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Fukuda Denshi LX-8000 Series, Operation Manual

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Fukuda Denshi LX-8000 Series Operation Manual Download Page 107

15. Specification 

83

 

Safety 

General Standard: 

ANSI / AAMI ES 60601-1: 2005(R)2012 and 
A1:2012, C1:2009(r)2012 and A2: 2010(r)2012 
(Medical electrical equipment - Part 1: General 
requirements for basic safety and essential 
performance) 

EMC Standard:   
 
 
 

IEC 60601-1-2: 2014 
(Medical electrical equipment – Part 1-2: General 
requirements for basic safety and essential 
performance – Collateral standard: 
Electromagnetic disturbances – Requirements and 
tests) 

The class of protection   
against electric shock: 

Internally Powered Equipment 

The type of protection   
against electric shock: 

ECG/RESP: Type CF Applied Part 
SpO

2

: Type CF Applied Part 

 

Operating Environment 

Temperature: 

10

C to 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% RH to 95% RH 
(40

C / 104

F, non-condensing) 

Atmospheric Pressure: 

70 kPa to 106 kPa 

 

Summary of Contents for LX-8000 Series

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Page 3: ... result in death or serious injury CAUTION Indicates a potentially hazardous situation which if not avoided could result in minor or moderate injury or property damage 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 liab...

Page 4: ... healthcare professionals Users should have a thorough knowledge of the function and operation before using this equipment The maintenance of this equipment should be performed by skilled personnel who received a training of possible hazards and measures to avoid those hazards Also your local regulation must be followed If this equipment is used for the purpose other than intended or if the user d...

Page 5: ...ndicates the need to refer to the related accompanying documents 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 power ON OFF status Indicates the point to close the battery compartment lid Indicates the battery type and direction Indicates that the alarm f...

Page 6: ...iration date of the SpO2 sensor is approaching The following icons are displayed only on the all data display Indicates that probe is disconnected or damaged Indicates that sensor check etc is required Indicates that the amplitude of the pulse waveform is too low or the sensor is not positioned correctly Indicates that the probe is damaged or the usable life of the sensor has expired ...

Page 7: ...ems Check the cable connection polarity etc to ensure safe and proper operation of the equipment Ensure that all cables are firmly and safely connected Especially make sure to check the attachment and connection condition of electrodes and transducers Pay special attention when the equipment is used in conjunction with other equipments as it may cause erroneous judgment and dangerous situation Che...

Page 8: ... check the equipment and parts It is recommended to conclude a maintenance contract Before reusing the equipment that has been left unused for a while make sure that the equipment operates properly and safely 9 When using electrosurgical knives or defibrillator with this equipment follow the precautions below To prevent patient from burn injury verify proper attachment of patient ground plate ECG ...

Page 9: ...cal 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 electrosurgical unit as far as possible from this equipment and the patient cable This will help reduce interference on the ECG through the monitor or cables Electrode Placement The amount of noise interference i...

Page 10: ...fibrillating keep away from the electrodes or medicament applied to the patient chest If this is not possible remove the electrodes or medicament before defibrillating If the defibrillator paddles directly touch the electrodes or medicament an electrical shock may result by the discharged energy When defibrillating do not touch the patient and the metal part of the equipment or cables Electric sho...

Page 11: ... arrhythmias Do not rely entirely upon rate meter alarms Keep pacemaker patients under close surveillance Reference Minute Ventilation Rate Adaptive Pacemakers FDA alerts health professionals that minute ventilation rate adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic equipment causing pacemakers to pace at their maximum programmed rate Octo...

Page 12: ...ot touch any conductive parts with bare hands Otherwise it may cause electric shock to the patient and or operator due to excessive leakage current The indication for continuous 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 irrita...

Page 13: ...itation or skin necrosis due to compression may be developed For the patient with bad perfusion check the sensor attachment position at least every 2 hours As skin for neonate premature infant is immature change the sensor attachment site more frequently depending on the condition When measuring the SpO2 of patient with high fever or peripheral circulatory insufficiency check the sensor attachment...

