1 7 TALI CALLOUS yaisca ca gstalesawiareataronndiaiystuiadiaratssoesanatscoayncansebaveandvenenutonaniasaxnnnaradedianeaudonales 1 8 Contraindications ge ence nee eee a eee RC ene Ran er ence ry erie ae een re eee eee 1 8 Safety Considerations au steccsiassincte tes erer EATEN EER E REE RAEE R Aik 1 8 Documentation and Training cceccceccseesceeseeesceceseceeceeeeeeseecsaeceaeeeeeeenseecseceeeeeeseeenseeneeeees 1 9 Getting Started Ge ting Acquainted sssri osisssa Eu Ea eRT EN EEEE E TEE ESTERE REEE EOE EENE EAEE 2 2 B si Orie tatiOi ose strep tees avn loco eee eanceieniee mee earns esaa iii seira ianae tiia ite takari seika ane 2 2 Manual Mode Controls isise ieseana iia ETENE a EKATE AR EEA EAEE 2 5 Display BUttONS 2 sccsenceecusiteptavcessirncrsivevansn cay axtuscetacnaurrasieeeea ace uate EREET SERE i anata ere 2 6 Displ y Lay t seniii ennea iE E AE EEEE E AEAEE EE Eie 2 7 Connecting to POW CI enstiti iiinn R EE E E EAE TENE E 2 9 Inserting th Battery pmuriiesnirerarcen iiin Ee a E E EEA Ei 2 10 Removing the Battery ssninencasssnenni ane R NE 2 11 Low Battery Warning sssessessesessssesseseseessresstssrssressesstestesseestssrnssteseestesstessesersseessessessres 2 12 Con nued USE cserercees ra ere ene ER EY EE A E NE aren ee cnr reer er eee 2 13 Using a Data Card OPtional s sssassedsenecsecehessoassctwncartbadseaschuspeced
68. addles press SHOCK to deliver a shock to the patient If using external paddles simultaneously press the shock buttons located on the paddle s to deliver the shock If using switched internal paddles press the shock button located on the paddles Figure 6 7 Manual Mode Shock Display LEAD SpO2 Sp02 7132 Pads 861 Pulse130 150J Shocks 0 00 15 02 SYNC DISARM ON OFF ey 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 M4735A HeartStart XL Defibrillator Monitor 6 11 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 SpO 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 6 12 Defibrillating in Manual Mode 7 Performing Synchronized Cardioversion This chapter describes how to perform synchronized cardioversion with the HeartStart XL Synchronized cardioversion is a Manual Mode function that allows you to synchronize the defibrillator shock with the R wave of the ECG being mo
69. application of the test level M4735A HeartStart XL Defibrillator Monitor 13 39 Emissions and Immunity 13 40 Table 13 8 Electromagnetic Immunity Life Supporting Functions mani Test IEC 60601 Compliance Electromagnetic Environment ty Test Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the HeartStart XL including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter 3 Vrms Recommended Separation Distance 150 kHz to 80 3 Vrms Conducted RF MHz IEC 61000 4 6 outside ISM d 1 24P bands 10 Vrms Recommended Separation Distance 150 kHz to 80 10 Vrms MHz in ISM bands d 12VP Specifications amp Safety Emissions and Immunity mmuri y Test IEC 60601 Compliance Electromagnetic Environment oy Test Level Level Guidance Radiated RF 10 V m 10 V m IEC 61000 4 3 80 MHz to 2 5 d 2 34 P 800 MHz to 2 5GHz where P is the maximum output power rat ing of the transmitter in watts W accord ing to the transmitter s specified output power and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following sym
70. ard as the ability of a system to perform with out degradation in the presence of an electromagnetic disturbance Degrada tion 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 34 Specifications amp Safety WARNING Electromagnetic Compatibility Electromagnetic Compatibility Devices with Serial Numbers US002XXXXX When using the M4735A HeartStart XL Defibrillator Monitor electromag netic compatibility with surrounding devices should be assessed A medical device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC with and without the appro priate accessories has been performed according to the international standard for EMC for medical devices IEC 60601 1 2 2001 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 2002 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 HeartStart XL Defibrillator Monitor Electromagnetic compatibility with surrounding devices should be assessed prior to using the 13 defibrillator Fixed port
71. aring for Pacing In addition for demand mode pacing 1 Apply monitoring electrodes See Applying Monitoring Electrodes on page 4 4 2 Use hfe to select the best lead with an easily detectable R wave See Selecting the Lead on page 4 8 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 If pacing for long periods of time you may need to periodically apply new monitoring electrodes and multifunction defib electrode pads Refer to the manufacturer s documentation for how often to replace the monitoring electrodes or defib pads 8 4 Pacing Optional Performing Pacing Performing Pacing To use pacing perform the following steps 1 Press Creer 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 pO HR ALARM SELECT ON OFF o 78 wm Leadil Pacer Stop Demand Mode 70ppm 30mA The Pacer Stop message indicates that the pacing function is on but paced Shocks 0 00 00 8 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 the 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 3
72. arries the CE 0123 mark accordingly For the Declaration of Conformity Statement please see the Philips Medi cal web site at http incenter medi cal philips com PMSPublic Scroll over the Quality and Regulatory Tab located in the upper left corner of the window Click to select Regulatory by Modality Then click to select Defibrillators and select the entry for Declaration of Con formity DoC Manufacturer Philips Medical Systems 3000 Minuteman Road Andover MA USA 01810 1099 Authorized EU representative Philips Medizin Systeme B blingen GmbH Hewlett Packard Str 2 71034 B blingen Germany Canada EMC ICES 001 China After sales service Beijing MEHECO PHILIPS Medical Equipment Service Center After sales service address No 208 2nd District Wang Jing Li Ze Zhong Yuan Chao Yang District Beijing Postal Code 100102 Telephone 010 64392415 Registration Number SFDA 1 20043212740 Product standard number YZB USA 2764 21 Warning Radio frequency RF interference from nearby transmitting devices may degrade the performance of the M4735A HeartStart XL Defibrillator Monitor Electromagnetic compatibil ity with surrounding devices should be assessed prior to using the defibrillator monitor This guide uses the following conventions WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life CAUTION Caution statements describe conditi
73. bol K At 80 MHz and 800 MHz the higher frequency range applies These guidelines my not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people M4735A HeartStart XL Defibrillator Monitor 13 41 Emissions and Immunity 13 42 IEC 60601 Compliance Electromagnetic Environment Immunity Test Test Level Level Guidance The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz and 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz gt The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvert ently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be con sidered If the measured field strength in the lo
74. brillator Monitor is configured Be sure to familiarize yourself with your configuration before using the M4735A HeartStart XL Defibrillator Monitor see Configuring the HeartStart XL on page 10 7 The M4735A HeartStart XL Defibrillator Monitor is powered by AC power and a rechargeable 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 HeartStart XL Defibrillator Monitor and to deliver the appropriate therapy See Battery Maintenance on page 11 8 Similarly performing the speci fied operational checks will ensure that the M4735A HeartStart XL Defibril lator Monitor is functioning properly and ready for use See Operational Checks on page 11 2 M4735A HeartStart XL Defibrillator Monitor 1 3 Intended Use Intended Use The M4735A HeartStart XL Defibrillator Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and quali fied 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 HeartStart 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 defib
75. cable into the ECG Output jack of the external monitor 5 Plug the other end of the cable into the ECG Connector on the HeartStart XL See Figure 2 2 Whenever possible we recommend that you perform synchronized cardioversion procedures while directly monitoring the patient through the defibrillator s electrodes or lead inputs If you use an external monitor as the ECG source the biomedical technician must verify that the external monitor and the HeartStart XL combination will deliver a synchronized shock within 60 ms of the peak of the R wave Use a 1 mV ORS complex with a ORS width of 40 ms This performance cannot be guaranteed with all commercially available monitors M4735A HeartStart XL Defibrillator Monitor 7 5 Delivering a Synchronized Shock Delivering a Synchronized Shock Once ECG monitoring is connected and operating properly perform the fol lowing steps 1 Press Cc located below the display to enable Sync Mode The message SYNC appears on the display 2 Use the gain control GL to adjust the ECG size so that the marker dot appears only once 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 LEAD Spo2 SpO2 HR ALARM SELECT ON OFF ALARM 87 J Shocks 0 00 00 8 oNOFR PSM
76. cal testing in adults These trials support the waveform s effectiveness for defibrillation of ventricular tachyarrhythmias at the 150J setting In Manual mode operation the M4735A HeartStart XL Defibrillator Monitor 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 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 HeartStart XL Defibrillator Monitor provides noninvasive tran scutaneous 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 defib electrode pads applied to the patient s bare chest Indications Noninvasive pacing is one method
77. cation in which the HeartStart XL is used exceeds the applicable RF compliance level above the HeartStart XL should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartStart XL d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Specifications amp Safety Emissions and Immunity Table 13 9 Electromagnetic Immunity Nonlife Supporting Functions Immunity IEC 60601 Compliance Electromagnetic Environment Test Test Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the HeartStart XL including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3 Vrms 3 Vrms IEC 61000 4 150 kHz to 80 Nie d 1 2VP Radiated RF 3 V m 3 V m IEC 61000 4 80 MHz to 2 5 E 80 MHz to 800 MHz Ge d 1 2VP M4735A HeartStart XL Defibrillator Monitor d 2 3P 800 MHz to 2 5 GHz where P is the maximum output power rat ing of the transmitter in watts W accord ing to the transmitter s specified output power and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance
78. cations amp Safety Specifications AED Mode AED Energy Profile Fixed energy 150 Joules AED Shock Series 1 2 3 or 4 shocks per series 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 13 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 shockable wide complex tachycardias Shockable tachycardias include wide complex rhythms of ventricular or unknown origin with heart rate greater than 150 bpm and polymorphic ventricular tachycardia at any heart rate Sensitivity and Specificity Meets AAMI guidelines M4735A HeartStart XL Defibrillator Monitor 13 5 Specifications ECG Monitoring Inputs Single channel ECG may be viewed on display and printed Pads ECG is obtained through 2 multifunc
79. cautions that apply to use of the M4735A HeartStart 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 HeartStart XL Defibrillator Monitor includes e M4735A HeartStart XL Defibrillator Monitor Instructions for Use e M4735A HeartStart 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 HeartStart XL include e Using the M4735A HeartStart XL Defibrillator Monitor a workbook e HeartStart XL User Training CD ROM e HeartStart XL User Training Video For additional online documentation and training please visit our website www medical philips com cms Available online training materials include e AED Application Note e SpO Concept Guide e Pacing Application Note M4735A HeartStart XL Defibrillator Monitor 1 9 2 Getting Started Congratulations on purchasing your HeartStart XL This chapter will give you a quick tour of your new defibrillator monitor s controls and display The HeartStart XL ships complete with the cables battery and paper neces sary for easy operation This chapter will help you get your HeartStart XL up and running by following a few easy steps includi
