L-8000 series ECG, Respiration and Sp Oz Transmitter LX-8300M Ver. 02 Operation Manual * Before using the product, please read this manual thoroughly. # Store this manual where it can be always referred to.
This manual is for the LX-8300M, Version 02. Federal Law restricts this device fo sale by A CAUTION or on the order of a physician. CAUTION @ Only physician or persons instructed by physicians are allowed to use the equipment. @ The information contained in this document is subject to change without notice due to improvement in the equipment. © 2019 Fukuoka Dens hi Co., Ltd. No part of this document may be reproduced or transmitted in any form without the prior written permission of Fukuoka Dens hi Co, Ltd.
Le Thank you for purchasing our product. Before using this product, read this operation manual thoroughly for correct handling and operation. in this manual, the operation procedure of is explained using the illustration and screen of the LX-8300M as examples. Safety Precautions The safety precautions shown in this manual contain important details on the safe use of this product, and must be keyed. Symbols and their meanings are shown below.
Le 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 Spoor and transmitting the measured data by wireless network to the central monitor continuously. This equipment is intended fo be used by healthcare professionals.
Graphic Symbols Le The following symbols are used for this equipment. Symbols indicated on the main unit Symbol Description Naming (indicated in yellow) Follow operating instructions (Whamming: (indicated in blue} indicates that the failure to follow operating instructions could place the patient or operator at risk. lone; Indicates the need to refer to the related accompanying documents before operation.
Le 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 Sp: sensors approaching. The following icons are displayed only on the all data display. indicates that prob is disconnected or damaged. Indicates that sensor check, efc. is required. indicates that the amplitude of the pulse waveform is too low, or the sensor is not positioned correctly.
at 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, verily following items. » Return all operating switches, knobs ete to the position before using the equipment, and then switch off the power. = When unplugging the cables, make sure fo pull from the connector part of the cabs 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.
Le Precautions about Magnetic Resonance Imaging (MRI) WARNING ® Do not use this equipment in magnetic resonance imaging (MR) 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 fo the patient. For details, refer to the operation manual for the MRI testing device.
Le Precautions about Using with the Defibrillator bill 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 defibrillation, keep away from the electrodes or medicament applied fo the patient chest. If this is not possible, remove the electrodes or medicament before defibrillation.
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 io high impact, the damage to the enclosure or lid may degrade the waterproof performance. In such case, contact your local service representative fo check the waterproof performance.
Precautions about Sp0; Monitoring WARNING @ For Sp Oz monitoring, use only the specified probe. Check the prob 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. @ (f 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 io the operation manual of the 3p0z sensor. ® Measuring on a limb with NIB cuff, arterial catheter, or catheterize 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 ("LRE" 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 xiv WARNING @ The 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 fo use the Fukuoka Dens hi products with the receiving range of 608 MHz614 MHz. ® For the receiving monitor of the transmitter, make sure to use the Fukuoka Dens hi products with the receiving range of 1385 MHz1400 MHz and 1427 MHz-1432 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 scaled from people who understand the characteristics and functionality of telemetry systems, and are skilled in operating telemetry. = When installing telemetry, the Coordinator has fo 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. e Mobile Phone The radii wave may cause malfunction fo the equipment.
EMC Guidance This equipment complies with [EC 80801-1-2 (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.
e Compliance to the Electromagnetic Immunity The is intended for use in the electromagnetic environment specified below. The customer or the user of the should assure that it is used in such an environment. Basic EMC standard or Immunity test levels Electrostatic discharge +8 kV contact IEC 81000-4-2 +158 kV air Radiated RF EM fields 3 Vim IEC 61000-4-3 80 MHz to 2.7 GHz kHz 80%AM Proximity fields from RF wireless communications Refer to the following table.
Contact if you need more information, please contact the following. {1} Fukuoka Dens hi Co, Lid, Head Office 3-39-4 Hong, Bunk yo-ku, Tokyo, Japan Tel: +81-3-5684-1455 Fax: +81-3-3814-1222 E-mail: information co jp Home Page: fukuda.com {2} Sales Representative Write the name, address, phone, fax number of your local sales representative.