Page 14: ...asuring at position with venous pulse Patient with body motion Patient with small pulse Excessive body motion patient s motion Excessive light direct sunlight fluorescent light therapy equipment surgical light infrared heat ramp etc External colorant such as nail polish Abnormally low or high hemoglobin concentration Precautions about Output Signal WARNING Do not use the output signal of the monit...

Page 15: ...he and terminals It may result in exothermic heat and fire Do not use different types of batteries at the same time The leakage from the batteries may damage the equipment or an explosion from the batteries may occur Precautions about Disposing of Equipment Accessories or Components CAUTION When disposing of the equipment accessories or components use an industrial waste distributor Do not dispose...

Page 16: ...al service representative The LX 8300M transmits 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 ...

Page 17: ...the Coordinator of the problems The Coordinator is to deal with the problem properly and or contact their nearest Fukuda Denshi representative for service Electromagnetic Compatibility This equipment complies with IEC 60601 1 2 2014 safety standard regarding the electromagnetic disturbances of medical electrical equipment To ensure maximum performance against the electromagnetic disturbances make ...

Page 18: ...ent 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 CAUTION If this equipment is installed close to or stacked with other equipment malfunction may occur Make sure to verify that the equipments operate properly in a used location Use of accessories probes or cable...

Page 19: ...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...

Page 20: ... 0 15 MHz and 80 MHz 1 kHz 80 AM Rated power frequency magnetic fields IEC 61000 4 8 30 A m 60 Hz Immunity test specifications for RF wireless communications equipment Test frequency MHz Modulation Maximum power W Distance m Immunity test level V m 710 745 780 PM 217 Hz 0 2 0 3 9 810 870 930 PM 18 Hz 2 0 3 28 1720 1845 1970 PM 217 Hz 2 0 3 28 2450 PM 217 Hz 2 0 3 28 5240 5500 5785 PM 217 Hz 0 2 0 ...

Page 21: ... Ltd Head Office 3 39 4 Hongo Bunkyo ku Tokyo Japan Tel 81 3 5684 1455 Fax 81 3 3814 1222 E mail info fukuda co jp Home Page http www fukuda com 2 Sales Representative Write the name address phone fax number of your local sales representative Name of Sales Representative Address Phone Fax ...

Page 22: ...xx ...

Page 23: ...autions about the Alkaline Batteries xiii Precautions about Disposing of Equipment Accessories or Components xiii Precautions about Disposing of Battery xiii Precautions for Use of Medical Telemeter xiv Electromagnetic Compatibility xv Precautions for Safe Operation under Electromagnetic Influence xvi EMC Guidance xvii Contact xix 1 General Description 1 2 Names of Parts and Their Functions 3 3 Pr...

Page 24: ...anging the Transmitter Channel and Group ID 51 Transmitter Channel 51 Group ID 51 11 Troubleshooting 53 In Case of Dropping the LX 8300M into Water 59 12 Cleaning and Disinfection 61 Cleaning the Housing 61 Cleaning the Connector 62 Disinfection 62 Cleaning the ECG lead cable 62 13 Maintenance and Inspection 63 Daily Check 63 Periodic Check 63 Periodic Replacement Parts 63 Periodic Check 65 Repair...

Page 25: ...vel and the conditions of the ECG electrodes and SpO2 probe sensor 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 The LX 8300M can also function as a transmitter to measure only the ECG Respiration without SpO2 or to measure only the SpO2 without ECG Resp...

Page 26: ...1 General Description 2 ...

Page 27: ...2 probe sensor Power Switch Turns ON OFF the power ENTER Button For Setup Button For Setup Display Displays measurement waveform and transmitter information Channel Number Paste the label with the number Refer to Safety Precautions in the preface of this manual Power Supply LED Indicates the power supply status Light ON In normal operation Light OFF Power Off Electrode Position Label Indicates sta...

