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M4735A Heartstream XL Defibrillator/Monitor

13-1

13 Specifications & Safety

This section provides:

Specifications for the Heartstream XL

Symbol definitions for symbols appearing on the Heartstream XL

Clinical Performance Summary data

Safety related information

Electromagnetic compatibility information

Содержание M4735A

Страница 1: ... JLOHQW 0 HDUWVWUHDP HILEULOODWRU 0RQLWRU 8VHU V XLGH ...

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Страница 3: ...User s Guide 0 HDUWVWUHDP HILEULOODWRU 0RQLWRU ...

Страница 4: ...ART Biphasic is a registered trademark of Agilent Technologies Use of supplies or accessories other than those recommended by Agilent Technologies may compromise product performance THIS PRODUCT IS NOT INTENDED FOR HOME USE IN THE U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN Medical Device Directive The M4735A Heartstream XL Defibril lator Monitor complies with t...

Страница 5: ...or loss of life 87 21 Caution statements describe conditions or actions that can result in damage to the equipment or loss of data 127 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 ...

Страница 6: ...vi ...

Страница 7: ...ndications for Manual Defibrillation Therapy 1 6 Contraindications for Manual Defibrillation Therapy 1 6 Precautions for Manual Defibrillation Therapy 1 6 Noninvasive Pacing Therapy Optional 1 7 Indications 1 7 Contraindications 1 7 SpO2 Monitoring Optional 1 7 Indications 1 8 Contraindications 1 8 Safety Considerations 1 8 Documentation and Training 1 9 ...

Страница 8: ...attery Warning 2 12 Using a Data Card Optional 2 13 Inserting a Data Card 2 14 Removing a Data Card 2 15 Defibrillating in AED Mode Overview 3 3 Defibrillation using the default configuration 3 4 Defibrillation with a modified configuration 3 5 Preparation 3 6 Defibrillating 3 7 Automatic Re analysis On 3 13 Automatic Re analysis Off 3 13 Pausing for CPR 3 14 Monitoring Rhythm 3 16 ERC Protocol 3 ...

Страница 9: ...arm 4 10 Adjusting the ECG Size 4 10 Adjusting the ECG Volume 4 10 Troubleshooting 4 11 Monitoring SpO2 Introduction 5 2 Understanding Pulse Oximetry 5 3 Selecting a Sensor 5 4 Reusable Sensors 5 5 Disposable Sensors 5 5 Applying the Sensor 5 6 Connecting the Sensor Cable 5 7 Monitoring 5 8 Setting Alarms 5 9 Responding to an Alarm 5 9 Discontinuing SpO2 Monitoring 5 10 Caring for Sensors 5 10 Tro...

Страница 10: ...e Pads 6 5 Defibrillation Procedure 6 6 1 Select Energy 6 6 2 Charge 6 7 3 Shock 6 8 Entering AED Mode 6 9 Performing Synchronized Cardioversion Using Multifunction Defib Electrode Pads 7 2 Using 3 or 5 wire ECG Leads 7 3 Using External Paddles 7 4 Delivering a Synchronized Shock 7 5 Using External ECG Monitors 7 7 Delivering Additional Synchronized Shocks 7 7 Disabling Sync Mode 7 7 ...

Страница 11: ...ing Pacing 8 3 Preparing for Pacing 8 3 Performing Pacing 8 5 Changing Pacing Modes 8 8 Defibrillating During Pacing 8 8 Troubleshooting 8 9 Storing Retrieving Printing Overview 9 2 Marking Events 9 3 Events Recorded 9 4 Creating a Patient Record 9 6 Printing the Internal Event Summary 9 7 Printing Events 9 9 ...

Страница 12: ...0 3 SpO2 Patient Cable 10 5 ECG Patient Cable 10 6 Configuring the Heartstream XL 10 7 Accessing the Configuration Menu 10 7 Configurable Parameters 10 8 Modifying the Configuration 10 13 Returning to the Default Configuration 10 13 Saving Settings to a Data Card 10 14 Loading Settings from a Data Card 10 14 Printing Settings 10 14 ...

Страница 13: ... 11 6 Battery Maintenance 11 7 Recharging Batteries 11 8 Battery Capacity 11 9 Battery Life Expectancy 11 9 Storing Batteries 11 9 Discarding Batteries 11 9 Loading Printer Paper 11 10 Cleaning Instructions 11 12 Cleaning the Heartstream XL 11 12 Cleaning the Printer Printhead 11 12 Cleaning Paddles Pads Electrodes Cables 11 13 Supplies Accessories 11 14 Disposing of the Heartstream XL 11 17 ...

Страница 14: ...ibrillator 13 2 ECG Monitoring 13 5 13 7 Display 13 8 Battery 13 8 Thermal Array Printer 13 9 Noninvasive Pacing 13 10 SpO2 Pulse Oximetry 13 11 Event Storage 13 11 Environmental 13 12 Symbol Definitions 13 14 Clinical Performance Summary 13 19 Methods 13 19 Results 13 19 Conclusion 13 20 Safety Considerations 13 21 Electromagnetic Compatibility 13 25 Reducing Electromagnetic Interference 13 26 Re...

Страница 15: ...gned to meet your resuscitation and monitoring needs This guide provides instructions for safe and proper operation set up configuration and care of your M4735A Heartstream XL Defibrillator Monitor In this chapter you ll find general information that you should become famil iar with before using the defibrillator monitor ...

Страница 16: ...forced by messages that appear on the display In Manual Mode the M4735A Heartstream XL Defibrillator Monitor turns control of the defibrillation process over to you You analyze the patient s ECG and select the energy setting for defibrillation if necessary Manual Mode also allows you to perform synchronized cardioversion and offers noninvasive pacing optional Defibrillation is performed through at...

Страница 17: ...s vary depending on how the M4735A Heartstream XL Defibrillator Monitor is configured Be sure to familiarize yourself with your configuration before using the M4735A Heartstream XL Defibrillator Monitor see Configuring the Heartstream XL on page 10 7 The M4735A Heartstream XL Defibrillator Monitor is powered by AC power and a rechargable sealed lead acid SLA battery which allows the defibrilla tor...

Страница 18: ...trained in advanced cardiac life support Defibrillation Therapy Defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias The M4735A Heartstream XL Defibrillator Monitor provides this therapy through the application of a brief biphasic pulse of electricity to the cardiac muscle This electrical energy is transferred through attached paddles or dis...

Страница 19: ...hing l Palpable pulse Precautions for AED Therapy The AED algorithm is not designed to handle erratic spiking problems caused by a properly or improperly functioning pacemaker In patients with cardiac pacemakers the M4735A Heartstream XL Defibrillator Monitor may have reduced sensitivity and not detect all shockable rhythms NOTE The AED algorithm is not intended for children under 8 years of age F...

Страница 20: ...fibrillator Moni tor incorporates some user selectable lower energy levels that were not used in the clinical trials There are currently no clinical studies related to the use of the SMART Biphasic waveform in pediatric applications or in direct defibrillation of the heart during open chest surgery Contraindications for Manual Defibrillation Therapy Asynchronous defibrillation therapy is contraind...

Страница 21: ...ing is one method of treating patients with symptomatic bradycardia It can also be helpful in patients with asystole if performed early Contraindications Noninvasive pacing is contraindicated in the treatment of ventricular fibrilla tion Noninvasive pacing in the presence of severe hypothermia may be con traindicated SpO2 Monitoring Optional A pulse oximeter is a noninvasive device that indicates ...

Страница 22: ... may result from the use of pulse oximeters in the pres ence of certain circumstances such as hemoglobin saturated with compounds other than oxygen such as carbon monoxide hypothermia hypovolemia patient movement nail polish and excessive ambient light Safety Considerations General warnings and cautions that apply to use of the M4735A Heartstream XL Defibrillator Monitor are provided in Chapter 13...

Страница 23: ...ce Card and l About Sealed Lead Acid Batteries an application note on battery maintenance Training tools available for use with the M4735A Heartstream XL include l Using the M4735A Heartstream XL Defibrillator Monitor a work book l Heartstream XL User Training CD ROM optional For additional online documentation and training please visit our website www agilent com healthcare heart Available online...

Страница 24: ...Documentation and Training 1 10 Introduction ...

Страница 25: ...splay The Heartstream XL ships complete with paddles and the cables necessary for easy operation This chapter will help you get your Heartstream XL up and running by following a few easy steps including l Connecting to AC Power l Inserting the battery l Inserting the optional Data Card if desired 127 To connect cables to the Heartstream XL refer to Setting Up and Configur ing the Heartstream XL in...

