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1. CAUTION Besides the maintenance requirements recommended in this manual comply with local regulations on maintenance and measurement The following safety checks should be performed at least every 12 months by a qualified person who has adequate training knowledge and practical experience to perform these tests a Inspect the recorder and accessories for mechanical and functional damage b Inspect the safety related labels for legibility c Inspect the fuse to verify compliance with the rated current and circuit breaking characteristics d Verify that the recorder functions properly as described in the instructions for use e Test the enclosure leakage current according to IEC EN 60601 1 Limit NC 1001A SFC 500pA f Test the patient leakage current according to IEC EN 60601 1 Limit NC a c 101A d c 10uA SFC a c 50uA d c SOWA g Test the patient auxiliary current according to IEC EN 60601 1 Limit NC a c 10uA d c 10uA SFC a c 50A d c 50A h Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC EN 60601 1 Limit SOJA CF The leakage current should never exceed the limit The data should be recorded in an equipment log If the recorder is not functioning properly or fails any of the above tests the recorder has to be repaired WARNING Failure on the part of the responsible individual hospital or institution employing this equipment to
2. EDAN SE 2003 amp SE 2012 Holter System Recorder Version 1 3 Ez About this Manual P N 01 54 455144 13 Release Date April 2014 Copyright EDAN INSTRUMENTS INC 2010 2014 All rights reserved Statement This manual will help you understand the operation and maintenance of the product better It is reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which Edan Instruments Inc hereinafter called EDAN can not be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adj
3. Not Mains power quality should be that transient burst supply lines applicable of a typical commercial or hospital IEC EN 61000 4 4 environment Surge 1 kV line to line Not Mains power quality should be that IEC EN 61000 4 5 2 kV line to applicable of a typical commercial or hospital ground environment Power frequency Power frequency magnetic fields 50 60 Hz should be at levels characteristic of a 3 A m 3 A m i magnetic field typical location in a typical IEC EN 61000 4 8 commercial or hospital environment Voltage dips short lt 5 Ur Not Mains power quality should be that interruptions and gt 95 dip in Ur applicable of a typical commercial or hospital voltage variations on power supply input lines IEC EN 61000 4 11 for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec If the user of the Holter System Recorder requires continued operation during power mains interruptions it is recommended that the Holter System Recorder be powered from an uninterruptible power supply or a battery environment NOTE Ur is the a c mains voltage prior to application of the test level 44 SE 2003 amp SE 2012 Holter System Recorder User Manual Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s decla
4. optional value can be set to on or off Default value is the value set last time If set to off the recorder will not detect write protect switch of SD card Recording will not be affected even if write protect is on Lock position If set to on and recorder detect that write protect switch is on Lock position the recorder will display a warning message and refuse to record NOTE It is recommended to set the parameter as on so as to avoid deleting protected data accidentally 4 3 9 Pole fall Sound The detection and warning for electrodes falling during recording can be set to on or off Default value is the value set last time 5030 SE 2003 amp SE 2012 Holter System Recorder User Manual 4 3 10 Battery Type Battery type used for the recorder can be set to alkaline or Ni MH Default value is the value set last time There are great differences on initial discharge voltage and final discharge voltage between alkaline battery and NI MH battery Please set it to be real battery type in use so as to ensure more accurate warning for battery under voltage 4 3 11 Date and Time Adjust year month date and hour minute second of real time clock Week will adjust itself automatically 25 12 2006 14 45 88 Wednesday Set second Exit SE 2003 SE 2012 has a clock backup battery inside Even if the battery of recorder is taken out for a long time the clock circuit still works normally Only if the recorder is unused for a long
5. After the end of analysis and unplugging of USB cable the recorder will restart and prompt as follows USB 16 unlinked System will restart 35 SE 2003 amp SE 2012 Holter System Recorder User Manual 6 Cleaning Care and Maintenance CAUTION 1 Remove the battery and the patient cable from the recorder before cleaning 2 Prevent any liquid from seeping into the recorder otherwise the safety and the performance of the recorder can not be guaranteed 6 1 Cleaning the Patient Cable CAUTION Any remainder of detergent should be removed from the patient cable after cleaning To clean the patient cable 1 Dampen a soft cloth with one of the disinfectants or cleaning agents listed below 2 Wring excess moisture from the cloth before cleaning Recommended Cleaning Solutions Mild soap and water 75 alcohol 6 2 Care and Maintenance 6 2 1 Visual Inspection Perform a visual inspection of all equipment and peripheral devices daily If you notice any items that need repair contact a qualified service engineer to make the repairs Check the case and display screen for cracks or other damage Regularly inspect all plugs cords cables and connectors for fraying or other damage Verify that all cords and connectors are securely seated Inspect keys and controls for proper operation 36 SE 2003 amp SE 2012 Holter System Recorder User Manual 6 2 2 Maintenance of the Recorder and the Patient Cable
6. Instruments Inc 4 1 Menu Setting SE 2003 SE 2012 employs two level menu structure The first level has four menu items Use left up key and right down key to move cursor to select menu items Press confirmation key to enter the second level menu of the selected menu item Still select menu items by left up key and right down key in the second level menu and then enter change status by pressing the confirmation key Change parameters of selected item by left up key and right down key Press confirmation key to exit change status Each second level menu has backspacing selection item press confirmation key to return to upper level menu when cursor is on the backspacing item 4 2 System Setting Set parameters of current recording in the parameters setting menu Press Exit to return to upper level menu Different parameters have to be set in different versions of recording formats Gain 0 5 Channels ich Record time eel 20 SE 2003 amp SE 2012 Holter System Recorder User Manual 4 2 1 Channels The number of recording channels of SE 2003 can be set to 3 2 or 1 4 2 2 Gain Gain can be adjusted to 0 5 1 or 2 The default startup setting is the value adjusted last time 4 2 3 Recording time Record time can be set to 1 day 2 days 3 days 4 days or Cont Default value is 1 day Cont means no recording time limit The recording won t stop until the battery runs out NOTE Long time recording needs software support