80. ch parameter is provided along with the possible choices Default settings are in bold Table 10 1 General Settings MDE Setting Parameter Description Choices Date dd mmm yyyy Current date where dd is the day mmm is any valid date the month and yyyy is the year Time hh mm Current time where hh is the hour andmm any valid time is the minutes Time is based on a 24 hour clock 10 8 Setting Up and Configuring the HeartStart XL Configuring the HeartStart XL Table 10 1 General Settings Continued Pee Setting Parameter Description Choice Print on Mark On Off Prints a 3 second strip when is pressed Print on Charge Prints a continuous strip during charging On Off Printing continues until a shock is deliv ered the device is disarmed or is pressed Print on Shock Prints a 12 second strip when a shock is On Off delivered Print on Alarm Prints a 6 second strip during alarms On Off Printer Delay Captures what you just saw All printed 6 Sec Delay strips including those generated by an No Delay 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 Pace Pulse Markers Shows pace pulse markers on the ECG Leads amp Pads displayed if an internal pacemaker is Leads Only detected ECG Lead Cable Selects the monitoring electrodes s
81. ction Delivered properly connected to the patient Minimal patient move ment is possible in this situation as the defibrillator attempts to deliver a shock The shock counter will remain at zero Key The key pressed only functions Turn the Energy Select knob to Inactive in Manual Mode Manual on prior to pressing the The key pressed does not func tion during analysis or charging The key pressed does not func tion while in a pause state key Wait for analysis or charging to complete prior to pressing the key Press RESUME prior to pressing the key Defibrillating in AED Mode 4 Monitoring the ECG This chapter provides information about applying monitoring electrodes selecting the correct lead setting and disabling the heart rate HR alarm and 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 HeartStart XL Defibrillator Monitor 4 1 Overview 4 2 Overview The HeartStart XL can be used for short or long term ECG monitoring The ECG monitoring function allows you to monitor through e multifunction defib electrode pads or e 3 or5 lead ECG monitoring electrodes as configured When the HeartStart XL is turned on the ECG acquired is shown on the dis play
82. ctor on the Heart Start XL Then select Lead I or Lead II on the HeartStart XL to view the selected lead coming from the monitor The HeartStart XL to an external monitor 1 Plug one end of the sync cable into the ECG Out Sync connector on the HeartStart XL 2 Plug the other end of the sync cable into the ECG In connector on the external monitor NOTE The signal from the external monitor is labelled Lead I or Lead II on the HeartStart XL even though it is not necessarily Lead I or II coming from the external monitor M4735A HeartStart XL Defibrillator Monitor 4 7 Selecting the Lead WARNING 4 8 Selecting the Lead Available monitoring leads depend upon how your device is configured Table 4 3 Lead Select Choices Lead Select Ghee Se If Configured 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 HE until the desired lead is displayed Figure 4 4 ECG Monitoring Display in AED Mode LEAD SpO2 HR ALARM SELECT ON OFF a 78 fm Lead I Monitoring Rhythm Shocks 3 00 00 49 The Power On Lead must be set to Paddles if you want to ensure that the waveform acquired from pads is displayed and voice and text prompts are active when enter ing AED Mode within 2 minutes of exiting Manual Mode If Pow
83. dannnssueumeatehussetedsoavieeeeeauetes 2 14 Inserting a Data Card seserinis ean eea t AEE EE EEE AE EE EREE EEEE 2 15 CMO VTS a Data Card srsrienciroiicioiiii iiini Ena RE E E A EEN 2 16 Contents Defibrillating in AED Mode OVEIVICW succanyiaieedienadeunisyadecin pntdctuwiahec task ian ceayl ANE AES EEEE EEE EE ELERE EAEG 3 3 Defibrillation using the default configuration s ssssessseeseesesssessesenssressessrssressessessre 3 4 Defibrillation with a modified configuration cccccccesceeeeeeceesseceeceeeeeeeeeeseeesseenes 3 5 Preparation ca sernsctnsnsi la cuss cnetetituoceaaapcasxuaiy beiualesidexcvananesass Ea O 3 6 STE PULAU osise en scrips Ge E AA E EE EO NEE E E E EE 3 8 A tomatic Re analysis ON scc s i secasedeuntssedenacesaseenssse a R EE E EEA 3 14 A tomatic Re analysis Off dassriariiosrssnnisiiserndi tiai ai 3 14 Pausing for OPR ecesanta aw A ae bende E eee ERTER RESE EE E RERE 3 15 Mo itormg Rhythm csse saari anna a aaa E ERE AEEA ened 3 17 ERG PrOtOCOL meer eer ee r eaea e a ae E a aE E EEE EERSTE 3 19 Troublesh oti g cisnienie h a E R E EE 3 21 Monitoring the ECG OVETVI W csiis eneren Er EEA E EEEE EEOAE EE E EEEE EEEa EERE TEE E AEE 4 2 Conn cting the ECG Patient Cable ay ss cjaccnsatdumnitns ach stmictucrss baie ucsnedpeanunteuesnretsensthadnieemetieieredse 4 3 Applying Monitoring Electrodes ccccssccssscssscessceeeecesecseceseaceaecseceseaeecsueceaeeeeeeesaeeesaeees 4 4 Hlectrode Placement
84. ded to quickly verify the viability of the HeartStart 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 Before You Begin Before you run the Shift System Check be aware of the following conditions Do not touch any of the controls on the HeartStart XL while the Shift System Check is running If a Failure or Service Unit message is displayed or if an unexpected Not Tested result is displayed check that the test is set up correctly Make sure that Q the paper is in the printer Q the test load is attached Q a Data Card with enough space is inserted into the HeartStart XL QO acharged battery is inserted into the HeartStart XL Run the Shift System Check again ensuring that no one touches any of the controls on the defibrillator unless prompted to do so The Pacing function is not tested with external paddles The Pacing function is only tested when using the patient cable for external pads If the Data Card is full the message Service Unit appears at the bottom of the screen and the message Data Card Full appears at the top of the screen Replace the Data Card and perform the Shift System Check again If the message Service Unit continues to appear do not use the device and call for service Main
85. diatric defib pads IEC M3504A Multifunction Pediatric defib pads AAMI M3507A Defib pads cable barrel connector M1781A Defibrillator test load barrel connector 05 10200 HeartStart Pads Adapter barrel connector Connects to M3507A pads connector cable Maintaining the HeartStart XL Supplies amp Accessories Table 11 3 Upgrades Supplies and Accessories Continued Part Number Description Defibrillation Pads Pads Cables Adapters and Test Load gray flat connector M3713A Multifunction Adult Plus Pads Adult Plus multifunction defib pads general use M3716A Multifunction Adult Radiolucent Pads Adult Radiolucent multifunction defib pads special purpose for X ray and special procedures M3717A Multifunction Pediatric Plus Pads Pediatric multifunction defib pads general use M3718A Multifunction Adult Radiotransparent Reduced Skin Irritation Pads Adult Radiotransparent Reduced Skin Irritation multi function defib pads special purpose for X ray and special procedures M3719A Multifunction Pediatric Radiotransparent Reduced Skin Irrita tion Pads Pediatric Radiotransparent Reduced Skin Irritation multifunction defib pads special purpose for X ray and spe cial procedures M3508A Defibrillator pads cable plug connector M3725A Defibrillator test load plug connector Paper 40457C 50 mm Strip Chart Thermal Paper 1 box 10 rolls 4045
86. duaceane 12 2 ISTE TEAR Messages serieen aea E E AN E ENEA ek 12 5 Troubleshooting Tips ax souneecescedecaedeceseescuesnnateressseecenstccunusecueceesnateesaussgsanemnansernshieesuaeretosente 12 7 Calling for Servi e nreesniensienanen an e EE E E eee 12 10 PTS TACT AIC TIO seriste rec inene renea Ena e a enea aeda neii Dae eade ikona aksoni 12 11 Specifications amp Safety SPE UGA OTE seriearen eeens EE EEE EAE REEE E GTE ER 13 2 Defibrillator seemai eunea a E E E ERE O EEEE 13 2 Contents ECG Monitoring sesei rnaen r arae E E RE EE EERE T R EEE 13 6 Display cosent i E E E OEE EE E R EEEa EN EENE 13 9 UN en E E E E E E es 13 10 Noninvasive Pacing sesunisniasroronianpnia iein AE RTE ATR S 13 12 SpPO2 Pulse OXIMEtY 375 ac vecercsictuseue crasuaenanerenps acwnaetoacereastentes das easenuanacdseattarmnaninteusemseators 13 13 Event Storage aay jscsakdsanccinustinapansqenaadasdcenssundecsneetuecvesiadacasindsauderbadaecanas odiniatacsmananncaaians 13 14 General coeire ea a E E r E A ae 13 14 Environmental pessian e are E EE E sadustosinssseaiiancatanseunstentecabieaccaias 13 14 Symbol Definitions ssrrraesnnnnn aree a E E 13 16 Clinical Performance Summary Defibrillation ssssnsessessseesseseesseesseserssressesseserssresseserss 13 21 Methods css aden awa ovine i R E E R econ aetna 13 21 RESUS aeree E A E E E csv ase eects 13 21 COMCIUSI OM serari e EEE REEE E A E E 13 22 Clinical Performance Summary Cardioversion c ccccceesseces
87. e when oper ating without a battery using AC power alone at 90 100 rated mains voltage Patient Impedance Range e Minimum 10 25 Ohm depending upon energy level e Maximum 180 Ohm M4735A HeartStart XL Defibrillator Monitor 13 3 Specifications Manual Mode Manual Output Energy Delivered 2 3 5 7 10 20 30 50 70 100 150 200 Joules When using internal paddles delivered energy is limited to 50 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 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 Specifi
88. e patient s tissue e The sensor site should be free of vibration and excessive motion e Power cables should be kept away from the sensor cable and connec tor M4735A HeartStart XL Defibrillator Monitor 5 3 Selecting a Sensor Selecting a Sensor Table 5 1 shows the SpO sensors that may be used with the HeartStart XL Table 5 1 Approved Sensors Sensor Type Patient Patient Size Ideal Site M1191A Reusable Adult gt 50 kg Finger M1192A Reusable Small adult 15 50 kg Finger Pediatric M1194A Reusable Pediatric gt 40 kg Fleshy part Adult of ear M1903B Disposable Pediatric 10 50 kg Toe Finger Nellcor D 20 M1904B Disposable Adult gt 30 kg Toe Finger Nellcor D 25 MI1131A Disposable Pediatric gt 20 kg Finger Adult NOTE To use Nellcor sensors you must connect the M1943A Nellcor Adaptor patient cable to the HeartStart XL See Connecting the SpO Patient Cable on page 10 5 NOTE A 2 meter SpO extension cable M1941A is available for use with the HeartStart XL 5 4 Monitoring SpO 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
89. eartStart XL are shown in the following table along with historical efficacy results of a standard monopha sic damped sine MDS waveform Energy 2J 5J 10J 20J 30J HeartStart XL biphasic Mean Success 4 47 77 86 88 Sample Size 48 53 53 51 41 Control Biphasic Mean Success 10 60 93 92 92 Sample Size 49 48 54 49 40 p value Fisher s Exact p lt 0 050 0 436 0 232 0 032 0 526 0 712 Historical MDS Mean Success 3 25 34 57 76 Conclusion Overall the intra thoracic defibrillation success rate for the HeartStart XL Biphasic versus a control biphasic waveform had no significant difference p lt 0 05 except at 10J 1 Zhang Y Davies R Coddington W Jones J Kerber RE Open Chest Defibrillation Biphasic versus Monophasic Waveform Shocks JACC 2001 37 320A M4735A HeartStart XL Defibrillator Monitor 13 27 Safety Considerations WARNING WARNING WARNING WARNING WARNING WARNING WARNING 13 28 Safety Considerations The following general warnings and cautions apply to use of the HeartStart XL Additional warning and cautions specific to a particular feature are provided in the appropriate section The HeartStart XL is not intended to be deployed in settings or situations that promote use by untrained personnel Operation by untrained personnel can result in injury or death Use of the HeartStart XL is restricted to a single patient at
