CardEX - Veterinary Instrumentation
Contents
1. 31 5 3 3 Date and Time Settings 32 5 3 4 Print Head Test 32 5 3 5 External Input Output Settings 32 5 3 6 Key and QRS Beep Settings 33 5 3 7 Rhythm Lead Settings 33 Next Back IV 5 4 Sensitivity Switching 33 5 5 Automatic Mode Operation 33 5 6 Manual Mode 34 5 7 ECG Record 35 5 8 Switch Off 35 6 Alarm Information2. 8 1 2 4 Cleaning amp Disinfection Cautions 9 2 Introduction 10 2 1 Function Features 10 2 2 List of Symbols 11 3 General Information 12 3 1 Top Panel 12 3 1 1 LCD Screen 12 3 1 2 Control Panel and Keys 14 3 2 Patient Cable Socket and Signal Interface 17 3 3 Mains Connection and Switch 19 3 4 Bottom Panel
3. 45 10 Accessories and Ordering Information 46 Next Back Go To Table Of Contents 5 1 Safety Guidance 1 1 Safety Information The design of the single channel electrocardiograph complies with the international standard IEC 60601 1 Medical Electrical Equipment General Requirements for Safety and IEC 60601 2 25 Particular Requirements for the Safety of Electrocardiographs etc The classification of this equipment is Class type CF which means a higher degree of protection against electric shock and the patient connection is fully isolated Furthermore it is defibrillation proof This equipment is not explosion proof Do not use it in the presence of flammable anesthetics This equipment is designed for continuous operation however it is not drip or splash proof Classification 1 Anti electric shock type Class with internal power supply 2 Anti electric shock degree CF with defibrillation proof applied part 3 Degree of protection against harmful ingress of water Ordinary equipment Sealed equipment without liquid proof 4 Disinfection sterilization method Refer to this user manual for details 5 Safety degree of application in the presence of flammable gas Equipment not suitable for use in the presence of flammable gas 6 Working Mode Continuous operation 7 EM
4. 36 7 Technical Specifications 37 8 Cleaning Care and Maintenance 40 8 1 Cleaning 40 8 1 1 Cleaning the Main Unit and Patient Cable 40 8 1 2 Cleaning the Electrodes 40 8 1 3 Cleaning the Print Head 40 8 2 Disinfection 41 8 3 Care and Maintenance 41 8 3 1 Recharge and Replacement of Battery 41 8 3 2 Recording Paper 42 8 3 3 Maintenance of Main Unit Patient Cable amp Electrodes 43 9 Service Warranty
5. Manual Ver V1 0 Release Date July 2008 Revised Date May 2009 Part Number CDX 03 0199 CardEX 100 Single Channel Electrocardiograph Go To Table Of Contents Next I EC Declaration of Conformity Manufactured for Midmark Address 10008 N Dale Mabry Hwy Suite 110 Tampa FL 33618 Product Electrocardiograph Model CARDEX 100 We herewith declare that the above mentioned product s meet the standards listed below EN 60601 1 1988 EN 60601 2 25 1995 EN 60601 1 2 2001 CE Mark Next Back Go To Table Of Contents II Copyright Copyright Midmark Corporation 2009 All rights reserved Statements Midmark Corporation hereinafter called Midmark makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Midmark assumes no responsibility for any errors that may appear in this document or for incidental or consequential damage in connection with the furnishing performance or use of this material No part of this document can be photocopied reproduced or translated to another language without prior written consent of Midmark Responsibility of the Manufacturer Midmark only considers itself responsible for effects on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repair
6. 21 4 Operation Preparations 23 4 1 Power Supply 23 4 2 Loading Replacing Recording Paper 24 4 3 Patient Cable Connection 25 4 4 Electrode Connections 26 4 5 Inspection before Switching on 27 5 Operation Instructions 29 5 1 Switching On 29 5 2 Animal Information Input 29 5 3 Menu Settings 30 5 3 1 Filter Settings 31 5 3 2 Recording Settings
7. 18 LOWPASS FILTER OFF 75HZ 100HZ 150HZ 19 LANGUAGE ENG CHN Setting Method 1 Press MENU key to enter menu settings displayed as the following figure 2 Press ID key upward or downward to move the arrow at the right of LCD screen to the item to be changed Take FILTER SETTING as an example The arrow stop at the item of FILTER SETTING 3 Then press M F key or AGE key to choose the setting options EMG AC ALL OFF 4 Repeat 2 and 3 to set other items in the same way 5 After modifying the items which need to be changed press MENU key again to quit the menu interface with new settings Note Set the DEFAULT SETTING as RESTORE and then the defaults of all items will be reloaded except date time and language Descriptions of some items and their settings are given in the following sections 5 3 1 Filter Settings The filter can be chosen among EMG AC ALL both of EMG and AC or OFF no filter When choose OFF the filter will not work Generally ALL is recommended to be set in order to get better ECG record 5 3 2 Recording Settings Recording settings includes start length count unit speed and contents Such as PWAVE START ON ALL ON 3 SECOND FILTER SETTING PWAVE START RECORD LENGTH RECORD COUNT Next Back Go To Table Of Contents 32 RECORD LENGTH 3 RECORD COUNT SECOND RECORD SPEED 25 HEART RATE PRINT ON Take the abov
8. Main Unit Avoid excessive temperature sunshine humidity and dirt Put on the dustproof coat after use and prevent from shaking violently when moving it to another place Prevent any liquid from seeping into the equipment for it will affect the safety and performance of the electrocardiograph 2 Patient Cable Integrity of patient cable including main cable and lead wires should be checked regularly Be sure that it is conductible Do not drag or twist patient cable with excessive stress while using Hold the connector plugs instead of the cable when connecting or disconnecting the patient cable Next Back Go To Table Of Contents 44 Align the patient cable to avoid twisting knotting or crooking in closed angle while using Store the lead wires in bigger wheel Once damage or aging of the patient cable has been found replace it with a new one immediately 3 Electrodes Electrodes must be cleansed after use and be sure there is no remainder gel on them After long term use the surface of electrodes will be oxidized because of erosion and other causes By this time electrodes should be replaced to achieve high quality ECG CAUTION The equipment and reusable accessories can be sent back to the manufacturer for recycling or proper disposal after their useful lives Next Back Go To Table Of Contents 45 9 Service Warranty Material
