Philips HEARTSTART XLT M3500B Instructions For Use Manual
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Philips HEARTSTART XLT M3500B Instructions For Use Manual

Philips HEARTSTART XLT M3500B Instructions For Use Manual

Defibrillator/monitor
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H E A R T S TA R T X LT
I N S T R U C T I O N S F O R U S E
M3500B

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Summary of Contents for Philips HEARTSTART XLT M3500B

  • Page 1 H E A R T S TA R T X LT I N S T R U C T I O N S F O R U S E M3500B...
  • Page 3 Instructions for Use...
  • Page 4 If your defibrillator has been sold, donated, lost, stolen, exported, or destroyed, or if it was not obtained directly from Philips Medical Systems, please notify Philips Medical Systems at (978) 659-3202.
  • Page 5 Conventions This guide uses the following conventions: Warning statements describe conditions or actions that can result WARNING in personal injury or loss of life. Caution statements describe conditions or actions that can result in CAUTION damage to the equipment or loss of data. Notes contain additional information on usage.

  • Page 7: Table Of Contents

    Introduction Overview ... 1-1 Intended Use ... 1-3 Defibrillation Therapy ... 1-3 Indications for AED Therapy ... 1-3 Contraindications for AED Therapy ... 1-4 Precautions for AED Therapy ... 1-4 Indications for Manual Defibrillation Therapy ... 1-4 Contraindications for Manual Defibrillation Therapy ... 1-5 Precautions for Manual Defibrillation Therapy ...
  • Page 8 Contents Defibrillating in AED Mode Overview ... 3-3 Defibrillation (with the default configuration) ... 3-3 Defibrillation (with a modified configuration) ... 3-4 Preparation ... 3-5 Defibrillating ... 3-6 Automatic Re-analysis On ... 3-11 Automatic Re-analysis Off ... 3-11 Pausing for CPR ... 3-12 Monitoring Rhythm ...
  • Page 9 Discontinuing SpO2 Monitoring ... 5-9 Caring for Sensors ... 5-9 Troubleshooting ... 5-10 Defibrillating in Manual Mode Enabling Manual Mode ... 6-2 Preparation ... 6-3 Defibrillating ... 6-4 Returning to AED Mode ... 6-6 Performing Synchronized Cardioversion Preparing for Synchronized Cardioversion ... 7-2 Delivering a Synchronized Shock ...
  • Page 10 Contents Setting Up and Configuring the HeartStart XLT Connecting/Disconnecting Patient Cables ... 10-1 This section describes how to connect and disconnect the: ... 10-1 Connecting the Pads Patient Cable ... 10-2 Disconnecting the Pads Patient Cable ... 10-3 Connecting the ECG Patient Cable ... 10-4 Disconnecting the ECG Patient Cable ...
  • Page 11 Loading Printer Paper ... 11-10 Cleaning Instructions ... 11-12 Cleaning the HeartStart XLT ... 11-12 Cleaning the Carrying Case ... 11-12 Cleaning the Printer Printhead ... 11-13 Cleaning the Power Modules ... 11-13 Cleaning Pads, Electrodes & Cables ... 11-14 Removing &...
  • Page 12 Contents Specifications & Safety Specifications ... 13-2 Defibrillator ... 13-2 Manual Mode ... 13-2 AED Mode ... 13-3 ECG Monitoring ... 13-4 Display ... 13-5 Thermal Array Printer ... 13-5 Thermal Array Printer (cont.) ... 13-6 Battery and Battery Power Module ... 13-6 Noninvasive Pacing ...

  • Page 13: Overview

    1 Introduction The M3500B HeartStart XLT 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 HeartStart XLT. In this chapter, you’ll find general information that you should become famil- iar with before using the defibrillator/monitor.
  • Page 14 Overview Defibrillation is performed through multifunction defib electrode pads. In addition, both AED and Manual Mode offer monitoring through pads, 3-lead ECG monitoring electrodes, or optional 5-lead ECG monitoring electrodes. Optional pulse oximetry (SpO well. While monitoring ECG or SpO alarms to alert you when these parameters are outside the limits defined.

  • Page 15: Intended Use

    Intended Use The M3500B HeartStart XLT Defibrillator/Monitor is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physi- cian-authorized emergency medical response. It must be used by or on the order of a physician.

  • Page 16: Contraindications For Aed Therapy

    Defibrillation Therapy NOTE Contraindications for AED Therapy An AED is not to be used on patients that exhibit one or any combination of the following: Responsiveness Spontaneous breathing 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.

  • Page 17: Contraindications For Manual Defibrillation Therapy

    Contraindications for Manual Defibrillation Therapy Asynchronous defibrillation therapy is contraindicated in patients that exhibit one or any combination of the following: 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.

  • Page 18: Spo2 Monitoring

    SpO2 Monitoring NOTE Monitoring 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.

  • Page 19: Learning To Use The Heartstart Xlt

    M3500B HeartStart XLT Defibrillator/Monitor Using the HeartStart XLT Defibrillator/Monitor, a videotape, and About Sealed Lead Acid Batteries, an application note on battery maintenance. www.medical.philips.com/cms. Learning to Use the HeartStart XLT...

  • Page 21: Getting Started

    2 Getting Started Your HeartStart XLT is shipped to you in its carrying case with most of the accessories in their compartments. All you need to do before getting started is: This chapter will acquaint you with the HeartStart XLT and then guide you through these activities.

  • Page 22: Basic Orientation

    Getting Acquainted Figure 2-1 Basic Orientation Print Controls Monitoring Controls Defibrillation Controls Speaker Connector Basic Orientation The figure below shows the general layout of the controls, where the patient cables connect, and where to insert the battery and Data Card. Audiovisual Controls Printer...
  • Page 23 Defibrillation Controls - softkeys that perform the defibrillation function displayed in the softkey label above each button; control both AED and Man- ual Mode defibrillation. Manual Mode Controls - provide access to Manual Mode and control of syn- chronized cardioversion and pacing (if the option is present). Audiovisual Controls: Monitoring Controls - softkeys that perform the monitoring function dis- played in the softkey label below each button;...

