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Contents

User Manual for Electrocardiograph --III--

8.1 Lead Fault .................................................................................................................................................. 53

8.2 Printer Failure ............................................................................................................................................ 54

8.3 Indicator of Lead Off ................................................................................................................................. 54

8.4 AC Interference .......................................................................................................................................... 55

8.5 EMG Interference ...................................................................................................................................... 55

8.6 Baseline Wander ........................................................................................................................................ 56

8.7 The ECG Machine cannot be turned on ..................................................................................................... 57

8.8 Paper Feeding Failure ................................................................................................................................ 57

8.9 Battery is quickly Charged and Discharged ............................................................................................... 58

8.10 File Uploading Failure ............................................................................................................................. 58

Appendix A Package and Accessories .................................................................................................................. 59

A.1 Packing List .............................................................................................................................................. 59

A.2 Dimensions and Weight ............................................................................................................................ 59

Appendix B Technical Specification ..................................................................................................................... 61

B.1 Specifications ............................................................................................................................................ 61

B.1.1 Main Unit ....................................................................................................................................... 61

B.1.2 Recorder Specification ................................................................................................................... 62

B.1.3 Other Specification......................................................................................................................... 62

B.2 Environment Requirements ....................................................................................................................... 63

Appendix C EMC-Guidance and manufacture’s declaration ............................................................................ 65

C.1 Guidance and manufacturer’s declaration – electromagnetic emission .................................................... 65

C.2 Guidance and manufacture’s declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS.

......................................................................................................................................................................... 66

C.3 Guidance and manufacture’s declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS

those are not LIFE-SUPPORTING .................................................................................................................. 67

C.4 Recommended separation distance between portable and mobile RF communications equipment and the

EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING ..................... 69

Summary of Contents for iE 101

Page 1: ...Digital Electrocardiograph Model iE 101 iE 300 for vet User Manual Shenzhen Biocare Bio Medical Equipment Co Ltd P N 02111785 01 Version V1 1 Date 2019 08 ...

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Page 3: ... contents Please forgive us as there may still be inconsistency with some descriptions We look forward to your corrections in case of any errors and omissions in this manual All rights reserved Shenzhen Biocare Bio Medical Equipment Co Ltd Information contained in this document is proprietary to Shenzhen Biocare Bio Medical Equipment Co Ltd No part of this publication may be reproduced stored in a...

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Page 5: ... not avoided may result in slight personal injury or equipment failure EXPLANATION Other important information besides warning or caution Explanation of part symbols Symbol Explanation Symbol Explanation Alternating Current Type CF Applied Part Direct Current Type CF applied part including defibrillation Proof Battery Charging LAN Port Equipotential Terminal USB Port Please refer to user manual ...

Page 6: ...Format Explanation Used to quote the texts in the screen of the machine Used to quote the shortcut buttons or keys in the screen of the machine TEXT Used to quote the referenced chapters or sections in this manual ...

Page 7: ...ter 2 Preparation 17 2 1 Locate the ECG Machine 17 2 2 Install Recording Paper 17 2 3 Connect to Power Supply 18 2 4 Connect to Animal Cable 19 2 5 Power On Off 20 2 6 Connect to Network 20 2 7 Apply Electrodes 21 2 7 1 Electrodes Attachment 22 Chapter 3 Entering Animal Information 23 3 1 Enter Animal Information 23 3 2 Introduction of Input Method 25 3 2 1 Standard Character Keyboard 25 3 2 2 Dig...

Page 8: ... 37 5 1 ECG Setting 37 5 2 Print Setting 39 5 3 Display Setting 40 5 4 Animal Information Setting 40 5 5 System Setting 41 5 6 Factory Maintain 43 Chapter 6 Data Management 45 6 1 Open an ECG File 46 6 2 Edit an ECG File 46 6 3 Delete ECG Files 46 6 4 Copy and Move ECG files 47 Chapter 7 Maintenance 49 7 1 Main Unit 49 7 2 Animal Cable 49 7 3 Cleaning and Disinfection 49 7 4 Recording Paper 50 7 5...

