Fukuda Denshi LX-7120 Скачать руководство пользователя страница 13 | Manualshive

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Electromagnetic Compatibility

The performance of this device under electromagnetic environment complies
with IEC 60601-1-2 (2007).

Precautions for Safe Operation under Electromagnetic Influence

CAUTION

If any sorts of electromagnetic wave, magnetic field, or static electricity
exist around the device, noise interference or malfunction of the device
may occur. If any unintended malfunction or noise occurs during
monitoring, check the magnetic influence and take appropriate
countermeasures.
The following are examples of the common cause and countermeasures.

●

Cellular Phone

The radio wave may cause malfunction to the device.
Cellular phones and radio sets should be turned off in the room
(building) where medical device is located.

●

Static Electricity

In a dry environment (room), static electricity is likely to occur. Take
the following countermeasures.



Both operator and patient should remove any static electricity before

entering the room.



Humidify the room.

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Содержание LX-7120

Страница 1: ...ECG Respiration Transmitter LX 7120 Operation Manual Before using this device read this operation manual thoroughly Keep this manual near the device for future reference ...

Страница 2: ...her nearby medical devices CAUTION This device for sale by or on the order of a physician The company and product names used in this manual are trademarks or registered trademarks If this manual has pages missing or out of order contact Fukuda Denshi for replacement Only physician or persons instructed by physicians are allowed to use the equipment The information contained in this document is sub...

Страница 3: ...us injury CAUTION Failure to follow this message may cause injury or failure to the equipment NOTE A note is not related to product safety but provides information about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment Precaution from Fukuda Denshi Fukuda Denshi is liable for the safety reliability and performance of its device only if Mainte...

Страница 4: ...ation manual before operation Type CF Applied Part with Defibrillation Proof Indicates that the degree of protection against electric shock is Type CF Applied Part with defibrillation proof Indicates the battery type and direction Symbols indicated on the LCD screen Symbol Description Heart Rate Synchronization Mark This mark flashes synchronizing with the heartbeat Battery Mark Indicates the rema...

Страница 5: ...uipment verify the following items Check the cable connection and polarity to ensure proper operation of the equipment Ensure that all cables are firmly and safely connected Especially recheck the attachment and connection condition of electrode Pay special attention when the equipment is used in conjunction with other equipment as it may cause erroneous judgment and danger Check the remaining bat...

Страница 6: ...Before reusing the equipment that has been left unused for a while make sure that the equipment works normally and safely 9 When using electrosurgical knives or defibrillator with this equipment take care of the following To prevent burn injury to the patient verify proper attachment of patient ground plate ECG electrode type for the electrosurgical knives and the quantity of gel output energy for...

Страница 7: ...he electrode site When using an electrosurgical instrument it may misidentify noise from the electrosurgical instrument as a heartbeat or arrhythmia Defibrillation Safety WARNING Use only the lead cable specified by Fukuda Denshi when defibrillating If used by unspecified lead cable the device may be damaged resulting in a safety hazard When using the defibrillator keep away from the electrodes or...

Страница 8: ... interact with certain cardiac monitoring and diagnostic equipment causing pacemakers to pace at their maximum programmed rate October 14 1998 Letter www fda gov cdrh safety html FDA ECG meter may continue to count the pacemaker rate during occurrences of cardiac arrest or arrhythmias Do not rely entirely upon the ECG meter alarms Keep pacemaker patients under close surveillance Check this manual ...

Страница 9: ...t be detected depending on the pacemaker type pulse voltage pulse width electrode lead type unipolar bipolar electrode placement or lead method which causes the pacemaker pulse amplitude to decrease and disables pacemaker pulse detection If signals similar to a pacemaker pulse are present such as electric blanket noise or excessive AC frequency noise these may be erroneously detected and displayed...

Страница 10: ...stall 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 Disposing of Equipment Accessories or Components CAUTION When disposing of the equipment accessories or components use an ind...

Страница 11: ...us consistently under this situation To get stable radio wave signals make sure to have a proper telemetry installation CAUTION For installation make sure the following The medical institution hereinafter referred to as the Institution must decide the telemetry installation plan for the medical department in order to prevent interference and interference between transmitters telemetry based on des...

Страница 12: ... needing zone alignment The Overall Manager 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 channel register it in the log and give proper instructions to the Zone Manager or to the user The Zone Manager assumes responsibility for managing the wireless channe...