7. O A A a a k 23 SDN OTM etre a Se ea a ek Sa a aga St oth aes a ee cate aes as aac altan 23 4 3 8 Cheek WP S Wate td A AR A AAA 23 SPARC aT AUS OR 23 AD AO Battery Typerende alaba ista 24 4 31 10866 ANN Time gered sah sia E enl casas a ad iad ca 24 4 3 12 Bt os econecaa sea decdaca pe aldas Pauses eae a a a eats 24 4A Sereen Description tipigi i e a e Ea avi ER Glades duane 25 44 Start Up Picture annee ee aa a e daca cline e E E TEA 25 4 42 Low Battery Message Tirronen AS A a a 25 Aa Oda E Message ca Se inso ahaa a a a ta E 25 4 4 4 Inserting SI Card Messagen rcs cineca adie da 26 4 4 5 Read write Errors of SD Card MeSsage sccssscsssssssecseecsesecsssctecesssscssacsenecereseaes 26 4 4 6 Write protect of SD Card Messages ssccssesiesssaisaesstazss taasanausssvadedensiaissdardsavtsesbansestaesecs 27 44 7 Data Protection Mess ar ease E yan 27 4 4 8 No Patient Cable Message ii 27 4 4 9 Automatic Shutdown 1641699886 00 0 28 A AAO Std Wit Wess Oe od datos 28 E 29 A O ca tanuc a ie n a chipnc cen ta a Aven tas a a Ae i aieia 29 52 Start RC COME eorr ok este O 29 diz Stait Recording ln li tios 30 5 2 2 A A o A hs 30 5 23 EGG PROVIGW mia ass id aa dasa aad aes eae e 31 A A caus semeneeeae ans 31 5 3 Recording Ss LADUIS sexe ito 32 Ss A a a E E RT 32 5 3 2 ECG Display ai scwusias ionam
8. as below IEC AHA Electrode Placement as Red CH1 Left Anterior Axillary line 6 rib Red CH1 ne Right Manubrial border of the Sternum os is Approximately 1 inch right of Xiphoid Process on the rib a ee Left Manubrial border of the Sternum Black RL Green RL Lower right rib margin over bone Orange Orange sa iia CH3 CH34 Left Mid Clavicular line 6 rib Blue CH3 Blue CH3 Center of the Manubrium 18 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 4 2 Attaching the Electrodes CAUTION The disposable electrodes can only be used for one time Disposable Electrode Connection 1 Clean the electrode areas on the body surface with 75 alcohol 2 Attach the disposable electrodes to the electrode positions on the body surface 3 Clip the disposable electrodes with the lead wires The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode In order to get a high quality ECG the skin electrode resistance must be minimized while connecting electrodes 19 SE 2003 amp SE 2012 Holter System Recorder User Manual 4 Recorder Preparation The menu displays recorder model serial number firmware version and manufacturer information All information is set before final sale and cannot be modified by users SE 2003 Holter Recorder Recorder SN 456789 Firmware Version 3 1 Manufactured by Edan
9. be guaranteed Table 7 1 Accessory List Accessory Quantity Patient Cable 1 SD Card 1 Belt Clip 1 Waistband 1 AAA alkaline battery 2 The Holter system recorder and accessories are available by contacting the manufacturer or your local distributor 39 SE 20038SE 2012 Holter System Recorder User Manual 8 Warranty and Service Policy 8 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty 16 void in the case of a Damage caused by handling during shipping b Subsequent damage caused by improper use or maintenance c Damage caused by alteration or repair by anyone not authorized by EDAN d Damage caused by accidents e Replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 8 2 Contact Information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN
10. implement a satisfactory maintenance schedule may cause undue equipment failures and possible health hazards 1 Recorder Avoid excessive temperature sunshine humidity and dirt Put the dustproof coat on the recorder after use and prevent shaking it violently when moving it to another place Prevent any liquid from seeping into the recorder otherwise the safety and the performance of the recorder can not be guaranteed 237 SE 2003 amp SE 2012 Holter System Recorder User Manual 2 Patient Cable Integrity of the patient cable including the main cable and lead wires should be checked regularly Make sure that it is conductible Do not drag or twist the patient cable with excessive stress while using it Hold the connector plug instead of the cable when connecting or disconnecting the patient cable Store the lead wires in a big wheel to prevent any people from stumbling Once damage or aging of the patient cable is found replace it with a new one immediately CAUTION The recorder and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal 38 SE 2003 amp SE 2012 Holter System Recorder User Manual 7 Accessories WARNING Only the patient cable and other accessories supplied by the manufacturer can be used Or else the performance and electric shock protection can not
11. into contact with the leakage liquid cleanse it with clean water at once If the leakage liquid splashes into your eyes do not wipe them Irrigate them with clean water first and go to see a doctor immediately Properly dispose of or recycle the depleted battery according to local regulations Remove the battery from the recorder when the recorder isn t used for a long time 2 3 General Cautions CAUTION Avoid liquid splash and excessive temperature The temperature must be kept between 5 C and 40 C during operation and it should be kept between 20 C and 55 C during transportation and storage Do not use the recorder in a dusty environment with bad ventilation or in the presence of corrosive Make sure that there is no intense electromagnetic interference source around the equipment such as radio transmitters or mobile phones etc Attention large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment etc is likely to bring electromagnetic interference The recorder and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do NOT dispose of them together with house hold garbage At the end of their lives hand the batteries over to the applicable collection points for the rec
12. service department at support edan com cn 40 SE 2003 amp SE 2012 Holter System Recorder User Manual Appendix 1 Technical Specifications A1 1 Safety Specifications IEC 60601 1 1988 A1 1991 A2 1995 EN 60601 1 1990 A1 1993 A2 1995 Comply with 1EC60601 1 2 2001 A1 2004 EN 60601 1 2 2001 A1 2006 IEC EN 60601 2 47 Anti electric shock type Internal power supply Anti electric shock degree Type CF Degree of protection against Ordinary equipment Sealed equipment without liquid harmful ingress of water proof Disinfection sterilization Refer to the user manual for details method Degree of safety of application in the presence of flammable gas Equipment not suitable for use in the presence of flammable gas Working mode Continuous operation EMC Group 1 Class B Patient NC lt 101 AC lt 101A DC Leakage Current SFC lt 50uA AC lt 50uA DC Patient NC lt 10pA AC lt 104A DC Auxiliary Current SFC lt 50uA AC lt S0uA DC A1 2 Environment Specifications Transport amp Storage Working 20 C 4 F 55 C 5 C 41 F 40 C Temperature 131 F 104 F ae 25 93 25 80 Relative Humidity f Non Condensing Non Condensing 41 SE 20038SE 2012 Holter System Recorder User Manual Atmospheric Pressure 700hPa 1060hPa 860hPa 1060hPa A1 3 Physical Specifica
