- Infiniti Medical
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1. 25 26 21 10 20 27 10 11 34 28 12 34 34 35 13 12 22 23 10 15 28 17 18 21 16 19 11 31 13 37 38 This page is intentionally blank 50 0037 Rev B Instruction and Technical Manual 39 www spacelabshealthcare com Spacelabs Healthcare inc Spacelabs Healthcare Ltd 5150 220th Ave SE 1 Harforde Court Issaquah 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 GD SPACELABS C Y Healthcare 01202. ORDINARY EQUIPMENT without protection against ingress of liquid Not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide or flammable cleaning agents Rated for CONTINUOUS OPERATION EQUIPMENT with an APPLIED PART specifically designed for application where a CONDUCTIVE CONNECTION is made to the PATIENT but not directly to the heart 2 9 Adjustment Replacement of Parts Maintenance amp Repair The device requires no routine adjustments to maintain its operation The device contains one user serviceable part It shall be serviced only by Spacelabs Healthcare or by an agent accredited by them to service device of this type Unauthorized repairs or dismantling of the device will invalidate the warranty Only use the docking station mains adapter supplied by Spacelabs Healthcare Use of the wrong adapter may damage the docking station 2 10 Defects and Abnormal Stresses For continued safety the device must not be maltreated used outside its specified opera tion conditions or stored outside its specified storage conditions The evo recorder contains protection against electrostatic discharge but there is no protection against defibrillators To avoid damage the device should be removed before defibrillating Instruction and Technical Manual 11 Whenever it is likely that protection has been impaired the device shall be made inopera tive and secured against any un
3. When the screen is lit use the button to End the test The recording length will be indicated on the screen A message will appear asking for confirmation that you wish to end the test When you confirm End test the display is cleared and the recorder enters sleep mode To find out what is available on a recorder press any arrow on the navigation button The patient ID and recording details are shown If you did not configure the recorder using Sentinel the recorder screen will show the recorder ID and recording details 2 Remove the recorder from the chest pouch or the belt pouch 3 Disconnect the leads from the recorder and the patient 4 Remove the electrodes and chest pouch if used and discard them 5 Remove the belt and belt mounted pouch if used and clean according to the instructions in the maintenance section of this manual 6 Clean the lead wires according to the instructions in the maintenance section of this manual 7 Clean the recorder according to the instructions in the maintenance section of this manual 24 50 0037 Rev B 3 12 Download the Recording The ECG recording is stored in the recorder s memory and must be transferred down loaded to a compatible Spacelabs Healthcare scanning system 1 Ensure the docking station is connected to the mains power The amber LED is lit when mains power is applied 2 Place the recorder in the docking station as shown The green LED will light The rec
4. e DOR ia SB ee A A Bie A a A A A E NI NS a A a e Ip PL pie a ea pata RR Ha STE ee e ae e Mie cr E F a mat Poate paz ae ia pu ee ie e a RETO pare 7 SP rae Tttt Ttt T 3 Pie A A A OS A A ES A A i A ARA A ANT AAA AAA Sep Pai Mir AA Al SE A a is ii id ii is pi Ti dee i an a oe ae apei alia ia razi a r a p m 7 ri E A A E A A MA A A 1 r m mm a LARA Hi a a a O A a e AL E re AU IRA E ee pa ee ee A A Ue LE El a i T be lada plasata ro 1 i 1 ri fers i i zi Sata Mu A Pa Ra A a a di a a i i a i i H i A PAP PEPA A BEE A A A E A A A A A A A tiation ama a aa a mea a ann Temi imisa m i maa a inmi ri iau i 1 Wie OE LI A GER IL STA A A pd i i Series ee e mpa mm Pie se ia i iasrresd faerie bbe hb rs n i bi a A IAE AT RSS AA 2 i i Li Li F a e i i i 1 A Sl PR UN aN ada LALALA LAA LALALA rs rs o a ao os i i AT 2 PA Breer A a 1 1 E i F 1 i f 4 t f FA Ty i Lend erie eva eee eee a ee ee ee A in ot Ba cl athe aa alert A a ati la oe dd au J La i r i mi i i Peres rs eS rey AAA rere eee ts ADA AAA A frit ilar LEA WE A Ea id d lar E i ini E ismi maimai iam a E 1 E a a ita i ela ee a dac dd im pp mmm boa m Mora rr hH TEA AAA Brisa aia TES oa Lo ana TE ra uu E 4 a i le a a a B i a E i f E 1 i Li bad E didnt sula unua rdarda taa rairrFiA AAA re A A a c m e i im i i ri a H m i f i 1 Peete tbe do Phe bee eae heehee