Page 9: ...B 1 Specifications 61 B 1 1 Main Unit 61 B 1 2 Recorder Specification 62 B 1 3 Other Specification 62 B 2 Environment Requirements 63 Appendix C EMC Guidance and manufacture s declaration 65 C 1 Guidance and manufacturer s declaration electromagnetic emission 65 C 2 Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS 66 C 3 Guidance and manufacture s decla...

Page 10: ...Contents IV User Manual for Electrocardiograph Blank Page ...

Page 11: ...e connected reliability The equipotential point and the protection ground of this ECG machine have been connected Total leak current should be measured by the users to determine that it meets the requirement and can be used after connection All the analog and digital equipment that is connected to this ECG machine in the using environment has to be in compliance with the standard IEC60601 1 All th...

Page 12: ...use of its larger contact area on the animal body which can keep the high frequency current density in an acceptable range When the relevant packaging material including depleted batteries and scrapping products are disposed please follow the local laws the user should properly follow requirements of local laws and recycling laws CAUTION Avoid contacting with water or other liquids and avoid using...

Page 13: ...ion Precautions Before operation CAUTION Make sure the ECG machine is in good condition and the recording paper is sufficient Make sure the temperature and humidity of operating environment comply with the requirements Do not operate ECG machine in a place with X ray equipment ultrasound scanner or other similar equipment Those equipments may interfere with the ECG machine If necessary power off t...

Page 14: ...ing only the built in battery can safely power the ECG machine Make sure equipotential connection is complete and reliable or else only use the built in battery If the ECG machine is used for the first time or stored for more than three months without use please verify that the system time is correct before use otherwise set the system time first In operation WARNING The physician should observe t...

Page 15: ...into the battery Do not hammer or beat the battery or use other ways to damage the battery otherwise it will cause heat smoke deform or burn which is very dangerous When you find battery leakage or its emitting unpleasant odors please get away from it immediately If the fluid leaks onto the skin or clothes wash with clean water at once If the electrolyte enters the eyes do not rub the eyes wash wi...

Page 16: ...should be taken to minimize the influence Influence of static electricity The static electricity in a dry environment indoor may affect this ECG machine especially in winter Please humidify the indoor air or pre discharge the static electricity on the cable and the electrocardiogram recording personnel prior to using this ECG machine Influence of thunder and lightning A thunder and lightning strik...

Page 17: ...ll as the products damaged by accidents fire disaster thunder and lightning flood and other disaster intentional damage improper installation and improper usage CAUTION For all dated reference documents in this manual its subsequent amendments excluding corrections or revisions do not apply to this manual for undated reference documents the latest version applies in this manual Due to product impr...

Page 18: ...Foreword 8 User Manual for Electrocardiograph Blank Page ...

Page 19: ...e ECG machine is mainly composed of the main unit animal cable and Animal ECG Electrode Holders Scope of application This ECG machine is used to extract the electrocardio complex from the animal body for clinical diagnosis and research Intended Use Only suitable for animals Used in animal hospitals animal clinics ...

Page 20: ...ront View Number Name Description 1 Switch Button Push down to open the Paper Drawer 2 Paper Drawer Place the recording paper 3 Display Screen Display the waveforms animals information and the device status 4 Operating Buttons For button operations and inputting methods Refer to Operating Buttons for more details ...

Page 21: ...o the AC power adaptor 2 Switch Button Push down to open the Paper Drawer 2 Equipotential Terminal Connect to the equipotential cable 1 1 3 Right View Figure 1 3 Side View Number Name Description 1 ECG Animal Cable Connector Connect to the Patient Cable 2 USB Ports Insert the USB device to save data Insert the Bar Scanner 3 LAN Port Connect to net cable ...

