CardEX - Midmark
Contents
1. sensitivity will be adjusted automatically under this mode RESET Lead Locking Key S RESET 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 11 4 1mV Calibration Key Imv Under manual mode this key can be pressed to record a 1mV calibration pulse at any time while recording 5 MODE Mode Switch Key MODE There are three automatic modes and a manual mode This key can be pressed to select recording mode The switching order of leads in each mode is listed in Table 3 1 Table 3 1 Lead Switching order of Different Modes Switching Order from left to right 2 channel automatic mode AUTO1 Rhythm Lead 6 LEAD Lead Switch Key Ciao Under manual mode press the key to switch the lead order 7 PRINT STOP Key Used to begin recording and stop recording 19 8 ON OFF Key ON OFF 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 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 cur2. WARNINGA 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 20 Precautions must be observed when using high frequency devices which may affect the quality of ECG 4 4 Electrodes Connections Clamp The identifier and color code of electrode connectors used complies with IEC EN 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 Red RA White Left fore limb Yellow LA Black Right rear limb Black RL Green Left rear limb Green LL Red Chest 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 high quality ECG the skin electrode resistance must be minimized while connecting electrodes Pjs 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 g
3. 115V 100V 115V can be chosen by the shift switch according to local mains supply specification 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 5x20 FUSE AC220V 240V T200mA AC1TO0V 115V T400mA 5x20 A WARNINGA Ruptured fuse must only be replaced with the same type and rating as the original 17 4 Operation Preparations O 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 A WARNINGA 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 220V 240V Rated 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
4. a ek er eee eee 27 Rae cc Prion Head TeS apnea A ea peste seen eM pent rey re re ere ee Perea een nC eer eee 21 5 3 9 External Input Output Settings AA AA ETENEE 28 3x0 Key and ORS Beep OCS a id 28 II Ja Rr Lead AAA I 28 SA Sensitivity o WENNE A A AAA OOR 28 SS Automatic Mode Opera Oe a 29 Manta Mod E a TNO 30 ZLEC RECO Oen E EEN N 30 KESON EO gaina E O S 31 6Alarm informano menssa E AA AAA A A 32 7 Technical Specification das 33 9 Cleaning Care 3nd Malmtenantes cidad 36 A E ISE 00 nee o O 36 8 1 1 Cleaning the Main Unit and Patient Cable ooccococnnnncnccnnnoncnnnconononononnnnanononos 36 Bole Canne the BCC tods it a 36 9 1 3 Cleamne the Print Acad caia 36 NA ica tata cet iateiat arab re re anced sche net N E oman sarinieuscacece ena ietadedes 37 Sar and MEA A ida 37 8 3 1 Recharge and Replacement ol Battery unicidad 37 SL RECO RAPE acto 38 8 3 3 Maintenance of Main Unit Patient Cable amp Electrodes oocooccoccncnncnncnncnncnns 39 Y Seryice WAarraniy sociscess ictal as a essa a tines 41 10 Accessories and Ordering Information cccccssscsssscssssccsssscsssccsssccesssccsssceessscesssceeess 42 MI 1 Safety Guidance 1 1 Safety Information The design of the single channel electrocardiograph complies with the international standard IEC EN 60601 1 Medical Electrical Equipment General Requirements for Safety and IEC EN 60601 2 25 Particular Requirements for the Safety of Electrocardio
5. all equipment is connected with the potential equalization bus bar of the electrical installation 1 2 2 Battery Care Warnings WARNINGA 4 4 Improper operation may cause the battery to be hot ignite or explode and it may lead to the declination of battery s capacity lt is necessary to read the user manual carefully and pay more attention to warning messages Only a qualified service engineer authorized by Midmark Corporation 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 Do not heat or splash the battery or throw it into fire or water zdi 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 lf 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 VCAUTION D Federal US law restricts this device to sale by or on the order of a veterinarian Avoid liquid splashes and excessive temperature The temperature must be kept between 5 C and 40 while worki
6. 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 4 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 1s 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 38 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 b c d e f g h Inspect the equipment and accessories for mechanical and functional damage Inspect the safety relevant labels for legibility Inspect the fuse to verify compliance with rated current and breaking characteristics Verify the
7. switch to power on the unit Then the mains supply indicator o will be lit as well as the battery recharging indicator 17 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 18 2 Built in rechargeable battery When the built in rechargeable lithium battery pack 1s used turn on the unit by pressing ON OFF key on control panel directly and the battery indicator ram will be lit The battery symbol 1 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 UU and 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 A WARNING Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical 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 pa