5. battery Hook up display Real time display of each channel with 60 uV 30 ms resolution and pacing annotation Electro Magnetic Compatibility General Complies with EN 60601 1 2 2001 and ANSI AAMI EC38 1998 ESD 1 4 kV air and 2 kV contact discharges no interruption in re corder function ESD 2 8 kV air and 6 kV contact discharges no damage to the re corder recording resumes automatically in lt 10 s Radiated emissions CISPR 11 1997 EN55011 1998 Group 1 Class B Radiated immunity 3 V m 26 MHz 2 5 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 comput ing 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 e Reorient the receiving antenna e Relocate the equipment with respect to the receiver e Move the equipment
6. ee TETERE 1 vama int bu y 1 fr i i i A F i i E i i pa i a i 5 T E E i E Larissa Brett ee Pk ewe pi ee ea ee ee oe ster ples pera a ig A E Oe ge india E ia k ia H p a i 1 D E eA E B na AS GEO NEA E AA eee fee ee Pe eres as ee so iisi ll Anne pi Technical Manual D Pon ee O aa eed e Al aa taa aa me aa aia a ee om er op Lanas i am ui Mirar LLORA rr rr p m m b b i a boi TERTRE os evo Recorder and Docking Station evo Recorder firmware version 2 XX evo Docking Station firmware version 1 xx ey SPACELABS Healthcare 90 0037 Rev B 50 0037 Rev B Contents Page 1 INTRODUCTION 5 1 1 About this Manual 5 1 2 Disclaimer 5 2 SAFETY AND REGULATORY 7 2 1 Device Description T 2 2 Indications and Intended Use 9 2 3 Contraindications 10 2 4 Precautions 10 2 Warning 10 2 6 Adverse Reactions 10 2 1 Caution 10 2 8 Conformance to Standards 11 2 9 Adjustment Replacement of Parts Maintenance 8 Repair 11 2 10 Defects and Abnormal Stresses 11 2 11 Modifications 12 2 12 Declaration of Conformity 12 2 13 Explanation of Markings 12 2 14 Manufacturer 13 3 DETAILED OPERATING INSTRUCTIONS 15 3 1 First time Use 15 3 2 Minimum Software Versions 15 33 Manual Recording Identification 15 3 4 Recording Procedure Overview 16 3 0 Prepare the Recorder 16 3 6 Prepare the Patient 18 3 7 Apply the Electrodes 19 3 8 Hook up the Recorder 20 3 9 Check the ECG Quality 22 3 10 Instruct the Patient 23 3 11 On
7. hygiene and to reduce the risk of cross infection The evo recorder is not intended for use on infants weighing less than 10 Kg Under normal operating conditions the recorder may feel slightly warm upon removal from the docking station During patient hook up ensure that the electrodes do not come into contact with other metal parts or ground 2 5 Warning This device must not be used for direct cardiac application Never attempt to connect any other device or instrument to the internal connections or circuitry of the evo recorder while it is connected to a subject 2 6 Adverse Reactions Patients may suffer allergic skin reactions from the adhesive of the electrodes causing reddening soreness or irritation Ask the patient if they suffer from these allergies Con tact the electrode provider for further specific information 2 7 Caution Federal USA law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he practices to use or order the use of the de vice 10 50 0037 Rev B 2 8 Conformance to Standards According to ANSI AAMI EC38 1998 the evo recorder is a Type 1 ambulatory ECG de vice This device has been designed in accordance with EN60601 1 Medical electrical equip ment Part 1 General requirements for safety as follows 1 2 o 4 SI EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE EQUIPMENT having a TYPE BF APPLIED PARI
8. still sufficient power remaining to perform a 48 hour recording If you suspect that the recorder is not functioning correctly or any assistance is required contact your supplier or the Service Department at Spacelabs Healthcare 28 50 0037 Rev B 4 3 evo Recorder Accessories and Consumables 50 0191 4 Electrode Hook Up Kit For evo Recorder With Single Use Pouch case of 20 kits 50 0050 0050 evo evo single use pouch bulk packaged packof50 use pouch bulk packaged pack of 50 O eun A user label Instruction and Technical Manual 29 30 This page is intentionally blank 50 0037 Rev B 5 TECHNICAL MANUAL 5 1 evo Recorder Technical Specifications Pacemaker Pulse 2 mV 100 us nominal in any lead detection sensitivity Noise filter Linear phase filter effective from 50 Hz to gt 1MHz Data Storage Media type 128 Mb non volatile internal memory Recording Length 24 or 48 Hours Data types full disclosure ECG with pacing and patient event markers recording time and date patient ID Physical and Environmental Characteristics Dimensions 92 x 45x 15 mm 3 6 x 1 8 x 0 6 welch Instruction and Technical Manual User Interface Type Text menus and keys for up down left and right Languages US English German French Spanish amp Italian Clock Clock and calendar to 2098 13 mm digit height for patient use Ancillary features Identify unread recordings warning error screens for circuit failure and
