Thank you for purchasing our product. Before using this product, read this operation manual thoroughly for correct handling and operation. Safety Precautions The safety precautions shown in this manual contain important details on the safe use of this product, and must be obeyed. Symbols and their meanings are shown below. Make sure to understand the following before reading the rest of the manual.
Intended Use of this Equipment This equipment is designed for the following . This equipment is intended for patient monitoring in surgery room, ICU, ward, emergency room in the medical facility by measuring ECG, respiration and SpO2 and transmitting the measured data by wireless network to the central monitor continuously. This equipment is intended to be used by healthcare professionals.
Graphic Symbols The following symbols are used for this equipment. Symbols indicated on the main unit Symbol Description Warning (indicated in yellow) Follow operating instructions (Warning); (indicated in blue) Indicates that the failure to follow operating instructions could place the patient or operator at risk. Follow operating instructions (Information); Indicates the need to refer to the related accompanying documents before operation.
Symbols displayed on the screen Symbol Description HR Synchronized Mark This mark flashes synchronizing to the heartbeat. Indicates the remaining battery level. Indicates that the expiration 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.
Precautions for Safe Operation of Medical Electrical Equipment This section contains general information on how to handle this equipment safely for the patient and users. The precautions specific to this equipment are described afterwards. CAUTION 1. User should have a thorough knowledge of the operation before using the equipment. 2. For installation and storage of the equipment, pay attention to the following. Install or store in a place where the equipment will not be exposed to splashing water.
CAUTION 5. After using the equipment, verify following items. Return all operating switches, knobs etc to the position before using the equipment, and then switch off the power. When unplugging the cables, make sure to pull from the connector part of the cable to avoid excessive force on the cable. Clean the accessories and cables, and keep them together in one place. Keep the equipment clean to ensure proper operation for the next use.
Precautions about Magnetic Resonance Imaging (MRI) WARNING Do not use this equipment in magnetic resonance imaging (MRI) environments. When conducting MRI test, remove the electrodes and sensors connected to the patient. The local heating caused by the induced electromotive force may cause burn injury to the patient. For details, refer to the operation manual for the MRI testing device.
Precautions about Using with the Defibrillator WARNING When using this equipment with a defibrillator, use only the specified lead cable. If unspecified lead cable is used, it may damage the equipment and safety cannot be ensured. When defibrillating, keep away from the electrodes or medicament applied to the patient chest. If this is not possible, remove the electrodes or medicament before defibrillating.
Precautions about the Pacemaker WARNING Minute ventilation rate-adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic equipment, causing the pacemakers to pace at their maximum programmed rate. The cardiac monitoring and diagnostic equipment may possibly send wrong information. If such event occurs, disconnect the cardiac monitoring and diagnostic equipment, or follow the procedures described in the operation manual of the pacemaker.
Precautions about Waterproof CAUTION To maintain the waterproof performance, replace the battery compartment lid periodically. Otherwise, the quality of the lid will deteriorate and cannot keep the waterproof performance. For periodic replacement, contact your local service representative. When the equipment is subjected to high impact, the damage to the enclosure or lid may degrade the waterproof performance. In such case, contact your local service representative to check the waterproof performance.
Precautions about SpO2 Monitoring WARNING For SpO2 monitoring, use only the specified probe. Check the probe before usage to make sure that it is the specified probe. If unspecified probe is used, not only that the equipment cannot deliver its maximum performance, the equipment may be damaged and safety cannot be ensured. If the nail is rough, dirty, or manicured, accurate measurement will not be possible. Change the finger or clean the nail before attaching the sensor.
WARNING cross contamination. It is intended for single patient use only. For details, refer to the operation manual of the SpO2 sensor. Measuring on a limb with NIBP cuff, arterial catheter, or intracatheter may result in incorrect measurement. Venous congestion may cause under reading of actual oxygen saturation. Therefore, assure proper venous outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the floor).
CAUTION Do not reuse disposable products. Store the disposable products properly as mentioned in their user manuals. Precautions about the Alkaline Batteries WARNING Use new "AA" size (“LR06” size) alkaline batteries which is within the expiration date. Install the batteries with the correct polarity. Do not charge the batteries. Any attempt to charge the batteries may cause them to leak or break. Do not short the (+) and (-) terminals. It may result in exothermic heat and fire.