Страница 26: ...onality is also provided Basic Orientation Review the figure for a general layout of the controls where the patient cables connect and where to insert the battery and Data Card Figure 2 1 Basic Orientation Front AC Power Batt Charge Print Strip Event Summary ECG Size Pacer Rate Mode Start Stop Output Data Card Battery Volume Mark Patient Cable Connector Energy Select Knob Speaker ...

Страница 27: ... Monitor 2 3 2 Figure 2 2 Heartstream XL Back 127 If your Heartstream XL does not have the SpO2 or Pacing option disregard these controls and the related information described in this section AC Power ECG Input Jack SpO2 Connector ECG Connector Printer ...

Страница 28: ...beeper off it must be changed from the configu ration menu Monitoring Controls Monitoring controls consist of a set of softkeys that perform monitoring functionality These functions are displayed in the softkey label below each button Monitoring softkeys also control heart rate and SpO2 alarms and selection of the ECG source to monitor Adjusts the volume of voice prompts and the QRS beeper Adjusts...

Страница 29: ...o stop printing Prints the Event Summary See Storing Retrieving Printing for more information Printing may be stopped by pressing the or button Inserts a time stamped annotation in the Event Summary May be configured to print an annotated ECG strip when pressed Manual Mode Controls Manual Mode controls provide access to manual defibrillation and synchronized cardioversion and optional pacing funct...

Страница 30: ...at enables synchronized cardioversion when first pressed in Manual Mode disables synchronized cardioversion when pressed again Activates the pacing function buttons as indicated by the green LED allowing you to use the buttons below to define pacing rate mode and current output Also turns off the Pacer function when pressed a second time Adjusts the pacing rate Starts pacing Delivers pacer pulses ...

Страница 31: ...e Heartstream XL was turned on provided patient contact was established If the Heartstream XL is powered on after being off for less than two minutes the Incident Timer resumes where it left off If power is off for more than two minutes the Inci dent Timer resets to zero If an Event Summary is printed the inci dent timer will be set to zero the next time the unit is turned on HR ALARM LEAD SELECT ...

Страница 32: ...vide status information or l offer recommendations A System Message remains on the display until the condition that generated the message no longer exists A Momentary Message is temporary and appears on the display for a minimum of 3 seconds For a list of system and momentary messages see Chapter 12 ANALYZE PAUSE 00 15 02 Shocks 0 User Message SHOCK 150J ECG Current Charge Shocks Delivered Inciden...

Страница 33: ...It is recommended that a second charged battery be available at all times 127 The Heartstream XL will take longer to charge to the desired energy level when using only AC Power and without the battery HR ALARM LEAD SELECT SYNC ON OFF CHARGE SHOCK Shocks 0 00 15 02 Sync 114J 132 86 System Message Momentary Message Lead II SpO2 value SpO2 alarm Pleth Bar Pulse Rate Heart Rate ECG Sync Display Curren...

Страница 34: ...wer 2 10 Getting Started Inserting the Battery To insert the battery slide it into the battery receptacle as shown in Figure 2 7 Then push the battery in until you hear an audible click Figure 2 7 Inserting the Battery ...

Страница 35: ...A Heartstream Defibrillator Monitor 2 11 2 Removing the Battery To remove the battery from the Heartstream XL press the black battery eject button and pull the battery out as shown in Figure 2 8 Figure 2 8 Removing the Battery ...

Страница 36: ...is off for less than 2 minutes while you change the battery the Heartstream XL assumes that you are continuing to treat the same patient provided patient contact was established and the Event Summary was not printed prior to turning the power off It continues to store data on the Data Card if being used and append events to the existing Event Summary Alarms set prior to the power loss remain activ...

Страница 37: ... recording stops a second Data Card may not be inserted for the current incident Data cards hold up to two hours of patient information Multiple incidents can be recorded on a single Data Card Each incident is assigned a unique incident number 127 Patient data from a Data Card may be downloaded to a CodeRunner Web data management system CodeRunner Web also allows you to erase patient data from a D...

Страница 38: ... compartment press the black button to the left of the card to eject the card see Figure 2 9 Then pull the card out 4 With the yellow label facing up and the pointing towards the Heart stream XL slide the Data Card into the compartment Be sure the card is seated securely within the compartment 5 Close the Data Card compartment door Make sure that you hear a click indicating that the door is latche...

Страница 39: ...tional M4735A Heartstream Defibrillator Monitor 2 15 2 Removing a Data Card To remove the Data Card press the black eject button see Figure 2 9 and pull the Data Card from the compartment Figure 2 10 Removing the Data Card ...

Страница 40: ...Using a Data Card Optional 2 16 Getting Started ...

Страница 41: ...es allow you to customize AED Mode to better follow a specific treatment algorithm and to meet the unique needs of your life saving team This chapter describes how to use the Heartstream XL to defibrillate in AED Mode It explains the prompts that guide you through the defibrillation pro cess and describes how prompts vary depending upon the disposition of the patient and the configuration of your ...

Страница 42: ...eathing l Pulseless Attach Pads Insert Data Card Optional Rotate Energy Select Knob to AED 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 ...

Страница 43: ... defibrillation process is shown in Figure 3 1 The process begins only after you have l assessed that the patient is unresponsive not breathing and pulseless l turned the Energy Select knob to AED On l prepared for defibrillation by attaching pads and cables and l inserting a Data Card if desired ...

Страница 44: ...tient cable and multifunction defib electrodes pads are properly connected If either connection is compro mised you are prompted to fix the problem Analysis begins automatically there is no need to press Once analysis is complete the Heartstream XL tells you 6KRFN GYLVHG or 1R 6KRFN GYLVHG If a shock is advised press After the first shock is delivered the Heartstream XL automatically begins analyz...

Страница 45: ... need 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 Heartstream XL is not analyzing defibrillating or paused The default setting is 2Q If you choose to set this parameter to 2II the Heartstream XL will not look for potentially shockable ...

Страница 46: ...en 1 Apply multifunction defib electrode pads to the patient as directed on the package Use the anterior apex electrode placement 2 Connect the pads to the pads patient cable as shown in Figure 3 3 3 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 LJXUH RQQHFWLQJ 3DGV WR WKH 3DWLHQW DEOH ...

Страница 47: ...1 Turn the Energy Select knob to AED On In this first step of the defibrillation process the Heartstream XL checks to see if the pads 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 RQQHFW 3DGV DEOH LJXUH RQQHFW 3DGV DEOH LVSOD Connect Pads Cable Shocks 0 00 00 02 ...

Страница 48: ...have adequate contact with the patient s skin Contact quality is measured by monitoring the electrical impedance between the two pads If the pads have not been applied or are not making proper contact with the patient you are prompted to SSO 3DGV and KHFN RQQHFWLRQV LJXUH SSO 3DGV LVSOD Apply Pads Shocks 0 00 00 03 ...

Страница 49: ...ovided Rhythm Monitoring is on The Heartstream XL prompts you to press if a potentially shockable rhythm is detected LJXUH 3UHVV 1 LVSOD 127 ECG Analysis is always performed through multifunction defib electrode pads Analysis can not be performed through monitoring electrodes 1 1 LEAD SELECT SpO2 ON OFF HR Press Analyze PAUSE Lead II ANALYZE Shocks 0 00 15 02 120 ...

Страница 50: ...you do not need to press ECG analysis begins automatically LJXUH QDO LQJ LVSOD 51 1 DQGOLQJ RU WUDQVSRUWLQJ WKH SDWLHQW GXULQJ DQDO VLV FDQ FDXVH LQFRUUHFW RU GHOD HG GLDJQRVLV 1 LEAD SELECT SpO2 ON OFF HR ALARM Analyzing Do Not Touch Patient STOP ANALYSIS Shocks 0 00 00 08 120 Pads ...

Страница 51: ...hythm is detected as indicated by the message 6KRFN GYLVHG analysis stops and the Heartstream XL automatically charges to 150J Charg ing is accompanied by an intermittent charge tone LJXUH KDUJLQJ LVSOD LEAD SELECT SpO2 ON OFF HR ALARM 120 Pads Charging to 150J 97J Shocks 0 00 00 10 ...

Страница 52: ...ly and loudly Stand Clear Then press to deliver a shock to the patient LJXUH 3UHVV 6 2 LVSOD 51 1 HILEULOODWLRQ FXUUHQW FDQ FDXVH RSHUDWRU RU E VWDQGHU LQMXU R QRW WRXFK WKH SDWLHQW RU HTXLSPHQW FRQQHFWHG WR WKH SDWLHQW GXULQJ GHILEULOODWLRQ The defibrillator automatically disarms within 30 seconds if you do not press 6 2 6 2 LEAD SELECT SpO2 ON OFF HR ALARM 120 Pads SHOCK Stand Clear Press SHOCK ...