Page 28: ... Close Lever To open close the battery compartment lid slide this lever up down Battery Lid Lock Button Unlocks the battery compartment lid EVENT Button Transmits EVENT Information Refer to Safety Precautions in the preface of this manual Strap Hole Attaches the strap ...

Page 29: ...xothermic heat and fire the leakage from the batteries may damage the equipment or an explosion from the batteries may occur Install the batteries with the correct polarity Do not charge alkaline batteries Any attempt to charge the batteries may cause them to leak or break Do not use a disassembled or a damaged battery due to drop or shock The leakage from the batteries may damage the equipment or...

Page 30: ...ed or unused batteries make sure that the terminals are not touching other batteries or metal parts Unlock and open the battery compartment lid by sliding the open close lever towards OPEN while pressing the lock button Install new batteries according to the polarity indication inside the battery compartment After installing the batteries lock the battery compartment lid by sliding the open close ...

Page 31: ...id and dust is not adhered to the edge of the lid to prevent water entering into the battery compartment area Do not keep the compartment lid unlocked as the batteries may unexpectedly get out from the compartment 2 Operating the Power Switch Turning the power switch to ON Press the power switch Display screen turns ON and measurement starts The display screen automatically turns itself OFF after ...

Page 32: ... Level After the power is turned ON make sure to check the remaining battery level on the display screen Refer to the following symbol to check the remaining battery level Battery Symbol Remaining Battery Level Full Getting low but still available Nearly empty Replace the batteries A message that prompts the battery check appears on the screen of the receiving monitor NOTE When ON OFF status of Sp...

Page 33: ...3 Preparation 9 Turning the power switch to OFF Press the power switch for two seconds then display screen displays as the left illustration to confirm Choose Yes and press the ENTER button ...

Page 34: ...3 Preparation 10 ...

Page 35: ...r monitoring may not be performed and also defibrillation may fail or cause a malfunction of the equipment when the equipment is used with a defibrillator For details of the usable lead cables refer to 14 Standard and Optional Accessories The relations between the attached electrode positions and lead method are as follows Attach the electrodes to monitor proper waveform For 3 electrode lead cable...

Page 36: ...ned on the chest Attaching the Electrodes CAUTION Always use the same type of electrodes If different types of electrodes are used at the same time the difference between the polarization potential from each electrode may interfere with monitoring Do not reuse the disposable electrodes It is intended for single patient use only Clean the electrode sites with alcohol wipes or other skin preparation...

Page 37: ...nnecting the ECG Lead Cable to the LX 8300M 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 ...

Page 38: ...em Pay attention to the difference when monitoring a patient 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 con...

Page 39: ...rate The cardiac monitoring 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 A...

Page 40: ...5 Respiration Monitoring 16 ...

Page 41: ...e wave and level meter are normalized for SpO2 measurement It does not indicate perfused blood volume Check proper probe attachment by observing the pulse wave Preparation for Monitoring Select the proper SpO2 sensors depending on the purpose and application sites defined in the sensors directions for use For details of the usable SpO2 sensors refer to 14 Standard and Optional Accessories WARNING ...

Page 42: ... or MetHb may occur with a seemingly normal SpO2 When elevated levels of COHb or MetHb are suspected laboratory analysis co oximetry of a blood sample should be performed Intravascular dyes such as indocyanine green or methylene blue Externally applied coloring and texture such as nail polish acrylic nails glitter etc Elevated levels of bilirubin Severe anemia Very low arterial perfusion Extreme m...

Page 43: ...he patient Electrical shock and flammability hazard Before cleaning this equipment make sure to turn off the power When patients are undergoing photodynamic therapy they may be sensitive to light sources Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy Do not place this equipment on electrical equipment tha...

Page 44: ...nimize radio interference other electrical equipment that emits radio frequency transmissions should not be in close proximity to this equipment Replace the sensor when a Bad Sens message is consistently displayed while monitoring patients even after following the troubleshooting steps explained in this manual NOTE A functional tester cannot be used to assess the SpO2 accuracy High intensity extre...

