- Frank`s Hospital Workshop
Contents
1. card contents have they been read out for analysis e Patient cable type If a recorder frequently requires the time and date to be entered or corrected it should be returned for service 3 5 Fault Protection While Recording During recording the recorder operation is supervised in various ways to ensure that all recorded data is correct and the recording is as complete as possible battery level is continually monitored Low battery shutdown is described in the user manual e Ifthe LCD is found to be in the wrong state the recorder will re load the display e Data written to the CF card includes error detection information which is checked before analysis recorder shuts down immediately if the cable is removed e Ifthe patient cable is removed and then replaced the recorder will continue after a countdown message The analyser will dis play a corresponding blank period in the ECG 32768Hz crystal is monitored via a watchdog to ensure that it is operating correctly Other transient faults can cause a short blank in the ECG while the recorder resets and restarts e Intermittent power supply due to contact corrosion bad joints or possibly severe shock e recorder software running improperly watchdog timer e Error messages from the CF card that cannot be resolved e other unexpected condition such as data errors due to large electrostatic discharge 22 18 0583 Rev C 32. are tested automatically If any errors are found the recorder will start to beep loudly before the patient cable is fitted The pattern of beeps indicates the cause of the problem 3 2 Second Level Built in Tests When the patient cable is fitted the microcontroller applies further automatic tests before proceeding with normal operation The integrity of the complete operating programme is tested at this point If any errors are found the recorder will start to beep after the cable has been fitted The pattern of beeps again indicates the cause of the problem 3 3 Third Level Built in Tests Lastly the microcontroller tests the remaining peripheral circuits com municating any errors with a text message on the LCD The following service screen codes are used 0001 Oscillator clock fault 0002 SRAM fault 0003 EEPROM data error data includes the unit serial number etc 0004 ADC operation fault 0005 ADC calibration fault 0006 Configuration fault 0007 LCD Voltage fault 0008 Varios Active Yoke EEPROM data error 012 TIMI recorders only Clock EEPROM SRAM or LCD Voltage fault Lifecard CF Service Manual 21 3 4 User Level Tests Before commencing the recording the recorder checks all aspects that are under the user s control and will display warning or error messages as described in the user manual Items checked include Battery voltage Loss of time and date since last use e CF card needs conditioning
3. 1 425 657 7200 Fax 44 0 1992 501213 Fax 1 425 657 7212 Web site www spacelabshealthcare com 2 7 Modifications For continued safety the device shall not be subjected to any Unauthorised modifications and must be used only for the purpose for which it was originally supplied Lifecard CF Service Manual 19 CIRCUIT BLOCK DIAGRAM wero PATIENT EVENT amp LOUD DISPLAY PHONE p SIE SPEAKER 96 X49 a o ntecrated driver eof PROTECTION INPUT MONITOR CIRCUTS AND hook up cable 771 COMPACTFLASH PATENTCABLE CARD SOCKET CONNECTOR and circuit tests SERIAL IF ANALOGUE HO _ MCRO 5 A PETAL gemanc PARALLEL BUS SCRATCHPAD channels ANDFLASH cei ie RAM MEMORY SERIAL IE PROGRAM MEMORY 32768 Hz MASTER CLOCK NON VOLATLE MEMORY EEPROM PACING PULSE DETECTOR REALTME POWER v 15veSUs BROWNOUT 0 CLOCK CONVERTER WATCHDOG single call to 3V3 RESETS battery backed LIFECARD 12 BLOCK DIAGRAM PATIENT TRUNK BATTERY aL pes UL ACTIVE R CA CLOCK L T NEUTRAL clock TI CONTROLLER S EEPRO SEL DIGITAL CIRCUITS amp EEPROM 22313 SUPPLY epp erty FIRMWARE PATIENT ACTIVE YOKE LIFECARDCF CFCARD 20 18 0583 Rev C 3 LCF BUILT IN TESTS 3 1 Primary Built in Tests When a battery is inserted the internal functions of the microcontroller
4. 6 Lifecard CF Menu Options The Lifecard displays are controlled by two buttons e The yellow A Up and V Down button is used to move up and down the menus to highlight the menu option You also use it to choose which channel is displayed on the monitor e The green gt Select button is used to select the highlighted option 3 6 1 Main Menu Options Displays options for starting and setting up the recorder CF Pacing Det ON Start Week ID Cardio A Set Up English Pbout 1 Lifecard CF Option If alternative operating modes are available on your recorder and you wish to use them contact Spacelabs Healthcare Ltd for the appropriate user manual k Pacing Det ON 2 Pacing option Use this option to select or deselect pacing detection Lifecard CF Service Manual 23 3 Start Option Select Start when you want to make a recording in Standard Recording Mode up to 48 hours of 2 or 3 channel ECG or 24 hours of 12 lead ECG Start Week 4 Start Week Option Select Start Week when you want to make a recording in Extended Recording Mode to record up to 7 days of continuous 2 channel ECG RIE 427 5 Recorder ID This is a name or number you have chosen for the recorder using an option in the Set Up menu Your chosen ID will appear in the Main Menu and on Pathfinder reports There is a space inside the recorder unit for you to affix a bar code or similar 6 Set