Page 22: ...ator and charging indicator 4 1 In Manual Mode press to print the calibration waveforms of 1mV to check the current sensitivity 2 In Auto Mode press to copy the previous report 5 Press to start or stop printing the ECG waveforms and report 6 7 Press Up Down Right Left button to select a menu or an option Press ENTER to confirm open a submenu or toggle between two options in a submenu 8 In Main int...

Page 23: ...d format 12 In manual mode press to switch among different lead groups In split screen mode press to switch among different screens 1 2 Handle Installation You can install the handle as required according to the figure below The accompanying handle set contains a handle a screw wrench and four inner hexangular screws Figure 1 5 Handle Installation Handle Screw Wrench Four inner hexangular screws ...

Page 24: ...tual functions of the product In same screen displayed interface 7 lead waveforms will be displayed on one interface In split screen displayed interface 7 lead waveforms will be displayed on several interfaces which make it possible to show the waveform details more clearly Select Display set the display format and lead format 1 3 1 Same Screen Display Waveform display in same screen 3 4 lead form...

Page 25: ...ion User Manual for Electrocardiograph 15 Waveforms display in same screen 7 1 lead format 1 3 2 Split screen Display Waveform under split screen 3 4 lead format Figure 1 7 Lead Switch Press to change displayed waveforms ...

Page 26: ...Chapter 1 Introduction 16 User Manual for Electrocardiograph Blank Page ...

Page 27: ...ng Paper EXPLANATION Installation of the recording paper may slightly differ from the product you purchased which will not affect your usage please operate according to the actual feature of the product See the descriptions below to install the rolling paper Figure 2 1 Install the Recording Paper 1 Push the button downwards 2 Open the Paper Drawer cover ...

Page 28: ...per is installed fitly and straightly otherwise it may be stuck If paper is absent or used up or not placed well alarm will appear on the main interface and the machine does not print 2 3 Connect to Power Supply Figure 2 2 Connect to AC Power Supply 1 Connect the AC Power Cable to the ECG machine and the Power Outlet 2 Connect Equipotential Cable to the ECG machine and the Equipotential Terminal i...

Page 29: ...from possible electric shock due to current leakage from those equipments It is forbidden to connect the Equipotential Cable to a conductive water pipe or other pipes Otherwise there may be hazard of electric shock to the animal 2 4 Connect to Animal Cable Figure 2 3 Connect to Animal Cable Connect the Animal Cable to the ECG machine CAUTION Do not use any other Animal Cable except that supplied o...

Page 30: ... following figure the cable network system is composed of the ECG machine the switchboard and the server 2 Go to Menu System Setting Cable Network and set the IP address Subnet Mask and Default Gateway of the ECG machine If the IP address is in the same network segment of the server the subnet mask and gateway shall be as the set value of the server If the IP address is not within the same network...

Page 31: ... of them is supposed to be replaced Don t use disposable electrodes more than one time Confirm the disposable electrodes are within the validity period Use the disposable electrodes as soon as possible after opening the package generally within 7 days Electrodes or conducting point of lead wires shall not be in contacting with any other metal part or conductor Avoid the electrodes to be dragged by...

Page 32: ...e properly stored When electrodes have been used for a certain period they may become corroded and oxidized at the surface Whenever this happens the electrodes must be replaced Do not mix electrodes of different types and manufacturers Do not use re useable electrodes and disposable ones together or it will affect the recording Please use our company s or authorized electrodes to make sure qualifi...

Page 33: ...rdiograph 23 Chapter 3 Entering Animal Information 3 1 Enter Animal Information You can enter ID Number gender and age of years Refer to Set Animal Information to get more details Input ID number Figure 3 1 Inputting Animal Information Enter the animal information ...

Page 34: ...e according to his own demand with numbers and letters Barcode Scanner you can directly scan the bar code using the scanner to generate ID code Figure 3 2 Barcode Scanning EXPLANATION When Barcode Scanner is chosen the onscreen keyboard will be disabled For the usage of the Barcode Scanner please refer to the User Manual of your Barcode Scanner CAUTION Improper animal information may lead to misdi...

