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15. Specification

85

LX-7230KM

SpO

2

Measurement Range:

0 to 100%

Resolution: 1%
Measurement Accuracy:

Accuracy of measurement with SpO

2

probe

is as follows.

Measurement Spot

Measurement Accuracy

(±1SD)

Finger ±2%

Big toe or the root

of the big toe

±3%

(When SpO

2

is 70 to 100%. Less than 70% is not specified.)

Wavelength:

658 to 665nm (Red light), 860 to 925nm
(infrared light)

Power Loss on Probe:

2.0mW

Measurement Reply Time:

12 sec (moving average time)

Measurement Value Update Rate: Continuous mode 1 second

Intermittent mode 25 seconds

NOTE

The SpO

2

measurement accuracy is determined based on the values of

the root-mean-square (rms) difference between SpO

2

readings of the pulse

oximeter equipment and values of SaO

2

determined with a CO-oximeter,

by healthy adult volunteers. The pulse oximeter equipment measurements
are statistically distributed; ±2% measurement accuracy means that only
about two-thirds of pulse oximeter equipment measurements can be
expected to fall within ±2% of the value measured by a CO-oximeter.

Pulse Wave

LX-7230N

Pulse Rate Measurement Range:

20 to 250bpm

Measurement Accuracy

±3bpm

LX-7230KM

Pulse Rate Measurement Range:

30 to 230bpm

Measurement Accuracy

±2bpm (30 to 100bpm)
±2% (100 to 230bpm)

Measurement Response Time:

6 sec. (Moving Average Time)

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Summary of Contents for LX-7230

Page 1: ...ECG Respiration and SpO2 Transmitter LX 7230 Operation Manual LX 7230N LX 7230KM Before using this device read this operation manual thoroughly Keep this manual near the device for future reference ...

Page 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...

Page 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...

Page 4: ...ibrillation 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 remaining battery level Intermittent SpO2 Mode Indicates that t...

Page 5: ...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 and the probe sensor Pay special attention when the equipment is used in conjunction with other equipment as it may cause erroneous judgment and danger Check the remaining battery level Whe...

Page 6: ...es 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 ...

Page 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...

Page 8: ...t 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 for disc...

Page 9: ...with a soft cloth and dry it thoroughly before use Precautions about ECG CAUTION When removing electrodes from the patient remove them carefully and slowly Do not apply excessive force to remove them Otherwise it may damage the skin There are some cases when the pacemaker pulse cannot be detected depending on the pacemaker type pulse voltage pulse width electrode lead type unipolar bipolar electro...

Page 10: ...ion of attachment may inhibit the blood flow and generate compression necrosis and burn injury When securing the probe sensor with tape do not apply the tape too tight At the same time check the blood flow constantly so that congestion is not generated at the peripheral When removing the tape remove it slowly with care not to damage the patient s skin CAUTION For the following case accurate measur...

Page 11: ...es WARNING Use only the accessories such as ECG Lead cable and SpO2 probe sensor relay cable specified by Fukuda Denshi for the LX 7230 Otherwise the LX 7230 cannot deliver its maximum performance and may be damaged resulting in a safety hazard CAUTION Do not reuse disposable products Store the disposable products properly as mentioned in their user manuals Precautions about Battery WARNING Use ne...

Page 12: ... LX 7230 requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service This radio frequency device is susceptible to interference from outside sources Interference may prevent the monitoring of patients connected to this device If a problem exists contact your local service representative The LX 7230 transmits vital signs to the recei...

Page 13: ...telemetry systems and are skilled in operating telemetry When installing telemetry the Overall Manager and the Zone Manager have to understand the precautions for use of telemetry in advance The Overall Manager is responsible for maintenance of wireless channel and storage and maintenance of telemeter in the overall medical facilities to give proper instructions to the Zone Manager when using tele...

Page 14: ...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...

Page 15: ...t verify that it is used within the environment specified below Compliance to the Electromagnetic Emissions The LX 7230 is intended for use in the electromagnetic environment specified below The customer or the user of the LX 7230 should assure that it is used in such an environment Emission Test Compliance Electromagnetic Environment Guidance RF Emission CISPR 11 Group 1 The LX 7230 uses RF energ...

Page 16: ...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...

Page 17: ... 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 structur...