5. 640hms 19 5074 Microphone Condenser 46 18 0583 Rev C 46 0056 PCB Insulator 19 5000 Lithium Battery Rechargeable ML621S 19 5044 LCF Speaker 64ohms Lifecard CF Service Manual 6 5 Patient Cable Mounting with Clip 48 46 0493 Catch Moulding LEE mr n eO ec ect ess no A litri 5 LJO 23 0223 Pocket Clip 23 0224 Mount 23 0226 Spring Pocket Clip 46 0037 Hinge Moulding 18 0583 Rev C 6 6 Short Patient Cable 46 0493 Catch Moulding A 46 0037 Hinge Moulding Lifecard CF Service Manual 49 Varios with 46 1123 Cable 46 1152 18 0583 Rev C 6 8 Varios Lead Parts LC12 EU PATIENT CABLE 46 1123 C I AIE E EEE Er Va Lifecard CF Service Manual 51 www Spacelabshealthcare com Spacelabs Healthcare Inc Spacelabs Healthcare Ltd 5150 220th Ave SE 1 Harforde Court Issaquah ud John Tate Road WA 98029 USA Hertford SG13 7NW UK Tel 1 425 657 7200 Tel 44 0 1992 507700 Fax 1 425 657 7212 Fax 44 0 1992 501213 Healthcare 0120 Rc onty SPACELABS C
6. LC12 Varios Yoke Assembly Lifecard CF Check out Spares amp Part Numbers Assembly Views Front Assembly Front View Complete Front Assembly Rear View Intermediate Moulding Circuit Board Patient Cable Mounting with Clip Short Patient Cable Varios with 46 1123 Cable 46 1152 Varios Lead Parts 37 37 37 39 41 43 43 44 45 46 48 49 50 51 18 0583 Rev C OCopyright 2010 Spacelabs Healthcare Ltd 1 Harforde Court John Tate Road Hertford SG13 7NW Lifecard CF Service Manual This Page is intentionally Blank 18 0583 Rev C 1 PRODUCT OVERVIEW 1 1 Introduction The Lifecard CF is a compact Holter Ambulatory ECG Recorder utilising a digital storage technique to store the ECG recording onto a Compact Flash CF card The Lifecard CF provides continuous recording of 2 or 3 leads of ECG for up to 48 hours in standard mode and up to 7 days in extended mode The Lifecard 12 option provides continuous recording of 12 leads of ECG for a period of 24 hours The recorder has a built in display for you to monitor the ECG and pacing detection during hook up This enables you to verify the ECG quality before starting the recording Menu options are selected using the 2 buttons on the front of the recorder unit The Lifecard CF requires one AAA battery The patient cables for the Lifecard CF are designed to prevent accidental disconnection from the recorder by the patient The Patient Event button on the front o
7. Lifecard CF generates sounds to confirm your actions or to in form you about the status of the recorder T Click The click sound is emitted whenever you press the yellow A Up or Down button 2 OK boing The OK boing tells you that the recorder is functioning properly and also sounds whenever you press the green Select button The tone is a higher note than the error tone 9 Error tone The Error tone tells you that the recorder has identified an error or warning condition The tone is a lower note than the OK boing 4 High Impedance or Lead Off Alarm ip 28 18 0583 Rev C During an extended recording if a lead becomes detached the Lifecard will generate an alarm to warn the patient The alarm is a ding dong tone lasting 15 seconds and the clock display will be replaced by the LEAD OFF message indicating which channel has been affected Once the patient has replaced the lead the clock display resumes You can turn the sound off by selecting Sound Off in the set up menu This does not affect the Lead Off alarm 3 8 Error and Warnings Displays 1 You will see this error message if you are trying to use Extended Recording Mode with a six electrode cable Either select Start for Standard Recording Mode or change the patient cable 2 You are trying to use Standard Recording Mode with a two elec trode cable Either select Start Week for Exten
8. name has been written on the card 1 the hook up screen scroll down the three channels check signal and quality when the cable is gently flexed to reveal any intermittent cable faults Channel 2 has a negative pacing spike only e When all the leads have been checked disconnect the Lif ecard CF and calibrator 4 2 LC12 Varios Yoke Assembly The Lifecard CF used to check these leads must have version VO7 xx firmware An Electromedicina ST 20 ECG Simulator is required select Pacemakers DVI test signal e Fit the battery and CF card to the Lifecard CF Connect the patient cable to the ST 20 simulator ST 20 N R 1 2 3 4 5 6 L F HIOEU cable R C 4 Cc C6 L F H10US cable RL RA V4 V6 IA LL e Connect the Lifecard CF to the Varios yoke e Verify that the Lifecard CF shows the Lifecard 12 splashscreen e Inthe main menu select Pacing On e Inthe main menu select Start Skip the voice recording e Verify that the patients name has been written on the card e n the hook up screen scroll down through 9 leads checking each one e All should have regular pacing markers small vertical arrow with P Lifecard CF Service Manual 37 aYR f avF 38 All should have baselines that settle in the central 1 3 of the screen The expected signals are shown in the figure below Checking leads and III is not necessary When all the leads have been checked disconnect the Lif eca