  • Page 24: Manual Mode Controls

    Getting Acquainted NOTE Manual Mode Controls The figure below shows the Manual Mode controls. These controls are accessed by lifting the door labeled "Manual." Figure 2-2 Manual Mode Controls Manual Sync Pacer Rate Start Mode Stop Output LEDs indicating the function is active (green light) or inactive (no light) Synchronized cardioversion and pacing controls only function when Manual Mode is enabled.
  • Page 25 Manual Sync Pacer Display Layout The following figures show the layout of the display in: ECG and SpO NOTE disabled independently in the configuration. M3500B HeartStart XLT Defibrillator/Monitor Toggles between Manual Mode and AED Mode. Manual Mode is enabled when the green LED next to the key is lit. A password may be required for Manual Mode entry.
  • Page 26 Getting Acquainted NOTE Figure 2-3 AED Mode Display Layout (ECG and SpO System Message Momentary Message Defibrillation PAUSE Soft Keys In its default configuration, the HeartStart XLT powers on in AED Mode where voice prompts and user messages are active. The Incident Timer shows the elapsed time since the HeartStart XLT was turned on.
  • Page 27 Figure 2-4 AED Mode Display Layout (ECG and SpO Heart Rate HR Alarm Selected Energy Defibrillation Soft Keys User messages accompany voice prompts to guide you through the defibrilla- tion process. System and Momentary Messages: A System Message remains on the display until the condition that generated the message no longer exists.

  • Page 28: Lcd Backlight

    Getting Acquainted Figure 2-5 Manual Mode Display Layout HR ALARM Heart Rate HR Alarm System Message Momentary Message 150J Selected Energy Defibrillation ENERGY Softkeys SELECT LCD Backlight Under normal operation, the HeartStart XLT reads the ambient light and turns on the LCD back light when low light conditions exist. To turn on the back light at other times, press normal operation, press the same keys again.

  • Page 29: Connecting To Power

    Connecting to Power The HeartStart XLT is powered by the M3516A battery. Prior to inserting the battery, make sure that the battery is charged and has been properly main- tained (See “Battery Maintenance” on page 11-8). A fully charged battery will last for about two hours.

  • Page 30: Removing The Battery

    Connecting to Power 2-10 Removing the Battery Before removing the battery, make sure the HeartStart XLT is powered off. Then, to remove the battery, press the black battery eject button and pull the battery out, as shown in Figure 2-7. Figure 2-7 Removing the Battery Low Battery Warning The message...

  • Page 31: Using A Data Card

    Multiple incidents can be recorded on a single Data Card. Each incident is assigned a unique incident number. Patient data from a Philips M3510A 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.

  • Page 32: Inserting A Data Card

    Using a Data Card 2-12 Inserting a Data Card To insert a Data Card: 1. Make sure the HeartStart XLT is powered off. 2. Press up on the release latch to open the door to the Data Card compart- ment. 3.

  • Page 33: Removing A Data Card

    Using a Data Card Removing a Data Card To remove the Data Card: 1. Make sure the HeartStart XLT is powered off, (wait 2 seconds). 2. Press the black eject button (see Figure 2-8). 3. Pull the Data Card from the compartment. M3500B HeartStart XLT Defibrillator/Monitor 2-13...

  • Page 35: Defibrillating In Aed Mode

    3 Defibrillating in AED Mode The HeartStart XLT’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.
  • Page 36 Figure 3-1 AED Mode Overview Shock Advised Press within a shock series If Patient is: Unresponsive Not Breathing Pulseless Attach Pads Insert Data Card (Optional) Press On If Instructed, Press at completion of shock series Press No Shock Advised Check Patient Pulse No Pulse Ventilate...

  • Page 37: Overview

    Overview An overview of the AED Mode defibrillation process is shown in Figure 3-1. The process begins only after you have: Then you are ready to turn the HeartStart XLT on. The defibrillation process is dependent upon the configuration of your HeartStart XLT, as described in the following paragraphs.

  • Page 38: Defibrillation (With A Modified Configuration)

    Overview Defibrillation (with a modified configuration) Chapter 10 describes, in detail, the configurable parameters for AED Mode. Three parameters significantly impact the defibrillation process. They are: Device Initiated Analysis - initiates ECG analysis when the HeartStart XLT is first turned on. The default configuration setting is On . If you choose to set this parameter to , you need to press of the defibrillation process.

  • Page 39: Preparation

    Preparation If the patient is: Then: 1. Apply multifunction defib electrode pads to the patient, as directed on the 2. Connect the pads to the pads patient cable, as shown in Figure 3-2. 3. If needed, insert a Data Card (as described in “Using a Data Card” on 2- Figure 3-2 Connecting Pads to the Patient Cable M3500B HeartStart XLT Defibrillator/Monitor unresponsive...

  • Page 40: Defibrillating

    Defibrillating Defibrillating Follow the voice and screen prompts as they guide you through the following steps: 1. Press On. In this first step of the defibrillation process, the HeartStart XLT checks to see if the pads patient cable and the pads are connected. If they are, it pro- ceeds to step 2.
  • Page 41 If the pads have not been applied or are not making proper contact with the patient, you are prompted to Figure 3-4 Apply Pads Display M3500B HeartStart XLT Defibrillator/Monitor Apply Pads Shocks: 0 00:00:03 Defibrillating...
  • Page 42 Defibrillating NOTE NOTE 2. If instructed, press If device-initiated analysis is off, the HeartStart XLT monitors the rhythm (provided Rhythm Monitoring is on) and prompts you to press a potentially shockable rhythm is detected. Figure 3-5 Press ANALYZE Display Check Patient If No Pulse Press ANALYZE ANALYZE...
  • Page 43 If device initiated analysis is on, you do not need to press analysis begins automatically. Figure 3-6 Analyzing Display Handling or transporting the patient during ECG analysis can cause incorrect or WARNING delayed diagnosis. If a shockable rhythm is detected, as indicated by the message analysis stops and the XLT automatically charges to 150J.
  • Page 44 Defibrillating WARNING 3-10 If shock advised, press 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 "Clear." Then press Figure 3-8 Press SHOCK Display Stand Clear! Press SHOCK Defibrillation current can cause operator or bystander injury.

  • Page 45: Automatic Re-Analysis On

    Defibrillating Delivery of the shock is confirmed by the message and the shock counter is updated. Figure 3-9 Shock Delivered Display Shock Delivered Shocks: 1 00:00:40 Automatic Re-analysis On If Automatic Re-analysis is on, the HeartStart XLT analyzes the ECG fol- lowing delivery of the shock.

  • Page 46: Pausing For Cpr

    Pausing for CPR NOTE 3-12 Pausing for CPR At the completion of a shock series or when no shock is advised, the Heart- Start XLT prompts you to you to check the pulse, then prompts you as follows: Figure 3-10 Press Pause Display If Needed Press PAUSE And Begin CPR...
  • Page 47 Pausing for CPR Figure 3-11 Pause Display Paused Elapse Time Total Pause Duration Shocks: 3 Timer: 21 / 60 00:01:40 ANALYZE RESUME The pause state ends when the Pause Timer reaches the preconfigured Pause state duration, or if you press .