Страница 53: ...ompted 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 Heartstream XL monitors the ECG for potentially shockable rhythms provided Rhythm Monitoring is on and prompts you to press if one is detected You can initiate ...

Страница 54: ... the Pause Timer indicates the elapsed time and the total duration of the pause state in seconds The Pause Timer is configurable to meet your local CPR protocol needs Rhythm SpO2 and heart rate monitoring alarms are suspended for the duration of the pause 127 If your Heartstream XL is configured to support the European Resuscitation Council Guidelines for Resuscitation refer to the ERC Protocol se...

Страница 55: ... the completion of the pause state the defibrillation process begins again If instructed press If you do not press the Heartstream XL begins monitoring the ECG rhythm provided Rhythm Monitoring is on You may initiate ECG analysis at any time by pressing LEAD SELECT SpO2 ON OFF HR ALARM 120 Pads Shocks 3 00 01 40 Paused RESUME ANALYZE Timer 21 60 Elapse Time Total Pause Duration 5 680 1 1 3 86 1 ...

Страница 56: ...J 5K WKP appears on the display to let you know this feature is active and remains on the display for the duration of the monitoring LJXUH 0RQLWRULQJ 5K WKP LVSOD 51 1 7KH UHFRPPHQGHG FRQILJXUDWLRQ VHWWLQJ IRU 5K WKP 0RQLWRULQJ LV 2Q I 5K WKP 0RQLWRULQJ LV RII RX DUH QRW DOHUWHG ZKHQ D SDWLHQW V UK WKP FKDQJHV IURP QRQ VKRFNDEOH WR VKRFNDEOH DV LQ UHILEULOODWLRQ RU DQ LQLWLDOO QRQVKRFNDEOH UK WKP ...

Страница 57: ...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 Sh...

Страница 58: ...he same with the exception of how the Pause state functions see Pausing for CPR on 3 14 As described you can enter a Pause state l at the completion of a shock series or l when no shock is advised In both cases the ERC protocol prompts you to Check Patient Then it prompts you as follows LJXUH KHFN 3DWLHQW 0HVVDJH 127 Using the ERC protocol you are not prompted or given time to check the patient s ...

Страница 59: ...e If you entered the Pause state l 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 l 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...

Страница 60: ...ot properly applied to the patient l Check that the pads are applied to the patient s bare chest as directed on the pads package Replace the pads if the prompt continues Pads Cable Off display or ApplyPads voice l The pads cable is not connected to the defibrillator l Check that the defibrillation pads connector is locked in place Artifact Detected Do Not Touch Patient l Patient motion interferes ...

Страница 61: ...unctions in Manual Mode l The key pressed does not func tion during analysis or charging l The key pressed does not func tion while in a pause state l Turn the Energy Select knob to Manual on prior to pressing the key l Wait for analysis or charging to complete prior to pressing the key l Press prior to pressing the key 7DEOH 7URXEOHVKRRWLQJ LQ 0RGH Prompt Possible Cause Corrective Action 5 680 ...

Страница 62: ...Troubleshooting 3 22 Defibrillating in AED Mode ...

Страница 63: ...trodes l selecting the correct lead l setting and disabling the heart rate HR alarm and l adjusting the ECG size For information on how to apply multifunction defib electrode pads follow the directions on the pads packaging 127 For information on storing and retrieving and printing patient information acquired while monitoring see Chapter 9 ...

Страница 64: ...is play ECG monitoring allows you to continue to monitor through the pads or to select a lead from an alternate ECG source 3 or 5 lead ECG monitoring also displays the heart rate HR and allows you to set HR alarms ECG monitoring is always active in Manual Mode In AED Mode ECG monitoring is only active if HDG 6HOHFW is configured to on the default is on Plug the 3 or 5 lead ECG patient cable into t...

Страница 65: ...cable 1 Align the keyed patient cable connector with the slot on the ECG receptacle as shown in Figure 4 1 2 Push the patient cable firmly into the ECG receptacle until the white por tion is no longer visible LJXUH 3DWLHQW DEOH RQQHFWRU 5HFHSWDFOH To disconnect the ECG patient cable gently pull the white patient cable connector out of the ECG receptacle ...

Страница 66: ...ve the electrode sites if necessary 3 Clean and abrade the skin at the electrode sites 4 Dry the skin at the electrode sites 5 Open a new package of M2202A Radio Translucent Monitoring Electrodes verify that the Use Before date has not passed 6 Apply the electrodes by peeling them one at a time from the protective backing and sticking them firmly to the patient s skin Press around the entire edge ...

Страница 67: ...ent cable The V C lead of the 5 lead cable can be placed in any of the precordial lead positions V1 C1 through V6 C6 shown in Figure 4 3 LJXUH LPE HDG OHFWURGH 3ODFHPHQW 7DEOH HDG HDG RUPDWLRQ 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 ...

Страница 68: ...aVL LA Vx V C 1 2 3 4 5 6 Lead 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 midclavicular line V5 C5 same level as V4 C4 on anterior axillary line V6 C6 same level as V4 C4 at left mid axillary line LA LL 2 RA LA 2 RA LL 2 RA LA LL 2 ...

Страница 69: ...essing until the desired lead is displayed LJXUH 0RQLWRULQJ LVSOD LQ 0RGH 127 To change to a different V Lead move the electrode rather than pressing the Lead Select softkey Lead Select Choices are If Configured for a Paddles Pads Lead I Lead II Lead III 3 lead ECG cable Paddles Pads Lead I Lead II Lead III aVR aVL aVF V lead 5 lead ECG cable 6 7 PAUSE HR ALARM LEAD SELECT ANALYZE Shocks 3 00 00 4...

Страница 70: ...s disconnected or the electrodes have poor patient con tact A dashed line on the display indicates that there is no ECG signal as shown in Figure 4 6 LJXUH HDGV 2II LVSOD LQ 0RGH HR ALARM LEAD SELECT DISARM Shocks 0 00 00 08 78 Pads Sync 87J SpO2 ON OFF SYNC ON OFF Leads Off HR ALARM LEAD SELECT Shocks 0 00 00 08 Lead II SpO2 ON OFF PAUSE ANALYZE __ __ __ __ __ __ __ __ __ __ ...

Страница 71: ...SDWLHQW FORVHO LI SDFHPDNHUV DUH XVHG The HR alarm may be configured to alert you when the heart rate is outside the specified limits Limit choices are listed in Table 4 5 HR Alarm Limit Choices 7DEOH 5 ODUP LPLW KRLFHV To 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 indicated that the HR alarm is set...

Страница 72: ...n con trol Preset ECG sizes are x 25 x 5 x1 0 x2 0 and x4 0 The default setting at power on is x1 0 Adjusting the ECG Volume To increase or decrease the volume of voice prompts and or alarms press or on the volume control 127 Note When using the Heartstream XL during a new event the ECG volume is set at the default volume level However if the unit is turned off and then back on within 2 minutes co...

Страница 73: ...nitoring cable is properly con nected 3DGV 2II message l The pads are not mak ing proper contact with the patient l Check that the pads are properly applied Poor ECG signal quality l The monitoring elec trodes are not making proper contact with the patient l The monitoring elec trodes are outdated or dried out l Radio frequency inter ference RFI is causing artifact l Check that the monitoring elec...

Страница 74: ...Check configurations QRS beeper inau dible or beeps do not occur with each QRS com plex l The QRS beeper is con figured to Off l The amplitude of the QRS complex is too small to detect l Check that the QRS beeper is configured to On l Adjust the volume l Adjust the size of the ECG Situation Cause Solution ...

Страница 75: ...rtstream XL Defibrillator Monitor 5 1 5 5 Monitoring SpO2 This chapter will provide information about l how pulse oximetry works l selecting and applying the correct sensor l monitoring SpO2 l discontinuing SpO2 ...

Страница 76: ...xplains how pulse oximetry works and describes how to use the Heartstream XL to moni tor SpO2 SpO2 monitoring is always available both in AED and Manual Mode if the option is purchased For information on printing storing and retrieving patient information acquired while monitoring see Chapter 9 51 1 R QRW UHO VROHO RQ 6S2 UHDGLQJV DVVHVV WKH SDWLHQW DW DOO WLPHV 6S2 UHDGLQJV PD EH LQDFFXUDWH LQ WK...

Страница 77: ... pulsation The amount of light getting through reflects the blood flow in the arterioles This measurement of light absorption during pulsation is translated into an oxygen saturation percentage and an SpO2 value is displayed For accurate SpO2 measurements the following conditions must apply l The patient must have perfusion in that extremity l The light emitter and the photodetector must be direct...