90. eceeeeeeeeeeseeceaeceeeeeeeenseees 13 23 Methods scssativst seated n E E A R E 13 23 Resulis eneen E ERR 13 23 CONClUSION serae ech ce asta eae a e E E E 13 25 Clinical Performance Summary Internal Defibrillation 2 0 0 ee eeeeeceteceeeeteeeeeeeeeeeees 13 26 OAE ETA E E E E 13 26 Methods sieren onae E a A EEEE 13 26 RG UI esssensninsnennnnre ce va cca R AE a ene me nets T REE 13 27 CONClUSION seser arree rE e scans pvay vassseas E meus AE CA R EE EEEE 13 27 Safety Considerations snseinta aerar e E A E EE E AERES 13 28 El ctroma gnetio C mpatibility ivccassccvinsmacousadoscsinwnsaiialencduscessetuiananni Maveiseatsuiessenlanasyudes 13 32 Devices with Serial Numbers USOOIXXXXX sssssssssssssnssessssssossssssnessssceseseeese 13 32 Reducing Electromagnetic Interference iis stsisssiecwsdauascascsasnecssssarsdesusaveovenasenerdsauvderauberss 13 33 Restrictions for Use s ssssesssesssessesssesseesessresstesestsstessesersstessesrtsseesseesesstsseesseeseesresset 13 34 Immunity Level sacs ninainin i a R A A E E Ea 13 34 Electromagnetic Compatibility ssiscssicssessscasscnsssesnncsossssectiacesarseceasensectsnacdascdenenescasacssntens 13 35 Devices with Serial Numbers USOO2XXXXX ooo ceessecesscecssececescecssececsseeeesseees 13 35 Reducing Electromagnetic Interference ssesincssscissssiasessarsassnisivevasceduitiossivesaneadsoatsesavedes 13 36 R strictions for USE sseni n e EE E E E REA E 13 36 Emissions aid IMMUNITY cssssnesni rinnan
91. ectrical fast 2 kV for power 2 kV for power Mains power quality should be transient burst supply lines supply lines that of a typical commercial or IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines hospital environment Surge IEC 61000 4 5 1 kV differen tial mode 2 kV common mode 1 kV differen tial mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short lt 5 U lt 5 U7 Mains power quality should be interruptions and gt 95 dipin Ur gt 95 dip in that of a typical commercial or voltage variations pros eycle Ux for 0 5 cycle hospital environment If the user on power supply a pi of the HeartStart XL requires input lines edd i as Uy continued operation during TEC 61000 4 11 60 dip in Ur 60 dip in Ur power mains interruptions it is for 5 cycles for 5 cycles recommended that the Heart 70 Ur 70 Ur Start XL be powered from an 30 dip in Ur 30 dip in Uy uninterruptible power supply or for 25 cycles for 25 cycles a battery lt 5 Urt lt 5 Ur gt 95 dip in Uy 95 dip in for 5 sec Ur for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz magnetic field IEC 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environ ment Uris the AC mains voltage prior to
92. ed annotation in the Event Summary May S JZ be configured to print an annotated ECG strip when pressed A Manual Mode Controls Manual Mode controls provide access to manual defibrillation and synchronized cardioversion and optional pacing functionality Figure 2 3 Manual Mode Controls Energy Select Knob and Pacing Controls Energy Select O C a 4 PD e 200 e M4735A HeartStart XL Defibrillator Monitor 2 5 Getting Acquainted Display Buttons Can enable both Manual Mode and AED Mode The AED Energy Select On position activates AED Mode Manual On enables a 59 7 rD o Manual Mode synchronized cardioversion and pacing optional ox auw 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 0000 NOTE Synchronized cardioversion and pacing controls only function when Manual Mode is enabled 2 6 Getting Started Getting Acquainted Display La
93. emain 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 SPO 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 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 1 3 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
94. en used with high frequency surgical equipment WARNING To break connection with main power remove plug from wall outlet M4735A HeartStart XL Defibrillator Monitor 13 31 Electromagnetic Compatibility WARNING 13 32 Electromagnetic Compatibility Devices with Serial Numbers US001XXXXX When using the M4735A HeartStart XL Defibrillator Monitor electromag netic compatibility with surrounding devices should be assessed A medical device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC with and without the appro priate accessories has been performed according to the international standard for EMC for medical devices IEC 60601 1 2 1993 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 1993 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 HeartStart XL Defibrillator Monitor Electromagnetic compatibility with surrounding devices should be assessed prior to using the defibrillator Specifications amp Safety Electromagnetic Compatibility Reducing Electromagnetic Interference The M4735A HeartStart XL Defibrillator Monitor and associated accessories may be susceptible to interference from other RF energy sources and continu ous
95. ensor 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 Change the application site at least every four hours More frequent checking may be required due to an individual patient s condi tion 5 6 Monitoring SpO 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 M4735A HeartStart XL Defibrillator Monitor 5 7 Monitoring 5 8 Monitoring To monitor SpO 1 Ifthe HeartStart 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 HeartStart XL 4 Press Sp0 ON 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 gt 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
96. ent and conductive fluids and or metal objects such as the gurney Contact with metal objects could cause unintentional current pathways Operating the HeartStart XL or its accessories in conditions outside the environmental specifications can result in device or accessory malfunction The HeartStart XL should be allowed to stabilize within the operating temperature range for 30 minutes prior to operation 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 Specifications amp Safety 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 doubt 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 1 3 for connection to the alternative voltage CAUTION Be aware of patient cables including ECG monitoring equipment wh
97. er On Lead is not set to Paddles voice and text prompts are suspended and no waveform analysis occurs until you either press ANALYZE select Pads as the lead or attach monitoring elec trodes Monitoring the ECG Selecting the Lead NOTE When V Lead is selected change to a different V Lead by moving the electrode to the new location rather than pressing the Lead Select softkey Figure 4 5 ECG Monitoring Display in Manual Mode LEAD SpO2 HR ALARM SELECT ON OFF 78 im Pads 87J Shocks 0 00 00 08 SYNC ON OFF DISARM O 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 TORAS SELECT ON OFF Lead Il Shocks 0 00 00 08 M4735A HeartStart XL Defibrillator Monitor 4 9 Setting the Heart Rate Alarm WARNING WARNING 4 10 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 The heart rate repre sents the number of QRS complexes detected in a minute If configured to on a QRS beeper identifies each QRS complex detected Heart rate displays and alarms function with internal and external pacemakers but they can be unreliable Observe the pa
98. ery 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 Specifications amp Safety Specifications Altitude Operating up to 15 000 ft Storage up to 15 000 ft Shock Philips Medical Systems Section 760 Class B1 Drop Test 200 G s lt 3 msec pulse Vibration Philips Medical Systems Section 759 Class B1 Vibration Water Resistance Meets IEC 601 2 4 IPX0 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 HeartStart XL Defibrillator Monitor 13 15 Symbol Definitions 13 16 Symbol Definitions The following table lists the meaning of each symbol shown on the HeartStart XL and the M3516A battery Table 13 1 Defibrillator and Battery Symbols Symbol Definition Defibrillation Shock Attention See operating instructions in user s guide Input Bal gt gt Meets IEC type BF leakage current requirements and is defibrilla
99. es a3ccsicvenccvosesnccavndesiicanustaceaniaanedssastncavessddocsadstaddesadeancdesdasncdinetadassauaters 8 8 D ornllating D ring Pacing scsreisoiserascka iaie a a N aiie 8 8 Troubleshooting srsioseei nn E EE EEE E REE E EE S 8 9 Storing Retrieving amp Printing OVEVIEW sae ces ie areira o EEA A coe tc OEE E ESE AEEA E ac anes EE AN EEEE EEES emma 9 2 Marking Events esnean a A E a 9 3 Events Recorded sssuersesesrririsice seanairean atiaeina ase ogee nme det 9 4 Creating d Patient RECOrd iciss caccdsnssatoedanicadesesstdesnestastannniendesnthvadeeds EREN EEEE 9 6 Printing the Internal Event Summary sessiiesssesuasdsuassstevbrswescsulnsessnsivsousseduvnsdssaumseauiasensdieevineys 9 7 Printing PH VOUS escrin e A E E EEA EE E EEEE 9 9 Setting Up and Configuring the HeartStart XL Connecting Disconnecting Patient Cables 0 cccccccseceeeceesceesceeeeeceeeeeeeeeeseecaeeneeeaeeeaeees 10 2 Connecting Cables to the Patient Cable Connector sesssssssesessssesseseesressessessesseessesse 10 3 Connecting the SpO2 Patient Cable sscacceosedoensantndanseecsasdapeishaxanesaseauiesuubincinbssnnndsastens 10 5 Connecting the ECG Patient Cable s s ccsiacestavoisicvnnns sdecanss asaaestaneasecianccinee sdecmeinnnasarenne 10 6 Configuring the HeartStart XL cists scarred 10 7 Accessing the Configuration Menu o ccccecceeecessceeeeceseceeeeeeeeeseecseeenseeseeeeeseeeseenees 10 7 C nfip rable P rameters sacs acivacacccvepadaccsnktaxaunandesced
100. eshooting Calling for Service Asia Asia Pacific Australia 1800 251 400 China Beijing 800 810 0038 Hong Kong 852 2876 7578 Macau 0800 923 India New Delhi 011 6295 9734 Mumbai 022 5691 2463 2431 Calcutta 033 485 3718 Chennai 044 823 2461 Bangalore 080 5091 911 Hyderabad 040 5578 7974 Indonesia 021 794 7542 Japan 0120 381 557 Korea 080 372 7777 02 3445 9010 Malaysia 1800 886 188 New Zealand 0800 251 400 Philippines 02 845 7875 Singapore 1800 PHILIPS Thailand 02 614 3569 Taiwan 0800 005 616 M4735A HeartStart XL Defibrillator Monitor 12 11 13 Specifications amp Safety This section provides e specifications for the HeartStart XL e definitions for symbols appearing on the HeartStart XL e clinical Performance Summary data e safety related information e electromagnetic compatibility information M4735A HeartStart XL Defibrillator Monitor 13 1 Specifications 13 2 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 Selected Delivered Energy J Accuracy Energy Load Impedance ohms J 25 50 100 125 150 5 47 5 5 2 5 4 5 2 2J 10 9 3 10 10 4 10 7 104 2J 20 18 6 20 20 8 21 4 20 8 4J 30 27 9 30 31 2 32 1 31 2
101. ess over to you You assess 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 external or internal paddles both optional or through multifunction defib electrode pads Monitoring is avail able in AED and Manual Mode through pads 3 lead ECG monitoring elec trodes or optional 5 lead ECG monitoring electrodes Optional pulse oximetry SpO 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 HeartStart XL Defibrillator Monitor automatically stores criti cal events in its internal memory such as shocks and alarm violations Addi tional events of interest may also be marked for storage These events can be printed as they occur or as part of an Event Summary The M4735A Heart Start XL Defibrillator Monitor also allows you to store data and events on an optional HeartStart XL compatible data card see Chapter 11 for a listing for downloading to HeartStart Event Review Data Management Systems The versatile M4735A HeartStart XL Defibrillator Monitor is highly config urable to better meet the needs of diverse users The messages and softkeys vary depending on how the M4735A HeartStart XL Defi
