lx-5120_operation_manual_rev_g_nov_2002.pdf
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ECG & Respiration Transmitter
LX -5120
Operation Manual
l Before using the LX-5120 you must first thoroughly read this manual.
l Remember to keep this operation manual in an easily accessible place
near the unit for future reference.
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This device bears the CE label in accordance with the provisions of
Medical Device Directive 93/42/EEC and Directive 1999/5/EC.
We，the manufacturer hereby declare that this equipment
model LX-5120 is in compliance with the essential requirements and
other relevant provisions of Directive 1999／5／EC.
Conformity assessment procedure is Annex III.
THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC
MARCET UNDER MDD 93/42/EEC
NAME
: FUKUDA DENSHI UK
ADDRESS : 13 WESTMINISTER COURT, HIPLEY STREET OLD
WORKING, SURREY GU22 9LG, U.K.
Important Information
・ Only a physician or a person under the guidance of a
physician can use this product.
・The information contained in this document is subject to
change without notice due to improvement in the equipment.
Copyright © 2002 by Fukuda Denshi Co., Ltd.
No part of this document may be copied or transmitted in any form without
the prior written permission of Fukuda Denshi Co., Ltd.
Printed in Japan
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TELEMETRY PRECAUTIONS
For proper management of the telemetry installation, consult your Fukuda
Denshi representative concerning the following:
• Plan the installation of your telemetry system taking into account your
entire medical facility needs and plant requirements.
• Be sure the antenna system installed meets the facility and plant
requirements.
WARNING
This radio frequency device is susceptible to interference from
television station and other outside sources. Interference
may prevent the monitoring of patients connected to this
device. If any problem occurs, contact your local service
representative.
NOTE: This device operates in the 400MHz UHF band.
The exact frequency of operation depending on the
designation, has been present for your facility and may
be identified by cross-referencing the channel
designator on the device with the Telemetry ChannelFrequency Table in this manual.
To assure safe and reliable operation, observe the following precautions:
• Be sure that no other devices are using the frequency assigned to this
transmitter.
• This device is susceptible to interference from electrosurgical knives and
other computerized equipment. If problems occur, contact your local
Fukuda Denshi service representative.
• Any obstruction such as reinforced concrete or large metallic surfaces
between the receiver and the transmitter can affect reception. If problems
occur, contact your local Fukuda Denshi service representative.
• When the low battery alarm is present, replace the battery.
CAUTION
Users are advised to periodically contact the FCC and local
TV station to determine television transmission and other
transmitter frequencies that may be used in their geographic
area.
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Thank you for purchasing this instrument from Fukuda Denshi.
Familiarize yourself with the correct operation of this instrument prior to
operation.
PRECAUTIONS FOR SAFE OPERATION AND HAZARD
PREVENTION
Installation and Storage
• Install or store the instrument where it is free from moisture, splashed
water, excessive dust, salt and direct sunlight.
• Avoid excessive vibration and shock during operation or transport.
• Do not store near chemicals, where gases are generated, or in a highly
sulfuric atmosphere.
Precautions before Operation
• Do not operate this instrument in the presence of flammable gases.
• Ensure the instrument is operating normally and safely.
• When using the instrument in conjunction with another instrument, follow
the appropriate instructions for both instruments.
Caution during Operation
Observe the instrument and patient for any abnormality. If abnormal
operation occurs, remove the instrument from use and have it checked by
the biomedical engineering department or contact your nearest Fukuda
Denshi service representative.
Cautions after Operation
• Turn off the power switch when operation is complete.
• Disconnect cables properly by holding the plug and pulling it out gently.
• Clean the instrument prior to storing.
Non-explosion-proof
The instrument is not designed for operation in areas in which there is a risk
of explosion.
Be sure to perform a periodical inspection of the instrument and all
accessories.
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CLEANING AND DISINFECTION
Electrodes and electrode cables
For disinfection, the electrodes and electrode cables should be rubbed with a
swab or cloth moistened with a formaldehyde solution, such as Cidex 5%.
Under no circumstances may the electrode cables be immersed in any
cleaning fluid, nor may they be subjected to heat sterilization with water,
steam, or air, or be subjected to ether sterilization.
Transmitter
The transmitter cabinet may be cleaned and disinfected in the following
manner.
Cleaning:
Rub the unit with a cleaning cloth moistened with water to which an
ordinary household cleaning agent can be added if necessary. But never
use ether or benzene.
Disinfection:
Thoroughly spray the cabinet with a 5% Cidex or a similar product.
Any and all modifications must be performed by an authorized Fukuda
Denshi service representative.
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CAUTION
Some pacemaker pulses are difficult or not possible to detect.
This is dependent on the amplitude and width of the
pacemaker pulse in addition to the type of pacemaker and
lead type used (unipolar, bipolar, etc.).
