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Compliance to the Electromagnetic Immunity

The LX-8100 is intended for use in the electromagnetic environment specified below. The customer or

the user of the LX-8100 should assure that it is used in such an environment.

Basic EMC standard or test method

Immunity test levels

Electrostatic discharge
IEC 61000-4-2

8kV contact

2kV,

4kV,

8kV,

15kV air

Radiated RF EM fields
IEC 61000-4-3

10V/m
80MHz to 2.7GHz
1kHz

80%AM

Proximity fields from RF wireless

communications equipment
IEC 61000-4-3

Refer to the following table.

Conducted disturbances induced by RF

fields
IEC 61000-4-6

3V
0.15MHz to 80MHz
1kHz

80%AM

6V
0.15MHz to 80MHz
(in ISM bands between 0.15 MHz and 80MHz)
1kHz 80%AM

Rated power frequency magnetic fields
IEC 61000-4-8

30A/m
50Hz

Immunity test specifications for RF wireless communications equipment.

Test frequency

(MHz)

Modulation

Maximum power

(W)

Distance

(m)

Immunity test level

(V/m)

810, 870, 930

PM, 18Hz

0.3

1720, 1845, 1970

PM, 217Hz

0.3

2450

PM, 217Hz

0.3

5240, 5500, 5785

PM, 217Hz

0.2

0.3

Содержание LX-8000 Series

Страница 1: ...Before installation maintenance read this service manual thoroughly After reading this service manual store it in a safe place Service Manual LX 8000 series ECG Respiration Transmitter LX 8100 LX 8100 G ...

Страница 2: ...This device bears the CE label in accordance with the provisions of Medical Device Directive 93 42 EEC This device bears the CE label in accordance with the provisions of RE Directive 2014 53 EU This device bears the CE label in accordance with the provisions of RoHS Directive 2011 65 EU We FUKUDA DENSHI CO LTD hereby declare that this transmitter model LX 8100 is in compliance with the essential ...

Страница 3: ...Revision History Equipment LX 8100 LX 8100 G Service Manual Edition Revised Items Reason of the Revision Date 1 New Edition 2018 01 2 The entire document Added description of LX 8100 G 2018 08 ...

Страница 4: ......

Страница 5: ...l Accessories ix Precautions about Battery ix Precautions about Nickel Metal Hydride Battery for Europe ix Precautions about Disposing of Equipment Accessories or Components ix Precautions about Disposing of Battery x Precautions about Disposing of Nickel Metal Hydride Battery for Europe x Precautions for Use of Medical Telemeter for Europe x Precautions for Use of Medical Telemeter for USA xi Ele...

Страница 6: ...ause immediate threat of death or serious injury or complete failure of the equipment WARNING Failure to follow this message may result in death or serious injury or complete failure of the equipment CAUTION Failure to follow this message may cause injury or failure of the equipment NOTE A note is not related to product safety but provides information about the correct use and operating procedures...

Страница 7: ...efibrillation Proof Indicates that the degree of protection against electric shock is Type CF Applied Part with defibrillation proof Indicates the power ON OFF status Indicates the point to close the battery compartment lid Indicates the battery type and direction Name and Address of Manufacturer Date of Manufacture Indicates the name and address of manufacturer and date of manufacture WEEE Waste ...

Страница 8: ...ainst electric shock is Type CF Applied Part with defibrillation proof Indicates the power ON OFF status Indicates the point to close the battery compartment lid Indicates the battery type and direction Name and Address of Manufacturer Date of Manufacture Indicates the name and address of manufacturer and date of manufacture Date of Manufacture Indicates the date of manufacture Non ionizing electr...

Страница 9: ...observe the equipment and patient to ensure safe operation of the equipment If any abnormality is found on the equipment or patient take appropriate measures such as ceasing operation of the equipment and or detaching the probe sensor and or electrode in the safest way for the patient Do not allow the patient to come in contact with other equipment 5 After using the equipment verify the following ...