Le Safety Precautions Precaution from Fukuoka Dens hi Intended Use of this Equipment Graphic Symbols Precautions for Safe Operation of Medical Electrical Equipment... v Non-Explosion Proof... i Precautions about Magnetic Resonance Imaging {MRI}. Neurosurgery Precautions about Using with the Defibrillator Precautions about the Pacemaker Precautions for Using This Equipment. Precautions about Waterproof Precautions about ECG Monitoring... Precautions about SpO: Monitoring.
Le 1. General Description The is a radio telemetry transmitter designed to measure the ECG, respiration waveform, Spot: (functional oxygen saturation of arterial hemoglobin}, pulse waveform with two "AA" size ("LRE" size) alkaline batteries. information such as ECG measurements, respiration waveform, Sp Oz measurements, pulse waveform, battery level, and the conditions of the ECG electrodes and Sp: probe (sensor) are displayed on the front panel.
2. Names of Parts and Their Functions ECG/RESP Input Connector Connects the ECG lead cable fo measure ECG and respiration waveform Refer to “Safety Precautions” in the preface of this manual. 8pG: Input Connector Refer to “Safety Connects the spoor; probe (sensor). Precautions” in the preface of this manual. Electrode Position Label indicates standard ECG electrode position.
[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 uptown. : TT — Battery Lid Lock Bunion Unlocks the battery compartment lid. Si rap Hole Attaches the strap.
Le 3. Preparation 1} installing the Batteries The functions with two “AA” size (“LRE" size) alkaline batteries. The battery operation time of is as follows. LX-8300M @ When Spot measurement is ON: Approximately 2.5 days (new batteries} Conditions: When measuring ECG, RESP, 8p0: with default settings, operating temperature 23°C 8 When Spot measurement is OFF: Approximately 8.
batteries may occur. ® Remove the exhausted batteries immediately. The Leakage from the batteries may damage the equipment, or an explosion from the batteries may scour. @ If the equipment is not in use for a long period of time, remove the batteries and store the equipment in an appropriate place. if the batteries are left in the equipment for a long period of time, the leakage from the batteries may damage the equipment or an explosion from the batteries may occur.
i 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.
Make sure that the battery compartment lid is locked. (If you can still see red, then iris 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.
i . Preparation Le Starting Screen When the power is fumed ON, the channel number configured on the is displayed at the lop of the display. CHIDE Make sure that the channel number on the display matches the channel number indicated er or on the label of the and LE-8300 the channel number configured on the receiving xe btm. monitor. Post Channel Display Screen CHT1I00 This display is automatically displayed after the starting screen and moves on to the waveform display screen.
sig Lad 3. Preps Turing the power switch to “OFF” Bolas oe Press the power switch for two seconds, then display screen displays as the left illustration to confirm. Choose “Yes” and Boise GEES press the [ENTER] button.
4. ECG Monitoring When the transmitter is used without the SpO: probe (sensor), it will measure only ECG and respiration. CAUTION When using the transmitter with only the ECG lead cable, Sp: measurements on the receiving monitor shall be turned off to prevent an erroneous alarm. s Connecting the ECG Lead Cable and Electrodes WARNING Use only the specified lead cable by Fukuoka Dens hi.
sig Lad 4. ECG Mon ii ring Two leads such as lead | and il can be measured. Lead lil, aVR, aVL, and aVF can be also displayed from the sifting on the receiving monitor. For details, refer to the operation manual of the receiving monitor For 5-electrode (chest) lead cable White Black {RAY Ani LA} By 2 Green & ed {RL} LL) Limb Lead +Chest One limb lead and one chest lead (brown) measurements are available. Standard Limb leads can be selected from lead 1, lead Ii, or lead Hl. Refer to "8. Operation”.
u Connecting the ECG Lead Cable to the insert the ECG lead cable firmly into the ECG/RESP input connector matching the transmitter's connector guide and the direction of the noised part on the connector.
14 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 defected depending on the pacemaker type, pulse voltage, pulse width, electrode lead type (uni polar, 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 fo detect the respiration. For 3-electrode and B-electrode (chest) lead cable, the electrodes fo detect the respiration are fixed as follows. Even if lead method is switched, they are no changes.