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Saadat Dena 640, User Manual

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Saadat Dena 640 User Manual Download Page 3

 

 
 

 

   

Table of  Contents

 

Explanations of the used expressions in this Manual  

II 

Explanations of the symbols in the Manual and device 

III 

Section 1 General Warnings…………………………………………………....

 

1 

General Warnings………………………………………………………………...

 

2 

Section 2 System Configuration………………………………………………..

 

5 

General …………….……………………………………………………………..

6

System Description……………………………………………………………....

 

7 

ECG Electrodes Connection…………………………………………………….

 

15 

Section 3 Device Setting…………………………………………………………

 

25 

General …………….……………………………………………………………..

 

25 

Main Menu………………………………………………………………………..

 

26 

System Setting Menu……………………………………………………………..

 

26 

User Setting Menu………………………………………………………………..

 

30 

Section 4 Patient Information………………………………………………….

 

33 

Section 5 

Data

 Management…………………………………………………....

 

38 

General …………….……………………………………………………………..

 

38 

Memory Menu……………………………………………………………..…......

 

39 

Section 6 Recording Operation……………………………………….………..

 

43 

General …………….……………………………………………………………..

 

43 

Recording Type………………………………………………………..…………

 

44 

Copy Mode……………………………………………………………..………...

 

46 

Recorder Paper………………………………………………………..………….

 

47 

Section 7 Patient Safety…………………………………………....……………

 

51 

Section 8 Getting Started……………………………………………….….…...

 

53 

Section 9 Technical Specifications………………………………………..….....

 

55 

Section 10 Care and Cleaning (PM)……………………………………………

 

59 

System Check………………………………………………………….….……...

 

57 

Cleaning………………………………………………………………..…...…….

 

68 

Disinfection……………………………………………………….………………

 

59 

Section 11 Troubleshooting ………………………...…………….……………

 

61 

Appendix I-Accessories

63

Appendix II-List of System parameters 

64

Appendix III- Error Messages 

67 

Appendix IV-EMC 

70 

Summary of Contents for Dena 640

Page 1: ...SAADAT Co User Manual Dena Electrocardiograph D00850 0 Dena 640 ...

Page 2: ...o 4 East First St Ettehad Blvd Damavand St TEHRAN IRAN Post box 16765 965 Tel 98 21 77965038 Fax 98 21 77964239 Customer Services Tel 98 21 77798910 Fax 98 21 77960761 Cell 98 912 1977157 Web site www saadatco com Email info saadatco com ...

Page 3: ...ting Menu 26 User Setting Menu 30 Section 4 Patient Information 33 Section 5 Data Management 38 General 38 Memory Menu 39 Section 6 Recording Operation 43 General 43 Recording Type 44 Copy Mode 46 Recorder Paper 47 Section 7 Patient Safety 51 Section 8 Getting Started 53 Section 9 Technical Specifications 55 Section 10 Care and Cleaning PM 59 System Check 57 Cleaning 68 Disinfection 59 Section 11 ...

Page 4: ...mer service Intended Audience This manual is provided for the clinical medical professionals Clinical medical professionals are expected to have working knowledge of medical terminology and procedures as required for the device operation Version Information This manual has a version number The version number changes whenever the manual is revised due to software or technical specification changes ...

Page 5: ...expressions in this Manual A WARNING symbol advises against certain actions or situations that could result in personal injury or equipment damage A NOTE symbol provides useful information and recommendations about device function ...

Page 6: ...s symbol provide an F type isolated floating patient applied part with a high degree of protection against shock and is suitable to use with defibrillator simultaneously For protection against defibrillator use only manufacturer recommended accessories The equipment shall be disposed of in an environmentally friendly manner AC power supply 100 240 VAC 60VA 50 60 Hz 3A fast fuse USB port USB SD por...

Page 7: ...1 Section 1 General Warnings Please refer to this section for overall safety information ...

Page 8: ...ned and authorized personnel by manufacturer company The electrocardiograph is intended for use only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Do not use the electrocardiograph system during magnetic resonance imaging MRI scanning Induced current could potentially cause burns The device may affect the MRI image and the MRI unit may affect t...

Page 9: ...n shall consider all well known side effects when using the electrocardiograph To prevent the environment pollution the device and accessories e g battery shall be disposed in accordance with national laws after their useful lives Contact your municipality to check where you can safely dispose of old batteries Do not expose the system near any local heating item such as the direct sunlight When de...