CAUTION
QRS detection allows for detection of low amplitude ECG.
But if excessive artifact is present on the ECG waveform, the
noise may be detected as QRS in error.
CAUTION
l Make sure each receiving telemetry channel corresponds to
that of the transmitter worn by the patient.
l Instruct the patient wearing a telemetry transmitter to
remain within the range of the antenna system.
l To avoid interference from other transmitters in the
adjacent area or hospital, make sure the proper channel
identification and group codes are used.
l Refer system settings to your Fukuda Denshi service
representative.
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CONTENTS
1. GENERAL DESCRIPTION ･････････････････････････････････ 1
2. CONTROLS AND INDICATORS ･･･････････････････････････ 2
3. PREPARATION & OPERATION ･････････････････････････････ 4
1) Loading a Battery ･････････････････････････････････････ 4
2) Turn the Power Switch to "ON" ･･････････････････････････ 5
3) Attaching Electrodes ･･･････････････････････････････････ 6
4) Connecting Lead Wires ･････････････････････････････････ 9
5) Connecting the Lead Wire Set to the Transmitter ････････････ 9
4. SET THE GROUP CODE ･････････････････････････････ 10
5. SELECT THE CORRESPONDING
RECEIVER CHANNEL ･････････････････････････････････ 11
6. CLEANING AND DISINFECTION ･･････････････････････ 12
7. MAINTENANCE AND INSPECTION ････････････････････ 13
8. SPECIFICATIONS ････････････････････････････････････････ 15
9. ACCESSORIES ･･･････････････････････････････････････････ 16
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1. GENERAL DESCRIPTION
The LX-5120 is a radio telemetry transmitter designed for monitoring the
ECG and Respiration. The transmitter will operate 5 continuous days from
one "AA" size alkaline battery. On the top panel, battery and electrodes
status displays are provided.
The LX-5120 is transmitting a digitized code that includes the transmitting
channel number and group codes to prevent interference by other radio
apparatus. Read the receiver and display unit operation manual before
using this transmitter.
EXTERNAL APPEARANCE
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2. CONTROLS AND INDICATORS
①ECG/Resp. Input Connector
②Poor Electrode Display
③Battery/Event Display
④Hole for Security Strap
⑤Event Switch
⑧Electrode Position Label
⑥Channel Number Label
⑦Battery Cap
⑨Power Switch
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①ECG/Resp. Input Connector
Connect the accessory patient cable.
②Poor Electrode Display
This lamp will light for two minutes when the electrodes are making poor
contact or the patient cables are broken or disconnected.
③Battery/Event Display
When the power switch is turned on, the battery check lamp will light for
about 10 seconds. If the battery is low, the lamp will not light after turning
on the power switch. The battery should be replaced with a new one.
Also, when the Event switch is pressed, this lamp will light.
④Hole for Security Strap
Attach the accessory security strap to prevent the transmitter from dropping.
Adjust the length of the strap to the appropriate length for the patient.
⑤Event Switch
When this switch is pressed, this function will be activated at the receiver.
This can be designated on or off at the receiver.
⑥Channel Number label
The transmitter channel number is printed on this label. Select the receiver
channel to correspond to this channel number.
⑦Battery Cap
This is the battery compartment cap. To close the battery compartment,
align the mark on the cap and arrow mark on the lower part of the
transmitter, then push and turn the cap clockwise to align the dot-marks with
each other.
⑧Electrode Position Label
Typical electrode positions are shown on this label.
⑨Power Switch
This is the power switch. When the switch is turned to the ON position,
the "Batt." lamp will be lit for about 10 seconds.
If the battery is weak or has no power, the "Batt." lamp will not light even
when the switch is turned to the ON position.
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3. PREPARATION & OPERATION
１
□
Loading a Battery
The LX-5120 uses one "AA" size alkaline cell (LR-6) for its power source.
Load a battery taking note of the polarity. To close the battery
compartment, align the mark (yellow) on the cap and the mark (yellow) on
the lower part of the transmitter, then gently push in and turn the cap
clockwise to the mark (white) on the transmitter to align the dot-marks
(white & yellow) with each other.
If the transmitter is not in use for a long period of time, remove the battery
and store in an appropriate place.
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２
□
Turn the Power Switch to "ON"
Turn the power switch, which is located at the bottom of the transmitter, on
the battery cap, to the "ON" position.
The battery life will be approximately 5 days of continuous operation.
CAUTION
Do not use in high humidity or in areas of high oxygen
concentration.
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３ Attaching Electrodes
□
Wipe the skin at the electrode site with alcohol. Then detach the electrode
from the electrode mount and attach it to the electrode site.
Color coding of the electrode positions are shown below.
Adhesive tape should be used to tape the electrode wire to the skin to
prevent the lead wire from moving on the electrode.
