Fukuda Denshi DSL-8001 User manual

Patient Monitor
●●●●●●●●●●●●●●●●●●●●●●●●●●●●
DSL-8001 System
Service Manual
DSL-8001/DSL-8001R
zBefore setting up/maintenance, please read this “Service Manual” thoroughly.
zAfter reading, keep this manual for future reference.

Service manual Delivery Notice
Service Manual (No. ): Q’ty 1
Please confirm your receipt of the above service manual by filling in
and sending us back this sheet by return.
Delivery of Service Manual
Please note that this service manual is a confidential document and
needs to be kept with an utmost care under person in charge. If the
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usability, viewability, readability, or if you notice anything hard to
understand on this service manual, please inform it to us.
Fukuda Denshi Co., Ltd.
Development & Production Support Dept.
2-35-8 Hongo, Bunkyo-ku, Tokyo 113-8420, Japan
Receivedby
of (Company/Hospital)
onthedayof

Revision History
Model Name
DSL-8001 System Service Manual
Edition Revised Items Reason of the Revision Date
1 － New Edition 2013.01

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Preface
Thank you for purchasing our Monitor.
Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of
the product.
Safety Precautions························································ii
Warning Label ··························································· ii
Measurement Unit for Each Parameter ···················· iii
Graphic Symbols ······················································ iv
Precautions for Safe Operation of Medical Electrical
Equipment ································································ vi
Precautions about the Maintenance ························ vii
Precautions about Medical Telemeter ·····················viii
Precautions about Bidirectional Wireless
Communications Module (TCON)······························
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xix
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xxi
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xxiv
Precautions about the Pacemaker····························
Non-Explosion Proof················································
Precautions about Magnetic Resonance Imaging ···
Defibrillation Safety··················································
Electrosurgery Safety ··············································
Precautions about Connections to Peripheral Devices
················································································
Accessories and Optional Accessories···················
Precautions about the DSL-8001 ···························
Precautions about the Ventilator Monitoring···········
Precautions about Use of SpO2Sensor ··················
Precautions for Use of NIBP Cuff ····························
Disposing of Equipment, Accessories, or Components
················································································
Precautions about Transportation····························
Precautions about RTC or Data Backup··················
To Prepare for Emergency Use ·······························
Electromagnetic Compatibility··································
Precautions for Safe Operation under Electromagnetic
Influence·································································
EMC Guidance ·······················································
Compliance to the Electromagnetic Emissions ·
Compliance to the Electromagnetic Immunity (1)
······································································
Compliance to the Electromagnetic Immunity (2)
·····································································
Recommended Separation Distances between
Portable and Mobile RF Communications
Equipment and the DSL-8001 System ·········
i

Safety Precautions
yRead the “Safety Precautions” thoroughly before use to ensure correct and safe use of the
product.
yMake sure to follow the precautions indicated below, as these are important messages related to
safety.
DANGER Failure to follow this message may cause immediate threat of death or
serious injury.
WARNING Failure to follow this message may result in death or serious injury, or
complete failure of the equipment.
CAUTION Failure to follow this message may result in death or serious injury.
NOTE
A note is not related to product safety, but provides information about the correct
use and operating procedures to prevent incorrect operation and malfunction of
the equipment.
Warning Label
Make sure to read the warning labels attached to the unit and comply with these requirements
while operating the unit.
CAUTION
Do not damage or erase the warning label attached to the equipment.
This warning label contains important descriptions for handling and
operating the equipment properly and safely. A damaged label may
compromise safe operation.
DSL-8001 System Main Unit
ii

Measurement Unit for Each Parameter
The measurement units for this equipment are as follows.
Description Parameter Display Unit Default
ECG HR
Bpm
(beats per minute)
NIBP PR bpm
Heart Rate /
Pulse Rate
SpO2PR bpm
Respiration Rate Impedance
Respiration RESP Bpm (breaths per minute)
Arterial Oxygen
Saturation SpO2SpO2%
Non-Invasive Blood
Pressure
Non-Invasive
Blood Pressure NIBP mmHg / kPa mmHg
Temperature Temperature TEMP
°C / °F °C
iii

