1 - Corizon
Contents
1. Return all components to ZOLL Lifecor Select 4 NOISE TRAINING Ww ARRHYTHMIA Press w to return to training menu Remove and reinsert battery to resume normal monitoring View ECG events Print reports if desired noise reports and compliance reports Recondition system See Service Manual Log off when finished 1 800 LIFECOR Appendix B Part Numbers 1 800 LIFECOR Description WCD 3100 Programmed Monitor Battery Battery Charger with Power Supply Modem Test Plug Holster Electrode Belt Garment Tote Bag WCD 3100 Patient Manual WCD 3100 Quick Guide WCD 3100 Operator s Manual WCD 3100 Service Manual WCD 3100 Patient Checklist Part numbers ZOLL Lifecor Part Number 10A0967 Axx 10A0894 A01 11B0009 A01 10A0924 A0x or 10A0903 A01 10A0922 A01 10B0844 A01 10A0889 A01 10A0964 A0x 10B0822 A01 20B0039 20B0042 20B0040 20B0041 20B0043 Page B 1 LifeVest System WCD 3100 Operator s Manual This page intentionally left blank Page B 2 1 800 LIFECOR Appendix C Symbols Symbols Battery charger Battery charged Battery charger Battery charger is charging or testing battery Battery charger Battery charger needs service Battery charger Battery needs service Battery Do not incinerate SVLR Battery Do not short circuit Caution Consult accompanying documents AA mA CE marking indicates conformance2. Pacemaker interactions WARNING Use appropriate caution when prescribing a LifeVest device to a patient who is dependent on a pacemaker All patients who have pacemakers should be examined for proper pacemaker function after a defibrillation Several interactions with pacemakers are possible e Ifa patient goes into a ventricular arrhythmia and the pacemaker continues to pace the pacemaker s pulses may be the dominant signal This may potentially cause the LifeVest device to lock on the pacemaker s signal as the cardiac rhythm and prevent the LifeVest device from detecting the arrhythmia The risk varies according to the type of pacemaker and the programmed mode of the pacemaker e If the patient is baselined with the pacemaker active an unpaced QRS complex may be interpreted by the LifeVest device as a change in the QRS morphology As a result if the rate goes above the arrhythmia rate threshold the LifeVest device may then declare the unpaced rhythm a treatable arrhythmia and begin the treatment alarm sequence As long as the patient uses the response buttons of the LifeVest device the device will not deliver a treatment shock However be aware that an increased potential for an unnecessary shock does exist e After the shock is delivered the pacemaker may have difficulty capturing the myocardium or may be reset to a default mode 1 Glikson et al Importance of Noise Reversion as a Potential Mechanism of Pacem
3. then press gt BASELINE SETTINGS TRAINING CONTINUE 4 Press gt or lt to select OK then press the response buttons ed CANCEL RESPOND 3 5 When you see the READY TO RECORD message press the READY TO response buttons RECORD RESPOND CEI 1 800 LIFECOR Page 4 7 LifeVest System WCD 3100 Operator s Manual RECORDING BASELINE BASELINE COMPLETE RESPOND CE BASELINE FAILED Page 4 8 This message displays while the monitor records the baseline The monitor also shows the patient s ECG Baseline recording time will vary depending on the patient strength of the ECG signal and the amount of noise on the ECG signal Recording the baseline may take up to 5 minutes When you see the BASELINE COMPLETE message press the response buttons The monitor returns to normal operation If you get the BASELINE FAILED message the monitor could not learn the patient s baseline Do the following e Verify that the ECG electrodes are properly contacting the patient s skin You may need to clean the skin or clip excessive hair before fitting the patient with the electrode belt and garment e Try to baseline the patient again Remove the battery and repeat this procedure starting on the previous page e f problems continue the patient may have a rhythm that is difficult for the monitor to learn If so discontinue attempting to baseline the patient and call ZOLL Lifecor 1 800
4. 800 LIFECOR Monitor setup for a new patient 4 Monitor setup for a new patient About this section e This section covers the basic procedures and menus for setting up the monitor before use by a new patient e This section applies to software version 5 1 and up e If you need to change any other settings see the programming section of the Service Manual Menu structure Startup Setup Language buttons preference pressed for operator Patient New patient Settings Training See service manual First name Last name VT IVF rate threshold Equipment Enter baseline mode Pulse test See service manual Exit Enter training mode Normal startup 1 800 LIFECOR Page 4 1 LifeVest System WCD 3100 Operator s Manual How to put the monitor in setup mode Before entering new patient information follow this procedure to place the monitor in setup mode View the navigation buttons from the top of the monitor with the display QO facing you 1 Remove and reinsert the battery 2 While the opening screen is displayed hold the response buttons and hold lt at the same time Continue holding these buttons until the screen changes This screen may be displayed for more than 10 seconds LANGUAGE 3 Press A or Y to choose a language then press gt PREFERENCE Note The language you choose only affects the setup screens and ENGLISH will not affect th