9. the Patient s Return 24 3 12 Download the Recording 25 3 13 Analyse the Recording 26 4 MAINTENANCE 27 4 1 Cleaning and Disinfecting the evo Recorder 27 4 2 Dynamic Energy Source Replacement Kit 28 4 3 evo Recorder Accessories and Consumables 29 Instruction and Technical Manual TECHNICAL MANUAL 5 1 evo Recorder Technical Specifications 5 2 evo Docking Station Technical Specifications 5 9 evo Error Messages 5 4 Software Error Messages and Warnings SES Firmware Update Utility 5 6 Installation of the Docking Station Sd Infrared Data Transfer 5 8 User Labelling of the Recorder 5 9 User labelling of the docking station INDEX Copyright 2008 Spacelabs Healthcare Ltd 1 Harforde Court John Tate Road Hertford SG13 7NW 50 0037 Rev B 31 31 33 34 34 34 34 35 36 37 1 INTRODUCTION 1 1 About this Manual This manual contains detailed operating instructions for the evo Holter ECG recorder and the evo docking station It is one of 3 manuals for this recorder e evo Recorder Instruction and Technical Manual e evo Recorder Quick Guide Sentinel Users e evo Recorder Quick Guide CardioNavigator Plus This manual has 6 chapters Chapter 1 Introduction Chapter 2 Safety and Regulatory Chapter 3 Detailed Operating Instructions Chapter 4 Maintenance Chapter 5 Technical Manual Chapter 6 Index 1 2 Disclaimer Every effort has been taken to ensure the accuracy of this manual but Spacelabs Health care can
10. types VL 00 S for 24 hour recordings and VLC 00 S for 48 hour recordings a saline wipe may be used if so wished Apply the electrodes The electrode positions shown on the following pages are suggested but not mandatory You may find alternative positions more suitable on individual patients 18 50 0037 Rev B Standard Hookup WHT REF BRN RED Cre o o CHI ORN CH3 Place all electrodes directly over bone to reduce muscle artifact Color Polarity White neg Center of manubrium Ch 1 Left anterior axillary line Modified CM V5 Reg POS Gth rib Two centimeters right of Brown pos the xiphoid process on the rib Ch 3 Orange pos Left mid clavicular line Modified CM V3 a 6th rib 3 7 Apply the Electrodes Ch 2 Modified CM V1 After you have prepared the electrode sites remove the electrodes from the package and apply the electrodes as described in the following procedure NOTE Use only silver silver chloride electrodes that are suitable for Holter recording 1 Connect a color coded snap lead wire to an electrode 2 Remove the adhesive backing of the electrode at the pre cut separation located behind the electrode near the gel Instruction and Technical Manual 19 3 Apply the electrode to the prepared site 4 Smooth the adhesive disk outward and press it firmly around the edges to en sure good adhesion to the skin NOTE Do not press in the middle of the electrode because doi
11. arger active Flashing Amber LED Recorder fitted data interface active Flashing Green LED For more detailed instructions please consult the information supplied with your docking station 5 7 Infrared Data Transfer Do not obscure the infra red port on the front of the recorder with a label Ensure surfaces are clean and free from dust 5 8 User Labelling of the Recorder The back of the recorder has an indented area reserved for a user label as shown in the diagram below Do not place a label lower down on the recorder back re energizing the Dynamic En ergy Source may be adversely affected This space is reserved for a user label DO NOT PLACE A LABEL IN THIS AREA Instruction and Technical Manual 39 5 9 User labelling of the docking station The underside of the docking station also has an indented area reserved for a user label 36 50 0037 Rev B 6 INDEX Belt Mount pouch Caution Chest pouch Cleaning products Contraindications Defibrillators Disclaimer Docking station Dynamic Energy Source replacement Electrostatic discharge Error Messages Firmware updates Indications and Intended Use LEDs Manufacturer Modifications Navigation button Pacing detection Patient Event button Patient instructions Precautions Quick Guide Self check Sentinel Skin preparation Skinfix Sleep mode Standard Hookup Standards Technical Specifications Web site Instruction and Technical Manual La 2d 39
