Philips HEARTSTART XLT M3500B, Instructions For Use Manual

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 ...

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Page 3: ...Instructions for Use 0 HDUW6WDUW 7 HILEULOODWRU 0RQLWRU ...

Page 4: ...sic is a registered trade mark of Philips Medical Systems Use of supplies or accessories other than those recommended by Philips Medical Systems may compromise product performance THIS PRODUCT IS NOT INTENDED FOR HOME USE IN THE U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHY SICIAN Medical Device Directive The M3500B HeartStart XLT Defibril lator Monitor complies with th...

Page 5: ...ury or loss of life CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of data NOTE Notes contain additional information on usage 7 7 represents messages that appear on the display represents softkey labels that appear on the display above or below the button to which they correspond 6RIWNH ...

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Page 7: ...Manual Defibrillation Therapy 1 5 Noninvasive Pacing Therapy 1 5 Indications 1 5 Contraindications 1 5 SpO2 Monitoring 1 6 Indications 1 6 Contraindications 1 6 Learning to Use the HeartStart XLT 1 7 Safety Considerations 1 7 Getting Started Getting Acquainted 2 1 Basic Orientation 2 2 Manual Mode Controls 2 4 LCD Backlight 2 8 Connecting to Power 2 9 Inserting the Battery 2 9 Removing the Battery...

Page 8: ...tocol 3 16 Troubleshooting 3 18 Monitoring the ECG Applying Monitoring Electrodes 4 2 Electrode Placement 4 3 Selecting the Lead 4 5 Setting the Heart Rate Alarm 4 6 Disabling the HR Alarm 4 7 Adjusting the ECG Size 4 7 Troubleshooting 4 7 Monitoring SpO2 Understanding Pulse Oximetry 5 2 Selecting a Sensor 5 3 Reusable Sensors 5 4 Disposable Sensors 5 4 Semi disposable Sensors 5 4 Applying the Sen...

Page 9: ...rdioversion 7 2 Delivering a Synchronized Shock 7 2 Delivering Additional Synchronized Shocks 7 4 Disabling Sync Mode 7 4 Pacing Demand Mode Versus Fixed Mode 8 2 Monitoring During Pacing 8 2 Preparing for Pacing 8 3 Pacing 8 4 Changing Pacing Modes 8 6 Defibrillating During Pacing 8 6 Troubleshooting 8 7 Storing Retrieving Printing Overview 9 1 Marking Events 9 2 Events Recorded 9 3 Creating a Pa...

Page 10: ...onfiguring the HeartStart XLT 10 7 Accessing the Configuration Menu 10 7 Configurable Parameters 10 8 Setting the Manual Mode Password 10 13 Modifying the Configuration 10 15 Returning to the Default Configuration 10 15 Saving Settings to a Data Card 10 16 Loading Settings from a Data Card 10 16 Printing Settings 10 16 Maintaining the HeartStart XLT Operational Checks 11 2 Before You Begin 11 2 Ev...

Page 11: ...dules 11 13 Cleaning Pads Electrodes Cables 11 14 Removing Replacing the Carrying Case 11 15 Putting On the Manual Door 11 17 Supplies Accessories 11 18 Disposing of the HeartStart XLT 11 22 Troubleshooting System Messages 12 2 Momentary Messages 12 5 Troubleshooting Tips 12 7 Calling for Service 12 9 United States of America 12 9 Latin America 12 9 Canada 12 9 Other International Areas 12 10 ...

Page 12: ...g 13 7 SpO2 Pulse Oximetry 13 7 Event Storage 13 8 General 13 8 Environmental 13 9 Symbol Definitions 13 10 Clinical Performance Summary Defibrillation 13 14 Methods 13 14 Results 13 14 Conclusion 13 15 Clinical Performance Summary Cardioversion 13 16 Methods 13 16 Results 13 16 Conclusion 13 18 Safety Considerations 13 19 Electromagnetic Compatibility 13 22 Reducing Electromagnetic Interference 1...

Page 13: ...llation z Semi Automatic External Defibrillation AED Mode z Manual Mode Both modes incorporates a low energy SMART Biphasic waveform for defibrillation In AED Mode the HeartStart XLT 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 instructions and patient information The voice prompts are reinforce...

Page 14: ...XLT also allows you to store data and events on a Data Card for downloading to HeartStart Event Review Data Management systems The versatile HeartStart XLT is highly configurable to better meet the needs of diverse users The messages and softkeys vary depending on how the HeartStart XLT is configured Be sure to familiarize yourself with your con figuration before using the HeartStart XLT see Confi...

Page 15: ...ation Therapy Defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias The HeartStart XLT provides this therapy through the application of a brief biphasic pulse of electricity to the cardiac muscle This electrical energy is transferred through disposable multifunction defib electrode pads applied to the patient s bare chest NOTE Successful resu...

Page 16: ...ion Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Dallas Texas AHA 2000 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 SMAR...

Page 17: ...ing Therapy The HeartStart XLT provides noninvasive transcutaneous pacing by deliver ing a monophasic electrical stimulus to the heart This stimulus is intended to cause cardiac depolarization and myocardial contraction The emergency 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 In...

Page 18: ...tes the measurement into a saturation percent age that is displayed as an SpO2 reading Indications SpO2 monitoring is indicated for use when it is beneficial to assess a patient s oxygen saturation level Contraindications None known NOTE 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 cert...

Page 19: ... and z About Sealed Lead Acid Batteries an application note on battery maintenance For additional training materials please visit our website at www medical philips com cms Safety Considerations General warnings and cautions that apply to use of the HeartStart XLT are provided in Chapter 13 Additional warnings and cautions specific to a partic ular feature are provided in the appropriate section o...

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Page 21: ...ith the HeartStart XLT and then guide you through these activities NOTE To connect cables to the HeartStart XLT or to arrange accessories in the carry ing case refer to Setting Up and Configuring the HeartStart XLT in Chapter 10 Getting Acquainted This section shows the HeartStart XLT controls buttons connections and dis play layout An overview of control functions is also provided NOTE If your He...

Page 22: ...tient cables connect and where to insert the battery and Data Card Figure 2 1 Basic Orientation Audiovisual Controls ECG Connector SpO2 Connector Manual Mode Controls Battery Ambient Light Sensor Pads Connector Off On Printer Print Controls Monitoring Controls AC Power Module Connector Data Card Defibrillation Controls Speaker ...

Page 23: ...djusts the volume of voice prompts and the QRS beeper Monitoring Controls softkeys that perform the monitoring function dis played in the softkey label below each button control heart rate and SpO2 alarms and select the ECG source to monitor Print Controls perform the function shown above each button The print controls from left to right are Print Strip Prints ECG data defibrillation events and ma...