5. 83 n 12 86 80 n 5 History of NSVT 89 n 9 80 n 5 100 n 4 History of VT 44 n 9 33 n 3 50 Beta blocker medication 82 n 11 67 n 6 100 n 5 Anti arrhythmia medication 9 n 11 0 n 6 20 n 5 Inotropic medications 0 n 11 0 n 6 0 n 5 The study population consisted of 13 patients with 105 patient weeks of patient device experience There were 214 false arrhythmia detections during that time The rate of false detections using the WCD 3000 device was 2 0 per patient week of use as compared to 4 5 per patient week using the WCD 2000 device There were no treatable tachyarrhythmic events during the study There were four true arrhythmias recorded during the study all four resolved spontaneously There were no inappropriate defibrillations during the study One adverse event was reported during the study This event involved a patient who received an asystole alarm due to incompletely connecting the electrode belt to the monitor The patient called an ambulance to take her to the hospital as the device directed She was hospitalized as a precaution and transferred from this local hospital to the investigational site where she was examined and discharged to home No injury resulted from this event The patient continued to wear the device 1 800 LIFECOR Quick charts Appendix A Quick charts Overview of new patient setup Fit patient with garment and Train patient electrode belt Verify normal monitoring Prog
6. LIFECOR Data management 5 Data management Have the patient follow the procedure in the Patient Manual to transfer patient data from the monitor to the LifeVest Network Follow the procedure in this section to view the data using a computer with Internet access About LifeVest Network LifeVest Network is an Internet Web site for viewing patient data When patients send data from a LifeVest monitor using a modem the data resides on LifeVest Network and forms a patient history of ECG recordings and other data You can view patient data from virtually any computer with Internet access This data is available at any time so it can be viewed at your convenience LifeVest Network is a secure site that guards patient privacy Only users with login names and passwords may enter the site Only users with specific permission may view each patient s data What you can do with LifeVest Network e View or change patient information from any computer with Internet access e View and print reports on patient ECG recordings treatment events compliance data and noise data e Download and print forms for patient care Computer requirements to use LifeVest Network Your computer will need to have Internet access and an Internet browser such as Internet Explorer or Netscape Navigator You will also need the Adobe Acrobat Reader to view and print reports Your screens may look different Due to product improvements your screens may not l
7. Patient training 3 Patient training This section gives guidelines for instructing the patient about the LifeVest system and how to respond to alarms We suggest that you 1 Go over the main points below 2 Explain the operating modes and alarms as described on page 3 3 3 Demonstrate the types of alarms that can occur as described on page 3 4 Main points to teach the patient When you instruct the patient stress the following points explained below and on the following page e Ifyou get a siren alarm hold the response buttons e If you get a gong alarm read the message e If you get shocked call your doctor and send data e Review the Patient Manual so that the patient is familiar with its contents and where to find things If you get a siren alarm hold the response buttons e The response buttons will light red when you are to press them so they will be easy to find even in the dark e As long as you are able to hold the response buttons to stop a treatment As long as you remain conscious and hold the response buttons you are in no danger of receiving a treatment shock e If you lose consciousness of course you will not be able to hold the response buttons In this case and if the lethal heart rhythm continues the device will go through the treatment cycle and deliver a treatment shock e It is very important that only you the patient hold the response buttons This is how the monitor knows whether or not yo
8. Press the response buttons again 3 TRAINING 8 The monitor is now in training mode with these messages MODE alternating ACTIVE TRAINING MODE Press the response buttons to silence the gong alarm RESPOND 3 A NOISE 9 The monitor is ready to demonstrate the noise and wv ARRHYTHMIA arrhythmia alarms TBODLIFECOR E T LifeVest System WCD 3100 Operator s Manual Connect patient for training mode 1 Outfit the patient with the electrode belt and garment 2 Connect the electrode belt to the monitor 3 Continue with the procedures on the next page Page 3 6 1 800 LIFECOR Patient training How to demonstrate the arrhythmia alarms A NOISE 1 With this screen displayed press V Y ARRHYTHMIA The device runs through the alarm sequence that will occur if an arrhythmia is detected e Vibration alarm activates and response buttons light red e Siren alarm sounds e Display shows that an arrhythmia has been detected and tells patient to press response buttons e Voice prompts announce to bystanders that that patient is going to be shocked es S pea aoe 2 Tell the patient to press and hold the response button during the alarms The alarms stop as long as the patient holds the response buttons Tell the patient to release the response buttons to show that the alarm sequence resumes 3 To stop the arrhythmia demonstration press V 1 800 LIFECOR Page 3 7 LifeVest
9. Recommendation for double counting of a normal rhythm Double counting of a normal rhythm is known to occur with ICDs and other rhythm analysis devices Patients likely to experience double counting declarations may have high T waves and or low QRS amplitudes If a patient does experience such false arrhythmia declarations there are two actions which may help increasing the arrhythmia rate threshold and or lengthening the response time Increasing the arrhythmia rate threshold should reduce the frequency of false arrhythmia declarations due to double counting while lengthening the response time gives the patient additional time to respond to the alarms if a shock is not necessary Asystole detection The LifeVest monitors the ECG signal and declares asystole when the amplitude of the ECG input signal falls below 100 microvolts for at least 16 seconds When the device declares asystole it generates the following voice messages to notify bystanders Device disabled Call ambulance To silence the alarms and restore the device to normal operation remove and reinsert the battery Page 6 2 1 800 LIFECOR Clinical information Clinical studies Initial FDA approved study Conducted between 1990 and 2001 the objective of the FDA approved trial was to demonstrate safety low false shock rate and efficacy survival after sudden cardiac arrest There were 289 high SCA risk patients who used the device an average of 3 months Of 8