9. no inter ruption in recorder function ESD 2 8 kV air and 6 kV contact discharges no damage to the recorder recording resumes automatically in 10 s Radiated emissions CISPR 11 1997 EN55011 1998 Group 1 Class B Radiated immunity 3 V m 26 MHz 1 GHz 80 AM modulated at 5 Hz Keyed carrier immunity to EN50082 1996 This equipment has been tested and found to comply with the limits for a class B computing device in accordance with the specifications in Subpart J of Part 15 of FCC Rules which are designed to provide reasonable protection against interference to radio and television reception This equipment generates and uses radio frequency energy and if not installed and used in accordance with the instructions it may cause interference However there is no guarantee that interference will not occur in a particular installation If this equipment does cause interference to radio or television reception which can be determined by turning the equipment off or on the user is encouraged to try to correct the interference by one or more of the following measures Reorient the receiving antenna e Relocate the equipment with respect to the receiver e Move the equipment away from the receiver If necessary the user should consult Spacelabs Healthcare or an experienced radio television technician for additional suggestions The user may find the following booklet prepared by the Federal Communications Commission helpful How
10. the AAA battery to check for jamming Analyse the recording on Pathfinder or Lifescreen Check for the Patient Event and recording break 30 minutes into the recording Lifecard CF Service Manual 39 CHECK LIST Hospital Serial No 1 Front case damage 2 Patient Cable 3 Battery contacts 4 Insert firmware update card battery 5 Display 6 Select Setup menu 7 Current software version 9 Insert initialised flashcard connect patient cable 10 Check leads for fractures connect to calibrator 11 Test recording 12 Test results on Pathfinder 40 Fault Reported Software Version before updating Cracks in moulding Replace front assy Lens scratched fogging Cracks in moulding Replace complete cable Catch moulding Hinge moulding Belt clip Connecting pins Replace if damaged Connect patient cable Unit will bleep for 10secs to update 1 company logo will appear 2 Lifecard 7 day will appear if not 7 day select from Lifecard heading Check for missing lines Contrast adjust if necessary Set Time Set Date Set speech Rec On Set sounds On Select Back to exit set up menu About heading note S W version upgrade via CF card if necessary Enter Start make voice recording confirm check for distortion Monitor signal on display Fracture at grommet Fracture at lead separation Up to 24 Hours Print results if required 18 0583 Rev C Checked Replaced
11. 0601 1 Medical electrical equipment Part 1 General requirements for safety as fol lows 1 EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE The equipment is designed to be battery operated only Under NO circumstances shall a mains powered battery elimina tor or any other external power source be used with the equip ment Lifecard CF Service Manual 15 2 EQUIPMENT having a TYPE BF APPLIED PART or 3 EQUIPMENT having a TYPE CF APPLIED PART if so marked 4 4 EQUIPMENT protected against the ingress of splashing water if so marked Otherwise ORDINARY EQUIPMENT without protection against ingress of liquid 5 Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide or flammable cleaning agents 6 Rated for CONTINUOUS OPERATION 7 EQUIPMENT with an APPLIED PART specifically designed for application where a CONDUCTIVE CONNECTION is made to the PATIENT but not directly to the heart According to ANSI AAMI EC38 1998 Lifecard CF is Type 1 ambulatory ECG device 2 3 Adjustment replacement of parts maintenance and repair The device requires no routine adjustments to maintain its operation The device contains no user serviceable parts It shall be serviced only by Spacelabs Healthcare or by an agent accredited by them to service device of this type Unauthorised repairs or dismantling of the device will invalidate the guarantee 2 4 Defects and a