Page 45: ...he monitoring can be continued after Bad Sens is displayed but after 12 hours disposable sensor 72 hours reusable sensor one of the following operation will make the sensor unusable 1 Sensor is detached from the patient for 2 hours or more 2 Probe is disconnected from the equipment 3 The power of the equipment is turned OFF The following table shows the expected life of sensor The indication of us...

Page 46: ...the sensor ensure that the sensor is physically intact with no broken or frayed wires or damaged parts Do not immerse the sensor or connector in any liquid solution With smaller digits in order to completely cover the detector window the digit might not need to be pushed all the way to the stop The sensor is not intended for use on the thumb or across a child s hand or foot The site must be checke...

Page 47: ...erly may cause incorrect measurements Do not use the sensor during MRI scanning If using pulse oximetry during full body irradiation keep the sensor out of the irradiation field If sensor is exposed to the irradiation the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period Avoid placing the sensor on any extremity with an arterial catheter or b...

Page 48: ...the connector on the LNCS TC I cable in any liquid solution The site must be changed every four hours Circulation distal to the sensor site should be checked routinely Exercise caution with poorly perfused patients skin erosion and or pressure necrosis may occur During low perfusion the sensor site needs to be assessed frequently for signs of tissue ischemia which can lead to pressure necrosis Wit...

Page 49: ...imeter pulse rate display Verify patient s pulse rate against the ECG heart rate Venous pulsations may cause erroneous low readings e g tricuspid value regurgitation Trendelenberg position Do not modify or alter the sensor in any way Alterations or modification may affect performance and or accuracy Applying the LNCS Adtx LNCS Pdtx RD SET Adt RD SET Pdt 1 Open the pouch and remove the sensor Remov...

Page 50: ...king from the sensor if present 2 For fragile skin the stickiness of the medical grade adhesive can be diminished or eliminated by daubing the adhesive areas with a cotton ball or with gauze Fig 1 This step does not apply to the NeoPt 500 3 Direct the sensor cable so that it either points away from the patient or runs along the bottom of the foot Apply the detector onto the fleshy part of the late...

Page 51: ...ischemia During low perfusion the sensor site needs to be assessed frequently for signs of tissue ischemia which can lead pressure necrosis Do not use tape to secure the sensor to the site this can restrict blood flow and cause inaccurate readings Use of additional tape can cause skin damage or damage the sensor Misapplied sensors or sensors that become partially dislodged may cause either over or...

Page 52: ...le and patient cable to reduce the possibility of patient entanglement or strangulation If using pulse oximetry during full body irradiation keep the sensor out of the irradiation field If sensor is exposed to the irradiation the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period To prevent interference from ambient light ensure that the senso...

Page 53: ...he SpO2 sensor to the LX 8300M 1 Insert the SpO2 sensor into the SpO2 input connector on the LX 8300M 2 Attach the sensor lock as shown in the following illustration to prevent the SpO2 sensor to be disconnected SpO2 Sensor Sensor Lock ...

Page 54: ...6 SpO2 Monitoring 30 ...

Page 55: ...s not have a diagnostic function Check the diagnostic function on the receiving monitor The LX 8300M 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 display of the LX 8300M do not interface with the ones displayed on the screen of the receiving monitor The heart rate and respiration rate displayed on ...

Page 56: ... onto the next screen The screen will switch in the following order Press and hold the ENTER button for 2 seconds Move onto ECG1 setup display Move onto ECG2 setup display Press the button Press the button Press the button Press the button Move onto RESP setup display Press and hold the ENTER button for 2 seconds Press and hold the ENTER button for 2 seconds Press the button Press and hold the ENT...

Page 57: ...ve display example the display range is 1mV 3 Displays the speaker mark when the synchronized tone is active For details refer to 8 Operation 4 Displays the heart rate 5 Displays the respiration rate 6 Indicates the horizontal scale of the displayed ECG One scale corresponds to 1 second 7 Displays the measured waveform 8 Displays the SpO2 value pulse rate SpO2 OFF is displayed when the SpO2 measur...