Страница 10: ...on of ECG electrodes ground plate attachment condition or the type of instrument used it may cause burn injury at the electrode site or noise on the ECG The noise is generated at the tip of the electrosurgical knife and is difficult to completely eliminate because of the frequency components of the ECG To reduce electrosurgical interference take the following precautions Location Locate the electr...

Страница 11: ...possibly send wrong information If such event occurs disconnect the cardiac monitoring and diagnostic equipment or follow the procedures described in the operation manual of the pacemaker Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter alarms Keep pacemaker patients under close surveillance Reference...

Страница 12: ...uous use of the electrode is about one day Replace the electrode if the skin contact gets loosen due to perspiration etc When an electrode is attached to the same location for a long period some patients may develop skin irritation Check the patient s skin condition periodically and change the electrode site as required For stable ECG monitoring verify proper electrode placement lead and waveform ...

Страница 13: ...y as mentioned in their user manuals Precautions about Battery WARNING Use new AA size LR6 size alkaline cell Install the battery with the correct polarity Do not charge the battery Any attempt to charge the battery may cause it to leak or break Do not short the and terminals It may result in exothermic heat and fire Do not throw the battery into fire It may explode Precautions about Nickel Metal ...

Страница 14: ...mits vital signs to the receiving monitor using radio wave signal Under unstable radio wave signals the receiving monitor will not generate any alarms This situation may miss sudden change in the patient s condition and may cause a serious accident Under unstable radio wave signals check the patient status consistently under this situation To get stable radio wave signals make sure to have a prope...

Страница 15: ...h FCC IC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency RF Exposure Guidelines and RSS 102 of the IC radio frequency RF Exposure rules This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption rate SAR Operation of LX 8100 LX 8100 G requires the prior coordination with a frequency coordina...

Страница 16: ... The Coordinator is responsible for maintenance of wireless channels and storage and maintenance of telemeter in the overall medical facilities to give proper instructions to the telemetry users The Coordinator should create a management log hereinafter referred to as the log which contains a list of the management status of the wireless channels for the whole Institution When changing a wireless ...

Страница 17: ...lectromagnetic Influence CAUTION If any sorts of electromagnetic wave magnetic field or static electricity exist around the equipment noise interference or malfunction of the equipment may occur If any unintended malfunction or noise occurs during monitoring check the magnetic influence and take appropriate countermeasures The followings are examples of the common cause and countermeasures Mobile ...

Страница 18: ...e technician The following is the information relating to EMC Electromagnetic Compatibility When using this equipment verify that it is used within the environment specified below Compliance to the Electromagnetic Emissions This equipment complies with the following emission standard Emission test Compliance RF Emission EN 55011 Group 1 Class A CAUTION The emission performance of this equipment is...

Страница 19: ... 1kHz 80 AM Proximity fields from RF wireless communications equipment IEC 61000 4 3 Refer to the following table Conducted disturbances induced by RF fields IEC 61000 4 6 3V 0 15MHz to 80MHz 1kHz 80 AM 6V 0 15MHz to 80MHz in ISM bands between 0 15 MHz and 80MHz 1kHz 80 AM Rated power frequency magnetic fields IEC 61000 4 8 30A m 50Hz Immunity test specifications for RF wireless communications equ...

Страница 20: ...ectromagnetic Influence CAUTION If any sorts of electromagnetic wave magnetic field or static electricity exist around the equipment noise interference or malfunction of the equipment may occur If any unintended malfunction or noise occurs during monitoring check the magnetic influence and take appropriate countermeasures The followings are examples of the common cause and countermeasures Mobile P...

Страница 21: ...he technician The following is the information relating to EMC Electromagnetic Compatibility When using this equipment verify that it is used within the environment specified below Compliance to the Electromagnetic Emissions This equipment complies with the following emission standard Emission test Compliance RF Emission CISPR 11 Group 1 Class A CAUTION The emission performance of this equipment i...