9. The surface of the main unit and patient cable can be wiped with a clean soft cloth damped in soapy water or non caustic neutral detergent After that remove detergent remainder with a clean dry cloth 8 1 2 Cleaning the Electrodes Remove the remainder gel from the electrodes with a clean soft cloth first Clean them in warm water and be sure there is no remainder gel Dry the electrodes with a clean dry cloth or air dry naturally 8 1 3 Cleaning the Print Head Dirty and soiled thermal print head will deteriorate the record definition So it should be cleaned at least once a month regularly Open the recorder casing and remove the record paper Wipe the print head and printer platen gently with a clean soft cloth damped in 75 alcohol For stubborn stain soak it with a little alcohol first and wipe it off with a clean soft cloth After air drying load the record paper and shut the casing of the recorder CAUTION Prevent the detergent from seeping into the main unit while cleaning Do not immerse the unit or patient cable into liquid under any circumstances Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes and thermal print head Next Back Go To Table Of Contents 41 8 2 Disinfection To avoid permanent damage to the equipment disinfection can be performed only when it has been considered as necessary according to your hospital s regulation
10. 220V 240V or 115V 100V 115V can be chosen by the shift switch according to local mains supply specification Fuse Label Battery Compartment Label Fuse Fuse Mains Supply Shift Switch Next Back Go To Table Of Contents 22 3 Fuse There are two fuses installed on the bottom of the main unit The specification is showed on the fuse label AC220V 240V T200mA AC100V 115V T400mA 5 20 WARNING Ruptured fuse must only be replaced with the same type and rating as the original Next Back Go To Table Of Contents 23 4 Operation Preparations CAUTION Before use the equipment patient cable electrodes and other accessories should be checked Replace it if there is any evident defectiveness or aging which may impair the safety or performance Be sure that the equipment is in proper working condition 4 1 Power Supply WARNING If the integrity of external protective conductor in installation or arrangement is in doubt the equipment should be operated from the built in rechargeable battery The electrocardiograph can be powered either by mains supply or the built in rechargeable lithium battery pack 1 Mains supply The mains connection socket is on the left of the unit If mains supply used connect the power cord to the socket first and then connect the plug of the cord to the hospital grade outlet Rated input voltage 100V 115V or 220V 240V Ra
11. signal detected by the Next Back Go To Table Of Contents 33 electrocardiograph can be transmitted to other external equipment Set the EXTINPUT RECORD as ON to turn on the function and OFF to turn off 5 3 6 Key and QRS Beep Settings KEY BEEP ON QRS BEEP OFF When KEY BEEP is ON a short beep sound will be heard when press the control key When KEY BEEP is OFF there is no sound while pressing the key When QRS BEEP is ON the unit will make a short beep sound when an R wave has been detected 5 3 7 Rhythm Lead Settings RHYTHM LEAD Under AUTO 3 mode ECG of one channel and a rhythm channel lead can be recorded The rhythm lead can be any one of 7 standard leads AVR AVL AVF and V 5 4 Sensitivity Switching There are five options of sensitivity 1 10mm mV 2 20mm mV AGC 25 2 5mm mV 5 5mm mV Press key to choose the appropriate sensitivity to achieve better ECG record according to the signal range that can be measured Refer to Section 3 1 2 for details about signal range under different sensitivity This key can be pressed during the course of examination or recording under manual mode while it is ineffective during the course of recording under automatic mode 5 5 Automatic Mode Operation Three automatic recording modes are provided by this electrocardiograph AUTO 1 AUTO 2 and AUTO 3 Two channels including a rhythm lead can be recorded to
12. 1 1 LCD Screen Normally the contents displayed on the LCD screen include described from left to right in row order LCD Screen Label Recorder Control Panel Next Back Go To Table Of Contents 13 First Row Operation mode AUTO1 AUTO2 AUTO3 and MANU II stop symbol which will turn to while recording Warning message LD OFF or PAPER etc Current time Second Row Current lead AVR AVL AVF V Heart rate actual heart rate or OVR message Third Row Filter setting FLT AC ALL OFF EMG ECG Fourth Row Sensitivity 1 2 AGC 25 5 Paper speed 25 50 Battery capacity symbol Display the ID sex Male Female and age group YOUNG MATURE OLD while setting and BATTERY WEAK will be shown here when the battery capacity is weak Next Back Go To Table Of Contents 14 3 1 2 Control Panel and Keys 1 Indicator Mains supply indicator when mains supply is used the indicator will be lit Battery indicator when the built in rechargeable lithium battery is used the indicator will be lit Battery recharging indicator both the battery recharging indicator and mains supply indicator will be lit after the mains power switch has been turned on After ON OFF key being pressed the battery recharging indicator will be black if the battery capaci
