DS-8500 System Service Manual Edition 1 Aug 2011.pdf
Page 1
●
●
●
Patient Monitor
DS-8500 System
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
Service Manual
DSC-8510/8530
CC-82/83
z Before setting up/maintenance, please read this “Service Manual” thoroughly.
z After reading, keep this manual for future reference.
●
●
Page 2
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
technical drawing in the service manual is unreadable, you can
request it to us by specifying a page or a part.
When you have received this service manual, verify that there is no
paging disorder or missing page. You are requested to kindly fill the
underlined area below in this sheet and send it back to us after
verification. Please be noted that photocopying of this manual is
strictly prohibited.
Also, for improvement of the future service manual, your comment and
request will be appreciated. If you have any comment or request on
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
Received by
of (Company/Hospital)
on the day of
Page 3
Revision History
Model Name
DS-8500 System
Edition
1
－
Service Manual
Revised Items
Reason of the Revision
New Edition
Revised Date
2011.8
Page 4
Blank Page
Page 5
Preface
Thank you for purchasing this product.
Before using this product, read the following precautions to make sure the product is
used correctly and safely.
Safety Precautions·························································· ii
Labels Attached to the Unit ·········································· ii
Measurement Unit for Each Parameter ······················· iv
Graphic Symbols ························································· vi
Precautions for Safe Operation of Medical Electrical
Equipment ·································································· vii
Precautions for Safe Operation of Medical Telemetry
(When using HLX-501) ·············································· viii
Precautions about the Maintenance ···························· ix
Precautions about Pacemaker ·····································x
Non-Explosion Proof·····················································x
Defibrillation Safety·······················································x
Electrosurgery Safety ·················································· xi
Precautions about Magnetic Resonance Imaging ······· xi
Precautions about Connections to
Peripheral Devices ····················································· xii
Precautions about the Fuse········································ xii
Accessories and Optional Accessories······················· xii
Precautions about the DS-8500 System···················· xiii
Precautions about the Wired Network System
(DS-LAN ΙΙ/DS-LAN ΙΙΙ)·············································· xx
Precautions about the Wireless Network System ······ xxi
Precautions for Use of Bidirectional Wireless
Communications (TCON) ········································· xxii
Precautions about the Ventilator Monitoring·············xxiii
Precautions for Use of SpO2 Sensor ······················· xxiv
Precautions for Use of NIBP Cuff ···························· xxiv
Disposing of Equipment, Accessories,
or Components ······················································ xxiv
Precautions about Transportation····························· xxv
Precautions about RTC or Data Backup··················· xxv
To Prepare for Emergency Use ································ xxv
Electromagnetic Compatibility···································xxvi
Precautions for Safe Operation under Electromagnetic
Influence·································································· xxvi
EMC Guidance ························································ xxvi
Compliance to the Electromagnetic Emissions ··xxvii
Compliance to the
Electromagnetic Immunity (1) ·························xxvii
Compliance to the
Electromagnetic Immunity (2) ························xxviii
Recommended Separation Distances between
Portable and Mobile RF Communications
Equipment and the DS-8500 System ············· xxix
i
Page 6
Safety Precautions
y Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the
product.
y Make sure to follow the precautions indicated below, as these are important messages related to
safety.
Failure to follow this message may cause immediate threat of death or serious
D A N G E R injury, or complete failure of the equipment.
Failure to follow this message may result in death or serious injury, or
W A R N I N G complete failure of the equipment.
C A U T I O N Failure to follow this message may cause injury or failure to the equipment.
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.
Labels Attached to the Unit
Make sure to read the warning labels attached to the unit and comply with these requirements
while operating the unit.
Do not damage or erase the warning labels attached to the unit.
These warning labels contain descriptions important for handling and
CAUTION
operating the unit properly and safely. A damaged label may compromise
safe operation.
ii
Page 7
DS-8500 System Main Unit (DSC-8500 Series)
iii
Page 8
Measurement Unit for Each Parameter
The measurement units for this equipment are as follows.