Graphic Symbols
Refer to the following for the meaning of the symbols indicated on the equipment.
DSL-8001 System
Symbol Description
Caution, refer to accompanying documents
Indicates the need to refer to related accompanying documents before
operation.
Refer to accompanying documents
Indicates the need to refer to related accompanying documents before
operation.
Potential Equalization Terminal
Indicates the terminal to equalize the potential difference when
interconnecting devices.
Power ON/OFF
Type CF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock, which is Type CF
Applied Part with defibrillation-proof.
Signal Output Part
Alarm Silence Key
NIBP Start/Stop Key
NIBP Measurement Interval Setup Key
Home Key
Menu Key
Record Key
Year of Manufacture
Indicates the manufactured year.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic equipment.
iv

Symbols displayed on the DSL-8001 System screen
Symbol Description Symbol Description
NIBP Elapsed Time
Pulse Amplitude Display
TCON Status Main Menu Icon
Alarm Silence Icon
Alarm Sound Suspend Icon Alarm Limit Setup Icon
Alarm OFF Icon Switch Display Icon
Ventilator Status Table/Trend Icon
Message Icon Remaining Battery Power Icon
Patient Classification: Adult Previous Screen Icon
Patient Classification: Child Next Screen Icon
Patient Classification:
Neonate Newest Screen Icon
SEC Alarm Indicator
NOTE The SEC alarm function utilizes SatSecondsTM technology of Covidien.
SatSecondsTM is a trademark of Covidien.
v

Precautions for Safe Operation of Medical Electrical Equipment
CAUTION
Read the following precautions thoroughly to correctly operate the
equipment.
zUsers should have a thorough knowledge of the operation before using
this equipment.
zPay attention to the following when installing and storing the equipment.
yDo not install or store in an area where the equipment will be subject to
splashing water.
yDo not install or store in an area where the environmental conditions,
such as atmospheric pressure, temperature, humidity, ventilation,
sunlight, dust, sodium, sulfur, will adversely affect the equipment.
yPlace the equipment on a stable surface where there is no inclination,
vibration, or shock (including during transportation).
yDo not install or store in an area where chemicals are stored or gasses
are evolved.
yVerify the power frequency, voltage and allowable current (or power
consumption).
yEnsure the grounding is proper by connecting the accompanying
power cable to the hospital grade outlet.
zBefore operating the equipment, verify the following items.
yVerify the power voltage.
yCheck the cable connection and polarity to ensure proper operation of
the equipment.
yMake sure the power system has adequate earth ground.
yEnsure that all cables are firmly and safely connected.
yPay special attention when the device is used in conjunction with other
equipment as it may cause erroneous judgment and danger.
yEnsure all patient connections are proper and secure.
zDuring operation of the equipment, verify the following items.
yAlways observe the equipment and patient to ensure safe operation of
the equipment.
yIf any abnormality is found on the equipment or patient, take
appropriate measures such as ceasing operation of the equipment in
the safest way for the patient.
yDo not allow the patient to come in contact with the equipment.
yDo not touch any of the signal input or output parts at the same time as
the patient.
zAfter using the equipment, verify the following items.
yUnplug all the cables from the patient before turning off the power.
yWhen unplugging the cables, do not apply excessive force by pulling
on the cable. Pull from the connector part of the cable.
yClean the accessories and cables, and keep them together in one
place.
yKeep the equipment clean to ensure proper operation for the next use.
zIf the equipment is damaged and in need of repair, stop using the
equipment, label it “OUT OF ORDER” and contact Fukuda Denshi.
zDo not disassemble or remodel the equipment.
zMaintenance Check
yMake sure to periodically check the equipment, accessories and
cables.
yBefore reusing the equipment that has been left unused for a while,
make sure that the equipment works normally and safely.
zTo prevent patient from burn injury, verify proper attachment of patient
ground plate, ECG electrode type when using the electrosurgical knife,
and verify paste volume, output energy when using the defibrillator. Also
verify that proper ground is selected.
vi

