Fukuda Denshi Co HLX561A Telemetry Transmitter Module User Manual Revised users manual

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Document ID	274933
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Document Description	Revised users manual
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Document Type	User Manual
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Date Submitted	2002-10-04 00:00:00
Date Available	2002-10-04 00:00:00
Creation Date	2002-10-03 10:15:20
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Document Title	Revised users manual
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Telemetry Transmitter Module g
H LX - 5 6 1 g
Operation Manual
ORead this manual prior to use of the HLX-561.
OStore this operation manual in an easily accessible place near the
unit for future reference.
FUKUDA
DENSHI
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits
set forth for an uncontrolled environment. This equipment
should be installed and operated with minimum distance 20cm
between the radiator and your body (excluding extremities :
hands, wrists, and feet) and must not be co-located or operated
with any other antenna or transmitter.
Federal law restricts this device to sale by or on the order of a
physician.
i NOTE: Only a physician or a person under the guidance of a
5 physician can use this device.
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
Telemetry Precautions
For proper management of the telemetry installation, consult your
Fukuda Denshi representative concerning the following:
0 Plan the installation of your telemetry system taking into account
your entire medical facility needs and plant requirements.
0 Be sure the antenna system installed meets the facility and plant
requirements.
This Radio Frequency device is susceptible to interference
from outside sources. Interference may prevent the
monitoring of patients connected to this device. If problems
exist contact your local service representative.
NOTE : This device operates in the GOOMHZ UHF band. The exact
frequency of operation depends on designation, and each
individual county's wireless service regulation.
To assure safe and reliable operation, observe the following
precautions:
0 Be sure that no other devices are using the frequency assigned to this
transmitter.
o This device is susceptible to interference from electrosurgical knives
and other computerized equipment. If problems occur contact your
local Fukuda Denshi service representative.
0 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 at the central monitor, charge
the battery in the patient monitor.
ii
Users are advised to periodically contact the FCC or specified
frequency coordinator and determine if other or your
transmitter frequencies that may cause interference.
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.
Thank you for purchasing the HLX—561 telemetry transmission module
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 HLX-561 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 under
the following message headings. Understand the meaning of the
different types of messages while reading this operation manual
Erroneous operation by failure to observe
Q WARN | N G instructions when this message is printed
may result in death or serious injury to the
patient, operator, or create a fire hazard.
Erroneous operation by failure to observe
instructions when this message is printed
A CAUT | O N may result in injury to the patient or
operator, or may cause damage to the
HLX—56l and/or related instruments.
A NOTE is not a warning instruction but
offers information for correct use of the
HLX-561 to avoid erroneous operation.
iii
Safety Considerations in Using Medical Electrical
Equipment
Contents described here are general safety considerations to be taken
for proper operation of medical electrical equipment and for the safety
of both the patient and operator. Safety considerations specific to the
use of the HLX—561 telemetry transmission module are described on
the next page,
1. Do not use the equipment unless 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.
0 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 equipment 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. (Refer
to the Section 9.
4. Precautions during Operation
- Do not to operate the equipment beyond the time period
necessary that is 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.
5. Cares after Operation
- Disconnect cords and cables by holding the connector plugs. Do
not apply excessive force to cords and cables by pulling to
disconnect.
- Keep the equipment clean in preparation for the next use.
6. If the equipment gets 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 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
normall and safel .
9. When using an electrosurgical unit or defibrillator in
conjunction with this equipment, take care of the following.
- The high-frequency energy produced by electrosurgy 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 recautiona instructions urior to use.