Page 24: ...s These controls are accessed by lifting the door labeled Manual Figure 2 2 Manual Mode Controls NOTE Synchronized cardioversion and pacing controls only function when Manual Mode is enabled Manual Sync Pacer Rate Start Stop Mode Output LEDs indicating the function is active green light or inactive no light ...

Page 25: ...ed when the green LED next to the key is lit A password may be required for Manual Mode entry Enables synchronized cardioversion when first pressed as indicated by the green LED disables synchronized cardio version 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...

Page 26: ...er shows the elapsed time since the HeartStart XLT was turned on If the HeartStart XLT 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 Incident Timer resets to zero ANALYZE PAUSE 00 15 02 Shocks 0 User Message SHOCK 150J ECG Current Charge Shocks Delivered Incident Timer System Message Momentary Mess...

Page 27: ...ndations 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 only a few seconds A list of messages is provided in Chapter 12 HR ALARM LEAD SELECT SPO2 PAUSE ANALYZE SHOCK Shocks 0 00 15 02 150J 114J 132 86 PR 130 System Message Momentary Message Lead II SpO2 value SpO2 alarm Pleth Ba...

Page 28: ...nd on simultaneously To return to normal operation press the same keys again The back light also returns to normal operation each time you turn the HeartStart XLT on HR ALARM LEAD SELECT SPO2 ENERGY SELECT CHARGE SHOCK Shocks 0 00 15 02 150J 114J 132 86 PR 130 System Message Momentary Message Lead II SpO2 value SpO2 alarm Pleth Bar Pulse Rate Heart Rate ECG Selected Energy Current Charge Shocks De...

Page 29: ... or the M3518A DC Power Module However the defibrillator will take longer to charge when powered by a power module with the battery absent The rec ommended practice when using a power module is to use the module in con junction with a battery For information on using the power modules see the documentation supplied with the modules NOTE To save battery capacity the HeartStart XLT shuts itself off ...

Page 30: ... cient remaining capacity to provide only about ten minutes of monitoring time and six shocks before the HeartStart XLT shuts off Replace the battery as soon as possible If the power is off for less than 2 minutes while you change the battery the HeartStart XLT assumes that you are continuing to treat the same patient It continues to store data on the Data Card and append events to the existing Ev...

Page 31: ...e inserted for the current incident because the device will only allow the use of one Data Card per incident Data Cards hold up to two hours of patient information Multiple incidents can be recorded on a single Data Card Each incident is assigned a unique incident number Patient data from a Philips M3510A Data Card may be downloaded to a HeartStart Event Review Data Management system HeartStart Ev...

Page 32: ...a Data Card is already in the compartment press the black button inside the compartment to eject the card see Figure 2 8 Then pull the card out 4 With the yellow label facing up and the pointing towards the Heart Start XLT slide the Data Card into 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 8 Inserting a D...

Page 33: ...Start XLT Defibrillator Monitor 2 13 2 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 ...

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Page 35: ...ces 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 XLT to defibrillate in AED Mode It explains the prompts that guide you through the defibrillation pro cess and describes how prompts vary depending upon the condition of the patient and the configuration of your d...

Page 36: ...esponsive z Not Breathing z Pulseless Attach Pads Insert Data Card Optional Press On If Instructed Press 1 Shock Advised Check Patient at completion of shock series within a shock series No Pulse Pulse Ventilate No Shock Advised Press Do CPR 3 86 if Rhythm Monitoring on Press 6 2 ...

Page 37: ...efibrillation with the default configuration In its default configuration the defibrillation process is Press the On button The HeartStart XLT checks to see if the pads patient cable and multi function defib electrode pads are properly connected If either con nection is compromised you are prompted to fix the problem Analysis begins automatically there is no need to press Once analysis is complete...

Page 38: ...d to press to initiate analysis in between shocks within a shock series i e after the first and second shock of a three shock series Rhythm Monitoring monitors the ECG for potentially shockable rhythms when the HeartStart XLT is not analyzing defibrillating or paused The default setting is 2Q If you choose to set this parameter to 2II the HeartStart XLT will not look for potentially shockable rhyt...

Page 39: ...eless Then 1 Apply multifunction defib electrode pads to the patient as directed on the package Use the anterior anterior electrode placement 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 11 Figure 3 2 Connecting Pads to the Patient Cable ...

Page 40: ... 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 RQ QHFW 3DGV DEOH Figure 3 3 Connect Pads Cable Display Once the cable is connected the HeartStart XLT checks to make sure the pads are making good contact with the patient s skin It does this by moni toring the electrical impedance between the tw...

Page 41: ...Start XLT Defibrillator Monitor 3 7 3 If the pads have not been applied or are not making proper contact with the patient you are prompted to SSO 3DGV and KHFN RQQHFWLRQV Figure 3 4 Apply Pads Display Apply Pads Shocks 0 00 00 03 ...

Page 42: ...e rhythm is detected Figure 3 5 Press ANALYZE Display NOTE If monitoring capabilities are enabled on your HeartStart XLT your display will contain monitoring information not shown in the graphics in this section NOTE ECG Analysis is always performed through multifunction defib electrode pads Analysis can not be performed through monitoring electrodes 1 1 Shocks 0 00 00 04 Check Patient If No Pulse...

Page 43: ...r transporting the patient during ECG analysis can cause incorrect or delayed diagnosis If a shockable rhythm is detected as indicated by the message 6KRFN GYLVHG analysis stops and the XLT automatically charges to 150J Charging is accom panied by an intermittent charge tone Figure 3 7 Charging Display 1 Shocks 0 00 00 08 Analyzing Do Not Touch Patient STOP ANALYSIS Shocks 0 00 00 10 Charging to 1...

Page 44: ...o the patient Call out Clear Then press to deliver a shock to the patient Figure 3 8 Press SHOCK Display 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 if you do not press in 30 seconds 6 2 6 2 Shocks 0 00 00 14 Stand Clear Press SHOCK 150J SHOCK 6 2 ...

Page 45: ...y of the shock You are prompted to press if an addi tional shock is advised This cycle repeats until the rhythm converts or a shock series is complete A shock series may be configured to 2 3 or 4 shocks Automatic Re analysis Off If Automatic Re analysis is off the HeartStart XLT monitors the ECG for potentially shockable rhythms provided Rhythm Monitoring is on and prompts you to press if one is d...

Page 46: ...he elapsed time and the total duration of the Pause state in seconds The Pause Timer is configurable to meet your local CPR protocol needs Rhythm SpO2 and heart rate monitoring alarms are suspended for the duration of the pause NOTE This section describes how the Pause state functions using the default con figuration If your HeartStart XLT is configured to support the European Resuscitation Counci...

Page 47: ...ion or if you press or At the completion of the pause state the defibrillation process begins again If instructed press If you do not press the HeartStart XLT begins monitoring the ECG rhythm provided Rhythm Monitoring is on You may initiate ECG analysis at any time by pressing Shocks 3 00 01 40 Paused RESUME ANALYZE Timer 21 60 Elapse Time Total Pause Duration 5 680 1 1 3 86 1 ...