13. C Group 1 2 Warnings and Cautions In order to use the electrocardiograph safely and effectively avoiding possible dangers caused by improper operations 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 attention to the following warning and caution information Next Back Go To Table Of Contents 6 1 2 1 Safety Warnings WARNING The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained And they should be familiar with the contents of this user manual before operation Only qualified service engineers can install this equipment And only service engineers authorized by Midmark can open the shell Only qualified installation or service engineers can shift the mains shift switch 100V 115V 220V 240V according to local mains supply The results given by the equipment should be examined with respect to the overall clinical condition of the animal It cannot substitute for regular checking WARNING EXPLOSION HAZARD Do not use the electrocardiograph in the presence of flammable anesthetic mixture with oxygen or other flammable agents SHOCK HAZARD The power receptacle must be a hospital grade grounded outlet Never try to adapt the three prong plug to fit a two slot outlet If the integrity of external protectiv
14. The switching order of leads in each mode is listed in Table 3 1 Next Back Go To Table Of Contents 16 Table 3 1 Lead Switching order of Different Modes Mode Switching Order from left to right MANU AVR AVL AVF V AUTO1 AVR AVL AVF V AUTO2 AVL AVR AVF V AUTO3 2 channel automatic mode AUTO1 Rhythm Lead 6 LEAD Lead Switch Key Under manual mode press the key to switch the lead order 7 PRINT STOP Key Used to begin recording and stop recording 8 ON OFF Key When the unit has been powered on press this key to turn on or turn off the electrocardiograph 9 MENU Key Press MENU key to enter menu settings interface Next Back Go To Table Of Contents 17 10 ID Setting Key These two ID keys can be pressed to set the animal s ID number Press the upward arrow key to increase ID number and press the downward arrow key to decrease ID number on the basis of current ID number 11 M F Press M F key to choose sex male M or female F 12 AGE Press AGE key to choose age YOUNG MATURE or OLD 3 2 Patient Cable Socket and Signal Interface There are sockets including the patient cable socket RS232 socket and external input output socket at the right side of the main unit as the following Figure shows 1 Patient Cable Socket Patient cable socket RS232 socket External Input Output socket Next Back Go To T
15. able for use while treating animals at home Note It is designed for direct cardiac application 2 1 Function Features Low weight and compact size Touch key for easy operation LCD for single channel ECG preview before recording Three automatic recording modes and manual mode option General menu setting for recording parameters Built in rechargeable Lithium battery with high capacity Alarm information for lead off lack of paper and weak battery etc Thermal dot matrix printer for high resolution printout Automatic adjustment of baseline for optimal recording Selectable printing formats standard single channel or single channel amp rhythm lead Standard external input output interface and RS232 communication interface Next Back Go To Table Of Contents 11 2 2 List of Symbols External output External input Equipment or part of CF type with defibrillation proof Attention general warning see accompanying document Potential equalization Mains supply or indicator On mains supply Off mains supply Battery indicator Battery recharging indicator Crossed out wheeled bin Next Back Go To Table Of Contents 12 3 General Information Figure 3 1 Main Unit CardEX Trade mark CardEX 100 Veterinary ECG Trade name Classification symbol equipment of CF type with defibrillation proof 3 1 Top Panel 3
16. able Of Contents 18 Defibrillation proof applied part of type CF Attention see accompanying document Definition of corresponding pins Signal Pin Signal Pin Signal 1 NC 6 SH 11 F LL input 2 NC 7 NC 12 NC 3 NC 8 NC 13 C V input 4 NC 9 R RA input 14 NC 5 NC 10 L LA input 15 N or RF RL input Note The left side of is European standard and the right side is American standard 2 RS232 Socket WARNING RS232 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed 15V DC Definition of corresponding pins Pin Signal Pin Signal Pin Signal 1 NC 4 NC 7 NC 2 RxD input 5 GND 8 NC 3 TxD output 6 NC 9 NC Next Back Go To Table Of Contents 19 3 External Input Output Socket Definition of corresponding pins Pin Signal Pin Signal 1 GND 4 GND 2 GND 5 ECG Signal input 3 GND 6 ECG Signal output WARNING Accessory equipment connected to the interfaces must be certified according to the respective IEC standards e g IEC60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard IEC 60601 1 1 Therefore anybody who connects additional equipment to the input or output connector to configure a medical system must make sure that it complies with t
17. and Manufacture The warranty period for the main unit and the accessories is 24 months from the date of shipment Midmark warrants that there s no defect in material and manufacture During the warranty period Midmark will repair or replace the defective part free if the defect has been confirmed as material or manufacture defect Software or Firmware For the software or firmware installed Midmark will replace the software or firmware free if the defect has been confirmed during 24 months from the date of shipment But Midmark cannot warrant it will not interrupt the use of the product CAUTION All services must be done by the engineers authorized by Midmark Limit of Warranty The charges of freight and others are excluded under warranty The warranty is void in the case of Assembly extensions readjustments of any parts Modification and repair by unauthorized persons Subsequent damage caused by improper use or maintenance Replacement or remove of the label of serial number and manufacturer Next Back Go To Table Of Contents 46 10 Accessories and Ordering Information The accompanying accessories of the electrocardiograph are listed in Table 10 1 Table 10 1 Accessories List No Accessory Manufacturer Part No 1 Power cord M13R 36014 2 Patient cable MS1R 109826 A0 European standard MS1R 109827 A0 American standard 3 Alligator clip electrod