  • Page 48: Monitoring Rhythm

    Monitoring Rhythm WARNING 3-14 Monitoring Rhythm When the HeartStart XLT is not analyzing, defibrillating, or paused, Rhythm Monitoring alerts you to potentially shockable rhythms (provided Rhythm Monitoring is set to the default configuration, appears on the display to let you know this feature is active and remains on the display for the duration of the monitoring.
  • Page 49 Monitoring Rhythm If Rhythm Monitoring detects a shockable rhythm, you are prompted as fol- lows: Figure 3-13 Shockable Rhythm Check Patient If No Pulse Press ANALYZE Shocks: 3 00:00:55 ANALYZE PAUSE This prompt is repeated periodically, as configured, until pressed. If you press , the defibrillation process starts again.

  • Page 50: Erc Protocol

    ERC Protocol NOTE 3-16 ERC Protocol The HeartStart XLT can be configured to support the European Resuscitation Council (ERC) Guidelines for Resuscitation (1998). If figured to , the defibrillation process described in this chapter is the same, with the exception of how the Pause state functions (see “Pausing for CPR” on 3-12).
  • Page 51 If CPR is needed, press time and the total duration of the Pause state, as shown: Figure 3-15 RESUME The total pause duration depends on the event preceding the Pause state. If you entered the Pause state: M3500B HeartStart XLT Defibrillator/Monitor .

  • Page 52: Troubleshooting

    Troubleshooting 3-18 Troubleshooting When the HeartStart XLT detects a problem, it provides display and/or voice prompts to guide you to resolution. The table below lists the prompts you may encounter in AED Mode, the cause, and the suggested corrective action. Prompts related to the battery and Data Card are discussed in Chapter 12.

  • Page 53: Monitoring The Ecg

    4 Monitoring the ECG The HeartStart XLT can be used for short or long-term ECG monitoring. The ECG monitoring function allows you to monitor through: When the HeartStart XLT is turned on, the ECG acquired through pads is shown on the display. ECG monitoring allows you to continue to monitor through the pads or to select a lead from an alternate ECG source (3- or 5- lead).

  • Page 54: Applying Monitoring Electrodes

    Applying Monitoring Electrodes WARNING NOTE 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. To apply electrodes: 1.

  • Page 55: Electrode Placement

    Electrode Placement Figure 4-1 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 4-2. Figure 4-1 Limb Lead Electrode Placement Table 4-1 3-Lead ECG Lead Formation M3500B HeartStart XLT Defibrillator/Monitor...
  • Page 56 Applying Monitoring Electrodes Figure 4-2 Precordial Lead Electrode Placement Table 4-2 5-Lead ECG Lead Formation Lead LA - RA LL - RA LL - LA LA + LL RA - RA + LA LL - RA + LL LA - RA + LA + LL (or C V/C -...

  • Page 57: Selecting The Lead

    Selecting the Lead Available monitoring leads are dependent upon your device configuration: Table 4-3 Lead Select Choices Pads, Lead I, Lead II, Lead III Pads, Lead I, Lead II, Lead III, aVR, aVL, aVF, V lead. To select a lead to monitor, cycle through the choices by pressing the desired lead is displayed.

  • Page 58: Setting The Heart Rate Alarm

    Setting the Heart Rate Alarm WARNING WARNING Setting the Heart Rate Alarm The computed heart rate (number of detected QRS complexes per minute) is displayed below the the number of QRS complexes detected in a minute. A QRS beeper, if config- ured to on, indicates each QRS complex detected.

  • Page 59: 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 Adjusting the ECG Size To increase or decrease the size of the ECG, press trol, Troubleshooting Table 4-5 provides troubleshooting tips for ECG Monitoring. Table 4-5 Troubleshooting Tips dashed line (------) M3500B HeartStart XLT Defibrillator/Monitor...
  • Page 60 Troubleshooting Table 4-5 Troubleshooting Tips (Continued) Situation Poor ECG signal The monitoring elec- quality trodes are not making proper contact with the patient. The monitoring elec- trodes are outdated or dried-out. Radio frequency inter- ference (RFI) is causing artifact. QRS beeper inau- The QRS beeper is con- dible or beeps do figured to Off.

  • Page 61: Monitoring Spo2

    5 Monitoring SpO Pulse oximetry is a noninvasive method of continuously measuring oxygen saturation (SpO percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen. SpO ing a patient’s cardiac and respiratory systems. This chapter explains how pulse oximetry works and describes how to use the HeartStart XLT to monitor chased).

  • Page 62: Understanding Pulse Oximetry

    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 A photodetector positioned opposite the light emitting diodes compares light absorption before and after pulsation.

  • Page 63: Selecting A Sensor

    Selecting a Sensor Table 5-1 shows the SpO Table 5-1 Approved Sensors M1191A M1192A M1194A M1903A/B (Nellcor D-20) M1904A/B (Nellcor D-25) M1906A (Nellcor P/I) M1907A (Nellcor A/N) To use Nellcor sensors, you must connect the M1943A Nellcor Adaptor NOTE patient cable to the HeartStart XLT. (See “Connecting the SpO Cable”...

  • Page 64: Reusable Sensors

    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.

  • Page 65: 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: Failure to apply the sensor properly may reduce the accuracy of the SpO WARNING ment.

  • Page 66: Connecting The Sensor Cable

    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.

  • Page 67: Monitoring

    Monitoring To monitor SpO 1. If the HeartStart XLT is not on, press On. 2. Apply the appropriate sensor to the patient. 3. Make sure the sensor cable is connected to the HeartStart XLT. 4. Press A dashed line (---) is displayed under measured and an SpO displayed in place of the dashed line.

  • Page 68: Setting Alarms

    Setting Alarms WARNING Setting Alarms An alarm may be set to alert you if the SpO lower limit. Lower limit alarm choices are repeatedly to cycle through the choices. Stop when the desired choice is displayed. A appears in three seconds, indicating that the selected alarm is active.

  • Page 69: Discontinuing Spo2 Monitoring

    Discontinuing SpO To shut off SpO below the Figure 5-5 SpO HR ALARM Caring for Sensors Refer to the manufacturers instructions for care and cleaning of sensors. To get the best results from your SpO and cable with care and protect them from sharp objects. The sensor sleeve houses a sensitive electronic device that can be damaged.

  • Page 70: Troubleshooting

    Troubleshooting 5-10 Troubleshooting The table below lists system messages that you may encounter when monitor- ing SpO Table 5-2 System Messages Problem or Message Possible Cause Corrective Action Pulse absent or too Check the sensor is weak to be detected. applied properly.
  • Page 71 Table 5-2 System Messages (Continued) M3500B HeartStart XLT Defibrillator/Monitor Problem or Message Possible Cause The SpO connected to the device. The transducer is bro- ken. There is a hardware fail- ure in the SpO system. Troubleshooting Corrective Action cable is not Attach the cable to the HeartStart XLT.

