Fukuda Denshi LX-5630 User manual

ECG, Respiration and SpO2
Transmitter
LX-5630
Operation Manual
lBefore using the LX-5630 you must first thoroughly read
this manual.
lRemember to keep this operation manual in an easily
accessible place near the unit for future reference.

•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.
CAUTION
Federal law restricts this device to sale by or on the order of a
physician.
CAUTION
Users are advised to periodically contact the FCC or specified
frequency coordinator and determine if other or your transmitter
frequencies that may cause interference.
CAUTION
The manufacturers, installers and users of Wireless Medical
Telemetry System equipment are cautioned that the operation of this
equipment could result in harmful interference to other nearby
medical devices.
Copyright © 2003 by Fukuda Denshi Co., Ltd.
No part of this document may be copiedortransmittedinanyform without the
prior written permission of Fukuda Denshi Co., Ltd.
Printed in Japan
Important Information

i
TELEMETRYPRECAUTIONS
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
yourentire 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 outside
sources. Interference may prevent the monitoring of patients
connected to this devices. If a problems exists, contact your local
service representative.
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
The manufacturers, installers and users of WMTS equipment are
cautionedthat the operation of this equipment could result in harmful
interference to other nearby medical devices.

ii
Thank you for purchasingthis instrument from Fukuda Denshi.
Before use, read this operation manual thoroughly for correct
handling and operation. If you are familiar with a similar type of
product, it is recommended this operation manual be read and
understood since the LX-5630 has unique operation and handling
methods.
Safety Information and Messages
•Be sure to observe the warning and cautionary messages related to
important safety information. These instructions are described
underthe following message headings. Understand the meaning of
the different types of messages while reading this operation manual.
WARNING Erroneous operation by failure to follow
this message may result in death or
serious injury to the patient, operator, or
create a fire hazard.
CAUTION
Erroneous operation by failure tofollow
this message may result in injury to the
patient oroperator, or may cause
damage to theLX-5630 and/or related
instruments.
NOTE A NOTE is not a warning instruction
but offers information for correct use of
the LX-5630 to avoid erroneous
operation.

iii
Safety Considerations in Using Medical Electrical Equipment
Contents described here are general safety considerations to be
taken forproper operation of medical electrical equipment and for
the safety of both the patient and operator. Safety considerations
specific to the use of the LX-5630 are described on the next page.
WARNING
Strangulation Hazard!
lMake sure all patient cables, leadwires, and tubing are positioned
away from the patient’s head to minimize the risk of accidental
strangulation.
lUnder no circumstances should any pouch be tied solely around a
patient’s neck.
CAUTION
1. Do not use the equipment unless you are familiar with its operation.
2. Observe the following when installing or storing the equipment:
·Select a place where the equipment may not be contaminated with splashing water.
·Consider the atmospheric pressure, temperature and humidity and provide
adequate ventilation. Avoid direct sunlight. The equipment should not be
installed or stored in a location where it may be
adversely affected by air containing
dust, saline or sulfur.
·Avoid inclination, vibration and shock, even during transport to ensure stable
operating conditions.
·Do not install or store the equipment where chemicals are stored or gases are
generated.
3. Precautions before Operation
·The equipment is not designed to be explosion-proof. Do not use the eq
uipment in
the presence of flammable gasses or anesthetics.
·Make sure the equipment is operating safely and normally at all times.
Ensure that all cords and cables are correctly connected.
·Improper use of multiple instruments simultaneously may result in erroneous
information or lead to a hazardous accident.
4. Precautions during Operation
·Do not operate the equipment beyond the time period required for diagnosis,
monitoring or treatment.
·Observe the equipment and patient constantly for any abnormality.
·If the equipment or patient indicates any abnormality, stop the equipment from
operating or take proper measures (e.g. disconnect transducers and electrodes) to
ensure patient safety.
·Instruct the patient not to contact the equipment.