18. aning and disinfection If mains supply used the power cord should be pulled out of the outlet also Prevent the detergent from seeping into the equipment Do not immerse the unit or patient cable into liquid under any circumstances Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes Any remaining detergent should be removed from the unit and patient cable after cleaning Do not use chloric disinfectant such as chloride and sodium hypochlorite etc Next Back Go To Table Of Contents 10 2 Introduction CARDEX 100 single channel electrocardiograph is a single channel digital ECG electrocardiograph recorder with high performance One channel cardiogram can be previewed on the LCD liquid crystal display screen and it can be recorded by high quality thermal recorder Moreover real time heart rate can be displayed on the screen which can also be printed out on the recorder Manual recording mode and three automatic recording modes can be chosen conveniently Either mains supply or built in rechargeable Lithium battery can be used as power supply Components Main unit and accessories including patient cable electrodes thermal recording paper and power cord etc Intended use The cardiogram and heart rate recorded by the electrocardiograph can help doctors to analyze and diagnose heart disease or arrhythmia Its compact size makes it suit
19. e The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests a Inspect the equipment and accessories for mechanical and functional damage b Inspect the safety relevant labels for legibility c Inspect the fuse to verify compliance with rated current and breaking Next Back Go To Table Of Contents 9 characteristics d Verify the device functions properly as described in the instructions for use e Test the protection ground resistance according to IEC 601 1 1988 Limit 0 2 ohm f Test the earth leakage current according to IEC 601 1 1988 Limit NC 500 uA SFC 1000uA g Test the patient leakage current according to IEC 601 1 1988 Limit 10 uA CF h Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC 601 1 1988 Limit 50uA CF The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired Ruptured fuses must only be replaced with the same type and rating as the original The equipment and reusable accessories can be sent back to the manufacturer for recycling or proper disposal after their useful lives 1 2 4 Cleaning amp Disinfection Cautions CAUTION Turn off the power before cle
20. e all configurations shall comply with the valid version of the standard IEC 60601 1 1 Therefore anybody who connects additional equipment to the signal input connector or output connector to configure a medical system must make sure that it complies with the requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult our technical service department or your local distributor The summation of leakage current should never exceed leakage current limits while several other units are used at the same time The potential equalization conductor can be connected to that of other equipment when necessary to make sure that all equipment is connected with the potential equalization bus bar of the electrical installation 1 2 2 Battery Care Warnings WARNING Improper operation may cause the battery to be hot ignite or explode and it may lead to the declination of battery s capacity It is necessary to read the user manual carefully and pay more attention to warning messages Only a qualified service engineer authorized by Midmark can open the battery compartment and replace the battery The battery of same model and specification provided by manufacturer should be used Danger of explosion Do not reverse the anode and cathode when connecting the battery Next Back Go To Table Of Contents 8 Do not heat or splash the battery or throw it i
21. e M15R 040144 4 Paper roller MS1 19992 5 Thermal paper MS1R 19917 The following accessories can also be ordered according to some special usage No Accessory Manufacturer Part No 1 Grounding wire MS1 20016 2 Input output signal cable MS1 19907 3 Flat clip electrode M15R 040145 4 Carrying Bag MS1 107119 A0 The main unit and accessories are available by contacting Midmark Next Back Go To Table Of Contents 10008 N Dale Mabry Hwy Suite 110 Tampa FL 33618 TEL 800 643 6275 FAX 813 264 6218 www Midmark com Back Go To Table Of Contents
22. e conductor in installation or arrangement is in doubt the equipment should be operated from the built in rechargeable battery Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks This equipment is designed for direct cardiac application WARNING Only patient cable and other accessories supplied by Midmark can be used Or else the performance and electric shock protection cannot be guaranteed Be sure that all electrodes have been connected to the animal correctly before operation Be sure that the conductive parts of electrodes and associated connectors including neutral electrode should not contact with earth or any other conducting objects Next Back Go To Table Of Contents 7 Electrodes with defibrillation protection should be used while defibrillating There is no danger for animals with pacemaker Do not touch the animal bed table and the equipment while using defibrillator or pacemaker simultaneously In order to avoid burning please keep the electrode far away from the radio knife while using electrosurgical equipment simultaneously WARNING Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermor
23. e settings as example the ECG will be recorded from P wave and the printing speed is 25mm s The record length of each lead is 3 seconds And the heart rate will be printed out at the bottom of the beginning of each lead recording When QRS is taken as recording count unit the record length will be 3 periods of QRS wave Note The record duration of each lead must be longer than 2 seconds So when QRS is chosen to be the count unit no matter how long the record length is if the period of QRS wave is too short the electrocardiograph will keep recording for 2 seconds 5 3 3 Date and Time Settings The date and time on LCD screen and ECG record can be set in the following items YEAR 7 MONTH 12 DAY 17 HOUR 14 MINUTE 25 Per the above settings the date amp time is Dec 17th 2007 14 25 PM And it will be printed out as 2007 12 17 14 25 on the record 5 3 4 Print Head Test PRINT HEAD TEST OFF Print head test is used to check whether the print head can work normally or not The default status of print head test is OFF Turn on this item when the print paper has been loaded Then the triangle wave in effective paper width will be printed out The status of print head can be estimated from this triangle wave 5 3 5 External Input Output Settings External input output signal interface is equipped in the electrocardiograph through which ECG signal from external equipment can be received and ECG