With the LX-5120, impedance measurements are used for respiration
monitoring. There is a possibility that a large amplitude ECG signal will
not always provide a large respiration signal. In general, lead CC5, as
illustrated below, will provide the best respiration waveform.
EXAMPLE OF ELECTRODE POSITIONS
For single lead ECG and respiration monitoring, use the CM-85B for AHA
color code or CM-86B for IEC color code patient cable (three electrodes).
AHA color code is applied in U.S.A. and IEC color code is applied in
Europe.
AHA color code electrode position
White
Black
Black
Red
Respiration sensing : White and Red
White
LEAD Ⅱ
Red
LEAD CC5
IEC color code electrode position
Red
Black
Yellow
LEAD Ⅱ
6
Black
White
Red
LEAD MCL1
Respiration sensing : Red and Yellow
Black
Red
Yellow
LEAD CC5
Black
Red
Yellow
LEAD MCL1
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For two lead ECG and respiration monitoring, use the CM-85C for AHA
color code or CM-86C for IEC color code patient cable (four electrodes).
AHA color code electrode position
CH 1
White
Black
CH 2
Green
Red
LEAD Ⅰ and LEAD Ⅱ
CH 1
Yellow
CH 2
Black
Green
LEAD Ⅰ and LEAD Ⅱ
− : White
+ : Red
− : White
LEAD Ⅰ
LEAD Ⅱ
Reference
: Green
Respiration sensing : White and Red
IEC color code electrode position
Red
+ : Black
+ : Yellow
− : Red
+ : Green
− : Red
LEAD Ⅰ
LEAD Ⅱ
Reference
: Black
Respiration sensing : Red and Green
CAUTION
The CM-85 and CM-86 series patient cable are designed for
ECG and Respiration monitoring. Other patient cables will
not measure the respiration signals.
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For dual channel ECG and respiration monitoring, use the CM-85D for
AHA color code or CM-86D for IEC color code patient cable (five
electrodes).
AHA color code electrode position
CH 1
Black
White
Brown
Green
CH 2
Red
LEAD Ⅱ and LEAD MCL 1
CH 1
Yellow
White
Black
CH 2
Green
LEAD Ⅱ and LEAD MCL 1
8
− : White
+ : Brown
− : Black
LEAD Ⅰ
LEAD Ⅱ
Reference
: Green
Respiration sensing : White and Red
IEC color code electrode position
Red
+ : Red
+ : Green
− : Red
+ : White
− : Yellow
LEAD Ⅱ
LEAD MCL
Reference
: Black
Respiration sensing : Red and Green
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４ Connecting the Lead Wires
□
Connect the tip of lead wire to the center of the electrode and gently swing it
right and left as shown below.
５
□
Connecting the Lead Wire Set to the Transmitter
Connect the patient cable firmly to the
ECG/Resp. input connector of the
transmitter.
When disconnecting the patient cable,
do not disconnect the lead wire set by
pulling on the wires. Also, confirm the
direction of the keyed plug to match
the transmitter’s guide key on the
connector.
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4. SET THE GROUP CODE
The LX-5120 transmits a digitized code which includes the transmitting
channel number and group code to prevent interference from other radio
apparatus or a neighboring hospital's transmitter.
There are 64 group codes. Zero ("0") is set for factory adjustment.
The receiver is required to set the group code to match the transmitter's
group code (The receiver group code's factory adjustment is "0").
The receiver is continuously checking the incoming channel number and
group code versus the number and code programmed to the receiver. If the
transmitter's group code is required to be changed, please contact Fukuda
Denshi.
NOTE: The system function to prevent interference will not work
if the receiver does not incorporate this function.
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5. SELECT THE CORRESPONDING
RECEIVER CHANNEL
Select the receiver channel at the patient monitor to correspond to the
telemetry transmitter. The channel number will be displayed on the screen.
If the receiver channel and transmitter channel do not match, the monitor
will display a caution and the unique waveform shown below. This
function will prevent telemetry channel interference from other transmitters
or external sources.
NOTE: This function is effective only if it is incorporated into the
receiver.
Example of the DS-5800N telemetry patient's display when interference is
present.
This unique waveform will also be displayed when a group or channel
number mismatch occurs.
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6. CLEANING AND DISINFECTION
Clean the transmitter and patient cable with gauze or sanitary cotton
dampened with alcohol or inert soap. Be sure not to get cleaning liquid
into the patient lead connector and battery compartment.
Do not use cleaner containing organic solution, thinners, toluene, and
benzene. Do not autoclave or heat the unit and patient cable above 60°C.
When the room is disinfected by spraying, take proper measures so the
chemical solution does not get on the connector or enter into the the
enclosure.
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7. MAINTENANCE AND INSPECTION
Items in this section include routine daily and periodic checks of the
equipment to ensure it is operating properly.
It is recommended that to maintain the safety and reliability of functions and
performance of the unit, the daily and periodical checks given in this section
be followed.