102. f no shock is advised If a non shockable rhythm is detected the message No Shock Advised Check Patient will appear You will then be instructed to press PAUSE and begin CPR if needed see page 3 15 Figure 3 8 No Shock Advised LEAD SpO2 HR ALARM SELECT ON OFF ae Pda EE dE I i 1 Jal alakaa radiata No Shock Advised Check Patient Shocks 0 00 00 49 3 12 Defibrillating in AED Mode Defibrillating 4 If a shock is advised If a shockable rhythm is detected the message Shock Advised will appear Anal ysis stops and the HeartStart XL automatically charges to 150J Charging is accompanied by an intermittent charge tone Figure 3 9 Charging Display HR ALARM LEAD SpO2 SELECT ON OFF Charging to 150J 975 Shocks 0 00 00 10 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 10 Press SHOCK Display HR ALARM LEAD SpO2 SELECT ON OFF Stand Clear Press SHOCK 150J Shocks 0 M4735A HeartStart XL Defibrillator Monitor 3 13 Defibrillating WARNING Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation The defibrillator automatically disarms within 30 seconds if you do not press SHOCK De
103. fibrillating in Manual Mode WARNING Clinicians must select an appropriate energy level for pediatric patients WARNING The HeartStart XL has a built in limitation of 50 Joules when using ee internal paddles M4735A HeartStart XL Defibrillator Monitor 6 7 Defibrillating in Manual Mode WARNING WARNING Using Switchless Internal Paddles In preparation for defibrillation in Manual Mode using switchless internal paddles perform the following steps 1 Ifneeded insert a Data Card as described in Using a Data Card Optional on page 2 14 Turn the Energy Select knob to Manual On 3 Connect the paddles to the paddle adapter cable Connect the paddle adapter cable to the patient cable connector on the defibrillator as follows a Align the white pointer on the cable with the white arrow on the defibrillator s patient cable connector as shown in Figure 6 4 b Insert the cable into the patient cable connector Push until you hear it click in place Clinicians must select an appropriate energy level for pediatric patients The HeartStart XL has a built in limitation of 50 Joules when using internal paddles Defibrillating in Manual Mode 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 5
104. fibrillation PAUSE ANALYZE SHOCK Soft Keys gt y a User messages accompany voice prompts to guide you through 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 EZJE OFF ALARM SpO alarm Heart Rate _ gt 132 a Ba HR Alarm Pleth Bar System Message Pulse 130 Pulse Rate Momentary Message ECG gt ECG Gain 114J Current Charge Shocks 0 Shocks Delivered 00 15 02 Incident Timer Sync Display gt Defibrillation SYNC CHARGE SHOCK Connecting to Power The HeartStart XL is powered by AC Power and the M3516A battery Prior to inserting the battery make sure that the battery is charged and has been prop erly maintained See Battery Maintenance on page 11 8 It is recommended that a second charged battery be available at all times The HeartStart XL will take longer to charge to the desired energy level when NOTE using only AC Power and without the battery M4735
105. for the patient s weight e Select a sensor site with adequate perfusion e Avoid application to sites with edematous tissue e Do not use disposable sensors on patients who have allergic reactions to adhesives Reusable Sensors Reusable sensors may be reused on different patients after they have been cleaned and disinfected see 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 HeartStart 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 s
106. g SpO2 Monitoring sssssssssssssssessesereseessesstssessesstsstesresseestssesseesesesseesseserst 5 10 Canine for SSMSOTS seidr iaer O ERE eA EEEE E AE E EE EREE EEE E EEE EEEE RE 5 10 Troubleshooting ssmimi A EER a E E EE aa 5 11 Defibrillating in Manual Mode Ma ual Mode Display evcrrsnenpnenrnennir rnin ea iR A EA R R ARS 6 2 Enabling Manual Mode xavscasveseraionsznasesansnenacusancsancunaniacaseunsavunenunsienesniaectusvencavactsaceneninecarentee 6 2 Defibrillating in Manual Mode sssnsonneensenssesssseessesssesresseessesrsseesseeseesrsseeseserssressessessresseest 6 3 Using External Paddles scanssucsncenssiwacce sacs ceinantiudeseatexconsnavac encase stensereneycuvexeiabaanuonnn acannon 6 3 Using Pediatric Paddles is cosutasoccriatavatenacsactsaskueadvedisncass E E EEEE 6 4 Using Multifunction Defib Electrode Pads ssciwsssccssesrncesssrovwdsvelvsssssuonssssbinsssesvbsswsdiseawuesd 6 5 Using Switched Internal Paddles isis ssiccavdssiccassissuxosnsnacavednatccantstoduedusheaxsodssdecunsedarsduatens 6 6 Using Switchless Internal Paddles xoccsisssucedasissebeisadenniassamndacuus ee ieeatphanedinleaaineraimnees 6 8 Defibrillation Procedure 5c adi endasrcssis aazvacostecgs ex encatteanseurtecerantonesstuttaccosearsavensanmacns art teupannes 6 9 I SLEEP MELOY ssicceusdeacctasccdncasposticcannstiuenp E EAN AEE EE E AEE EE 6 9 PAE E aE i A E E EEE E E A E T 6 10 By SHOCK A E meeaaeIE Neh an eRmRIR 6 11 Entering AED Mode 9 c ncccecsscactuantcosa
107. ged battery 6 While pressing Cr turn the Energy Select knob to either Manual On or AED On to start the test 7 Follow the prompts on the display to proceed with the test If the message Service Unit appears check the information in Table 12 2 and Table 12 3 If the message continues to appear do not use the device and call for service 8 Reconnect the HeartStart XL to AC power 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 1999 13 52 17 SN 00000001 Current Tests 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 Pads ____ Charged Batteries Pacer Test Pass ____ AC Power Cord _ Printer Paper __ Data Card ___ Ancillary Supplies ____ Pads M4735A HeartStart XL Defibrillator Monitor 11 5 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 Defibrillator Inspection make sure the HeartStart 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
108. gered LEAD pO Sp02 78 a i A Pulse 78 Monitoring Rhythm Shocks 3 00 00 49 PAUSE ANALYZE Press Sp0 ALARM to turn off the alarm Refer to Setting Alarms if subse quent alarms are desired M4735A HeartStart XL Defibrillator Monitor 5 9 Discontinuing SpO2 Monitoring WARNING Discontinuing SpO Monitoring To shut off SpO monitoring press p02 ON OFF once The Sp0 ALARM softkey and related information will disappear Figure 5 5 Sp0 Monitoring Off LEAD SpO02 HR ALARM cerecr ON OFF 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 Do not use a damaged sensor or one with exposed electrical circuits Monitoring SpO Troubleshooting Troubleshooting Table 5 2 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 e Pulse absent or too weak to be detected Corrective Action Check that the sensor is applied properly Make sure the sensor site has a pulse Relocate the sensor to a site w
109. hock was delivered with the other defibrillator if necessary The sequence of energy settings was 100J 150J 200J through the first three shocks on either type of defibrillator A fourth shock if necessary was delivered at 200J if the initial defibrillator was bipha sic and at 360J if the initial defibrillator was monophasic The cross over shock was 360J monophasic if the initial defibrillator was biphasic and 200J biphasic if the initial defibrillator was monophasic Successful cardioversion was defined as the occurrence of two P waves uninterrupted by atrial fibrilla tion within 30 seconds of the shock Results Randomization to the use of monophasic or SMART Biphasic defibrillators was done in 212 elective cardioversions involving 210 patients at eleven clin ical sites in the United States and Europe Of these 203 results met the proto col criteria for inclusion in this analysis The biphasic and monophasic groups were similar in terms of age sex weight current medical history cause of heart disease and estimated ejection fraction M4735A HeartStart XL Defibrillator Monitor 13 23 Clinical Performance Summary Cardioversion The 150J SMART Biphasic waveform successfully converted far more patients with an initial 100J shock 60 compared with 22 for the monophasic waveform and successfully converted patients at least as well with a maximum energy of 200J as the monophasic did with its maximum energy of 360J 91 compared
110. in between shocks within a multi 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 HeartStart XL is not analyzing defibrillating or paused The default setting is On If you choose to set this parameter to Off the HeartStart 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 multi 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 M4735A HeartStart 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 anterior electrode placement Connect the pads to the pads patient cable as shown in Figure 3 3 3 Connect the patient cable to the patient cable connector on the defibrilla tor as described in Connecting Cables to the Patient Cable Connector on page 10 3 4 Ifneeded insert a Data Card as described in Using a Data Card Optional on 2 14 Figure 3 3 Connecting Pads to the Patient Cable 3600 0 OO Defibrillating in A
111. ing QRS beeper 4 10 settings 10 10 troubleshooting 4 13 Index Radio frequency RF interference 13 32 13 35 Re analysis 3 5 3 14 Recording events See Event Summary RF interference 13 32 13 35 Rhythm Monitoring 3 5 3 17 AED Mode 3 10 configuring 3 17 10 11 events recorded 9 4 Safety precautions See Precautions Saving settings to Data Card 10 16 Select Leads 12 5 Semi Automatic External Defibrillation See AED Mode Index Sensors 5 4 applying 5 6 caring for 5 10 cleaning 11 17 ordering 11 21 selecting 5 4 troubleshooting 5 12 12 4 Service 12 10 Settings See Configuration Shock AED Mode 3 13 events recorded 9 4 settings 10 11 troubleshooting 3 22 12 6 Shock Series Timer 10 11 shockable rhythms 13 8 Softkeys See also Controls SP02 Non Pulsatile message 12 4 Specifications defibrillator 13 2 specifications ECG analysis performance 13 8 non shockable rhythm specificity 13 8 shockable rhythm sensitivity 13 8 SpO2 alarm 5 9 SpO2 cable cleaning 11 17 connecting 10 5 ordering 11 21 SpO2 Cable Off message 5 12 SpO2 Light Interf message 5 12 SpO2 Low Signal message 5 11 SpO2 monitoring 5 2 cable connection 5 7 defined 1 7 5 2 discontinuing 5 10 events recorded 9 5 inaccuracies 1 7 noisy signal 5 11 procedure 5 8 process 5 3 sensors applying 5 6 sensors caring for 5 10 11 17 settings 10 13 troubleshooting 5 11 12 4 SpO2 Noisy Signal message 5 11 SpO2 Senso
112. ing 4 2 enabling from Manual Mode 6 12 events recorded 9 4 Events Summary 9 3 indications for use 1 5 overview 1 2 3 2 3 3 pausing 3 15 3 18 preparation 3 6 re analysis 3 14 rhythm monitoring 3 17 training required 1 4 troubleshooting 3 21 Alarms heart rate 4 10 8 3 interruption of power 9 6 SpO2 monitoring 5 9 symbols 13 16 Analysis 3 10 AED Mode 3 10 re analysis 3 14 settings 3 5 Artifact Detected message 3 21 Asynchronous defibrillation 1 6 Asystole 1 6 pacing 1 7 Attach Leads 12 5 Attach Paddles 12 5 Attach Pads Cable message 12 2 Attach Pads message 12 5 Audiovisual controls 2 4 Automatic Re analysis 3 14 setting 3 5 10 11 Batteries 1 3 charging 11 9 checking 11 6 inserting and removing 2 10 maintenance 11 8 ordering 11 22 specifications 11 12 storing and discarding 11 12 symbols 13 16 troubleshooting 12 2 See also Power supply Battery Capacity Test 11 10 Bradycardia 1 7 Cables checking 11 6 cleaning 11 16 11 17 ECG 4 3 10 6 Paddles Adapter 11 20 SpO2 5 7 5 12 10 5 Cal Pulse 2 4 Check Patient Timer setting 10 11 Check Printer message 12 6 Cleaning HeartStart XL 11 15 pads electrodes amp cables 11 16 11 17 printer printhead 11 15 Clinical Performance 13 21 13 23 Configuration 10 7 accessing menu 10 7 AED Mode 3 5 Automatic Re analysis 3 5 default 10 15 Device Initiated Analysis 3 5 ECG filters 10 13 heart rate alarm 4 10 list of configurable items 1
113. ion Lead Heart Rate and Heart Rate alarm limits Storing Retrieving amp Printing Events Recorded Table 9 1 Event Information Continued Event Types Related Information Stored SpO Violation SpO gt value and SpO alarm limit Mark ECG waveform with annotation A Epi Atro Lido or Other Print Strip ECG waveform Sync Sync on Sync off Sync marker Pacing Pacer start Pacer stop Pacer settings M4735A HeartStart XL Defibrillator Monitor 9 5 Creating a Patient Record Creating a Patient Record The HeartStart XL creates an Event Summary patient record for each new patient Each record is assigned a unique incident number The HeartStart 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 HeartStart 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 HeartStart 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 HeartStart XL off and or patient contact was never