Page 58: ...Indicates the ECG waveform size displayed on the display 5 Indicates the horizontal scale of the displayed ECG waveform One scale corresponds to one second 6 Displays the ECG waveform 7 Displays the detection marker when a pacemaker pulse is detected 8 Displays the speaker mark when synchronized tone is active For details refer to 8 Operation 9 Displays the heart rate is displayed in synchronizati...

Page 59: ...receiving monitor When Wide is selected in the QRS Detection and if HR is outside the display range 12 bpm to 300 bpm 0 bpm will be displayed if 11 bpm and below is measured and 300 bpm will be displayed if 300 bpm and above is measured When Narrow is selected in the QRS Detection and if HR is outside the display range 30 bpm to 300 bpm 0 bpm will be displayed if 29 bpm and below is measured and 3...

Page 60: ...waveform One scale corresponds to one second 5 Displays the respiration waveform 6 Displays the respiration rate 7 Indicates the remaining battery level For details of the battery level refer to 3 Preparation CAUTION The displayed respiration waveform size setting does not interact with the one displayed on the receiving monitor If the respiration waveform size displayed on the receiving monitor i...

Page 61: ...e following display example is when the SpO2 measurement is set to ON When the SpO2 measurement is set to OFF SpO2 OFF is displayed SpO2 Standard Display SpO2 Enlarged Display 1 Indicates the SpO2 display 2 Indicates the amplitude level of the pulse wave in 8 steps 3 Displays the SpO2 measurement value 4 Displays the PI measurement value 5 Displays the speaker mark when the synchronized tone is ac...

Page 62: ... operation manual of the receiving monitor NOTE The perfusion index PI is calculated by pulsatile signal divided by apulsatile signal times 100 and indicates patient s circulation condition at the monitoring site This can be used to find a good perfusion site to attach the sensor Also it can be used as diagnosis index to predict the patient s critical condition when at low perfusion Reference Perf...

Page 63: ...ead I II III II Yes Display Size of ECG 1 1 1 2 1 Yes Display Size of ECG 2 1 1 2 1 Yes Display Size of RESP 1 1 2 1 Yes ECG Setup In the ECG display the waveform size and lead can be changed and the synchronized tone can be set Switching Lead ECG lead can be switched when 3 electrode lead cable or 5 electrode Chest lead cable is used Select an appropriate lead by checking the ECG waveform on the ...

Page 64: ... 8300M does not interact with the one displayed on the receiving monitor To change the waveform size of the receiving monitor follow the instruction in the operation manual of the receiving monitor Generating a Synchronized Tone When the speaker mark is displayed a synchronized tone will generate along with the mark Press and hold the ENTER and button for 2 seconds to display the speaker mark Pres...

Page 65: ...wn on left up to 4Ω change can be displayed CAUTION The waveform size displayed on the LX 8300M does not interact with the one displayed on the receiving monitor To change the waveform size of the receiving monitor follow the instruction in the operation manual of the receiving monitor SpO2 Setup In the SpO2 display the synchronized tone and ON OFF of SpO2 measurement can be set Generating a Synch...

Page 66: ...ss the ENTER button for 2 seconds A confirmation screen will be displayed Select Yes and press the ENTER button The SpO2 measurement will stop and SpO2 OFF will be displayed NOTE If no selection is made for 10 seconds on the confirmation screen the display will automatically return to SpO2 display without changing the ON OFF status of SpO2 measurement While the SpO2 probe is connected to the trans...

Page 67: ...isplay The display automatically turns itself OFF after the preprogrammed duration if no operation is performed Press the ENTER button or press and hold the button to restart the display The starting screen with the telemetry channel number appears and then the waveform display screen appears The display timeout duration can be changed For details refer to 9 Other Settings CAUTION The heart rates ...