Страница 22: ...z 80 AM Proximity fields from RF wireless communications equipment IEC 61000 4 3 Refer to the following table Conducted disturbances induced by RF fields IEC 61000 4 6 3V 0 15MHz to 80MHz 1kHz 80 AM 6V 0 15MHz to 80MHz in ISM bands between 0 15 MHz and 80MHz 1kHz 80 AM Rated power frequency magnetic fields IEC 61000 4 8 30A m 60Hz Immunity test specifications for RF wireless communications equipme...

Страница 23: ...echanical specification and accessories 3 Optional Settings Explains procedures of optional settings 4 Maintenance Explains repair and the replacing process of the battery compartment lid unit 5 Troubleshooting Explains check items and procedures for each trouble situation 6 Periodic Check Explains cleaning and periodic check procedures ...

Страница 25: ...1 1 General Description Provides the overview of the LX 8100 LX 8100 G Chapter 1 General Description 1 2 External Appearance 1 2 Names of Parts and Their Functions 1 3 ...

Страница 26: ... ECG measurements respiration waveform battery level and the conditions of the ECG electrodes are displayed on the front panel ECG lead selection is available using the two buttons Enter and on the front panel In case of using a 3 electrode lead cable or a 5 electrode chest lead cable Before using the LX 8100 LX 8100 G read also the operation manual of the central monitor at the receiving side tho...

Страница 27: ...lectrode position Channel Number Paste the label with the channel number Power Supply LED Indicates the power supply status Light ON In nomal operation Light OFF Power Off Enter Button For Setup Button For Setup Display Displays measurement waveform and transmitter information ECG RESP Input Connector Connects the ECG lead cable to measure ECG and respiration waveform Refer to Safety Precautions i...

Страница 28: ... putting it in the pocket of the patient s clothing Strap Hole Attaches the strap Battery Compartment Lid Open Close Lever To open close the battery compartment lid slide this lever up down Battery Lid Lock Lever Button Unlocks the battery compatrment lid Refer to Safety Precautions in the preface of this manual ...

Страница 30: ...A AA size LR6 size alkaline battery Approximately 6 days with MX1500 DURACELL Conditions ECG measurement RESP measurement Set as the initial setting operating temperature 23 LX 8100 G Continuous Operating Time for USA AA size LR6 size alkaline battery Approximately 1 5 days with MX1500 DURACELL Conditions ECG measurement RESP measurement Set as the initial setting operating temperature 23 Operatio...

Страница 31: ...r Undershoot Rejection is not possible Protection to Defibrillation Complies with IEC 60601 2 27 Lead off Detection Current 100 nA and below Tall T wave Rejection Capability 1 2 mV T wave can be removed when tested according to IEC 60601 2 27 Average of Heart Rate HR measured from 6 seconds of heartbeat for setting QRS width wide and 4 seconds of heartbeat for setting QRS width narrow Response tim...

Страница 32: ...dB Transmitting Antenna Dielectric Antenna Safety For Europe General Standard EN 60601 1 2006 A1 2013 Medical electrical equipment Part 1 General requirements for basic safety and essential performance EMC Standard EN 60601 1 2 2015 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic disturbances Requirements and...

Страница 33: ...40 C 50 F to 104 F Humidity 30 RH to 85 RH non condensing Atmospheric Pressure 70 kPa to 106 kPa Transport Storage Environment Temperature 10 C to 60 C 14 F to 140 F Humidity 10 to 95 40 C 104 F non condensing Atmospheric Pressure 70 kPa to 106 kPa ...

Страница 34: ...ise the LX 8100 LX 8100 G cannot deliver its maximum performance and may be damaged resulting in a safety hazard CAUTION For quality improvement specifications are subject to change without prior notice No Item Q ty Remarks 1 Neck Strap 1 2 4 electrode ECG Lead Cable 1 3 Disposable Portable Case 1 4 Operation Manual 1 ...