Page 48: ...P 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 12 Monitoring Rhythm Display 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 ...

Page 49: ...in If you press rhythm monitoring is suspended for the duration of the pause is used when administering CPR as noted earlier It may also be useful when performing medical procedures or encountering artifact during patient transport Active SpO2 and heart rate alarms are suspended during the pause duration as well Press to restore rhythm monitoring Active SpO2 and heart rate alarms are also restored...

Page 50: ... same with the exception of how the Pause state functions see Pausing for CPR on 3 12 As described you can enter a Pause state z at the completion of a shock series or z when no shock is advised When either of these events occurs the ERC protocol prompts you to Check Patient Then it prompts you as follows Figure 3 14 NOTE Using the ERC protocol you are not prompted to or given time to check the pa...

Page 51: ...If you entered the Pause state z at the completion of a shock series or shortly after a shock is deliv ered the duration is equal to the 3RVW 6KRFN 35 7LPHU configuration set ting the default setting is 60 seconds z when no shock was advised the duration is equal to the 16 7LPHU configuration setting where NSA is an acronym for No Shock Advised the default setting is 180 seconds 3 86 Shocks 3 00 0...

Page 52: ...or Check that the defibrillation pads connector is locked in place Artifact Detected z Patient motion interferes with analysis z Electrical sources are causing interference z Attempt to eliminate patient motion Avoid analyzing during transport or while performing CPR z Move hand held communication devices or other suspected devices away from the defibril lator when possible Shock Can celled Shock ...

Page 53: ... 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 HDG 6HOHFW is configured to on the default is off A fully charged battery provides approximately 2 7 hours of continuous mon itoring This chapter describes how to apply monitoring electrodes select the lead to monitor and set a heart rate HR alarm To apply mul...

Page 54: ...s 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 WARNING Be sure that the electrodes do not come ...

Page 55: ...he 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 Lead Reference I LA RA LL II LL RA LA III LL LA RA AHA Labels IEC Labels RA Right Arm R Right LA Left Arm L Left RL Right Leg N Negative LL Left Leg F Foot RA R LA L RL N LL F Not used for 3 lead ...

Page 56: ... LA Vx or Cx where x 1 6 V C 1 2 3 4 5 6 LA LL 2 RA LA 2 RA LL 2 RA LA LL 3 Electrode Location V1 C1 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 midclav icular line V5 C5 same level as V4 C4 on anterior axil lary line V6 C6 same level as V4 C4 at left mid axil lary li...

Page 57: ...e softkey Figure 4 3 ECG Monitoring Display If the desired lead is not connected or the electrodes are not making proper contact with the patient the message HDGV 2II is displayed in the System Mes sage Area and accompanied by a beep to alert you A dashed line on the dis play indicates that there is no ECG signal Table 4 3 Lead Select Choices Lead Select Choices are If Configured for a Pads Lead I...

Page 58: ... set a HR alarm cycle through the limit choices by pressing until the desired limits are shown The then appears next to the heart rate value to indicate that the HR alarm is set WARNING Heart rate alarms are temporarily suspended in AED Mode during ECG analysis or when is pressed for the duration of the paused period Heart rate alarms are also suspended while charging for defibrillation and delive...

Page 59: ...oubleshooting Table 4 5 provides troubleshooting tips for ECG Monitoring 5 50 Table 4 5 Troubleshooting Tips Situation Cause Solution HDGV 2II message or dashed line z The monitoring elec trodes are not applied or are not making proper contact with the patient z The monitoring cable is not connected z Check that the monitoring electrodes are properly applied z Check that the monitoring cable is pr...

Page 60: ...the patient s skin and apply new electrodes z Check the date code on the electrodes Do not open the electrode pack age until immediately prior to use z Relocate or turn off equip ment that may be causing RFI QRS beeper inau dible or beeps do not occur with each QRS com plex z The QRS beeper is con figured to Off z The amplitude of the QRS complex is too small to detect z Check that the QRS beeper ...

Page 61: ...y works and describes how to use the HeartStart XLT to monitor SpO2 SpO2 monitoring is always available in Manual Mode if the option is pur chased In AED Mode SpO2 monitoring is only available if SpO2 is config ured to 2Q For information on printing storing and retrieving patient information acquired while monitoring see Chapter 9 WARNING Do not rely solely on SpO2 readings assess the patient at a...

Page 62: ...ulsation 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 SpO2 value is displayed For accurate SpO2 measurements the following conditions must apply z The patient must have perfusion in that extremity z The light emitter and the photodetector must be directly...

Page 63: ...ent Cable on page 10 5 Table 5 1 Approved Sensors Sensor Type Patient Patient Size Ideal Site M1191A Reusable Adult 50 kg Finger M1192A Reusable Small adult Pediatric 15 50 kg Finger M1194A Reusable Pediatric Adult 40 kg Fleshy part of ear M1903A B Nellcor D 20 Disposable Pediatric 10 50 kg Toe Finger M1904A B Nellcor D 25 Disposable Adult 30 kg Finger M1906A Nellcor P I Semi reus able Pediatric I...

Page 64: ...ication to sites with edematous tissue 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 giv...

Page 65: ...he sensor cable and connection z Avoid placing the sensor in an environment with bright lights if nec essary cover the sensor with opaque material z Avoid placing the sensor on any extremity with an arterial catheter blood pressure cuff or intravascular venous infusion line WARNING Failure to apply the sensor properly may reduce the accuracy of the SpO2 measur ment WARNING Inspect the sensor appli...

Page 66: ...nsor 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 ...

Page 67: ...shed line As the patient s oxygen saturation changes the SpO2 value is updated continuously Figure 5 3 SpO2 Monitoring Display To the right of the SpO2 value a pleth bar and SpO2 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...

Page 68: ...pO2 alarms are temporarily suspended in AED Mode during ECG analysis or when is pressed for the duration of the paused period SpO2 alarms are also sus pended while charging for defibrillation and delivering a shock Responding to an Alarm When the SpO2 value falls below the alarm limit a continuous tone alerts you and the SpO2 value is displayed in inverse video Figure 5 4 SpO2 Alarm Triggered Pres...

Page 69: ...ons for care and cleaning of sensors To get the best results from your SpO2 reusable sensors always handle the sensor and cable with care and protect them from sharp objects The sensor sleeve houses a sensitive electronic device that can be damaged Harsh treatment of sensors will drastically reduce their lifetime WARNING Do not use a damaged sensor or one with exposed electrical circuits 6S2 6S2 P...

Page 70: ...nsor type 6S2 RZ 6LJQDO z SpO2 signal is too low to give an accurate read ing z Check the sensor is applied properly z Try another sensor type 6S2 1RLV 6LJQDO z Excessive patient move ment electrical interfer ence or optical interference z Minimize patient motion or apply sen sor to site with less movement z Secure the sensor cable loosely to the patient z Reduce sources of electrical or optical i...