  • Page 73: Defibrillating In Manual Mode

    6 Defibrillating in Manual Mode In Manual Mode you assess the ECG, decide if defibrillation is indicated, select the discharge energy level, and deliver the shock. The defibrillation process is under your control. There are no voice prompts, however, system and momentary messages provide relevant information throughout the pro- cess.

  • Page 74: Enabling Manual Mode

    Enabling Manual Mode WARNING Enabling Manual Mode From AED Mode, press Manual the softkeys above the display to enter the password. Figure 6-1: Manual Password Display Enter Password EXIT PASSWORD To return to AED Mode, without entering a password, press Once Manual Mode is enabled, the green LED next to In its default configuration, the HeartStart XLT powers on into AED Mode.

  • Page 75: Preparation

    Preparation In preparation for defibrillation: 1. Apply multifunction defib electrode pads as directed on the package. Use 2. Connect the pads to the pads patient cable, as shown in Figure 6-2. 3. If needed, insert a Data Card (as described in “Using a Data Card” on 2- 4.

  • Page 76: Defibrillating

    Defibrillating Defibrillating The defibrillation process is as follows: 1. Select Energy The default energy setting is 150 joules. To change the energy setting, press repeatedly to cycle through the energy level choices. Stop when the desired energy is displayed. The choices are 5, 10, 25, 50, 70, 100, 150, or 200 joules.
  • Page 77 If desired, you may increase or decrease the selected energy level after pressing the desired energy level is displayed. The defibrillator charges to the selected energy automatically. Wait until the current charge reaches the selected energy level before proceeding. 3. Shock Confirm that a shock is still indicated.

  • Page 78: Returning To Aed Mode

    Returning to AED Mode Returning to AED Mode To enable AED Mode, from Manual Mode, press next to goes out, indicating Manual Mode is no longer active. Manual If ECG and/or SpO monitoring are enabled in AED Mode, alarms set in Manual Mode remain active when you switch to AED Mode.

  • Page 79: Performing Synchronized Cardioversion

    7 Performing Synchronized Cardioversion Synchronized cardioversion is a Manual Mode function that allows you to synchronize the defibrillator shock with the R-wave of the ECG being moni- tored. During synchronized cardioversion, the ECG being monitored is shown on the display and may be derived from: When selecting a lead, choose the best lead that displays a large QRS com- plex.

  • Page 80: Preparing For Synchronized Cardioversion

    Preparing for Synchronized Cardioversion Preparing for Synchronized Cardioversion In preparation for synchronized cardioversion: 1. Apply multifunction defib electrode pads as directed on the package. Use either the anterior-anterior or anterior-posterior placement, as appropriate. 2. Connect the pads to the patient cable. (See Figure 6-2.) 3.
  • Page 81 Figure 7-1: Charging in Sync Mode 5. Make sure no one is touching the patient or anything connected to the Defibrillation current can cause operator or bystander injury. Do not touch the WARNING patient, or equipment connected to the patient, during defibrillation. M3500B HeartStart XLT Defibrillator/Monitor LEAD HR ALARM...

  • Page 82: Delivering Additional Synchronized Shocks

    Disabling Sync Mode Delivering Additional Synchronized Shocks If additional synchronized shocks are indicated, make sure Sync Mode is still enabled and repeat steps 2-5. In its default configuration, the HeartStart XLT remains in Sync Mode after a shock is delivered, as indicated by the message on the display and the lighted green LED next to The HeartStart XLT can be configured to exit Sync Mode after each shock is delivered.

  • Page 83: Pacing

    8 Pacing 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 applied to the patient’s bare chest. This chapter explains the pacing options and describes how to perform pacing.

  • Page 84: Demand Mode Versus Fixed Mode

    Demand Mode Versus Fixed Mode WARNING WARNING Demand Mode Versus Fixed Mode The HeartStart XLT 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.

  • Page 85: Preparing For Pacing

    Preparing for Pacing In preparation for pacing: 1. Apply multifunction defib electrode pads as directed on the package. Use 2. Connect the pads to the patient cable. (See Figure 6-2.) 3. If needed, insert a Data Card (as described in “Using a Data Card” on 2- 4.

  • Page 86: Pacing

    Pacing Pacing To perform pacing: 1. Press Pacer . The green LED next to logue box appears. Figure 8-1 Pacing Display LEAD HR ALARM SELECT Lead II Pacer Stop Demand Mode 150 J 70ppm 30mA CHARGE ENERGY SELECT The message indicates that the pacing function is on but paced pulses are not being delivered.
  • Page 87 4. Adjust the rate to the desired number of paced pulses per minute (ppm). 5. Press Pacing will not start if there is a problem with the multifunction defib elec- NOTE trode pads connections or, in demand mode, a problem with the ECG monitor- ing electrodes connections.

  • Page 88: Changing Pacing Modes

    Changing Pacing Modes 6. Increase the output until cardiac capture occurs. Press up Output 7. Decrease the output to the lowest level that still maintains capture. Press Output to decrease the output in increments of 5 mA. Start Press to stop pacing. Press Stop green LED next to the button goes out, indicating pacing is no longer active.

  • Page 89: Troubleshooting

    Troubleshooting The table below lists the pacing-related system and momentary messages that you may encounter during pacing. Table 8-1 Pacing System Messages M3500B HeartStart XLT Defibrillator/Monitor Message Possible Cause The selected monitoring lead is not making proper contact with the patient. Pacing was attempted in demand mode without monitoring electrodes...

  • Page 91: Storing, Retrieving & Printing

    9 Storing, Retrieving & Printing This chapter describes how the HeartStart XLT creates a patient record, called an Event Summary, for later retrieval and printing. It covers how to mark events for storage in the Event Summary, as well as how to print individual events as they occur.

  • Page 92: Marking Events

    Marking Events NOTE Marking Events Mark button allows you to annotate the ECG strip at the point in time the Event button is pressed. In AED Mode, when monitoring is disabled, the event is marked with a . In Manual Mode, or when monitoring is enabled in AED Mode, you use the softkeys to select the annotation from the choices dis- played (See Figure 9-1)*.

  • Page 93: Events Recorded

    Events Recorded The following events and related information are stored in the Event Summary: Table 9-1 Event Information Power Change Pads Change AED Mode Analysis Mode Change Rhythm Monitoring Charging Shock Shock Failed Disarm ECG Monitoring Heart Rate Alarm Violation M3500B HeartStart XLT Defibrillator/Monitor Event Related Information Stored...
  • Page 94 Events Recorded Table 9-1 Event Information (Continued) Event Violation Mark Print Strip Sync Pacing Related Information Stored value and SpO alarm limit. ECG waveform with annotation ( Atro, Lido, or Other). ECG waveform. Sync on, Sync off, Sync marker. Pacer start, Pacer stop, Pacer settings. Storing, Retrieving &...