Page 35: ...d return to the previous page Or select End button on the screen and press ENTER to exit the onscreen keyboard Figure 3 3 Standard Character Keyboard Number Name Description 1 Characters Area Input letters or punctuations 2 Delete Delete previous inputted character 3 Cursor Moving Move the position of cursor on the screen 4 End Exit the onscreen keyboard 5 Page Down 6 Page Up 7 Space Input null ch...

Page 36: ...nd then press ENTER to confirm Use Up Down to exit the digital keyboard Or press to exit the digital keyboard and return to the previous page Figure 3 4 Digital Keyboard Number Name Description 1 Characters Area Input numbers or punctuations 2 Cursor Moving Move the position of cursor on the interface 3 Delete Delete previous inputted character 4 End Exit the Digital Keyboard 5 Space Input null ch...

Page 37: ...r Name Description 1 Heart Rate Icon Display animal s heart rate 2 Lead Status Display the location and state of the electrode in the animal body Select for a larger view If the lead wires are not connected properly such as electrode falls off the corresponding electrodes on the view will flash to alarm 3 Record Setting Display record mode and record format Use to select other record mode and form...

Page 38: ...mute recording network USB connecting battery etc 8 Shortcut Keys Quick operation to set up parameters and execute functions 9 Waveform Display Display real time waveform 4 1 Introduction of Sensitivities Filters Print Speed Before printing set the following configuration Press to select the desired sensitivites Press to select the desired Low pass Filter Baseline Filter and AC Filter On the main ...

Page 39: ...cording mode When the Pre acquisition mode is enabled the ECG machine print and upload waveforms automatically when the Pre acquisition mode is disabled press to print or upload waveforms Record Format is a waveform pattern traced on the recording paper Please see Technical Specification for specific recording formats Synchronous and Real Time are activated only when waveforms are printed in more ...

Page 40: ... under any record mode except manual mode the system will carry on the interpretation automatically Please refer to Auto Mode Set up the record mode and record format Record the ECG waveforms Observe the waveforms display Normal Abnormal Lead off data overflow and etc Refer to Troubleshooting to find solutions Exit the recording Stop Print ...

Page 41: ...G machine including electrodes and lead wires Alarm will disappear when connections become reliable 4 3 Introduction of Record Mode EXPLANATION Set up the Waveform length to be printed and uploaded in Menu ECG Setting Wave Sample Time In ECG Setting if Auto Upload is enabled the ECG machine will automatically upload the waveforms and the reports after printing the waveforms If Auto save is enabled...

Page 42: ... report 1 and analysis report 2 After printing waveforms and report press to print waveforms and report of the last animal Auto Print In Automatic mode select Menu Print Setting Auto Print Enable the ECG machine wil automatically print the waveforms and reports when the following 3 conditions are satisfied Lead off does not detected for 2s none of any electrodes Five or more QRS complex detected W...

Page 43: ...cal axis measurement and the identification of QRS dividing point can be unreliable Occasionally the frequent repetitive ventricular premature beat might be detected as the median beat When several kinds of arrhythmia occur simultaneously the identification of P wave might be difficult and the relative parameters might be unreliable 4 3 2 Manual Mode In Manual Mode press to start or stop printing ...

Page 44: ...eform will be collected and analyzed After waveforms collecting the ECG machine will automatically analyze the waveforms and enter report interface In rhythm report interface select Page up and Page down to review more information select Print Save Upload to print save upload the Rhythm report Please refer to ECG Setting to set Rhythm Lead and Rhythm Time EXPLANATION During the waveform collection...

Page 45: ...ter analysis report mode Report 1 includes simple measurements median beat waveforms and rhythm waveforms Report 2 includes waveforms of all the leads Analysis report interface is as follows Figure 4 3 Analysis Report 1 Main interface Report Enter analysis report Simple measurements Beat waveforms Rhythm waveforms ...