Page 71: ...device z Attach the cable to the HeartStart XLT 6S2 6HQVRU DLO z The transducer is bro ken z Apply a new trans ducer 6S2 DLOXUH z There is a hardware fail ure in the SpO2 sub system z Remove device from active use and call for service Table 5 2 System Messages Continued Problem or Message Possible Cause Corrective Action ...

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Page 73: ...e prompts however system and momentary messages provide relevant information throughout the pro cess It is important to be attentive to these messages This chapter describes how to access Manual Mode and use it for defibrilla tion For Manual Mode features such as synchronized cardioversion and pac ing see the Performing Synchronized Cardioversion and Pacing chapters For information on printing sto...

Page 74: ... LED next to is lit In its default configuration the HeartStart XLT powers on into AED Mode If you prefer you can configure it to power on into Manual Mode You have the option to require users to enter a password in order to enable Manual Mode from AED Mode See Configuring the HeartStart XLT on page 10 7 WARNING Use of a password for Manual Mode is recommended as a safety measure to deter untraine...

Page 75: ...placement as appropriate 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 11 4 Press On 5 Enter Manual Mode if AED Mode is active Figure 6 2 Connecting Pads to the Patient Cable NOTE Defibrillation is always performed through pads However during defibrilla tion you may choose to monitor ECG using an alternate ...

Page 76: ...el choices Stop when the desired energy is displayed The choices are 5 10 25 50 70 100 150 or 200 joules Figure 6 3 Energy Select Display 2 Charge Press As the defibrillator charges the current charge is displayed above the shock counter A charging tone beeps until the desired energy level is reached at which point you ll hear a continuous charge tone 1 5 6 7 ENERGY SELECT HR ALARM LEAD SELECT CHA...

Page 77: ...at a shock is still indicated Make sure no one is touching the patient or anything connected to the patient Call out Clear Then press to deliver a shock to the patient To disarm the defibrillator press If is not pressed in 30 sec onds the defibrillator disarms automatically If additional shocks are indicated repeat the defibrillation process WARNING Defibrillation current can cause operator or bys...

Page 78: ...g to AED Mode To enable AED Mode from Manual Mode press The green LED next to goes out indicating Manual Mode is no longer active If ECG and or SpO2 monitoring are enabled in AED Mode alarms set in Manual Mode remain active when you switch to AED Mode Manual Manual ...

Page 79: ...on the display and may be derived from z the multifunction defib electrode pads or z the 3 or 5 lead monitoring electrodes When selecting a lead choose the best lead that displays a large QRS com plex The synchronized shock is delivered through the mulifunction defib electrode pads regardless of the lead being monitored This chapter describes how to perform synchronized cardioversion with the Hear...

Page 80: ...anual Mode See Enabling Manual Mode on page 6 2 7 Use to select the best lead that displays a large QRS complex See Selecting the Lead on page 4 5 Delivering a Synchronized Shock To perform synchronized cardioversion 1 Press to enable Sync Mode The green LED next to lights up and the message 6 1 appears on the display 2 Use the gain control to adjust the ECG size so that the marker dot appears onl...

Page 81: ...he current charge reaches the selected energy level before proceeding 5 Make sure no one is touching the patient or anything connected to the patient Call out Clear Then press and continue to hold down until the shock is delivered The defibrillator shocks with the next detected R wave WARNING Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connec...

Page 82: ...guration the HeartStart XLT remains in Sync Mode after a shock is delivered as indicated by the message 6 QF 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 Disabling Sync Mode To disable Sync Mode press The green LED next to goes out and the message 6 QF is no longer displayed Sync Mode is also disabled when you...

Page 83: ...scutaneous 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: ...toring electrodes as the source of ECG during pacing In demand mode ECG electrodes must be used because the HeartStart XLT 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 possi...

Page 85: ...e See Enabling Manual Mode on page 6 2 In addition for demand mode pacing 1 Apply monitoring electrodes See Applying Monitoring Electrodes on page 4 2 2 Use to select the best lead with an easily detectable R wave See Selecting the Lead on page 4 5 If you do not select a lead i e pads is the selected ECG source HDG is automatically selected when the pacing function is turned on NOTE If pacing for ...

Page 86: ...S 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 The ECG will only appear if the 3 or 5 lead monitoring cable and elec trodes are used 3 Press to change to fixed mode if R wave detection is unreliable The pacing dialogue box displays the current mode To switch back to demand mode pres...

Page 87: ...g delivered in the selected mode at the rate and output level displayed Figure 8 2 Pacing Display NOTE Pacing will not start if there is a problem with the multifunction defib elec trode pads connections or in demand mode a problem with the ECG monitor ing electrodes connections Should a problem exist a system message is displayed Be attentive to system messages Rate Start Stop ENERGY SELECT HR AL...

Page 88: ... changing the pacing mode 1 Press to stop pacing 2 Press to change the mode 3 Adjust the rate if needed 4 Press 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 4 Pacing is automatically turned off when you charge the defibrillator and the...

Page 89: ...ly applied z Check that the monitoring cable and electrodes are properly connected 3DFHU DLOXUH The pacing system is not func tioning Remove the device from active use and call for service 3DFHU 2XWSXW RZ High patient impedance is resulting in the delivery of less current to the patient than specified in the output current setting Check that the pads are applied properly 6WRS 3DFHU is pressed whil...

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Page 91: ... include things such as charging shocks and alarm violations In addition you trigger an event each time you press or 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 is also stored You can print the internal Event Summary at any time You can also configure ...

Page 92: ...s marked with a Figure 9 1 Annotations NOTE In Australia and the U K 3 is replaced by 51 adrenaline The marked event is stored in the Event Summary If the printer is configured to 3ULQW RQ 0DUN an ECG strip prints when is pressed If the printer is configured to VHFRQG GHOD the strip is 9 seconds and includes 6 seconds pre ceding the event and 3 seconds following the event If 1R HOD is configured a...

Page 93: ...n 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 Leads ...

Page 94: ... SpO2 value and SpO2 alarm limit Mark ECG waveform with annotation Epi Atro Lido or Other Print Strip ECG waveform Sync Sync on Sync off Sync marker Pacing Pacer start Pacer stop Pacer settings Table 9 1 Event Information Continued Event Related Information Stored ...

Page 95: ...efly for 2 minutes while preserving the current patient record Events recorded after the power interruption are appended to the patient record Continued use also preserves alarm settings Table 9 2 Patient Record Summary If Then Power is off for more than 2 minutes and a new event is recorded You are caring for a new patient The last internal Event Summary is deleted a new Event Summary is started ...

Page 96: ...curred during the incident and the time of their occurrence z 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 Print Summary Print Summary Print Strip Patient ___________________ Operator __________________ Device On 03 Jan 00 12 41 00 Last Event 03 Jan 00 01 09 04 Total Shocks 2 Incident 0000045 Serial Number...