Страница 35: ...electrode Red Black Green Yellow ECG Hook Type Lead Cable CMT 03HTH 0 8DU 5 electorode Chest Red Yellow Black White Green For USA Item Model Type Remarks ECG Clip Type Lead Cable CMT 01CTH 0 8DA 3 electrode White Black Red ECG Clip Type Lead Cable CMT 02CTH 0 8DA 4 electrode White Black Red Green ECG Clip Type Lead Cable CMT 03CTH 0 8DA 5 electorode Chest White Black Red Green Brown ECG Hook Type ...

Страница 36: ...2 8 ...

Страница 37: ...ing the Group ID 3 7 Changing the Time Constant 3 10 Changing the Detection Sensitivity of the Pacemaker Pulse 3 12 Changing QRS Detection 3 14 Changing the Respiration Detection Signal ON OFF 3 15 Changing Sound ON OFF 3 17 Changing the Display Brightness 3 19 Changing Display Timeout Duration 3 20 Changing Battery Setting Only Europe 3 21 ...

Страница 38: ... 1200 to 1279 1300 to 1379 1100 LX 8100 G Transmitter Channel CH For USA One from the following channels 9501 to 9539 9600 to 9639 9700 to 9739 9800 to 9839 9900 to 9938 2701 to 2739 2800 to 2839 2900 to 2918 2921 to 2939 3000 to 3039 3100 to 3118 9501 Group ID One from 00 to 63 00 ECG Time Constant Time Const 0 4 sec 0 1 sec 0 4 sec Detection Sensitivity of Pacemaker Pulse Pace Sens Low Mid High ...

Страница 39: ...he password entering screen The password will be incremented each time the Enter key is pressed Set the password as 8100 If exceeding 8100 continue pressing the EVENT key until 8095 then press the Enter key The password display will return to 8095 3 Press the key to highlight the Enter message While highlighting the Enter message press the Enter key to move to the preset screen If pressing the Ent...

Страница 40: ...nnel message While the Channel message is highlighted press the Enter key to switch to the transmitter channel setup screen 2 On the transmitter channel setup screen the current number 4 digit will be highlighted Europe USA Each time the Enter key is pressed the band number will be incremented Set the appropriate transmitter channel 3 The last three digits of the transmitter channel can be changed...

Страница 41: ...o not turn off the equipment during this process The Complete message will appear when the channel setting change is completed Make sure that the receiving monitor can receive the signal from the transmitter after changing the channel setting Europe USA Highlight the icon and press the Enter to return to the preset screen 5 Select the icon on the transmitter channel setting screen to return to the...

Страница 42: ...ighlight icon on the preset screen and then press the Enter key to return to the home screen Other items other than the transmitter channel can be selected for the setting The equipment can be turned off on this preset screen ...

Страница 43: ...ther than radio telemetry from neighboring hospital s transmitter are the proximity of mobile phone amateur radio station radio taxi and illegal citizens band which may be a cause of interference In such a case the situation should be carefully observed to find the cause of interference 1 Press the key to highlight the Channel While the Channel message is highlighted press the Enter key to switch ...

Страница 44: ...ess The Complete message will appear when the channel setting change is completed Make sure that the receiving monitor can receive the signal from the transmitter after changing the channel setting Europe USA To backup the changed setting keep pressing the key until the icon is highlighted as and then press the Enter key 4 Select the on the transmitter channel setting screen to return to the prese...

Страница 45: ...hlight the icon on the preset screen and then press the Enter key to return to the home screen Other items other than the transmitter channel can be selected for the setting The equipment can be turned off on this preset screen ...

Страница 46: ...LX 8100 G to distinguish whether the selection of time constant has changed 1 After entering the password the following preset screen will appear 2 Display the ECG setup screen Make sure that the ECG is highlighted and then press the Enter key to switch to the ECG setup screen 3 While the Time Const is highlighted on the ECG setup screen the Time Constant setting change 0 1S or 0 4S is available T...