12. 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 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 32 50 0037 Rev B 5 2 evo Docking Station Technical Specifica tions Docking Station PC Interface Type 2 0 Full Speed 12 Mb s Power supply Spacelabs Healthcare 15W Part numbers 50 0044 EU 50 0045 US 50 0169 UK Mains supply 100 240 V AC 50 60 Hz 400 mA Data transfer Optical infra red link between recorder and docking station Firmware Upgradeable Standard EN60950 compliant The docking station has no user replaceable paris Ensure that there is no obstruction to the recorder detection switches Del Mar Reynolds If there is no message on the display after placing the recorder in the docking station inspect the switches and remove any dust or debris 33 Instruction and Technical Manual 5 3 evo Error Messages The evo recorder performs a self test when woken from sleep mode by pressing the menu navigation button If the self test fails the following screen will appear Please return the recorder to your supplier if you see this message Failed test 01 Fai
13. ears on the recorder screen Now go to Section 3 6 Prepare the Patient From page 15 The recorder has already been prepared for the next scheduled test Check that this patient name is correct and press the gt Confirm button to continue Instruction and Technical Manual 17 When the recorder is removed from the docking station the recorder screen is cleared and the amber LED on the docking station will be illuminated You should now prepare the patient and hook up the recorder Note that you may delete the patient details at this stage if they are not correct by press ing on the lt Delete button You will be asked to confirm your decision You should then configure the recorder with the correct patient details 3 6 Prepare the Patient e Proper preparation of the electrode sites and accurate placement of the elec trodes are two crucial steps for successful ECG data recording and analysis e Success of Holter analysis depends largely on the quality of the recording e The recording quality is significantly reduced by artifact which is caused by improper skin preparation and improper placement of the electrodes e Carefully following the steps in this section for preparing all patients will help in obtaining the best recording by reducing artifact Prepare the skin Shave Hair Clean skin with Gently abrade the skin alcohol wipe Use good quality electrodes for the final hook up We recommend Ambu Blue Sensor
14. gy Information Management software The recorder is also compatible with the CardioNavigator Plus database used in conjunc tion with Impresario scanners evo Front View Instruction and Technical Manual evo Top View evo Rear View Docking Station Rear View EVO DOCKING STATION ss MA e 2008 Healincare Lid 1 pr aha io Moe John q on ai tddi EVO PSU 50 0037 Rev B evo placed in Docking Station 2 2 Indications and Intended Use The evo Holter recorder is to be used for the non invasive ambulatory recording of three channel electrocardiograms on an internal non removable flash memory The recorder allows data to be collected over a continuous period of up to 48 hours while allowing the subject to perform most of their normal daily activities No analysis is performed by the evo recorder the recordings can be analyzed on compat ible Holter 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 only be operated by suitably competent personnel trained in the use and procedures of Holter electrocardiography for diagnostic purposes Instruction and Technical Manual 2 3 Contraindications None known 2 4 Precautions Follow the cleaning instructions for reasons of basic
15. in the hook up display the recorder will start recording automatically Check the ECG is of proper amplitude and artifact free Positional changes and the ef fects of movement may also be tested Press the button to move to the next step Start the recording by pressing gt Yes again During the recording the screen shows the time in bold numerals the semi colon will flash The screen is not lit 22 50 0037 Rev B 3 10 Instruct the Patient 1 Carry out your normal daily routine 2 Do not pull on the electrodes or leads or scratch the electrodes 3 Do not bathe or shower while wearing the recorder 4 Avoid electric blankets magnetic fields industrial machinery 5 Use the evo clock time to record your activity and 15 16 symptoms in the diary Patient 6 If you experience symptoms press the navigation button on the front of the recorder and make a note in your pa tient diary You may press any of the arrows on the outer rim 7 To record a diary event the patient pushes the navigation button briefly If the button is held down for too long the End Test menu will appear The patient will hear a click The screen is lit for a few seconds 23 Instruction and Technical Manual 3 11 On the Patient s Return 1 When the patient returns STOP the recording by pressing the navigation button down for 3 seconds Any arrow may be used The patient event screen will appear for 3 seconds