Page 97: ... Advised 11 seconds of ECG just prior to the message 1R 6KRFN GYLVHG Cannot Analyze 11 seconds of ECG just prior to the message DQQRW QDO H Shock Delivered 11 seconds 3 seconds prior to the shock plus 8 seconds after the shock Print Strip 11 seconds 3 seconds prior to being pressed plus 8 seconds after is pressed Mark Event 11 seconds 3 seconds prior to being pressed plus 8 seconds after is presse...

Page 98: ...ed to have a 6 second delay the printout contains an additional 6 seconds of the ECG that occurred just prior to pressing Table 9 4 Printing Events Event Real Time Strip Length Delayed Strip Length 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 s...

Page 99: ...to set up and configure your HeartStart XLT It covers z Connecting Patient Cables z Arranging Accessories in the Carrying Case z Configuring the HeartStart XLT Connecting Disconnecting Patient Cables This section describes how to connect and disconnect the z Pads Patient Cable z ECG Patient Cable 3 or 5 lead z SpO2 Patient Cable ...

Page 100: ...ct 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 Insert the patient cable into the pads connector Push until you hear it click in place Figure 10 1 Pads Patient Cable Connector Pointer Pads connector ...

Page 101: ...e pads patient cable 1 Rotate the green locking mechanism on the patient cable in the direction clockwise of the blue arrow on the defibrillator until it stops as shown in Figure 10 2 2 Hold the locking mechanism in this position as you pull the patient cable away from the defibrillator Figure 10 2 Disconnecting the Pads Patient Cable Blue arrow ...

Page 102: ...ed 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 Figure 10 3 ECG Patient Cable Connector Disconnecting the ECG Patient Cable To disconnect the ECG patient cable gently pull the white patient cable plug out of the ECG connector as shown in Figure 10 3 ...

Page 103: ...ient 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 Figure 10 4 Connecting the SpO2 Patient Cable Disconnecting the SpO2 Patient Cable To disconnect the SpO2 patient cable gently pull it out of the SpO2 connector ...

Page 104: ...se 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 Pads Patient Cable ECG Patient Cable SpO2 Patient Cable Monitoring Electrodes Pads ...

Page 105: ...items and their setting options z How to change the configuration z How to save the configuration to a Data Card z How to load the configuration from a Data Card z How to print the configuration 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 s...

Page 106: ...lists the categories of settings that may be configured Figure 10 7 Configuration Menu Configurable Parameters The following tables show the configurable parameters for each category of settings A description of each parameter is provided along with the possible choices Default settings are in bold ENTER MAIN AED Settings Manual Settings ECG Filter Settings Save Settings to Data Card Load Settings...

Page 107: ... time where KK is the hour and PP is the minutes Time is based on a 24 hour clock any valid time 3ULQW RQ 0DUN Prints a 3 second strip when is pressed On Off 3ULQW RQ KDUJH Prints a continuous strip during charging Printing continues until a shock is deliv ered the device is disarmed or is pressed On Off 3ULQW RQ 6KRFN Prints a 12 second strip when a shock is delivered On Off 3ULQW RQ ODUP Prints ...

Page 108: ...ing being initi ated 6 Sec Delay No Delay 3DFH 3XOVH 0DUNHUV Shows pace pulse markers on the ECG displayed if an internal pacemaker is detected Leads Pads Leads Only HDG DEOH Selects the monitoring electrodes source 3 lead 5 lead 3RZHU RQ 0RGH Defines the operating mode when the device is turned on Applies to a new use not to a continued use AED Manual 456 HHSHU Provides an audible beep with each ...

Page 109: ...shocks within a shock series On Off 5K WKP 0RQLWRULQJ Monitors the ECG for potentially shockable rhythms when the HeartStart XLT is not ana lyzing defibrillating or paused On Off KHFN 3DWLHQWµ 7LPHU Defines how often in seconds the KHFN 3DWLHQW prompt is repeated when Rhythm Mon itoring detects a potentially shockable rhythm 30 45 60 90 Off XURSHDQ 3URWRFRO Modifies Pause state prompts and replace...

Page 110: ...either 2II or 16 7LPHU Defines the duration of the Pause time in sec onds when is pressed and the time since the last shock is greater than the 6KRFN 6HULHV 7LPHU setting typically when 1R 6KRFN GYLVHG 30 60 120 180 If XURSHDQ 3URWRFRO is set to Off the following configuration choice appears 3DXVHµ 7LPHU Defines the duration of the pause time in sec onds when is pressed when XURSHDQ 3URWRFRO is se...

Page 111: ...on 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 Parameter Description Choices 0DQXDO 0RGH 6HFXULW Requires entry of a password to access Manual Mode On Off 6 QF IWHU 6KRFN Determines if the Sync function stays on after a synchronized shock is delivered On Off 1 2 3 4 Enter Password _...

Page 112: ...LVSOD Selects the display filter frequency for the pads ECG Monitor 15 40Hz EMS 1 30 Hz 3DGV IRU 3ULQWHU Selects the printer filter frequency for the pads ECG Monitor 15 40Hz EMS 1 30 Hz HDGV IRU LVSOD Selects the display filter frequency for the monitoring electrodes ECG Monitor 15 40Hz EMS 1 30 Hz HDGV IRU 3ULQWHU Selects the printer filter frequency for the monitoring electrodes ECG Diag 05 150...

Page 113: ...he softkeys or to select the desired setting To select the default setting press 6 Press to save the change To exit without making the change press 7 Press to return to the main menu To make additional changes repeat steps 1 7 Returning to the Default Configuration Press and on simultaneously while in the main configuration menu to return all settings to their default settings Although there is no...

Page 114: ... Press in response to the question 6DYH 6HWWLQJV WR DWD DUG The HeartStart XLT saves the configuration settings to the Data Card and returns to the main configuration menu Loading Settings from a Data Card To load configuration settings 1 Make sure a Data Card is in the HeartStart XLT 2 Select RDG 6HWWLQJV IURP DWD DUG from the main configuration menu 3 Press in response to the question RDG 6HWWLQ...

Page 115: ...instructions z Instructions for removing and replacing the carrying case z A list of approved supplies and accessories and z Instructions for disposal of the device The operational checks described must be performed at the specified intervals in order to help prevent and detect electrical and mechanical problems The battery maintenance procedures specified must be adhered to in order to ensure tha...

Page 116: ...LT while the Shift System Check is running z If a DLOXUH or 6HUYLFH 8QLW message is displayed or if an unexpected 1RW 7HVWHG result is displayed check that the test is set up correctly Make sure that the paper is in the printer the test load is attached a Data Card with enough space is inserted into the HeartStart XLT a charged battery is inserted into the HeartStart XLT Run the Shift System Check...