10. SCA events that occurred during the trial 6 were successfully converted There were 6 appropriate shocks during the trial The trial design was to demonstrate superiority of the wearable defibrillator to reliance on the EMS system for SCA treatment Biphasic electrophysiology laboratory sub study This study was conducted between March 2001 and November 2001 Twelve patients were electively induced into VT or VF and all 12 were converted or defibrillated with the first biphasic shock either 70 or 100 joules A total of 23 successful biphasic shocks were delivered There were no post shock arrhythmias or skin burns The average patient impedance was 68 8 ohms WCD 3000 clinical evaluation This study was conducted between September 2001 and April 2002 The objective was to demonstrate the safety of the LifeVest WCD 3000 device by comparing the incidence of false arrhythmia declarations false alarms with the WCD 3000 device to the WCD 2000 device The study would be considered successful if the incidence of false arrhythmia declarations was less than or equal to the WCD 2000 device A minimum of 10 patients and 100 weeks of cumulative device use would be required A prospective non randomized multi national trial involving four centers three U S centers and one European center evaluated the safety of the WCD 3000 device with patients at risk of sudden cardiac death Two populations at SCA risk were chosen e The first population
11. consisted of patients waiting for heart transplant or patients having an equivalent cardiac status namely New York Heart Association Class III or IV heart failure and an ejection fraction below 30 percent e The second patient population included acute myocardial infarction MI patients and patients immediately following a coronary artery bypass graft procedure Additional requirements for both the MI and bypass patients included VT VF within the first 48 hours or a left ventricular ejection fraction of less than 30 percent A Killip Class Ill or IV 72 hours following the MI and syncopal VT VF after 48 hours post MI also qualified patients for WCD 3000 device use 1 Feldman et al Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patient at High Risk for Sudden Death Results of WEARIT BIROAD PACE 2004 27 4 9 Reek et al Clinical Efficacy of a Wearable Defibrillator in Acutely Terminating Episodes of Ventricular Fibrillation Using Biphasic Shocks PACE 2003 26 2016 2022 1 800 LIFECOR Page 6 3 LifeVest System WCD 3100 Operator s Manual Page 6 4 Table 4 Patient demographics Parameter Total Study n 13 WEARIT n 7 BIROAD n 6 Ejection fraction 21 7 n 11 18 6 25 5 n 4 QRS width msecs 105 15 n 9 106 18 n 5 104 12 n 4 Age years 56 11 56 13 57 9 Male 69 71 67 History of smoking 83 n 12 67 n 6 100 History of hypertension
12. device What s in this manual Here s how to use this manual 1 800 LIFECOR The next few pages contain details about the LifeVest system plus safety information Patient fitting explains how to fit a patient and assemble the components of the LifeVest belt Patient training gives guidelines for instructing the patient about the LifeVest system and how to respond to alarms Monitor setup for a new patient covers the basic procedures and menus for setting up the monitor before use by a new patient If you need to change other settings see the programming section of the Service Manual Data management tells how to view patient data on the LifeVest Network using a computer with Internet access Clinical information contains indications contraindications a summary of the clinical studies and other clinical details Appendixes include Quick charts Part numbers and Symbols The quick charts are particularly helpful as reminders of how to do things Use the Index at the back of the manual to find what you re looking for quickly Page 1 1 LifeVest System WCD 3100 Operator s Manual About the LifeVest system The LifeVest is a cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest SCA It monitors the patient s heart continuously and if the patient goes into a life threatening arrhythmia can deliver a shock treatment to restore the patient s heart to normal rhythm Two main compon
13. with European Medical Device Directive Laundering symbol Normal cycle in warm water Laundering symbol Tumble dry warm Laundering symbol Only non chlorine bleach when needed Laundering symbol No anti static spray UXIO Laundering symbol Iron on low temperature 1 800 LIFECOR Page C 1 LifeVest System WCD 3100 Operator s Manual Laundering symbol No fabric softener Manufacturing date Monitor connector Type BF defibrillator proof connector Packaging Battery Packaging Battery charger Packaging Monitor Packaging Modem Packaging Electrode belt Packaging Garment Power supply electrical information Alternating current AC Power supply electrical information Direct current DC Therapy pad label Place this side foil side of the therapy pad next to your skin 1 800 LIFECOR Page C 2 Index A accessory part numbers B 1 address ZOLL Lifecor ii alarms demonstrating 3 4 arrhythmia demonstrating 3 7 assembly electrode belt to garment 2 3 asystole detection 6 2 B baseline 4 5 failed 4 6 4 8 manual 4 7 basic programming 4 4 belt components 2 1 BF symbol C 2 C cautions 1 5 CE symbol C 1 chapters of this manual 1 1 chest measurement 2 2 clinical information 6 1 component part numbers B 1 computer for LifeVest Network 5 1 contact ZOLL Lifecor ii contents of this manua