Страница 78: ...you must connect the M1943A Nellcor Adaptor patient cable to the Heartstream XL See Connecting the SpO2 Patient Cable on page 10 5 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 ...

Страница 79: ...ct a sensor appropriate for the patient s weight l Select a sensor site with adequate perfusion l Avoid application 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 disca...

Страница 80: ...sor cable and connection l Avoid placing the sensor in an environment with bright lights if nec essary cover the sensor with opaque material l Avoid placing the sensor on any extremity with an arterial catheter blood pressure cuff or intravascular venous infusion line 51 1 DLOXUH WR DSSO WKH VHQVRU SURSHUO PD UHGXFH WKH DFFXUDF RI WKH 6S2 PHDVXU PHQW 51 1 QVSHFW WKH VHQVRU DSSOLFDWLRQ VLWH DW OHDV...

Страница 81: ...5 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 LJXUH RQQHFWLQJ WKH 6HQVRU DEOH ...

Страница 82: ...s the patient s oxygen saturation changes the SpO2 value is updated continuously LJXUH 6S2 0RQLWRULQJ LVSOD LQ 0RGH 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 influenced...

Страница 83: ...review the alarm limit press 51 1 6S2 DODUPV DUH WHPSRUDULO VXVSHQGHG LQ 0RGH GXULQJ DQDO VLV RU ZKHQ LV SUHVVHG IRU WKH GXUDWLRQ RI WKH SDXVHG SHULRG 6S2 DODUPV DUH DOVR VXV SHQGHG ZKLOH FKDUJLQJ IRU GHILEULOODWLRQ DQG GHOLYHULQJ D VKRFN 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 LJXUH 6S2 OD...

Страница 84: ...ensors 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 51 1 R QRW XVH D GDPDJHG VHQVRU RU RQH ZLWK H SRVHG HOHFWULFDO FLUFXLWV 6S2 21 2 6S2 50 PAUSE HR ALARM LEAD SELECT ...

Страница 85: ...e sensor site has a pulse l Relocate the sensor to a site with improved circulation l Try another sensor type l Make sure nail polish is not present 6S2 RZ 6LJQDO l SpO2 signal is too low to give an accurate read ing l Check the sensor is applied properly l Try another sensor type 6S2 1RLV 6LJQDO l Excessive patient move ment electrical interfer ence RF interference or optical interference l Minim...

Страница 86: ... dam aged l Cover sensor with an opaque material l Check sensor for dam age try another sen sor 6S2 DEOH 2II l The SpO2 cable is not connected to the device l Attach the cable to the Heartstream XL 6S2 6HQVRU DLO l The transducer is bro ken l Apply a new trans ducer 7DEOH 7URXEOHVKRRWLQJ ZKHQ 0RQLWRULQJ 6S2 Problem or Message Possible Cause Corrective Action ...

Страница 87: ...s However system and momentary messages provide relevant information throughout the process It is important to be attentive to these messages This chapter describes how to defibrillate using Manual Mode For Manual Mode features such as synchronized cardioversion and pacing see Chapter 7 Performing Synchronized Cardioversion and Chapter 8 Pacing Optional For information on storing retrieving and pr...

Страница 88: ... synchronized cardioversion and self selected energy levels LJXUH 0DQXDO 0RGH LVSOD Enabling Manual Mode To enable Manual Mode turn the Energy Select knob to Manual On Pulse HR ALARM LEAD SELECT SpO2 ON OFF 6KRFNV SYNC ON OFF Sync CHARGE SHOCK Sp02 ALARM HDUW 5DWH 6KRFN 6RIWNH 6S 9DOXH 3OHWK DU 3XOVH 5DWH DLQ DYHIRUP 6KRFN RXQWHU ODSVHG 7LPH Pads XUUHQW HDG KDUJH LVDUP 6RIWNH HDUW 5DWH ODUP 6 QF 6...

Страница 89: ... always performed through paddles or pads However during defibrillation you may choose to monitor leads acquired through an alternate ECG source 3 or 5 lead monitoring electrodes Using External Paddles In preparation for defibrillation in Manual Mode using external paddles per form the following steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 2 Turn the Ener...

Страница 90: ...ill be registered in the Event Summary and may damage paddles 5 Apply paddles to patient s chest using the anterior apex placement 127 To optimize patient contact adjust paddle pressure and placement Once proper contact has been made the patient contact indicator PCI located on the Sternum paddle will show a green LED See Figure 6 2 LJXUH 3DWLHQW RQWDFW QGLFDWRU RQ 6WHUQXP 3DGGOH 3DWLHQW RQWDFW QG...

Страница 91: ...steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 2 Turn the Energy Select knob to Manual On 3 If you are using multifunction electrode pads apply as directed on the package Use either the anterior apex or anterior posterior electrode placement as appropriate 4 Connect the pads to the pads patient cable as shown in Figure 6 3 LJXUH RQQHFWLQJ 3DGV WR WKH 3DWLHQ...

Страница 92: ...to defibrillate in Manual Mode perform the follow ing steps 1 Select Energy To select the energy setting move the Energy Select knob to the desired energy level as shown in Figure 6 4 Energy choices range from 2 to 200 joules with the suggested level for adults being 150 joules LJXUH QHUJ 6HOHFW QRE 0DQXDO 2Q 2Q ...

Страница 93: ... is reached at which point you ll hear a continuous charge tone LJXUH KDUJLQJ LVSOD You may increase or decrease the selected energy level after pressing the button Simply move the Energy Select knob to desired energy level as before The defibrillator charges to the selected energy level automatically 51 1 DLW XQWLO WKH FXUUHQW FKDUJH UHDFKHV WKH VHOHFWHG HQHUJ OHYHO EHIRUH UHDGMXVWLQJ WKH VHOHFWH...

Страница 94: ...e shock buttons located on the paddle s until the shock is delivered LJXUH 0DQXDO 0RGH 6KRFN LVSOD To disarm the defibrillator press If or the shock buttons are not pressed within 30 seconds the defibrillator disarms automatically If additional shocks are indicated repeat the defibrillation process 51 1 HILEULOODWLRQ FXUUHQW FDQ FDXVH RSHUDWRU RU E VWDQGHU LQMXU R QRW WRXFK WKH SDWLHQW RU HTXLSPHQ...

Страница 95: ...ing AED Mode To enter AED Mode from Manual Mode simply turn the Energy Select knob from Manual On to AED On ECG and or SpO2 monitoring are defaulted enabled in AED Mode If these settings are still active the alarms set in Manual Mode remain active when you switch to AED Mode ...

Страница 96: ...Entering AED Mode 6 10 Defibrillating in Manual Mode ...

Страница 97: ...es or l external paddles attached to the M4735A Heartstream XL You may also use an external Agilent or Hewlett Packard ECG monitor while performing synchronized cardioversion When selecting a lead choose the best lead that displays a large QRS com plex The synchronized shock is delivered through the mulifunction defib electrode pads or external paddles regardless of the lead being monitored This c...

Страница 98: ...y monitoring electrodes if desired See Applying Monitoring Elec trodes on page 4 4 3 Turn Energy Select knob to Manual On 4 Apply multifunction defib electrode pads to the patient as directed on the package Use either the anterior apex or anterior posterior placement as appropriate 5 Connect the pads to the patient cable See Figure 6 3 6 Press the Sync On Off button to turn synchronized cardiovers...

Страница 99: ...g steps 1 If needed insert a Data Card as described in Using a Data Card Optional on 2 13 2 Apply monitoring electrodes if desired See Applying Monitoring Elec trodes on page 4 4 3 Turn Energy Select knob to Manual On 4 Connect the ECG cable to the Heartstream XL See Figure 6 3 5 Press Sync On 6 Use to select the best lead that displays a large QRS complex See Selecting the Lead on page 4 7 6 7 ...

Страница 100: ... Manual On 4 Remove paddles from pockets by simultaneously pulling out and up Apply conductive material 127 Do not apply conductive matter by rubbing paddles together Improper usage will result in a Paddles On event that will be registered in the Event Sum mary and may cause paddle damage 5 Apply paddles 6 Press Sync On 7 Use to select the best lead that displays a large QRS complex See Selecting ...

Страница 101: ...ode The message 6 1 appears on the display 2 Use the gain control to adjust the ECG size so that the marker dot appears only with each R wave 3 Select the desired energy level 4 Press or the yellow charge button located on the Apex paddle Wait until the current charge has reached the energy level selected and you hear a continuous charge done tone LJXUH KDUJLQJ LQ 6 QF 0RGH 5 HR ALARM LEAD SELECT ...