8. the system standard IEC EN 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 15 3 3 Mains Connection and Switch Potential Mains Power Switch Equalization Conductor Mains Supply Socket At the left side of the main unit there is the mains supply socket power switch and potential equalization conductor as the above figure shows 1 Potential Equalization Conductor y 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 Ns AC SOURCE alternating current supply socket 3 Power Switch Switch on the mains power supply O Switch off the mains power supply 3 4 Bottom Panel Mains Supply Shift Switch Fuse Battery Compartment Fuse Fuse Label Label 16 1 Battery Compartment LITHIUM BATTERY PACK RECHARGEABLE 14 44 1600mAh The battery label indicates the rated voltage and rated capacity of rechargeable Lithium battery pack Rated voltage 14 4V Rated capacity 1600mAh A Caution AN WARNING The battery of same model and specification provided by manufacturer must be used 2 Mains Supply Shift Switch 230V 115V Mains supply with rated input voltage 230V 220V 240V or
9. FF EMG ECG Fourth Row Sensitivity x1 x2 AGC 25 5 Paper speed 25 50 Battery capacity symbol w a 11 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 3 1 2 Control Panel and Keys 10 1 2 3 Indicator AX Mains supply indicator when mains supply is used the indicator will be lit a Battery indicator when the built in rechargeable lithium battery is used the indicator will be lit gt 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 1f the battery capacity is full However 1f the battery capacity is not full the battery recharging indicator will be lit until the battery 1s full recharged and after that the battery recharging indicator will be black SENS Sensitivity Switch Key SENS The sensitivity switching order x1 x2 AGC gt 25 5 The ECG signal range which can be measured and recorded is different according to different sensitivity as the following list shows Sensitivity Signal range measured 10mm mV 2 5mV 2 5mV 20mm mV 1 25mV 1 25mV 2 5mm mV 10mV 10mV If the fluctuating range of the ECG signal is great AGC should be chosen since the
10. User Manual CardEX 100 Single Channel Electrocardiograph MIDVMARK Manual Ver V1 1 Release Date April 2012 Part Number 003 2511 00 Rev A FOR VETERINARY USE ONLY Copyright Copyright Midmark Corporation 2012 All rights reserved Statements Midmark Corporation 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 Corporation 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 Corporation Responsibility of the Manufacturer Midmark Corporation only considers itself responsible for effects on safety reliability and performance of the equipment 1f Assembly operations extensions re adjustments modifications or repairs are carried out by personnel authorized by Midmark Corporation 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 WARNINGA This device is not intended for treatment Using This Label Guide WARNING A WARNING label advises against certain actions or
11. al output External input Equipment or part of CF type with defibrillation proof Caution Consult Instructions for Use Potential equalization Mains supply On mains supply Off mains supply Battery indicator Battery recharging indicator Recycle 7 Rx only U S pad Part Number Serial Number Date of Manufacture Manufacturer Authorized Representative in the European Community Federal US law restricts this device to sale by or on the order of a veterinarian It indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life 3 General Information Label LCD Screen Recorder Control Panel Figure 3 1 Main Unit CardEX Trade mark CardEX 100 Veterinary ECG Trade name ol Classification symbol equipment of CF type with defibrillation proof 3 1 Top Panel 3 1 1 LCD Screen AUTO 1 Il 10 50 I 6 FIT ALL a a a AL Lo Ao x 25 ay Normally the contents displayed on the LCD screen include described from left to right in row order 9 First Row Operation mode AUTO1 AUTO2 AUTO3 and MANU Il stop symbol which will turn to while recording Warning message LD OFF or PAPER etc Current time Second Row Current lead I II IH AVR AVL AVF V Heart rate W actual heart rate or OVR message Third Row Filter setting FLT AC ALL O
12. ally ALL is recommended to be set in order to get better ECG record 26 5 3 2 Recording Settings Recording settings includes start length count unit speed and contents Such as PWAVE START ON RECORD LENGTH as RECORD COUNT SECOND RECORD SPEED lt 29 HEART RATE PRINT ON Take the above 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 T MONTH ra DAY 17 HOUR 14 MINUTE 220 Per the above settings the date amp time is Dec lore 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 1s 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 wil