Precautions for Use of Medical Telemeter WARNING The LX-8300M transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. For the receiving monitor of the LX-8300M transmitter, make sure to use the Fukuda Denshi products with the receiving range of 608 MHz614 MHz.
CAUTION For management, make sure to follow the precautions below. The Institution should appoint a person (hereinafter referred to as the "Coordinator") to manage the wireless channels for the whole Institution. The Coordinator must be selected from people who understand the characteristics and functionality of telemetry systems, and are skilled in operating telemetry. When installing telemetry, the Coordinator has to understand the precautions for use of the telemetry in advance.
Precautions for Safe Operation under Electromagnetic Influence CAUTION If any sorts of electromagnetic wave, magnetic field, or static electricity exist around the equipment, noise interference or malfunction of the equipment may occur. If any unintended malfunction or noise occurs during monitoring, check the magnetic influence and take appropriate countermeasures. The followings are examples of the common cause and countermeasures. ●Mobile Phone The radio wave may cause malfunction to the equipment.
EMC Guidance This equipment complies with IEC 60601-1-2 (2014). However, if portable transmitter or wireless LAN equipment is used extremely nearby, the electromagnetic influence may largely exceed the compliance level and may cause unexpected phenomenon such as noise interference on the waveform, etc. Therefore, this equipment should be used in a location specified by each medical institution.
●Compliance to the Electromagnetic Immunity The LX-8300M is intended for use in the electromagnetic environment specified below. The customer or the user of the LX-8300M should assure that it is used in such an environment.
Contact If you need more information, please contact the following. (1) Fukuda Denshi Co., 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.
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Contents Safety Precautions .................................................................................... i Precaution from Fukuda Denshi....................................................... i Intended Use of this Equipment .......................................................ii Graphic Symbols............................................................................. iii Precautions for Safe Operation of Medical Electrical Equipment .... v Non-Explosion Proof ..................................
■Setup Mode ................................................................................ 39 ■ECG Setup.................................................................................. 39 ■Respiration Setup ....................................................................... 41 ■SpO2 Setup ................................................................................. 41 ■Restarting the Display ................................................................. 43 ■Pressing the [EVENT] Button........
1. General Description The LX-8300M is a radio telemetry transmitter designed to measure the ECG, respiration waveform, SpO2 (functional oxygen saturation of arterial hemoglobin), pulse waveform with two “AA” size (“LR06” size) alkaline batteries. Information such as ECG measurements, respiration waveform, SpO2 measurements, pulse waveform, battery level, and the conditions of the ECG electrodes and SpO2 probe (sensor) are displayed on the front panel.
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2. Names of Parts and Their Functions ECG/RESP Input Connector Connects the ECG lead cable to measure ECG and respiration waveform Refer to “Safety Precautions” in the preface of this manual. Refer to “Safety Precautions” in the preface of this manual. SpO2 Input Connector Connects the SpO2 probe (sensor). Electrode Position Label Indicates standard ECG electrode position.
2. Names of Parts and Their Functions [EVENT] Button Transmits EVENT Information Refer to “Safety Precautions” in the preface of this manual. Battery Compartment Lid Open/Close Lever To open/close the battery compartment lid, slide this lever up/down. Battery Lid Lock Button Unlocks the battery compartment lid. Strap Hole Attaches the strap.
3. Preparation 1) Installing the Batteries The LX-8300M functions with two “AA” size (“LR6” size) alkaline batteries. The battery operation time of LX-8300M is as follows. When SpO2 measurement is ON: Approximately 2.5 days (new batteries) Conditions: When measuring ECG, RESP, SpO2 with default settings, operating temperature 23C When SpO2 measurement is OFF: Approximately 6.
3. Preparation CAUTION Use only alkaline battery (AA). Other battery will shorten the continuous operating time. Once the power switch is on the OFF position, then open the battery compartment lid. Do not replace the batteries with wet hands. In case of storing the used 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.
3. Preparation Make sure that the battery compartment lid is locked. (If you can still see red, then it is not locked properly.) 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. Do not keep the compartment lid unlocked as the batteries may unexpectedly get out from the compartment.
3. Preparation Starting Screen When the power is turned ON, the channel number configured on the LX-8300M is displayed at the top of the display. Make sure that the channel number on the display matches the channel number indicated on the label of the LX-8300M and the channel number configured on the receiving monitor. Channel Display Screen This display is automatically displayed after the starting screen and moves on to the waveform display screen.