Precautions about the Maintenance
Safety Inspection and Maintenance
For safe operation of the equipment, regular inspection and maintenance are required. Once a
year, check all cables, devices, and accessories for damage, earth impedance, earth and leakage
currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of
these safety inspections.
Immediate maintenance has to be carried out if;
ythe equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
ythe equipment was subjected to liquid spill.
ythe monitoring function is interrupted or disturbed.
yparts of the equipment enclosure are cracked, removed, or lost.
yany connector or cable shows signs of deterioration.
Reference Refer to "9. Maintenance", “10. Periodic Check” for details.
WARNING Never open the housing while the equipment is in operation or connected
to hospital grade outlet as it may result in electric shock.
Maintenance, Modifications, and Repairs
Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if;
yMaintenance, modifications, and repairs are carried out by authorized personnel or organization.
yComponents are used in accordance with Fukuda Denshi operating instructions.
vii

Precautions about Medical Telemeter
DANGER
When monitoring a patient using wireless telemetry, make sure the patient
data is properly received at the central monitor. Pay special attention when
the channel ID at the bedside monitor is changed.
WARNING
zDepending on the wireless combinations, interference may generate
with other telemeters.
zBefore selecting a channel, verify it will not interfere with other
channels.
zMake sure the telemetry manager of your system is aware of any
changes to the telemetry channels.
zIf transmitters are used in a neighboring medical facility, your facility
and neighboring facility must make agreements on the setting of
telemetry channels to prevent telemetry interference.
CAUTION
zPrecautions about the Installation
yThe medical institution (hereinafter referred as “Institution”) must
decide the telemetry installation plan for the medical institution in
order to prevent interference and interference between transmitters
(telemetry based on destination country’s radio law). When telemetry
has already been installed and been used, radio format, frequency,
and antenna power are required to be examined to prevent
interference.
yWhen using telemetry which requires zone location, the Institution is
to set up the zones as an operation unit for each transmitter to
prevent electronic interference between telemetry throughout the
medical institution.
yWhen using telemetry which requires zone location, display and
identify each prepared zone in the equipment.
yWhen laying receiver antenna for each transmitter, the Institution has
to examine the installation so that electronic interference does not
occur.
yBased on the above examination result, the Institution should place
each receiver antenna as required.
CAUTION
zPrecautions about the Management
yThe institution appoints a person to manage the wireless channels for
the whole medical institution. And when using telemetry which
requires zone location, the Institution should nominate a person to
manage the wireless channels in each zone (a “Zone Manager”).
However, when using such telemetry in a local medical institution,
one person can perform both functions.
ySelect a telemetry manager who understands the characteristics and
functionality of telemetry systems, and is skilled in operating
telemetry.
yWhen installing telemetry, the Overall Manager and the Zone
Manager have to understand the precautions for use of the telemetry
in advance.
yThe Overall Manager takes responsibility of wireless channel
management and transmitter storage for the whole Institution by
giving proper instruction.
viii

CAUTION
zPrecautions about the Management (contd.)
yThe Overall Manager should create a management log (hereinafter
referred to as the “log”), which contains a list of the management
status of the wireless channels for the whole Institution. When
changing a wireless channel, register it in the log and give proper
instructions to the Zone Manager or to the user.
yThe Zone Manager assumes responsibility for managing the wireless
channels, storing, and managing telemetry.
yThe Zone Manager assigns the transmitter to the user, and provides
enough education for use inside the zone.
yThe telemetry user verifies operation of the transmitter/receiver
before use.
yThe telemetry user, if using the telemetry in a zone location, follows
the instructions of the Zone Manager for the zone and gives
instructions to the patient if required.
yWhen interference or breakdown occurs in telemetry communication,
the user is required to inform the zone manager and the overall
manager of the problems. The Zone Manager and Overall Manager
are to deal with the problem properly and/or contact their nearest
Fukuda Denshi representative for service.
zPrecautions about the Setting
yConnection of the HLX-801 Telemetry Transmitter Module will be
performed by our service representative. Users should not perform
this procedure as malfunction of the equipment may occur.
yThe setup of channel ID and group ID should be performed only by
our service representative. Users should not perform this procedure
as malfunction may occur.
yOn a wireless network, the alarm generated on this unit will be
transmitted to the central monitor with a maximum of 15 seconds
delay.
ix