  • Page 95: Creating A Patient Record

    Creating a Patient Record The HeartStart XLT creates an Event Summary patient record for each new patient. Each record is assigned a unique incident number. The HeartStart XLT keeps the Event Summary in its internal memory until you begin caring for a new patient.

  • Page 96: Printing The Internal Event Summary

    Printing the Internal Event Summary Printing the Internal Event Summary To print the internal Event Summary, press the complete summary is printed, press The Event Summary includes the following information, in the order listed: a header with a place for you to write in the patient’s name and the operator’s name.
  • Page 97 The Event Summary also includes waveforms and the appropriate annotation for each of the following events: Table 9-3 Event Waveform Information Shock Advised No Shock Advised Cannot Analyze Shock Delivered Print Strip Mark Event ECG or SpO M3500B HeartStart XLT Defibrillator/Monitor Printing the Internal Event Summary Event 11 seconds of ECG just prior to the...

  • Page 98: Printing Events

    Printing Events Printing Events The HeartStart XLT 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.

  • Page 99: 10 Setting Up And Configuring The Heartstart Xlt

    10 Setting Up and Configuring the HeartStart XLT This chapter describes how to set-up and configure your HeartStart XLT. It covers: Connecting/Disconnecting Patient Cables This section describes how to connect and disconnect the: M3500B HeartStart XLT Defibrillator/Monitor Connecting Patient Cables Arranging Accessories in the Carrying Case Configuring the HeartStart XLT Pads Patient Cable...

  • Page 100: Connecting The Pads Patient Cable

    Connecting/Disconnecting Patient Cables Pads connector 10-2 Connecting the Pads Patient Cable To connect the pads patient cable to the defibrillator: 1. Align the white pointer on the pads patient cable with the white arrow on the defibrillator’s pads connector, as shown in Figure 10-1. 2.

  • Page 101: Disconnecting The Pads Patient Cable

    Disconnecting the Pads Patient Cable To disconnect the pads patient cable: 1. Rotate the green locking mechanism on the patient cable in the direction 2. Hold the locking mechanism in this position as you pull the patient cable Figure 10-2 Disconnecting the Pads Patient Cable M3500B HeartStart XLT Defibrillator/Monitor (clockwise), of the blue arrow on the defibrillator until it stops (as shown in Figure 10-2).

  • Page 102: Connecting The Ecg Patient Cable

    Connecting/Disconnecting Patient Cables 10-4 Connecting the ECG Patient Cable To connect a 3- or 5-lead ECG patient cable: 1. Align the keyed patient cable plug with the slot on the ECG connector, as shown in Figure 10-3. 2. Push the patient cable firmly into the ECG connector, until the white por- tion is no longer visible.
  • Page 103 Connecting/Disconnecting Patient Cables Connecting the SpO Patient Cable To connect the SpO patient cable: 1. Hold the connector with the flat side up, as shown in Figure 10-4. 2. Insert the connector into the receptacle and push until the blue portion of the connector is no longer visible.

  • Page 104: Arranging Accessories In The Carrying Case

    Arranging Accessories in the Carrying Case 10-6 Arranging Accessories in the Carrying Case The HeartStart XLT carrying case is designed to hold your essential defibrilla- tion and monitoring accessories. Figure 10-5 shows the recommended place- ment for each of these accessories. Figure 10-5 Recommended Accessory Placement Spare Battery Paper...

  • Page 105: Configuring The Heartstart Xlt

    Configuring the HeartStart XLT Configuration options allow you to customize the HeartStart XLT to best meet your needs. This section describes: Accessing the Configuration Menu There is a special combination of softkeys that, when pressed simultaneously, turn the HeartStart XLT on in Configuration Mode. For the purposes of exe- cuting this procedure, softkeys are assigned numbers as shown in Figure 10-6.

  • Page 106: Configurable Parameters

    Configuring the HeartStart XLT 10-8 To turn the HeartStart XLT on in Configuration Mode: 1. If the device is already on, press Off. 2. While holding down softkeys 4 & 5, press 1. The configuration menu appears as shown in Figure 10-7. The menu lists the categories of settings that may be configured.
  • Page 107 Table 10-1 General Settings M3500B HeartStart XLT Defibrillator/Monitor Parameter Description Current date, where the month, and Current time, where is the minutes. Time is based on a 24 hour clock. Prints a 3 second strip when pressed. Prints a continuous strip during charging. Printing continues until a shock is deliv- ered, the device is disarmed, or pressed.
  • Page 108 Configuring the HeartStart XLT 10-10 Table 10-1 General Settings (Continued) Parameter Captures what you just saw. All printed strips, including those generated by an event (mark, charge, shock or alarm), include an additional 6 seconds of infor- mation - the 6 seconds of information that occurred just prior to printing being initi- ated.
  • Page 109 Table 10-2 AED Settings: Parameter M3500B HeartStart XLT Defibrillator/Monitor Configuring the HeartStart XLT Description Defines the maximum number of shocks to deliver before prompting Defines the number of seconds that must pass before the next shock is considered the first shock of a new shock series, rather than the next shock of the current shock series.
  • Page 110 Configuring the HeartStart XLT NOTE NOTE 10-12 Table 10-2 AED Settings: (Continued) Parameter Defines the duration of the Pause time (in sec- onds) when since the last shock is greater than the is set to Off, the following configuration choice appears: Defines the duration of the pause time (in sec- onds), when is set to Off).

  • Page 111: Setting The Manual Mode Password

    Table 10-3 Manual Settings Setting the Manual Mode Password When Manual Mode Security is set to On (see “Modifying the Configuration” on page 10-15), the password entry screen is displayed. Use the softkeys on the top of the display to enter a four digit password. Figure 10-8 Password Entry Screen M3500B HeartStart XLT Defibrillator/Monitor Parameter...
  • Page 112 Configuring the HeartStart XLT 10-14 Table 10-4 ECG Filter Settings Item Description Selects the setting used to filter out AC line noise. Selects the display filter frequency for the pads ECG. Selects the printer filter frequency for the pads ECG. Selects the display filter frequency for the monitoring electrodes ECG.

  • Page 113: Modifying The Configuration

    Modifying the Configuration To modify the configuration, from the main menu: 1. Use 2. Press 3. Use 4. Press 5. Use the softkeys ( 6. Press To make additional changes, repeat steps 1-7. Returning to the Default Configuration Press menu, to return all settings to their default settings. Although there is no visi- ble change in the display, default settings are restored.

  • Page 114: Saving Settings To A Data Card

    Configuring the HeartStart XLT 10-16 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 XLTs or to restore the configuration, if necessary. To save the configuration: 1.