3. Preparation 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.
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4. ECG Monitoring When the transmitter is used without the SpO2 probe (sensor), it will measure only ECG and respiration. CAUTION When using the transmitter with only the ECG lead cable, SpO2 measurements on the receiving monitor shall be turned off to prevent an erroneous alarm. ■Connecting the ECG Lead Cable and Electrodes WARNING Use only the specified lead cable by Fukuda Denshi.
4. ECG Monitoring Two leads such as lead I and II can be measured. Lead III, aVR, aVL, and aVF can be also displayed from the setting on the receiving monitor. For details, refer to the operation manual of the receiving monitor For 5-electrode (chest) lead cable Black (LA) White (RA) Brown (V) Green (RL) Red (LL) Limb Lead +Chest One limb lead and one chest lead (brown) measurements are available. Standard Limb leads can be selected from lead I, lead II, or lead III. Refer to “8. Operation”.
4. ECG Monitoring ■Connecting 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.
4. ECG Monitoring CAUTION The threshold level for HR detection of this equipment and the receiving monitor changes with ECG waveform size. Set a proper waveform size for monitoring. There are some cases when pacemaker pulse cannot 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.
5. Respiration Monitoring Follow the procedure explained in “4. ECG Monitoring” to perform the respiration monitoring. This respiration monitoring is performed with impedance method. The ECG electrodes are also used for detecting the respiration. Each lead cable specifies the electrodes to detect the respiration. For 3-electrode and 5-electrode (chest) lead cable, the electrodes to detect the respiration are fixed as follows. Even if lead method is switched, they are no changes.
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6. SpO2 Monitoring When the transmitter is used without the ECG lead cable, it will measure only SpO2. WARNING When the SpO2 probe (sensor) is in a connector-off condition, the SpO2 alarm will not be generated on the receiving monitor regardless of the SpO2 measurement ON/OFF status. Make sure that the SpO2 probe (sensor) is securely connected. If the SpO2 waveform/numeric data is not displayed, check the patient’s condition and pay attention not to miss the connector-off condition.
6. SpO2 Monitoring WARNING Do not use this equipment if it appears or is suspected to be damaged. Explosion hazard: Do not use this equipment in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. To ensure safety, avoid stacking multiple devices or placing anything on the instrument during operation.
6. SpO2 Monitoring WARNING This equipment may be used during electrocautery, but this may affect the accuracy or availability of the SpO2 parameters and measurements. The SpO2 data cannot be used for arrhythmia analysis. SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). Do not adjust, repair, open, disassemble, or modify this equipment or accessories. Injury to personnel or equipment damage could occur.
6. SpO2 Monitoring CAUTION status should be repeated and/or supplemented with additional test data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. Do not submerge this equipment in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage this equipment.
6. SpO2 Monitoring NOTE Precautions about the Masimo Sensors A technology called X-Cal for patient safety and reinforcement of efficiency in a clinical site is implemented for Masimo sensors. X-Cal is designed to address the following three common factors that can impact measurement accuracy and patient safety due to reliability risks.
6. SpO2 Monitoring ●Applying the LNCS DCI, RD SET DCI 1. Open the sensor by pressing on hinge tabs. Place the selected digit over the sensor window of the LNCS DCI or DCIP. The fleshiest part of the digit should be covering the detector window in the lower half of the sensor. The top half of the sensor is identified by the cable. On finger sites, the tip of the finger should touch the raised digit stop inside the sensor. If the fingernail is long, it may extend over and pass the finger stop (Fig. 1). 2.
6. SpO2 Monitoring CAUTION 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. The sensor should be free of visible defects. Never use a damaged sensor or one with exposed electrical circuitry. To prevent damage, do not soak or immerse sensor in any liquid solution. Do not attempt to sterilize the sensor.
6. SpO2 Monitoring ●Applying the LNCS TCI 1. To improve perfusion to the ear, rub the earlobe vigorously for 25-30 seconds. The ear lobe can also be rubbed with rubefacient cream (1030% methylsalicylate and 2-10% menthol). 2. Clip the sensor onto the ear lobe (Fig. 1) or pinna. Orient the cable so that it runs down the neck toward the body. If the LNCS TC-I sensor does not fit properly on the ear, consider using an LNCS adhesive sensor or LNCS reusable finger clip on another measuring site.