Page 18: ...ted 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 wher...

Page 19: ...ecautions about Disposing of Equipment Accessories or Components x Precautions about Disposing of Battery x Precautions for Use of Medical Telemeter x Electromagnetic Compatibility xii Precautions for Safe Operation under Electromagnetic Influence xii EMC Guidance xiii 1 General Description 1 2 Names of Parts and Their Functions 3 3 Preparation 5 1 Installing the Batteries 5 2 Operating Power Swit...

Page 20: ... the Transmitter Channel and Group ID 67 Changing the Transmitter Channel 67 Changing the Group ID 67 11 Troubleshooting 69 List of Displayed messages 69 Troubleshooting 72 In Case of Dropping the LX 7230 into Water 74 12 Cleaning and Disinfection 75 Cleaning 75 Disinfection 75 13 Maintenance and Inspection 77 14 Standard and Optional Accessories 79 Standard Accessories 79 Optional Accessories 80 ...

Page 21: ...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 7230 can also function as a transmitter to measure only the ECG Respiration without SpO2 or to measure only the SpO2 without ECG Respiration Before using the LX 7230 read also the operation manual of the patient monitor at the receiving s...

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

Page 23: ...Precautions in this manual s preface SpO2 Input Connector Connects the SpO2 probe sensor relay cable Channel Number Label Indicates transmitter channel number LCD Displays measurement waveform and transmitter information Power Switch Turn ON OFF the power EVENT Button Activates the function assigned on the receiving monitor Electrode Position Label Indicates standard ECG electrode position Enter b...

Page 24: ...ts and Their Functions 4 Battery Lid Lock Lever Uses to open lock the battery compartment lid Battery Compartment Lid This is the lid for the battery compartment Make sure to close it when the transmitter is operated ...

Page 25: ...atteries may occur Do not use different types of batteries at the same time The leakage from the batteries may damage the device or an explosion from the batteries may occur Remove the exhausted batteries immediately The leakage from the batteries may damage the device or an explosion from the batteries may occur If the transmitter is not in use for a long period of time remove the batteries and s...

Page 26: ...ment 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...

Page 27: ...urns 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 batteries Turning the power switch to OFF Ro...

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

Page 29: ... 1CH 3 electrode Hook Type White Black Red CMT 02HTH 0 8DA Limb Lead 2CH 4 electrode Hook Type White Black Red Green CMT 03HTH 0 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...

Page 30: ...d I lead II or lead III under the setting of the device Refer to 8 Operation Changing Setup ECG Display Screen 1 Switching Lead in page 57 Black LA White RA Red LL 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...

Page 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 8 Operation Changing Setup ECG Display Screen 1 Switching Lead in page 57 Black LA White RA Brown V Green RL Red LL ...

Page 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...

Page 33: ...onnecting the ECG Lead Cable to the LX 7230 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 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...

Page 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 ...

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

Page 37: ... attention not to miss the connector off condition CAUTION When using the transmitter with only the SpO2 sensor cable ECG and respiration measurements on the receiving monitor shall be turned off to prevent an erroneous alarm There are varieties of SpO2 sensors depending on the purpose and intended use for LX 7230N and LX 7230KM Select a proper one and attach it to the patient CAUTION SpO2 sensor ...

Page 38: ...MAX I Infant weight of 3 to 20Kg Toe OxiMax MAX P Pediatric weight of 10 to 50Kg Finger OxiMax MAX A AL Adult weight of 30Kg and over Finger Durasensor DS 100A Adult weight of 40Kg and over Finger OxiMax MAX R Adult weight of 50Kg and over Nose OxiMax MAX FAST Adult Pediatric weight of 10Kg and over Forehead Adult weight of 40Kg and over Finger OxiMax MAX N Neonate weight of less 3Kg Foot WARNING ...

Page 39: ...UTION The accuracy of SpO2 measurement may be influenced by abnormal hemoglobin such as carbon monoxide hemoglobin COHb and methemoglobin MetHb It may be also affected by cardiogreen or intravascular dyes In addition the following case may affect the accuracy of SpO2 and pulse rate measurement Outside light direct sunlight fluorescent light therapy equipment surgical light infrared heat ramp etc H...