12. Additional Specifications 12 Lead Mode Channels Standard 12 lead one neutral and nine active electrodes Cable types 10 electrode defibrillation protected IEC or AHA code Isolation DEFIBRILLATION PROOF TYPE CF APPLIED PART Input impedance 10 Mohm Sampling rate 4096 samples per second per channel CMRR gt 80dB per IEC and ANSI AAMI methods Suppression Active neutral system right leg drive Resolution 0 6uV Noise lt 0 60 V RMS Pacing detection 22mV 200ys to 5ms pulse in any electrode Capacity required 256 MByte card for 24 hour recording Battery An alkaline AAA cell is required for 24 hour recording Fault tolerance In the event of electrode detachment noise is suppressed and the available leads are recorded differential V leads only if R L or F is detached Note other specifications are the same as Standard Recording Mode 1 2 8 Physical and Environmental Dimensions 96 x 57 x 17 5mm with patient cable fitted Weight Recorder body 55g patient load 130g including battery card and typical patient cable User labelling Area provided is 52 x 15 mm Temperature 0 to 45 C operation 20 to 65 C storage Humidity Operation or storage 5 to 95 non condensing Pressure Operation or storage air pressure 700 1060 mbar Shock 1 m drop 12 18 0583 Rev C 1 29 Electro Magnetic Compatibility General Complies with EN60601 1 2 1993 and ANSI AAMI EC38 1998 ESD 1 4 kV air and 2 kV contact discharges
13. L LUH bee E 5 Spares amp Part Numbers Product Code 19 5000 Lithium Battery Rechargeable 19 5044 LCF Speaker 64 Ohms 46 0418 3 Electrode Patient Cable with Clip 46 0480 3 Electrode Patient Cable Short Lifecard CF Service Manual 41 46 0556 4 Electrode Patient Cable with Clip 46 0557 4 Electrode Patient Cable Short 046 0031 6 Electrode Patient Cable with Clip 19 7509 6 Electrode Wire Lead Set 046 0523 7 Electrode Patient Cable with Clip 46 1125 LC12 Varios Active Yoke No Leads 42 18 0583 Rev C 6 Assembly Views 6 1 Front Assembly Front View Complete 46 0062 Top Cover Assembly Complete Lifecard CF Service Manual 43 6 2 Front Assembly Rear View 46 0059 Main Seal 46 0551 Lens 46 0051 Switch Moulding es 46 0050 Switch Moulding Up Down 46 0047 Retainer Moulding Select 46 0046 Retainer Moulding Up Down 46 0420 Mic Spacer 46 0043 Top Cover Moulding Join in Main Seal 46 0426 Must be placed here Acoustic Membrane AA 18 0583 Rev C 6 3 Intermediate Moulding 19 7508 Screw PT 1 8 x 10mm Philips 46 0057 Internal label 46 0045 Card Ejector Moulding 46 0044 Intermediate Moulding Lifecard CF Service Manual 45 Ircul oar 19 5075 Batterry Contact Positive 46 0464 Batterry Contact Negative 19 5077 LCD Display 46 1570 LCF PCB Assembly 46 0421 Speaker Seal LCF 19 5044 LCF Speaker
14. Up Option Select this option to configure the recorder 7 Language Option Select this to change the language displayed on the monitor Keep pressing the green Select button to switch between the languages until the correct one is displayed 8 About option This option displays the Software Version number and Hardware Serial number Pressing the green gt Select button returns you to the Main Menu 24 18 0583 Rev C 3 6 2 Setup Menu 1 Contrast Option Displays a bar indicating the current setting of the contrast ID Enabled Sounds Off The display can be darkened or lightened by pressing the yellow Up or Down button Press the green Select button to return to the Set Up Menu 2 Time Adjustment Option This option enables you to select a 12 or 24 hour clock display Use the yellow A Up or V Down button to change the selection and then press the green gt Select button to select it Clock 24 hr Clock 12 hr Select Lifecard CF Service Manual 25 Adjust the hours by pressing the yellow A Up or V Down button until the correct one is displayed then press the green gt Select button This moves the highlight onto the minutes which you then adjust in the same way Pressing the green gt Select button again returns you to the Set Up Menu Date Adjustment Option This option enables you to select a European or American date for mat Use the yellow A Up or V Down button to change the s
15. alised Remove the card and initialise the card FEFERR OR Memory Card Needs Conditioning 11 If the Flashcard contains a recording that has not previously been analysed you have the option to delete it Select the DETAILS option if the patient information is available then the Patient screen is displayed Otherwise the screen will display just the time that the recording was started AXokXERROR Recording started 0830 05 07 05 Unread ECG Data Delete ECG Details Lifecard CF Service Manual 31 12 Ifthe recorder detects that the rechargeable clock battery has discharged since the last use you must enter the time and date 3oEXERR OR Time 00 00 Time 09 20 Date 05 07 05 13 If this message is displayed before you start a recording you should insert a new battery immediately Date 01 01 00 Battery Low 0 97V 3 9 Decontamination Before commencing any service or maintenance procedures ensure the Lifecard CF recorder has been suitably decontaminated Unless contamination with body fluids is known or suspected we recommend low level disinfection See the user instructions for further details on cleaning and disinfecting the recorder In the case of severe contamination the recorder may be beyond repair Please contact Spacelabs Healthcare for further advice 32 18 0583 Rev C atient Gable Lifecard CF patient cables use screened lead w