Page 68: ...itor The following message appears on the display while the EVENT is transmitted After the transmission is completed the monitoring display appears EVENT operation is available as a remote recording For details of the receiving monitor operation and settings related to the EVENT function refer to the operation manual of the receiving monitor ...

Page 69: ...ns Low Mid High Mid Yes QRS Detection QRS Width Wide Narrow Wide Yes Respiration Detection Signal Display ON OFF ON Yes Display Brightness Brightness 8 levels 5 Yes Turn Off Display Time Display OFF 1 min 3 min 10 min OFF 3 min Yes Sound Sound ON OFF ON Yes Displayed Color of SpO2 Color Yellow Blue Yellow Yes Transmit PI Information PI Data Send ON OFF OFF Yes Transmitter Channel CH One from the f...

Page 70: ...nstant Make sure to take measures such as marking on the LX 8300M to distinguish whether the selection of time constant has changed Detection Sensitivity of the Pacemaker Pulse The default setting of pacemaker pulse detection sensitivity is Mid The Mid setting can detect and reject the following pacemaker pulse specified in IEC 60601 2 27 standard Detection Rejection of Pacemaker Pulse a Pacemaker...

Page 71: ...r local Fukuda Denshi service representative CAUTION The display screen in normal use does not indicate the setting status of the pacemaker pulse detection Make sure to take measures such as marking on the LX 8300M to distinguish whether the setting of the pacemaker pulse detection has changed QRS Detection The QRS detection mode of the LX 8300M is initially set as Wide The setting can be changed ...

Page 72: ... 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 8300M to distinguish whether the setting of th...

Page 73: ... related parameters can be selected from yellow or blue The default setting is Yellow When changing the settings contact your local service representative Transmit PI Information The PI value can be transmitted to the receiving monitor by setting to ON The default setting is OFF When changing the settings contact your local service representative CAUTION To display the PI value on the receiving mo...

Page 74: ...9 Other Setting Items 50 ...

Page 75: ...the transmitter channel has been changed Group ID The LX 8300M 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 that of the receiving monitor There are 64 group codes available The default setting is 00 The transmitter group ID can be changed if there is interference ...

Page 76: ...10 Changing the Transmitter Channel and Group ID 52 ...

Page 77: ...ement in the situation contact your local Fukuda Denshi service representative Transmitter Message Cause Solution Faulty SpO2 module Contact your local Fukuda Denshi service representative Failed to transmit waveform and value Faulty EEPROM Failed to initialize CPU Faulty Speaker ...

Page 78: ...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 telemetry channel in your facility and use the transmitter with the correct channel setting Channel interference Follow the inst...

Page 79: ...ace the electrode with a new one Polarization potential of the electrode is too high Replace the electrode with a new one Situation Cause Solution 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 up...

Page 80: ...e the probe SpO2 is not measured correctly Verify that the sensor is properly attached Avoid exposure to ambient light Unspecified probe is used Replace the probe The probe is damaged or the usable life of the sensor is expired Replace the probe For the expiration date of the sensor refer to 6 SpO2 Monitoring About the Expected Life of Masimo Sensors ...

Page 81: ... the light emitting and receiving parts of the sensor LED are aligned The expiration date of the sensor is approaching Replace the probe For the expiration date of the sensor refer to 6 SpO2 Monitoring About the Expected Life of Masimo Sensors The SpO2 measurement is turned OFF To turn ON the SpO2 measurement refer to Turning ON the SpO2 measurement ...

Page 82: ...the instruction Transmitting and measuring LEDs sensor are dirty Clean both LED sensors from dirt Details of the Electrode Message The following Electrode messages are displayed depending on the selected lead cable and lead Check Position 3 electrode Lead I display 3 electrode Lead II display 3 electrode Lead III display LL RA LA Several Position Simultaneously Check Position 4 electrode 5 electro...

Page 83: ...ed After cleaning wipe off any moisture thoroughly before removing the ECG lead cable SpO2 probe sensor or batteries CAUTION Do not use a dryer The LX 8300M shape may change or be broken When rinsing the LX 8300M with running water make sure to close the battery compartment lid In case of dropping the equipment into dirty water it is recommended to contact Fukuda Denshi or your nearest service rep...