13. time or time zone is changed the clock has to be adjusted 4 3 12 Exit Press confirmation key to return to upper level menu 24 SE 2003 amp SE 2012 Holter System Recorder User Manual 4 4 Screen Description 4 4 1 Start up Picture The start up picture below will show up for a couple of seconds when SE 2003 SE 2012 is powered on SE 2003 HOLTER RECORDER 4 4 2 Low Battery Message 1 The warning information below will show up if battery voltage is detected to be too low and cannot operate normally The recorder will automatically shut off in 30 seconds WARNING Low Battery Power off in 30 seconds 4 4 3 Low Battery Message 2 The warning message below will show up if battery is detected to be under voltage and cannot support long time recording If you choose No to stop recording the recorder will automatically shut off in 5 seconds if you choose Yes the recorder will keep working Low Battery Continue No 25 SE 2003 amp SE 2012 Holter System Recorder User Manual WARNING If you operate the recorder for less than 24 hours you can choose Yes to continue Otherwise you need to replace it with new battery 4 4 4 Inserting SD Card Message The prompt message below will show up if no SD card is detected when the recorder starts up Recorder will wait until user inserts SD card SD card not found Please insert 4 4 5 Read write Errors of SD Card Message The prompt mess
14. 003 SE 2012 Holter System Recorder 1 1 Intended Use The SE 2003 SE 2012 Holter System including analysis software and recorder is intended to record analyze display edit and generate report of ambulatory ECG It is mainly used for but not limited to the following indications 1 Evaluation of symptoms suggesting arrhythmia or myocardial ischemia 2 Evaluation of patients for ST segment changes 3 Evaluation of drug response in patients taking anti arrhythmic medications 4 Evaluation of patients with pacemakers The Holter system is intended to be used in hospitals and clinics by trained personnel under the direction of doctors The analysis results are offered to doctors on an advisory basis only The Holter system is intended for adult paediatric patients and infants weighing less than 10 kg WARNING 1 This recorder is not designed for internal use or direct cardiac application 2 This recorder is not intended for treatment 3 The results given by the recorder should be examined based on the overall clinical condition of the patient and they can not substitute for regular checking 1 2 Warnings and Cautions Consideration of Safety and Efficiency The dependability of the recorder depends on the proper operation in accordance with operation and maintenance guidance given in the manual The lifetime of the recorder mainly depends on the components validity which is 5 years under normal conditions If componen
15. 6 or CH1 CH2 CH3 under 3 channle mode Press left up key or right down key to change ECG lead channel press left up key and confirmation key together to shift to information display mode 5 4 Stopping Recording 1 Recording will automatically stop if recording has lasted for 1 day or 2 days 3 days set beforehand 2 Recording will automatically stop if battery is used up 3 Recording will automatically stop due to limited SD card capacity 4 Directly connect with USB cable after removing patient cable 5 Press confirmation key left up key and right down key together to stop recording The above are recommended regular ways to terminate recording Directly taking out battery will also terminate recording while it may cause damages to data SD card may have to be scanned and repaired through disk scanning program of operating system which shall be avoided Take out SD card and insert it into analysis system card reader or connect USB cable with recorder to prepare for analysis Remove leads and electrodes from patients and do necessary cleaning for them 33 SE 2003 amp SE 2012 Holter System Recorder User Manual WARNING 1 Electrodes are for one off use only as they may cause cross infection between different patients Repeated use is forbidden 2 For disposal of abandoned electrodes please follow hospital requirements or local laws and regulations Do not discard them carelessly After necessar
16. HA 1 Red CH1 2 Brown CH2 O 3 Orange CH3 O 4 White COM O 5 Green RL IEC 1 Green CH1 2 White CH2 3 Orange CH3 4 Red COM O 5 Black RL Table 3 2 Electrode Connectors and Their Identifiers and Color Codes Electrode Code IEC Code AHA Positive Electrode Green Red Channel 1 Negative Electrode Red White Positive Electrode White Brown Channel 2 Negative Electrode Red White Positive Electrode Orange Orange Channel 3 Negative Electrode Red White Neutral Electrode Black Green aJe SE 2003 amp SE 2012 Holter System Recorder User Manual 3 2 2 3 7 Electrodes 3 Channels AHA O 1 Red CH1 O 2 White CH1 _ 3 Brown CH2 O 4 Black CH2 5 Orange CH3 6 Blue CH3 7 Green RL IEC 1 Green CH1 0 2 Red CH1 O 3 White CH2 O 4 Yellow CH2 O 5 Orange CH3 6 Blue CH3 7 Black RL Table 3 3 Electrode Connectors and Their Identifiers and Color Codes Electrode Code IEC Code AHA Positive Electrode Green Red Channel 1 Negative Electrode Red White Positive Electrode White Brown Channel 2 Negative Electrode Yellow Black Positive Electrode Orange Orange Channel 3 Negative Electrode Blue Blue Neutral Electrode Black Green 14 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 3 Preparing the Patient 3 3 1 Instructing the Patient Give neces
17. Not all formats support long time recording 4 3 Advanced Setting Operation interface procedure and time are set in this menu 4 3 1 ECG Preview ECG Preview on Set Patient ID off ECG Display on LCD Contrast 100 Data Protected ECG preview can be set to on or off The default value is off If set to off ECG preview will be skipped 21 SE 2003 amp SE 2012 Holter System Recorder User Manual 4 3 2 Patient ID Writing E label registration detection can be set to on or off Default value is the value set last time When set to on SD card will be checked whether E label is registered during start up process If not the recorder will enter Patient ID writing process and you need to input Patient ID through keyboard When set to off the recorder will skip Patient ID writing process which will not affect normal E label registration process If more than one patient is tested at the same time it is recommended to set the item as on If only one patient is tested and registration process is found to be troublesome the item can be set to off so as to simplify the process 4 3 3 ECG Display ECG display during recording process can be set to on or off Default value is the value set last time Set the value as on and enter ECG display mode by pressing Left up key and confirmation key during recording process and observe waveform It is unable to enter ECG display mode by pressing Left up key and confirmatio