14. LifeVest LifeVest System Model WCD 3100 Operator s Manual PN 20B0040 Rev FI LifeVest System WCD 3100 Operator s Manual Restricted sale Federal USA law restricts this device to sale by or on the order of a physician Effectivity This manual describes the LifeVest WCD 3100 wearable defibrillator system with software version 5 1 and up Disclaimer Information operation specifications and product appearance may change without notice Names and data used in examples are fictitious Trademarks Lifecor WCD and LifeVest are trademarks or registered trademarks of ZOLL Lifecor Corporation in the United States of America All other product names mentioned herein are the trademarks of their respective owners Copyright notice Copyright 2006 Zoll Lifecor Corporation Patents US patents 6 681 003 6 280 461 6 253 099 6 169 387 6 097 982 6 065 154 5 944 669 5 929 601 5 741 306 5 078 134 4 928 690 others pending Software nonexclusive license The LifeVest device includes certain software Software ZOLL Lifecor grants you a nonexclusive license to use the Software solely for diagnostic and treatment purposes as part of use of the LifeVest device You are prohibited from i reproducing the Software ii removing or destroying any proprietary markings copyright notices or other legends which are part of the Software iii modifying or reverse engineering the Software or iv removing the Softwa
15. System WCD 3100 Operator s Manual How to demonstrate a noise alarm Page 3 8 A NOISE 1 With this screen displayed press A Y ARRHYTHMIA ADJUST BELT TRAINING MODE RESPOND 2 Tell the patient what to do when the gong alarm sounds Read the display This particular message states that ECG signal is not clear The ECG electrodes are not sending a good signal to the monitor Take action to correct problem In this case adjust the belt so that the ECG electrodes make better contact with the skin Press response buttons if display so states This stops the gong alarm 3 With a noise alarm when you press the response buttons PLEASE the monitor checks for an improvement in the ECG signal WAIT TRAINING MODE For the demonstration the ADJUST BELT message returns CHECK 4 After three cycles the monitor displays this message BELT SEE MANUAL When this happens the patient is expected to check the belt TRAINING MODE as described in the Patient Manual Pressing the response buttons does not make this message go away 5 To stop the noise alarm demonstration press A 1 800 LIFECOR Patient training How to exit training mode 1 Remove and reinsert the battery 2 Press the response buttons as normal RESPOND CE ae PATIENT 3 Monitor resumes normal operation NAME 1 800 LIFECOR Page 3 9 LifeVest System WCD 3100 Operator s Manual This page intentionally left blank Page 3 10 1
16. aker ICD Interactions PACE May 1998 21 1111 1121 Altamura et al Transthoracic DC Shock May Represent a Serious Hazard in Pacemaker Dependent Patients PACE January 1995 18 Part Il 194 198 Other articles of interest Brode et al ICD Antiarrhythmic Drug and CD Pacemaker Interactions Journal of Cardiovascular Electrophysiology July 1997 8 830 842 Geiger et al Interactions Between Transvenous Nonthoracotomy Cardioverter Defibrillator Systems and Permanent Transvenous Pacemakers PACE March 1997 20 Part 1 624 630 1 800 LIFECOR Page 6 1 LifeVest System WCD 3100 Operator s Manual Recommendations for patients with pacemakers If the pacemaker does pace during ventricular fibrillation there is a risk that the pacemaker stimulus artifact would be tracked by the LifeVest device as a valid heart rate during ventricular fibrillation In order for this to occur the pacemaker stimulus artifact must be greater than the ventricular fibrillation signal Patients whose pacemaker stimulus artifact is greater that 0 5 mV in any ECG lead should not use the LifeVest device Because of the risk that the patient s unpaced ECG signal may be interpreted as a ventricular tachycardia if it exceeds the arrhythmia rate threshold set the VT rate threshold above the maximum paced rated when a patient is baselined while being paced After shock delivery check the pacemaker s programming and ability to capture
17. e patient screens PATIENT 4 The main menu displays showing that the monitor is in setup mode EQUIPMENT PULSE TEST You may now proceed to program the monitor See page 4 4 for EXIT details on setting up a new patient Page 4 2 1 800 LIFECOR Monitor setup for a new patient PATIENT 5 When you are finished programming the monitor do one of the EQUIPMENT following to return to normal operation PULSE TEST e Navigate back to the main menu select EXIT then press gt EXIT e Wherever you are in any menu remove and reinsert the battery 1 800 LIFECOR Page 4 3 LifeVest System WCD 3100 Operator s Manual How to set up a new patient New patient setup consists of entering the patient s name and the rate thresholds for ventricular tachycardia and ventricular fibrillation PATIENT 1 With the monitor in setup mode see page 4 2 and with PATIENT EQUIPMENT selected press gt PULSE TEST EXIT NEW PATIENT 2 With NEW PATIENT selected press BASELINE re SETTINGS Note that the response buttons light red to show you are in edit mode TRAINING FIRST NAME 3 Enter patient s first name or ID number as follows e Press A and to select characters Al e To advance to next character press gt To go back press lt e To save the name press the response buttons LAST NAME 4 Enter patient s last name Follow same procedure as with first name A 5 To accept the values shown for the rate thresho