Contents
Telemetry Precautions .................................... o a « n i
Safety Information and Messages ............................ iii
Safety Considerations in Using
Medical Electrical Equipment """""""" iv
1. General Description ----------------------- a 0 o .............. 1
2. Controls and Indicators ............................... . n - n e 2
3. Mounting the HLX-561 to the Bedside Monitor
[Mounting into the DS-5100 1 ........................ 4
[Mounting into the DS-5300 ] """"""""""""" 7
4. Setting the Receiving Channel of the Monitor ““““““““ 10
5. Cleaning, Sterilization and Disinfection """""""""" 11
6. Maintenance and Inspection """""""""""""""""" 12
7. Specifications ...................................... 14
s_Access0ries caroxnecooot .................................. 16
1. General Description
The HLX—56l is a telemetry transmission module to transmit
physiological parameters monitored by a bedside monitor in the
DS-SOOO series via Wireless technology. Thus, the HLX—56l allows the
user to configure an integrated telemetry patient monitoring system in
combination with a central telemetry receiver and central monitor such
as the DS-5800N.
For compatibility with monitors other than DS-SOOO series, contact
your Fukuda Denshi representative.
Operation of this equipment requires the prior coordination
with a frequency coordinator designated by the FCC for the
Wireless Medical Telemetry Service.
External
Appearance
HLX—561
0A-287(opfi0n)
2. Controls and Indicators
(DAntemm
®Channel Label
®Connector
(DMuunl‘ing Fixture (option)
©Wire Adapte nunfing Hole
—fMim=
®Wire dapter (0pm!!!) ©Cnnnector (option)
(DAntenna
Transmitting antenna for the physiological parameters.
®Channel Label
Contains the channel identification number of the transmitter. The
receiver must be set to the same channel number. If the channel
number is changed, the channel label must be replaced.
©Connector
Connects to the bedside monitor.
@Wire Adapter Mounting Hole
Connects to the optional wire adapter OA-287.
©Wire Adapter OA-287 (option)
Allows for mounting the HLX—561 onto a bedside monitor.
©Connector (option)
Allows for external connection of the HLX-5 61 to the bedside monitor.
Connect to the F-LINK connector of the bedside monitor.
®Mounting Fixture (option)
For mounting the HLX-SGI into the bedside monitor. The illustration
shows the method for mounting to the DS—5300.
3. Mounting the HLX-561 to the Bedside Monitor
Described here are the procedures for mounting the HLX-561 to the
DS-SlOO and DS-53OO as typical bedside monitors. If the radio channel
is changed, it is recommended the channel label be changed in advance.
[Mounting to the DS—SIOO ]
NOTE: Before starting the mounting work, turn the main
1 power switch on the DS-5100 OFF and disconnect the
power cable from the wall outlet.
ll The transmission module
housing is located at the
upper left of the DS-SIOO as
viewed from the rear.
Remove the screw that holds
the cover in place and
remove the cover as shown.
Emu
\':
Zl The F-LINK / HLX switch
is now accessible Switch
to the HLX position to
effect internal
communication (Setting
this switch to the HLX
position disables the
external F -LINK
connector.)
Connect the cable from the
bottom of the module
housing to the connector at
the bottom of the
HLX-561. Remove the cap
which covers the antenna
hole in the top of HLX-561
transmission module
housing cover.
Place the HLX—561 into the
housing, taking care not to
jam the cable in the inside.
Place the cover back in its
original position While at the
same time inserting the
antenna into the antenna
hole. Replace the cover onto
the DS-5100 by replacing
the screw at the bottom.
5 Reconnect the power cord and turn the DS-5100 ON. Set the
telemetry channel from the telemetry set-up display on the
DS-S 100.
For details in selecting the telemetry channel, refer to the operation
manual for the DS-5100.
Operation of this equipment requires the prior coordination
with a frequency coordinator designated by the FCC for the
Wireless Medical Telemetry Service.
5 To check the system, and verify proper transmission from the
HLX-56l to the telemetry receiver, check the central receiver and
monitor to ensure the waveforms and alphanumeric data are
properly displayed.
The wireless network system is now functioning properly.
[Mounting into the DS-5300 ]
from the wall outlet.