24. efore first usage Next Back Go To Table Of Contents 42 3 Replacement When the useful life of battery is over or foul smell and leakage has been found please contact with manufacturer or local distributor for replacement of battery WARNING Only qualified service engineer authorized by Midmark can open the battery compartment and replace the battery The battery of same model and specification provided by manufacturer must be used Danger of explosion Do not reverse the anode and cathode when connecting the battery When the battery s useful life is over contact the manufacturer or local distributor for disposal or dispose the battery according to local regulations 8 3 2 Record Paper Storage requirements Record paper should be stored in dry dark and cool area avoiding excessive temperature humidity and sunshine Do not put the paper under fluorescence for long time Be sure that there is no polyvinyl chloride or other chemicals in the storage environment which will lead to color change of the paper Do not overlap the recorded paper for a long period or else the ECG record may trans print each other Note Recording paper provided by manufacturer should be used Other paper may shorten thermal print head s life And the deteriorated print head may lead to illegible ECG record and block the advance of paper etc Next Bac
25. gether under AUTO 3 mode The lead switching orders under different modes are listed in Table 3 1 in Section 3 1 2 Next Back Go To Table Of Contents 34 Under automatic mode leads will be switched in order automatically while recording ECG That means when ECG signal from one lead has been recorded for the set length such as 3 seconds it will be switched to the next lead and begin recording another ECG signal There is a pause for several seconds before recording the next ECG signal under the modes of AUTO1 and AUTO2 Moreover a 1mV calibration pulse will be printed on the record automatically before ECG of each lead Operation Procedures 1 Press MODE key to choose automatic mode which will be displayed in the left top corner on LCD screen 2 If AUTO3 has been chosen rhythm lead can be selected by pressing MENU key to set RHYTHM LEAD The rhythm lead can also be set before selecting mode Moreover there is no pause between different leads while recording 3 Then press PRINT STOP key to begin recording The symbol means ECG is being recorded now It will stop automatically after a full 7 lead ECG prints out Pressing PRINT STOP again during the course of recording can stop printing However when beginning recording later ECG will be recorded in order from the first lead again And ID number will increase one automatically If the ID number does not need to be changed ID key should be pressed to ad
26. h quality ECG the skin electrode resistance must be minimized while connecting electrodes Clamp Next Back Go To Table Of Contents 27 Electrodes connection 1 Ensure the electrodes are clean 2 Align lead wires of patient cable to avoid twisting 3 Clean electrode area with alcohol 4 Daub the electrode area with gel evenly 5 Place a small amount of gel on the metal part of electrode clamp 6 Clamp the electrode to the electrode area Attach all electrodes in the same way WARNING Be sure that all electrodes have been connected to the animal correctly before operation Be sure that the conductive parts of electrodes and associated connectors including neutral electrode do not contact ground or any other conducting objects There is no danger when using the electrocardiograph with electrical stimulation equipment However the stimulation units should only be used at a sufficient distance from the electrodes If in doubt the animal should be disconnected from the device Electrodes with defibrillation protection should be used while defibrillating Do not touch the unit casing during defibrillation 4 5 Inspection before Switching on In order to avoid safety hazards and get good ECG records the following inspection procedures are recommended before turning on the unit and beginning operation 1 Environment Check and make sure that there i
27. he requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult our technical service department or your local distributor The summation of leakage current should never exceed leakage current limits while several other units are used at the same time 3 3 Mains Connection and Switch At the left side of the main unit there is the mains supply socket power switch and potential Mains Power Switch Potential Equalization Conductor Mains Supply Socket Next Back Go To Table Of Contents 20 equalization conductor as the above figure shows 1 Potential Equalization Conductor Potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation when necessary 2 Mains Supply Socket AC SOURCE alternating current supply socket 3 Power Switch Switch on the mains power supply Switch off the mains power supply Next Back Go To Table Of Contents 21 3 4 Bottom Panel 1 Battery Compartment The battery label indicates the rated voltage and rated capacity of rechargeable Lithium battery pack Rated voltage 14 4V Rated capacity 1600mAh Attention general warning see accompanying document WARNING The battery of same model and specification provided by manufacturer must be used 2 Mains Supply Shift Switch Mains supply with rated input voltage 230V