16. intended operation The protection is likely to be impaired if for example the device a b shows visible damage fails to perform the intended measurements has been subjected to prolonged storage under unfavorable conditions has been subjected to severe transport stresses the device has been connected to a patient during defibrillation 2 11 Modifications For continued safety the device shall not be subjected to any unauthorized modifications and must be used only for the purpose for which it was originally supplied 2 12 Declaration of Conformity This product is in conformity with the essential requirements and 0120 provisions of Council Directive 93 42 EEC concerning medical de vices 2 13 Explanation of Markings 12 CE MARK Year of Manufacture Consult Documents THIS SYMBOL MEANS YOU SHOULD READ THE ACCOMPANYING DOCUMENTS EQUIPMENT having a TYPE BF APPLIED PART If you wish to dispose of this equipment it must not be disposed of to gether with ordinary waste but either returned to the manufacturer or to a specialised collection system for used electrical and electronic products Federal USA law restricts this device to sale by or on the order of a medi cal practitioner licensed by the law of the State in which he practices to use or order the use of the device 50 0037 Rev B 2 14 Manufacturer Manufactured for Spacelabs Healthcare Limited 1 Harforde Court John Tate Road Hertford He
17. led test 02 Failed test 03 Repeat Test gt 5 4 Software Error Messages and Warnings sentinel and CardioNavigator Plus may present error messages when attempting to communicate with evo for example if the dock is not powered If you are unable to resolve the problem please note the error number given in the mes sage before contacting Spacelabs Healthcare 5 5 Firmware Update Utility evo recorder and evo docking station firmware updates will be available for the user through the evo firmware update CD The CD will contain a program to upload firmware updates to the evo recorder or to the evo docking station Full instructions for use will be provided with the CD 5 6 Installation of the Docking Station 1 Connect the dock power supply to the mains and to the dock When mains power is applied a green LED will appear on the power supply and the amber LED on the dock will light 2 Connect the USB cable between the docking station and the PC 3 The System will recognise that the dock has been connected and will initiate the appropriate driver First connection only Place the recorder in the docking station 34 50 0037 Rev B The green LED will flash during data transfer and will turn off when data transfer is com plete The green and amber LED displays on the dock thus allow the user to distinguish be tween the following conditions Dock Power OK Amber LED ON Recorder docked Green LED ON Recorder fitted ch
18. m the label Please see section 5 8 of this manual for further details The recorder stores the date and start time of the recording together with the serial number of the recorder If a label is not available simply note down the recorder serial number shown on the back of the recorder date and start time of the recording to gether with the patient s name in a suitable log book Instruction and Technical Manual 15 3 4 Recording Procedure Overview see Desorption O Prepare the recorder Prepare the patient Apply the electrodes Hook up the recorder Check the ECG quality and start recording Instruct the patient On the patients return end the recording Download the recording Analyze the recording 3 5 Prepare the Recorder When the recorder is not in use the recorder screen will be blank The recorder is then in Sleep mode 1 Press the menu navigation button briefly the recorder will perform a self test If a Patient ID is displayed the recorder has already been configured for a specific pa tient Go to Page 17 No Patient ID is shown there is no patient ID information stored in the recorder Follow the instructions shown below The recorder will indicate the time date and recording length This screen indicates that there is no patient ID or ECG data in the recorder You may proceed directly to Section 3 6 Prepare the Patient but it is highly recom mended that you load the patient details co