Страница 47: ...The equipment can be turned off on this preset screen since the changed setting has been stored 5 Press the key to highlight icon on the preset screen and then press the Enter key to return to the home screen Other items other than the ECG can be selected for the setting ...

Страница 48: ...ed However the High setting may lead to erroneous detection due to interference noise such as AC frequency If erroneous detections occur due to interference noise such as AC frequency turn OFF the setting of the pacemaker pulse detection in the receiving monitor If erroneous detections occur due to interference noise such as AC frequency while monitoring a patient with a pacemaker and the setting ...

Страница 49: ...urn to the previous one To backup the changed setting keep pressing the key until the icon is highlighted as and then press the Enter key By pressing the Enter key when the icon is highlighted the changed ECG setting will be stored Therefore this setting will be activated even if the equipment is turned off and then is turned on 2 Select icon on the ECG setup screen to return to the preset screen ...

Страница 50: ...s the Wide mode On this screen the setting change can be performed but the changed setting cannot be stored without the following backup procedure If turning off the equipment the setting will return to the previous one To backup the changed setting keep pressing the key until the icon is highlighted as and then press the Enter key By pressing the Enter key when the icon is highlighted the changed...

Страница 51: ...espiration detection signal is turned OFF Make sure to turn OFF the respiration measurement function on the receiving monitor to prevent an erroneous detection of the respiration alarm on the receiving monitor side The display screen in normal use does not indicate the setting status of the respiration detection signal ON OFF Make sure to take measures such as marking on the LX 8100 LX 8100 G to d...

Страница 52: ...g the key until the icon is highlighted as and then press the Enter key By pressing the Enter key when the icon is highlighted the changed ECG setting will be stored Therefore this setting will be activated even if the equipment is turned off and then is turned on 4 Select the icon on the RESP screen to return to the preset screen Europe USA The equipment can be turned off on this preset screen si...

Страница 53: ...und is highlighted and then press the Enter key to switch to the Sound setup screen 3 Press the Enter key to set ON OFF for Sound The content to be set up is highlighted On this screen the setting change can be performed but the changed setting cannot be stored without the following backup procedure If turning off the equipment the setting will return to the previous one To backup the changed sett...

Страница 54: ... USA The equipment can be turned off on this preset screen since the changed setting has been stored 5 Press the key to highlight the icon on the preset screen and then press the Enter key to return to the home screen Other items other than the sound can be selected for the setting ...

Страница 55: ...so become minimum Image in left lower On this screen the setting change can be performed but the changed setting cannot be stored without the following backup procedure If turning off the equipment the setting will return to the previous one To backup the changed setting keep pressing the key until the icon is highlighted and then press the Enter key By pressing the Enter key when the icon is high...

Страница 56: ...t be stored without the following backup procedure If turning off the equipment the setting will return to the previous one To backup the changed setting keep pressing the key until the icon is highlighted as and then press the Enter key By pressing the Enter key when the icon is highlighted the changed display timeout duration setting will be stored Therefore this setting will be activated even i...

Страница 57: ...ghlighted and then press the Enter key to display the next page Make sure that the Battery is highlighted and then press the Enter key to switch to the Battery setup screen 3 Press the Enter key to change battery setting to AA Ni MH The content to be set up is highlighted On this screen the setting change can be performed but the changed setting cannot be stored without the following backup proced...

Страница 58: ...g change is completed To backup the changed setting keep pressing the key until the icon is highlighted as and then press the Enter key 5 Select the on the Battery setup screen to return to the preset screen The equipment can be turned off on this preset screen since the changed setting has been stored 6 Press the key to highlight the icon on the preset screen and then press the Enter key to retur...