Страница 102: ...oceeding 5 Make sure no one is touching the patient or anything connected to the patient Call out clearly and loudly Stand Clear Then press If you are using external paddles deliver the shock by pressing and simulta neously holding the orange keys on both external paddles 127 It is important to continue to hold or the buttons down until the shock is delivered The defibrillator shocks with the next...

Страница 103: ...the cable into the external monitor ECG Output jack and plug the input end of the cable into the ECG Input plug on the Heartstream XL Delivering Additional Synchronized Shocks If additional synchronized shocks are indicated make sure Sync Mode is still enabled and repeat steps 2 5 In its default configuration the Heartstream XL remains in Sync Mode after a shock is delivered as indicated by the me...

Страница 104: ...Disabling Sync Mode 7 8 Performing Synchronized Cardioversion ...

Страница 105: ... is a Manual Mode function that is used to deliver paced pulses to the heart Paced pulses are delivered through multi function defib electrode pads that are applied to the patient s bare chest This chapter explains the pacing option available with the Heartstream XL and describes how to perform pacing ...

Страница 106: ...andle of the Heartstream XL LJXUH 3DFLQJ RQWUROV 0DQXDO 0RGH RQO Demand Mode Versus Fixed Mode The Heartstream XL can deliver paced pulses in either demand or fixed mode In demand mode the pacer only delivers paced pulses when the patient s heart rate is lower than the selected pacing rate In fixed mode the pacer delivers paced pulses at the selected rate ...

Страница 107: ...RGH SDFLQJ ZKHQ PRWLRQ DUWLIDFW RU RWKHU QRLVH PDNHV 5 ZDYH GHWHFWLRQ XQUHOLDEOH 51 1 HDUW UDWH PHWHUV DQG DODUPV IXQFWLRQ GXULQJ SDFLQJ EXW WKH FDQ EH XQUHOLDEOH 2EVHUYH WKH SDWLHQW FORVHO ZKLOH SDFLQJ R QRW UHO RQ KHDUW UDWH DODUPV RU WKH LQGLFDWHG KHDUW UDWH DV D PHDVXUH RI WKH SDWLHQW V SHUIXVLRQ VWDWXV Preparing for Pacing To prepare for pacing perform the following steps 1 Apply multifunctio...

Страница 108: ...able R wave See Selecting the Lead on page 4 7 If you do not select a lead i e pads is the selected ECG source HDG is automatically selected when the pacing function is turned on 127 If pacing for long periods of time new monitoring electrodes and multifunc tion defib electrode pads may need to be applied periodically Refer to the manufacturer s documentation for recommendations regarding frequenc...

Страница 109: ...e indicates that the pacing function is on but paced pulses are not being delivered The pacer turns on in the mode last used 2 Verify that the dot markers appears near the middle of the QRS complexes of 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 Pacer Pacer HR ALARM LEAD SELECT CHARGE Shocks 0...

Страница 110: ...desired number of paced pulses per minute ppm Press up or down on to increase or decrease the number of paced pulses per minute 5 To start pacing press The message 3DFLQJ indicates that paced pulses are being delivered in the selected mode at the rate and output level displayed LJXUH 3DFLQJ ZLWK 3DGV LVSOD Mode Mode Rate Start Stop HR ALARM LEAD SELECT CHARGE Shocks 0 00 00 8 78 Pads Pacer Stop De...

Страница 111: ... 9 Press to exit the pacing function The green LED next to the but ton goes out indicating pacing is no longer active 127 If pacing using pads pacing will not start if there is a problem with the multi function defib electrode pads connections If in demand mode pacing will not start if there is a problem with the ECG monitoring electrodes connections In either case if a problem occurs a system mes...

Страница 112: ...to obtain capture Defibrillating During Pacing If the patient must be defibrillated during pacing follow the procedure for defibrillating in Manual Mode on page 6 1 Pacing is automatically turned off when you charge the defibrillator and the pacing dialogue box is removed from the display After a shock pacing remains off To resume pacing refer to Performing Pacing on page 8 5 When you resume setti...

Страница 113: ... properly applied l Check that the monitoring cable and electrodes are properly connected 3DFHU DLOXUH The pacing system is not functioning Remove the device from active use and call for service 3DFHU 2XWSXW RZ High patient impedance is resulting in the delivering less current to the patient than specified in the output current setting Check that the pads are applied properly 6WRS 3DFHU is pressed...

Страница 114: ...Troubleshooting 8 10 Pacing Optional ...

Страница 115: ...ing Retrieving Printing This chapter describes how the Heartstream XL creates an Event Summary or patient record for later retrieval and printing Marking events for storage in the Event Summary and printing individual events as they occur are also dis cussed ...

Страница 116: ...ta Card is limited only by available space on the card In addi tion to storing all of the events that occur a continuous copy of the displayed ECG and Patient Contact Impedance are stored You can print the internal Event Summary at any time You can also configure your Heartstream XL to print individual events automatically as they occur Finally you can activate printing of individual events and pa...

Страница 117: ...o selection is made the event is marked with just a LJXUH QQRWDWLRQV 127 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 ev...

Страница 118: ... off AED Mode Analysis Analyzing Analysis Stopped Artifact Detected Cannot Analyze Shock Advised No Shock Advised Mode Change AED Mode or Manual Mode Rhythm Monitoring Check Patient Pause Resume Charging ECG waveform Energy charged to Shock ECG waveform Shock Delivered energy Peak current and Patient impedance Shock Failed No Shock Delivered Disarm ECG waveform ECG Monitoring Leads on off Lead cha...

Страница 119: ...2 Violation 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 pace marker Pacing Pacer start Pacer stop Pacer settings 7DEOH YHQW QIRUPDWLRQ Event Types Related Information Stored ...

Страница 120: ... off briefly for 2 minutes or less while preserving the current patient record Events recorded after the power interruption are appended to the patient record Continued use also preserves alarm settings If Then Power is off for more than 2 minutes and a new event is recorded The Heartstream XL assumes you are caring for a new patient The last inter nal Event Summary is deleted a new Event Summary ...

Страница 121: ...ist of events that occurred during the incident and the time of their occurrence l ECG strips of the events in the directory list where relevant Figure 9 2 shows the beginning of an Event Summary LJXUH YHQW 6XPPDU Summary Summary 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 123...

Страница 122: ...vised 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 pressed 11 seconds 3 seconds prior to being pressed plus 8 seconds after is pressed pressed 11 seconds 3 seconds prior to being pressed plus 8 seconds after is pressed Heart Ra...

Страница 123: ...gth Defibrillator charges continuous 6 seconds just prior to charging plus continuous printing throughout the charge duration Shock Delivered 12 seconds 6 seconds just prior to shock plus 12 seconds after shock Shock Failed 6 seconds 6 seconds just prior to the message 1R 6KRFN HOLYHUHG plus 6 seconds after the message Defibrillator disarmed 6 seconds 6 seconds just prior to disarm plus 6 seconds ...

Страница 124: ... strip by pressing To print additional events that you observe in the course of caring for your patient press 127 An ECG strip will print continuously until you press a second time to stop printing If the printer is configured to have a 6 second delay the print out contains an additional 6 seconds of the ECG that occurred just prior to pressing Strip Strip Strip Strip ...

Страница 125: ...fibrillator Monitor 10 1 10 10 Setting Up and Configuring the Heartstream XL This chapter describes how to set up and configure your Heartstream XL Chapter 10 covers l Connecting Patient Cables l Configuring the Heartstream XL ...

Страница 126: ...ables 10 2 Setting Up and Configuring the Heartstream XL Connecting Disconnecting Patient Cables This section describes how to connect and disconnect the l Pads Paddles Patient Cable l ECG Patient Cable 3 or 5 lead l SpO2 Patient Cable ...

Страница 127: ...ble To connect external paddles to the defibrillator 1 Align the white arrow on the patient cable with the white arrow on the defibrillator s cable connector as shown in Figure 10 1 2 Insert the cable into the connector Push until you hear it click in place LJXUH WWDFKLQJ WKH 3DWLHQW DEOH IRU 3DGV DQG WHUQDO 3DGGOHV ...

Страница 128: ...nect the patient cable from the defibrillator 1 Rotate the green locking mechanism on the cable in the direction of the green arrow clockwise until it stops as shown in Figure 10 2 2 Hold the locking mechanism in this position as you pull the cable out LJXUH LVFRQQHFWLQJ WKH 3DGV 3DGGOHV 3DWLHQW DEOH ...

Страница 129: ...ble 1 Hold the connector with the flat side facing away from the Heartstream XL as shown in Figure 10 3 2 Insert the connector into the receptacle and push until the blue portion of the connector is no longer visible LJXUH RQQHFWLQJ WKH 6S2 3DWLHQW DEOH To disconnect the SpO2 patient cable gently pull the connector out of the SpO2 receptacle ...