Precautions about Bidirectional Wireless Communications Module
(TCON)
CAUTION
zPrecautions about the Installation
yThe medical institution (hereinafter referred to as "Institution") must
execute investigation required to prevent interference including types
of radio waves, frequencies, and antenna power if wireless
equipment is already installed and being used in the facility.
yEven if this device is installed within the range of radio
communication, the communication may not be possible due to noise
or multi-path phasing etc.
yIf the TCON is installed in a line-of-sight distance where there are no
obstacles or on the upper floors, unexpected long distance
transmission may occur which may cause interference with nearby
medical institution. Before using the TCON system, test the reception
to make sure that it does not interfere with other channels. If the
channel is used by other medical institution, change the channel ID.
zPrecautions about the Management
yThe Institution should appoint a person (hereinafter referred as the
“Overall Manager") to manage the wireless devices for the whole
facility.
yWhen installing TCON, the Overall Manager has to receive an
explanation of the precautions for use of the TCON from the
manufacturer or sales representative.
yThe Overall Manager is responsible for the maintenance and storage
of the equipment.
yThe Overall Manager should create a management log (hereinafter
referred to as the “log”), which contains a list of the management
status of the wireless channels for the whole facility. When assigning
or changing wireless channels, register it in the log, and give proper
instructions to the TCON user.
yThe user needs to verify the transmitting/receiving operation before
use.
yIf interference or breakdown occurs in the communication, the TCON
user is required to stop using the TCON and to inform the Overall
Manager of the problem. The Overall Manager is to deal with the
problem properly and/or contact the nearest Fukuda Denshi
representative for service.
zPrecautions for Operation
The Bidirectional Wireless Communications Module (TCON) uses radio
waves to transmit data. Therefore, necessary precautions need to be
taken for the characteristics and difficulties of using the device that
emits radio waves. The TCON user should fully understand these
precautions beforehand, and use the TCON device safely.
Furthermore, situations in which interference may occur are outlined
below. In such cases, pay special attention to the condition of the
patient connected to the bedside monitor, and eliminate the cause of
interference.
<When the patient’s data become mixed with a different patient’s
data due to interference.>
yWhen there are multiple TCON communication devices set to the
same TCON ID and channel (group).
<When symptoms such as being unable to communicate,
unstable communication, or poor reception occur.>
yWhen the radio communication is bad because there are metal,
concrete, or other such obstacles between the Bidirectional Wireless
Communications Modules (TCON).
x

CAUTION
yWhen a different wireless device is using the same frequency
(channel).
yWhen there are other TCON devices nearby using different channels
(groups).
yWhen a cell telephone or other wireless device is being used nearby.
yWhen citizens broadcast bands such as amateur radio or truck radios
are used in the vicinity of the TCON operating area.
yWhen a computer or word processor, or electrical device that has an
internal computer, is used near the TCON device antenna.
yWhen the TCON device is installed or moved to a location that is
outside the radio communication range.
yIf a nearby different group is set with a TCON channel frequency that
is too close to the channel frequency set for the current TCON group.
zPrecautions about the Setting
yThe Bidirectional Wireless Communications Module connection and
TCON Setup will be performed by our service representative. Users
should not perform this procedure as malfunction may occur.
yOn TCON system, the alarm generated on this unit will be
transmitted to the central monitor with a maximum of 5 seconds
delay.
yIf the TCON is set to [OFF], all TCON messages such as "Check
TCON Comm." will not be displayed.
yCheck that three antenna bar marks ( ) are displayed.
yMake sure that the TCON group ID between the bedside monitor and
central monitor is the same.
yDo not move the equipments during TCON operation. The radio
waves may not be transmitted.
<There are following restrictions when connecting the DS-8001 to the
TCON network.>
yThe NIBP measurement cannot be started from the central monitor
via TCON system if the NIBP measurement interval is set to 5 min. or
less, or during the 1-minute measurement or continuous
measurement. However, it can be stopped.
yWhen the TCON network is constructed, temperature alarm setting
cannot be changed from the central monitor.
Precautions about the Pacemaker
WARNING
zMinute 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, please disconnect the cardiac monitoring and
diagnostic equipment, or follow the procedures described in the
operation manual of the pacemaker.
For more details, contact FUKUDA DENSHI personnel, your institution’s
professionals, or your pacemaker distributors.
zRate meters may continue to count the pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely
upon rate meter alarms. Keep pacemaker patients under close
surveillance. See this manual for disclosure of the pacemaker pulse
rejection capability of this equipment.
See “Minute Ventilation Rate-Adaptive Pacemakers”
FDA alerts health professionals that minute ventilation
rate-adaptive implantable pacemakers can occasionally interact
with certain cardiac monitoring and diagnostic equipment,
causing pacemakers to pace at their maximum programmed rate.
xi