13. 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 im Full capacity 121 Not full but enough 11 Capacity is limited and recharge should be taken into account 11 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 gt L and the mains supply indicator will be lit at the same time When the capacity of battery is full the battery recharge indicator gt 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 before first usage BT 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 WARNINGA 4 Only qualified service engineer authorized by Midmark Corporation can open the battery compartment and replace the battery The battery of same model and specification provided by manufacturer
14. creen 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 The compact size makes it suitable for clinic and hospital use Note It is not 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 26 2 2 List of Symbols gt i Extern
15. device functions properly as described in the instructions for use Test the protection ground resistance according to IEC EN60601 1 Limit 0 1 ohm Test the earth leakage current according to IEC EN60601 1 Limit NC 500uA SFC 1000A Test the patient leakage current according to IEC EN60601 1 Limit NC a c 10uA d c 10uA SFC a c SOUA d c SOUA Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC EN 601 1 Limit SOUA 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 A WARNINGA 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 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 whi
16. el 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 A WARNINGA 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 ata 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 is 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 Do 2 Power Supply If mains
17. graphs etc The classification of this equipment is Class I 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 I with internal power supply 2 Anti electric shock degree CF with defibrillation proof applied part 3 Degree of protection against harmful Ordinary equipment Sealed equipment without ingress of water liquid proof 4 Disinfection sterilization method Refer to this user manual for details 5 Safety degree of application in the Equipment not suitable for use in the presence presence of flammable gas of flammable gas 6 Working Mode Continuous operation 7 EMC Group I Class A 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 1 2 1 Safety Warnings WARNINGA 4 The electrocardiograph is provided for the use of qualified veterinarian or personnel professional
18. he 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 and heart rate At the beginning of each lead s ECG lead name and 1mV calibration pulse is printed On the top of the ECG record of each lead sensitivity 1s marked The sensitivity may be different for 1t can be changed during the course of recording 30 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 aa 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 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 The ECG signal exceeds the measuring range under certain sens
19. itivity 239 7 Technical Specifications 1 IEC EN 60601 1 A 1 A2 Safety Standards 2 IEC EN 60601 1 2 A1 3 IEC EN60601 2 25 Anti electric shock type Class I with internal power supply Anti electric shock degree Type CF with defibrillation proof Degree of protection against Ordinary equipment Sealed harmful ingress of water equipment without liquid proof Classification Disinfection sterilization method Refer to the user manual for details Degree of safety of application in Equipment not suitable for use in the the presence of flammable gas presence of flammable gas Dimensions 300mmx260mmx75mm About 2 3kg Display 192 x 64 pixels color LCD 20 C 4 F 55 C 5 C 41 F 40 C Temperature 131 F 104 F Environment Relative 25 93 25 80 Humidity Non Condensing Non Condensing Atmospheric 700hPa 1060hPa 60hPa 1060hPa Pressure Operating Voltage 100V 115V 220V 240V Power Supply Mains Supply pS Frequency 50Hz 60Hz Input Power 3SVA 00 Power 35VA oo Rated voltage 14 8V Rated capacity 2200mAh Built in Lithium Battery Charge mode Constant current voltage Pack Charge current standard 0 16C5A 360mA Charge voltage standard 16 8 0 1V Cycle life gt 300 times Thermal dot matrix printer Dot structure 384 dots line Thermal Print Head Dot pitch 0 125mm 8 dots mm Dot size 0 125mmx0 12mm Recording Record Paper Rolled thermal pape
20. l be printed out The status of print head can be estimated from this triangle wave a 5 3 5 External Input Output Settings External input output signal interface 1s equipped in the electrocardiograph through which ECG signal from external equipment can be received and ECG signal detected by the 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 ORS 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 II 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 I II LU AVR AVL AVF and V 5 4 Sensitivity Switching There are five options of sensitivity x1 10mm mV X2 20mm mV AGC gt 25 2 5mm mV 5 Smm mV Press sens 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 cour