16. ambulatory ECG device according to ANSI AAMI EC38 1998 This product must be sent to separate collection facilities for recovery and recycling 12 LEAD E with Varios Active Yoke amp 10 electrode 2 6 Warranty Subject to the conditions set out below Spacelabs Healthcare The Company warrants that its Products will be free from defects in material and workmanship for a period of 12 months from delivery This warranty is given by The Company subject to the following conditions 1 The Company shall be under no liability in respect of any defect arising from fair wear and tear willful damage negligence abnormal working conditions failure to follow instructions whether oral or in writing misuse improper installation or alteration or repair of the Products without The Company s approval 2 Theabove warranty does not extend to parts materials or devices not manufactured by The Company in respect of which the Customer shall only be entitled to the benefit of any such warranty or guarantee as is given by the manufacturer to The Company 3 Subject as expressly provided here all warranties conditions or other terms implied by statute or common law are excluded to the fullest extent permitted by law 4 Any claim by the Customer which is based on any defect in material or workmanship of the Products shall be notified to The Company immediately after discovery of the defect If the Customer does not notify The Company ac
17. ble 3 13 Checking the Hardware amp Software Revision 1 Insert a battery and close the back cover 2 Press the Yellow DOWN key to highlight the About menu op tion then press the Green SELECT key 3 Therevision numbers are displayed on the LCD 34 18 0583 Rev C 3 14 Compact Flashcard The recorder uses a CF card type 1 Compact Flashcard non volatile memory card meeting the Compact Flash Association type 1 standard A new flashcard must be conditioned before first time use which may be done by the user from a menu option in the Spacelabs Healthcare Ltd Holter analyser However cards supplied by Spacelabs Health care are already conditioned Full details are in the user instructions manual If the card has not been supplied by Spacelabs Healthcare Ltd ensure the type is exactly as listed in the Accessories section of this manual Other types may give short or unreadable recordings Lifecard CF Service Manual 35 36 This Page is intentionally Blank 18 0583 Rev C 4 Test Procedure 4 1 Checking the Patient Cable e Fita battery and CF card to the Lifecard CF e Connect the patient cable to the 9270 Tracker calibrator For a lead cable Red to CH1 Yellow to CH2 Green to CH2 and select Cal1 PACE 2 If using another cable or source ensure that there is a unique signal in each channel Inthe main menu select Start e Skip the voice recording Verify that the patients
18. bnormal stresses For continued safety the device must not be maltreated used outside its specified operation conditions or stored outside its specified stor age conditions Lifecard CF contains protection against electrostatic discharge but there is no protection against defibrillators To avoid damage the device should be removed before defibrillating The Varios active yoke and 46 1123 46 1127 patient cables have defibrillator protection The protection is a combination of the cable and the yoke 16 18 0583 Rev C Whenever it is likely that protection has been impaired the device shall be made inoperative and secured against any unintended opera tion The protection is likely to be impaired if for example the device shows visible damage a shows visible damage b fails to perform the intended measurements C has been subjected to prolonged storage under unfavorable conditions d has been subjected to severe transport stresses the device has been connected to a patient during defibrillation 2 Explanation of Markings C CE Mark 0120 Date of Manufacture o Consult Documents This symbol means you should read the accompanying documents EQUIPMENT having a TYPE BF APPLIED PART EQUIPMENT having a DEFIBRILLATION PROOF TYPE CF APPLIED PART Ft Battery Eject symbol Lifecard CF Service Manual 17 Protected against ingress of splashing water when the patient cable is fitted AECG Type 1