Page 10: ...in the APPENDIX IV To prevent EMC effect on the electrocardiograph it should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the system should be checked for normal operation in the configuration in which it will be used If any liquid is spilled on the system or accessories immediately turn off the system and wipe up it by a soft cloth and t...

Page 11: ...rm separately on the screen _ 6 channel waveform recording _ Data storage in internal and external memories _ Displaying and printing stored data Signal recovery accuracy With regard to maximum frequency bandwidth of 150 Hz and sampling rate of 1000 samples s the signal recovery accuracy of Dena Electrocardiograph complies with the requirements of IEC 60601 2 25 standard ...

Page 12: ...C Humidity 20 90 Altitude 200 to 3000m Power Supply 100 240VAC 50 60Hz 60 VA Intended Use Dena is an advanced electrocardiograph which is designed to record electrical signals of the heart in six channels 10 wire using a thermal printer with adjustable filter gain speed and mode This device is applicable to adults and neonates in all parts of the medical center and used by healthcare professionals...

Page 13: ...ECG waveforms patient information messages and etc are displayed on the screen See 2 1 for details Recorder Release Button to open the recorder door Recorder to load recording paper and print ECG waveforms Control panel to control the system operation See 2 2 for details ...

Page 14: ...area Figure 2 2 2 2 informative and system error messages area Figure 2 2 3 and touch keys area Figure 2 2 4 Figure 2 2 Display Screen Header Area The Header Area is at the top of the screen The parameters displayed in Header Area are heart rate patient name ID current date and time and system operating status This information is displayed on the screen throughout the system operation Symbol will ...

Page 15: ...continuously by the system and in case of improper connection the related message will appear in this area in red Figure 2 2 2 2 2 Informative and system error messages area Figure 2 2 3 The system messages are displayed in white background and red text Refer to Appendix III for the system messages Touch screen keys The function of touch keys is the same as their corresponding hard keys on the con...

Page 16: ...ed data 5 Calib Press to record a 1mv calibration signal 6 Speed Use to adjust the recording speed 7 Reset Use to reset Drift filter and restore signals quickly to the screen 8 Enter Press to enter software menus or select menus options 9 Lead Press to select next lead s 10 Lead Press to select previous lead s 11 Sens Use to adjust the amplitude of ECG waveform on the screen and recording paper 12...

Page 17: ... on the control panel The green power indicator lights up when the device is powered on 15 in Figure 2 3 The battery indicator illuminates green when the battery is fully charged otherwise it is orange 14 in Figure 2 3 Before using the electrocardiograph check function of all keys and make sure that it is in proper working order Figure 2 3 Control Panel ...

Page 18: ...loading the battery 3A fast fuse 3 Connectors The following connector are located at the back side of the device Figure 2 5 Rear Panel Power Supply 100 240 VAC 60 VA 50 60 Hz If the device is to be stored for a long period more than 10 days the fuse should be removed in order to prevent battery discharge ...

Page 19: ...ollowing connectors are located at the right side of the device Figure 2 6 Side Panel 1 Connector of ECG cable 2 Programmer connector it should only be used by the manufacturer trained and authorized personnel ...

Page 20: ...arge This symbol is only displayed when the AC INPUT is not plugged in The status of the battery charging is also shown by the battery indicator on the control panel When the battery indicator is solid green the battery is fully charged Orange indicator means that the battery is being charged When the battery is depleted in less than 1 hour it needs to be replaced Please call customer service for ...

Page 21: ...y be severe enough to prevent obtaining an ECG trace Using dissimilar metals may also increase recovery time after defibrillation When you connect the cables and electrodes make sure that no metal part is in contact with the safety ground Verify that all ECG electrodes are correctly attached to the patient Interference from a non grounded instrument near the patient and or ESU Electrosurgical Unit...

Page 22: ...ease note the position of leads In order to reduce the hazard of burns the leads should be located away from the electrocautery pen and return electrode Use intact and clean electrodes only Electrodes with damaged surface may cause ECG waveform inaccuracy ...

Page 23: ...onductor of electricity therefore preparation of the patient s skin is important to facilitate good electrode contact to skin Wash sites thoroughly with soap and water 2 Apply some gel on the skin of these sites 3 Place the electrode on proper site of the patient body The limb electrodes of 12 lead ECG should be placed in the following sites Left arm LA Right arm RA Left leg LL Right leg RL Figure...