114. is con figured 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 15 As described you can enter a Pause state e after a shock or e when no shock is advised In both cases the ERC protocol prompts you to press PAUSE and begin CPR of needed Figure 3 16 Check Patient Message HR ALARM LEAD SpO2 SELECT ON OFF 120m Pads If Needed Press PAUSE And Begin CPR Shocks 1 00 00 50 S O M4735A HeartStart XL Defibrillator Monitor 3 19 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 17 Display in Paused State HR ALARM LEAD SpO02 SELECT ON OFF 120m Pads Paused Elapsed Time J y Total Pause Duration Timer 35 120 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 shortly after a shock is delivered the duration is equal to the Post Shock CPR Timer configuration setting The default setting is 120 sec onds 60 seconds for software versions Main 19 and lower 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 Defibrillating in AED Mode Troubleshooting Troubleshooting
115. ith 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 that the sensor is applied properly Try another sensor type p0 Noisy Signal Excessive patient move ment electrical interfer ence RF interference or optical interference Minimize patient 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 HeartStart XL Defibrillator Monitor 5 11 Troubleshooting 5 12 Table 5 2 Troubleshooting when Monitoring Sp09 Continued Problem or Message p0 Light Interf Possible Cause e The level of ambient light is so high that the sensor cannot obtain an SpO reading Sensor or cable is dam aged Corrective Action Cover sensor with an opaque material Check sensor for dam age try another sen sor Sp0 Cable Off The SpO cable is not Attach the cable to the connected to the device HeartStart XL Sp04 Sensor Fail The transducer is bro Apply a new trans ken ducer Monitoring SpO 6 Defibrillating in Manual Mode In Manual Mode you assess 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 The
116. itor 13 37 Emissions and Immunity 13 38 Guidance and Manufacturer s Declaration The HeartStart XL is intended for use in the electromagnetic environment specified in the tables below The customer or the user of the HeartStart XL should assure that it is used in such an environment Table 13 6 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The HeartStart XL uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and not likely to cause interference in nearby electronic equipment RF emissions Class B The HeartStart XL is suitable for use in all estab CISPR 11 lishments including domestic and those directly connected to the public low voltage power sup Harmonic emis Class A ply network that supplies buildings used for SIONS domestic purposes IEC 61000 3 2 Voltage fluctua Complies tions flicker emissions IEC 61000 3 3 Specifications amp Safety Table 13 7 Electromagnetic Immunity General Emissions and Immunity Immunity Test Electrostatic dis IEC 60601 Test Level 6 kV contact Compliance Level 6 kV contact Electromagnetic Environment Guidance Floors should be wood con charge ESD 8 kV air 8 kV air crete or ceramic tile If floors IEC 61000 4 2 are covered with synthetic mate rial the relative humidity should be at least 30 El
117. k 6 11 display 2 7 ECG monitoring 4 2 enabling 2 6 energy setting 6 9 Events Summary 9 3 indications for use 1 6 overview 1 2 preparation 6 3 6 5 returning to AED Mode 6 12 SpO2 monitoring 5 2 training required 1 4 Marking events 9 3 See also Event Summary Messages defined 2 8 list of 12 2 Momentary messages 2 8 list of 12 5 Monitoring See ECG monitoring Monitoring electrodes See Electrodes Index Monitoring Rhythm See Rhythm Monitoring Multifunction defib electrode pads See Pads Nellcor sensors 5 4 No Data Card Present message 12 6 No Paddles Connected message 12 3 No Pads message 12 3 No Shock Advised Timer 3 20 10 12 No Shock Delivered message 3 22 12 6 Non Pulsatile message 5 11 Noninvasive transcutaneous pacing See Pacing non shockable rhythms 13 8 Index O P Operational checks every month 11 3 every shift 11 3 using external paddles 11 4 using internal paddles 11 7 using pads 11 5 Output Low message 8 9 Oxygen saturation See SpO2 monitoring Pace Pulse Markers 10 9 Pacemakers AED therapy 1 5 heart rate alarm 4 10 Pacing 8 1 defibrillation 8 8 defined 1 7 8 1 demand v fixed mode 8 2 8 6 8 8 ECG monitoring 8 3 events recorded 9 5 function buttons 2 6 indications for use 1 7 messages 12 3 preparation 8 3 procedure 8 5 selecting leads 8 3 8 9 system messages 8 9 troubleshooting 8 7 8 9 12 6 Paddles Attach Paddles 12 5 using
118. keys and Ww 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 Press SAVE to save the change To exit without making the change press CANCEL 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 E simultaneously while in 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 HeartStart XL Defibrillator Monitor 10 15 Configuring the HeartStart 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 HeartStart XLs or to restore the configuration if nec essary To save the configuration 1 Make sure a Data Card is in the HeartStart XL before you turn the defibrillator monitor on 2 Select Save Settings to Data Card from the main configuration menu 3 Press SAVE in response to the question Save Settings to Data Card The HeartStart XL saves the configuration settings to the Data Card and returns to the main configuration menu NOTE 10 16 To avoid possible confusion designate one Data Card as the Configuration Card and label it clearly Keep this card physically separate from cards
119. l remain audible NOTE When using the HeartStart 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 M4735A HeartStart XL Defibrillator Monitor 4 11 Troubleshooting Troubleshooting Table 4 5 provides troubleshooting tips for ECG Monitoring Table 4 5 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 Solution Check that the monitoring electrodes are properly applied Check that the monitoring cable is properly con e The monitoring cable is nected not connected Pads Off message e The pads are not mak Check that the pads are ing proper contact with properly applied the patient 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 not open the electrode pack age until immediately pri
120. lation 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 Manual On AED On yp 1 The HeartStart XL checks to see if the pads patient cable and multifunction defib electrode pads are properly connected If either connection is compro mised you are prompted to fix the problem O Analysis begins automatically there is no need to press ANALYZE Once analysis is complete the HeartStart XL tells you Shock Advised or No Shock Advised If a shock is advised press SHOCK After a shock is delivered the HeartStart XL automatically prompts you to press pause and begin CPR if needed 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 HeartStart 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 multi 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
121. livery of the shock is confirmed by the message Shock Delivered and the shock counter is updated You will then be instructed to press PAUSE and begin CPR if needed see page 3 15 Figure 3 11 Shock Delivered Display HR ALARM LEAD SpO2 SELECT ON OFF Shock Delivered Shocks 1 00 00 40 Automatic Re analysis On If Automatic Re analysis is on and you have a shock series of two or more the HeartStart XL analyzes the ECG following delivery of the shock You are prompted to press SHOCK if an additional shock is advised This cycle repeats until the rhythm converts or a shock series is complete A shock series may be configured to 1 2 3 or 4 shocks Automatic Re analysis Off If Automatic Re analysis is off the HeartStart 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 Defibrillating in AED Mode Pausing for CPR Pausing for CPR After a shock or when no shock advised the HeartStart XL prompts If Needed Press Pause and Begin CPR Figure 3 12 Press Pause Display HR ALARM LEAD Spo2 SELECT ON OFF 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
122. made If the HeartStart 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 Start 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 9 6 Storing Retrieving amp Printing Printing the Internal Event Summary Printing the Internal Event Summary To print the internal Event Summary press Gamaryy To stop printing before the complete summary is printed press again or press Garp 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 adirectory 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 Operator Device On 03 Jan 00 12 41 00 went N2 Tan NN N1 NO NA Tit UJJ US ULF IT ait Total Shocks 2 Incident 0000045 Serial Number 123456789 M4735A HeartStart XL Defibrillator Monitor Device On AED Mode Pads On Leads On Analyzing Shock Advised Shack 1 Analyzing Shock Advised Shock 2 Manual Mode 12 41 00 12 41 00 12
123. mmary 9 2 events recorded 9 4 information included 9 7 interruption of power 9 6 marking events 9 3 printing 9 7 9 9 External paddles using in Manual Mode 6 3 F Failure message 8 9 H Heart rate alarm disabling 4 11 events recorded 9 4 interruption of power 9 6 pacing 8 3 settings 4 10 See also ECG monitoring heart rhythms non shockable 13 8 shockable 13 8 HeartStart XL 1 2 assessment of 1 4 cleaning 11 15 configuring 10 7 operational checks 11 3 11 4 11 5 safety precautions 13 29 specifications 13 2 symbols 13 16 training required 1 4 troubleshooting 12 7 HR alarm See Heart rate alarm Hypothermia pacing 1 7 SpO2 monitoring 5 2 Incident number See Event Summary Incident Timer 2 7 Incompatible Data Card message 12 6 Indications for use AED mode 1 5 Manual Mode 1 6 pacing 1 7 SpO2 monitoring 1 8 Internal paddles switched using in Manual Mode 6 6 Internal paddles switchless using in Manual Mode 6 8 K Key Inactive message 3 22 8 9 12 6 L Leads formation 4 5 Lead Select setting 10 13 selecting 4 8 7 2 8 4 troubleshooting 4 12 8 9 12 3 iii Leads Off message 4 12 8 9 12 3 Loading printer paper 11 13 settings from Data Card 10 16 Low Battery message 12 2 Maintenance batteries 11 8 cleaning 11 15 operational checks 11 2 supplies and accessories 11 18 Manual Mode 6 1 controls 2 5 current charge 6 10 defibrillation process 6 9 delivering shoc
124. n the event preceding the Pause state M4735A HeartStart XL Defibrillator Monitor 10 11 Configuring the HeartStart XL 10 12 Table 10 2 AED Settings Continued Parameter If European Protocol Description Setting Choices is set to On the following two configuration choices appear Post Shock CPR Appears only when European Protocol is on 30 60 120 Timer Defines the duration of the Pause time in sec 180 For software onds when PAUSE is pressed and the time version Main 20 since the last shock is less than or equal to the Shock Series Timer setting typically at the com pletion of a shock series Post Shock CPR Appears only when European Protocol is on 30 60 120 Timer Defines the duration of the Pause time in sec 180 For software onds when PAUSE is pressed and the time versions Main 19 since the last shock is less than or equal to the and lower Shock Series Timer setting typically at the com pletion of a shock series NSA Timer Appears only when European Protocol is on 30 60 120 Defines the duration of the Pause time in sec 180 onds when PAUSE is pressed and the time since the last shock is greater than the Shock Series Timer setting typically when No Shock Advised If European Protocol is set to Off the following configuration choice appears Pause Timer Defines the duration of the pause time in sec 30 60 120 For