18. age below will show up if errors take place during read write process even though SD card is detected before recording The recorder will wait until SD card is inserted The recorder will shut off in 60 seconds WARNING SD card error Error code 40h CAUTION It is possible that users use incompatible SD card or something is wrong with SD card if such prompt pops up The SD card has to be repaired or changed 26 SE 20038SE 2012 Holter System Recorder User Manual 4 4 6 Write protect of SD Card Message The prompt message below will show up if write protect switch is detected to be at Lock position and item of data protect under Advanced setting is set to on The recorder will shut off in 60 seconds WARNING SD card is locked ECG can t be recorded 4 4 7 Data Protection Message If the Data Protection is set to ON in the advanced settings and there is unanalyzed data in the SD card the recorder will show the message WARNING ECG file isn t analyzed Power off in 5 minutes NOTE To proceed running data in the SD card has to be analyzed at least once or be canceled on PC 4 4 8 No Patient Cable Message The prompt message below will show up if no patient cable is detected before recording The recorder will wait until patient cable is inserted No patient cable Please insert 27 SE 2003 amp SE 2012 Holter System Recorder User Manual 4 4 9 Automatic Shutdown Message The rec
19. ance Electromagnetic environment guidance Holter System Recorder uses RF energy 0 only for its internal function Therefore its RE EMINE Group 1 RF emissions are very low and are not CISER I likely to cause any interference in nearby electronic equipment RF emission Holter System Recorder is suitable for use CISPR 11 CB in all establishments including domestic Harmonic establishments and those directly connected emissions Not applicable to the public low voltage power supply IEC EN 61000 3 2 network that supplies buildings used for Voltage domestic purposes fluctuations flicker No apolicable emissions Ag SE 2003 amp SE 2012 Holter System Recorder User Manual Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity Holter System Recorder is intended for use in the electromagnetic environment specified below The customer or the user of Holter System Recorder should assure that it is used in such an environment IEC EN 60601 Complianc Electromagnetic environment Immunity test test level e level guidance Electrostatic ae kV Floors should be wood concrete or discharge ESD 6 kV contact dl ceramic tile If floors are covered IEC EN 61000 4 2 8 kV air 48 KV aj with synthetic material the relative Vair humidity should be at least 30 Electrical fast 2 kV for power
20. can be used Or else the performance and electric shock protection can not be guaranteed Make sure that all electrodes are connected to the patient correctly before operation Ensure that the conductive parts of electrodes and associated connectors including neutral electrodes do not come in contact with earth or any other conducting objects The disposable electrodes can only be used for one time 10 The use of equipment that applies high frequency voltages to the patient including 11 electrosurgical equipment and some respiration transducers is not supported and may produce undesired results Disconnect the patient data cable from the recorder or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment If multiple instruments are connected to a patient the sum of the leakage currents may exceed the limits given in the IEC EN 60601 1 and may pose a safety hazard Consult your service personnel SE 2003 amp SE 2012 Holter System Recorder User Manual 1 2 2 Alkaline Battery Care Warnings WARNING Do not heat or splash the battery or throw it into fire or water Do not destroy the battery Do not pierce battery with a sharp object such as a needle Do not hit with a hammer step on or throw or drop to cause strong shock Do not disassemble or modify the battery When leakage or foul smell is found stop using the battery immediately If your skin or cloth comes
21. d check placement quality of electrodes 10 End of recording NOTE 1 SE 2012 supports three kinds of lead mode 10 electrode standard 12 lead mode 7 electrode 3 channel mode and 5 electrode 3 channel mode Recorder will automatically identify and record data generated from different leads accordingly 2 SE 2003 supports 7 electrode or 5 electrode 3 channel mode 5 2 Start Recording The start menu of initiating recording is process based According to different parameters set in Advance Setting all processes from simplified to complete are listed as below Startup Start Input EEG preview confirmation recording Patient ID 29 SE 2003 amp SE 2012 Holter System Recorder User Manual 1 Make electronic labeling registration of SD card recorder in analysis system or other specialized software or stick the labeling on the SD card surface manually 2 Insert the SD card into SE 2003 SE 2012 Holter System Recorder or unplug USB cable 3 Attach electrodes on patient as per guidance mentioned in previous section and then insert patient cable into recorder 4 Load one AAA battery in correct polarity 5 Set parameters through recorder LCD and keyboard and then preview ECG wave 6 If the wave quality is not good adjust electrodes to receive good ECG graph Reduce electrode impedance by adding weight of electrodes if baseline shifts when patient breathes 7 Start to record and write down starting time i
22. e skin with a gauze pad to increase capillary blood flow to the tissues and to remove the dead dry skin cells and oils NOTE If you don t have enough time for the steps above you can use pledget to scrub the electrode sites to remove the dead dry skin cells and oils and increase capillary blood flow to the tissues 15 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 4 Attaching the Electrodes to the Patient Use qualified and valid silver silver chloride disposable monitoring electrodes specially used for the recorder It is recommended to choose disposable electrodes complying with YY T 0196 94 or ANIS AAMI EC12 1991 requirements 3 4 1 Electrode Placement The application of electrodes should be performed by trained medical personnel It s better to place electrodes on skin over ribs or cartilage to avoid interference resulting from movement of soft tissues 3 4 1 1 10 Electrodes 12 Leads 10 electrode standard lead wires are utilized by the recorder 12 channel to create a 12 lead ECG signal Different placement positions of 10 electrodes will form different lead modes and it is recommended to place electrodes as below IEC AHA Electrode Placement Red R White RA Below clavicle close to right shoulder Yellow L Black LA Below clavicle close to left shoulder Black N Green RL Lower right rib margin over bone Green F Red LL Lower left rib margin over bone Red Cl Red V1 Right of Mid Clav
23. e skipped if the setting of ECG preview is off under Advance Setting menu MN Venn PS er Wo The upper part displays one channel ECG wave while the bottom displays name of the lead channel I IL UI aVR aVF aVL V1 V2 V3 V4 V5 V6 or CH1 CH2 CH3 in 3 channel mode Press left up key or right down key to change ECG lead channel and press confirmation key to enter next process NOTE The time axis paper speed in waveform display mode is around 1 5cm s or 3cm s which is slightly different from regular ECG with paper speed of 2 5cm s or 5cm s Actually the main purpose is to visually assess signal quality and basic form but not to be basis of quantitative measurement 5 2 4 Confirmation Start Recording ECG Exit Shift cursor between OK and Exit by pressing left up key or right down key Press Exit to return to main menu or press OK to start recording ae q ES SE 2003 amp SE 2012 Holter System Recorder User Manual 5 3 Recording Status The SE 2003 5E 2012 will shift from recording process to information display mode to display current date time recording time patient information and recording parameters Only one second is needed to shift to real time waveform display mode by pressing left up key and confirmation key together 5 3 1 Information Display Current date time recording time patient information and recording parameters are displayed in a top down order If recording time is