Page 24: ...s 3 Place the chest electrode on proper site and press its suction bulb to attach it to the skin The chest electrodes of 12 lead ECG should be placed in the following sites C1 V1 Fourth intercostal space at the right margin of the sternum C2 V2 Fourth intercostal space at the left margin of the sternum C3 V3 Midway between V2 and V4 C4 V4 Fifth intercostal space at the left midclavicular line C5 V...

Page 25: ...electrodes Site for electrodes Red R Right arm Yellow L Left arm Black N RF Right leg Green F Left leg White Red C1 Chest White Yellow C2 White Green C3 White Brown C4 White Black C5 White Violet C6 Color code for electrodes Symbol for electrodes Site for electrodes White RA Right arm Black LA Left arm Green RL Right leg Red LL Left leg Brown Red V1 Chest Brown Yellow V2 Brown Green V3 Brown Blue ...

Page 26: ... waves duration and PR QT and QTc waves interval are measured in millisecond Also Heart Axis is same electrical axes of P QRS and T waves which can be calculated During measurement process the signal of each 12 lead are analyzed separately Comment EGC Parameters P wave Onset to P wave Offset P Duration Q wave Onset to S wave Offset QRS Duration P wave Onset to Q wave Offset PR Interval Q wave Onse...

Page 27: ...ing duration and intervals The measurement result of ECG signal parameters are recordedon the recorder paper Figure 2 11 Figure 2 11 Measurement Table When the signal is saved and the measurement is enabled the measured parameters table is recordedon the recorder paper while recording the relevant signal ...

Page 28: ...ignal slope the exact situation of each wave and their onset and offset points will be determined This process is implemented on all leads separately and in each step the relevant outputs are saved Finally the best value for the start end points of P QRS and T waves is selected based on Multi Lead Selection algorithm The general block diagram of the used method to determine the time intervals is a...

Page 29: ...and T waves among above axes QRS axis is used clinically more and can be calculated simply Leads I II and III or aVF aVL and aVR can be used to calculate QRS axis Each of these leads indicates electrical activity of heart in the specific direction Axes corresponding with each lead are indicated in figure 2 13 The relevant diseases according to heart axis are indicated in figure 2 14 Normal heart a...

Page 30: ...amplitude of QRS complex in lead II So based on researches done using the lead with the maximum net amplitude makes the results more accurate In DENA electrocardiograph system the combination of 2 leads with highest amplitude is used to calculate the heart axis according to the equations defined in the above table Saving Enabling Save option on the memory menu all data recorded in Rhythm and Auto ...

Page 31: ...e explained in this section For date and time settings please refer to System setting Time and Date For manufacturer information please refer to System setting About For recording setting please refer to User Setting It is recommended that the device is set properly before recording ...

Page 32: ...g Menu key on the control panel or touching Menu on the screen Figure 3 1 Figure 3 1 Main Menu The Main menu consists of four options User Setting System Setting Patient Info and Memory System Setting Menu By pressing System Setting in the Main menu you can access System Setting Menu Figure 3 2 Figure 3 2 System Setting Menu ...

Page 33: ...ian Date To set the current date Time To set the current time Power Off To shut down the device automatically after 5 60 min Select Off to disable this function Rec Test To test the recorder function Default Factory To load factory default settings Because of changing all your previous settings the system asks if you are sure to change all by this message Figure 3 4 Figure 3 4 Default Factory ...

Page 34: ...n access the following window Only manufacturer s authorized personnel have access to this menu Figure 3 5 Factory Code About By selecting this option you can view product and manufacturer information as shown in the figure below Figure 3 6 About Menu ...

Page 35: ...art beat sound Hospital Ward By selecting this option you can access the following window and enter hospital or ward name Figure 3 7 Hospital Ward Note After any change occured in System Setting Menu when you want to exit from this menu a message will appear on the screen asking you whether to save changes or not Figure 3 8 Confirmation Menu ...

Page 36: ... Lead The Rhythm lead can be one of the leads I II III aVL aVR aVF V1 V2 V3 V4 V5 and V6 Low Pass Filter Press to toggle between 25 35 75 and 150 Hz This filter is used to remove muscle artifacts and high frequency noises The frequency of selected filter is displayed on the screen Rec Time Press to set recording duration for different leads in Auto mode It ranges from 3 to 12 seconds Length of Rhy...

Page 37: ...n and otherwise 0 05 Periodic Interval Repetition Press to set repetition of recording Available options are 1 20 and Infinite Measurement when this option is Enabled ECG parameters will be measured Since the ECG parameters measurement is done on Auto and Sync mode by enabling this option Rec Mode is changed to Sync in Auto and Auto 1 1 modes When this option is Enabled by pressing Start key Proce...