Page 117: ...perly and to ensure that necessary supplies and accessories are present and ready for use Every Month Check expiration dates on multifunction defib electrode pads and monitoring electrodes every month Replace them if the expiration date has passed Every Three Months Perform a Battery Capacity Test on each battery every three months to ensure that your batteries meet the specifications for safe and...

Page 118: ... call for service The test takes less than a minute to complete When it is done a report is printed as shown in Figure 11 1 Test results are listed as Pass or Fail with the exception of the Data Card Test For the Data Card Test the results indi cate either the amount of storage time remaining on the data card or that no data card is present Figure 11 1 Shift System Check Report Print Strip Shift S...

Page 119: ...has no visible signs of damage Cables Connectors make sure there are no cracks broken wires or other visible signs of damage Make sure the connectors engage securely Supplies make sure the carrying case has z two sets of multifunction defib electrode pads in sealed packages within the expiration date z an adequate supply of monitoring electrodes within the expiration date z alcohol wipes z hand to...

Page 120: ...Power Module 1 Make sure a battery is in the HeartStart XLT 2 Plug the power module into a power outlet and connect it to the Heart Start XLT 3 Verify that the power and charging indicators on the power module are lit 4 Remove the battery from the HeartStart XLT and verify that the charg ing indicator on the power module is no longer lit Replace the battery Printer make sure the printer z has suff...

Page 121: ...est 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 1 Battery Capacity Test Results If Then Elapsed Time 2 5 hours and Low Battery Time 10 minutes 1 The battery passed the test 2 Record pass CT and the date on the bottom of the ...

Page 122: ...artStart XLT or the M3506A Battery Charger Adapter by connecting the device with the battery to the M3517A AC Power Module Refer to the charging procedures provided in the operating instructions for the power module s you use Batteries charge to 90 of their capacity in about 2 5 hours It then takes about 12 more hours to reach a fully charged state Batteries should be charged at temperature betwee...

Page 123: ...eries should not be stored without charging for more than one month if installed in the defibrillator or more than three months if not installed in the defibrillator Storage at temperatures between 15o C 59o F and 30o C 86o F is recommended to maximize life expectancy CAUTION Storing at temperatures above 35oC 95oF for extended periods of time will significantly reduce a battery s life expectancy ...

Page 124: ...LT Loading Printer Paper To load printer paper 1 Slide the printer door to the right until the paper roller pops up 2 If there is an empty or low paper roll in the printer pull up on the plastic removal tab to remove the roll Figure 11 2 Opening the Printer ...

Page 125: ...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 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 over the paper and release the door Figure 11 3 Loading Paper ...

Page 126: ... 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 The HeartStart XLT may not be autoclaved ultrasonically cleaned or immersed Do not use abrasive cleaners or strong solvents such as acetone or acetone based cleaners Cleaning the Carrying Case ...

Page 127: ...above the brush with a cotton swab dipped in rubbing alcohol 4 Replace the roll of paper see Loading Printer Paper on page 11 10 Cleaning the Power Modules The following cleaning products may be used to clean the exterior surfaces of the AC power modules z Isopropyl alcohol 70 in water z Mild soap and water z Chlorine bleach 3 in water z Quaternary ammonium compounds such as Lysol 10 in water When...

Page 128: ...n water z Quaternary ammonium compounds such as Lysol z Isopropyl alcohol The ECG cable may be cleaned by wiping it with any of the following z 2 gluteraldehyde solution such as Cidex z Alcohol free hand soap z Chlorine bleach 100ml l CAUTION Do not ultrasonically clean immerse autoclave or steam sterilize the pads or ECG cable Do not clean the ECG cable with alcohol Alcohol can cause the plastic ...

Page 129: ... 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 Then slide the defib out of the case as shown in step 7 Figure 11 4 Removing the Carrying Case ...

Page 130: ...o 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 Figure 11 5 Putting the Carrying Case On ...

Page 131: ...nitor 11 17 11 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 Figure 11 6 Aligning the Manual Door Figure 11 7 Snapping the door in place ...

Page 132: ... philips com cms and fol low the Supplies link Table 11 3 Supplies and Accessories Part Number Description Paper 40457C 50 mm Strip Chart Thermal Paper 1 box 10 rolls 40457D 50 mm Strip Chart Thermal Paper 1 box 80 rolls M3501A Multifunction Adult defib pads AAMI M3502A Multifunction Adult defib pads IEC M3503A Multifunction Pediatric defib pads IEC M3504A Multifunction Pediatric defib pads AAMI M...

Page 133: ...diotransparent 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 special procedures M3508A Defibrillator pads cable...

Page 134: ... AAMI 8 pin M1590A 3 lead ECG Trunk Cable IEC 8 pin M1610A 5 Lead ECG Trunk Cable IEC 8 pin Monitoring Electrodes M2202A High Tack Foam ECG Electrodes 5 electrodes pouch 300 electrodes case SpO2 Cable Sensors M1191A Adult Reusable SpO2 sensor M1192A Pediatric Reusable SpO2 sensor M1194A Adult Pediatric Ear Clip Reusable SpO2 sensor M1941A SpO2 extension cable 2 m M1943A Nellcor SpO2 Sensor adapter...

Page 135: ... Battery M3517A AC power module M3518A DC Power Module M3506A Battery charger adapter Extension Cable M4748A Adapter extension cable Carrying Case M3509A Carrying case If a new Quick Reference Card is needed for the carrying case it must be ordered separately Table 11 3 Supplies and Accessories Continued Part Number Description ...

Page 136: ... Prior to disposing of the HeartStart XLT remove the battery Then dispose of the device and its accessories in accordance with local standards WARNING Disposal of the device with the battery inserted presents a potential shock hazard ...

Page 137: ...tary 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 NOTE For instructions for repair or for further technical information refer to the service manual part number M3500 90900 ...

Page 138: ...sent or inserted after the HeartStart XLT was turned on If possible turn the HeartStart XLT off for more than 2 minutes insert an empty compatible Data Card and turn the device on DXOW The ECG data acquisition system failed and data is unavailable from the 3 or 5 lead monitoring electrodes Remove the device from active use and call for service RZ DWWHU The battery has sufficient capacity remaining...

Page 139: ...t ting Check the pads are applied properly 6HUYLFH 8QLW Appears during a Shift System Check May indicate that the Data Card is full OR There is a system failure z Replace the Data Card z Perform a Shift System Check z If 6HUYLFH 8QLW continues to appear do not use the device and call for service 6 VWHP DLOXUH FOH 3RZHU An internal error occurred If this occurs during actual use z Substitute anothe...

Page 140: ...ak to be detected z Check that the sensor is applied prop erly z Make sure the sensor site has a pulse z Relocate the sensor to a site with improved circulation z Try another sensor 6S2 RZ 6LJQDO SpO2 signal is too low to give an accurate reading z Check the sensor is applied properly z Try another sensor type 6S2 1RLV 6LJQDO Excessive patient movement electrical interference or optical interferen...