Page 40: ...cular infusion line 2 Orient the MAX I so that the window next to the cable is aligned on the bottom of the big toe as shown The cable should extend towards the heel Figure 2 3 Wrap the MAX I firmly but not too tightly around the toe Windows must oppose each other for correct measurement Figure 3 4 Wrap any excess tape loosely around the toe Use additional tape provided to secure the cable across ...

Page 41: ... allergic reactions to the adhesive tape Failure to apply the sensor properly may cause incorrect measurements While the sensor is designed to reduce the effects of ambient light excessive light may cause inaccurate measurements In such cases cover the sensor with an opaque material If the sensor is wrapped too tightly or supplemental tape is applied venous pulsations may lead to inaccurate satura...

Page 42: ... Orient the MAX P MAX A MAX AL so that the dashed line in the middle of the sensor is centered on the tip of the finger toe Figure 2 Wrap the adhesive flaps around the digit Note that the cable must be positioned on the top of the hand or foot 3 Fold the cable end over the top of the finger toe so that the windows are directly opposite to each other Wrap the adhesive securely around both sides of ...

Page 43: ...rements In such cases cover the sensor with an opaque material If the sensor is wrapped too tightly or supplemental tape is applied venous pulsations may lead to inaccurate saturation measurements Excessive motion may compromise performance In such cases try to keep the patient still or change the sensor site to one with less motion Intravascular dyes or externally applied coloring such as nail po...

Page 44: ...r use other OxiMax sensor Do not use the DS 100A on a thumb or toe or across a child s hand or foot NOTE When selecting the sensor site priority should be given to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion line 4 The sensor should be oriented in such a way that the cable is positioned along the top of the hand Figure 4 5 Connect the DS 100A into the LX...

Page 45: ...ffects of ambient light excessive light may cause inaccurate measurements In such cases cover the sensor with an opaque material Do not apply tape to secure the sensor in place or to tape it shut venous pulsations may lead to inaccurate saturation measurements Excessive motion may compromise performance In such cases try to keep the patient still or change the sensor site to one with less motion I...

Page 46: ... and the dashed center line b midway between the marks Figure 1 3 Orient the MAX R so that the dashed line is centered on the nose a and the alignment marks are at the bone cartilage junction b The cable should extend toward the patient s right side Figure 2 4 Press the MAX R firmly onto the nose and hold in place for 10 seconds to ensure adhesion Figure 3 The MAX R must be secured firmly for prop...

Page 47: ... of ambient light excessive light may cause inaccurate measurements In such cases cover the sensor with an opaque material Intravascular dyes or externally applied coloring such as dye or pigmented cream may lead to inaccurate measurements Take care when removing the MAX R so that the adhesive does not damage delicate facial tissue The MAX R is not recommended for patients wearing oxygen or anesth...

Page 48: ... on the lateral edge of the site a Neonates The preferred site is the foot Alternatively use the hand The window next to the cable goes on the sole of the foot as shown Figure 2 Adults The preferred site is the index finger Alternatively other fingers may be used The window next to the cable goes on the nail side distal to the first joint Do not place on a joint Note that the cable must be positio...

Page 49: ...curs reposition the sensor in a different location or choose an alternate Nellcor sensor to use on a different site Reapplication 1 The MAX A can be reused on the same patient as long as the adhesive tape attaches without slippage 2 Enclosed adhesive dots are provided for reapplication Place the transparent dot over each window as shown and then remove the protective paper that covers each dot Fig...

Page 50: ... In such cases cover the sensor with an opaque material If the sensor is wrapped too tightly or supplemental tape is applied venous pulsations may lead to inaccurate saturation measurements Excessive motion may compromise performance In such cases try to keep the patient still or change the sensor site to one with less motion Intravascular dyes or externally applied coloring such as nail polish dy...

Page 51: ...ready to be applied on the patient 2 NOTE There are three adhesive pads attached to the sensor each with a pull tab for removal When repositioning the sensor on the same patient first expose the new adhesive pad by grasping the tab and peeling off the old adhesive pad The sensor is now ready to be reapplied to the patient 3 Place the sensor onto a flat hairless portion of the patient s forehead ju...

Page 52: ...ied coloring such as dye or pigmented cream to permit appropriate light transmission If any of these situations occurs reposition the sensor in a different location or choose an alternate Nellcor sensor to use on a different site WARNING Precautions for Use of headband Do not use headband on children age 24 months and younger Do not use headband on children with open fontanelles For details refer ...