Страница 130: ...e 1 Align the keyed patient cable connector with the slot on the ECG receptacle as shown in Figure 10 4 2 Push the patient cable firmly into the ECG receptacle until the white por tion is no longer visible LJXUH 3DWLHQW DEOH RQQHFWRU 5HFHSWDFOH To disconnect the ECG patient cable gently pull the white patient cable connector out of the ECG receptacle ...

Страница 131: ...ble items and their setting options l how to change the configuration l how to save the configuration to a Data Card l how to load the configuration from a Data Card l how to print the configuration Accessing the Configuration Menu There is a special combination of softkeys that when pressed simultaneously turn the Heartstream XL on in Configuration Mode For the purposes of executing this procedur...

Страница 132: ... shown in Figure 10 6 The menu lists the categories of settings that may be configured LJXUH RQILJXUDWLRQ 0HQX 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...

Страница 133: ... 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 a 6 second strip during alarms On Off 3ULQWHU HOD 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...

Страница 134: ...10 Off HYLFH QLWLDWHG QDO VLV Initiates ECG analysis when the Heartstream XL is turned on in AED Mode for new use On Off XWRPDWLF 5H DQDO VLV Initiates ECG analysis in between shocks within a shock series On Off 5K WKP 0RQLWRULQJ Monitors the ECG for potentially shockable rhythms when the Heartstream XL is not ana lyzing defibrillating or paused On Off HDG 6HOHFW Turns on ECG monitoring via ECG Le...

Страница 135: ...ff Appears only when European Protocol is configured off Pause Timer is the default 30 60 120 180 XURSHDQ 3URWRFRO Modifies Pause state prompts and replaces the Pause Timer with either the Post Shock CPR Timer or the NSA Timer depending on the event preceding the Pause state Off On 3RVW 6KRFN 35 7LPHU Appears only when European Protocol is on Defines the duration of the Pause time in sec onds when...

Страница 136: ...appears on the display during an event On Off Item Description Setting Choices LQH LOWHU Selects the setting used to filter out AC line noise 60 Hz 50 Hz 3DGV IRU LVSOD Selects the display filter frequency for the therapy cable attached Monitor 15 40Hz EMS 1 30 Hz 3DGV IRU 3ULQWHU Selects the printer filter frequency for the therapy cable attached Monitor 15 40Hz EMS 1 30 Hz HDGV IRU LVSOD Selects...

Страница 137: ...em you want to change 4 Press 5 Use the softkeys to select the desired setting 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 v...

Страница 138: ...settings to the Data Card and returns to the main configuration menu 127 To avoid possible confusion designate one Data Card as the Configuration Card and label it clearly Keep this card physically separate from cards used for storing patient data Loading Settings from a Data Card To load configuration settings 1 Make sure a Data Card is in the Heartstream XL before you turn the defibrillator moni...

Страница 139: ...rinter paper l cleaning instructions l a list of approved supplies and accessories and l instructions for disposal of the device The operational checks described must be performed at the specified intervals in order to help prevent and detect electrical and mechanical problems The battery maintenance procedures specified must be strictly adhered to in order to ensure that your batteries have the e...

Страница 140: ...efib electrode pads and monitoring electrodes Every Shift Perform a Shift System Check every shift see Using External Paddles on page 11 3 to verify that the Heartstream XL is functioning properly and to ensure that necessary supplies and accessories are present and ready for use Every Month Check expiration dates on multifunction defib electrode pads and monitoring electrodes every month Replace ...

Страница 141: ...nician 6 Follow the prompts on the display to proceed with the test If the message 6HUYLFH 8QLW appears do not use the device and call for service The test takes less than a minute to complete When it is done a report is printed as shown in Figure 11 1 LJXUH 6KLIW 6 VWHP KHFN 5HSRUW 8VLQJ WHUQDO 3DGGOHV 51 1 H VXUH WR VDIHO GLVFKDUJH H WHUQDO SDGGOHV Strip Shift System Check 8 Jan 1999 13 52 17 M4...

Страница 142: ...the display to proceed with the test If the message 6HUYLFH 8QLW appears do not use the device and call for service The test takes less than a minute to complete When it is done a report is printed as shown in Figure 11 2 LJXUH 6KLIW 6 VWHP KHFN 5HSRUW 8VLQJ 3DGV Strip Shift System Check 8 Jan 1999 13 52 17 SN 00000001 Current Tests Pass General System Test Pass ECG Test Pass Backup Power Test Pas...

Страница 143: ...ble signs of damage Make sure the connectors engage securely Battery make sure l a charged battery is in the Heartstream XL l another battery is charged or being charged l the batteries have no visible signs of damage AC Power 1 Make sure a battery is in the Heartstream XL 2 Plug the power cord into a power outlet and connect it to the Heart stream XL 3 Verify that the power and charging indicator...

Страница 144: ...o 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 7DEOH DWWHU DSDFLW 7HVW 5HVXOWV If Then Elapsed Time 85 minutes and Low Battery Time 10 minutes 1 The battery passed the test 2 Record pass CT and the date on the bottom of the battery 3 Rec...

Страница 145: ...re is provided in the application note About Sealed Lead Acid Batteries that came with your Heartstream XL Table 11 2 lists battery maintenance activities and when they should be per formed 7DEOH DWWHU 0DLQWHQDQFH FWLYLWLHV Activity When to Perform Perform a visual inspection Daily as part of the Shift System Check Charge the battery After each use or if the message RZ DWWHU is displayed Perform a...

Страница 146: ... battery will typically be 90 charged after 3 hours at 25o C as indicated by the Batt Charge LED on the front panel turning from amber to green After the LED turns green the battery will typically be fully recharged after an additional 12 hours at 25oC 87 21 The battery should be fully charged whenever possible Repeated charges to just the 90 level will degrade the battery reducing its life and ca...

Страница 147: ...ake sure that the battery terminals do not come in contact with metallic objects Batteries should not be stored without charging for more than one month if installed in the defibrillator or more than three months if not installed in the defibrillator Storage at temperatures between 15o C 59o F and 30o C 86o F is recommended to maximize life expectancy 87 21 Storing at temperatures above 40o C 104o...

Страница 148: ...am XL 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 LJXUH 2SHQLQJ WKH 3ULQWHU ...

Страница 149: ...ell 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 LJXUH RDGLQJ 3DSHU ...

Страница 150: ...ce Use of a soft cloth is recommended for cleaning the display to prevent scratching 87 21 The Heartstream XL may not be autoclaved ultrasonically cleaned or immersed Do not use abrasive cleaners or strong solvents such as acetone or acetone based cleaners Cleaning the Printer Printhead If the printout has light or varying density printing clean the printhead to remove any buildup of paper residue...

Страница 151: ...s cable may not be ultrasonically cleaned or immersed Nor may they be autoclaved or steam sterilized The ECG cable may be cleaned by wiping it with any of the following l 2 gluteraldehyde solution such as Cidex l Alcohol free hand soap l Chlorine bleach 100ml l 87 21 Do not ultrasonically clean immerse autoclave or steam sterilize the pads or ECG cable Do not clean the ECG cable with alcohol Alcoh...

Страница 152: ... or visit our Medical Supplies website at www healthcare agi lent com mpgsupplies 7DEOH 8SJUDGHV 6XSSOLHV DQG FFHVVRULHV Part Number Description Upgrades M4738A Pacing Upgrade M4739A SpO2 Upgrade Defibrillation Pads Electrodes M3501A Multi function Defib Adult Electrodes AAMI M3502A Multi function Defib Adult Electrodes IEC M3503A Multi function Defib Pediatric Electrodes IEC M3504A Multi function...

Страница 153: ...box 80 rolls External Paddles PCI Sterilizable M4745A Sterilizable External Paddles M4746A External Paddles with PCI M17898 Adult Adapter clips onto external paddle Pads Cables M3507A Agilent Pad Connector Cable M3508A Heartstream Pad Connector Cable 05 10200 Heartstream Pads Adapter DP2 DP6 use with M3507A 7DEOH 8SJUDGHV 6XSSOLHV DQG FFHVVRULHV Part Number Description ...

Страница 154: ... M1615A 3 lead ECG Lead Set IEC M1520A 5 lead ECG Trunk Cable AAMI M1625A 5 lead ECG Lead Set with Snaps AAMI M1530A 5 lead ECG Trunk Cable IEC M1635A 5 lead ECG Lead Set with Snaps IEC Sync Cable M1783A 12 pin Sync Cable Monitoring Electrodes M2202A High Tack Foam ECG Electrodes 5 electrodes pouch 300 electrodes case 7DEOH 8SJUDGHV 6XSSOLHV DQG FFHVVRULHV Part Number Description ...