Page 38: ...noise take the following steps 1 At first remove any noise sources for more details please refer to Troubleshooting chapter 2 If after taking above action the noise is not rejected set On EMG filter 3 If the signal is still noisy use low pass filter 4 Using LOW PASS FILTERS 25 35 75 Hz may decrease the amplitude of QRS Complex Note After any change occured in User Setting Menu when you want to exi...

Page 39: ...ent information Touch Patient Info in the Main Menu or select Patient Info using arrow keys and then press Enter the Patient Info Menu will appear Figure 4 1 Patient Info Menu Enter the patient information correctly otherwise it may be confused with the information of other patients ...

Page 40: ...to access the related window Name Enter the patient name and press Save to exit from this window Figure 4 2 Up to 14 characters can be input in this field Figure 4 2 Name Press Cancel to exit from this window and return to the previous menu ...

Page 41: ...or month according to the selected option Enter the patient age and press Save to exit this window Figure 4 3 Age Press Cancel to exit from this window and returning to the previous menu Gender Available options for sexuality of patient are Male Female and None Factory default setting is None ID Enter the patient ID and press Save to exit this window Up to 10 characters can be input in this field ...

Page 42: ...efault setting is Kg Enter the patient weight and press Save to exit this window Figure 4 5 Weight Press Cancel to exit from this window and return to the previous menu Height Available options are Foot and cm Factory default setting is cm Enter the patient height and press Save to exit this window Figure 4 6 Height ...

Page 43: ...ld Figure 4 7 Physician Name Press Cancel to exit from this window and return to the previous menu Blood Type Press to toggle between A A B B AB AB O O and Unknown Factory default setting is Unknown Note After any change occured in Patient Info Menu when you want to exit from this menu a message will appear on the screen asking you whether to save changes or not Figure 4 8 Confirmation Menu ...

Page 44: ...ecorded data in Auto Periodic modes will be automatically stored in the internal memory of the device for future reference This data can be Recall in Memory Menu Up to 100 records can be stored in the internal memory When the memory is full the new data will overwrite the oldest data automatically ...

Page 45: ...nals in Auto Periodic mode will saved in internal memory of device The stored data can be recall by Show Records menu If this option is set to Disable no data recorded Note After any change occured in Memory Menu when you want to exit from this menu a message will appear on the screen asking you whether to save changes or not Figure 5 2 Confirmation Menu ...

Page 46: ...to enter the patient name as shown in the figures below Figure 5 4 Name Memory Menu Search Enter patient name ID and press Search to view all stored data of that patient If you leave Patient name ID blank and select Search all stored records in the memory will be displayed in a list as shown in the figure 5 5 If no data is available the message There is no record will appear ...

Page 47: ... any _ Date and time of recording _ Recording mode R indicates Rhythm mode and P indicates Periodic mode You can also see current page number total pages and remaining records for storage in this window The last record is always displayed at the top of the list Press or to move to the previous or next pages Press or to move to the previous or next records Press Review to observe the information of...

Page 48: ...e contains _ ECG waveforms _ HR value _ Speed Gain and recording mode _ Filter name _ Patient name and ID _ Date and time of recording Press Start Stop key to print the stored ECG signals in the same condition as the recording time ...

Page 49: ...orm recording MAX Real time and Synchrone recording Periodic recording with adjustable time intervals Rhythm lead recording in six channels Please refer to section 2 User Setting Menu for details on recording settings Signal recovery accuracy With regard to maximum frequency bandwidth of 150 Hz and sampling rate of 1000 samples s the signal recovery accuracy of Dena Electrocardiograph complies wit...

Page 50: ...the second one is the waveform of selected Rhythm lead Manual 3 Select this mode and press Lead and Lead keys to choose between lead groups Then press the Start Stop key to start recording Manual 3 1 Select this mode and press Lead and Lead keys to choose between lead groups Then press the Start Stop key to start recording In the recording paper the first three waveforms are the waveforms of selec...

Page 51: ... will continue for the next lesd lead group automatically By pressing the Start Stop key at any time record will stop Auto 1 1 Select this mode and press the Start Stop key to start recording In the recording paper the first waveform indicates the waveform of selected lead and the second one is the waveform of Rhythm lead Auto 3 Select this mode and press the Start Stop key to start recording Auto...