28. ic shock degree Type CF with defibrillation proof Degree of protection against harmful ingress of water Ordinary equipment Sealed equipment without liquid proof Disinfection sterilization method Refer to the user manual for details 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 type A Dimensions 300mm 260mm 75mm Weight About 2 3kg Display 192 64 pixels color LCD Environment Transport Storage Working Temperature 20 50 10 40 5 40 Relative Humidity 25 95 No Condensation 25 95 No Condensation 25 85 No Condensation Atmospheric Pressure 700hPa 1060hPa 700hPa 1060hPa 860hPa 1060hPa Power Supply Mains Supply Rated input voltage 100V 115V 220V 240V Rated frequency 50 60Hz Rated input power 35VA Built in Lithium Battery Pack Rated voltage 14 4V Rated capacity 1600mAh Next Back Go To Table Of Contents 38 Charge mode Constant current voltage Charge current standard 0 2C5A 320mA Charge voltage standard 16 8 0 1V Cycle life 300 times Power Consumption 35VA Fuse T200mA 5 20 or T400mA 5 20 Recording Recorder Thermal dot matrix printer Thermal Print Head Dot structure 384 dots line Dot pitch 0 125mm 8 dots mm Dot size 0 125m
29. ion pulse is printed On the top of the ECG record of each lead sensitivity is marked The sensitivity may be different for it can be changed during the course of recording 5 8 Switch Off When built in battery pack used press ON OFF key directly to turn off the unit after finishing ECG record When mains supply used press ON OFF key first after finishing ECG record and then switch off the mains supply by pressing the switch on the left side of the unit Un plug from the outlet last Next Back Go To Table Of Contents 36 6 Alarm Information Alarm information will be displayed on the LCD screen when there is something wrong Alarm information provided by the electrocardiograph and corresponding cause is listed in Table 6 1 Table 6 1 Alarm Information and Causes Alarm Information Causes LD OFF Electrodes fall off from the animal or the patient cable falls off from the unit PAPER Record paper has not been loaded or it has been used out BATTERY WEAK The built in battery is weak The heart rate is over 300BPM or below 30BPM or heart rate has not been detected in 2 seconds OVR The ECG signal exceeds the measuring range under certain sensitivity Next Back Go To Table Of Contents 37 7 Technical Specifications Safety Standards 1 IEC60601 1 2 IEC60601 2 25 3 EN 60601 1 2 Classification Anti electric shock type Class with internal power supply Anti electr
30. just it before recording Note Recording mode cannot be changed during the course of printing Stop recording before choosing another recording mode 5 6 Manual Mode Under manual mode users can determine the lead to be recorded and set the recording settings or other parameters according to different leads Operation Procedures 1 Press MODE key to choose MANU mode which can be discerned by the identifier on the left corner of LCD screen as MANU 2 Press LEAD key left arrow or right arrow key to select the lead to be recorded Next Back Go To Table Of Contents 35 3 Press MENU key to set the record settings or other settings After setting press MENU key again to confirm the settings 4 Then press PRINT STOP key to begin recording 5 1mV calibration key can be pressed to print out 1mV pulse wave in the record while ECG recording 6 Press PRINT STOP key to stop printing after finishing ECG record Note LEAD left and right arrow key can be pressed to switch the lead during the course of recording 5 7 ECG Record As the above figure shows the ECG record includes date and time ID number owner written by doctor name written by doctor type written by doctor weight written by doctor sex age sensitivity paper speed filter settings lead name 1mV calibration pulse ECG heart rate and model of the equipment At the beginning of each lead s ECG lead name and 1mV calibrat
31. k Go To Table Of Contents 43 8 3 3 Maintenance of Main Unit Patient Cable amp Electrodes The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests a Inspect the equipment and accessories for mechanical and functional damage b Inspect the safety relevant labels for legibility c Inspect the fuse to verify compliance with rated current and breaking characteristics d Verify the device functions properly as described in the instructions for use e Test the protection ground resistance according to IEC 601 1 1988 Limit 0 2ohm f Test the ground leakage current according to IEC 601 1 1988 Limit NC 500uA SFC 1000uA g Test the patient leakage current according to IEC 601 1 1988 Limit 10uA CF h Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC 601 1 1988 Limit 50uA CF The leakage current should never exceed the limit The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired WARNING Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 1
32. l installation when necessary 4 2 Loading Replacing Record Paper Rolled thermal paper with 50mm width is used as ECG record paper When there is no record paper loaded or it reaches the end of record paper warning message PAPER will be given on the LCD screen Under this circumstance record paper should be loaded or replaced immediately Loading Replacing Procedures 1 Place fingers under the flange of the recorder casing pull upwards directly to release the casing 2 Take out the paper roller and remove remaining paper from the left of roller if necessary 3 Take off the wrapper of the new thermal paper roll and then put through the roller from the left with the paper s grid side facing downward Paper Roller Groove Roller Pin Casing Printer Platen Paper Tray Scale Thermal Print Head Next Back Go To Table Of Contents 25 4 Then place the paper and roller gently in the paper tray with the roller pin on the roller s left side facing to the groove 5 Pull about 2cm of the paper out and put down the recorder casing with the paper s side edges in parallel with the scale on the surface of casing 6 Secure the casing by pressing it firmly 4 3 Patient Cable Connection Patient cable includes two parts main cable and lead wires with associated electrode connectors The electrode connectors can be distinguished by the color and identifier on them Connec