24. ect cardiovascular without the inference of distance time environment the restriction of body position and activity It can detect large amount of ECG information and is unique in capture of transient myocardial ischemia and diagnosis of transient arrhythmia SE 2003 SE 2012 is powered by an AAA battery SD card is used as storage media and LCD screen is used to set parameters and check wave quality With a normal AAA alkaline battery SE 2012 can continuously record non compressed and full disclosure 12 lead ECG data for 24 48 hours or 3 channel ECG data for 24 96 hours With a normal AAA alkaline battery SE 2003 can continuously record non compressed and full disclosure 3 channel ECG data for 24 96 hours With a Li Fe battery SE 2003 7d can continuously record non compressed and full disclosure 3 channel ECG data for 7 days SE 2003 SE 2012 can detect and record pacemaker pulse information NOTE Long time recording analysis should be supported by software with corresponding functions SE 2003 amp SE 2012 Holter System Recorder User Manual 2 1 Appearance Please find appearance of SE 2003 SE 2012 Holter System Recorder below Multifunctional Socket LCD Screen Left up Key Confirmation Key Right down Key SD Card Port Battery Cathode Battery Cover SE 2003 amp SE 2012 Holter System Recorder User Manual 2 2 Lead Input USB Socket SE 2003 SE 2012 is featured by a 26 pin lead input USB multi functional connector s
25. edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
26. ee Goaceeiecsentencatonceansecmeas gues couataoeacencahacebcngiewerecasmunetonnns 11 Delo REQUCBIS Materiali rarasaan a td da added 11 3 2 Connecting the Patient Cable to the Recorder and Electrodes ooonoonnccniccncnonccococoncncncnncnns 11 3 2 1 Connecting the Patient Cable to the Recorder ooooococnoccinoccnoccconncconoconc cono noonnccnocannconnno 11 3 2 2 Connecting the Patient Cable to Electrodes ooooconinccinccnnccnnococoncconnnonnnonnnoconacnnncnnnno 11 3 32 Preparmo the Patti 15 ds LATS ES LT PA didas 15 Deed Preparing the e EN Sci 15 3 4 Attaching the Electrodes to the Patti 16 3 4 1 Electrode Placement ii A A A EA aks 16 DADA ain tS Electrodes A A a Seca n Sass Ud Manes Mens 19 4 Recorder Preparation ag cocccccsssccsvescesxooceiuseeessnsseiqusiaesebs osestesd ound cuvasasscecessbeuevondeds des eeeenesusenteatens 20 4 1 METIA a deta eid oaducssa nae Mets tated uadccartaaelaa aac a a Gera 20 ADS WSU CTI LETT D one th jac acest E E eds Sepa guna Gataneea aire nema T ema A a E 20 Bh DN AA E 21 Bh DD GIA gts de casa enna E EE mea ptdnsebeaiatrs sak E E S ase ta aha sepeed mee odes 21 4 2 3 Recording a o o ails eal a ane 21 413 Advanced Setting AA deine Aes Anke AAA 21 OS A ECG PEC VOW oh ila haere Ae aaa Saka Tac een toad cena tat loa eee ah af tian te til Rea Man 21 AS 2 Patient ID WO ii 22 4 3 3 ECG Display nada meta cits 22 AS AT CD COMAS Ei A a a 22 NA 4 26 22 A O
27. enan a a Ae Sed n a a aides Ae a seed 33 5 4 Stopping Recordin A 33 5 5 Data Transmissions i i e E A AE AA AEO dass TOO EAREN A AAE ALEEN 34 5 5 1 Tranismitbys Cardin i E a a a E nd a a EA 34 5 5 2 USB Conn ctioi ces enn eae os 34 6 Cleaning Care and Maintenance sseessseessecssocesocesoosesocssocessocesocesoosesoeessecssocesocesoosessesssecesoses 36 b Cleaning the Patient Cal E AA 36 6 2 Gare and Waite tance to RTS 36 LLO EA ias 36 6 2 2 Maintenance of the Recorder and the Patient Cable oooooninccinnccioccnoccnoncconnoconcconnconnnon 37 IV T ACCOSSOLIES sicicsscscdse sasatcceacusucdesesdecdecdescsdescseccscscescesescsdecsedddsessesdssecscecsdcassdcsdeccecdesedssacecesedesdecdedscss 39 8 Warranty and Service Policy eessoessoesssccssocescoosscosesocessccssocesoosccocesoccsoccesocesocesoesssecesocssocsssossse 40 Sd Warranty Ree a a ree A A eee en ne 40 8 2 Contact Informatio A a e ash eres a AE E Ea 40 Appendix 1 Technical Specifications ooooomsss 41 Poll Saf ty Spec Cations a ue casa ata 41 Al 2 Environment Specifications A 41 PAT 3 Physical Special ds 42 A Battery Specifications AO SS 42 AS Performance Special OMS id A a dia 42 Appendix 2 EMC Information viescececcsvivesusesciocdceashoousseadeonconayvencevuns nteaudesacbet sovaesseveudevduesvivucsonnse 43 SE 2003 amp SE 2012 Holter System Recorder User Manual 1 Safety Guidance This chapter provides important safety information related to the use of SE 2
28. icular line 4 rib Yellow C2 Yellow V2 Left of Mid Clavicular line 4 rib 16 SE 2003 amp SE 2012 Holter System Recorder User Manual Green C3 Green V3 In the middle of V2 and V4 Brown C4 Blue V4 Brown V4 Left Mid Clavicular line 5 rib Black C5 Orange V5 Left Anterior Axillary line the same level of V4 Purple C6 Purple V6 Left Middle Axillary line the same level of V4 3 4 1 2 5 Electrodes 3 Channels Five electrode three channel lead wires are utilized by the recorder to create a 3 channel ECG signal Different placement positions of 5 electrodes will form different lead modes and it is recommended to place electrodes as below enn SY IEC AHA Electrode Placement om ao Right Manubrial border of the Sternum a gt a 1 Left Anterior Axillary line 6 rib equivalent to V5 breast lead White Brown ae z CH2 CH2 Right of Xiphoid Process on the rib equivalent to V1 Orange Orange Left Mid Clavicular line 6 rib equivalent to V3 CH3 _ CH3 ie Black RL Green RL Lower right rib margin over bone s17 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 4 1 3 7 Electrodes 3 Channels Seven electrode three channel lead wires are utilized by the recorder to create a 3 channel ECG signal Different placement positions of 7 electrodes will form different lead modes and it is recommended to place electrodes
29. ion or check if any articles block in the slot 2 The first step to unload SD card is to push card inside and then let it pop up automatically Never pull out the card by force before it pops up It may cause damage to recorder and SD card SE 2003 amp SE 2012 Holter System Recorder User Manual 2 5 Battery Loading SE 2003 SE 2012 is powered by one AAA battery Large capacity AAA alkaline battery is recommended Press mark on battery compartment on the back of recorder by thumb and push outwards with force The cover of battery compartment will open Load one AAA battery according to polarity indication inside battery compartment NOTE There is battery type setting in the setting menu of SE 2003 SE 2012 alkaline battery and Ni MH battery The purpose is to give more exact warning message on battery under voltage according to discharge performance of different battery types Please set the menu according to used battery type WARNING 1 Take out battery if the recorder is not to be used for a long time Or else damage from corrosion could result 2 Do not throw off used or scrapped batteries Observe operation instructions and local laws for battery disposal 2 6 Features Refined appearance 68 x 53 x16 mm 42g SE 2012 Holter System Recorder is able to create standard 12 leads or 3 channels complete ECG data EDAN s unique multi channel pacemaker detect circuit effectively prevents wrong detection of pacemaker signal ca