Page 53: ...fects of ambient light excessive light may cause inaccurate measurements In such cases cover the sensor with an opaque material Do not use tape with the sensor Use of additional tape or other types of adhesives may cause skin damage Applying the headband too tightly can lead to inaccurate saturation measurements or possibly to temporary pressure marks from sensor Excessive motion may compromise pe...

Page 54: ...he Nellcor SpO2 Sensor to the LX 7230N 1 Insert the SpO2 sensor into the SpO2 input connector on the LX 7230N SpO2 Sensor 2 Attach the sensor lock as shown in the following illustration to prevent the SpO2 sensor to be disconnected Sensor Lock ...

Page 55: ...ger Clip SR 5C Adult and Pediatric weight of 30Kg and over Finger Spot Check SP 5C Adult and Pediatric weight of 30Kg and over Finger Universal Probe UD 5C Adult and Pediatric weight of 40Kg and over Finger Adult and Pediatric weight of 15Kg and over Finger Personal Probe SD 5C 25 SD 5C 20 Pediatric and Infant weight of 5 to 15Kg Big toe or the root of the big toe WARNING For SpO2 monitoring alway...

Page 56: ... damage to it may result Do not pick up the device pulling the probe relay cable part It may get disconnected from the device and the device may be dropped A message is displayed when the SpO2 sensor is disconnected from the device A message is displayed when the device detects that the SpO2 probe is disconnected from the patient Properly attach the SpO2 probe to the patient Read through the instr...

Page 57: ...er than the actual value when the SpO2 value is around 50 The following case may affect the accuracy of SpO2 and pulse rate measurement Outside light direct sunlight fluorescent light therapy equipment surgical light infrared heat ramp etc Hypoperfusion Excessive body motion patient s motion Pigment injected to the blood for testing In case of measurement during receiving CPR treatment Placement o...

Page 58: ...stion CAUTION Precautions for Use of Finger Clip Probe SR 5C The probe should be positioned so that the light source is at the base of the fingernail Take care not to insert the finger too deep to prevent injury When removing the probe do not pull on the cord Cover the probe with the finger mesh cover FC M if it is exposed to high intensity light such as direct light and surgical light to prevent ...

Page 59: ... SP 5C The probe should be positioned so that the light source LED is at the base of the fingernail Take care not to insert a finger too deep to prevent injury When removing the probe do not pull on the cord Cover the probe with a black cover if it is exposed to high intensity light such as direct light and surgical light to prevent measurement error The SP 5C is designed for use on finger of an a...

Page 60: ... site frequently If the use of adhesive tape causes skin irritation it should be discontinued When securing the probe with bandage tape do not tighten it too hard as this may cause edema or congestion When removing the tape be careful not to damage the skin CAUTION Precautions for Use of Universal Probe UD 5C When removing the probe do not pull on the cord and remove the tape Do not apply excessiv...

Page 61: ...or the root of the big toe of a pediatric infant 5 to 15kg by using bandage tape 1 Before attaching the probe clean the probe using a cloth moistened with sterilizing alcohol 2 When used on finger position the LED light source on the base of the fingernail and secure the sensor using bandage tape 3 When used on the big toe position the LED light source on the base of the big toenail and secure the...

Page 62: ...Personal Probe SD 5C 20 and SD 5C 25 When removing the probe do not pull on the cord and remove the tape Do not apply excessive force to remove the tape It may break the probe Do not apply excessive force on the LED and sensor otherwise damage to the probe may result Cover the probe with a black cover if it is exposed to high intensity light such as direct light and surgical light to prevent measu...

Page 63: ...able CI 129 Connect the SpO2 probe connector to the SpO2 relay cable CI 129 as shown in the figure below Relay Cable CI 129 SpO2 probe Connecting the Relay Cable CI 129 to the LX 7230KM Connect the relay cable CI 129 to the SpO2 input connector on the LX 7230KM CI 129 ...

Page 64: ...6 SpO2 Monitor LX 7230KM 44 Blank Page ...