Страница 13: ...alfunction or noise occurs during monitoring check the magnetic influence and take appropriate countermeasures The following are examples of the common cause and countermeasures Cellular Phone The radio wave may cause malfunction to the device Cellular phones and radio sets should be turned off in the room building where medical device is located Static Electricity In a dry environment room static...

Страница 14: ...t verify that it is used within the environment specified below Compliance to the Electromagnetic Emissions The LX 7120 is intended for use in the electromagnetic environment specified below The customer or the user of the LX 7120 should assure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance RF Emission CISPR 11 Group 1 The LX 7120 uses RF energ...

Страница 15: ...e relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2kV Power supply lines 1kV Input output lines N A Surge IEC 61000 4 5 1kV differential mode 2kV common mode N A 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...

Страница 16: ...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 80MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structure...

Страница 17: ...ated Maximum Output Power of Transmitter W 150kHz to 80MHz d 1 2 P 80MHz to 800MHz d 1 2 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter whe...

Страница 18: ...xvi Blank Page ...

Страница 19: ...osing of Equipment Accessories or Components viii Precautions about Disposing of Battery viii Precautions for Use of Medical Telemeter ix Electromagnetic Compatibility xi Precautions for Safe Operation under Electromagnetic Influence xi EMC Guidance xii 1 General Description 1 2 Names of Parts and Their Functions 3 3 Preparation 5 1 Installing the Battery 5 2 Operating Power Switch 7 4 ECG Monitor...

Страница 20: ...ing the Transmitter Channel 35 Changing the Group ID 35 10 Troubleshooting 37 List of Displayed messages 37 Troubleshooting 38 In Case of Dropping the LX 7120 into Water 40 11 Cleaning and Disinfection 41 Cleaning 41 Disinfection 41 12 Maintenance and Inspection 43 13 Standard and Optional Accessories 45 Standard Accessories 45 Optional Accessories 46 14 Specification 47 Specification 47 Displays ...

Страница 21: ...spiration waveform battery level and the conditions of the ECG electrodes are displayed on the LCD of 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 7120 read also the operation manual of the patient monitor at the receiving side thoroughly External Ap...

Страница 22: ...1 General Description 2 Blank Page ...

Страница 23: ...ion waveform Refer to Safety Precautions in this manual s preface Channel Number Label Indicates transmitter channel number Power Switch Turn ON OFF the power LCD Displays measurement waveform and transmitter information EVENT Button Activates the function assigned on the receiving monitor Electrode Position Label Indicates standard ECG electrode position Battery Compartment Lid This is the lid fo...

Страница 24: ...2 Names of Parts and Their Functions 4 Blank Page ...

Страница 25: ...p or shock The leakage from the battery may damage the device or an explosion from the battery may occur Remove the exhausted battery immediately The leakage from the battery may damage the device or an explosion from the battery may occur If the transmitter is not in use for a long period of time remove the battery and store the device in an appropriate place If the battery is left in the transmi...

Страница 26: ...ent from the minus terminal as shown in the left picture Hook the lock lever on the projection from the body and press it down until it is horizontal flat position CAUTION Make sure that any foreign particles such as hairs are not held on the battery compartment lid and dust is not adhered to the edge of the lid to prevent water entering into the battery compartment area Make sure to only turn ON ...

Страница 27: ...turns itself OFF after a minute After the power is turned ON make sure to check the remaining battery level on the LCD screen Refer to the following symbol about the remaining battery level Battery Symbol Remaining Battery Level Full Getting low but still available Nearly empty Replace the battery The battery level estimation is in case of using alkaline battery Turning the power switch to OFF Rot...

Страница 28: ...3 Preparation 8 Blank Page ...

Страница 29: ...8DA Limb Lead 1CH Chest 1CH 5 electrode Hook Type White Black Red Green Brown CMT 01FTH 0 8DA Limb Lead 1CH 3 electrode Clip Type White Black Red CMT 02FTH 0 8DA Limb Lead 2CH 4 electrode Clip Type White Black Red Green CMT 03FTH 0 8DA Limb Lead 1CH Chest 1CH 5 electrode Clip Type White Black Red Green Brown WARNING Use only the specified lead cable from Fukuda Denshi Otherwise proper monitoring m...