  • Page 115: 11 Maintaining The Heartstart Xlt

    11 Maintaining the HeartStart XLT This chapter describes how to care for your HeartStart XLT Defibrillator/ Monitor and its accessories. It provides: The operational checks described must be performed at the specified intervals in order to help prevent and detect electrical and mechanical problems. The battery maintenance procedures specified must be adhered to in order to ensure that your batteries have the energy required to operate the defibrillator and deliver the appropriate therapy.

  • Page 116: Operational Checks

    Operational Checks 11-2 Operational Checks The following operational checks are intended to quickly verify the proper operation of the HeartStart XLT. Perform these checks regularly, at the inter- vals specified, along with visual inspection of the device and all cables, con- trols, accessories and supplies.

  • Page 117: Every Shift

    Operational Checks Every Shift Perform a “Shift/System Check” every shift (see “Shift/System Check” on page 11-4) to verify that the HeartStart XLT is functioning properly and to ensure that necessary supplies and accessories are present and ready for use. Every Month Check expiration dates on multifunction defib electrode pads and monitoring electrodes every month.

  • Page 118: Shift/System Check

    Operational Checks 11-4 Shift/System Check To perform the Shift/System Check: 1. Turn the HeartStart XLT off. 2. Connect a 50 ohm test load to the pads patient cable (instead of pads). 3. If a Data Card is routinely used, insert a Data Card into the HeartStart XLT.
  • Page 119 The report also lists 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 XLT is clean, clear of objects on top and has no visible signs of damage.
  • Page 120 Operational Checks 11-6 Power Supply Battery - make sure: a charged battery is in the HeartStart XLT another battery is charged or being charged the batteries have no visible signs of damage AC/Power Module 1. Make sure a battery is in the HeartStart XLT. 2.

  • Page 121: Battery Capacity Test (Ct)

    Battery Capacity Test (CT) To perform a Battery Capacity Test: 1. Turn the HeartStart XLT off. 2. Place a "Test in Progress" label on the HeartStart XLT to indicate to oth- 3. Insert a charged battery. 4. If an AC power module is connected, unplug the power module from the 5.

  • Page 122: Battery Maintenance

    Battery Maintenance 11-8 Battery Maintenance The HeartStart XLT 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 battery care is provided in the application note “About Sealed Lead Acid Batteries,”...

  • Page 123: Battery Capacity

    Battery Capacity A fully charged M3516A battery, operating at room temperature, provides greater than 2.7 hours 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 2 years.

  • Page 124: Loading Printer Paper

    Loading Printer Paper 11-10 Loading Printer Paper To load printer paper: 1. Slide the printer door to the right until the paper roller pops up. 2. If there is an empty or low paper roll in the printer, pull up on the plastic removal tab to remove the roll.
  • Page 125 3. Place a new roll of printer paper (40457C/D) into the printer paper well, 4. 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 M3500B HeartStart XLT Defibrillator/Monitor positioning the roll so that the end of the roll is on the top and the grid faces down.

  • Page 126: Cleaning Instructions

    Cleaning Instructions CAUTION 11-12 Cleaning Instructions Following are recommendations for cleaning the HeartStart XLT and its asso- ciated case, cables, etc. Cleaning the HeartStart XLT The following cleaning products may be used to clean the exterior surfaces of the HeartStart XLT, as well as the battery and data card: Isopropyl alcohol (70% in water) Mild soap and water Chlorine bleach (3% in water)

  • Page 127: Cleaning The Printer Printhead

    Cleaning the Printer Printhead If the printout has light or varying density printing, clean the printhead to remove any buildup of paper residue. To clean the printhead: 1. Slide the printer door to the right until the paper roller pops up. 2.

  • Page 128: Cleaning Pads, Electrodes & Cables

    Cleaning Instructions CAUTION 11-14 Cleaning Pads, Electrodes & Cables Defibrillation pads and monitoring electrodes are single use and do not require cleaning. The pads cable may be cleaned with: Alcohol-free hand soap 2% gluteraldehyde solution (such as Cidex) Sodium hypochlorite (chlorine bleach) solution 10% in water Quaternary ammonium compounds (such as Lysol) Isopropyl alcohol The ECG cable may be cleaned by wiping it with any of the following:...

  • Page 129: Removing & Replacing The Carrying Case

    Removing & Replacing the Carrying Case Removing & Replacing the Carrying Case To remove the carrying case from the HeartStart XLT, follow steps 1 through 7 in Figure 11-4. After loosening the screws (step 6), lay the unit flat and lift the defib up off the metal mounting plates to disengage it from the two metal pins at the rear of the case.
  • Page 130 Removing & Replacing the Carrying Case 11-16 To put the carrying case on the HeartStart XLT, follow the steps 1 through 7 in Figure 11-5. Slide the unit into the case as shown in step 1, then lower it onto the two metal pins at the rear of the case before tightening the screws (step 2).

  • Page 131: Putting On The Manual Door

    Putting On the Manual Door To put on the manual door, align the door with the door hinges as shown in Figure 11-6. Then push, as shown in Figure 11-7, until the door snaps in place. M3500B HeartStart XLT Defibrillator/Monitor Figure 11-6 Aligning the Manual Door Figure 11-7 Snapping the door in place Putting On the Manual Door...

  • Page 132: Supplies & Accessories

    In the USA, call 1-800-225-0230 (electrodes, cables, paper, etc.) or 1-800-934-7372 (HeartStart Pads adapters only). Outside the USA, contact your local Philips Medical Systems Sales Office, your authorized Philips Medical Systems Dealer or Distribu- tor, or visit our online store at www.medical.philips.com/cms and fol- low the Supplies link.
  • Page 133 Table 11-3 Supplies and Accessories (Continued) Part Number Defibrillation Pads, Pads Cables, Adapters and Test Load (gray flat connector) M3713A M3716A M3717A M3718A M3719A M3508A M3725A M3500B HeartStart XLT Defibrillator/Monitor Description Multifunction Adult Plus Pads - Adult Plus multifunction defib pads (general use). Multifunction Adult Radiolucent Pads - Adult Radiolucent multifunction defib pads (special purpose - for X-ray and special procedures).
  • Page 134 Supplies & Accessories 11-20 Table 11-3 Supplies and Accessories (Continued) Part Number ECG Cables M1733A 3-lead ECG Trunk cable, AAMI (8-pin). M1734A 5-lead ECG Trunk cable, AAMI (8-pin). M1735A 3-lead ECG Trunk cable, IEC (8-pin). M1736A 5-lead ECG Trunk cable, IEC (8-pin). M1580A 3-lead ECG Trunk cable, AAMI (8-pin) M1600A...
  • Page 135 Table 11-3 Supplies and Accessories (Continued) Part Number Battery/Power Modules/ Adapter M3516A M3517A M3518A M3506A Extension Cable M4748A Carrying Case M3509A M3500B HeartStart XLT Defibrillator/Monitor Description Sealed Lead Acid Battery. AC power module. DC Power Module Battery charger adapter. Adapter extension cable Carrying case.