Страница 59: ...pter 4 Servicing Replacement Procedure of the Repair Parts 4 2 Repair 4 2 Replacing the Battery Compartment Lid Unit 4 3 Life of the Battery Compartment Lid Unit 4 3 Tools 4 3 Spare Parts 4 3 Assembly and Disassembly 4 4 ...

Страница 60: ...io law Do not attempt any other repairs except above item since a required waterproof test need to be performed It can only be done in our factory Repairing support outside the factory may be considered as illegal remodeling under the radio law However replacement of the battery compartment lid unit can be supported outside the factory DANGER Do not replace to any part other than the items describ...

Страница 61: ...lid unit to maintain its waterproof performance CAUTION The battery unit must be replaced at specified period Even if the LX 8100 LX 8100 G is used less than one 1 year the unit may be damaged from high impact If the LX 8100 LX 8100 G is dropped or is subjected to a high impact make sure that the unit is not damaged Tools Phillips screwdriver 0 Spare Parts Item code 9G0115350 Item name Battery com...

Страница 62: ...ly and Disassembly Follow the procedure below to remove the battery compartment lid unit 1 Remove the label 2 Remove the 2 installation screws then remove the battery compartment lid unit Label Installation Screw ...

Страница 63: ...ure below to attach the battery compartment lid unit 1 Set the battery compartment lid unit adjusting to the front case 2 Secure the battery compartment lid unit with new 2 installation screws Make sure that the screws are securely tightened ...

Страница 64: ...4 6 1 2 3 Make sure that the battery compartment lid unit opens closes smoothly 4 Attach the label firmly aligning with the groove of the battery compartment lid unit Label Groove ...

Страница 65: ...ubleshooting Chapter 5 List of Displayed Status 5 2 Transmitter Main unit 5 2 ECG 5 3 Displays 5 5 Troubleshooting 5 6 Transmitter Main unit 5 6 ECG 5 7 In Case of Dropping the LX 8100 LX 8100 G into Water 5 8 ...

Страница 66: ... for explanation Transmitter Main unit Display Description Error message Telemeter Comm Error Displayed when the transmitter is faulty EEPROM Read Error Displayed when the EEPROM is faulty CPU Error Displayed when the CPU is faulty Speaker Error Displayed when the speaker is faulty ...

Страница 67: ...ed such as LA depends on the detached electrode position Electrode is off Check the electrode condition Details of the ELECTRODE Message The following ELECTRODE messages are displayed on the display depending on the selected lead cable and lead For Europe Check Position 3 electrode lead cable Lead I display 3 electrode lead cable Lead II display 3 electrode lead cable Lead III display F R L Severa...

Страница 68: ...rode lead cable Lead III display LL RA LA Several Position Simultaneously For Europe Check Position 4 electrode lead cable 5 electrode Chest lead cable F R L N C Several Position Simultaneously For USA Check Position 4 electrode lead cable 5 electrode Chest lead cable LL RA LA N V Several Position Simultaneously ...

Страница 69: ...ope USA Displays the transmitter channel after turning on the power and also when refreshing the screen Automatically moves onto the waveform display screen Event Europe USA Displays when the EVENT button is pressed Automatically moves onto the channel display screen Electrode Europe USA Displays when the ECG electrode is disconnected or the ECG RESP waveform cannot be measured normally For detail...

Страница 70: ...Replace the battery with a new one Nothing is displayed on the receiving screen The channel number between the transmitter and the receiving monitor do not match up Set the same channel number for the transmitter and the receiving monitor Transmission problem Same channel number is already used Make sure to not duplicate channel numbers Follow the instruction by the person in charge of radio telem...

Страница 71: ...lectrode is too high Replace the electrode with a new one ECG waveform contains noise Electrode gel is dry Replace the electrode with a new one Electrode is peeling off Electric blanket is used Cover the electric blanket with a shield cover AC filter setting of the receiving monitor is OFF Set the AC filter to ON Respiration waveform cannot be measured Electrode gel is dry Replace the electrode wi...