19. nfigure the recorder via the docking station as shown in the next step 2 Place the recorder in the docking station The green LED will light The con figuration procedure depends upon the database that you are using Sentinel or CardioNavigator Plus Instructions are given in the relevant user manual 16 50 0037 Rev B Configuration Procedure for Sentinel Users Please see the Sentinel User Manual for details Configuration Procedure for CNAV Systems 1 2 3 With the recorder in the docking station click on the desktop icon The Evo Configuration screen will open Enter in the patient details select the recording length then click on Config EVO Configuration New details Recorder details ent ip 12345 Patient iD 12345 ooo PaientiD O Recording Length 24 hrs O 48 hrs Read Config Recording Length A 10 April 2007 Clear Details Note that if the evo clock is not a the current system time a message will inform you that the clock in the recorder will be synchronised with the PC Once configuration is complete the Configuration complete message will appear The Recorder details will then appear inside the evo configuration screen at the right hand side EVO Configuration New details Recorder details antim 3334 Patent 834 2 Patient ID Recording Length 24 hrs 48 hrs Read Config Recording Length Remove the recorder from the dock when the OK TO REMOVE message app
20. ng so will squeeze out the gel 3 8 Hook up the Recorder The evo recorder is either suspended from the patient s neck using a chest pouch or at tached to the patient s belt using the belt mounted pouch option Chest pouch To attach the recorder to the patient using the chest pouch perform the following steps 1 Open the plastic clip on the recorder pouch 2 Feed the free strap end through the clip 3 Adjust to the correct length for the patient and press the clip closed The strap may be cut to the correct length once the clip is fastened 4 You may fix the lower end of the pouch using a Skin Fix if so wished Optional 20 50 0037 Rev B Belt Mount pouch To attach the recorder to the patient using the belt mounted pouch perform the following steps 1 Using the belt clip attach the pouch to the belt 2 Insert the recorder into the pouch 3 Connect the lead wires from the electrodes to the recorder 4 Secure the wires using a Skin Fix or equivalent Optional 21 Instruction and Technical Manual 3 9 Check the ECG Quality Press the Confirm button to monitor the ECG The current channel being displayed is highlighted on the right of the recorder screen To review a different chan nel press on the A Up or Y Down arrows on the naviga tion button Channels Pacemaker symbol 1mV 1 second calibration signal Pacing pulses Note If left uninterrupted for 10 minutes
21. not take liability for consequences caused by errors or omissions You are ad vised to check with Spacelabs Healthcare on any point on which you are unsure or need confirmation Instruction and Technical Manual This page is intentionally blank 50 0037 Rev B 2 SAFETY AND REGULATORY 2 1 Device Description The evo recorder is a compact lightweight three channel Holter Ambulatory ECG re corder utilizing a digital storage technique to store the ECG recording onto an internal flash memory This recorder provides continuous monitoring of 3 leads of ECG for 24 hours or 48 hours The on board display allows the user to monitor the ECG and pacing detection during hook up Pacing detection is always enabled on all 3 channels It is important to verify the ECG quality before starting the recording Menu navigation is controlled by the single button on the front of the recorder This but ton also acts as a Patient Event button when Recording Mode is active This enables the patient to indicate symptomatic episodes in the recording for correlation with the Patient Diary Four separate lead wires with color coded snap leads are used to connect the electrodes on the chest to the recorder The internal Dynamic Energy Source is automatically re energized when each recording is downloaded into the Holter Analyser via the docking station Recordings may be analyzed using an Impresario Holter analyzer in conjunction with the Sentinel Cardiolo
22. order screen display will show that download is in progress The docking station green LED flashes during download Do not remove the recorder during this time Remove the recorder from the dock when the OK TO REMOVE screen appears During the download procedure the Dynamic Energy Source is topped up and will be fully re energized when download is complete The amber LED flashes during re ener gizing The re energize cycle lasts approximately 5 minutes when a 24 hour recording has been made 10 minutes for a 48 hour recording The OK TO REMOVE screen will appear when the docking station is inactive and the recorder may be removed from the dock without causing disruption Instruction and Technical Manual 29 It is normal for the recorder to feel slightly warm when it is removed from the docking station after re energizing A message COMMUNICATING DO NOT REMOVE will be displayed when transfer of information is taking place between the PC and the recorder This can be for the transfer of the patient ID updating the recorder clock or for software updates DO NOT remove the recorder from the docking station if this message is displayed data may be compromised as a result 3 13 Analyse the Recording Sentinel Users Once data has been acquired the recording may be analyzed using Pathfinder Life screen or Impresario for Sentinel CardioNavigator Plus Users CardioNavigator Plus users should click on the name of the