Detail
Heart Rate / Pulse Rate
ST Level
VPC
Respiration Rate
Apnea
Invasive Blood Pressure
Non-Invasive Blood
Pressure
Arterial Oxygen Saturation
Temperature
End-Tidal CO2
Concentration
Inspiratory CO2
Concentration
Cardiac Output
Blood Temperature
Injectate Temperature
Airway Flow
Airway Pressure
Tidal Volume
Minute Ventilation
Compliance
Airway Resistance
Airway Pressure
Spontaneous Respiration
Peak End Expiratory
Pressure
Fraction of Inspiratory
Oxygen
iv
Parameter
Display
Unit
bpm
(beats per minute)
bpm
bpm
mm, mv
beat/minute
Bpm
(breaths per
minute)
Bpm
Bpm
Bpm
s (second)
s (second)
s (second)
mmHg, kPa
cmH2O (CVP only)
Default
ECG
HR
Invasive Blood Pressure
SpO2
ECG
ECG
PR_IBP
PR_SpO2
ST
VPC
Impedance Respiration
RR_IMP
CO2
Ventilator
Gas Module
Impedance Respiration
CO2
Ventilator
RR_CO2
RR_VENT
RR_GAS
APNEA
APNEA
APNEA
Invasive Blood Pressure
BP
Non-Invasive Blood Pressure
NIBP
mmHg, kPa
SpO2
Temperature
SpO2
TEMP
%
°C
CO2
EtCO2
mmHg, kPa, %
mmHg
CO2
InspCO2
mmHg, kPa, %
mmHg
Cardiac Output
Blood Temperature
Injectate Temperature
Airway Flow
Airway Pressure
Expiratory Tidal Volume
Inspiratory Tidal Volume
Tidal Volume
Inspiratory/Expiratory Ratio
Minute Ventilation
Spontaneous Minute Ventilation
Compliance
Static Compliance
Dynamic Compliance
Expiratory Resistance
Inspiratory Resistance
Static Airway Resistance
Dynamic Airway Resistance
Mean Airway Pressure
Maximum Airway Pressure
Pause Airway Pressure
Minimum Airway Pressure
Spontaneous Respiration
CO
Tb
Ti
AWF
AWP
E-TV
I-TV
TV
I:E
MV
SMV
COMP
S_COMP
D_COMP
E-RES
I-RES
S-RES
D-RES
MEAN
PEAK
PAUSE
P_Min
S_RR
L/minute
°C
°C
L/minute
cmH2O
mL
mL
mL
(none)
L/minute
L/minute
mL/cmH2O
mL/cmH2O
mL/cmH2O
cmH2O/L/Sec
cmH2O/L/Sec
cmH2O/L/Sec
cmH2O/L/Sec
cmH2O
cmH2O
cmH2O
cmH2O
Bpm
Peak End Expiratory Pressure
PEEP
cmH2O
Fraction of Inspiratory Oxygen
FIO2
%
mv
mmHg
mmHg
Page 9
Detail
Vigilance Data
・Vigilance
・Vigilance CEDV
・VigilanceΙΙ
・Vigileo
Multigas Unit
BIS Monitor Data
aepEX Monitor Data
Parameter
Mixed Venous Oxygen Saturation
Central Venous Oxygen
Saturation
Arterial Oxygen Saturation
Oxygen Uptake Index
Oxygen Transport
Oxygen Consumption
Stroke Volume
Stroke Volume
(STAT Mode)
Stroke Volume Index
Stroke Volume Index
(STAT Mode)
Display
SvO2
%
Unit
ScvO2
%
SaO2
O2EI
DO2
VO2
SV
%
%
mL/minute
mL/minute
mL
SV_STAT
mL
SVI
mL/m2
SVI_STAT
mL/m2
Heart Rate
HR
Mean Arterial Pressure
Central Venous Pressure
Continuous Cardiac Output
Continuous Cardiac Output
(STAT Mode)
Continuous Cardiac Index
Continuous Cardiac Index
(STAT Mode)
Systemic Vascular Resistance
Systemic Vascular Resistance
Index
Blood Temperature
Ejection Fraction
Ejection Fraction
(STAT Mode)
End-Diastolic Volume
End-Diastolic Volume
(STAT Mode)
End-Diastolic Volume Index
End-Diastolic Volume Index
(STAT Mode)
End-Systolic Volume
End-Systolic Volume Index
Stroke Volume Variance
Et CO2 Concentration
Insp CO2 Concentration
End Tidal Oxygen
Inspired Oxygen
Expired Nitrous Oxide
Inspired Nitrous Oxide