18. ents The LifeVest system consists of two main components 1 an electrode belt and garment that surrounds the patient s chest and 2 a monitor that the patient wears around the waist or from a shoulder strap Washable garments are available in sizes to suit most patients The LifeVest device s electrodes are dry and non adhesive to provide patient comfort The monitor weighs about 1 8 pounds making it the lightest external defibrillator available The device contains pushbuttons and indicators for the user as well as a speaker for sounding alarms and voice prompts Treatment cycle less than a minute When the device detects a treatable arrhythmia an alarm sequence begins giving a conscious patient time to stop the treatment This keeps inappropriate arrhythmia detections from becoming inappropriate shocks a key difference between the wearable defibrillator and an implanted defibrillator If the patient holds the two response buttons at any time during the treatment sequence the alarms stop and no shocks will be delivered If the patient does not respond or releases the response buttons the device continues to give alarms and spoken warnings to bystanders that a treatment shock is about to be delivered Gel within the electrodes is released just prior to delivering the treatment shock in order to deliver the shock most efficiently The entire event from arrhythmia detection to delivery of the shock treatment typicall
19. esas4iaeni a ey 3 1 Main points to teach the patient cccccccccceceeeseenneceeeeeeeseeecaeeeeeeeeeesesenceaeeeeeeesetsnsaaeeeeeees 3 1 Summary of Operating MOdES a aee TE AEAT REEE T EAER 3 3 Demonstrating the aamiS erir naea a E E ee ee 3 4 4 Monitor setup for a new patient sanasssssnnunnnenrnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nennen 4 1 Abo t this SectiOMi issu a aeiitecy ves bonicnedeeved Meme deanlwcnrl eens dele aeenieed dove 4 1 Menu Structure iarria ce neces slati de ini ne dive ibaa del aed nies aie 4 1 How to put the monitor in setup MOE 2 cece ce ceeeeecee cece ee eeeeeeaeceeeeeeeeecaaaeaeeeeeeesesennanaeeeeeess 4 2 How to set up a new patient 2 cece ceeccccce cece eeeeee cece cece ee eeeeeeaeee seer ee sgeeaaaeeeseeeeeeeeennaeeeeeereeeees 4 4 How to baseline a patient cccccceccccecceceeeeeeeeeeeaececeeeeeseeaaeaeceeeeeegseneaneeseeeeeeeeseeeineeeeeeeees 4 5 How to manually re baseline a patient 0 ccc eeeeeeeeeeenneeeeeeeaeeeeeeaeeeeeeeaeeeeeeneeeeseaes 4 7 5 Data management orriren ce ctcetie ted eccedvecetine ceecetev RONNA SANAA NAE NEE AANE EENE EEEE 5 1 About LifeVest Network cccccceeecseccececeeeeee cece aeaeee cece ee seceaaaeeeeeeeeesegaeaeeeeeeeeeseeeeeninaeeeeeeees 5 1 How to view patient data on LifeVest Network ccccccceceeesecceeeeeeeeeseenaeceeeeeeeesesennaeaeeeeeess 5 2 6 Clinical INTOFMAtION 02 cccscccscaseeceanccerecs
20. essnecnanceisaesaasuecuauadanednsudaiscceneinsdedassanscenednsiaatdscnceenetnns 6 1 WAGIGATIONS a iaieersae A aahete teed apicetbad ed leut E A EE ah E habete seeded EE ea th 6 1 GCoOntraindiGations ci a a sda vcathabseetad cleaat a ake arhereved gaceet E AAE 6 1 Pacemaker interacts tsiera siae aaaeei Teee a Go aaaeeeaa dee Aaaa AEEA ns Ee sd teen Rea 6 1 Recommendations for patients with paceMAaKeLS cceceeeececceceeeeeeeceeaeceeeeeeeeseteeneeaeeeeeess 6 2 Recommendation for double counting of a normal rhythm cece centres eee eeeeeeeeeeeeeaaes 6 2 GliniGal StUGIOS 53 2525 seis 2S eed eds sesie eee a aeaa Na E A erae elas eat e aati saree Meade sary 6 3 Appendix A QUICK charts srini ikenien anaran aaeain anaa oi asiaani ananasa rde Si dinsin A 1 Appendix B Part NUMPCIS 0 s e inenneneenn anaran aenean aa eaea cout bedcaedeccetaensecbepedestessaptocduecnes cvnsaetes B 1 Appendix C SYM HO S r e err aaa ae a aaar EAE s aa a aaa aeaa ea AKA adipa aaRS C 1 Index 1 800 LIFECOR Page iii LifeVest System WCD 3100 Operator s Manual This page intentionally left blank Page iv 1 800 LIFECOR Introduction 1 Introduction About this manual This manual is for operators of the LifeVest wearable defibrillator gives you instructions on how to fit patients as well as instruct patients in the use and care of the device supplements the patient manual which gives patient instructions on the use and care of the LifeVest
21. garment doesn t get twisted as the patient puts it on e Tell the patient that the metal mesh pockets must touch bare skin in order for a defibrillating pulse to be delivered e Female patients should be encouraged to wear a bra over the garment Make sure the metal surface of the front therapy pad presses against the patient s body rather than the underside of her left breast Position straps over the patient s shoulders and bring them under the patients arms around to the patient s back 1 800 LIFECOR Page 2 4 Patient fitting 5 Without stretching the strap find the hole that lines up with the button Then stretch the strap slightly and attached the button to the next hole e Do not cut the strap e Excess strap can be folded over and buttoned again e Repeat for each of the two long straps e Adjust the garment for a good fit 6 Bring the remaining strap down the front of the patient s chest and button it to the front of the garment e Do not cut the strap e Excess strap can be folded over and buttoned again 1 800 LIFECOR Page 2 5 LifeVest System WCD 3100 Operator s Manual At left is the garment and belt assembly as viewed from the patient s front 7 Have the patient look in a mirror to make sure that e Garment and belt assembly is being worn correctly e Garment is not twisted e Electrodes and therapy pads are pressing against bare skin Page 2 6 1 800 LIFECOR
22. he sizes in this chart are suggested sizes You may vary from the sizes indicated in order to suit patient Example Patient measures 44 inches Read the chart to locate this measurement Chest measurement Garment inches centimeters 10A964 A0X 26 27 66 70 A01 28 30 71 78 A02 31 33 79 85 A03 34 36 86 93 A04 37 40 94 103 A05 41 45 104116 A06 46 50 117 128 A07 51 56 129 142 A08 According to the chart patient needs garment A06 1 800 LIFECOR Patient fitting How to assemble the electrode belt to the garment 1 800 LIFECOR Assemble the belt and garment as described in the Patient Manual but do not fasten the straps The fully assembled electrode belt and garment should look like the following figures Toward patient s body Make sure that this side faces toward the patient s body Away from patient s body Make sure that this side faces away from patient s body Page 2 3 LifeVest System WCD 3100 Operator s Manual How to put the garment on the patient and finalize assembly Place the garment and belt assembly on the patient as follows 1 All clothing and undergarments must be removed before putting on the garment All clothing including underwear must be worn over the device not under it Apply unscented hand lotion or skin cream to the four ECG electrodes Help the patient put on the garment Connect the ends of the garment together in the front e Make sure that the