19. cordingly the Customer shall not be entitled to reject the Products and The Company shall have no liability for such defect 5 Where any valid claim in respect of any of the Products which is based on any defect in the material or workmanship of the Products is notified to The Company The Company shall be entitled to replace or repair at The Company s sole discretion either at the Customer s premises or at The Company s premises in the United Kingdom the Products or part in question but The Company shall have no further liability to the Customer 18 18 0583 Rev C 6 The Company shall not be liable to the Customer by reason of any representation or implied warranty condition or other term or any duty at common law or for any consequential loss or damage whether for loss of profit or otherwise costs expenses or other claims for consequential compensation whatsoever arising out of or in connection with any act or omission of The Company relating to the manufacture or supply of the Products or use by the Customer 7 Spacelabs Healthcare recommends the use only of approved accessories and parts The use of third party accessories may result in damage to recordings or equipment and may invalidate your warranty 2 7 Contact Details Spacelabs Healthcare Ltd Spacelabs Healthcare Inc 1 Harforde Court 5150 220th Ave SE John Tate Road Issaquah Hertford WA 98029 SG13 7NW USA United Kingdom Tel 44 0 1992 507700 Tel
20. ded Recording Mode or change the patient cable 3AOEXE RR OR One Channel Start week 3 There may be a fault in the cable or you may require a firmware upgrade to use this cable type SEAGKERR OR IE Cable not recognised Lifecard CF Service Manual 29 4 fthis error message is displayed contact the Service Department at Spacelabs Healthcare Ltd 0007 Service required by Del Mar Reynolds 5 This message is displayed if a patient loses a lead during an Ex tended Recording The Lifecard will also generate an alarm which will consist of a series of dingdong tones lasting 15 seconds Once the patient has replaced the lead the clock display resumes KELE AD OFF Channels 1 and 2 11 11 03 15 48 6 This warning is generated if you have selected Start Week and the battery is partially discharged 7 day recording needs a new alkaline battery 7 You will see a warning of this format if you have selected Start Week and the capacity is too small to record 7 days Select Continue only if the recording description meets or exceeds your requirements 30 18 0583 Rev C 8 This message appears if the card capacity and patient cable are not appropriate to provide a 24 hour recording 9 The Lifecard has been closed without a Flashcard inserted Reopen the recorder and insert the card 10 The Flashcard has been inserted before being correctly initi
21. election and then press the green Select button to select it Date European Date American Select Adjust the date in the same way as you have adjusted the time Thursday 30 09 04 Adjust 4 Speech Recording On Off Press the green gt Select button to switch between the Speech Recording option being on or off 26 18 0583 Rev C Time 13 38 Date 18 10 04 Speech Rec On ID Enabled 5 ID Enabled Disabled This option enables you to give the recorder a personalised name or number ID Your chosen ID will appear in the Main Menu and on reports Speech Rec On b D Enabled Sounds Off To use this option highlight the ID Disabled line in the Set Up menu and press on the green gt Select button Press either of the yellow A Y buttons until 10 enabled is displayed Then press the green gt Select button to enter your recorder ID The first character of the ID will be highlighted Use the yellow A V buttons to change the character as required and then press the green gt Select to move the highlight onto the next character You can enter a name or number up to 10 characters long 6 Sounds On Off Use the green gt Select button to select or deselect the Lifecard sounds ID Enabled Sounds Off Service Lifecard CF Service Manual 21 T Service The recorder will remind you when the annual service is due ounds Off Service ack 3 7 Lifecard CF Sounds The
22. f Service Manual Lifecard CF and Lifecard 12 Firmware revision 7 SPACELABS Healthcare 18 0583 Rev This Page is intentionally Blank 18 0583 Rev C 1 2 Contents Page PRODUCT OVERVIEW 1 1 INTRODUCTION 1 2 Specification 1 21 Standard Recording Mode Inputs ONN 1 2 2 Standard Recording Mode Pacemaker Pulse Detection 10 1 2 3 Standard Recording Mode Data Storage 1 2 4 User Interface 1 2 5 Power Requirements 1 2 6 Extended Recording Mode 1 27 Additional Specifications in 12 Lead Mode 1 2 8 Physical and Environmental 1 2 9 Electro Magnetic Compatibility SAFETY AND REGULATORY 2 1 Intended Use of Equipment 2 2 Safety Classification 2 5 Explanation of Markings LCF BUILT IN TESTS 3 1 Primary Built in Tests 3 2 Second Level Built in Tests 3 3 Third Level Built in Tests 3 4 User Level Tests 3 5 Fault Protection While Recording 3 6 Lifecard CF Menu Options 3 6 1 Main Menu Options 3 6 2 Setup Menu 3 7 Lifecard CF Sounds 3 8 Error and Warnings Displays 3 9 Decontamination 3 10 Patient Cable 3 11 Battery 3 12 Battery Check 3 13 Checking the Hardware amp Software Revision 3 14 Compact Flashcard 10 10 11 11 12 12 13 15 15 15 17 21 21 21 21 22 22 23 23 25 28 29 32 33 34 34 34 35 Lifecard CF Service Manual 4 4 1 4 2 4 3 5 6 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 Test Procedure Checking the Patient Cable