23. patient in the CardioNaviga tor Plus database and click the ECG Edit button More detailed information is provided in the Sentinel Instruction Manual and the Instruc tion Manual for each Holter analyzer 26 50 0037 Rev B 4 MAINTENANCE 4 1 Cleaning and Disinfecting the evo Recorder The evo Holter recorder has no moving parts and requires no routine maintenance other than cleaning after each use It has one user replaceable part the Dynamic Energy Source Please see section 4 2 for further details The plastic parts of the recorder are strong and generally very durable but some chemi cals can attack them Such chemicals may be found in specialist cleaning products dis infectants and skin care products e g sun blocks Due to the enormous range of chemical products and the fact that some are corrosive in very small quantities it is often impossible to find out what has caused damage To ensure trouble free service from your recorders use only the cleaners and disinfectants recommended here 1 Clean the recorder using a soft damp cloth A mild detergent solution may be used provided that it is wiped off with a damp cloth and the recorder is dried afterwards Alternately you may use an Alcohol Free Cleansing Wipe 2 It can be difficult to remove adhesive residues from the patient cable We recom mend Uni Patch UP228 swabs which are also applicable to removing residue from the patient s skin and to cleaning the recorder Al
24. rts SG13 7NW United Kingdom Tel 44 0 1992 507700 Fax 44 0 1992 501213 Distributed by Spacelabs Healthcare Inc 5150 220th Avenue SE Issaquah Washington 98027 United States Tel 425 657 7200 Fax 425 657 7212 Web site www spacelabshealthcare com Instruction and Technical Manual 13 14 This page is intentionally blank 50 0037 Rev B 3 DETAILED OPERATING INSTRUCTIONS This chapter of the manual provides detailed operating instructions for the evo record er and the docking station To help you get started refer to the separate evo Quick Guides You may also need to refer to the Sentinel CardioNavigator Plus Instruction Manuals 3 1 First time Use The evo is ready to use out the box with the Dynamic Energy Source energized for a full 48hour recording 3 2 Minimum Software Versions If you are using the Sentinel Data Management software you must ensure that the soft ware version is V6 0 2 188 or greater If you are using the CardioNavigator Plus database the software version must be V3 05 or greater 3 3 Manual Recording Identification If interface with an evo programmer is not available there is a location for a user label on the back of the recorder Write the name of the patient on the label and attach the label to the back of the recorder Note that a suitable pen and a pack of user labels are included with your recorder A 70 alcohol wipe may be used to erase writing fro
25. ternately isopropyl alcohol swabs may be effective but in either case the wipe must be used genily to avoid damaging the cables The patient electrodes are single use disposable do not attempt to clean or re use them 3 The belt pouch can be cleaned with isopropyl alcohol or a soft damp cloth and the belt can be washed in hot soapy water Disinfecting the recorder 4 If low level surface disinfection is necessary wipe the recorder and cable thor oughly with isopropyl alcohol 70 such as isopropyl alcohol prep pads To avoid damage to the display window wipe the alcohol off with a soft damp cloth and then dry the window Instruction and Technical Manual 2 4 2 Dynamic Energy Source Replacement Kit This kit contains detailed instructions for replacement of the Dynamic Energy Source NOTE This procedure may only be performed by a technician who has been trained and accredited by Spacelabs Healthcare Anti static precautions MUST be used while carrying out this procedure This kit part No 050 051 7 00 is specific to the evo recorder and may ONLY be obiained from Spacelabs Healthcare The Dynamic Energy Source is guaranteed for 3 years The evo recorder performs its own self check before starting a recording The message on the recorder screen will change from Battery good to Battery OK as an advance warning to indicate to the user that the Dynamic Energy Source needs to be replaced At this stage there is
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