Page 84: ...11 Troubleshooting 60 ...

Page 85: ... make sure that the battery compartment lid is locked After cleaning wipe off any moisture thoroughly before removing the ECG lead cable SpO2 probe sensor or batteries CAUTION Clean the equipment frequently so stains can be removed easily To prevent injury it is recommended to wear gloves when cleaning the equipment Do not allow any chemical solution to enter the LX 8300M or connectors The LX 8300...

Page 86: ... using a squeezed gauze or an absorbent cotton cloth dampened with alcohol or invert soap CAUTION Do not immerse the connector parts of the LX 8300M in any chemical solution to prevent connection failure When disinfecting the entire room using a spray solution pay close attention not to have liquids get into the LX 8300M or connectors Cleaning the ECG lead cable After using the cable clean it with...

Page 87: ...odic 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 Perform Periodic check using the Periodic Check List The periodic check should be performed once a year If there is an item with Fail judgement the overall judgement will be Fail Make sure to take countermeasu...

Page 88: ...nnectors Visually check the connectors of the cable and the LX 8300M 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 SpO2 Sensor Probe Visually check the cable optical receiver LED and connector for damages No crack chip damage and adhesion of dust should be found OK NG Wireless Channel Verify w...

Page 89: ...eriodic Check Items The periodic check items are as follows No Check Item 1 External Appearance 2 Power Supply Switch 3 Display Operation 4 ECG 5 Respiration 6 Arterial Oxygen Saturation SpO2 7 Speaker 8 Electrical Safety No Check Item Check Procedure Criteria 1 External Appearance Accessories 01 Appearance Visually check the exterior for scratches cracks deformation and rust No abnormality should...

Page 90: ... 10 Should be 10 mmp p or below for standard sensitivity sensitivity 1 03 Transient Characteristic With comprehensive tester apply standard voltage of 1 mV and check the time the amplitude natural logarithmically drops and becomes 37 of the waveform of 0 04 sec after the application of standard voltage Should be 0 4 0 1 seconds When the time constant is set to 0 4 seconds 04 Frequency Characterist...

Page 91: ...r the corresponded lead should be displayed 10 ECG Lead Cable Recognition Switch the ECG lead cable or switch the setup of lead cable Should correctly recognize the connected lead cable As these functions are dependent on the design or software these items are not mandatory for periodic checks Perform the test as necessary No Check Item Check Procedure Criteria 5 Respiration 01 Respiration Wavefor...

Page 92: ... be within 6 03 SpO2 Probe Off Detection Check the display by disconnecting the probe Waveform and numeric data should disappear from the display No Check Item Check Procedure Criteria 7 Speaker 01 Generation Generate synchronized tone and check the sound Generating synchronized tone No Check Item Check Procedure Criteria 8 Electrical Safety 01 Contact current Measure the leakage current that runs...

Page 93: ...nection in the Type F attaching part SFC Measure the leakage current when external voltage is applied to the patient connection in the Type F attaching part using a leak measurement safety tester According to test procedure of IEC 60601 1 8 7 4 Leakage current when external voltage is applied to the patient connection in the Type F attaching part SFC 0 01mA 06 Patient auxiliary current NC Measure ...

Page 94: ...13 Maintenance and Inspection 70 Periodic Check List ...

Page 95: ...placing the Battery Compartment Lid Unit Life of the Battery Compartment Lid Unit Life of the waterproof battery compartment lid unit is one year If this unit is used for more than a year the waterproof IPX8 performance cannot be guaranteed Replace the battery compartment lid unit to maintain its waterproof performance CAUTION The battery unit must be replaced at specified period Even if the LX 83...

Page 96: ...Phillips screwdriver 0 Assembly 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 ...

Page 97: ... 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 3 Make sure that the battery compartment lid unit opens closes smoothly 1 2 ...