Page 46: ... 300s In the Freeze interface waveforms of different pages can be by tapping PgUp PgDn and step can be adjusted by the user In the Freeze interface tap Print to print the waveforms Tap Report and then choose the type of the report you can print the selected report In the Freeze mode split screen display of lead waveforms is same as that in the main interface please refer to Split screen display fo...

Page 47: ... loss of settings caused by sudden power loss 5 1 ECG Setting Enter ECG Setting to adjust parameters about Electrocardiograph See following table Name Value Default Description Low pass Filter 25 Hz 35 Hz 75 Hz 100 Hz 150 Hz 250 Hz 100 Hz Select one option for low pass Filter Baseline Wander Filter and AC Filter Baseline Wander Filter 0 01 Hz 0 02 Hz 0 05 Hz 0 35 Hz 0 5 Hz 0 8 Hz 0 5 Hz AC Filter ...

Page 48: ...ut Duration 3 12s 3s Set the printout duration Note that this option is only available for iE 101 Pre acquisition Disable Enable Disable Set the pre acquisition mode If enabled it can print out previous waveforms Auto save Disable Enable Enable Set whether to automatically save the report Data Format ECG JPEG PDF ECG The data format for storage Auto Upload Disable Enable Disable Set to upload the ...

Page 49: ...n Beat Report Detail Report Waveform Current Page Click to select the format to print the report Print Grid Disable Enable Disable Select whether to print the grid on the paper PDF Grid Disable Enable Enable Select whether to print the grid on the PDF file Printer Built in Thermal Printer Disable Built in Thermal Printer Select whether to print using built in printer Record Mode Refer to the Appen...

Page 50: ...sable Enable Enable Set to display the background gird or not Display Format Same Screen Split screen Same Screen Select to display all the waveforms in one screen or split the waveforms and display them in different screens Lead Format Refer to Appendix B Technical Specification 3 4 Select one option for lead format Lead Standard IEC Standard AHA Standard IEC Standard Select a lead standard to di...

Page 51: ...em Time Current Time Date Format Date Time Display the details of time and date and to set the date format Network Setting Cable Network Cable Network Select one option for network setting Transfer Protocol TCP TCP The Default setting is TCP FTP is disabled in iE 101 300 Cable Network IP Address Subnet Mask Default Gateway Set the value of IP Address Subnet Mask and Default Gateway Server Setting ...

Page 52: ...o power off time System Password Disable Enable Disable Select to disable or enable to set a system password Password Setting 0 9999 1234 Set the password when the system password is enabled General Setting 1 10 1 Select one option and then set up according to your habit all your setup will be stored in this option to facilitate your next use Different doctor or different check up can occupy diffe...

Page 53: ...ed for representation only Do not use this mode in clinical analysis for demo waveforms may be mistaken as that of the animal and misdiagnose may happen 5 6 Factory Maintain Only the authorized service engineer can enter Factory Maintain please contact with our Customer Service Department if necessary ...

Page 54: ...Chapter 5 Setting System Parameters 44 User Manual for Electrocardiograph Blank Page ...

Page 55: ...t Button Press to select all the ECG files in the current page 2 File Attributes Area Select any file attribute and sorting files by pressing ENTER 3 ECG Files Display Area Display basic animal information of all the ECG files 4 Open Open the animal s ECG file 5 Upload Upload selected ECG files to ECG workstation or server 6 and 7 Page Up Page Down Browse ECG files in previous or next page 8 Opera...

Page 56: ...pen and press ENTER to open the file EXPLANATION When you select more than one file to open the default file is the first selected file 6 2 Edit an ECG File After opening the ECG file you can edit the animal information can also upload save and print the file You can refer to Analysis Report Mode to know the content and function of the ECG file 6 3 Delete ECG Files Select Operate Delete and press ...

Page 57: ...raph 47 6 4 Copy and Move ECG files Select one or more ECG files operate as following to transfer the ECG files Data Management Select one or more files Operate Select Copy or Move Select a storage medium ECG files are copied or moved to the selected medium ...