23. f the recorder unit enables the patient to indicate symptomatic episodes in the recording for correla tion with the patient diary Pacemaker pulse detection may be enabled and disabled by the physician or cardiac technician Recordings may be analysed using a Spacelabs Healthcare Pathfinder Impresario or Lifescreen Holter analysis system if they have compatible hardware and software Lifescreen is incompatible with 12 lead recordings The Lifecard CF comprises two sections the Recorder Unit and the Patient Cable Unit Lifecard CF Service Manual LIFECARD CF RECORDER UNIT Recorder Unit Lifecard CF Display Yellow Button Green Button Menu Navigation Menu and Selection Patient Event and Patient Event Microphone Loudspeaker Patient Cable Unit Patient Cable Electrode Color Code label Belt Clip long cables only Slot for Neck Lanyard Attachment 18 0583 Rev C o Patient Cable Varios Active Yoke SPACELABS Healthcare u E 1 2 Specification 1 2 1 Standard Recording Mode ECG Inputs Channels 3 type BF applied part patient isolation types 2 or 3 channel 3 electrode 2 4 electrode 3 channel 6 electrode with detachable leadwires Input impedance 5MO Ohms Input DC offset 300 mV with saturation recovery circuit 3 seconds max CMRR gt 60 dB at 10Hz gt 80 dB at 50 Hz and above 2 Vpp signal Dynamic range 10 mV Resolution 2 5uV L
24. ifecard CF Service Manual Calibration Bandwidth Sampling rate Noise filter 5 0 05 40 Hz 3 dB 1024 samples per second per channel Linear phase filter effective from 60Hz to gt 1MHz 128 samples per second out put rate 1 2 2 Standard Recording Mode Pacemaker Pulse Detection Sensitivity 7 mV nominal channels 1 and 2 only Noise rejection gt 50 mVpp for sinusoids up to 200 Hz CMRR 2 V common mode spikes are rejected Refractory period 40 ms 1 2 3 Standard Recording Mode Data Storage Media type Data types Capacity req 1 2 4 Type Languages Clock Removable card CompactFlash Association standard Type 1 Full disclosure ECG with pacing and patient event markers Recording Time and Date Patient name and record number Pathfinder systems Encrypted patient record file CardioNavigator 8 second voice recording Recorder serial number 15 Mbytes per channel per 24 hours eg a 48 hour three channel recording occupies 90 Mbytes User Interface Text menus with audio cues and keys for up down and select English German French Italian Spanish Danish and Polish languages also Hebrew patient ID support Clock and calendar to 2098 selectable 12 24 hour and US European date formats 13mm digit height for patient use 18 0583 Rev C Basic features Ancillary features Hook up display Set up options Pacing detection on off hook up display voice recording for pa
25. ires with tinsel con ductors and an antimicrophonic barrier to provide strength flexibility and low noise There is a choice of 7 patient cable units e 4 electrode cable with belt clip e 4 electrode cable short no belt clip e electrode cable with belt clip e electrode cable short no belt clip 6 electrode cable with belt clip and renewable lead wires unscreened 10 electrode cable for Varios Active Yoke AHA code 10 electrode cable for Varios Active Yoke IEC code Two electrode cables for single channel ECG are no longer offered We recommend three electrode hook up in long term applications Cables with 4 electrodes provide two channels of ECG The popper colour code which is detailed on the cable conforms to AHA 1985 recommendations The short cable without belt clip is designed to maximise patient comfort when the recorder is worn under clothes The 3 electrode scheme and popper colour code as detailed on the cable label is proprietary to Spacelabs Healthcare The 6 electrode cable provides three channels of ECG from 6 elec trodes The individual lead wires are detachable and can be replaced with any DIN42802 connector lead wire useful in situations requiring unusual hook up or electrode termina tions The yoke is colour coded to AHA 1985 recommendations The cable yoke back unit forms a complete assembly and is not serviceable In the case of failure the complete assembly must be replaced In
26. rd CF and ST 20 simulator SEDED ure de Ai l 18 0583 Rev C 4 3 Lifecard CF Check out Connect the 3 Lead Patient Cable to the 9270 Tracker Calibrator Red to CH1 Yellow to CH2 Green to CH2 and select Cal 1 PACE 2 If using another cable or source ensure that there is a unique signal in each channel Fit a CF card a AAA battery and the 3 Lead Patient Cable to the unit under test Check that the speaker tone and display are normal In the main menu ensure that PACING DET Is ON and then select START Select RECORD and speak clearly into the microphone from a dis tance of approximately 150 mm The recording is replayed automati cally check that the recording replay is clear and audible Select CONFIRM and then check the Channel 1 Channel 2 and Channel 3 hook up displays push the down button twice Using the 9270 calibrator Channel 2 has a negative pacing spike only Press the select button to leave the hook up display then select START NOW Approximately 30 minutes after starting the recording press the Green button to mark a Patient Event in the recording Wait for 1 minute and remove the Patient Cable Wait for another minute before re attaching the Patient Cable After 30 seconds the Recording should continue Leave the recording running for up to 24 hours Remove the 3 Lead Patient Cable and eject the CF card eject