CAUTION
zThere are some cases when the pacemaker pulse can not be detected
depending on the pacemaker type, pulse voltage, pulse width,
electrode lead type (unipolar, bipolar), or electrode placement which
causes the pacemaker pulse amplitude to decrease and disables the
pacemaker pulse detection.
zIf signals similar to a pacemaker pulse are present, such as electric
blanket noise or excessive AC frequency noise, these may be
erroneously detected and displayed as a pacemaker pulse.
zWhen a spontaneous QRS overlaps pacemaker pulse (e.g. fusion beat,
etc.), the heart rate will decrease because QRS detection cannot be
properly performed.
zIf a pacemaker pulse is continuously detected due to AC frequency
interference, QRS detection will be suspended and the heart rate will
be reduced.
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics,
high concentration of oxygen, or inside hyperbaric chamber. Also, do not
operate the equipment in an environment in which there is a risk of
explosion.
Explosion or fire may result.
Precautions about Magnetic Resonance Imaging
WARNING
Do not use this equipment in magnetic resonance imaging (MRI)
environments. This equipment may be pulled towards the MRI device. And
the local heating by the induced electromotive force may cause burn injury
to the subject or deteriorate the performance of this equipment.
Defibrillation Safety
WARNING
zWhen defibrillating, keep away from the electrodes or medicament
applied to the patient chest. If this is not possible, remove the
electrodes or medicament before defibrillating.
If the defibrillator paddles are directly in contact with the electrodes or
medicament, an electrical shock may result by the discharged energy.
zWhen defibrillating, make sure that the electrodes, sensor cables, or
relay cables are firmly connected to the device.
Contacting the metal part of the disconnected cable may result in
electrical shock from the discharged energy.
zWhen defibrillating, do not touch the patient and the metal part of the
device or cables. Electric shock may result from the discharged energy.
xii

Electrosurgery Safety
WARNING
The monitoring system contains protection against interference generated
by electrosurgical instruments. However, operating conditions, surgery site
with respect to the location of ECG electrodes, or the type of instrument
used, may cause noise on the ECG. Noise is generated at the tip of the
electrical knife and is difficult to completely eliminate because of the
frequency components of the ECG. To reduce electrosurgical interference,
take the following precautions:
Installation Location
Locate the electrosurgical unit as far as possible from this unit and the
patient cable. This will help reduce interference on the ECG through
the monitor or cables.
Power Supply
Connect the electrosurgical unit to a power supply that is different from
that of the monitor. This will help prevent interference through the
power cable.
Electrode Placement
The amount of interference is considerably different depending on the
electrode position and surgery site. Place the ECG electrodes as far
away as possible from the surgery site and the ground plate. Do not
place electrodes in the path between the surgery site and the ground
plate. If the electrodes are placed in this path, the amount of
interference will be quite large. Position (+) and (–) electrodes as close
as possible to each other.
Ground Plate
When using electrosurgical instruments, make sure the contact
between the patient and the ground plate is secure. If the connection is
incomplete, the patient may suffer from burn at the electrode site.
Precautions about Connections to Peripheral Devices
In the interest of safe and sufficient performance of this equipment, the connection of other
manufacturers’ equipment to the monitor is not authorized, unless the connection is explicitly
approved by Fukuda Denshi. It is the user’s responsibility to contact Fukuda Denshi to determine
the compatibility and warranty status of any connection made to another manufacturer’s
equipment.
WARNING
Regarding the connector with the mark, only the peripheral devices
specified by Fukuda Denshi should be connected with the given procedure.
Use of an unspecified device may cause electric shock to the patient
and/or operator due to excessive leakage current.
CAUTION
All the peripheral device connectors on the DSL-8001 system are isolated
from the power supply, but the peripheral devices are not isolated. To
prevent danger of electric shock, always position the peripheral devices
away from the patient.
When connecting peripheral devices to this unit, it is the user’s responsibility to verify that the
overall system complies with EN 60601-1-1/IEC 60601-1-1, “Collateral Standard: Safety
Requirements for Medical Electrical Systems”.
xiii