Page 58: ...new folder in the USB device to store the selected files for example ecg database When there is not enough memory the system will indicate that You should choose new memory to make files copying or moving successfully Please regularly clear data in a storage medium or the speed of the machine will be slowed down CAUTION When copying or moving the files the continuity of power supply must be assure...

Page 59: ...time of the Animal Cable will be shortened 7 3 Cleaning and Disinfection Before cleaning power off the ECG machine and disconnect it from the AC power Do cleaning first before disinfection The process to clean and disinfect the ECG machine cables lead wires and reusable electrodes are as follows 1 Use a clean soft cloth absorbing an amount of cleanser or disinfectant to wipe the surface carefully ...

Page 60: ...r the ECG machine It may cause serious problems to the printer head When exposed to high temperature high humidity and direct sunlight the recording paper will deteriorate It is therefore required to store the thermal recording paper in a dry and cool environment When exposed to fluorescent light for long time the recording paper will deteriorate When stored with polyvinyl chloride PVC the recordi...

Page 61: ...tery capacity indication displayed on the LCD For example Full battery capacity it can work continuously for about 3 hours Battery capacity is sufficient Insufficient battery capacity charging is required Battery capacity is going to running out immediate charging is demanded Battery capacity has already run out and blackout may happen at once immediate charging is demanded Battery replacement The...

Page 62: ...aft wipe the shaft with soft cotton moistened with medical alcohol and at the same time rotate shaft until it is clear enough 7 7 Thermal Print Head Residue and dirt on the thermal print head could affect the clarity of recorded ECG waveform To clean the thermal print head open the paper cover and clean the print head with soft cotton moistened with medial alcohol It is not permitted to clean the ...

Page 63: ...gnal reception 4 Please clean the joints of lead wires and electrode holders reinstall and tighten all joints After long term use the joints will have dirt or become loose resulting in poor signal transmission 5 Check if the appearance of the lead wires has obvious fracture if yes replace with new lead wire If not connect a proper lead wire to the device If the waveform is stable the lead wires ha...

Page 64: ...Upper half or lower half is blank Solution Check if the bearing on both ends of the rubber shaft of the paper compartment cover is worn and replace with new bearing if yes 3 All paper or most part is blank Solution 1 Make sure that the thermal recording paper is not installed backwards 2 Check if the print head is stuck by dirt such as adhesive tape this often occurs when new print paper is replac...

Page 65: ...re the animal is not in touch with the wall or the metal part of the bed 6 Make sure the animal is not in touch with anybody else 7 There shall be no large power electric equipment such as x ray machine ultrasound scanner and so on operating nearby CAUTION Set AC filter to ON if AC interference still exists after the above checks are completed 8 5 EMG Interference Irregular trembling of ECG wavefo...

Page 66: ...sure the electrodes are in good contact with skin 2 Make sure the connection between the Animal Cable and electrodes is normal 3 Make sure the electrodes are clean and animal skin contacted with the electrodes has been well pretreated 4 Make sure the electrodes and skin are covered with ECG gel 5 Keep the animal silent and motionless and keep the animal from hyperventilation 6 Used electrodes shal...

Page 67: ...g the battery but the battery power is insufficient resulting in automatic shutdown Please supply the machine with AC power or charge the battery before working if the user is using AC power and the machine still turns off automatically please check according to step1 8 8 Paper Feeding Failure 1 Press but paper is not fed Solution Check if the keyboard has been damaged and replace damaged keyboard...

Page 68: ...teriorated Solution It is recommended to charge the battery continuously until the battery is fully charged and activated for the first two times Supply the machine with AC power as far as possible 8 10 File Uploading Failure The most possible reason is that network settings have problems please check the network connection and refer to Network Connection to re set the network ...