End Tidal Anesthetic Gas
Expired Agent gas
Bispectral Index
Signal Quality Index
Electromyograph
Suppression Ratio
AEPIndex
MAP
CVP
CCO
bpm
(beats per minute)
mmHg
mmHg
L/minute
CCO_STAT
L/minute
CCI
L/minute/m2
CCI_STAT
L/minute/m2
SVR
dynes-sec/cm5
SVRI
dynes-sec/cm5
BT
EF
°C
%
EF_STAT
%
EDV
mL
EDV_STAT
mL
EDVI
mL/m2
EDVI_STAT
mL/m2
ESV
ESVI
SVV
CO2-E
CO2-I
O2-E
O2-I
N2O-E
N2O-I
AGT-E
AGT-I
BIS
SQI
EMG
SR
aepEX
mL
mL
%
mmHg, kPa, %
mmHg, kPa, %
%
%
%
%
%
%
(no unit)
%
dB
%
(no unit)
Default
mmHg
mmHg
v
Page 10
Graphic Symbols
Refer to the following for the meaning of the symbols indicated on the equipment.
DS-8500 System Main Unit
Symbol
Description
Caution; 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 the devices.
Protective Earth
Indicates the protective earth inside the equipment.
Power ON
Indicates that the main power switch is in the ON position.
Power OFF
Indicates that the main power switch is in the OFF position.
Electrostatic Sensitive Part
Directly touching this connector part with hands should be avoided.
DS-8500 System Symbols displayed on the screen
Symbol
Description
Alarm OFF
Indicates the alarm is OFF.
Heart Rate Synchronization Mark
This mark flashes synchronizing to the heartbeat.
Respiration Synchronization Mark
This mark flashes synchronizing to the inspiration.
Message Icon
This mark will be displayed inside the parameter key when an alarm
message is present for that parameter. Whether or not to display this
icon can be selected on the monitor setup menu.
TCON Mark
Displays the Bidirectional Wireless Communication (TCON)
connection status while in communication.
vi
Page 11
Precautions for Safe Operation of Medical Electrical Equipment
Read the following precautions thoroughly to correctly operate the device.
z Users should have a thorough knowledge of the operation before using this
system.
z Pay attention to the following when installing and storing the equipment.
y Do not install or store in an area where the equipment will be subject to
splashing water.
y Do 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 system.
y Place the equipment on a stable surface where there is no inclination,
vibration, or shock (including during transportation).
y Do not install or store in an area where there are chemical or gasses
stored.
y Verify the power frequency, voltage and allowable current (or power
consumption).
y Ensure the grounding is proper by connecting the accompanying power
cable to the hospital grade outlet.
z Before operating the system, verify the following items.
y Verify the power voltage.
y Check the cable connection and polarity to ensure proper operation of
the equipment.
y Make sure the power system has adequate earth ground.
y Ensure that all cables are firmly and safely connected.
y Pay special attention when the device is used in conjunction with other
equipment as it may cause erroneous judgment and danger.
y Ensure all patient connections are proper and secure.