Page 52: ...r of recording repetitions Available options are infinite and 1 20 3 Select recording mode using Mode key For more information about Periodic recording settings refer to User Setting Menu in section 2 You can also perform Automatic and Manual recordings during Periodic recording For this purpose 1 Select the recording mode 2 Press the Start Stop key After that recording in the selected mode is fin...

Page 53: ...ly the manufacturer recommended record paper otherwise the recording quality may be poor or the thermosensitive printhead may be damaged Do not touch the recorder head while recording and immediately after recording because it is so hot and may lead to personal injury including burns ...

Page 54: ...Paper loading Press the recorder release button as shown in figure below Open the recorder door Place the paper roll in the recorder awry and push it Place the other side of the paper roll in the recorder ...

Page 55: ...corder Be careful when loading the paper in the recorder Avoid damaging the thermosensitive printhead Do not touch thermosensitive print head The paper detector may not operate properly if covered with foreign matter Therefore if you find foreign matter on the sensor remove it and clean the sensor If the paper is jammed open the recorder door and remove the paper Do not pull the paper out by force...

Page 56: ...the print quality Clean the head elements and platen roller surface using a cloth moistened with alcohol Wait until the alcohol dries then close the recorder door Do not clean the recorder immediately after recording because thermal head and its surrounding area are hot during and after recording It is recommended to use the paper with coloured marks intended to aware user that the paper is near t...

Page 57: ... IEC60601 1 The modules with this symbol contain a CF Type Cardiac Float and Defibrillation Proof applied part providing a high degree of protection against shock and is usable during defibrillation Follow the instructions below to ensure safety of the device installation The environment where the device will be used should be reasonably free from vibration dust corrosive or explosive gases extrem...

Page 58: ...s the instrument to the power line ground protective earth when plugged into an appropriate 3 wire receptacle If a 3 wire receptacle is not available consult the hospital electricians If there is any doubt regarding the integrity of the protective grounding wire the equipment should run on the battery Possible explosion hazard if the device is used in the presence of flammable anesthetic agents ...

Page 59: ...stributor immediately 8 2 Connect the power cable to the device Make sure the AC power supply complies with the following specification 100 240 VAC 50 60Hz Plug the power cable to the power supply socket of the device Connect the other end of the power cable to a grounded power receptacle 1 unit Electrocardiograph device 1 piece Patient cable 1 roll Recorder thermosensitive paper Set of 4 Limb ele...

Page 60: ... only connect the system to AC INPUT The battery needs to be charged after transportation or storage If the power cable is not plugged in before turning on the device the device may not work properly because of insufficient power Connect the device to AC INPUT for about 8 hours while it is off Make sure that the battery indicator lights If it does not light check your local power supply and power ...

Page 61: ...80 272 Waveforms 12 Lead ECG Rhythm Lead Numeric Parameters HR Operation Method Membrane Keys and Touch Displayed data Waveforms Patient Information Name and ID Data Time Recording Speed Sensitivity Operation Mode Filter HR Value Message ECG Input Channel Simultaneous acquisition of all 12 leads Rhythm Lead Standard leads acquired I II III aVR aVF aVL V1 V2 V3 V4 V5 V6 Sensitivity Selection 2 5 5 ...

Page 62: ...rinted data 12 Lead ECG Waveforms HR Value Patient Information Hospital ward system model software version date and time paper speed sensitivity filter Recording Mode Normal Periodic Recording Format Auto 1 1 Auto 3 Auto 3 1 Auto 6 Manual 1 1 Manual 3 Manual 3 1 Manual 6 and Rhythm GENERAL Safety Class I Based on IEC60601 1 Protection Against Defibrillator AC Power 100 240 VAC 60VA 50 60 Hz Intern...

Page 63: ...gineer of the hospital or the manufacturer After Sales Service The overall check of the device including the safety check should be performed only by qualified personnel All checks which need the electrocardiograph to be opened or may affect the device safety should be performed by After Sales Service If users do not follow a satisfactory maintenance schedule the device may become invalid and huma...

Page 64: ... Use soft cloth moistened with mild soap liquid or cleaning agent containing 70 ethanol to clean the ECG cable Recorder Accumulation of paper powder or foreign matter on the thermal head and platen roller deteriorates the print quality Clean the head elements and platen roller surface using a cloth moistened with alcohol Wait until the alcohol dries then close the recorder door Before cleaning the...