6. SpO2 Monitoring CAUTION If the sensor is damaged in any way, discontinue use immediately. Carefully route cable and patient cable to reduce the possibility of patient entanglement or strangulation. Intravascular dyes may lead to inaccurate SpO2 measurements. Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements. Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2 measurements.
6. SpO2 Monitoring ●Applying the LNCS inf-L, LNCS inf-3, RD SET Inf 1. Open the pouch and remove the sensor. Remove the backing from the sensor, if present. 2. Direct the sensor cable so that it either points away from the patient or runs along the bottom of the foot. Position the detector onto the fleshy part of the great toe (Fig 1). Complete coverage of the detector window is needed to ensure accurate data. 3.
6. SpO2 Monitoring 1 2 3 4 Precautions for Using the LNCS Adtx, LNCS Pdtx, RD SET Adt, RD SET Pdt, LNCS inf-L, LNCS inf-3, RD SET Inf, LNCS Neo-L, LNCS NeoPt-L, LNCS NeoPt3, RD SET Neo, RD SET NeoPt CAUTION The site must be checked frequently or per clinical protocol to ensure adequate adhesion, circulation, skin integrity and correct optical alignment. Circulation distal to the sensor site should be checked routinely.
6. SpO2 Monitoring CAUTION Intravascular dyes or externally applied coloring (such as nail polish) may lead to inaccurate SpO2 measurements. Sensors applied too tightly or that become tight due to edema will cause inaccurate readings and can cause pressure necrosis. Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored site. Sensor should not be below heart level (e.g.
6. SpO2 Monitoring ■Connecting the SpO2 sensor to the LX-8300M 1. Insert the SpO2 sensor into the SpO2 input connector on the LX-8300M. SpO2 Sensor 2. Attach the sensor lock as shown in the following illustration to prevent the SpO2 sensor to be disconnected.
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7. Measurement Turn ON the power and the measurement starts. ■Monitoring Screen ECG waveform (1 channel when using 3-electrode lead cable, 2 channels when using other lead cable), heart rate, pacemaker marker, respiration waveform, respiration rate, pulse wave, SpO2 measurement value, remaining battery level, and various messages are displayed. CAUTION The LX-8300M does not have a diagnostic function. Check the diagnostic function on the receiving monitor. The LX-8300M does not have an alarm function.
7. Measurement ●Switching the Display The screen (e.g. ECG) can be switched to other screens (respiration, pulse, or SpO2, etc.) The screen automatically turns itself OFF after preprogrammed duration if no operation is done. For procedure to restart the display, refer to “8. Operation”. When the display is active, press the [▽ ] button to move onto the next screen. The screen will switch in the following order. Press the [▽ ] button. Press and hold the [ENTER] button for 2 seconds.
7. Measurement ●All Data Display ECG1 waveform and all other measured data (heart rate, respiration rate, pulse rate, SpO2 value) pacemaker marker, remaining battery level, electrode check message, and SpO2 OFF status are displayed. The displayed contents are as follows. 6 1 7 2 3 8 4 9 5 1. Indicates that ECG1 waveform is displayed. 2. Indicates the vertical scale of the displayed ECG. One scale corresponds to 1 mV. For the above display example, the display range is ±1mV. 3.
7. Measurement ●ECG Display ECG1/ECG2 waveform, heart rate, pacemaker mark, remaining battery level, and electrode check message are displayed. NOTE If 3-electrode lead cable is used, ECG2 display will not appear. The descriptions of the displayed contents are as follows. 5 1 2 6 7 3 8 4 9 10 1. Indicates ECG1 or ECG2. 2. Indicates the vertical scale of the displayed ECG waveform. One scale corresponds to 1 mV. 3. Indicates the measuring lead. 4.
7. Measurement CAUTION The displayed ECG waveform size setting does not interact with the one displayed on the receiving monitor. If the ECG waveform size displayed on the receiving monitor is changed, follow the instruction in the operation manual of the 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.
7. Measurement ●Respiration Display Respiration waveform, respiration rate, remaining battery level, and electrode check message are displayed. The descriptions of the displayed contents are as follows. 4 1 5 2 6 3 7 1. Indicates the respiration waveform display screen. 2. Indicates the vertical scale of the displayed respiration waveform. One scale corresponds to 1Ω. For the above display example, it can display between -1Ω and +1Ω. 3. Indicates the respiration waveform size displayed on the display.