125. nd Configuring the HeartStart XL Configuring the HeartStart XL Table 10 2 AED Settings ee Setting Parameter Description Choices AED Shock Series Defines the maximum number of shocks to 1 2 3 4 For software deliver before prompting If Needed Press PAUSE version Main 20 And Begin CPR AED Shock Series Defines the maximum number of shocks to 2 3 4 For software deliver before prompting Check Patient Check versions Main 19 Pulse If Needed Press PAUSE And Begin CPR and lower Shock Series Timer Defines the number of seconds that must pass 30 60 90 before the next shock is considered the first 120 150 180 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 HeartStart 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 HeartStart XL is not ana lyzing defibrillating or paused Check Patient Defines how often in seconds the Check 30 45 60 90 Timer Patient prompt is repeated when Rhythm Mon Off itoring detects a potentially shockable rhythm European Protocol Modifies Pause state prompts and replaces the Off On Pause Timer with either the Post Shock CPR Timer or the NSA Timer depending o
126. ng e Connecting to AC Power e Inserting the battery e Ifdesired inserting the optional HeartStart XL compatible Data Card see Chapter 11 for a listing NOTE To connect cables to the HeartStart XL refer to Setting Up and Configuring the HeartStart XL in Chapter 10 M4735A HeartStart XL Defibrillator Monitor 2 1 Getting Acquainted Getting Acquainted This section provides an overview of the HeartStart XL controls connections 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 Batt Charge Print Strip Event Summary Energy Select Knob Volume ECG Size Pacer Rate Mode Start Stop Output lt Battery Patient Cable ee aes Data Card 2 2 Getting Started Getting Acquainted Figure 2 2 HeartStart XL Back Printer ECG Connector SpO Connector ECG Out Sync Jack AC Power N NOTE If your HeartStart XL does not have the SpO or Pacing option disregard these controls and the related information described in this section M4735A HeartStart XL Defibrillator Monitor 2 3 Getting Acquainted Defibrillation Controls Defibrillation controls consist of an energy select knob and a set of
127. ni tored To perform synchronized cardioversion you must select a means of monitor ing ECG and a means of delivering the synchronized shock The HeartStart XL provides three ways to monitor ECG using defib electrode pads monitoring electrodes or the external paddles The synchronized shock is delivered through the mulifunction defib electrode pads or through the external paddles NOTE See Chapter 4 Monitoring the ECG for information on how to apply electrodes and select a lead M4735A HeartStart XL Defibrillator Monitor 7 1 Monitoring the ECG Monitoring the ECG The HeartStart XL provides three ways to monitor ECG for synchronized car dioversion e multifunction defib electrode pads through the patient cable e monitoring electrodes through a 3 or 5 lead ECG cable and leads or e external paddles In addition you may monitor ECGs using an external Philips Agilent or Hewlett Packard branded ECG monitor When selecting an ECG lead choose the lead that provides the clearest signal and the largest QRS complex Using Multifunction Defib Electrode Pads To monitor ECG for cardioversion using multifunction defib electrode pads perform the following steps 1 Ifneeded insert a Data Card as described in Using a Data Card Optional on 2 14 Turn Energy Select knob to Manual On 3 Apply multifunction defib electrode pads to the patient as directed on the package Use either the anterior a
128. nterior or anterior posterior placement as appropriate 4 Connect the pads to the patient cable See Figure 6 3 5 Use HE to select Pads See Selecting the Lead on page 4 8 Performing Synchronized Cardioversion Monitoring the ECG Using 3 or 5 wire ECG Leads To monitor ECG for cardioversion using monitoring electrodes and 3 or 5 wire ECG leads perform the following steps 1 Ifneeded insert a Data Card as described in Using a Data Card Optional on 2 14 2 Apply monitoring electrodes See Applying Monitoring Electrodes on page 4 4 3 Turn Energy Select knob to Manual On Connect the ECG cable to the HeartStart XL See Figure 4 1 5 Use thee to select the best lead that displays a large QRS complex See Selecting the Lead on page 4 8 M4735A HeartStart XL Defibrillator Monitor 7 3 Monitoring the ECG Using External Paddles To monitor ECG for cardioversion using the external paddles perform the following steps l 2 3 4 5 If needed insert a Data Card as described in Using a Data Card Optional on 2 14 Turn the Energy Select knob to Manual On Use HE to select Paddles See Selecting the Lead on page 4 8 Remove paddles from pockets by simultaneously pulling out and up Apply conductive material to paddles NOTE WARNING Do not apply conductive matter by rubbing paddles together Improper usage will result in a Paddles On event tha
129. o either Off or 210 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 elapsed time appears on On Off Timer the display during an event M4735A HeartStart XL Defibrillator Monitor 10 13 Configuring the HeartStart XL 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 14 Setting Up and Configuring the HeartStart XL Configuring the HeartStart XL Modifying the Configuration To modify the configuration from the main menu 1 Nw A a a T Use the soft
130. 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 HeartStart XL Defibrillator Monitor 1 7 Safety Considerations NOTE 1 8 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 SpO gt 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 movement nail polish and excessive ambient light Safety Considerations General warnings and
131. ompts vary depending upon the condition 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 HeartStart XL Defibrillator Monitor 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 Press ANALYZE Shock Advised J Press SHOCK No Shock Advised Check Patient If needed press PAUSE if shock series is set to greater than one 3 2 and begin CPR 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 assessed that the patient is unresponsive not breathing and pulseless prepared for defibrillation by attaching pads and cables inserted a Data Card if desired and turned the Energy Select knob to AED On NOTE If AED prompts are not active in AED Mode press ANALYZE to activate voice and text prompts M4735A HeartStart XL Defibrillator Monitor 3 3 Overview 3 4 The defibrillation process is dependent upon the configuration of your HeartStart XL as described in the following paragraphs Defibril
132. ons 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 ili Contents Introduction CDVEEVICW indcinsistocSiunasesesahaseatasnniua ATERA AEE EAEE E E E R E Eak 1 2 T tended s veitari esaa entea E r ES ery eee EEE E T enor e 1 4 Defibrillation Therapy svaisexcsarexunecerasvsccosuiedasenensanternsstteenswintaranensnsterssalaeesanvexcunnseaatneanetorsnns 1 4 Indications for AED Therapy issssiiisnmisienr oeir cns ae n R E E REN 1 5 Contraindications for AED Therapy ssesssssssssesesseesessresseesesersstesesreserssresesressressesere 1 5 Precautions for AED Therapy as cccscsciaceessotiastiashvacssedasacesoamaadonnsatuassoinieesetisacioaandinenaneus 1 5 Indications for Manual Defibrillation Therapy essssseessesssessessseseesseeseesesseesseseesseesee 1 6 Contraindications for Manual Defibrillation Therapy 0 ccccceccseeeseceeeeeeeeeeteeesseeees 1 6 Precautions for Manual Defibrillation Therapy c cccecceeeceeeeeeteeceeceeeeeeeeeeseeesaeens 1 6 Noninvasive Pacing Therapy Optional ccccccccceceseceseceeseeececeseceeeeseeceaeceeeeeeeeeeseeeaeens 1 7 TiN I AUIS sensn a A A cee aaa 1 7 C Gilt AITO AIGIAS y 15csicscvuriiswesivageunddehuninnadanaaneedscassauerdaws duslade
133. or skin contact pads are not properly connected to the patient Minimal patient movement is possible in this situation as the defibrillator attempts to deliver a shock The shock counter will remain at zero Corrective Action e Make sure the pads are applied properly e Replace the pads if necessary Check Printer Printer paper is absent or jammed the printer door is not closed properly Reload the printer paper Make sure the door is closed properly Data Card Full e The incident is more than 2 hours in duration causing the Data Card to fill e Anempty Data Card was not inserted for the incident causing the Data Card to fill sooner e None A new Data Card cannot be inserted during an incident e Use one Data Card per incident patient to decrease the chance of the card filling Data Card Interrupted Data Card Not In Service The Data Card is removed during an inci dent The Data Card is inserted while the Heart Start XL is on e None The Data Card cannot be re inserted during an incident e Do not remove the Data Card during an incident None A Data Card must be inserted prior to turning the HeartStart XL on for the current patient Incompatible Data Card A Data Card other than a HeartStart XL compatible Data Card is inserted Use only HeartStart XL compatible Data Cards see Chapter 11 for listing No Data Card Present A Data Card is not in the HeartStart XL T
134. or to use Relocate or turn off equip ment that may be causing RFI 4 12 Monitoring the ECG Troubleshooting Table 4 5 Troubleshooting when Monitoring the ECG Continued Situation Cause Solution QRS Volume e No sound e Adjust the volume e Too low e Check configurations e Too loud QRS beeper inau e The QRS beeper is con e Check that the QRS dible or beeps do figured to Off beeper is configured to not occur with e The amplitude of the On each QRS com QRS complex is too e Adjust the volume plex small to detect e Adjust the size of the ECG M4735A HeartStart XL Defibrillator Monitor 4 13 5 Monitoring SpO This chapter provides information about e how pulse oximetry works e selecting and applying the correct sensor e monitoring SpO e discontinuing SpO M4735A HeartStart XL Defibrillator Monitor 5 1 Introduction Introduction Pulse oximetry is a noninvasive method of continuously measuring oxygen saturation SpO gt 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 HeartStart XL to monitor SpO SpO monitoring is always available both in AED and Manual Mode if the
135. ource 3 lead 5 lead M4735A HeartStart XL Defibrillator Monitor Configuring the HeartStart XL WARNING 10 10 Table 10 1 General Settings Continued He Setting Parameter Description Choices Power On Lead Allows you to select the ECG lead dis Paddles any played when the HeartStart XL is powered lead available on in Manual Mode Lead II ORS Beeper Provides an audible beep with each QRS On Off complex detected If the Paddles setting choice is selected the HeartStart XL will display the waveform acquired through either paddles or multifunction defib electrode pads The default configuration setting is Lead II If the HeartStart XL will be used by BLS users it is recommended that the configuration setting be changed to Paddles This ensures that if a BLS user inadvertently enters Man ual Mode prior to AED Mode the ECG waveform acquired through the mul tifunction defib electrode pads is displayed and AED Mode voice and text prompts are active The Power On Lead must be set to Paddles if you want to ensure that the waveform acquired from pads is displayed and voice and text prompts are active when enter ing AED Mode within 2 minutes of exiting Manual Mode If Power On Lead is not set to Paddles voice and text prompts are suspended and no waveform analysis occurs until you either press ANALYZE select Pads as the lead or attach monitoring elec trodes Setting Up a
136. r Fail message 5 12 Stop message 8 9 Stop Pacer message 12 6 Strip See Print strip Supplies ordering 11 18 Symbols list of 13 16 Sync After Shock setting 10 13 Sync control 2 6 vil Index Synchronized y Aa dioversion il Ventricular fibrillation disabling Sync Mode manual defibrillation i 1 6 enabling 2 6 pacing 1 7 selecting leads 7 1 Ventricular tachycardia 1 System messages 2 8 6 list of 12 2 System tests See W Warnings See Maintenance Precautions T Web site 12 10 Telephone assistance 12 10 Thermal Array Printer See Printer Time 10 8 12 8 Training required 1 4 13 28 Troubleshooting 12 1 AED Mode 3 21 Data Card 12 6 ECG monitoring 4 12 pacing 8 7 8 9 12 3 12 6 SpO2 monitoring 5 11 12 4 time and date 12 8 U User messages 2 8 viii PHILIPS HEARTSTART XL M4735 91900 Edition 7 Copyright 2006 Koninklijke Philips Electronics N V Printed in the U S A April 2006 Un MA amp