Accessories and Optional Accessories
WARNING
Use only the cables specified by Fukuda Denshi.
Use of other cables may result in an increase in emission (generation
of unwanted electromagnetic energy from this equipment) or decrease
in immunity (resistance to electromagnetic interference generated
from other devices).
Precautions about the DSL-8001
DANGER When connecting other equipment, contact your nearest representative.
Danger such as electric shock may result to the patient and operator.
WARNING
zDo not connect any equipment or cable not authorized by Fukuda
Denshi to any I/O connector. If done so by mistake, the device cannot
deliver its maximum performance and the connected units may be
damaged, resulting in a safety hazard.
zIf the equipment is used in an environment that does not fulfill the
specified conditions, the equipment cannot deliver the maximum
performance, equipment may become damaged and safety cannot be
ensured. If using in an environment other than the specified
environment, contact our service representative.
zUse only the accompanying 3-way AC power cable. Use of other
cables may result in electric shock to the patient and the operator.
zThe power cable must be connected to a hospital grade outlet.
zWhen using multiple ME equipment simultaneously, perform
equipotential grounding to prevent potential difference between the
equipments. Even a small potential difference may result in electric
shock to the patient and the operator.
zAlarm Setup
ySet the appropriate upper and lower alarm limit for each parameter
according to the monitoring condition.
yWhen the upper/lower alarm limit of the individual parameter is set to
OFF （”- - -“）, alarm will not be generated even if the individual
parameter alarm is set to ON. Be cautious when setting them OFF.
yHR/PR alarm and HR zero alarm is independent and the setting is
not linked with each other.
yRESP alarm and RR zero alarm is independent and the setting is not
linked with each other.
zRate meters may continue to count the pacemaker rate during
occurrences of cardiac arrest. Do not rely entirely upon rate meter
alarms. Keep pacemaker patients under close surveillance. See this
manual for disclosure of the pacemaker pulse rejection capability of this
equipment.
zThe purpose of the RR zero alarm is to alert the user to evaluate for
the possible occurrence of apnea events by identifying the absence of
respiration. It is not intended to be classified as an “Apnea Monitor” and
will not identify the condition creating the possible event. (Central.
Obstructive or Mixed)
xiv