7. Measurement ●SpO2 Display Pulse wave, pulse rate, SpO2 measurement value, PI measurement value, remaining battery level, probe condition, and SpO2 OFF status are displayed. The descriptions of the displayed contents are as follows. NOTE The following display example is when the SpO2 measurement is set to ON. When the SpO2 measurement is set to OFF, “SpO2 OFF” is displayed. 8 1 9 2 5 6 3 7 4 SpO2 Standard Display 1 2 5 3 6 4 7 SpO2 Enlarged Display 1. Indicates the SpO2 display. 2.
7. Measurement For details, refer to “8. Operation”. 6. Displays the pulse rate. 7. Indicates the remaining battery level. For details of the battery level, refer to “3. Preparation”. 8. Indicates the horizontal scale of the displayed SpO2 waveform. One scale corresponds to one second. 9. Displays the pulse wave. The waveform size is adjusted automatically. For details of the displayed messages and icons, refer to “11.
8. Operation ■Setup Mode To Enter Setup Mode Press and hold the [ENTER] button for 2 seconds. To Terminate Setup Mode Press the [▽ ] button to highlight , and press the [ENTER] button. CAUTION Make sure to terminate the setup mode after the setting to prevent the settings to be changed by unintended operation. Setup Items The following settings can be perfomred.
8. Operation Changing the ECG Waveform Size Press the [▽ ] button to highlight the size indication. Pressing the [ENTER] button will sequentially change the size in the order of ×1 ×1/2 ×1 When the waveform size is changed, the ECG scale will also change. For the example shown on left, the scale between -2mV and +2mV can be selected. CAUTION The ECG waveform size displayed on the LX-8300M does not interact with the one displayed on the receiving monitor.
8. Operation ■Respiration Setup In the respiration display, the respiration waveform size can be changed. Changing Respiration Waveform Size Press the [▽ ] button to highlight the size indication. Press the [ENTER] button to sequentially change the waveform size in the order of ×1 ×1/2 ×1. When the waveform size is changed, the respiration scale will also change. In the example shown on left, up to 4Ω change can be displayed.
8. Operation Press and hold the [ENTER] and [▽ ] button for 2 seconds to display the speaker mark. Press and hold the [ENTER] and [▽ ] button again for 2 seconds to clear the speaker mark and synchronized tone. This setting will be applied to ECG1, ECG2, and SpO2 display. The synchronized tone changes with the SpO2 value. The tone is highest when the SpO2 value is 100%, and decreases in 1% step until 80% which is the lowest tone.
8. Operation The SpO2 measurement will resume. 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. Connecting the SpO2 probe while the display is ON will also resume the SpO2 measurement. ■Restarting the Display The display automatically turns itself OFF after the preprogrammed duration if no operation is performed.
8. Operation ■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 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.
9. Other Setting Items The following settings are available for the LX-8300M depending on the usage and condition of the patient. For details of the settings, contact your local Fukuda Denshi service representative. Items Time Constant Detection Sensitivity of Pacemaker Pulse (Pace Sens.
9. Other Setting Items ■Time Constant The default setting of the time constant is “0.4 second”. 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, contact your local Fukuda Denshi service representative.
9. Other Setting Items 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 detection cannot be turned OFF, replace the electrodes or change the lead to remove the interference noise, such as AC frequency.
9. Other Setting Items ■Respiration Detection Signal ON/OFF The default setting of the respiration detection signal is “ON”. The respiration waveform can be detected when the setting of the respiration detection signal is turned “ON”. WARNING If the LX-8300M is used with minute ventilation rate-adaptive implantable pacemaker, the respiration detection signal may cause the pacemaker to pace at its maximum programmed rate.
9. Other Setting Items ■Sound ON/OFF When the sound setting is “ON”, alarm will generate in the following situation. ・ ECG Lead Off ・ SpO2 probe Off The default setting is “ON”. Alarm will not generate with Display OFF status. For details of the setting, contact your local Fukuda Denshi service representative. ■Displayed Color of SpO2 The displayed color for SpO2 related parameters can be selected from yellow or blue. The default setting is “Yellow”.
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10. Changing the Transmitter Channel and Group ID ■Transmitter Channel The LX-8300M is a transmitter of PLL synthesizer type, and its transmitter channel can be programmed. It can be set up with an arbitrary channel among the channels assigned by the Telemetry Laws (according to each country). For details of the setting, contact your local Fukuda Denshi service representative.