Page 65: ... cable heart rate pacemaker marker respirogram respiration rate pulse wave SpO2 measurement value remaining battery level and various messages are displayed CAUTION The LX 7230 does not have a diagnostic function Check the diagnostic function on the receiving monitor The LX 7230 does not have an alarm function Check the alarm function on the receiving monitor The ECG waveform size and sweep speed ...

Page 66: ...the battery level on the waveform display screen Battery Symbol Remaining Battery Level Full Getting low but still available Nearly empty Replace the battery A message that prompts the battery check appears on the screen of the receiving monitor ...

Page 67: ...D display refer to page 62 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...

Page 68: ...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...

Page 69: ... is done To restart the LCD display refer to page 62 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...

Page 70: ... 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...

Page 71: ...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...

Page 72: ...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...

Page 73: ...ne To restart the LCD display refer to page 62 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 the SpO2 display screen Displays the pulse wave The waveform size displayed on the LCD is adjusted automatically Displays the SpO2 measurement value Displays...

Page 74: ...are displayed The LCD display will automatically turn itself OFF after 60 seconds if no operation is done To restart the LCD display refer to page 62 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 the SpO2 display screen Displays the pulse wave The wa...

Page 75: ...SpO2 intermittent mode the SpO2 is measured at 25 seconds interval Even when the SpO2 value suddenly changes during this interval the LX 7230 and receiving monitor will only show the last SpO2 measurement value For a patient with the possibility of sudden change select SpO2 continuous mode Pulse wave and pulse wave level meter are not displayed on the LCD during the SpO2 intermittent measurement m...

Page 76: ...7 Measurement 56 Blank Page ...

Page 77: ...rode Chest lead cable is used Select an appropriate lead by checking the ECG waveform on the LCD The lead indication of ECG 1 is highlighted Pressing the Enter button will sequentially change the lead of ECG 1 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 ...

Page 78: ...ing monitor is changed follow the instruction in the operation manual of the receiving monitor Returning to ECG Display Screen 1 Press the button to highlight the Return button Press the Enter button to return to the ECG display screen 1 CAUTION Do not operate the LX 7230 with the setup screen open to prevent the settings to be changed due to an unintended operation Make sure to press the Return b...

Page 79: ...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 7230 does not interact with the one displayed on the screen of the receiving monitor because the LX 7230 cannot transmit the setting information of the waveform size to the receiving monitor If the ECG waveform size display...

Page 80: ... 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 7230 does not interact with the one displayed on the screen of the receiving monitor because the LX 7230 cannot transmit the setting information of the waveform size to the receiving monitor ...

Page 81: ...nge modes Mode Continuous intermittent Continuous Returning to SpO2 display screen Press the button to highlight the Return button Press the Enter button to return to the SpO2 display screen CAUTION In the SpO2 intermittent mode the SpO2 is measured at 25 seconds interval Even when the SpO2 value suddenly changes during this interval the LX 7230 and receiving monitor will only show the last SpO2 m...

Page 82: ...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...

Page 83: ...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...

Page 84: ...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...

Page 85: ...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...

Page 86: ...9 Other Setting Items 66 Blank Page ...

Page 87: ...tter channel has been changed Changing the Group ID The LX 7230 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...

Page 88: ...10 Changing the Transmitter Channel and Group ID 68 Blank Page ...

Page 89: ...y SpO2 module 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 ...

Page 90: ... condition of the probe Faulty Probe Replace the probe with new one Check the attached condition of the probe SpO2 is not measured correctly Cover the probe with an opaque material to cut off the outside light Due to excessive body motion SpO2 is not measured correctly Keep the patient still ...

Page 91: ...eplace the probe with a specified one Check the attached condition of the probe SpO2 is not measured correctly Cover the probe with an opaque material to cut off the outside light When the pulse rate is less than 30bpm under the measuring range When the pulse rate is more than 230bpm over the measuring range Due to excessive body motion SpO2 is not measured correctly Keep the patient still ...

Page 92: ...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 7230 with the correct channel setting Channel i...

Page 93: ... 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...

Page 94: ...table Transmitting and measuring LEDs sensor are dirty Clean both LED sensors from dirt In Case of Dropping the LX 7230 into Water In case of dropping the LX 7230 into water containing disinfectant pick up the LX 7230 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 7230 shape may change or be broken When the LX 7230 is rins...