21. le using Hold the connector 39 plugs instead of the cable when connecting or disconnecting the patient cable 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 YCAUTION The equipment and reusable accessories can be sent back to the manufacturer for recycling or proper disposal after their useful lives 40 9 Service Warranty Material and Manufacture The warranty period for the main unit and the accessories is 24 months from the date of shipment Midmark Corporation warrants that there s no defect in material and manufacture During the warranty period Midmark Corporation will repair or replace the defective part free 1f the defect has been confirmed as material or manufacture defect Software or Firmware For the software or firmware installed Midmark Corporation will replace the software or firmware free 1f the defect has been confirmed during 24 months from the date of shipment But Midmark Corporation cannot warrant 1t will not interrupt the use of
22. ly 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 Corporation can open the shell Only qualified personnel 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 A WARNINGA 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 Ifthe integrity of external protective 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 not designed for direct cardiac application A WARNINGA Only patient cable and other accessories supplied by Midmark Corporation 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
23. m battery used press ON OFF key on the control panel directly to turn on the unit and then the battery indicator ca is lit After self test the electrocardiograph is ready for examination and recording 5 2 Animal Information Input AUTO 1 ll I FLT ALL x 254 ECG9803 MALE 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 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 24 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 N
24. ng And it should be kept between 20 C and 99 during transportation and 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 VDCAUTION D 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 performance 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 Inspect the equipment and accessories for mechanical and functional damage a Inspect the safety relevant labels for legibility b Inspect the fuse to verify compliance with rated current and breaking characteristics _4 c Verify the device functions properly as described in the instructions for use d Test the protection ground resistance according to IEC EN60601 1 Limit 0 1 ohm e Test the earth leakage current according to IEC EN60601 1 Limit NC 500pA SFC 100014 f Test the patient leakage cu
25. 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 VCAUTION D 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 26 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 regulations 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 V CAUTION Do not use chloric disinfectant such as chloride and sodium hypochlorite etc 8 3 Care and Maintenance 8 3 1 Recharge
26. ote 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 J5 15 KEY BEEP ON OFF 16 QRS BEEP ON OFF 18 LOWPASS FILTER OFF 75HZ 100HZ 150HZ 19 LANGUAGE ENG CHN Setting Method RHYTHM LEAD I LI MI AVR AVL AVF V 1 Press MENU key to enter menu settings displayed as the following figure FILTER SETTING PWAVE START ON RECORD LENGTH 2 RECORD COUNT SECOND 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 Gener
27. per warning message PAPER will be given on the LCD screen Under this circumstance record paper should be loaded or replaced immediately Casi 1 Seme _ ie Paper Roller Sa 11 Scale i Thermal Print Head Roller Pin Printer Platen Groove Paper Tray 19 Loading Replacing Procedures 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 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 Main Cable Screw Connecting to the ECG Sampling Box Electrodes Lead Wires Electrode Connectors Connect Main Cable Plug the connector of main cable into the patient cable socket on the right side of the unit and secure the screw
28. power used please check whether the power cord has been connected to the 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 A WARNING 41 The electrocardiograph is provided for the use of qualified veterinarians or personnel professionally trained They should be familiar with the contents of this user manual before using 203 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 o 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 1s ready for examination and recording When built in rechargeable lithiu
29. r 50mm x30m HR a HR Range 30BMP 300BMP Recognition ECG Unit A D Resolution 12 digit BH Frequency Response 0 05Hz 150Hz Input Impedance gt 50MA 10Hz Input Circuit Current lt 0 05uA Input Voltage Range lt 5 mVpp Calibration Voltage ImV 3 DC Offset Voltage 300mV EMG Filter 35Hz 3dB Filter ACIDET Filter SOHz 60Hz 2048 Filter 50Hz 60Hz ACIDET Filter SOHz 60Hz 2048 20dB CMRR gt 110dB lt 10uA AC lt 10uA DC Patient Leakage Current lt SQuA AC lt 50pA DC lt 10uA AC lt 10uA DC Patient Auxiliary Current lt SQuA AC lt 50pA DC Dielectric Strength 4000V rms External Input Single ended gt 100k Q Sensitivity 10mm V 5 Input Output Optional Output Single ended lt 100Q Sensitivity V mV 5 Communication Interface 35 8 Cleaning Care and Maintenance 8 1 Cleaning DCAUTION Y 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 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