ZI
~' NOTE: Before starting, be sure to turn the main power switch '
of the DS-5300 OFF and disconnect the power cable
Connect the optional
OA-287 adapter to the
HLX-561, connector to
connector. Attach the
adapter to the HLX—561
with the accessory screw
(MZ.6 x 8).
Attach the optional
mounting fixture onto
the HLX-561 with two
accessory screws (M2.6
X 6).
Attach the assembly
consisting of the
HLX-561, OA—287 and
mounting fixture, to the
DS-5300 with the two
accessory screws (M3 x
6)‘
Connect the cable from the OA—287 to the F-LINK connector of
DS-5300.
Reconnect the power cord and turn the DS-5300 ON. Select the
telemetry channel from the telemetry set-up display on the
DS-5300.
For details on the telemetry channel set-up procedure, refer to the
operation manual for to the DS-5300.
Operation of this equipment requires the prior coordination
with a frequency coordinator designated by the FCC for the
Wireless Medical Telemetry Service.
Setting or changing the telemetry channel may cause
interference with another telemetry system. Be sure to consult
engineering for telemetry channels to select the proper radio
channel which does not cause interference.
6 To check the system, and verify proper transmission from the
HLX-561 to the telemetry receiver, check the central receiver and
monitor to ensure the waveforms and alphanumeric data are
properly displayed.
The wireless network system is now functioning properly.
10
4. Setting the Receiving Channel of the Monitor
Select the telemetry receiver channel to match that of the telemetry
transmission module. The monitor will display the channel number. If
the transmission module has a different group code than that of the
receiver, set the telemetry receiver group code to correspond to the
telemetry transmission module. (For details on selecting the channel
and group code, refer to the operation manual for the appropriate
monitor.)
If the selected channel number does not correspond to the frequency
that is actually received, an alarm waveform will be displayed to alert
the staff to interference (see example below).
function.
NOTE: The interference prevention function is not effective v
unless the receiver has the interference detection
Verify the receiver has the interference detection
function and the proper channel number set.
(Example of display on the DS-5800NX central monitor)
Le—Lu—La—L—k—L—L—Lv—L—L—L‘L
w 1201 um m m w a in;
new ms:
" “35-362
MAMA/MW
s!
INTERFERENCE
(S101)
s—L—t—L—L—L—l—L—lfi—‘p—L—L
an Izfl/ am as: m 25/ z. in)
INTERFERENCE
our 0 c
«was
m nu m m on no} m m
message with alarm
v e/sv o s
emu;
»—l~——L—L——L~——l~—L——l~——t~—L——L~—L
m way no: m we w 11 1111
v was:
-—AL——l-—-L——L-—-L—-L—AL——L—AL——l-—-L
m Izo/ am sex m w z( m,
v was;
LAWN
mp ow m 75) my us/ or m
v em a s
emu!
WWW
RAP ws/ em m m ”at m m
eu-ozé
m:
“mm. . zs
w-om
5. Cleaning, Sterilization and Disinfection
Clean, sterilize and disinfect the HLX—561 and accessories as follows.
- Cleaning ..............................................
Use a clean, soft cloth dampened with alcohol or a weak
acid/alkalescent/neutral cleanser. Clean the HLX—S 61 and accessories
with the dampened cloth, taking care that the cleaning solution does not
enter into any connectors or get inside the HLX-561.
Do not use cleaning agents containing organic solutions, thinner,
toluene and benzene. Such chemical solutions may damage the resin
casmg.
I Sterilization and Disinfection ----------------------------
QFor Disinfection, wipe the HLX-56l and accessories using a gauze
or sanitary cotton moistened with inert soap or alcohol. Do not
moisten allow moisture inside of the connector to avoid contact
failure.
.For sterilization, use a gas sterilization method, Sterilization
methods utilizing high temperatures such as an autoclave will
damage the HLX-561 and accessories.