  • Page 136: Disposing Of The Heartstart Xlt

    Disposing of the HeartStart XLT Prior to disposing of the HeartStart XLT, remove the battery. Then dispose of the device and its accessories in accordance with local standards. Disposal of the device with the battery inserted presents a potential shock hazard. WARNING...

  • Page 137: 12 Troubleshooting

    12 Troubleshooting If the HeartStart XLT detects an error or potential problem during use, it dis- plays a system or momentary message. In AED Mode, these messages are often accompanied by a voice prompt. This chapter describes the messages and what you should do in response. In addition, this chapter provides general troubleshooting tips and information on calling for service.

  • Page 138: System Messages

    System Messages Table 12-1 System Messages Message The pads cable is not properly attached to the device. The configuration is reset to the default settings. The PC card is not in use because it is full, incompatible, absent, or inserted after the HeartStart XLT was turned on.
  • Page 139 Table 12-1 System Messages (Continued) Message The multifunction defib electrode pads are not properly connected to the Heart- Start XLT. The pads cable is not connected to the defibrillator. The pads are not making proper contact with the patient. The pacing system is not functioning. High patient impedance is resulting in the pacer delivering less current to the patient than specified in the output current set-...
  • Page 140 System Messages Table 12-1 System Messages (Continued) Message The SpO device. A failure has occurred in the SPO circuitry. The level of ambient light is so high that the sensor cannot obtain an SpO or the sensor or cable is damaged. The patient’s pulse is absent or too weak to be detected.

  • Page 141: 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 The multifunction defib electrode pads are not making proper contact with the patient.
  • Page 142 System Messages Table 12-2 Momentary Messages (Continued) Message The Data Card is removed during an inci- dent. The Data Card is inserted while the Heart- Start XLT is on. A Data Card other than the M3510A is inserted. A Data Card is not in the HeartStart XLT. The key pressed is currently inactive (i.e.

  • Page 143: Troubleshooting Tips

    Troubleshooting Tips Table 12-3 lists some situations that you may encounter, causes, and actions to take. Table 12-3 Troubleshooting Tips Situation The HeartStart XLT There is no power. does not turn on. A corrupt Data Card may prevent the unit from powering on.
  • Page 144 Troubleshooting Tips Table 12-3 Troubleshooting Tips (Continued) Situation There is a dashed (----) ECG data is not being acquired. line on the display instead of an ECG. The HeartStart XLT does not appear to be functioning properly. The displayed time is The time was not correctly set in the con- incorrect.

  • Page 145: Calling For Service

    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 service. United States of America Medical Response Center Latin America Medical Response Center Canada Medical Response Center...

  • Page 146: Other International Areas

    Calling for Service 12-10 Other International Areas Australia Tel: 131147 Germany Tel: 0180 5 47 50 00 Netherlands Tel: 31 20 547 2555 Fax: 31 29 547 2949 Belgium (for Dutch) Tel: 32 2 525 7102 Fax: 32 2 525 71 91 Spain Tel: 34 902 30 40 50 Fax: 34 91 326 39 66...

  • Page 147: 13 Specifications & Safety

    13 Specifications & Safety This section provides: M3500B HeartStart XLT Defibrillator/Monitor Specifications for the HeartStart XLT, Symbol definitions for symbols appearing on the HeartStart XLT, A clinical performance summary, Safety related information, and Electromagnetic compatibility information. 13-1...

  • Page 148: Specifications

    Specifications 13-2 Specifications Defibrillator Waveform: Biphasic Truncated Exponential. Waveform parameters adjusted as a function of patient impedance. Shock Delivery: Via multifunction defib electrode pads. Charge Time: Less than 3 seconds to 200 Joules with a new, fully charged M3516A SLA battery pack at 25 powered by a M3517A or M3518A power module with no battery installed.

  • Page 149: Aed Mode

    Specifications Defibrillator (cont.) AED Mode AED Energy Protocol: Fixed Energy (150 Joules). AED Shock Series: 2, 3, or 4. 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.

  • Page 150: Ecg Monitoring

    Specifications 13-4 ECG Monitoring Inputs: Single channel ECG may be viewed on display and printed. PADS ECG is obtained through two multifunction defibrillation electrode pads. Lead I, II, or III is obtained through the 3-lead ECG cable and separate moni- toring electrodes.

  • Page 151: Display

    Display Display Size: 96 mm x 72 mm. Display Type: Transflective active matrix LCD with LED backlight. Display Resolution: 320 x 240 pixels. Sweep Speed: 25 mm/s nominal (stationary trace; sweeping erase bar). Viewing Time: 4 seconds. Thermal Array Printer Continuous Real Time Strip: User starts and stops the print strip.

  • Page 152: Thermal Array Printer (Cont.)

    Specifications 13-6 Thermal Array Printer (cont.) 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 six second delay. Reports: The following can be printed: Event Summary, Configuration, Extended Self Test, System Log.

  • Page 153: Noninvasive Pacing

    Noninvasive Pacing Waveform: Monophasic Truncated Exponential. Current Pulse Amplitude: 10 mA to 200 mA (5 mA resolution); accuracy 10 mA - 50 mA Pulse Width: 20 ms with accuracy +0, -5 ms. Rate: 30 ppm to 180 ppm (10 ppm increments); accuracy Modes: Demand or Fixed Rate.

  • Page 154: Event Storage

    Specifications 13-8 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 Event symbol and, if configured for drug annotation, the following labels can be added: Epinephrine, Atropine, Lidocaine, or Other.

  • Page 155: Environmental

    Environmental Temperature: 0 Humidity: Up to 95% Relative Humidity Altitude: Operating: up to 15,000 ft. Shipping: up to 20,000 ft. Shock (drops onto concrete): Unit survives 39" (1 m) drops onto all surfaces (faces, corners, and edges) enclosed in carrying case. Exposed handle surfaces survive 24"...