30. le and mobile RF communications equipment transmitters and Holter System Recorder as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 80 MHz to 800 output power of MBz MHz 800 MHz to 2 5 GHz transmitter W Z d 12 P d 12 P d 234P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 46 P N 01 54 455144 13 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipments Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA Email info
31. lysis software after finishing recording SE 2003 amp SE 2012 Holter System Recorder User Manual Only the SD card specified by manufacturer can be used in SE 2003 SE 2012 If you need to add or replace SD card please contact manufacturer or dealer Do not insert incompatible or unknown SD card into SE 2003 SE 2012 recorder That is to avoid unnecessary damages CAUTION SD card is a light and precise device Do not knock or bend it or insert articles into the jacks Keep the SD card in the recorder and it helps to prevent foreign matters from falling into SD card slot 2 4 1 Capacity Requirements Capacity of SD card accompanied with recorder is 2G If the SD card is not provided together with recorder please contact the manufacturer or distributor 2 4 2 SD Card Loading and Unloading SD card holder is push push structure Load Face front of SD card with a cut angle toward back cover of recorder slightly push it into SD card slot until the end of SD card and card slot are at the same level Release the finger and let SD card automatically draw back 1 mm or so It means SD card is in the right place Unload Use finger to push SD card inside until its end and card slot are at the same level Release the finger and SD card will automatically eject 5 mm or so Use fingernail to catch the end of SD card and slightly pull it out CAUTION 1 Do not load SD card with too much force If you feel resistance please check load direct
32. n key during recording process if the value is set to off This helps to prevent unnecessary influence to patients Whether entering ECG display mode or not recording signals will not be influenced 4 3 4 LCD Contrast LCD contrast can be adjusted in the range of 10 100 with 10 of grade difference Default value is the value set last time The item is adjusted according to light environment and user habits There is no need to modify it under normal situations 4 3 5 Data Protection Data protection is used to detect if the recorded data has been analyzed If it is set to on the recorded data has to be analyzed by analysis software at least once before starting the next recording It can also be set to off The last configuration will be the default 22 SE 20038SE 2012 Holter System Recorder User Manual NOTE Please confirm that your analysis system supports this function It s suggested to turn on this setting to effectively prevent the unanalyzed data from being deleted unexpectedly 4 3 6 Languages Language of menu and prompting message can be set to Chinese or English or other languages Default value is the value set last time Language English Font Large Check WP Switch On Pole off sound On Battery type 4 3 7 Font Font of menu and prompting message can be set to Large or Small Default value is the value set last time 4 3 8 Check WP Switch Detection of write protect switch of SD card
33. n patient log 8 If necessary switch recording screen to ECG display so as to observe ECG while recording data NOTE The inner placed clock in SE 2003 SE 2012 exactly records starting and ending time which can be obtained from creating time of event files or data files afterwards Some analysis software possibly does not support the function Manual recording time depends on the analysis software used 5 2 1 Start Recording Move cursor to Start Recording in the first level menu press confirmation key to initiate Start recording process 5 2 2 Input Patient ID The process will be skipped if the setting of Input Patient ID is off under Advance Setting menu ID 345604560 OK Reset The value of position selected by cursor changes from 0 to 9 by pressing left up key or right down key The cursor will move one digit backward after pressing confirmation key and move to OK until all of ten patient ID numbers are entered Shift the cursor between OK and Reset by pressing left up key or right down key Confirm the selection by pressing confirmation key to move to the next process Press Reset to delete entered patient ID and re input If the patient has been registered in the analysis software beforehand it will show 30 SE 20038SE 2012 Holter System Recorder User Manual ID 2345604560 Name Mary Reset Press OK to enter next step Press Reset to reset the patient information 5 2 3 ECG Preview The process will b
34. not 24 hours reverse signal of 2 3 4 0 continuous recording will show up If recording channel of SE 2003 is set to 3 reverse signal of 3 will show up If recording channel of 3 channel recording is set to 2 or 1 reverse number of 2 or 1 will show up If electrodes fall during recording process reverse signal of the name of fallen electrode will show up Indications of ERA WAIT and REC reflect working status Reverse signal of END will show up at the end of recording Date 4 Time passed Time passed 12 34 56 ABE Ena of record 0 El Patient ID OF 0209 E information Marne Rose White Patient event Meanings of various states will be specified in other sections The recorder will erase the existing data first and wait for two minutes to stabilize the circuit and ECG electrodes NOTE Erasing time varies with SD card models and working time SD card needs to be changed in case erasing time is over 2 minutes 30 SE 2003 amp SE 2012 Holter System Recorder User Manual 5 3 2 ECG Display If ECG display is set to on in advanced setting menu only one second is needed to shift to real time waveform display mode by pressing left up key and confirmation key together Users can observe the validity of recorded waveform Bee ere ome eee Wo Display one lead channel ECG waveform bottom center displays the name of lead channel I II UI aVR aVF aVL V1 V2 V3 V4 V5 V
35. ocket It serves as lead input socket when collecting records After recording finishes insert USB cable into the socket and data could be read into analysis system through USB 2 0 high speed transfer By using the same socket possibility of connection of lead and USB with recorder at the same time is prevented and potential safety hazards are effectively avoided NOTE Pay attention to the plug direction Please insert the side with marker toward recorder with appropriate force CAUTION Do not sway plug during use Plug may fall off and that will cause record failure and even damages to socket 2 3 Control Key SE 2003 SE 2012 keyboard is composed of confirmation key left up key and right down key Confirmation key is used to confirm choice operations and change cursor status in menu operation mode Confirmation key serves as patient events key in monitoring process If patients feel uncomfortable or want to record time of symbolic meaning start to do exercise begin to sleep etc press the key and the recorder will record the time Left up key is used to move the cursor to left or move up in menu operation mode Right down key is used to move the cursor to right or move down in menu operation mode For detailed functions of different buttons please refer to parameter setting section 2 4 Data Storage SE 2003 SE 2012 stores ECG data in Secure Digital card SD card which will be analyzed by Holter ana