33. m 0 12mm Record Paper Rolled thermal paper Paper Width 50mm Effective Width 48mm Paper Speed 25mm s 50mm s Accuracy 3 HR Recognition Technique Peak peak detection HR Range 30BMP 300BMP Accuracy 1BMP Next Back Go To Table Of Contents 39 ECG Unit Leads 7 standard leads Acquisition Mode One lead A D Resolution 12 digit Time Constant 3 2s Frequency Response 0 05Hz 150Hz Sensitivity 2 5 5 10 20 mm mV Input ImpMidmarkce 10M Input Circuit Current 50nA Input Voltage Range lt 5 mVpp Calibration Voltage 1mV 3 Noise lt 15 Vp p Filter EMG Filter 35Hz 3dB AC DFT Filter 50Hz 60Hz 20dB CMRR gt 90dB gt 100dB with AC filter Patient Leakage Current lt 10 A 220V 240V Patient Auxiliary Current lt 0 1 A DC Dielectric Strength 4000V rms External Input Output Optional Input Single ended 100k Sensitivity10mm V 5 Output Single ended 100 Sensitivity1V mV 5 Communication Interface RS232 Refer to Section 3 2 for details Next Back Go To Table Of Contents 40 8 Cleaning Care and Maintenance 8 1 Cleaning CAUTION Turn off the power before cleaning and disinfection If mains supply used the unit should be switched off first and the power cord should be unplugged from the outlet 8 1 1 Cleaning the Main Unit and Patient Cable
34. nto fire or water When leakage or foul smell is found stop using the battery immediately If your skin or clothes come 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 When the battery s useful life is over contact the manufacturer or local distributor for disposal or dispose the battery according to local regulations 1 2 3 General Cautions CAUTION Avoid liquid splashes and excessive temperature The temperature must be kept between 5 and 40 while working And it should be kept between 20 and 50 during transportation and between 10 and 40 during storage Do not use the equipment in dusty environment with bad ventilation or in the presence of corrosives Be sure that there is no intense electromagnetic interference source around the equipment such as radio transmitter or mobile phone etc Attention large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment etc are likely to bring electromagnetic interference CAUTION Before use the equipment patient cable and electrodes etc should be checked Replacement should be made if there is any evident defectiveness or aging symptom which may impair the safety or performanc
35. s Before disinfection clean the equipment first Then wipe the surface of the unit and patient cable with 70 isopropyl alcohol Wipe the surface of electrodes with 70 alcohol or isopropyl alcohol Never immerse the unit cable or electrodes into disinfectant solution CAUTION Do not use chloric disinfectant such as chloride and sodium hypochlorite etc 8 3 Care and Maintenance 8 3 1 Recharge and Replacement of Battery 1 Capacity Identification Current capacity of the rechargeable battery can be identified according to the battery symbol in the last row on LCD screen Full capacity Not full but enough Capacity is limited and recharge should be taken into account Battery is weak and warning message BATTERY WEAK will be displayed on LCD screen The battery should be recharged immediately 2 Recharge The electrocardiograph is equipped with recharge control circuit together with built in rechargeable lithium battery Once the main unit is connected to mains supply with power cord the battery will be recharged automatically And then the battery recharge indicator and the mains supply indicator will be lit at the same time When the capacity of battery is full the battery recharge indicator will be black Because of the capacity consumption during storage and transport the capacity of battery is not full while being used at the first time Battery recharge is recommended b
36. s are carried out by personnel authorized by Midmark The electrical installation of the relevant room complies with safety standards The instrument is used in accordance with the instructions for use Note This device is not intended for home use WARNING This device is not intended for treatment Using This Label Guide 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 about a function or procedure Next Back Go To Table Of Contents III Table of Contents 1 Safety Guidance 5 1 1 Safety Information 5 1 2 Warnings and Cautions 5 1 2 1 Safety Warnings 6 1 2 2 Battery Care Warnings 7 1 2 3 General Cautions
37. s no electromagnetic interference source around the equipment especially large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equipment etc Switch off these devices when necessary Keep the examination room warm to avoid muscle action voltages in ECG signal caused by cold 2 Power Supply If mains power used please check whether the power cord has been connected to the Next Back Go To Table Of Contents 28 unit well The grounded three phase outlet should be used Recharge the battery first before use when the battery capacity is weak 3 Patient Cable Check whether the patient cable has been connected to the unit firmly and keep it far away from the power cord 4 Electrodes Be sure that all electrodes have been connected to the animal correctly Ensure that the electrodes haven t contacted with each other 5 Recorder Paper Ensure that there is enough recorder paper loaded correctly Make sure the recorder case has been secured 6 Animal The animal should not be in contact with conducting object such as ground or metal table etc Ensure the animal is warm and relaxed and breathing calmly WARNING The electrocardiograph is provided for the use of qualified veterinarians or personnel professionally trained They should be familiar with the contents of this