Page 98: ...13 Maintenance and Inspection 74 4 Attach the label firmly aligning with the groove of the battery compartment lid unit Groove Label ...

Page 99: ...Model Type Q ty Remarks 4 electrode ECG lead cable CMT 02CTH 0 8DA 1 AHA color code Clip Type Limb Lead 2CH Operation Manual 1 Optional Accessories The following optional accessories are available for the LX 8300M Purchase them as required ECG Lead Cables Item Model Type Remarks Clip Type Lead Cable CMT 01CTH 0 8DA 3 electrode White Black Red Limb Lead 1ch Clip Type Lead Cable CMT 02CTH 0 8DA 4 el...

Page 100: ...ngle Patient Use LNCS NeoPt L 1901 Preterm weight of less 1kg Hand Foot Single Patient Use LNCS Inf 3 2319 Infant weight of 3 to 20kg Thumb Great toe Single Patient Use LNCS NeoPt3 2321 Preterm weight of less than 1kg Hand Foot Single Patient Use The LNCS Sensors can be directly connected to the LX 8300M RD SET Sensor Model Type Remarks RD SET DCI 4050 Adult weight of 30kg and over Finger Toe Reus...

Page 101: ...ng the RD SET Sensor the following conversion cables are required Types of Conversion Cable Length RD to LNCS adapter cable 4089 3 ft RD to LNCS adapter cable 4105 1 5 ft Other Item Item Model Type Remarks Disposable Portable Case ABT 720D 5 pieces pack ...

Page 102: ...14 Standard and Optional Accessories 78 ...

Page 103: ...CD Built in Waterproof IPX8 If periodic replacements are performed IPX5 IPX5 Protection from water IPX8 Protection from submerge Power Supply DC Two 1 5 V AA size LR06 size alkaline batteries Continuous Operating Time Standard Operation Two AA size LR6 size alkaline batteries Approximately 2 5 days with MX1500 DURACELL Conditions When measuring ECG RESP SpO2 with default settings operating tempera...

Page 104: ...s follows HR measurement range 0 12 bpm to 300 bpm HR Display Range QRS Detection Wide 0 12 bpm to 300 bpm 1bpm increment QRS Detection Narrow 0 30 bpm to 300 bpm 1 bpm increment Frequency Characteristic 0 5 Hz to 40 Hz within 3dB Time Constant 0 4 sec 25 Can be switched to 0 1 sec 25 Rejection of Pacemaker Pulse a Pacemaker Pulse without Over Undershoot Capable to reject pulses of pulse width 0 1...

Page 105: ... female volunteers against a laboratory CO Oximeter The SpO2 accuracy has been validated for the range from 70 to 100 by testing on healthy adult male and female volunteers with light to dark skin pigmentation Without body motion the standard deviation is 2 which encompasses 68 of the population With body motion the standard deviation is 3 which encompasses 68 of the population For the validation ...

Page 106: ...t 15 mW and below SpO2 Measurement Range 1 SpO2 to 100 SpO2 Resolution 1 SpO2 Measurement Accuracy Without body motion Adult 2 SpO2 when 70 SpO2 to 100 SpO2 Neonate 3 SpO2 when 70 SpO2 to 100 SpO2 With body motion Adult 3 SpO2 when 70 SpO2 to 100 SpO2 Neonate 3 SpO2 when 70 SpO2 to 100 SpO2 Measurement Value Update Rate 1 sec Averaging Time 8 sec Pulse Rate Measurement Range 26 bpm to 239 bpm Meas...

Page 107: ...mance Collateral standard Electromagnetic disturbances Requirements and tests The class of protection against electric shock Internally Powered Equipment The type of protection against electric shock ECG RESP Type CF Applied Part SpO2 Type CF Applied Part Operating Environment Temperature 10 C to 40 C 50 F to 104 F Humidity 30 RH to 85 RH non condensing Atmospheric Pressure 70 kPa to 106 kPa Trans...

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