137. re 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 storing retrieving and printing patient information acquired in Manual Mode see Chapter 9 Storing Retrieving and Printing M4735A HeartStart 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 HRACARM SELECT ON OFF ALARM Sp0 Value Heart Rate v1 32 Pads Piet Bat Heart Rate Alarm an p96 30 Pulse Rate Current Lead lt ECG Gain ECG Waveform Shock Counter Sync Statu ync Status gt Sync Elapsed Time 0 Sync On Off Softkey SYNC CHARGE SHOCK q Shock Softkey ON OFF EEE ee Charge Disarm Softkey Enabling Manual Mode To enable Manual Mode turn the Energy Select knob to Manual On 6200 Defibrillating in Manual Mode Defibrillating in Manual Mode Defibrillating in Manual Mode This sec
138. repetitive power line bursts Examples of other sources of RF interfer ence are medical devices cellular products information technology equipment and radio television transmission Should interference be encoun tered as demonstrated by artifact on the ECG or dramatic variations in SpO values attempt to locate the source Assess e Is the interference intermittent or constant e Does the interference occur only in certain locations e Does the interference occur only when in close proximity to certain medical devices e Does the SpO 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 13 is needed call your local service representative M4735A HeartStart XL Defibrillator Monitor 13 33 Electromagnetic Compatibility Restrictions for Use Artifact on the ECG caused by electromagnetic interference should be evalu ated 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 Heart Start XL defibrillator monitor is designed to receive and amplify low level signals in the same bandwidth as the interference Immunity is defined in the stand
139. rillator monitor in Manual Mode the M4735A HeartStart XL Defibrillator Monitor is suitable for use by healthcare profes sionals 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 HeartStart XL Defibrillator Moni tor provides this therapy through the application of a brief biphasic pulse of electricity to the cardiac muscle This electrical energy is transferred through attached internal paddles applied directly to the patient s heart or through attached paddles or disposable multifunction defib electrode pads applied to the patient s bare chest NOTE 1 4 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 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 patient
140. rized personnel to determine if it will negatively impact patient diagnosis or treatment Specifications amp Safety WARNING Emissions and Immunity Emissions and Immunity The HeartStart XL with serial numbers appearing as USO002XXXXX is designed and tested to comply with the radiated and conducted emissions requirement of international and national standards IEC 60601 1 2 2001 and EN 60601 1 2 2002 See Tables 13 6 through 13 10 for detailed information regarding declaration and guidance The use of accessories transducers and cables other than those specified below may result in increased emissions or decreased immunity of the HeartStart XL The list of cables transducers and other accessories with which Philips claims compliance with the emissions and immunity requirements of IEC standard 60601 1 2 are listed in Maintaining the HeartStart XL The EMC standards state that manufacturers of patient coupled equipment must specify immunity levels for their systems Immunity is defined in the standard as the ability of a system to perform with 13 out degradation in the presence of an electromagnetic disturbance Degrada tion 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 M4735A HeartStart XL Defibrillator Mon
141. s 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 HeartStart XL Defibrillator Monitor may have reduced sensitivity and not detect all shockable rhythms NOTE The Philips HeartStart XL AED algorithm is not intended for children under 8 years of age For children older than 8 years the American Heart Association recommends that standard operating procedures for AEDs be followed American Heart Association Guidelines 2005 for Cardiopulmonary Resusci tation and Emergency Cardiovascular Care Dallas Texas AHA 2005 M4735A HeartStart XL Defibrillator Monitor 1 5 Defibrillation Therapy 1 6 Indications for Manual Defibrillation Therapy Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients who are pulseless and unresponsive Synchronous defibrillation is indicated for termination of atrial fibrillation The SMART Biphasic waveform utilized in the HeartStart XL Defibrillator Monitor has undergone clinical testing demonstrating its effectiveness for cardioversion of atrial fibrillation The SMART Biphasic waveform utilized in the M4735A HeartStart XL Defibrillator Monitor has undergone clini
142. sible Cause e The selected monitoring lead is not making proper contact with the patient e Pacing was attempted in demand mode without monitoring electrodes attached The pacing system is not functioning Corrective Action e Check that the monitoring electrodes are properly applied e Check that the monitoring cable and electrodes are properly connected Remove the device from active use and call for service Pacer Output Low High patient impedance results in delivering less current to the patient than specified in the output current setting Check that the pads are applied properly Stop Pacer is pressed while paced pulses are being delivered Stop pacing before changing the pacing mode Key Inactive r or one of the other pacing function keys is pressed when Manual Mode is not active Make sure Manual Mode is active before pressing or one of the other pacing function keys M4735A HeartStart XL Defibrillator Monitor 8 9 9 Storing Retrieving amp Printing This chapter describes how the HeartStart 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 HeartStart XL Defibrillator Monitor 9 1 Overview 9 2 Overview The HeartStart XL automatically creates an Event Summary for each patient
143. software onds when PAUSE is pressed when European 180 version Main 20 Protocol is set to Off Appears only when European Protocol is configured off Pause Timer is the default Pause Timer Defines the duration of the pause time in sec 30 60 120 For software 180 versions Main 19 and lower 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 Up and Configuring the HeartStart XL Configuring the HeartStart XL Table 10 2 AED Settings Continued Setting Parameter Description 5 oun ipii Choices The following two configuration choices are always available regardless of the European Protocol setting Lead Select Turns on ECG monitoring via ECG Leads On Off Sp0 Turns on SpO monitoring Only listed as a On Off configurable item if the SpO option was pur chased If 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 If European Protocol is set to On the setting for the Shock Series Timer must be lt Post Shock CPR Timer lt NSA Timer Also the Shock Series Timer can not be config ured t
144. t Interf The level of ambient light is so high that the sensor cannot obtain an SpO gt 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 Sp0 Non Pulsatile The patient s pulse is absent or too weak to be detected e Check that the sensor is applied prop erly e Make sure the sensor site has a pulse e Relocate the sensor to a site with improved circulation e Try another sensor p0 Failure A failure has occurred in the SpO Remove the device from active use and circuitry call for service Sp0 Low Signal SpO signal is too low to give an accurate e Check that the sensor is applied reading properly e Try another sensor type Sp0 Noisy Signal Excessive patient movement electrical e Minimize patient movement or apply interference or optical interference is 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 Sp0 Sensor Fail The SpO transducer is broken Try another sensor 12 4 Troubleshooting Momentary Messages Momentary Messages Momentary messages are temporary and only appear on the display for a few seconds Each message is accompanied by a three second beep to alert you Table 12 2 lists momentary messages Table 12 2 Momentary Messages Message Possible Cause Corrective
145. t con nected No Pads The multifunction defib electrode pads Check the pads cable connection are not properly connected to the Heart Start XL Pads Cable Off The pads cable is not connected to the Check that the pads connector is locked in defibrillator place Pads Off The pads are not making proper contact Make sure the pads are properly applied with the patient to the patient 50J Maximum When using internal paddles the maxi Select a lower energy 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 that the pads are applied properly No Paddles Connected The paddles are not properly connected to the HeartStart XL Check that external paddles are con nected Service Unit Appears during a Shift System Check May indicate that the Data Card is full e Replace the Data Card e Perform a Shift System Check e If Service Unit continues to appear do not use the device and call for service M4735A HeartStart XL Defibrillator Monitor System Messages Table 12 1 System Messages Continued Message Sp0 Cable Off Description The SpO cable is not connected to the device Corrective Action Attach the SpO cable to the HeartStart XL p0 Ligh
146. t will be registered in the Event Sum mary and may cause paddle damage 6 Apply paddles to patient s bare skin Artifact introduced by paddle movement may resemble an R wave and trigger a defibrillation shock When performing synchronized cardioversion pads or ECG electrodes are recommended for ECG monitoring Performing Synchronized Cardioversion Monitoring the ECG Using External ECG Monitors An external Philips Agilent or Hewlett Packard branded monitor can be connected to the HeartStart XL for the purposes of sending or receiving an ECG signal between the two devices A sync cable is used to make this con nection One end of the sync cable plugs into the ECG Output connector on the bedside monitor and the other end plugs into the ECG Connector on the HeartStart XL This cable connects the ECG signal from the monitor into the HeartStart XL where the signal is displayed and synchronization occurs NOTE WARNING The signal from the external monitor is labelled Lead I or Lead II on the HeartStart XL even though it is not necessarily Lead I or II coming from the external monitor To use an external monitor with the HeartStart XL perform the following steps 1 Ifneeded insert a Data Card as described in Using a Data Card Optional on 2 14 2 Turn Energy Select knob to Manual On 3 Use H to select Lead I or Lead II on the HeartStart XL See Select ing the Lead on page 4 8 Plug the
147. tStart XL Defibrillator Monitor 11 15 Cleaning Instructions Cleaning Defib Pads amp Monitoring Electrodes Defibrillation pads and monitoring electrodes are single use and do not require cleaning Cleaning the External and Internal Paddles The following procedure for general cleaning of the paddle sets is recom mended e Clean the electrode surface and handle with standard hospital solu tion Do not use acetone enzymatic or ammonia based cleaners e Use a small soft brush with cleaning solution to clean any contamina tion from the electrode surface and edges e Before sterilizing remove any excessive residue accumulated on the handles or electrode surfaces e Do not immerse the connector in cleaning solution This product was not designed to be soaked in cleaning fluid and should only be surface cleaned CAUTION Do not ultrasonically clean or immerse the paddles and paddles cables NOTE For information about paddle sterilization procedures see the M4741 91000 Sterilizable Paddles Instructions for Use 11 16 Maintaining the HeartStart XL Cleaning Instructions Cleaning the Pads Cable The defib pads 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 compounds such as Lysol e Isopropyl alcohol CAUTION Do not ultrasonically clean immerse autoclave or steam