23. k chart A 2 phone number ii prescription note ii programming 4 1 basic 4 4 new patient 4 4 Q quick charts A 1 R re baseline patient 4 7 reconditioning after patient is finished with device A 2 record baseline 4 5 reference guides A 1 Index 2 rescue defibrillation 1 5 S safety information 1 5 search patient on LifeVest Network 5 2 sections of this manual 1 1 send patient data 5 1 setup 4 1 quick charts A 1 setup mode 4 2 software license ii symbols C 1 system components B 1 T teaching patient 3 1 therapy pads label symbol C 2 timing treatment sequence 1 3 trademarks ii training alarms 3 4 arrhythmia 3 7 exit 3 9 mode 3 4 noise 3 8 patient 3 1 transfer patient data 5 1 transmitting data 5 1 treatment sequence 1 3 V view patient data quick chart A 2 viewing patient data 5 2 W warnings 1 5 Web address company ii LifeVest Network 5 2 Z ZOLL Lifecor address ii 1 800 LIFECOR
24. l iii contraindications 6 1 copyright ii D data management 5 1 quick chart A 2 defibrillation conventional warning 1 5 demonstrating alarms 3 4 device description 1 2 double counting recommendation 6 2 downloading 5 1 1 800 LIFECOR Index E effectivity ii exclamation point symbol C 1 F fit patient quick chart A 1 G garment sizes 2 2 garment and electrode belt quick chart A 1 garment on patient 2 4 indications 6 1 instructing patient 3 1 Internet access 5 2 introduction 1 1 L laundering symbols C 1 LifeVest Network 5 1 computer 5 1 login 5 2 patient search 5 2 login LifeVest Network 5 2 manual baseline 4 7 manual organization 1 1 manufacturing date symbol C 2 measure and fit patient quick chart A 1 measure patient 2 2 menu structure 4 1 monitor setup for new patient quick chart A 1 Index 1 LifeVest System WCD 3100 Operator s Manual N new patient programming 4 4 programming quick chart A 1 new patient setup quick chart A 1 noise demonstrating 3 8 O operating modes 3 3 organization of this manual 1 1 P pacemaker interactions 6 1 recommendations 6 2 packaging symbols C 2 part numbers B 1 patents ii patient data transfer 5 1 fitting 2 1 programming quick chart A 1 training 3 1 viewing data 5 2 patient finished with device quick chart A 2 patient setup quick chart A 1 patient training quic
25. lds without changing them press the response buttons To change one or both values e Use or lt to select the threshold you want to change e Then press A or to change the value e Repeat to change the other value e To save the new values press the response buttons 6 Press gt or lt to select OK then press the response buttons CENTER NAME Baseline the patient as described on the next page od CANCEL Page 4 4 1 800 LIFECOR Monitor setup for a new patient How to baseline a patient The monitor s arrhythmia detection algorithm uses the patient s baseline ECG as a template to help determine if a treatable arrhythmia exists When you set up a new patient the monitor automatically goes into the baseline mode when you exit the setup mode or the next time the system powers up Follow this procedure to baseline the patient READY TO RECORD RESPOND CE RECORDING BASELINE Prepare the patient attach the garment and electrode belt and connect the electrode cable to the monitor Have the patient sitting or lying down relaxed and not talking or moving around Put a fully charged battery into the monitor When you see the READY TO RECORD message press the response buttons This message displays while the monitor records the baseline The monitor also shows the patients ECG Baseline recording time will vary depending on the patient strength of the ECG signal and the amount of noise
26. lt and garment e Read through these procedures completely e Familiarize yourself with the components and what they re called e Have a clean flat area to lay out and assemble the components such as a table or counter You might want to put a towel or cloth on the table to protect the components as you assemble them Components of the LifeVest belt assembly Electrode Belt The electrode belt comes in one size and fits any patient The parts of the electrode belt are as follows 1 Therapy pads CTN N J OJ 2 ECG electrodes 3 Vibration box 4 Cable and connector Garment The garment comes in a variety of sizes to suit the patient In this chapter you will measure the patient to determine what size garment to use 1 800 LIFECOR Page 2 1 LifeVest System WCD 3100 Operator s Manual How to measure the patient Page 2 2 Measure the patient to determine what size garment to use N 1 Have patient stand and remove all upper body clothing including undergarments Place a measuring tape around the patient s chest centered at the xiphoid Measure to the closest inch or centimeter garment indicated Chest measurement inches 26 27 28 30 31 33 34 36 37 40 41 45 46 50 51 56 centimeters 66 70 71 78 79 85 86 93 94 103 104 116 117 128 129 142 Garment Find the patients measurement in the chart below and get the size 10A0964 A0X A01 A02 A03 A04 A05 A06 A07 A08 Note T
