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

3
1. SpO2input connector
The accompanied SpO2 relay cable (CI-128A) is connected here.
Different types of SpO2probe can be connected to this SpO2relay cable.
2. SpO2Alarm switch
This is the SpO2 alarm function able/disable switch. When the SpO2
alarm is disable, LCD display (3) will show .
When the SpO2 measurement value drops to 90% or lower with the
alarm ON condition, the alarm sound generates. When the power is
turned ON, the alarm is in ON mode.
3. LCD Display
Displays the SpO2 value,pulse amplitude, SpO2 alarm ON/OFF, battery
status, ECG electrode status, SpO2 probe status, and operation mode.
Pulse amplitude : Up and down by pulse amplitude
Intermittent SpO2mode :
Displayed when alarm is OFF.
Flashes when battery is low.
Flashes when ECG electrode is off.
SpO
2
Value
:
Numeric display
SpO2not measured :Displays ” ”
Cannot measure SpO2:Displays  
When alarm
ON/OFF switch is
pressed.
When alarm is ON :
When alarm is OFF :

4
4.Event Switch
The function assigned at the receiver side will activate. The function
corresponded to the event switch is set at the receiver side.
5.Electrode Position Label
Indicates standard ECG electrode position and precautions for using the
SpO2probe.
6.ECG/Resp Input Connector
The accompanied patient lead cable isconnected here.
7.Mode Switch
This is the SpO2 measurement mode switch to select continuous or
intermittent mode. When the power is turned ON, this mode is in
continuous mode.
The SpO2measurement mode are shown on the LCD display as follows.
SpO2 continuous mode SpO2 intermittent mode SpO2 probe off
Transmits ECG, Resp., SpO2Transmits ECG, Resp., SpO2Transmits ECG, Resp.

5
8. Holes for Security Strap
12.
C
hannel
Number
Label
9.
Battery Cap Lock
Plate
10. Battery Cap
11. Power Supply Switch

6
8. Holes for Security Strap
The accompanied security strap is attached here to prevent the
transmitter from dropping. Adjust the length of the strap to the
appropriate length for the patient.
9. Battery Cap Lock Plate
Locks the battery cap. To release the lock, open the lock plate
outward while pressing the top of the battery cap.
10. Battery Cap
This is the battery compartment cap. To close the battery
compartment, insert the protrusion part of the battery cap into the
rectangular hole on the transmitter, then push in the batteries with the
battery cap and lock the battery lock plate.
11. Power Supply Switch
This is the switch to turn ON or OFF the power supply. When the
power is turned ON, the SpO2measurement mode is in continuous
mode. When the remaining battery becomes low, the " " mark
flashes in the LCD display and the alarm beeps. As the remaining
battery gets lower, nothing will be displayed on the LCD display.
12. Channel Number Label
The transmitter channel number is printed on this label. At the
receiver side, select the same channel number.

7
3. Preparation and Operation
[1] Loading a battery.
The battery cap can be removed by opening the lock plate outward
while pressing the top of the battery cap.
The LX-5630 uses two "AA" size alkaline cell (LR-6) for its power
source.
When installing the battery, take note of the polarity. To close the
battery compartment, insert the protrusion part of the battery cap into
the rectangularhole on the transmitter, then push the batteries with the
battery cap and lock the battery lock plate.
CAUTION
If the transmitter is not in use for a long period of time, remove the
battery and store in an appropriate place. The leakage from the
battery may damage the equipment.

8
[2]Turn the power switch to "ON".
When the power is turned ON, the SpO2 measurement mode is in
continuous mode. To change the mode to intermittent mode, press the
mode switch. In the intermittent mode, the SpO2 will be measured at
30 seconds interval and no pulse waveform is sent, but ECG and
respiration will be continuously measured. In the continuous SpO2
measurement mode, the SpO2 value and pulse waveform will be
continuously measured.
CAUTION
In the intermittent mode, the SpO2 is measured at 30 seco
nds interval.
Even when the SpO2 value suddenly changes during this interval, the
transmitter will only show the last SpO2 measurement value. For the
patient with the possibility of sudden change, select the continuous
mode.
In the intermittent mode, the battery life is about 5 days and about 3
days in continuous mode.

9
[3] Attach the electrodes.
For single lead ECG and respiration monitoring, use the CM-85B for
AHA color code.
AHA color code electrode position Respiration sensing : WhiteandRed
LEAD II LEAD CC5 LEAD MCL1
For twolead ECG and respiration monitoring, use the CM-85C for
AHA color code.
AHA color code electrode position
LEAD I and LEAD II
White
White
White
Red
RedRed
Black
Black
Black
Red
White
Black
Green
+: Black
CH 1 LEAD I
−: White
+: Red
CH 2 LEAD II
−: White
Reference :Green
Respiration sensing : White and Red

10
For dual channel ECG and respiration monitoring, use the CM-85D for
AHA color code patient cable (five electrodes).
AHA color code electrode position
LEAD II and LEAD MCL 1
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
The time constant of ECG input is shorter than general hard wired
patient monitor. The ST level measurement may be different
compared to the general hard wired patient monitors.
Red
White
Black
Gree
n
Brown
+: Red
CH 1 LEAD II
−: White
+: Brown
CH 2 LEAD MCL1
−: Black
Reference :Green
Respiration sensing :White and Red

11
[4] Connect the lead wire to the electrode.
Connect the tip of lead wire to the center
of the electrode and gently swing it right
and left.
Refer the electrodes positions and color
code in previous page.
[5] Connect the lead wire 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.
To send only the ECG and Resp., remove
the SpO2relay cable (CI-128A) from the
transmitter.
In this case, the transmitter will operate
for 6 continuous days.
CAUTION
Confirm the direction of the keyed plug to match the transmitter's
guide key on the connector. Improper connection will cause damage
to the transmitter, patient cable, and will not provide proper
monitoring.

12
[6] Attach the SpO2probe.
There are several types of SpO2probe depending on the monitoring
purpose. Select an appropriate type according to the intended use.
The lightweight type such as SD-5C or TG-26(UD-5C) is suitable for
the LX-5630.
SR-5C TG-25(SP-5C) TG-26(UD-5C)
for adult, reusable for adult, reusable for universal use
SD-5C(25) for adult, semi-disposable CE-5C for earlap
SD-5C(20) for pediatric, semi-disposable
NOTE:The accuracy of this instrument, like that of all other dual-wavelength
oximeters, can be influenced by the presence of abnormal
hemogrobins such as carboxyhemoglobin (HbCO) and methemoglbin.
The tables below show the errors which may occur due to these
hemoglobins. The instrument may be also affected by cardiogreen or
intravascular dyes.
HbCO METHEMOGLOBIN
SpO21%
5%
10%
1%
5%
10%
50%
-0.1%
-0.7%
-1.5%
0.2%
1.3%
3.2%
70%
-0.1%
-0.7%
-1.5%
-0.6%
-2.3%
-3.2%
90%
-0.2%
-0.8%
-1.6%
-1.5%
-6.0%
-9.6%
100%
-0.2%
-0.8%
-1.7%
-1.8%
-7.5%
-12.2%
Note The value will be displayed
lower than the actual value.
The value may be displayed
higher than the actual value
when SpO2value is around
50%.