Page 95: ...solvents thinner toluene 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 resi...

Page 96: ...12 Cleaning and Disinfection 76 Blank Page ...

Page 97: ...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 ...

Page 98: ...e LX 7230 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 Relay Cable LX 7230KM only Visually check the cable and connector for damages No crack chip and damage should be found OK NG SpO2 Sensor Probe Visually check the cable optical receiver LED and connector for damages No crack chip dama...

Page 99: ...se the LX 7230 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 4 SpO2 Relay Cable CI 129 1 L...

Page 100: ...rode White Black 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...

Page 101: ... OxiMax MAX A AL Single Use Adult weight of 30Kg and over Finger OxiMax MAX I Single Use Infant weight of 3 to 20Kg Toe OxiMax MAX R Single Use Adult weight of 50Kg and over Nose Single Use Adult weight of 40Kg and over Finger OxiMax MAX N Neonate weight of less 3Kg Foot OxiMax MAX FAST Single Use Adult Pediatric weight of 10Kg and over Forehead CAUTION SpO2 sensors for the LX 7230N cannot be used...

Page 102: ...lt and Pediatric weight of 30Kg and over Finger Universal Probe UD 5C Semi Disposable Adult and Pediatric weight of 40Kg and over Finger SD 5C 25 Semi Disposable Adult and Pediatric weight of 15Kg and over Finger Personal Probe SD 5C 20 Semi Disposable Pediatric and Infant weight of 5 to 15Kg Big toe or the root of the big toe CAUTION SpO2 sensors for the LX 7230KM cannot be used with the LX 7230N...

Page 103: ...des SpO2 Sensor Off LCD Built in Waterproof IPX8 Power Supply DC Two 1 5 V AA size LR06 size alkaline batteries Continuous Operating Time LX 7230N Approximately 2 5 days LX 7230KM Approximately 5 days Continuous operating time is assumed when using new AA size LR06 size Alkaline batteries specified by Fukuda Denshi ECG Numbers of Lead Electrode 3 electrode 4 electrode or 5 electrode Limb Chest Num...

Page 104: ...0Ω Display Coverage of Respiration Rate 0 9 to 150Bpm Display Error of Respiration Rate 3Bpm Measured Current of Respiration Below 100μA at 42kHz SpO2 LX 7230N SpO2 Measurement Range 1 to 100 Resolution 1 Measurement Accuracy Accuracy of measurement with SpO2 Probe is as follows SpO2 Probe Measurement Accuracy 1SD OxiMax MAX I 2 OxiMax MAX P 2 OxiMax MAX A AL 2 Durasensor DS 100A 3 OxiMax MAX R 3 ...

Page 105: ...he SpO2 measurement accuracy is determined based on the values of the root mean square rms difference between SpO2 readings of the pulse oximeter equipment and values of SaO2 determined with a CO oximeter by healthy adult volunteers The pulse oximeter equipment measurements are statistically distributed 2 measurement accuracy means that only about two thirds of pulse oximeter equipment measurement...

Page 106: ...General requirements for safety EMC Standard IEC 60601 1 2 2007 Medical electrical equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests The class of protection against electric shock Internally Powered Equipment The type of protection against electric shock Type CF Applied part Operating Environment Temperature 10 to 40 C Humid...

Page 107: ...ECG respiration waveform cannot be measured normally For details about electrode check message refer to page 89 SpO2 measurement Status Probe Displays when the SpO2 probe is disconnected from the device Sensor Displays when the SpO2 probe is off from the measuring position or SpO2 cannot be measured normally due to outside light etc PR UNDER PR 30 Displays when the pulse rate is less than 30bpm th...

Page 108: ...cription Error Message SpO2 Error Displays when the SpO2 measurement module is faulty Telemeter Error Displays when the transmitter is faulty EEPROM Error Displays when the EERPROM is faulty CPU Error Displays when the CPU is faulty ...

Page 109: ...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 ...

Page 110: ...1 2 1 Yes SpO2 Measurement mode LX 7230KM only Continuous Intermittent Continuous 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 fol...

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Page 112: ...39 4 Hongo 3 chome Bunkyo ku Tokyo Japan Phone 81 3 3815 2121 Fax 81 3 3814 1222 Printed in Japan 4L0105700 20100805 01 ...

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