If sterilizing the room utilizing spray chemical solution methods, take
proper measures to ensure the chemical solution will not contact the
inside of the HLX—56l and connectors.
ll
12
6. Maintenance and Inspection
To maintain the safety and reliable functionality and performance of the
HLX-561, it is preferable to perform routine and periodic inspections
before use. A recommendation is described in this section. Failure to
perform routine maintenance and inspection may void the
responsibility of Fukuda Denshi.
QPersons other than your authorized Fukuda Denshi service
representative must not remove the external casing of the
HLX—561.
.Alvvays take care to avoid spilling alcohol or any other
liquids inside of the HLX—561.
. Routine Inspection .....................................
It is recommended that a routine inspections be performed daily. A
sample Routine Inspection Record is provided on the next page.
I Periodical Inspection ...................................
Periodic inspections are necessary to prevent trouble and accidents and
to maintain the safety and efficacy of medical electrical equipment.
Ensure normal operation of the equipment by correcting adverse
environmental conditions, if any, and by keeping the equipment in good
repair, Periodic inspection becomes a part of the maintenance and
inspection to ensure the equipment operates properly, efficiently, and
safely.
Periodic inspection may be conducted by either the user or an
authorized Fukuda Denshj service representative.
For details, contact your Fukuda service representative.
Routine Inspection Record
Inspection Date: Inspected by:
Model: HLX—561 Serial No.:
Location:
No.
Purchase Date:
Items Inspection Judgement criteria Judgement
Check the external N0 abnormalities
appearance for scratches,
breaks, cracks, loose
External screws, or labels. Pass/Fail
appearance Check the antenna for bends
or breaks.
Under normal operating Waveforms and data
conditions, check the received in normal
functions at the central manner.
Function monitor. Pass/F ail
Check the data of the most Periodic Inspections
recent inspection. should be performed per
Periodic the institutions standard ,
. . Pass/Fan
Inspection operating procedures,
13
7. Specifications
Transmitting Information (will depend on bedside monitor used)
Waveforms : ECG X 1, 5 additional waveforms (e‘g.
Respiration, pulse, 2 blood pressure
waveforms)
Numeric Parameters : NIBP, SpOz, Temp 1, Temp 2, BPl,
BP2, Heart Rate, Respiration Rate, etc.
Status Information : Low Battery, Electrode fail, Group
code (64 types), Alarm, Alarm suspend,
Remote record, Model ID number,
Transmitter channel No.
Interface
Communications Method : RS-232C Serial Interface
Radio Frequency Specification
Modulation Method : Digital, Frequency Shift Keying (FSK)
RF Output Power : —15 dBm Standard, 0 dBm MAX
Transmission Frequency : 608~6l4 MHz
Channel spacing : 12.5 kHz
Power Requirements : +5 V, 60 mA supplied from the bedside
monitor
14
Dimensions and Weight
Dimensions : 61.5(W) >< 108.5(H) >< 20.5(D) mm
Weigh : Approximately 100 grams
Environmental Conditions
Operating Temperature : 10 to 40 °C
Operating Humidity : 30 to 85 %RH. no dew condensation
Storage Temperature : —10 to 60 °C
Storage Humidity : 30 to 95 %R.H.(at 60 °C)
Specifications subject to change without notice
15
8. Accessories
To ensure the HLX-561 will perform to its published specifications, use
only those accessories specified by Fukuda Denshi. When ordering
spare parts or accessories, specify the part name and model number.
I Standard Accessories
No. Item I Model Q'ty Remarks
Operation Manual T—l
I Optional Accessories
The following item is not included in standard accessories. Purchase it
separatelyr
No. Item Model Remarks
Comes complete with the mounting
fixture for the DS-5300 and
mounting screws (M2.6x6 : 2 pcs,
And M3x6 : 2 pcs, all with washer)
(D Wire Adapter OA-287
16
V FUKUDA DENSHI CD.,LTD.
Head office : 39-4, Hongo 3-chome, Bunkyo-ku, Tokyo, Japan
Phone: —81—3»3815—2121
Telex : 23498 FUKUMED J
Fax : -81-3-5684-3791
4L2869 200105®

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