36. order will automatically shut off in non recording state and when no action on keyboard is performed for 15 minutes The prompt message below will show up and last 5 seconds before recorder shuts off WARNING No key activity in 15 minutes Power off in 5 seconds 4 4 10 Shutdown Message The recorder will shut down if battery voltage is detected to be too low to keep recording or recording terminates for 30 seconds The information below will show up before closing WARNING Low battery Power off in 30 seconds 28 SE 2003 amp SE 2012 Holter System Recorder User Manual 5 Recording 5 1 Overview The operation steps of SE 2003 SE 2012 recorder are as follows 1 Decide recording plan such as lead mode pacemaker pulse data needed or not 2 Insert SD card into card reader of analysis system or directly connect it with analysis system via USB cable to register E label The registered SD cards prevent possible confusion caused by recording of different patients at the same time 3 Place electrodes 4 Load a full and fresh AAA battery 5 Set recording parameters through recorder keyboard and LCD 6 Preview ECG wave through LCD and check whether electrodes are properly placed and make adjustment if necessary 7 Start to record through menu when all steps above are ok 8 Begin to record formally after recorder initialization 9 Check wave quality of ECG signal during recording process through LCD an
37. ration electromagnetic immunity Holter System Recorder is intended for use in the electromagnetic environment specified below The customer or the user of Holter System Recorder should assure that it is used in such an environment IEC EN 60601 Compliance Electromagnetic environment e Immunity test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the model recorder including cables than the recommended separation Conducted RF 3 Vrms distance calculated from the equation IEC EN 150 kHz to 3 Vrms applicable to the frequency of the 61000 4 6 80MHz transmitter Recommended separation distance Radiated RF 3 V m 3 V m P 2 i IEC EN 80 MHz to 1 61000 4 3 2 5GHz 4 l 80 MHz to 800 MHz d pl 21 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range gt Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and
38. reflection from structures objects and people 45 SE 2003 amp SE 2012 Holter System Recorder User Manual Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitter an electromagnetic site survey should be considered If the measured field strength in the location in which the model recorder is used exceeds the applicable RF compliance level above the model recorder should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the model recorder gt Over the frequency range 150 kHz to 80MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and Holter System Recorder Holter System Recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of Holter System Recorder can help prevent electromagnetic interference by maintaining a minimum distance between portab
39. sary guidance to patients before they leave 1 Show them how to use events button and explain when to press the button 2 Explain to the patients or nursing staff the importance of registering patient log timely and completely Introduce writing format contents what to record recording time location activities and self feeling in detail 3 Warn patients Do not get the recorder wet No bathing shower or shampooing Do not touch electrodes or unplug leads Do not open recorder Do not take out battery or SD card Do not place mobile TV or other electrical appliances one meter around the recorder o Do not place heat source like heater close to the recorder 4 Tell them to stop recording when they feel extremely uncomfortable and tell them how to stop 5 Let them revisit 24 hours 48 hours or longer later 3 3 2 Preparing the Skin Thorough skin preparation is very important The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG signals By performing methodical skin preparation you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift ensuring high quality ECG waves There is natural resistance on the skin surface due to dry dead epidermal cells oils and dirt To Prepare the Skin 1 Shave hair from electrode sites if necessary Excessive hair prevents a good connection 2 Wash the area thoroughly with soap and water 3 Dry th
40. tection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used SE 2003 SE 2012 adopts optimized and incorporated lead structure which can reduce potential difference disturbance during monitoring process 3 2 1 Connecting the Patient Cable to the Recorder Connect the patient cable to the patient cable socket on the top side of the recorder 3 2 2 Connecting the Patient Cable to Electrodes Standard lead name and color code are marked on each electrode head of every lead Snap the electrodes to the lead wires according to the color identifiers 11 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 2 2 1 10 Electrodes 12 Leads AHA White RA O BlackLA Green RL O Red LL O Red Vi O Yellow V2 O Green V3 O Blue V4 O Orange V5 O Purple V6 IEC RedR YellowL BlackN GreenF O Red Ci O Yellow C2 O Green C3 O Brown C4 O Black C5 O Purple C6 Table 3 1 Electrode Connectors and Their Identifiers and Color Codes IEC AHA Right arm Right deltoid R Red RA White Left arm Left deltoid L Yellow LA Black cose to torso aepossibie NYRE Black ee a A A Chest 1 C1 Red YI Red Chest 2 C2 Y ellow V2 Yellow Chest 3 C3 Green V3 Green Chest 4 C4 Brown V4 Blue Chest 5 C5 Black V5 Orange Chest 6 C6 Purple V6 Purple 12 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 2 2 2 5 Electrodes 3 Channels A
41. tions Dimensions 68mm x 53mm x 16 mm 2 68 in x 2 08 in x 0 63in Weight Approx 42 g 0 1 lbs excluding battery Enclosure Molded plastic water resistant Operating position Belt Clip Lanyard A1 4 Battery Specifications Battery type 1 AAA alkaline battery or Ni MH battery Battery life Alkaline battery gt 48 hours A1 5 Performance Specifications Channels 3 or 12 channels Recording Full disclosure no data compression Frequency Response 0 4dB 0 05 60Hz _3 ogp Input impedance 10MQ Gain 1 2X 1X and 2X CMRR gt 60dB Sample Rate 128 to 1024 samples second A D Resolution 8 10 12 16 Bit Sampling ECG Signal Verification LCD at hook up or on demand Data Transmission Through USB cable or SD card reader NOTE Sampling rate and A D Resolution are adapted to software and set before sales 42 SE 2003 amp SE 2012 Holter System Recorder User Manual Appendix 2 EMC Information Guidance and manufacture s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission such an environment Holter System Recorder is intended for use in the electromagnetic environment specified below The customer or the user of Holter System Recorder should assure that it is used in IEC EN 61000 3 3 Emission test Compli