148. taining the HeartStart XL Operational Checks Every Shift Perform a Shift System Check every shift to verify that the HeartStart XL is functioning properly and to ensure that necessary supplies and accessories are present and ready for use You should test every shock delivery method that is used with this unit e Ifyou only use external paddles test only with external paddles see Using External Paddles on page 11 4 e Ifyou only use defib pads test only with defib pads see Using Pads on page 11 5 e Ifyou use both pads and external paddles test both e If your usage also includes internal paddles perform the Shift Sys tem Check with the pads patient cable as described in Using Pads on page 11 5 Then test the unit and the internal paddles just before use as described in Using Internal Paddles on page 11 7 Every Month Check expiration dates on multifunction defib electrode pads and monitoring electrodes every month Replace them if the expiration date has passed M4735A HeartStart XL Defibrillator Monitor Operational Checks WARNING Using External Paddles To perform the Shift System Check using external paddles Turn the HeartStart XL off If routinely used insert a Data Card into the HeartStart XL Unplug the AC power cord Insert a charged battery Be sure the paddles are both fully seated in their holders While pressing Grip turn the Energy Select knob to either
149. tate the green locking mechanism on the cable in the direction clock wise of the blue arrow on the defibrillator until it stops as shown in Fig ure 10 2 2 Hold the locking mechanism in this position as you pull the cable away from the defibrillator Figure 10 2 Disconnecting Cables from the Patient Cable Connector Blue arrow 10 4 Setting Up and Configuring the HeartStart XL Connecting Disconnecting Patient Cables Connecting the SpO Patient Cable To connect the SpO patient cable 1 Hold the connector with the flat side facing away from the HeartStart XL as shown in Figure 10 3 Insert the cable into the SpO connector on the HeartStart XL and push until the blue portion of the cable connector is no longer visible Figure 10 3 Connecting the Sp0 Patient Cable eee To disconnect the SpO gt patient cable gently pull the cable out of the SpO connector M4735A HeartStart XL Defibrillator Monitor Connecting Disconnecting Patient Cables Connecting the ECG Patient Cable To connect a 3 or 5 lead ECG patient cable 1 Align the keyed ECG patient cable with the ECG connector as shown in Figure 10 4 2 Push the ECG patient cable firmly into the ECG connector until the white portion is no longer visible Figure 10 4 ECG Patient Cable Connector Receptacle To disconnect the ECG patient cable gently pull the cable out of the ECG connector 10 6 Setting Up and Configuring the HeartStart
150. 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 Table 13 4 M4735A HeartStart XL Defibrillator Monitor 13 21 Clinical Performance Summary Defibrillation Table 13 4 Clinical Summary Defibrillation 13 22 Conclusion Biphasic Patients Monophasic Patients P Value Number Percent Number Percent chi square Defibrillation Efficacy Single shock only 52 54 96 36 61 59 lt 0 0001 lt 2 shocks 52 54 96 39 61 64 lt 0 0001 lt 3 shocks 53 54 98 42 61 69 lt 0 0001 Patients Defibrillated 54 54 100 49 58 84 0 003 Return of Spontaneous 41 54 76 33 61 54 0 01 Circulation Survival to Hospital 33 54 61 31 61 51 0 27 Admission Survival to Hospital 15 54 28 19 61 31 0 69 Discharge CPC 1
151. the defibrillator See Connecting Cables to the Patient Cable Connector on page 10 3 M4735A HeartStart XL Defibrillator Monitor 6 3 Defibrillating in Manual Mode 5 Apply conductive matter NOTE 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 damage paddles 6 Apply paddles to patient s chest using the anterior anterior placement NOTE 6 4 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 Patient Contact Indicator Using Pediatric Paddles The HeartStart XL s external paddle set comes with pediatric paddles included To use the pediatric paddles set 1 Depress the latch at the front of the external paddle set while pulling for ward on the adult paddle electrode Store the adult paddle electrodes in the paddle tray pockets 3 To defibrillate see Using External Paddles on page 6 3 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 Ifneeded insert a Data Card as described in Using a Data Card Optional
152. tiencccseletcecasssecaxteendderaisanlcaetttacnpunanets ladeemperetinines 6 12 Performing Synchronized Cardioversion M nitorine the ECG issposnosenseen nea a T EEE 7 2 Using Multifunction Defib Electrode Pads s uscvocassevsacsasiiiensasudsseasvasdsvsessdusssabioviscaniiouneas 7 2 Using 3 or 5S wire ECG Leads oiee sio E EEE EE E EE EREE EEEa 7 3 Using Ex Perna Paddles siscsscusscaveredseuniaysvssvincecsunsuscastanniddusluendenaleossdseonisieteundsuaniouisemnncdle 7 4 Using External ECG Monitors sescissccesadeessnsnscensvenssaachonevnesnensenteneanssncananreaeiventeatensanrtacsentes 7 5 Delivering a Synchronized Shock vais sassescastenneedenetinelandeaseuiacvantabeiateniaxs linderman 7 6 Delivering Additional Synchronized Shocks s sssnesseeseesensseessesersseessessesersseessessrssresseeseese 7 8 Disabling Syne Mode sisirin rerai ai ianei a AEE REE EAE EAEE 7 8 Pacing Optional vii Contents Pacing Operational Controls ocsscc es caceinassiaas baviebsndenade ear AA ER EEES EE R 8 2 Demand Mode Vers s Fixed Mode swccevestausscevawscadeniaveatinnessianpiantsedvesseaearveunevianilvsatnnnctaiineises 8 2 Monitoring During Pacing icacssavcxcsvenatenasscndcxeusanenecsxeacesacenieaaarceuractontanticerealacatesenaceeentueastnrne 8 3 Preparing for Pacing sec secaty vs etonetus eda ceotsenanna EAEE EE eee 8 3 WET OTIS Pacing 5 acca casaveus ann iarere seee aerae reee Ae sE i Reer OEE EES AEE ESEA EERTE ENEK ER T SE E iae 8 5 Changing Pacing Mod
153. tient 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 4 HR Alarm Limit Choices Table 4 4 HR Alarm Limit Choices Alarm If Under Or Over 30 100 60 140 90 160 120 200 To set an 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 the unit is charging for defibrillation and delivering a shock Monitoring the ECG 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 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 CD 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 QRS Beeper and Voice Prompt Volume To increase or decrease the volume of the QRS Beeper and voice prompts used in AED Mode press A or W on the volume control Ga The low est volume setting will silence the QRS Beeper however voice prompts wil
154. tion defibrillation electrode pads Lead I II or HI is obtained through the 3 lead ECG cable and separate monitoring electrodes With a 5 lead cable lead aVR aVL aVF and any one of the V 1 6 leads can also be obtained Lead Fault LEADS OFF message and dashed line appear on the display if an electrode or lead wire becomes disconnected 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 9 ft 2 74 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 Specifications amp Safety 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
155. tion 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 ECG using an alternate ECG source 3 or 5 lead monitoring electrodes NOTE Impedance is the resistance between the defibrillator s pads or paddles that the defibrillator must overcome to deliver an effective discharge of energy The degree of impedance differs from patient to patient and is affected by sev eral factors including the presence of chest hair moisture and lotions or pow ders on the skin The low energy SMART Biphasic waveform is an impedance compensating waveform that is designed to be effective across a wide range of patients However if you receive a No Shock Delivered message check that the patient s skin has been washed and dried and that any chest hair has been clipped If the message persists change the pads and or the pads cable Using External Paddles In preparation for defibrillation in Manual Mode using external paddles per form the following steps 1 Ifneeded insert a Data Card as described in Using a Data Card Optional on 2 14 Turn the Energy Select knob to Manual On 3 Remove paddles by simultaneously pulling them up and out of the holders 4 Make sure the paddles are connected to
156. to 85 for the monophasic waveform Over all the biphasic waveform required fewer shocks 1 7 compared to 2 8 for the monophasic waveform and lower delivered energy 217J compared to 548J for the monophasic waveform Outcomes are summarized in Table 13 5 Table 13 5 Clinical Summary Cardioversion Biphasic Patients Monophasic Patients P Value Number Percent Number Percent Cumulative Cardioversion Efficacy Single shock only 58 96 60 24 107 22 lt 0 0001 lt 2 shocks 74 96 77 47 107 44 lt 0 0001 lt 3 shocks 86 96 90 57 107 53 lt 0 0001 lt 4 shocks 87 96 91 91 107 85 29 Skin burn 0 0001 None 25 90 28 15 105 14 Mild 50 90 56 47 105 45 Moderate 15 90 17 41 105 39 Severe 0 90 0 2 105 2 Number of shocks 1 7 1 0 2 8 1 2 lt 0 0001 Cumulative delivered 217 176J 548 331J lt 0 0001 energy Skin reaction definitions Evaluated 24 48 hours after procedure Mild erythema no tenderness Moderate erythema tenderness Severe blistering or necrosis tenderness 13 24 Specifications amp Safety Clinical Performance Summary Cardioversion Conclusion The SMART Biphasic waveform cardioverted at higher rates than the monophasic damped sine waveform at each step of the protocol although the cumulative biphasic rate after 4 shocks was not significantly different from the monophasic rate Tissue damage was more pronounced in the monophasic
157. urn the HeartStart 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 is inactive in AED Mode Stop Pacer i Stop pacing before changing the pacing is pressed while pacing pulses mode are being delivered i Attach Cable Patient cable is not properly attached to Check cable connections HeartStart XL 12 6 Troubleshooting Troubleshooting Tips Troubleshooting Tips Table 12 3 lists some situations that you may encounter their possible causes and a few suggested solutions Table 12 3 Troubleshooting Tips Situation Cause Possible Solution The HeartStart XL does There is no power e Insert a fully charged battery not turn on or turns Attach AC Power cord itself off The Data Card is corrupt e Turn the Energy Select Knob to the Off position e Remove the Data Card e Insert a new Data Card if available e Turn on the device e Ifthe unit does not turn on normally it cannot be used e Remove this unit from clinical use and call for service Hardware failure M4735A HeartStart XL Defibrillator Monitor 12 7 Troubleshooting Tips Table 12 3 Troubleshooting Tips Continued Situation Cause Possible Solution The display is blank An internal error occurred If this occurs during actual use except for e Substitute another defib if possible S
158. yout The following figures show the layout of the display in e AED Mode with ECG and SpO monitoring capabilities enabled e AED Mode with ECG and SpO monitoring capabilities disabled e Manual Mode NOTE ECG and SpO monitoring 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 LEAD Ring HR ALARM SELECT Nok OFF Heart Rate gt SpO alarm HR Alarm Pleth Bar System Message Pulse oe Pulse Rate Momentary Message es ECG Gain User Message 114J Current Charge Shocks 0 Shocks Delivered 00 15 02 Incident Timer Defibrillation PAUSE ANALYZE SHOCK Soft Keys gt gt tf The Incident Timer shows the elapsed time since the HeartStart XL was turned on provided patient contact was established If the HeartStart 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 HeartStart XL Defibrillator Monitor 2 7 Getting Acquainted Figure 2 5 AED Mode Display Layout ECG and SpO disabled System Message Momentary Message ECG gt ECG Gain User Message 150J Current Charge Shocks 0 Shocks Delivered 00 15 02 Incident Timer De

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