Страница 30: ...d I lead II or lead III under the setting of the device Refer to 7 Operation Changing Setup ECG Display Screen 1 Switching Lead in page 25 Black LA Red LL White RA For 4 electrode lead cable For AHA color code electrode position No CMT 02HTH 0 8DA CMT 02FTH 0 8DA Standard Limb leads Two leads measurements lead I and II are fixed Lead III aVR aVL and aVF can be also displayed from the setting on th...

Страница 31: ...b lead and one chest lead Brown measurements are available Standard Limb leads can be selected from lead I lead II or lead III under the setting of the device The chest lead waveform is measured from the chest lead Brown positioned on the chest Refer to 7 Operation Changing Setup ECG Display Screen 1 Switching Lead in page 25 Black LA White RA Red LL Green Brown V RL ...

Страница 32: ...e with monitoring CAUTION Do not reuse the disposable electrodes It is intended for single patent use only Clean the electrode sites with alcohol wipes or other skin preparation If necessary shave the electrode sites to remove excessive hair Peel off the disposable electrode Pay attention not to touch the electrode gel Attach the lead cable end to the electrode convex part Turn right and left to v...

Страница 33: ...onnecting the ECG Lead Cable to the LX 7120 Insert the ECG lead cable firmly into the ECG RESP input connector matching the transmitter s connector guide and the direction of the notched part on the connector ECG Lead cable ...

Страница 34: ...atient from a transmitter or a monitor When an electrode is attached on the same location for a long time some patients may develop skin irritation Check the patient s skin condition periodically and change the electrode position as required The indication for continuous use of an electrode is about one day Replace the electrode if the skin contact gets loosen due to perspiring etc Make sure to us...

Страница 35: ...ring and diagnostic equipment may possibly send wrong information If such event occurs please disconnect the cardiac monitoring and diagnostic equipment or follow the procedures described in the operation manual of the pacemaker For more details contact FUKUDA DENSHI personnel your institution s professionals or your pacemaker distributors Reference Minute Ventilation Rate Adaptive Pacemakers FDA ...

Страница 36: ...5 Respiration Monitoring 16 Blank Page ...

Страница 37: ...yed CAUTION The LX 7120 does not have a diagnostic function Check the diagnostic function on the receiving monitor The LX 7120 does not have an alarm function Check the alarm function on the receiving monitor The ECG waveform size and sweep speed settings displayed on the LCD of the LX 7120 do not interface with the ones displayed on the screen of the receiving monitor The heart rate and respirati...

Страница 38: ...D display refer to page 29 When the LCD display is active press the button to move onto the next waveform display screen Descriptions of the Screen The descriptions of contents displayed on the LCD are as follows Indicates ECG 1 Indicates the scale of the displayed ECG One scale corresponds to 1mV In the left illustration it can display ECG waveform between 1mV and 1mV Displays the ECG waveform Di...

Страница 39: ...ation of the waveform size to the receiving monitor If the ECG waveform size displayed on the screen of the receiving monitor is changed follow the instruction in the operation manual of the receiving monitor In case of the outside of the heart rate range 12 to 300bpm 0bpm will be displayed if 11bpm and below is measured and 300bpm will be displayed If 300bpm and above is measured Indicates the re...

Страница 40: ... is done To restart the LCD display refer to page 29 When the LCD display is active press the button to move onto the next waveform display screen Descriptions of the Screen The descriptions of contents displayed on the LCD are as follows Indicates ECG 2 Indicates the scale of the displayed ECG One scale corresponds to 1mV In the left illustration it can display ECG waveform between 1mV and 1mV Di...

Страница 41: ... information of the waveform size to the receiving monitor If the ECG waveform size displayed on the screen of the receiving monitor is changed follow the instruction in the operation manual of the receiving monitor In case of the outside of the heart rate range 12 to 300bpm 0bpm will be displayed if 11bpm and below is measured and 300bpm will be displayed If 300bpm and above is measured Indicates...

Страница 42: ...ive press the button to move onto the next waveform display screen Descriptions of the Screen The descriptions of contents displayed on the LCD are as follows Indicates the respiration waveform display screen Indicates the scale of the displayed respiration waveform One scale corresponds to 1Ω In the left illustration it can display the change of respiration waveform between 1Ω and 1Ω Displays the...