27. the case of the 6 electrode cable the individual lead wires may be replaced if broken The 10 electrode cable is replaceable as a complete assembly by releasing the screw securing it to the Varios active yoke The Active Yoke itself it not serviceable and must be returned to Spa celabs Healthcare for repair Lifecard CF Service Manual 33 3 11 Battery Lifecard CF requires one AAA cell either Disposable cell Single AAA alkaline Duracell MN2400 or equivalent two 24 hour recordings or one 48 hour recording or in Extended Recording Modeup to 7 days or in 12 lead mode 24 hours Rechargeable cell Single AAA nickel metal hydride Ansmann 600 mAh or equivalent one 24 hour recording per charge or in Extended Recording Mode up to 3 days Not suitable for 12 lead recording 3 12 Battery Check The user is warned of poor battery condition before recording when starting the recorder Please refer to the detailed instructions in this user manual The real time clock is maintained by an internal rechargeable lithium cell charged during recording from the main battery With a full charge the clock is maintained for at least 3 months after the main battery is removed or exhausted The clock cell is not replaceable by the user and in the case of suspected failure the Lifecard CF should be returned to Spacelabs Healthcare for service Dispose of used batteries carefully using environmentally friendly methods wherever possi
28. tient identification Identify and delete unread recordings warning error screens for battery and memory card conditions Real time display of each channel with 60 Ju V 30 ms resolution and pacing annotation Time and date language display contrast recorder identification 1 2 5 Power Requirements Disposable cell Rechargable cell Battery check Clock battery Single AAA alkaline Duracell MN2400 or equivalent two 24 hour recordings or one 48 hour recording Single AAA nickel metal hydride Ansmann 600 mAh or equivalent one 24 hour recording per charge User is warned of poor battery condition before recording Internal rechargeable cell charged during re cording The clock is maintained for 3 months between recordings 1 2 6 Extended Recording Mode Channels Cable Types Resolution Sampling Rate Compression Capacity required Disposable Cell User Interface 2 channel recording with pacing detection 2 channel 3 electrode or 2 channel 4 electrode 10uV 256 samples per second per channel 10uV maximum compression error when tested with MIT BIH Arrhythmia and Compression databases 90 Mbytes for dual channel 1 week AAA alkaline Duracell MN2400 or equivalent for 1 week Includes an audible alarm to alert the patient if an electrode becomes detached Sense current is 10 nA Note other specifications are the same as Standard Recording Mode Lifecard CF Service Manual 11 1 2 7
29. to Identify and Resolve Radio TV Interference Problems This booklet is available from the U S Government Printing Office Washington DC 20402 Stock No 004 000 00345 4 Lifecard CF Service Manual 14 This Page is intentionally Blank 18 0583 Rev C 2 SAFETY AND REGULATORY 2 1 Intended Use of Equipment The Lifecard CF Holter recorder is to be used for the non invasive ambulatory recording of two or three channel electrocardiograms on a standard commercial compact flash card The Lifecard 12 option is to be used for the non invasive ambulatory recording of 12 lead electrocardiograms on a standard commercial compact flash card The recorder allows data to be collected over a continuous period of up to 7 days whilst allowing the subject to perform most of their nor mal daily activities The recordings can be analysed on compatible analysis systems from Spacelabs Healthcare This device has been designed and supplied specifically for the long term recording of electrocardiograms in ambulatory patients using standard Holter monitoring techniques It shall not be used for any other purposes The device shall be operated only be suitably competent personnel trained in the use and procedures of Holter electrocardiography for diagnostic purposes The Lifecard CF comprises two sections the Recorder Unit and the Patient Cable Unit 2 2 Safety Classification This device has been designed in accordance with EN6
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