WARNING
zSpO2Monitoring
yWhen measuring the SpO2of a patient with high fever or peripheral
circulatory insufficiency, check the sensor attachment periodically
and change the attachment site. The temperature of the attachment
site will increase 2 to 3 °C due to the sensor heat which may result in
compression necrosis and burn injury.
yFor the following case, accurate measurement may not be possible.
- Patient with excessive abnormal hemoglobin (HbCO, MetHb)
- Patient with the pigment injected to the blood
- Patient receiving CPR treatment
- When a sensor is applied to a limb with NIBP cuff, arterial catheter,
or intracatheter
- When measuring at site with venous pulse
- Patient with body motion
- Patient with small pulse
zNIBP Monitoring
yBefore the NIBP measurement, make sure the patient classification
([Adult]/[Child]/[Neonate]) is properly selected. Otherwise, correct
measurement cannot be performed, and congestion or other injury
may result.
zNight Mode Setup
When selecting [Silence] for Volume or [Time Only] for Screen
Brightness, pay attention not to miss any important alarm by
simultaneously monitoring the bed on other monitors such as central
monitor.
CAUTION
zSystems
yThe DSL-8001 is intended for patient monitoring in ICU, CCU,
surgery, and ward and during transportation within the hospital. Do
not use the monitor out of hospital (like in airplane and ambulance
car), in MRI environment, inside hyperbaric chamber, or in the
presence of flammable anesthetics.
yUse only the accessories specified for this device. Otherwise, proper
function cannot be executed.
yFor quality improvement, specifications are subject to change
without prior notice.
yThis equipment is intended to be used for only one patient.
yThe operation and maintenance of this equipment should be
performed by well-trained and authorized personnel.
yThe installation of this equipment should be performed by our
service representative or a person who is well acquainted with this
equipment.
yThe installation of the battery will be performed by our service
representative. Users should not perform this procedure as electric
shock may result to the patient and operator or malfunction of the
equipment may occur.
yIf not using for a long period, make sure to turn OFF the power of
the main unit.
yDuring transportation, make sure to firmly grasp the handle of the
monitor to avoid dropping it. The operator may be injured or the
equipment may be damaged.
yWhen installing the recording paper, pay attention not to touch the
thermal head or sensor. The temperature of those parts rises
immediately after printing and may cause burn injury. Also, it may
cause failure to the thermal head and sensor.
xv

CAUTION
zPatient Admit / Discharge
yThis unit cannot display the patient information (patient ID, patient
name, etc.) received from the central monitor, even when a wireless
network or TCON system is constructed.
yThe patient classification selection influences the precision of the
QRS detection or NIBP measurement and Alarm Limit Setup area.
Make sure the correct selection is made.
yIf monitoring of new patient is started without discharging the previous
patient, the measurement data of the previous and new patient will
become mixed up on the table and trend data.
yWhen the discharge procedure is performed, patient data such as
trend data will be initialized. The parameter and alarm will be reset
according to the setting on [Main Menu]>[Maintenance]>[Backup
Setup]>[Backup at Discharge].
zECG Monitoring
yIf different types of electrodes are used at the same time, the
difference between the polarization potential from each electrode may
interfere monitoring. Make sure to use electrodes of the same type.
yDo not reuse/re-sterilize the disposable electrodes.
yECG measurement part is Type CF applied part, but it is not intended
to directly apply on patient's heart.
yThe indication for continuous use of the electrode is about one day.
yReplace the electrode if the skin contact gets loosen due to
perspiring, etc.
yWhen an electrode is attached to the same location for a long period,
some patients may develop skin irritation. Check the patient's skin
condition periodically and change the electrode site as required.
yUse only the specified relay cables, lead cables, and electrodes.
yThe conductive parts of electrodes and associated connectors for
applied parts, including the neutral electrode, should not contact other
conductive parts including earth.
yVerify proper electrode placement, lead, waveform size, and filter
mode selection. If not properly selected, it may cause erroneous
detection.
zRespiration Monitoring
yWhen a defibrillator is used during respiration monitoring, a large
offset voltage will be placed on the ECG electrodes, which may cause
interruption of monitoring for a few seconds.
zSpO2Monitoring
yIf the nail is rough, dirty, or manicured, accurate measurement will not
be possible. Change the finger or clean the nail before attaching the
probe and sensor.
yIf irritation such as skin reddening or skin fit appears with the sensor
use, change the attachment site or stop using the sensor.
yWhen fixating the sensor with tape, do not wind the tape too strong.
At the same time, check the blood flow constantly so that congestion
is not generated at the peripheral.
yEven attachment over a short duration of time may inhibit the blood
flow and generate compression necrosis or burn injury. Additionally,
blood flow inhibition may prevent correct measurements.
yCheck the sensor attachment site constantly in every 4 hours when
probes or reusable sensor are used, and at least every 8 hours when
a single-patient-use sensor is used. Be especially careful of a patient
with bad perfusion. If the sensor attachment position is not changed
constantly, skin irritation or skin necrosis due to compression may be
developed. For the patient with bad perfusion, check the sensor
attachment position at least every 2 hours.
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