Страница 43: ...rm size displayed on the screen of the receiving monitor is changed follow the instruction in the operation manual of the receiving monitor In case of the outside of the respiration rate range 9 to 150Bpm 0Bpm will be displayed if 8Bpm and below is measured and 150Bpm will be displayed If 150Bpm and above is measured Indicates the remaining battery level For details of the battery level refer to p...

Страница 44: ...6 Measurement 24 Blank Page ...

Страница 45: ... Lead I II III I Changing ECG1 Waveform Size on LCD Press the button to highlight the size indication of ECG 1 Pressing the Enter button will sequentially change the size of ECG 1 Size 1 1 2 1 When changing the size of the ECG waveform on the LCD the ECG scale will also change In the left illustration it can display the ECG waveform between 2mV and 2mV CAUTION The ECG waveform size setting display...

Страница 46: ... to the ECG display screen 1 CAUTION Do not operate the LX 7120 with the setup screen open to prevent the settings to be changed due to an unintended operation Make sure to press the Return button to terminate the setup screen The LCD display will automatically turn itself OFF after 60 seconds if the Return button is not pressed ...

Страница 47: ...LCD the ECG scale will also change In the left illustration it can display ECG waveform between 2mV and 2mV CAUTION The ECG waveform size setting displayed on the LCD of the LX 7120 does not interact with the one displayed on the screen of the receiving monitor because the LX 7120 cannot transmit the setting information of the waveform size to the receiving monitor If the ECG waveform size display...

Страница 48: ... the LCD the respiration scale will also change In the left illustration it can display the respiration waveform until 4Ω of change CAUTION The respiration waveform size setting displayed on the LCD of the LX 7120 does not interact with the one displayed on the screen of the receiving monitor because the LX 7120 cannot transmit the setting information of the waveform size to the receiving monitor ...

Страница 49: ...e button to restart the LCD display The starting screen with telemetry channel number appears and then the waveform display screen appears Pressing the EVENT button Press and hold the EVENT button for 2 seconds to activate the function assigned on the receiving monitor The following message appears on the LCD while the EVENT is transmitted After the transmission is completed the starting screen wi...

Страница 50: ...7 Operation 30 Blank Page ...

Страница 51: ...If a stable monitoring is difficult with excessive change in the baseline due to excessive body motion of the patient or an interference noise such as AC frequency by changing the time constant to 0 1 second the monitoring may become relatively stable For details of the setting change contact your local Fukuda Denshi service representative CAUTION When changing the time constant to 0 1 seconds the...

Страница 52: ...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 of the pacemaker pulse detec...

Страница 53: ...ur local Fukuda Denshi service representative CAUTION The respiration waveform cannot be measured if the setting of the respiration 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 LCD screen in normal use does not indicate the setting statu...

Страница 54: ...8 Other Setting Items 34 Blank Page ...

Страница 55: ...tter channel has been changed Changing the Group ID The LX 7120 transmits its group ID which it belongs to to prevent interference with neighboring hospital s transmitter The receiving monitor checks whether the incoming group ID is the same as the programmed one that the receiving monitor has There are 64 group codes available The default setting is 00 The transmitter group ID can be changed if t...

Страница 56: ...9 Changing the Transmitter Channel and Group ID 36 Blank Page ...

Страница 57: ...ion Failed to transmit waveform and value Faulty EEPROM Failed to initialize CPU Contact your local Fukuda Denshi service representative ECG Message Cause Solution Character string displayed such as LA depends on the detached electrode position Electrode is off Check the electrode condition ...

Страница 58: ...r 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 Same channel number is already used Make sure to not duplicate channel numbers Follow the instruction by the person in charge of radio telemetry channel in your facility and use the LX 7120 with the correct channel setting Channel i...

Страница 59: ... electrode is too high Replace the electrode with a new one Electrode gel is dry Electrode is peeling off Replace the electrode with a new one Electric blanket is used Cover the electric blanket with a shield cover ECG waveform contains noise AC filter setting of the receiving monitor is OFF Set the AC filter up as ON Electrode gel is dry Electrode is peeling off Replace the electrode with a new o...

Страница 60: ...o water containing disinfectant pick up the LX 7120 quickly from it Rinse it well with running water and dry it thoroughly with a soft cloth CAUTION Do not use a drier The LX 7120 shape may change or be broken When the LX 7120 is rinsed with running water make sure to close the battery compartment lid ...