Страница 155: ...EDWWHU LQVHUWHG SUHVHQWV D SRWHQWLDO VKRFN KD DUG SpO2 Cables Sensors M1191A Adult Reusable SpO2 Sensor M1192A Pediatric Reusable SpO2 Sensor M1194A Adult Pediatric Ear Clip Reusable SpO2 Sensor M1943A Nellcor SpO2 Sensor Adapter Cable Data Card M3510A Data Card Battery M3516A Sealed Lead Acid Battery M4747A Battery Charger Kit Test Load M1781A 50 ohm defibrillator test load User Training CD ROM M...

Страница 156: ...Disposing of the Heartstream XL 11 18 Maintaining the Heartstream XL ...

Страница 157: ...omentary message These messages are often accompa nied by a voice prompt This chapter describes the messages and what you should do in response In addition this chapter provides general troubleshoot ing tips and information on calling for service 127 For instructions for repair or for further technical information refer to the M4735 90900 Heartstream XL Service Manual ...

Страница 158: ... DWD DUG LVDEOHG The Data Card is not in use because it is full incompatible absent or inserted after the Heartstream XL was turned on If possible turn the Heartstream XL off for more than 2 minutes insert an empty compatible Data Card and turn the device on You may also enter configuration mode and turn the machine off then on again DXOW The ECG data acquisition system failed and data is unavaila...

Страница 159: ...pads cable is not connected to the defibrillator Check pads connector is locked in place 3DGV 2II The pads are not making proper contact with the patient Make sure the pads are properly applied to the patient 3DFHU DLOXUH The pacing system is not functioning Remove the device from active use and call for service 3DFHU 2XWSXW RZ High patient impedance is resulting in the pacer delivering less curre...

Страница 160: ...rop erly l Make sure the sensor site has a pulse l Relocate the sensor to a site with improved circulation l Try another sensor 6S2 RZ 6LJQDO SpO2 signal is too low to give an accurate reading l Check the sensor is applied properly l Try another sensor type 6S2 1RLV 6LJQDO Excessive patient movement electrical interference or optical interference is present l Minimize patient movement or apply the...

Страница 161: ...tinues HILE LVDUPHG l The pads connection is compromised l The mode is changed from Manual to AED while the defibrillator is charged l or shock buttons are not pressed within 30 seconds of the defibrillator being charged l is pressed l Check the pads are applied to the patient properly l If a shock is indicated deliver the shock before changing modes l To deliver a shock press or shock buttons on ...

Страница 162: ...s inserted while the Heart stream XL is on None A Data Card must be inserted prior to turning the Heartstream XL on for the current patient 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 Heartstream XL Turn the Heartstream XL off and insert a Data Card prior to the first event for the patient H QDFWLYH The k...

Страница 163: ...roperly applied l Check that the desired lead is selected The Heartstream XL does not appear to be functioning properly l The battery is low l There is a system failure l Change the battery l 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 pri...

Страница 164: ...gilent com mpgcsd United States of America Canada Other International Areas Medical Response Center Tel 800 548 8833 Eastern Region Central Western Regions Tel 800 361 9790 Tel 800 268 1221 Australia France Tel 131147 Tel 0803 35 34 33 Germany Italy Tel 0130 4730 Tel 0292 122999 Netherlands United Kingdom Tel 0 20 547 6333 Tel 44 344 36633 Belgium Tel 32 2 778 35 31 ...

Страница 165: ...Specifications Safety This section provides l Specifications for the Heartstream XL l Symbol definitions for symbols appearing on the Heartstream XL l Clinical Performance Summary data l Safety related information l Electromagnetic compatibility information ...

Страница 166: ...pedance Shock Delivery Via multi function defib electrode pads or paddles Delivered Energy Accuracy Charge Time Less than 3 seconds to 200 Joules with a new fully charged M3516A SLA battery pack at 25º C Less than 15 seconds to 200 Joules when powered by AC with no battery installed Patient Impedance Range Minimum 10 25 Ohm depending upon energy level Maximum 180 Ohm ...

Страница 167: ...nes for sync and asychronous modes AC Power LED Battery Charging LED Sync LED Pacer LED Armed Indicators Charge done tone and available energy indicated on display Energy Selection Front panel rotary knob Charge Control Front panel 2 key or buttons on paddles Shock Control Front panel 3 key or buttons on paddles Synchronizer SYNC message appears on the monitor and is annotated on the printer if pr...

Страница 168: ... Indicators EL display for ECG waveform and text prompts Audio alerts Voice Prompts QRS Beeper Charging Tone Charge Done Tone Printer AC Power LED Battery Charging LED Armed Indicators Charge Done Tone Available Energy indicated on display Voice Message Patient Analysis Per protocol evaluates patient ECG and signal quality to determine if a shock is appropriate and evaluates connection impedance f...

Страница 169: ...n electrode or lead wire becomes disconnected Paddle Fault NO PADDLES CONNECTED message and dashed line appear on the display if paddles become disconnected Pad Fault PADS OFF message and dashed line appear on the display if a pad becomes disconnected Heart Rate Display Digital readout on display from 15 to 300 bpm with an accuracy of 10 Heart Rate Alarms Configurable pairs of low and high heart r...

Страница 170: ... Hz Pads ECG for Display Monitor 15 40 Hz or EMS 1 30 Hz Pads ECG for Printer Monitor 15 40 Hz or EMS 1 30 Hz Leads ECG for Display Monitor 15 40 Hz or EMS 1 30 Hz Leads ECG for Printer Diagnostic 05 150 Hz or EMS 1 30 Hz or Monitor 15 40 Hz Patient Isolation defibrillation proof ECG Type CF SpO2 Type CF Defib Type BF ...

Страница 171: ...ult defibrillation Non Shockable Rhythm Asystole 500 Meets AAMI DF39 requirement and AHA recommenda tionb specificity 95 for adult defibrillation Non Shockable Rhythm All other non shockable rhythms 600 Meets AAMI DF39 requirement and AHA recommenda tionb specificity 95 for adult defibrillation a From Agilent Technologies ECG rhythm databases b American Heart Association AHA AED Task Force Subcomm...

Страница 172: ...s to 100 Approximately 3 hours to 90 indicated by LED on front panel Capacity 100 minutes ECG monitoring or 50 full energy discharges or 75 minutes ECG monitoring while pacing with a new fully charged battery at room temperature 25º C Battery Indicators LOW BATTERY message appears on display when at least 10 minutes of monitoring time and 5 maximum energy discharges remain with a new battery at ro...

Страница 173: ...acing the patient Prints every 12 sec onds with Header 1 Header 3 Changes in Mode Gain Lead Sync and Pacer Settings Footer Drug Annotations HR SpO2 limits on a Limit Alarm the Results of Analysis in AED Mode No Shock Advised Shock Advised or Cannot Ana lyze Charging to xxx J Shock Delivered No Shock Delivered Disarm Bat tery Low Symbols Mark Triangle for presses of the Mark key an Alarm Bell Alarm...

Страница 174: ...t System Log Battery Capacity Test Shift System Check Speed 25 mm s with an accuracy of 5 Amplitude Accuracy 10 or 50 uV whichever is greater Paper Size 50 mm by 30 m 100 ft Noninvasive Pacing Waveform Monophasic Truncated Exponential Current Pulse Amplitude 10 mA to 200 mA 5 mA resolution accuracy 10 mA to 50mA 5mA 50mA 200mA 10 Pulse Width 20 ms with accuracy 0 5 ms Rate 30 ppm to 180 ppm 10 ppm...

Страница 175: ...imits Three preset low alarm limits 90 85 and 80 INOP Alerts Triggered by disconnected sensor noisy signal light interfer ence or low signal non pulsatile Event Storage Internal Event Summary The internal Event Summary stores up to 300 events and up to 50 waveforms Events can be marked with a Mark symbol and if configured for drug annota tion the following labels can be added Epinephrine Adrenalin...

Страница 176: ...t Standard Configuration weighs 6 5 kg 14 3 lbs including battery full roll of paper and external paddles Environmental Temperature 0º C to 55ºC operating 20º to 70ºC storage l Charging the battery at temperatures above 35ºC may degrade bat tery life l Storing the battery for extended periods at temperatures above 40ºC will reduce battery capacity and degrade battery life Humidity Up to 95 Relativ...