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11. Troubleshooting Make sure of the following. However, if there is no improvement in the situation, contact your local Fukuda Denshi service representative. Transmitter Message Cause Faulty SpO2 module. Solution Contact your local Fukuda Denshi service representative. Failed to transmit waveform and value. Faulty EEPROM. Failed to initialize CPU. Faulty Speaker.
11. Troubleshooting Situation Cause Nothing is displayed on No batteries or wrong the display when the polarity. power switch is turned Battery level is empty. ON. The system restarts. Battery level is empty. Solution Install the batteries correctly. Replace the batteries with new ones. Replace the batteries with new ones. Nothing is displayed on The channel number Set the same channel number the receiving screen. between the transmitter for the transmitter and the and the receiving receiving monitor.
11. Troubleshooting ECG Message/Icon The displayed character string indicates the detached electrode position. For details, refer to “Details of the “Electrode” Message”. Situation ECG waveform contains noise. Cause Solution Electrode is off. Check the electrode condition. Lead cable is off. Check the connection between the lead cable and this equipment. Check the connection between the lead cable and the electrode. Faulty Lead cable. Replace the ECG cable with a new one.
11. Troubleshooting SpO2 Message/Icon Cause Solution The probe is disconnected. Verify that the probe is properly attached. The probe is damaged. Replace 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. 56 Replace the probe. For the expiration date of the sensor, refer to “6.
11. Troubleshooting Message/Icon Cause Solution The amplitude of the pulse Check that the light emitting waveform is too low, or the and receiving parts of the sensor LED are aligned. sensor is not positioned correctly. 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 To turn ON the SpO2 turned OFF.
11. Troubleshooting Situation SpO2 value is unstable. Cause Solution The probe size is improper. Use a probe, which fits properly. The probe is peeling off or Attach the probe properly is affected by the outside following the instruction. light due to the poor condition 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.
11. Troubleshooting ■In Case of Dropping the LX-8300M into Water In case of dropping the LX-8300M into water containing disinfectant, pick up the LX-8300M as soon as possible. In case of dropping the equipment into dirty water, clean it without disconnecting the ECG lead cable and SpO2 probe (sensor), and 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 Do not use a dryer.
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12. Cleaning and Disinfection The cleaning and disinfection of the LX-8300M, ECG lead cable, and SpO2 probe (sensor) shall be performed as follows. CAUTION Do not sterilize the LX-8300M, ECG lead cable, and SpO2 probe (sensor) in any manners, such as radioactive rays, steam, or ethylene oxide. ■Cleaning the Housing 1. Clean the equipment using squeezed gauze or an absorbent cotton cloth dampened with alcohol or a neutral cleanser.
12. Cleaning and Disinfection ■Cleaning the Connector Do not wipe the ECG connector and SpO2 connector with a swab, gauze, or absorbent cotton. Use an air duster to clean the dust and dirt in the connector. CAUTION If a swab, gauze, or cotton is used to clean the connector, dust or cotton fibers may enter the connector causing inadequate contact. Also, chemical solution may enter the connector causing inadequate contact.
13. Maintenance and Inspection This section explains the daily checks and periodic checks of the LX-8300M. To ensure safety, reliability, and high performance, a “Daily Check” and “Periodic Check” must be performed. We are not liable for any accident arising from lack of maintenance. A full technical description of the LX-8300M is available from your local Fukuda Denshi representative. CAUTION Do not open the housing.
13. Maintenance and Inspection Daily Check List No. Inspected Date Inspected by Location Device Type S/No. Date of Purchase Items Criteria Judgment Visually check for any damage, cracks, chip, peeled label, and loosen screw on the housing. No abnormality should be found. □OK/ □NG Visually check for the ring condition of the battery compartment lid. No damage, kink, floating, and adhesion of dust should be found.
13. Maintenance and Inspection ■Periodic Check The periodic maintenance check is intended to check the medical equipment used daily in a medical institution to prevent failures and accidents and to ensure safety and reliability. The check procedures are described for daily and periodic checks. Each check item must be performed according to the described check procedure. The consignee can select the check items according to the product quality, frequency of usage, and maintenance check period.
13. Maintenance and Inspection No Check Item 3. Display, Operation 01 Labels 02 03 Operation, Switches and keys Display No Check Item 4. ECG 01 Input Impedance* 02 03 Suppression Characteristic of Common-Mode Signal* Transient Characteristic* 04 Frequency Characteristic* 05 Heart Rhythm Detection* 66 Check Procedure Criteria Visually check the labels, caution labels, etc. Check by operating the switches and keys. Should be clean, clear and firmly attached. Should operate properly.