30. rent ID number 11 M F Press MIF key to choose sex male M or female F 12 AGE Press AGE key to choose age YOUNG MATURE or OLD 13 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 3 as po ae r RS232 socket External Input Output socket Patient cable socket 1 Patient Cable Socket t Defibrillation proof applied part of type CF A Caution Definition of corresponding pins 6 Oo netfee e so nc s nc n cr veinputy psf nc o rno re o o oe Note The left side of is European standard and the right side is American standard 2 RS232 Socket WARNINGA RS232 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed 15V DC 14 ECG Signal input ECG Signal output NWARNINGA Accessory equipment connected to the interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard IEC EN 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 the requirements of the valid version of
31. rrent according to IEC EN60601 1 Limit NC a c 10uA d c 10UA SFC a c 50A d c 50A g Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC EN60601 1 Limit 50A 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 VCAUTION V Turn off the power before cleaning 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 ES 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 s
32. se of recording under automatic mode 28 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 together under AUTO 3 mode The lead switching orders under different modes are listed in Table 3 1 in Section 3 1 2 AUTO gt 10 50 1 6 FLE ALL a A ALa 4 x 245 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 AUTO 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
33. situations that could result in personal injury or death VCAUTION Y 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 Table of Contents 1 Sately Gumi ane ide 1 Mol AAA E l 122 Warnings and autos ai is l 1 2 US ato WAS eraan E T enaeaedeasacseaemieusesteus 2 122 Batey Care Wan 3 2 ICME ECONS ane E sansa uaaesns cance ace noeeuniansaauteseenateeees 4 1 2 4 Cleaning Disinfection Cautions silo 5 2 nroddu ioi ssion A seawadsedsaea secs soesesdscucatesssieeesesds couves 6 2 PUNO E AUUIRCS eee darretae snes isi aa 6 2D WAS POW SV MID ONS ia 7 General IOMA OM id onis E E E a 9 TOM Pane isan A 9 A E A Matsa 9 IEZ Control panela dnde 10 3 2 Patient Cable Socket and Signal Interface coooonnnnconcnononcnnononccnnonccnononccnnnononononccnnnanos 14 3 Mains Conmmecuonand Wills ida iio elos 16 do A O eer 16 4 Operation Preparados isis dicta 18 Bl Power SUP PI siones 18 42 loading Replacito Record Papel Ei 19 Foran able COMMON iisccin 20 AIL ctrodes CONE CUASI 21 A MSP ECUOM DELOES SWite MN OA EA AAA AAA 22 gt Operation Instructions segern o a a a tana A a aao Eaa 24 Aa on A aes Gal eopaneneeeanneaas ease tegen 24 5 2 Pini Ori an LUG eaaa N oe a ae 24 Di MENE SSO OS oars aida 25 la A e A E Ri OOO In 26 IL IRE CONCING SS CU MNOS domes NNO 21 a sE PR
34. 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 adjust it before recording Note Recording mode cannot be changed during the course of printing Stop recording before choosing another recording mode 29 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 2 3 4 5 6 Note Press MODE key to choose MANU mode which can be discerned by the identifier on the left corner of LCD screen as MANU Press LEAD key left arrow or right arrow key to select the lead to be recorded Press MENU key to set the record settings or other settings After setting press MENU key again to confirm the settings Then press PRINT STOP key to begin recording 1mV calibration key can be pressed to print out 1mV pulse wave in the record while ECG recording Press PRINT STOP key to stop printing after finishing ECG record LEAD left and right arrow key can be pressed to switch the lead during the course of recording 5 7 ECG Record 2007 12 13 13 24 1 ma y im imma AC n 1 iin m OWNER aes SS TYFE iH i ii 4 ki T k r 4 E 4 A i r E OE ia don a El a ol o ARCADIA Bd Cea As the above figure shows t
35. sure that the conductive parts of electrodes and associated connectors including neutral electrode should not contact with earth or any other conducting objects Electrodes with defibrillation protection should be used while defibrillating de 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 NWARNINGA 4 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard IEC EN 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 EN 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
36. the product DCAUTION D All services must be done by the engineers authorized by Midmark Corporation Limit of Warranty The charges of freight and others are excluded under warranty The warranty 1s 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 4 10 Accessories and Ordering Information The accompanying accessories of the electrocardiograph are listed in Table 10 1 Table 10 1 Accessories List Rechargeable Lithium CD 0014 Replacement Battery 2200MAH Alligator Style Veterinary ECG T CD 0012 Banana Clips EN Carrying Bag CD 0004 EN Ground Cable 015 3091 00 The main unit and accessories are available by contacting Midmark Corporation 42 MIDMABRIL Midmark Corporation 60 Vista Drive Box 286 Versailles OH 45380 0286 1 800 MIDMARK midmark com
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