27. messages can Patient needs to take Read monitor and do what it appear for example action says Check Patient Manual for more ADJUST information See section 5 If you BELT get alarms aeck BELT SEE xA Siren alarm An arrhythmia is being detected RESPOND Press and hold the response buttons if conscious Check Patient Manual for more information See section 5 If you get alarms 1 800 LIFECOR Page 3 3 LifeVest System WCD 3100 Operator s Manual Demonstrating the alarms Demonstrate the alarms to help the patient learn how to respond Follow the procedures below to e Place the system in training mode then e Simulate alarm conditions How to enter training mode View the navigation buttons from the top of the monitor with the display facing you 1 Remove and reinsert the battery 2 While the opening screen is displayed hold the response buttons and hold lt at the same time Continue holding these buttons until the screen changes This screen may be displayed for more than 10 seconds LANGUAGE 3 Press A or Y to choose a language then press PREFERENCE ENGLISH Page 3 4 1 800 LIFECOR Patient training PATIENT 4 With PATIENT selected press gt EQUIPMENT PULSE TEST EXIT NEW PATIENT 5 Press A or to select TRAINING then press gt BASELINE SETTINGS TRAINING CONTINUE 6 Press gt to select OK then press the response buttons fd CANCEL RESPOND 7
28. on the ECG signal Recording the baseline may take up to 5 minutes 1 800 LIFECOR Page 4 5 LifeVest System WCD 3100 Operator s Manual 3 When you see the BASELINE COMPLETE message press the BASELINE response buttons COMPLETE The monitor returns to normal operation RESPOND O If you get the BASELINE FAILED message the monitor could not BASELINE learn the patient s baseline Do the following FAILED e Verify that the ECG electrodes are properly contacting the patient s skin You may need to clean the skin or clip excessive hair before fitting the patient with the electrode belt and garment e Try to baseline the patient again Remove the battery and repeat this procedure starting on the previous page e f problems continue the patient may have a rhythm that is difficult for the monitor to learn If so discontinue attempting to baseline the patient and call ZOLL Lifecor Page 4 6 1 800 LIFECOR Monitor setup for a new patient How to manually re baseline a patient Use this procedure if you need to manually re baseline a patient 1 Prepare the patient attach the garment and electrode belt and connect the electrode cable to the monitor Have the patient sitting or lying down relaxed and not talking or moving around 2 With the monitor in setup mode see page 4 2 press A or to EQUIPMENT select PATIENT then press gt PULSE TEST EXIT NEW PATIENT 3 Press A or to select BASELINE
29. ook exactly like what s shown in this manual 1 800 LIFECOR Page 5 1 LifeVest System WCD 3100 Operator s Manual How to view patient data on LifeVest Network This procedure requires a computer connected to the Internet 1 From your Internet browser enter the LifeVest Network web site address https wcdnet lifecor com 2 When the login screen appears select your language preference Select Languag Login Name Password EAA f 3 Type your Login Name and Password then click Login 4 When the opening screen appears select a patient name to be viewed You can also search by the patien s last name or ID Demonstration USA DEMOUSA I Show Inactive Patients Select A Patient Name Patient ID Number Last Data Download 5 With a patient name displayed click on the options along the left side of the screen to view ECG recordings treatment events compliance data and noise data Some pages include a Help For This Page button along the left side Click on the button for more detail 6 Log off LifeVest Network when finished Page 5 2 1 800 LIFECOR Clinical information 6 Clinical information Indications The LifeVest system is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator Contraindications The LifeVest system is contraindicated for use on patients with an active implantable defibrillator
30. ram monitor for new patient Program monitor for new patient Remove and Enter Select Select Enter patient s Enter patient s reinsert battery setup mode PATIENT NEW PATIENT FIRST NAME LAST NAME Set VT RATE Set VF RATE Verify settings Ready for THRESHOLD THRESHOLD gs monitoring Fit patient with garment and electrode belt Make sure garment and belt assembly are being worn correctly Gather electrode Put garment on patient and finalize assembly Assemble electrode belt to garment belt and proper size garment 1 800 LIFECOR Page A 1 LifeVest System WCD 3100 Operator s Manual Train patient Explain what you re going to do Show response buttons to patient Enter setup mode First we ll Press demonstrate an W ARRHYTHMIA arrhythmia alarm Next we ll demonstrate an Press electrode noise 4 NOISE alarm To view patient data Log on to LifeVest Network Start computer Access Internet Select PATIENT This is an arrhythmia alarm When you hear this alarm hold the response buttons Do not let anyone else hold the buttons for you If you get this alarm look at the display for instructions Select patient name When patient is finished with device Remove battery from monitor and put into charger Yes Is this a reconditioning site Remove battery from monitor Page A 2 Send patient data
31. re from the LifeVest device Title to the Software will remain at all times with ZOLL Lifecor You must keep the Software confidential Contact information Page ii ZOLL Lifecor Corporation Phone 412 826 2146 121 Freeport Road Toll free USA 1 800 LIFECOR 1 800 543 3267 Pittsburgh PA 15238 3495 Fax 412 826 9485 USA Web www lifecor com 1 800 LIFECOR Contents Contents AIMCO CUCTION Soon EE TE EET E A 1 1 About this manualna ana a eee ad ce a a ee 1 1 Whats init is manualisizosris tects iea a e E A R e a E eae 1 1 About the LifeVest SYSteM eccceeceee cence eee eeneeeeeeeeeeeeeseeeeeeseeeaeeeseneaeeeseeeaaeeesenaeeesenaeees 1 2 Safety informato aenaran aaria a ele ete A he eel eels eed 1 5 22 Pathe nt PHttn in Gy wien seed tds ccc cece E cans atte E auti seegtits enna steve seat ide svegatii eveaettvsveestistesscestesactiees 2 1 Before YOu start orreri piensi ised aa aa eed ee teh goin ieee A a 2 1 Components of the LifeVest belt assembly ee ececeeeeeeeeeeeete eter eeteeeeeeaeeeeetaeeeeeeetaeeeeeeaes 2 1 How to measure the patient cccecccceccececeeeeeeeecaeeeeeeeeesececeaeeeeeeeeeseseaaeceeeeeeeesetennesaeeeeeess 2 2 How to assemble the electrode belt to the garment c ce eeeeeeeeeeeeeeeeeteeeeeeseeeeeeneeeeeneaes 2 3 How to put the garment on the patient and finalize ASSEMDIY eee eee ee eeeeeeeeeeteeeeeeeaes 2 4 3 Patient trainin aa aE A N csscecee eabeaueessseuetessusasns cssecuecasedue