Page 65: ... liquid enters the device No part of the electrocardiograph should be subjected to immersion in liquid Do not pour liquid onto the device during sterilization Use a soft cloth to wipe up any agent remaining on the device Do not use ETO gas to disinfect the electrocardiograph Manufacturer does not accept any responsibility for effective control of infectious diseases using these chemical agents Ple...

Page 66: ... is recommended 1 Calibration label Send the system to the manufacturer for calibration on the predetermined date 2 System intactness no mechanical damage 3 System cleanness 4 Keys and indicators function 5 Accessories intactness no mechanical damage 6 Recorder function It is recommended that the system is calibrated by manufacturer every year but it has to be calibrated once every 2 years In addi...

Page 67: ...connection failure Faulty ECG cable Improper placement of electrodes Check ECG cable connection Short circuit all leads with each other If ECG cable is ok lead error message will not appear Do not use old and faulty electrodes Call After Sales Services Inappropriate HR value Noisy and improper ECG signal Please wait a few seconds after conncting the electrodes before recording Check leads and elec...

Page 68: ...des Insufficient gel is applied Contact with metal parts of bed trolley etc Lead wires patient cable or power cable fails to make connection There are other electronic devices in the vicinity of the electrocardiograph Improper ambient light for example using fluorescent lamp in the room which ECG record is taken Incorrect HUM Filter is used Improper Earth system Check electrodes and lead wires con...

Page 69: ...009SSC EKG Suction chest electrode Adult FMT P28021 SE1 ECG Suction chest electrode Pediatric FIAB P28048 F9015SSC ECG Suction chest electrode Pediatric FMT P28039 SE2 ECG Suction chest electrode Child FIAB F9008SSC ECG Suction chest electrode Oversize FIAB F9016SSC ECG GEL P28045 Thermal Recording Paper 110mm P28026 The accessories listed below are specified to be used for the electrocardiograph ...

Page 70: ...r Speed User Setting Menu Real time Sync in Auto Real time Rec Mode II I II III aVL aVF aVR V1 V2 V3 V4 V5 V6 Rhythm lead 150 25 35 75 150 HZ Low Pass Filter 3 3 12 Seconds interval 1 s Rec Time 30 30 60 90 120 150 180 Seconds Length of Rhythm Recording 50 50 60 HZ Off HUM Filter Off 5 60 min Off interval 5 Periodic Recording Off On Off Pace On On Off Drift Filter Infinite 1 20 Infinite interval 1...

Page 71: ...Date Time Off 5 60 min Off interval 5min Power Off Rec Test Default Factory About On On Off Key Touch Sound Off 1 2 3 Off Beat Volume Blank Hospital Ward Date Time Menu Christian Solar Christian Calendar Date Time About Menu Manufacture Version Fax Website E mail Tel ...

Page 72: ...Name Search Show Records Menu Page up Page down Cursor up Cursor down Delete Review Review Back Patient Info Menu Blank Name Blank ID Years Years Months Age None Male Female None Gender Kg Kg lb Weight Cm Cm Foot Height Blank Physician Name Unknown A A B B AB AB O O Unknown Blood Type ...

Page 73: ...nnected to patient The message is displayed in red color on the screen CHECK C2 Improper connection of C2 electrode Make sure that C2 electrode is properly connected to patient The message is displayed in red color on the screen CHECK C3 Improper connection of C3 electrode Make sure that C3 electrode is properly connected to patient The message is displayed in red color on the screen CHECK C4 Impr...

Page 74: ...ead voltage is high Turn the system off and on If problem still exists contact the manufacturer s After Sales Service The message blinks in red color on the screen Head Low Vol 1 The print head voltage is low 2 The battery voltage is low 1 Turn the system off and on 2 Make sure that the battery is sufficiently charged If problem still exists contact the manufacturer s After Sales Service The messa...

Page 75: ...g the patient The error message prints on recorder paper Abnormal Heart Rate The RR duration is less than 166 ms HR 180 bpm Record again after check the patient situation control The error message prints on recorder paper Abnormal Heart Rate The RR duration is more than 750 ms HR 40 bpm Record again after check the patient situation The error message prints on recorder paper Weak Signal Lead II Th...

Page 76: ...s used for domestic purposes Harmonic emissions IEC 61000 3 2 Complies Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Use only the recommended manufacturer accessory Using the accessory other than in relevant chapter may cause to increase the EMISSION or decrease the IMMUNITY of system Measurements can be affected by mobile and RF communications equipment It should be assured that t...

Page 77: ...nment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in ...

Page 78: ...om fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption...

Page 79: ...ion distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 7 11 7 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the fr...

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