Страница 177: ...Technologies Section 759 Class B1 Vibration Water Resistance Meets IEC 601 2 4 IPX0 EMC Meets EN 60601 1 2 Safety Meets IEC 601 1 EN 60601 1 UL 2601 1 CAN CSA C22 2 No 601 1 Other Considerations Equipment not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Mode of Operation Continuous AC Line Powered 100 240 VAC 50 60 Hz 1 5 A Class 1 Battery Pow...

Страница 178: ...s in user s guide Input Meets IEC type BF leakage current requirements and is defibrilla tor protected Patient Applied Part is isolated and defib proof suitable for direct patient contact except the heart or major arteries Meets IEC type CF leakage current requirements and is defibrilla tor protected Patient Applied Part is isolated and defib proof suitable for direct patient contact including the...

Страница 179: ... Defibrillator Monitor 13 15 13 Biphasic energy is being used Must be recycled or disposed of properly Unlock Audio Speaker Protective earth ground Alternating current Dangerous voltage 7DEOH HILEULOODWRU DQG DWWHU 6 PEROV Symbol Definition b ...

Страница 180: ...tions Safety 7DEOH EEUHYLDWLRQV DQG FURQ PV Abbreviation Acronym Definition AC Alternating Current AED Automated External Defibrillator ECG Electrocardiogram SpO2 Pulse oximetry Batt Battery ECG Out Monitoring Signal from Defibrillator ...

Страница 181: ... 13 The following table lists the symbols that appear on the Heartstream XL ship ping carton 7DEOH 6KLSSLQJ DUWRQ 6 PEROV Symbol Definition Atmospheric pressure range Temperature range Relative humidity range Recyclable paper product Fragile Right side up Do not get wet ...

Страница 182: ...Symbol Definitions 13 18 Specifications Safety Shelf life Long term storage conditions Short term transport storage 7DEOH 6KLSSLQJ DUWRQ 6 PEROV Symbol Definition ...

Страница 183: ...orm 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 automatic externa...

Страница 184: ... lower energy SMART Biphasic waveform were more likely to have good cerebral performance CPC cerebral performance cate gory p 0 04 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 0 001 Patients Defibrillated 54 54 100 49 58 84 0 003 ...

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Страница 187: ...ery simultaneously 51 1 YRLG FRQWDFW EHWZHHQ WKH SDWLHQW DQG FRQGXFWLYH IOXLGV DQG RU PHWDO REMHFWV VXFK DV WKH JXUQH RQWDFW ZLWK PHWDO REMHFWV FRXOG FDXVH XQLQWHQWLRQDO FXUUHQW SDWKZD V 51 1 2SHUDWLQJ WKH HDUWVWUHDP RU LWV DFFHVVRULHV LQ FRQGLWLRQV RXWVLGH WKH HQYLURQPHQWDO VSHFLILFDWLRQV FDQ UHVXOW LQ GHYLFH RU DFFHVVRU PDOIXQFWLRQ 51 1 0HGLFDO HOHFWULFDO HTXLSPHQW ZKLFK GRHV QRW LQFRUSRUDWH GHI...

Страница 188: ...FRUGLQJ WR ORFDO UHJXODWLRQV R QRW SXQFWXUH GLVDVVHPEOH RU LQFLQHUDWH EDWWHULHV 51 1 KHUH WKH LQWHJULW RI WKH H WHUQDO SURWHFWLYH HDUWK FRQGXFWRU LV LQ GRXEW WKH GHYLFH VKDOO EH RSHUDWHG IURP LWV LQWHUQDO SRZHU VRXUFH 127 For operation in the U S the attachment plug must be the proper NEMA type for connection to the alternative voltage 87 21 Be aware of patient cables including ECG monitoring equi...

Страница 189: ... appropriate accessories has been performed according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 The EMC standards describe tests for both emitted and received interference Emission tests deal with interference generated by the device being tested 51 1 5DGLR IUHTXHQF 5 LQWHUIHUHQFH IURP QHDU...

Страница 190: ...ansmission Should interference be encountered as demonstrated by artifact on the ECG or dramatic variations in SpO2 values attempt to locate the source Assess Is the interference intermittent or constant Does the interference occur only in certain locations Does the interference occur only when in close proximity to certain medical devices Does the SpO2 value change dramatically when the AC line c...

Страница 191: ...or is designed to receive and amplify low level signals in the same bandwidth as the interference Immunity is defined in the standard as the ability of a system to perform without degradation in the presence of an electromagnetic disturbance Degradation in ECG quality is a qualitative assessment which can be subjective Caution should therefore be taken in comparing immunity levels of different dev...

Страница 192: ...Electromagnetic Compatibility 13 28 Specifications Safety ...

Страница 193: ... 18 Alarms heart rate 4 6 8 2 interruption of power 9 5 SpO2 monitoring 5 8 symbols 11 Analysis 3 8 AED Mode 3 8 re analysis 3 11 settings 3 4 Arrhythmias 1 6 Artifact Detectedmessage 3 18 Asynchronous defibrillation 1 6 Asystole 1 6 pacing 1 7 Attach Pads message 12 5 Audiovisual controls 2 2 2 3 Automatic Re analysis 3 11 setting 3 4 10 10 B Batteries 1 3 2 9 charging 11 7 checking 11 5 insertin...

Страница 194: ... list of configurable items 10 7 modifying 10 14 printing settings 10 15 Rhythm Monitoring 3 4 3 14 saving and loading from Data Card 10 15 Configuration Lost message 12 2 Continued Use feature 9 5 Controls 2 2 CPR 3 12 D Data Card 2 11 downloading and erasing information 9 1 inserting and removing 2 11 ordering 11 19 saving and loading settings 10 15 specifications 13 8 troubleshooting 12 2 12 6 ...

Страница 195: ...fications 13 4 synchronized cardioversion 7 1 troubleshooting 4 7 Electrode pads See Pads Electrodes applying 4 2 checking 11 2 cleaning 11 13 ordering 11 18 placing 3 5 4 3 settings 10 9 Electromagnetic compatibility EMC 16 Environmental specifications 13 9 safety precautions 14 15 Erratic spiking 1 5 European 10 11 European Protocol 10 11 Event Summary 9 1 events recorded 9 3 information include...

Страница 196: ...d Select setting 10 10 selecting 4 5 7 1 8 3 troubleshooting 4 7 8 7 12 2 Leads Off message 4 7 8 7 12 2 Loading printer paper 11 9 settings from Data Card 10 15 Low Battery message 12 2 M Maintenance batteries 11 7 cleaning 11 11 operational checks 11 2 supplies and accessories 11 17 Manual Mode 6 1 controls 2 2 2 4 current charge 6 4 defibrillation process 6 4 delivering shock 6 5 display 2 5 2 ...

Страница 197: ...CG monitoring 8 2 events recorded 9 4 function buttons 2 5 indications for use 1 7 messages 12 3 preparation 8 3 procedure 8 4 selecting leads 8 3 8 7 specifications 13 7 system messages 8 7 troubleshooting 8 5 8 7 12 6 Pads applying 3 6 13 14 cleaning 11 13 ECG monitoring 4 1 4 7 events recorded 9 3 safety precautions 13 troubleshooting 3 18 12 3 12 5 Pads Cable Off message 3 18 12 3 Pads cables ...

Страница 198: ...ontrols 2 3 Event Summary 9 6 events automatically 9 8 settings 10 15 Pulse checking 3 12 5 10 Pulse oximetry defined 1 7 5 1 described 5 2 specifications 13 7 See also SpO2 monitoring Q QRS beeper 4 6 adjusting 2 2 settings 10 9 troubleshooting 4 8 R Radio frequency RF interference 16 Re analysis 3 4 3 11 Recording events See Event Summary RF interference 16 Rhythm Monitoring 3 4 3 14 AED Mode 3 ...

Страница 199: ...inuing 5 9 events recorded 9 4 inaccuracies 1 7 indications for use 1 7 noisy signal 5 10 procedure 5 7 process 5 2 sensors applying 5 5 sensors caringfor5 9 11 13 settings 10 10 specifications 13 7 troubleshooting 5 10 12 4 SpO2 Noisy Signal message 5 10 SpO2 Sensor Fail message 5 11 Stop message 8 7 Stop Pacer message 12 6 Strip See Print strip Supplies checking 11 4 ordering 11 17 Symbols list ...

Страница 200: ...AED Mode 3 18 Data Card 12 6 display 12 7 ECG monitoring 4 7 pacing 8 5 8 7 12 3 12 6 SpO2 monitoring 5 10 12 4 time and date 12 7 U User messages 2 7 V Ventricular fibrillation manual defibrillation 1 6 pacing 1 7 Ventricular tachycardia 1 6 W Warnings See Precautions Web site 12 8 ...

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