32. ry or death caused by misuse of the device This includes device failure that could lead to the patient not being protected by the device CAUTION Alerts of a possible problem with the device Such problems include damage to the device or other property or minor injury Rescue defibrillation e If the patient should require conventional defibrillation a warning label on the garment informs medical personnel to unfasten and lay open the garment thus removing the front therapy pad from the patient s chest If medical personnel fail to do so the LifeVest device may interfere with the defibrillation and the conventional defibrillator may damage the device Shock hazard e Do not attempt to open the monitor battery battery charger or modem This may expose you to high voltage and damage the system To help ensure proper operation e Use only the cables batteries and accessories specified in this manual If you use any other items the system may not operate correctly e Operate the system within the range of 0 C to 50 C 32 F to 122 F up to 95 relative humidity non condensing and up to 10 000 feet in altitude 1 800 LIFECOR Page 1 5 LifeVest System WCD 3100 Operator s Manual This page intentionally left blank Page 1 6 1 800 LIFECOR Patient fitting 2 Patient fitting This section explains how to fit a patient and assemble the components of the LifeVest belt Before you start e Gather the electrode be
33. sicians can then access their patient s information from virtually any computer with an Internet connection LifeVest Network allows physicians to view ECG recordings patient use ECC interference and other device related information Biphasic waveform delivers efficient energy 1 800 LIFECOR The LifeVest device delivers its defibrillating energy in a biphasic truncated exponential waveform whereby the signal goes positive then negative very quickly This type of waveform has been shown to be effective defibrillating at lower energy levels The amplitude and width of the phases of the energy waveform are automatically adjusted to deliver a precise energy amount regardless of the patient s body impedance Page 1 3 LifeVest System WCD 3100 Operator s Manual Reliable detection algorithm The LifeVest has proved to be effective at detecting ventricular tachycardia VT and ventricular fibrillation VF The detection algorithm was 100 sensitive for VF and 95 sensitive for VT in bench testing The algorithm uses the patient s baseline vectorcardiogram as a template for detecting changes in cardiac signal morphology in addition to standard rate determination of arrhythmias Page 1 4 1 800 LIFECOR Introduction Safety information This information helps you safely operate the LifeVest system Read and understand these warnings cautions and symbols before using the device Terms used WARNING Alerts of possible inju
34. u are conscious DO NOT let anyone else hold the response buttons for you If you get a gong alarm read the message e Read the display and do what it says to fix the problem Check the Patient Manual section 5 for reminders about what to do for various messages e Keep in mind that the monitor gives alarms messages and voice prompts to guide you in what to do 1 800 LIFECOR Page 3 1 LifeVest System WCD 3100 Operator s Manual If you have an event call your doctor and send data e If you have any kind of cardiac event even if you manage to stay conscious and hold the response buttons you should contact your physician and report the incident e Any cardiac event is recorded by the monitor so you can send the data later e As soon as possible after any cardiac event you should send data using the modem Review the contents of the Patient Manual Review how to e change and charge the battery e change the garment e disassemble and reassemble the garment and electrode belt e send data using the modem Also be sure to review the warnings and cautions located in the Patient Manual Page 3 2 1 800 LIFECOR Summary of operating modes Patient training As you instruct the patient keep in mind that the device has basically three operating modes Mode Message What it means What the patient needs to do Normal PATIENT Monitor is operating Nothing monitoring no NAME normally alarms Gong alarm Various
35. y takes less than one minute If the arrhythmia continues after the first shock up to 5 shocks may be given Page 1 2 1 800 LIFECOR Introduction Treatment sequence After identifying VF there is a response time of 25 seconds programmable up to 55 seconds to allow the patient time to respond to the alarms as shown below The lower threshold for VF identification can be set from 120 to 250 beats per minute bpm with a default of 200 bpm If the system identifies VT there is a response time of 60 seconds programmable up to 180 seconds The lower threshold for VT identification can be set from 120 to the VF threshold with a default setting of 150 bpm Typical treatment sequence during ventricular fibrillation Seconds 0 5 10 15 20 25 N fos Arrhythmia detected Vibration alarm Siren Loud siren Bystander warning Gel release Treatment shock i The LifeVest device can deliver up to 5 defibrillating pulses during an arrhythmic episode The energy of the pulses can be programmed individually to between 75 and 150 joules 5 with a default setting of 150 joules ECG recording of events The patient s electrocardiogram ECG is recorded for all detected arrhythmias including before and after treatment The patient can also manually record an ECG at any time by pressing the response buttons on the device Patients transmit information from their devices by telephone to the LifeVest Network Phy
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