C A U T I O N z During operation of the system, verify the following items.
y Always observe the system and patient to ensure safe operation of the
equipment.
y If 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.
y Do not allow the patient to come in contact with the device.
y Make sure not to touch all Signal Input/Output parts in the device with the
patient at the same time.
z After using the system, verify the following items.
y Unplug all the cables from the patient before turning off the power.
y When unplugging the cables, do not apply excessive force by pulling on
the cable. Pull from the connector part of the cable.
y Clean the accessories and cables, and keep them together in one place.
y Keep the unit clean to ensure proper operation for the next use.
z If the equipment is damaged and in need of repair, user should not attempt
service. Label the unit “OUT OF ORDER” and contact our service
representative.
z Do not remodel the equipment.
z Maintenance Check
y Make sure to periodically check the equipment, accessories and cables.
y Before reusing the device that has been left unused for a while, make
sure that the device works normally and safely.
z To prevent burn injury to the patient, verify proper attachment of patient
ground plate or ECG electrode type when using the electrosurgical knife,
and verify paste volume or output energy when using the defibrillator. Also,
verify that proper ground is selected.
vii
Page 12
Precautions for Safe Operation of Medical Telemetry (When using
HLX-501)
To operate the device correctly, read the following precautions carefully.
z The medical institution (hereinafter referred to as the “Institution”) must
decide the telemetry installation plan 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.
z When 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.
z When using telemetry which requires zone location, display and identify
each prepared zone in the equipment.
z When laying receiver antenna for each transmitter, the Institution has to
examine the installation so that electronic interference does not occur.
z Based on the above examination result, the Institution should place each
receiver antenna as required.
In managing, make sure to follow the precautions below.
z The 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.
CAUTION
z Select a telemetry manager who understands the characteristics and
functionality of telemetry systems, and is skilled in operating telemetry.
z When installing telemetry, the Overall Manager and the Zone Manager
have to understand the precautions for use of the telemetry in advance.
z The Overall Manager takes responsibility of wireless channel management
and transmitter storage for the whole medical institution by giving proper
instruction.
z The Overall Manager creates a management log, list of wireless channels,
management status for the whole medical institution (hereinafter referred to
as the “management log”. When changing a wireless channel, register it
in the log and give proper instructions to the zone manager or to the user.
z The Zone Manager assumes responsibility for managing the wireless
channels, storing, and managing telemetry.
z The Zone Manager assigns the transmitter to the user, and provides
enough education for use inside the zone.
z The telemetry user verifies operation of the transmitter/receiver before use.
z The 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.
z When 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.
viii
Page 13
Precautions about the Maintenance
Safety Inspection and Maintenance
For safe operation of the equipment, regular inspection and maintenance is 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 ;
y the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
y the equipment was subjected to liquid spill.
y the monitoring function is interrupted or disturbed.
y parts of the equipment enclosure are cracked, removed, or lost.
y any connector or cable shows signs of deterioration.
Reference
Refer to “12. Periodic Check” for details.
Never open the housing while the equipment is in operation or connected to
W A R N I N G 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;
y Maintenance, modifications, and repairs are carried out by authorized personnel.
y Components are used in accordance with Fukuda Denshi operating instructions.
ix
Page 14
Precautions about Pacemaker
z Minute 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.
WARNING
For more details, contact FUKUDA DENSHI personnel, your institution’s
professionals, or your pacemaker distributors.
Reference
“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.
[October 14, 1998 (Letter: www.fda.gov/cdrh/safety.html) – FDA]
Non-Explosion Proof
Never operate the equipment in the presence of flammable anesthetics,
high concentration of oxygen, or inside hyperbaric chamber. Also, do not
D A N G E R operate the equipment in an environment in which there is a risk of
explosion.
Explosion or fire may result.
Defibrillation Safety
z When 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 from the discharged energy.
W A R N I N G z When 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.
z When defibrillating, do not touch the patient and the metal part of the
device or cables. Electric shock may result from the discharged energy.
x
Page 15
Electrosurgery Safety
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. The 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:
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.
WARNING
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. 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 a burn at the electrode site.
Precautions about Magnetic Resonance Imaging
z Do not operate this equipment in magnetic resonance imaging (MRI)
environments.
z When conducting MRI test, remove the electrodes and sensors
WARNING
connected to the patient (test subject).
The local heating caused by the induced electromotive force may cause
burn injury to the patient (subject). For details, refer to the operation
manual for the MRI testing device.
xi
Page 16
Precautions about Connections to Peripheral Devices
For safety and good performance of this equipment, 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.