Страница 72: ... equipment into dirty water clean it without disconnecting the ECG lead cable and make sure that the battery compartment lid is locked After cleaning wipe off any moisture thoroughly before removing the ECG lead cable or battery CAUTION Do not use a dryer The LX 8100 LX 8100 G shape may change or be broken When rinsing the LX 8100 LX 8100 G with running water make sure to close the battery compart...

Страница 73: ...Periodic Check 6 2 About Maintenance and Inspection 6 2 Daily Check 6 2 Periodic Check 6 2 Periodic Replacement Parts 6 2 The Battery Compartment Lid Unit 6 2 Periodic Check 6 4 Service Tools Measurement Device 6 4 Periodic Check Items 6 5 Periodic Check List 6 9 ...

Страница 74: ...y checks using the Daily Check List on the next page Periodic Check Periodic check of medical electronic equipment is mandatory to prevent failures and accidents and to ensure safety and reliability Periodic maintenance may be performed by the medical institution or by a third party by concluding a Maintenance Contract Periodic Replacement Parts The Battery Compartment Lid Unit The Battery Compart...

Страница 75: ...ation With a battery installed the display should turn ON OK NG ECG Connectors Visually check the connectors of the cable and the LX 8100 LX 8100 G No damage chip and adhesion of dust should be found OK NG ECG Lead cable Visually check each lead for damages No crack and damage should be found OK NG Wireless Channel Verify whether the transmitting channel and group ID are the same with the receivin...

Страница 76: ...of the electrical safety check procedure refer to IEC 60601 1 Service Tools Measurement Device The measurement devices used for this periodic check are as follows Name Model type Reference Comprehensive Tester SG 2000 or equivalent Chunichi ECG RESP BP TEMP CMRR Waveform Simulator Prosim8 or equivalent FLUKE ECG RESP Leakage Measurement Safety tester ST5540 or equivalent HIOKI Contact Current Exte...

Страница 77: ...if the operation manual and other accompanying documents are stored in the specified places Should be stored in the specified place No Check Item Check Procedure Criteria 2 Power Supply Switch 01 Power Supply Switch Turn ON OFF the power switch Should turn ON OFF the power switch properly No Check Item Check Procedure Criteria 3 Display Operation Record 01 Labels Visually check the labels caution ...

Страница 78: ...t rhythm should be detected with sensitivity 1 according to the peak to peak signal of 0 3 mV and 3 mV 06 ECG Sensitivity With comprehensive tester apply 1mV voltage and measure the displayed amplitude According to test procedure of IEC 60601 2 27 2011 201 12 1 101 1 Wave form size on the receiving monitor should be within 0mm 10 at sensitivity1 07 Heart Rate Accuracy With ECG simulator test heart...

Страница 79: ... respiration rate display Test with the respiration reference load signal of 60 120 min Error should be within 5 Bpm 03 Frequency Characteristic With comprehensive tester or reference respiration signal generator input 0 5 Hz and 1 5 Hz or 2 5 Hz and measure the frequency characteristic The crest value at 1 5 Hz should be more than 70 of the crest value at 0 5 Hz input As these functions are depen...

Страница 80: ...patient connecting part NC Measure the total patient leakage current that runs through the ground from the patient According to test procedure of IEC 60601 1 8 7 4 AC DC From the patient connecting part to the ground NC 0 05mA 05 Leakage current when external voltage is applied to the patient connection in the Type F attaching part SFC Measure the leakage current when external voltage is applied t...

Страница 81: ...6 9 Periodic Check List ...

Страница 82: ...6 10 ...

Страница 83: ...The company and product names used in this manual are trademarks or registered trademarks of respective companies ...

Страница 84: ...3 39 4 Hongo Bunkyo ku Tokyo Japan Tel 81 3 5684 1455 Fax 81 3 3814 1222 http www fukuda com 4R010138A 201808 ...

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