iv
CAUTION
5. Cares after Operation
·Disconnect the cables by holding the connector plugs. Do not apply excessive
force to cords by pulling.
·Keep the equipment clean in preparation for the next use.
6. If the equipment is out of order, ensure patient safety by immediately
turning the equipment off and disconnecting electrodes and/or
transducers from the patient.
Contact your nearest Fukuda Denshi representative and label the
device as "OUT OF ORDER".
7. Do not disassemble or attempt service on the equipment. Contact
your nearest Fukuda Denshi representative for service.
8. Maintenance and Inspection
·Be sure to perform periodic inspection of the equipment and accessories.
·Before operating the equipment which has not been used for a long
period of time,
make sure that the equipment operates normally and safely.
9. When using an electrosurgical unit or defibrillator in conjunction
with this equipment, take care of the following.
·The high-frequency energy produced by electrosurgery equipment may result in
burns to the patient or possible damage to the equipment. Be
sure to observe the
precautionary instructions described in the
operation manual of the electrosurgical
unit.
·Some types of equipment may be damaged by the energy discharged by a
defibrillator. Ensure a thorough understanding of the precautionary
instructions
described in the operation manual of the equipment before using a defibrillator.
·Some types of equipment other than electrosurgical units and defibrillators may
cause accidental hazards to the patient and operator when operated under adverse
conditions. Read the operation manual attached to each individual unit and
understand the precautionary instructions prior to use.

v
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
lMake sure each receiving telemetry channel corresponds to that of
the transmitter worn by the patient.
lInstruct the patient wearing a telemetry transmitter to remain
within the range of the antenna system.
lTo avoid interference from other transmitters in the adjacent area
or hospital, make sure the proper channel identification and group
codes are used.
lRefer system settings to your Fukuda Denshi service
representative.
CAUTION
Do not use in high humidity or in areas of high oxygen concentration.

CONTENTS
1. General Description..............................................................................1
2. Controls and Indicators.......................................................................2
3. Preparation and Operation...............................................................7
[1] Loading a Battery. .........................................................................7
[2] Turn the power switch to "ON"................................................8
[3] Attach the electrodes. ..................................................................9
[4] Connect the lead wire to the electrode...............................11
[5] Connect the lead wire to the transmitter............................11
[6] Attach the SpO2probe.................................................................12
SR-5C (Finger Clip Probe ) Attachment................................13
TG-25 (SP-5C) (Finger Clip Probe) Attachment.................14
TG-26 (UD-5C) Attachment..........................................................15
SD-5C (20) & SD-5C (25) Attachment.......................................16
CE-5C (Earlap Probe) Attachment...........................................18
[7] Connectthe SpO2relay cable (CI-128A) and
SpO2probe to the transmitter................................................20
4. Group Code Setup.................................................................................22
5. Receiver Channel Setup.....................................................................23
6. Cleaning and Disinfection..................................................................24
7. Maintenance and Inspection............................................................25
8. Specifications..........................................................................................27
9. Accessories...............................................................................................29

1
1. General Description
The LX-5630 is a radio telemetry transmitterdesigned for monitoring
the ECG, respiration, SpO2 (arterial oxygen saturation) and pulse
waveform. In the continuous mode, the transmitter will monitor ECG,
respiration, SpO2 and pulse waveform for 3 continuous days with two
"AA" size alkaline battery. In the intermittent mode, the transmitter
measures the SpO2 every 30 seconds, and monitors ECG and respiration
continuously for 5 days. Pulse waveform will not be measured in this
mode.
The LX-5630 is provided with LCD display to show SpO2 measurement,
pulse waveform amplitude, SpO2alarm ON/OFF, battery status, ECG
electrode status, SpO2probe status, and operation mode.
Before using this transmitter, read also the operation manual for the
patient monitor at receiving side before using this transmitter.
WARNING
Operation of this equipment requires the prior coordination with a
frequency coordinator designated by the FCC for the Wireless
Medical Telemetry Service.
EXTERNAL APPEARANCE

2
2. Controls and Indicators
1. SpO2Input connector
3. LCD Display
7. Mode switch
6.
ECG/Resp. Input
Connector
2. SpO2Alarm switch
4. Event Switch
5. Electrode Position Label