38. t Main Cable Plug the connector of main cable into the patient cable socket on the right side of the unit and secure the screw WARNING This product is CF classified and defibrillation protected only when the original patient cable is used However as a safety precaution when possible remove electrodes before defibrillation Precautions must be observed when using high frequency devices which may affect the quality of ECG Main Cable Lead Wires Connector Electrodes Electrode Connectors Next Back Go To Table Of Contents 26 4 4 Electrodes Connections The identifier and color code of electrode connectors used complies with IEC requirements In order to avoid incorrect connections the electrode identifier and color code is specified in Table 4 1 Moreover the equivalent code according to European requirements is given too Table 4 1 Electrodes Identifier and Color Code European American Electrodes Identifier Color code Identifier Color code Right fore limb R Red RA White Left fore limb L Yellow LA Black Right rear limb N or RF Black RL Green Left rear limb F Green LL Red Chest C White V Brown As the following figure shows the electrode areas on body surface are European Standard American Standard Dog Cat Dog Cat The contacting resistance between the animal and the electrode will affect the quality of ECG greatly In order to get a hig
39. ted frequency 50Hz 60Hz Rated input power 35VA Make sure the mains supply meets the above requirements before powering on And then press the mains power switch to power on the unit Then the mains supply indicator will be lit as well as the battery recharging indicator If the built in rechargeable battery is weak when mains supply used the battery recharging indicator will be still lit after ON OFF key pressed which means the battery is being recharged If the battery capacity is full the recharging indicator will be black after ON OFF key pressed 2 Built in rechargeable battery When the built in rechargeable lithium battery pack is used turn on the unit by pressing ON OFF key on control panel directly and the battery indicator will be lit The battery symbol will be displayed on the LCD screen Because of the consumption during storage and transport the capacity of battery may not be full If the symbol and Next Back Go To Table Of Contents 24 the alarm information BATTERY WEAK are displayed which means the battery capacity is weak please recharge the battery first Note Please refer to the maintenance section for how to recharge the battery During recharging the battery the electrocardiograph can be powered by mains supply at the same time WARNING Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrica
40. to record ECG If PRINT STOP key is pressed during the course of recording the ID number will automatically increase one when recording begins again AUTO 1 II NO FLT ALL 1 25 E C G 9 8 0 3 MALE OLD 10 50 Next Back Go To Table Of Contents 30 2 SEX Press M F key to set the sex female or male which will be displayed for one or two seconds in the last row on LCD screen 3 AGE Animals are divided into three groups based on age YOUNG MATURE OLD Press AGE key to set the age group which will be displayed for one or two seconds in the right lower corner of LCD screen Note The animal information mentioned above cannot be set or changed during the course of recording 5 3 Menu Settings 19 items in the menu are listed in Table 5 1 In the Options column the value double underlined is the default settings Table 5 1 Menu Items No Menu Items Options 1 FILTER SETTING AC ALL OFF EMG 2 PWAVE START ON OFF 3 RECORD LENGTH 2 3 4 11 12 4 RECORD COUNT SECOND QRS 5 RECORD SPEED 25 50 unit mm s 6 HEARTRATE PRINT ON OFF 7 YEAR 0 99 8 MONTH 1 12 9 DAY 1 31 10 HOUR 0 23 11 MINUTE 0 59 12 PRINT HEAD TEST ON OFF 13 DEFAULT SETTING OFF RESTORE 14 EXTINPUT RECORD ON OFF 15 KEY BEEP ON OFF Next Back Go To Table Of Contents 31 16 QRS BEEP ON OFF 17 RHYTHM LEAD AVR AVL AVF V
41. ty is full However if the battery capacity is not full the battery recharging indicator will be lit until the battery is full recharged and after that the battery recharging indicator will be black 2 SENS Sensitivity Switch Key The sensitivity switching order 1 2 AGC 25 5 Next Back Go To Table Of Contents 15 The ECG signal range which can be measured and recorded is different according to different sensitivity as the following list shows Options Sensitivity Signal range measured 1 10mm mV 2 5mV 2 5mV 2 20mm mV 1 25mV 1 25mV AGC Auto Gain Control Adjust sensitivity automatically 25 2 5mm mV 10mV 10mV 5 5mm mV 5mV 5mV If the fluctuating range of the ECG signal is great AGC should be chosen since the sensitivity will be adjusted automatically under this mode 3 RESET Lead Locking Key Press this key to lock the lead while ECG recording After that the corresponding ECG will be a line It is always used to draw the baseline to zero quickly in the case of baseline excursion in actual ECG recording The lead will be unlocked automatically after 0 4 seconds 4 1mV Calibration Key Under manual mode this key can be pressed to record a 1mV calibration pulse at any time while recording 5 MODE Mode Switch Key There are three automatic modes and a manual mode This key can be pressed to select recording mode
42. user manual before using Next Back Go To Table Of Contents 29 5 Operation Instructions 5 1 Switching On While mains supply used press the power switch on the left side of the unit first and the mains supply indicator is lit Then press ON OFF key on the control panel to turn on the unit Equipment information such as name and version etc will be displayed on LCD screen after self test Then the electrocardiograph is ready for examination and recording When built in rechargeable lithium battery used press ON OFF key on the control panel directly to turn on the unit and then the battery indicator is lit After self test the electrocardiograph is ready for examination and recording 5 2 Animal Information Input 1 ID Number Press ID upward arrow key to increase ID number or ID downward arrow key to decrease it on the basis of current number The number will be displayed for one or two seconds in the last row on LCD screen such as ECG 9803 in the above figure Under the following circumstances the ID number may increase automatically Under automatic recording mode PRINT STOP key can be pressed to record the ECG automatically When one full lead ECG record finished or PRINT STOP key is pressed during the recording course the ID number will automatically increase one when recording begins again Under manual recording mode press PRINT STOP key
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