13. Maintenance and Inspection No 06 Check Item ECG Sensitivity 07 Heart Rate Accuracy* 08 ECG Lead Switch 09 10 Check Procedure With comprehensive tester, apply 1mV voltage and measure the displayed amplitude. According to test procedure of IEC 60601-2-27: 2011 201.12.1.101.1 With ECG simulator, test heartbeat 60, 180 beats/min., and check the displayed HR value. According to test procedure of IEC 60601-2-27: 2011 201.12.101.15 With ECG simulator, check that each lead is displayed properly.
13. Maintenance and Inspection * 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 6. Arterial Oxygen Saturation (SpO2) 01 SpO2 Accuracy Measure the error at 75%, 90% using a SpO2 simulator. 02 03 Pulse Rate Accuracy SpO2 Probe-Off Detection No Check Item 7. Speaker 01 Generation No Check Item 8.
13. Maintenance and Inspection No 03 04 05 06 Check Item Leakage current when external voltage is applied to the patient connection in the Type F attaching part (SFC) Total patient leakage current that runs through the ground from the total patient connecting part.
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13. Maintenance and Inspection ■Repairing the Equipment This equipment is basically repaired at Fukuda Denshi factory. If detailed information about the repair is needed, contact Fukuda Denshi. On-site repair is possible for the following parts. ・Replacing the battery compartment lid CAUTION Make sure to replace the parts correctly. Otherwise, it may cause damage and heat generation of the equipment.
13. Maintenance and Inspection ●Tools ・Phillips screwdriver (#0) ●Assembly and Disassembly Follow the procedure below to remove the battery compartment lid unit. 1. Remove the label. Label 2. Remove the 2 installation screws, then remove the battery compartment lid unit.
13. Maintenance and Inspection Follow the procedure below to attach the battery compartment lid unit. 1. Set the battery compartment lid unit adjusting to the front case. 2. Secure the battery compartment lid unit with new 2 installation screws. Make sure that the screws are securely tightened. Installation screw 3. Make sure that the battery compartment lid unit opens/closes smoothly.
13. Maintenance and Inspection 4. Attach the label firmly aligning with the groove of the battery compartment lid unit.
14. Standard and Optional Accessories WARNING Use only the accessories specified by Fukuda Denshi for the LX-8300M. Otherwise, the LX-8300M 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 Item 4-electrode ECG lead cable Model Type Q’ty CMT-02CTH-0.
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14. Accessories and Optional Accessories When using 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.
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15. Specification ■Specification CAUTION For quality improvement, specifications are subject to change without prior notice. General Size: 72.0(W) mm x 27.0(D) mm x 102.0(H) mm (not including the protrusion) Weight: Approximately 190 g (with batteries) Transmitting Waveform: ECG 1CH or 2CH (selectable from the ECG lead cable), Respiration waveform, pulse waveform (with SpO2 value) ECG Lead Cable Type: 3-electrode, 4-electrode, or 5-electrode (Limb+Chest) lead cable.
15. Specification ECG Numbers of Lead 3-electrode, 4-electrode, or 5-electrode Electrode: (Limb+Chest) lead cable Numbers of Input Channel: 1CH (3-electrode) or 2CH Accuracy of Sensitivity: Complies with IEC 60601-2-27: 2011 and 201.12.1.101.1 (±20% or 100uV, whichever is greater.) ECG Input Impedance: Complies with IEC 60601-2-27: 2011 and 201.12.1.101.3 (2.5MΩ and above) Input Dynamic Range and Complies with IEC 60601-2-27: 2011 and Offset Voltage: 201.12.1.101.
15. Specification Heart rate 80 bpm Ventricular Bigeminy: 80 bpm meter accuracy and response to irregular 60 bpm Ventricular Bigeminy: 60 bpm rhythm: 120 bpm Ventricular Bigeminy: 120 bpm 90 bpm Bidirectional Systoles: 90 bpm Respiration (Impedance Method) Accuracy of Sensitivity: Resp. Display Range: Display Error of Respiration Rate: Measured Current of Respiration: 10 mm/1Ω ± 2 mm (When standard Impedance is 480Ω.
15. Specification NOTE The 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 measurements can be expected to fall within ±2% of the value measured by a CO-oximeter.
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