Страница 61: ...oluene and benzene to avoid damaging the resin case Do not polish the housing with abrasive or chemical cleaner Use only neutral detergent to clean the housing Do not use chemical cloth scrub brush abrasive polishing powder hot water volatile solvent and chemicals cleanser thinner benzine benzol and synthetic detergent for house and furniture or sharp edged tools The surface resin coating may be d...

Страница 62: ...11 Cleaning and Disinfection 42 Blank Page ...

Страница 63: ...nic 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 For more details contact your local Fukuda Denshi service representative Periodic Replacement Parts The Battery Compartment Lid Waterproof is the only periodic replacement part To ...

Страница 64: ...roper switch operation With battery installed the LCD should turn ON OK NG ECG Connectors Visually check the connectors of the cable and the LX 7120 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 receivi...

Страница 65: ...herwise the LX 7120 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 Standard Accessories No Item Model Type Q ty Note 1 Neck Strap OA 311 1 2 4 electrode ECG lead cable CMT 02HTH 0 8DA 1 AHA color code Hook Type Limb Lead 2CH 3 Operation Manual 1 1 2 3 This manual ...

Страница 66: ...ack Red Limb Lead 1CH ECG Hook Type Lead Cable CMT 02HTH 0 8DA 4 electrode White Black Red Green Limb Lead 2CH ECG Hook Type Lead Cable CMT 03HTH 0 8DA 5 electrode White Black Red Green Brown Limb Lead 1CH Chest 1CH ECG Clip Type Lead Cable CMT 01FTH 0 8DA 3 electrode White Black Red Limb Lead 1CH ECG Clip Type Lead Cable CMT 02FTH 0 8DA 4 electrode White Black Red Green Limb Lead 2CH ECG Clip Typ...

Страница 67: ...ID 64group Codes LCD Built in Waterproof IPX8 Power Supply DC one 1 1 5 V AA size LR06 size alkaline battery Continuous Operating Time Approximately 6 days Continuous operating time is assumed when using new AA size LR06 size Alkaline battery specified by Fukuda Denshi ECG Numbers of Lead Electrode 3 electrode 4 electrode or 5 electrode Limb Chest Numbers of Input Channel 1CH 3 electrode or 2CH Ac...

Страница 68: ...ion Method Modulation Mode Digital Frequency shift keying Frequency 608 to 614MHz Oscillation Method PLL Synthesizer method by crystal control Channel Spacing 12 5kHz Occupied Frequency Bandwidth 8 5kHz RF output power 1mW 2dB Transmitting Antenna ECG lead cable Safety General Standard IEC 60601 1 1988 A1 1991 A2 1995 Medical electrical equipment Part 1 General requirements for safety EMC Standard...

Страница 69: ...ment Temperature 10 to 40 C Humidity 30 to 85 RH No condensation Vibration Shock Comply with IEC60068 2 64 1987 IEC60068 2 32 1975 IEC60068 2 6 1995 Transport Storage Environment Temperature 10 to 60 C Humidity 10 to 95 RH No condensation ...

Страница 70: ... the screen Automatically move onto the waveform display screen EVENT Displays when the EVENT button is pressed Automatically move onto the channel display screen ELECTRODE Displays when the ECG electrode is disconnected or the ECG respiration waveform cannot be measured normally For details about electrode check message refer to page 51 Display Description Error Message Telemeter Error Displays w...

Страница 71: ...cted lead cable and lead For AHA color code Check Position 3 electrode lead cable Lead I display 3 electrode lead cable Lead II display 3 electrode lead cable Lead III display LL RA LA Several Position Simultaneously Check Position 4 electrode lead cable For 5 electrode Chest lead cable LL RA LA RL V Several Position Simultaneously ...

Страница 72: ...isplay Size of Respiration Waveform 1 1 2 1 Yes For details of the following settings contact our service representative Items Selection Default Backup Time Constant 0 4 sec 0 1 sec 0 4 sec Yes Detection Sensitivity of Pacemaker Pulse Low Mid High Mid Yes Respiration Detection Signal ON OFF ON Yes LCD Contrast 8 steps 8 Yes Transmitter Channel One from the following channels 0801 to 0879 0900 to 0...

Страница 73: ......

Страница 74: ...39 4 Hongo 3 chome Bunkyo ku Tokyo Japan Phone 81 3 3815 2121 Fax 81 3 3814 1222 Printed in Japan 4L0106260 20100805 01 ...

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