42. ts validity exceeds the time limit the possibility of aging failure will increase and it may lead to operational failure The measure result provided by the recorder is just a reference for physician The final diagnosis is made by physician SE 2003 amp SE 2012 Holter System Recorder User Manual In order to use the recorder safely and effectively and avoid possible dangers caused by improper operation please read through the user manual and be sure to be familiar with all functions of the equipment and proper operation procedures before use Please pay more attention to the following warning and caution information 1 2 1 Safety Warnings 9 WARNING The recorder is intended to be used by qualified physicians or personnel professionally trained They should be familiar with the contents of this user manual before operation Only qualified service engineers can install this recorder and only service engineers authorized by the manufacturer can open the shell EXPLOSION HAZARD Do not use the recorder in the presence of flammable anesthetic mixtures with oxygen or other flammable agents Do not use this recorder in the presence of high static electricity or high voltage equipment which may generate sparks Prevent any liquid from seeping into the recorder otherwise the safety and the performance of the recorder can not be guaranteed Only the patient cable and other accessories supplied by the manufacturer
43. used by all kinds of artifacts such as movement polarized voltage and skin impedance and missing detection caused by software detecting only The detection sensitivity can reach 10 second 128 X 64 graphic LCD plus a 3 key keyboard make it easy to set recording parameters of the Holter System Recorder Real time ECG waves display helps to check electrode placement quality During recording you can switch to ECG display window at any time to master ECG recording situation Multi languages menu easy and friendly to operate Real time clock real time display of year month and date the recording time is actual time which prevents trouble and poor accuracy caused by recording manually E label Support either registration in analysis software or entry of patient ID by recorder keyboard Basic information patient ID name gender age of patients is written into data package before making records In this way recorders used by different patients will 9 NOTE SE 2003 amp SE 2012 Holter System Recorder User Manual not be mixed up when reviewing data package Numerous data are included in the package like hospital signal channel sampling rate event information recording date and time so as to facilitate data management and exchange Leads off warning Poor electrode connection will be warned by voice or icon Power supply management prompt of detection of battery under voltage the power supply will shut off automaticall
44. ustments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure II Table of Contents o OR 1 VEIA US A A Ri 1 12 Wy SEMIN OG an CAOS NN a adds 1 1 2 Sac AIM tentar lotd 2 1 2 2 Alkaline Battery Care Wants succinic aati adulis aeyauaaes 3 1 2 3 General Cautions ds 3 Ee Ao oA a 11015 OE A A I 4 LIMA ota 5 ZV PROC AAI cS Se E ca ates Saas el ca ta ga ala ea EER sien taet TS 6 2 2 Cead Input USB SOCK A A ARAS 7 iD OMT A A A a a 7 D A DBAS WOT ACE rats ios 7 2 4 1 Capacity REQUIEM o acia 8 2 4 2 SD Card Loading and Unloading taa 8 E A O 9 A A O a PT 9 3 Operation Pre PALALIOMS ws sseessiiceteseasiccecadsene
45. y after long time idling 15 minutes after last keyboard response or 30 minutes after end of recording so as to save battery capacity and avoid battery leakage Flexible communication mode support plug and play SD card as well as USB 2 0 high speed direct communication SD card helps to speed up patient turnaround and is convenient to maintain so as to alleviate users burden on the other hand USB 2 0 high speed communication mode is simple and easy Events button precisely records event time Press Confirmation key to restart SE 2003 SE 2012 if it shuts off automatically There is no need to load battery again 10 SE 2003 amp SE 2012 Holter System Recorder User Manual 3 Operation Preparations WARNING Before use the recorder patient cable and electrodes should be checked Replace them if there is any evident defectiveness or aging which may impair the safety or the performance and make sure that the equipment is in proper working condition 3 1 Requested Materials Recorder patient cables leads SD card 2 An analysis system able to make electronic labeling registration or other specialized software 10 or 5 7 disposable electrodes 1 AAA Alkaline battery or 1 fully charged Ni MH rechargeable battery Patient log pen SP Ye Other supplementary materials like alcohol medical adhesive plaster 3 2 Connecting the Patient Cable to the Recorder and Electrodes WARNING The performance and electric shock pro
46. y cleaning and disinfection to recorder and leads it is well prepared for the next patient 5 5 Data Transmission After the end of recording the collected data shall be transmitted to analysis software to make analysis and diagnosis SE 2003 SE 2012 supports transmission by SD card or connection by USB cable And these two methods are equally effective 5 5 1 Transmit by SD Card Take out SD card from recorder and insert it into card reader of analysis system Recording data is then transmitted NOTE It is recommended to equip one recorder with two SD cards so as to facilitate patient turnover Move to next patient quickly by change of SD card only 5 5 2 USB Connection 1 Connect USB cable distributed together with recorder directly with host of analysis system Remove patient cable plug and insert USB cable into the socket Recording data will be transmitted into analysis system through high speed USB 2 0 m 2 Check whether battery is loaded or not when recorder connects with computer through USB cable 3 When USB cable is connected with recorder LCD will display as follows 34 SE 20038SE 2012 Holter System Recorder User Manual Linking PC It means correct connection of the recorder with computer A new disk signal and files under this disk can be found under resource manager of operating system The next step is to run analysis system program
47. ycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product SE 2003 amp SE 2012 Holter System Recorder User Manual 1 3 List of Symbols Symbol Description g Type CF equipment Caution Consult Instructions for Use Waste Electrical and Electronic Equipment WEEE It is the responsibility of the end user to dispose of this equipment at a designated collection point for recycling Year of Manufacture A AR pt el Manufacturer SN SD CARD t Serial Number Insert SD card in the direction the arrow indicates Ev Ec REP The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices Authorized Representative in the European Community Rx only U S Federal U S law restricts this device to sale by or on the order of a physician SE 2003 amp SE 2012 Holter System Recorder User Manual 2 Introduction The manual mainly describes how to operate and maintain SE 2003 SE 2012 Holter System Recorder thereafter referred as SE 2003 SE 2012 SE 2003 SE 2012 plus SE 2003 SE 2012 Holter Analysis System compose SE 2003 SE 2012 Holter System For the operation of analysis software refer to software manual Ambulatory Electrocardiogram Holter detection technology is an effective tool to det

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