Page 141: ...to begin pacing in Demand Mode without ECG leads attached to the patient Attach leads to patient HILE LVDUPHG z The pads connection is compromised z The mode is changed from Manual to AED while the defibrillator is charged z is not pressed within 30 sec onds of the defibrillator being charged z is pressed z Check the pads are applied to the patient properly z If a shock is indicated deliver the sh...

Page 142: ...DWD DUG 1RW Q 6HUYLFH The Data Card is inserted while the Heart Start XLT is on None A Data Card must be inserted prior to turning the HeartStart XLT on for the current patient QFRPSDWLEOH DWD DUG A Data Card other than the M3510A is inserted Use only M3510A Data Cards 1R DWD DUG 3UHVHQW A Data Card is not in the HeartStart XLT Turn the HeartStart XLT off and insert a Data Card prior to the first ...

Page 143: ...call for service The display is blank except for SYSTEM FAILURE CYCLE POWER An internal error occurred If this occurs during actual use z Substitute another defib if possible Remove this unit from clinical use and call for service z If no other defib is available turn power off then on If unit turns on normally use for this one incident After this incident remove from clini cal use and call for se...

Page 144: ...ning properly z The battery is low z There is a system failure z Change the battery z Take the device out of use and call for service The displayed time is incorrect The time was not correctly set in the con figuration Set the time in the General Settings menu 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 Se...

Page 145: ...e 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 Latin America Canada Medical Response Center Tel 800 548 8833 Medical Response Center Tel 954 835 2600 Medical Response Center Tel 800 323 2280 ...

Page 146: ...ed Kingdom Tel 31 20 547 2555 Fax 31 29 547 2949 Tel 00 44 7002 432584 Belgium for Dutch Belgium for French Tel 32 2 525 7102 Fax 32 2 525 71 91 Tel 32 2 525 710 3 Fax 32 2 525 71 91 Spain Poland Tel 34 902 30 40 50 Fax 34 91 326 39 66 Tel 48 22 5710499 Austria Finland Tel 43 1 60101 820 Tel 09 6158 0400 Switzerland Russia Tel 0800 80 10 23 Tel 7 095 933 0339 Fax 7 095 933 0338 ...

Page 147: ...pecifications Safety This section provides z Specifications for the HeartStart XLT z Symbol definitions for symbols appearing on the HeartStart XLT z A clinical performance summary z Safety related information and z Electromagnetic compatibility information ...

Page 148: ...s Manual Mode Sync Pacer Pacer Start Stop Pacer Rate Pacer Current Pacer Mode Display Contrast ECG Gain Vol ume Print Strip Print Summary Annotated Mark Event Indicators LCD display for ECG waveform and text prompts Audio alerts QRS Beeper Charging Tone Charge Done Tone Manual Mode LED Sync LED Pacer LED Printer Armed Indicators Charge done tone and available energy indicated on display Energy Sel...

Page 149: ...ad Select SpO2 HR Alarms Display Contrast ECG Gain Volume Print Strip Print Summary Annotated Mark Event Manual Mode Entry Indicators LCD Display for ECG waveform and text prompts Audio Alerts Voice Prompts QRS Beeper Charging Tone Charge Done Tone Printer Armed Indicators Charge Done Tone Available Energy indicated on display Voice Message Patient Analysis Per protocol evaluates patient ECG and s...

Page 150: ...lay 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 Defibrillation Patient Cable Length 7 ft 2 13 m ECG Cable Length 10 ft 3 05 m Common Mode Rejection Greater than 90 dB measured per AAMI stan dards for cardiac monitors EC 13 ECG Size 2 5 5 10 20 40 m...

Page 151: ... filter setting the text Sync if Sync has been enabled and the Pacer Settings consisting of the Pacer Mode Rate and Current if currently pac ing the patient Prints every 12 seconds 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 an Analysis in AED Mode No Shock Advised Shock Advised or Cannot Analyze Ch...

Page 152: ...ry Dimensions 2 4 H x 0 94 W x 7 2 D 61 7 mm H x 23 9 mm W x 182 mm D Weight 1 4 lb 0 65 kg Charge Time Approximately 14 5 hours to 100 indicated by LED on power module Approximately 2 5 hours to 90 indicated by LED on power module Capacity 2 7 hours ECG monitoring or 50 full energy discharges or 2 1 hours ECG monitoring while pacing with a new fully charged battery and temperature above 20oC Batt...

Page 153: ... Demand or Fixed Rate Refractory Period 340 msec 40 to 80 ppm 240 msec 90 to 180 ppm SpO2 Pulse Oximetry Accuracy with M1191A sensor 1 standard deviation 70 to 100 2 5 M1192A sensor 1 standard deviation 70 to 100 2 5 M1194A sensor 1 standard deviation 70 to 100 4 0 NELLCOR sensors 1 standard deviation 80 to 100 3 0 Resolution 1 SpO2 Alarm Limits Three preset low alarm limits 90 85 and 80 default i...

Page 154: ...nephrine Atropine Lidocaine or Other The Print Summary key on the front panel is used to print the internal Event Summary Data Card Event Summary One Data Card can store approximately 2 hours of continuous ECG waveforms and events General Dimensions 4 05 H x 11 25 W x 13 65 D 103 mm x 286 mm x 347 mm Weight Standard Configuration weighs approximately 10 lbs 4 55 kg including battery full roll of p...

Page 155: ... paper may jam if paper is wet z Thermal printer may be damaged if wet paper is allowed to dry while in contact with printer elements 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 drops Vibration Mil Std 810E 514 4 Category 6 Heli...

Page 156: ...s 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 Definition On Off Shock hazard Attention See operating instructions in user s guide Power module input Input ...

Page 157: ... 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 arteries Alarms are active Alarms are inactive Recyclable material Must be recycled or disposed of properly Unlock IPX4 Ingress of fluids classification protected against splashing water Table 13...

Page 158: ...g table lists the symbols that appear on the HeartStart XLT ship ping carton Table 13 2 Shipping Carton Symbols Symbol Definition Atmospheric pressure range Temperature range Relative humidity range Recyclable paper product Fragile Right side up Do not get wet ...

Page 159: ...ymbol Definitions M3500B HeartStart XLT Defibrillator Monitor 13 13 13 Shelf life Long term storage conditions Short term transport storage Table 13 2 Shipping Carton Symbols Continued Symbol Definition ...

Page 160: ...hasic 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 termination of VF for at least five seconds without regard to hemodynamic factors Results Randomization to the use of monophasic or SMART Biphasic automa...