Page 69: ...imal ECG Electrode Holders 1 set Power Cable 1 piece Equipotential cable 1 piece Thermal Recording Paper 1 piece Paper Roller 1 piece Handle Set 1 set User Manual 1 copy Warranty Card 1 copy Qualified Certificate 1 copy Packing List 1 copy A 2 Dimensions and Weight Length Width Height 281 mm 191 mm 59 mm iE 101 281 mm 191 mm 59 mm iE 300 Net Weight About 1 3 kg iE 101 About 1 3 kg iE 300 ...

Page 70: ...ng to the packing list before starting checking on the unit Whenever there will be mismatch of the accompanying materials with the packing list contact our Customer Service Department immediately To ensure good performance and safe operation of the ECG machine please use the accessories supplied by the manufacturer The package box should be kept well for the regular inspection or maintenance for t...

Page 71: ... Ventricular Rate PR Interval QRS Time Limit QT QTC Interval P QRS T Axis Filters AC Filter Baseline Wander Filter Low pass Filter Input CIR Current 0 1 μA Input Impedance 30 M 10Hz Time Constant 3 2 s Frequency Response 0 01 Hz 250 Hz Noise Level 12 5 μVp p Sensitivity Threshold 20 μVp p Sensitivity Auto 0 625 mm mV 1 25 mm mV 2 5 mm mV 5 mm mV 10 5 mm mV 10 mm mV 20 10mm mV 20 mm mV and 40 mm mV...

Page 72: ...ecorder Specification Recorder Thermal Dot Matrix Word Printing System Recording Paper 50 mm roll paper iE 101 80 mm roll paper iE 300 Paper Speed 5 6 25 10 12 5 25 50 mm s 5 B 1 3 Other Specification Display on LCD 5 inch TFT LCD screen iE 101 5 inch TFT LCD screen iE 300 Safety Classification IEC60601 1 Class I Type CF AC Power Supply 100 V 240V 50 Hz 60 Hz 80 VA iE 101 100 V 240V 50 Hz 60 Hz 80...

Page 73: ...ondensation Air Pressure 70 kPa 106 kPa Transportation avoid direct sunshine and rain 2 Storage Environment Temperature 20 55 Relative Humidity 95 No condensation Air Pressure 70 kPa 106 kPa The packed ECG should be stored in the well ventilated room without corrosive gases 3 Using Environment temperature 5 40 Relative humidity 95 No condensation Air pressure 70 kPa 106 kPa ...

Page 74: ...Appendix B Technical Specifications 64 User Manual for Electrocardiograph Blank Page ...

Page 75: ...ent will affect the performance of the equipment C 1 Guidance and manufacturer s declaration electromagnetic emission Guidance and manufacturer s declaration electromagnetic emission The Digital Electrocardiograph is intended for use in the electromagnetic environment specified below The customer or the user of the ECG machine should assure that it is used in such an environment Emissions test Com...

Page 76: ...ransient burst IEC61000 4 4 2KV for power supply lines 1KV for input output lines 1KV for power supply lines 1KV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC61000 4 5 1KV differential mode 2KV common mode 1KV differential mode 2KV common mode Mains power quality should be that of a typical commercial or hospital environment Vol...

Page 77: ...rms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the ECG machine including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P V 5 3 d 1 P E 5 3 d 1 80MHz 800 MHz P E 7 d 1 800MHz 2 5 GHz Where P is the maximum output power rating of the transmi...

Page 78: ...rom 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 transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ECG m...

Page 79: ...G machine as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz 80 MHz P V 5 3 d 1 80 MHz 800 MHz P E d 1 5 3 800 MHz 2 5 GHz P E 7 d 1 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 maximu...

Page 80: ...Appendix C EMC Guidance and manufacture s declaration 70 User Manual for Electrocardiograph Blank Page ...

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Page 82: ...Medical Equipment Co Ltd Address 16 1 Jinhui Road Jinsha Community Kengzi Sub District Pingshan New District 518122 Shenzhen PEOPLE S REPUBLIC OF CHINA Tel 86 755 33005899 Fax 86 755 27960643 Website http www biocare com cn ...

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