CAUTION
l Do not open the unit or attempt service. Refer service to
Fukuda Denshi.
l Do not allow excessive moisture or cleaning agents into the
connectors or inside the housing.
■Daily Check
Perform daily checks in accordance with the recommended daily check list.
■Periodical Check
Periodical checks of the equipment for safety and performance of medical
equipment is normally required by every institution at least once or twice
per year. Contact Fukuda Denshi for recommended periodic maintenance.
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Daily Check List
No.
Date
Checker
Installation Place
Unit LX-5120
S/No.
Purchase Date
Items
Details of the Check
Criteria
Judgement
Appearance
Visually check for any
damage, cracks, chink, chips
and peeled nameplate on the
outer enclosure.
No abnormality.
□ OK
□ NG
Battery
Compartment
Visually check the battery
connecting spring inside the
device and battery cap.
No spring transformed,
deformed or rusted.
□ OK
□ NG
Power
Turn ON/OFF power to verify
proper switch operation.
With battery in, the
Batt. lamp will be
illuminated for about
10 seconds.
□ OK
□ NG
ECG
Connector
Visually check for plug
connector of main unit and
patient cable.
No scratch and chips.
No dust attached.
□ OK
□ NG
Patient
Cable
Visually check for wire coating No cracks, kinks, or
of patient cable.
damage.
□ OK
□ NG
Wireless
Channel
Visually verify the transmit
channel, and group No.
Follow instructions of the
wireless channel manager for
the receiver.
Must correspond with
wireless channel check
list.
□ OK
□ NG
Function
Turn on the power and make
sure operation is normal.
Waveform is received
without any problem.
□ OK
□ NG
Periodic
Check
Check the dates of previously
performed periodic checks.
Should be within one
month.
□ OK
□ NG
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8. SPECIFICATIONS
Parameters
ECG input impedance
ECG max. input range
ECG freq. response
ECG time constant
Resp. measurement
Resp. max. input range
Resp. meas. electrodes
Resp. freq. response
Defibrillator protection
Status information
Transmission freq.
RF output power
Channel spacing
Occupied band width
Modulation mode
Power source
Battery polarity protection
Battery life
Water immersion degree
Weight
Dimensions
Operating temperature
Operating humidity
Storage temperature
Storage humidity
: 1 or 2 channel ECG and respiration
: More than 50 Meg-ohms
: ±5 mV
: 40 Hz (refer also to the receiver filter)
: 0.8 seconds (1.5 seconds for option)
: Impedance pneumography
: ±5 ohms
: RA & LL, ECG channel 1
: 0.3 to 3 Hz (refer also to the receiver filter)
: By protection circuit in the patient cable
: Electrode fail, Low battery (below 1 volt),
Event switch, Pacemaker detection, Channel
ID, 64 kinds of Group code
: 400 MHz band.
Exact freq. depends on the destination
: 1.0 mW ±2 dB
: 12.5 kHz
: 8.5 kHz
: Digital, Frequency shift keying
: One 1.5 V AA size alkaline battery
: Mechanical reverse polarity protection
: 5 days min.
: IP-66
: Approx. 110 g (including battery)
: 54(W) × 86(H) × 22(D) mm
: 10 to 40 °C
: 30 to 85 % RH (no dew condition)
: -10 to 60 °C
: 10 to 95 % RH
CAUTION: Specifications are subject to change without prior
notice.
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9. ACCESSORIES
■Standard Accessories
・Patient cable
・Pouch
・Security Strap
・Battery
・Instruction manual
: One CM-85B or CM-86B, three electrodes
type or CM-85C or CM-86C, four electrodes
type. The type of cable depends on the
destination.
: Two AB-95, disposable pouch
: One OB-25 belt kit
: One LR-6, 1.5 V alkaline AA battery
: One
Patient cable
CM-85B (AHA color code)
CM-86B (IEC color code)
Pouch AB-95
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Patient cable
CM-85C (AHA color code)
CM-86C (IEC color code)
Security Strap
OA-25
Battery
LR-6
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■Optional Accessories
・CM-85B or CM-86B, Patient cable for single ECG lead and respiration.
・CM-85C or CM-86C, Patient cable for two ECG leadⅠ,Ⅱ and
respiration.
・CM-85D or CM-86D, Patient cable for dual ECG for any two channel
differential ECG and Respiration, five electrode type.
Patient cable
CM-85B(AHA color code)
CM-86B(IEC color code)
Patient cable
CM-85C(AHA color code)
CM-86C(IEC color code)
Patient cable
CM-85D(AHA color code)
CM-86D(IEC color code)
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Head office :
39-4, Hongo 3-chome, Bunkyo-ku, Tokyo, Japan
Phone : -81-3-3815-2121
Fax
: -81-3-3814-1222
4L2492G 200211