  • Page 156: Symbol Definitions

    Symbol Definitions 13-10 Symbol Definitions The following table lists the meaning of each symbol shown on the HeartStart XLT and the M3516A battery. Table 13-1 Defibrillator and Battery Symbols Symbol Off. Shock hazard. Attention - See operating instructions in user’s guide. Power module input.
  • Page 157 Symbol Definitions Table 13-1 Defibrillator and Battery Symbols (Continued) Symbol Definition Meets IEC type BF leakage current requirements and is defibrilla- tor protected (Patient Applied Part is isolated and defib-proof suit- able 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 suit- able for direct patient contact including the heart and major...
  • Page 158 Symbol Definitions 13-12 The following table lists the symbols that appear on the HeartStart XLT ship- ping carton. Table 13-2 Shipping Carton Symbols Symbol Atmospheric pressure range. Temperature range. Relative humidity range. Recyclable paper product. Fragile. Right side up. Do not get wet. Definition Specifications &...
  • Page 159 Symbol Definitions Table 13-2 Shipping Carton Symbols (Continued) Symbol Definition Shelf life. Long-term storage conditions. Short-term transport storage. M3500B HeartStart XLT Defibrillator/Monitor 13-13...

  • Page 160: Clinical Performance Summary - Defibrillation

    Clinical Performance Summary - Defibrillation 13-14 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.

  • Page 161: Conclusion

    Table 13-3 Clinical Summary - Defibrillation Biphasic Patients Number/(Percent) Defibrillation Efficacy Single shock only <2 shocks <3 shocks Patients Defibrillated Return of Spontaneous Circulation Survival to Hospital Admission Survival to Hospital Dis- charge CPC = 1 (Good) Conclusion The 150J SMART Biphasic waveform defibrillated at higher rates than 200- 360J monophasic waveforms, resulting in more patients achieving return of spontaneous circulation (ROSC) (p=0.01).

  • Page 162: Clinical Performance Summary - Cardioversion

    Clinical Performance Summary - Cardioversion 13-16 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.
  • Page 163 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 to 85% for the monophasic waveform).

  • Page 164: Conclusion

    Clinical Performance Summary - Cardioversion 13-18 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.

  • Page 165: Safety Considerations

    Safety Considerations The following general warnings and cautions apply to use of the HeartStart XLT. Additional warning and cautions specific to a particular feature are pro- vided in the appropriate section. The HeartStart XLT is not intended to be deployed in settings or situations that pro- WARNING mote use by untrained personnel.
  • Page 166 Safety Considerations WARNING WARNING WARNING WARNING WARNING WARNING WARNING 13-20 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.
  • Page 167 Avoid contact between the patient and conductive fluids and/or metal objects, such WARNING as the gurney. Contact with metal objects could cause unintentional current path- ways. Operating the HeartStart XLT or its accessories in conditions outside the environ- WARNING mental specifications can result in device or accessory malfunction. Avoid exposing the display to direct sunlight on a hot day.

  • Page 168: Electromagnetic Compatibility

    Electromagnetic Compatibility WARNING 13-22 Electromagnetic Compatibility When using the M3500B defibrillator/monitor (with or without the M3517A AC Charger), electromagnetic compatibility with surrounding devices should be assessed. A medical device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility EMC) of the M3500B with and without the appropriate accessories has been performed according to the inter- national standard for EMC for medical devices (IEC 60601-1-2).

  • Page 169: Restrictions For Use

    The criteria used for degradation is not specified by the standard and may vary with the manufacturer. For additional information about compliance with the EMC standards NOTE see the Philips Medical web site at http://www.medical.philips.com/cms and follow the regulatory link. M3500B HeartStart XLT Defibrillator/Monitor Electromagnetic Compatibility...
  • Page 171 AC Power Module. See Power modules Accessories arranging 10-6 checking 11-5 ordering 11-18, 13-19 AED Mode 3-1 configuring 3-4, 10-10 CPR 3-12 defibrillation process display 2-5, 2-7 ECG monitoring 4-1 enabling from Manual Mode 6-6 events recorded 9-3 Events Summary 9-2 indications for use 1-3 overview 1-1, 3-2, 3-3 pausing 3-12, 3-15...
  • Page 172 Index Cables checking 11-5 cleaning 11-14 connecting 2-2, 3-6 ECG 10-4 Pads 3-6, 10-2 SpO2 5-6, 10-5 Cal Pulse 2-3 Carrying case arranging accessories in 10-6 cleaning 11-12 ordering 11-21 removing & replacing 11-15 Check Patient Timer setting 10-11 Check Printer message 12-5 Cleaning carrying case 11-12...
  • Page 173 Device Initiated Analysis settings 3-4, 10-11 Display AED Mode 2-7 controls 2-2 layout 2-5 Manual Mode 2-8 specifications 13-5 troubleshooting 12-8 ECG analysis. See Analysis ECG cables cleaning 11-14 connecting 10-4 ordering 11-20 See also Cables ECG electrodes. See Electrodes ECG Fault message 12-2 ECG Filter Settings 10-14 ECG monitoring 4-1...
  • Page 174 Index HeartStart XLT 1-1 assessment of 1-3 cleaning 11-12 configuring 10-7 controls 2-2 operational checks 11- 3, 11-4 safety precautions 13- specifications 13-2, 13-8 symbols 13-10 training materials 1-7 training required 1-3 troubleshooting 12-7 HR alarm. See Heart rate alarm Hypothermia pacing 1-5 SpO2 monitoring 5-1...
  • Page 175 Monitoring electrodes. See Electrodes Monitoring Rhythm. See Rhythm Monitoring Multifunction defib electrode pads. See Pads Nellcor sensors 5-3 No Data Card Present message 12-6 No Pads message 12-3 No Shock Advised Timer 3-17, 10-12 No Shock Delivered message 3-18, 12-5 Non Pulsatile message 5- 10, 5-11 Noninvasive...
  • Page 176 Index Power modules 2-9 cleaning 11-13 electromagnetic compatibility 13- ordering 11-21 specifications 13-2 Power supply checking 11-6 events recorded 9-3 interruption of power overview 2-9 specifications 13-2 troubleshooting 12-7 See also Batteries Precautions 13-19 asystole 1-5 batteries 11-9 defibrillation current (shock) 3-10 ECG analysis 3-9 electrodes 4-2...
  • Page 177 RF interference 13-22 Rhythm Monitoring 3-4, 3-14 AED Mode 3-8 configuring 3-14, 10- events recorded 9-3 Safety precautions. See Precautions Saving settings to Data Card 10-16 Security (password) 10- Semi-Automatic External Defibrillation. See AED Mode Sensors 5-3 applying 5-5 caring for 5-9 cleaning 11-14 ordering 11-20 selecting 5-3...
  • Page 178 Index Sync control 2-5 Synchronized cardioversion 7-1 delivering shock 7-2 disabling Sync Mode enabling 2-5 indications for use 1-4 preparation 7-2 selecting leads 7-1 synchronizer specifications 13- System Failure Service Unit message 12-3 System messages 2-7 list of 12-2 System tests. See Maintenance Telephone assistance 12-9 Thermal Array Printer.
  • Page 180 M3500-91900 Edition 3 Copyright © 2002 Philips Electronics North America Corporation Printed in the U.S.A. October 2002 ' " (&&...

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