Page 161: ... SMART Biphasic waveform were more likely to have good cerebral performance CPC cerebral performance cate gory p 0 04 Table 13 3 Clinical Summary Defibrillation Biphasic Patients Number Percent Monophasic Patients Number Percent P Value chi square Defibrillation Efficacy Single shock only 2 shocks 3 shocks 52 54 96 52 54 96 53 54 98 36 61 59 39 61 64 42 61 69 0 0001 0 0001 0 0001 Patients Defibril...

Page 162: ...the initial defibrillator and a fifth cross over shock 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 3...

Page 163: ...y 217J compared to 548J for the monophasic waveform Outcomes are summarized in Table 13 4 Table 13 4 Clinical Summary Cardioversion Biphasic Patients Number Percent Monophasic Patients Number Percent P Value Cumulative Cardioversion Efficacy Single shock only 2 shocks 3 shocks 4 shocks 58 96 60 74 96 77 86 96 90 87 96 91 24 107 22 47 107 44 57 107 53 91 107 85 0 0001 0 0001 0 0001 29 Skin burn Non...

Page 164: ...T 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 population ...

Page 165: ... of therapy Delay in delivering a shock may result in a rhythm that was analyzed as shockable converting spontane ously to non shockable and could result in inappropriate delivery of a shock WARNING Use only the multifunction defib electrode pads battery and accessories listed in Supplies Accessories on page 11 18 Substitutions may cause the HeartStart XLT to function improperly WARNING Use multif...

Page 166: ... skin Do not use dried out pads do not open pads package 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 Do not operate the HeartStart XLT in standing water When using the HeartStart XLT in wet environments make sure the Data Card door is securely shut WARNING Do not immerse or pour fluids o...

Page 167: ...ations can result in device or accessory malfunction WARNING Avoid exposing the display to direct sunlight on a hot day Overheating can occur and cause the display to black out making the HeartStart XLT temporarily unusable WARNING Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation WARNING Electric shock hazards exist inter...

Page 168: ...te interference WARNING Radio frequency RF interference from nearby transmitting devices may degrade performance of the HeartStart XLT defibrillator monitor Electromagnetic compati bility with surrounding devices should be assessed prior to using the defibrillator Reducing Electromagnetic Interference The M3500B defibrillator monitor and M3517A AC Charger are susceptible to interference from other...

Page 169: ...must specify immunity levels for their systems It is recognized that the Heart Start XLT defibrillator monitor is designed to receive and amplify low level signals in the same bandwidth as the interference Immunity is defined in the standard as the ability of a system to perform with out degradation in the presence of an electromagnetic disturbance Degrada tion in ECG quality is a qualitative asse...

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Page 171: ... 1 3 troubleshooting 3 18 Alarms heart rate 4 6 8 2 interruption of power 9 5 SpO2 monitoring 5 8 symbols 13 11 Analysis 3 8 AED Mode 3 8 re analysis 3 11 settings 3 4 Artifact Detected message 3 18 Asynchronous defibrillation 1 4 Asystole 1 5 pacing 1 5 Attach Pads message 12 5 Audiovisual controls 2 2 2 3 Automatic Re analysis 3 11 setting 3 4 10 11 B Batteries 1 2 2 9 charging 11 8 checking 11 ...

Page 172: ...Analysis 3 4 ECG filters 10 14 heart rate alarm 4 6 list of configurable items 10 8 modifying 10 15 password 10 13 printing settings 10 16 Rhythm Monitoring 3 4 3 14 saving and loading from Data Card 10 16 Configuration Lost message 12 2 Continued Use feature 9 5 Controls 2 2 CPR 3 12 D Data Card 2 11 downloading and erasing information 9 1 inserting and removing 2 12 ordering 11 20 saving and loa...

Page 173: ...ions 13 4 synchronized cardioversion 7 1 troubleshooting 4 7 Electrode pads See Pads Electrodes applying 4 2 checking 11 3 cleaning 11 14 ordering 11 20 placing 3 5 4 3 settings 10 10 Electromagnetic compatibility EMC 13 22 Environmental specifications 13 9 safety precautions 13 20 13 21 Erratic spiking 1 4 European 10 11 European Protocol 10 11 Event Review 2 11 Event Summary 9 1 events recorded ...

Page 174: ...10 12 selecting 4 5 7 1 8 3 troubleshooting 4 7 8 7 12 2 Leads Off message 4 7 8 7 12 2 Loading printer paper 11 10 settings from Data Card 10 16 Low Battery message 12 2 M Maintenance batteries 11 8 carrying case 11 15 cleaning 11 12 operational checks 11 2 supplies and accessories 11 18 Manual Mode 6 1 controls 2 2 2 4 current charge 6 4 defibrillation process 6 4 delivering shock 6 5 display 2 ...

Page 175: ...1 defibrillation 8 6 defined 1 5 8 1 demand v fixed mode 8 2 8 4 8 6 ECG monitoring 8 2 events recorded 9 4 function buttons 2 5 indications for use 1 5 messages 12 3 preparation 8 3 procedure 8 4 selecting leads 8 3 8 7 specifications 13 7 system messages 8 7 troubleshooting 8 5 8 7 12 6 Pads applying 3 6 13 19 13 20 cleaning 11 14 ECG monitoring 4 1 4 7 events recorded 9 3 safety precautions 13 ...

Page 176: ...fety symbols 13 10 sensors 5 5 5 9 SpO2 alarm 5 8 SpO2 monitoring 5 1 Print strip contents 13 5 controls 2 2 events recorded 9 4 settings 10 9 See also Event Summary Printer checking 11 6 cleaning printhead 11 13 specifications 13 5 Printer paper loading 11 10 ordering 11 18 specifications 13 9 troubleshooting 12 5 Printing controls 2 3 Event Summary 9 6 events automatically 9 8 settings 10 16 Pul...

Page 177: ...illator 13 2 display 13 5 ECG monitoring 13 4 environmental 13 9 Event Summary 13 8 HeartStart XLT 13 8 Manual Mode 13 2 pacing 13 7 power supply 13 2 printer 13 5 SpO2 monitoring 13 7 SpO2 alarm 5 8 specifications 13 7 SpO2 cable cleaning 11 14 connecting 10 5 ordering 11 20 SpO2 Light Interf message 5 10 SpO2 monitoring 5 1 cable connection 5 6 controls 2 3 defined 1 6 5 1 discontinuing 5 9 even...

Page 178: ...ist of 12 2 System tests See Maintenance T Telephone assistance 12 9 Thermal Array Printer See Printer Time 10 9 12 8 Training materials 1 7 Training required 1 3 13 19 Troubleshooting 12 1 AED Mode 3 18 Data Card 12 6 display 12 7 ECG monitoring 4 7 pacing 8 5 8 7 12 3 12 6 SpO2 monitoring 5 10 12 4 time and date 12 8 U User messages 2 7 V Ventricular fibrillation manual defibrillation 1 4 pacing...

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Page 180: ...M3500 91900 Edition 3 Copyright 2002 Philips Electronics North America Corporation Printed in the U S A October 2002 ...