For the connector with
mark, only the peripheral devices specified by
Fukuda
Denshi
should
be
connected
with the given procedure. Use of an
WARNING
unspecified device may cause electric shock to the patient and/or operator
due to excessive leakage current.
All the peripheral device connectors on the DS-8500 system are isolated
from the power supply, but the peripheral devices are not isolated. To
C A U T I O N prevent danger of electric shock, always position the peripheral devices
away from the patient.
When connecting peripheral devices to DS-8500 system, it is the user’s responsibility to verify that
the overall system complies with IEC 60601-1-1, “Collateral Standard: Safety Requirements for
Medical Electrical Systems”.
Precautions about the Fuse
If the fuse blows, do not continue using it as internal damage to the
D A N G E R equipment may be considered.
Accessories and Optional Accessories
Use only the cables specified by Fukuda Denshi.
Use of other cables may result in increase in emission (unnecessary
WARNING
generation of electromagnetic energy from this unit) or decrease in
immunity (resistance characteristics to electromagnetic interference
generating from other device).
xii
Page 17
Precautions about the DS-8500 System
Be cautious when connecting to other device.
D A N G E R Danger such as electric shock may result to the patient and operator.
z Do not connect a unit or cable not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the DS-8500 system cannot deliver its
maximum performance and the connected units may be damaged, resulting
in a safety hazard.
z If the DS-8500 system is used under an environment not fulfilling the
specified condition, not only that the equipment cannot deliver its maximum
performance, the equipment may be damaged and safety cannot be
ensured.
z Use only the accompanying 3-way AC power cable. Use of other cables
may result in electric shock to the patient and the operator.
z The power cable must be connected to hospital grade outlet.
z When using multiple ME equipment simultaneously, perform equipotential
grounding to prevent potential difference between the equipment. Even a
small potential difference may result in electric shock to the patient and the
operator.
z The patient classification selection influences the precision of the QRS
detection and NIBP measurement. Make sure the correct selection is
made.
z The pacemaker use selection influences the precision of the QRS detection
and arrhythmia analysis. Make sure the correct selection is made.
z If the QRS pace pulse mask function is set to OFF , 10ms or 20ms ,
a decrease in heart rate may not generate HR or ASYSTOLE alarms due to
erroneously detected QRS. Set this function to OFF , 10ms or
20ms only if you are sure that pacing failure will not occur, or when the
patient can be constantly monitored.
z When measuring the SpO2 of patient with high fever or peripheral
WARNING
circulatory insufficiency, check the sensor attachment periodically and
change the attachment site. The temperature of attachment site will rise 2
to 3°C due to the sensor heat which may result in burn injury.
z For the following case, accurate measurement may not be possible.
y Patient with excessive abnormal hemoglobin (HbCO, MetHb)
y Patient with the pigment injected to the blood
y Patient receiving CPR treatment
y When a sensor is applied to a limb with NIBP cuff, arterial catheter, or
intracatheter
y When measuring at site with venous pulse
y Patient with body motion
y Patient with small pulse
z Before the 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.
z Use the specified sampling tube and nasal prong manufactured by Oridion.
z For CO2 concentration measurement, always consider the circumference of
the intubation tube when using the airway adapter. If inappropriate airway
adapter is used for a patient with low ventilation, CO2 may mix in to the
inspired air resulting in incorrect measurement, or apnea detection may
become difficult.
z When measuring CO2 concentration of a patient treated with
mouth-to-mouth resuscitation, Jackson-Rees circuit, Mapleson D circuit of
which CO2 gas may mix in, the value may be displayed lower than the
actual value.
xiii
Page 18
z When the system alarm is suspended, all the alarm will be suspended even
if the parameter alarm is set to ON. Also, the alarm event will not be stored
as recall.
z If the upper/lower alarm limit of the parameter is set to OFF, or arrhythmia
alarm is set to OFF, alarm will not function even if the system alarm is set
to ON. Pay attention when setting them OFF.
z Objective and constant arrhythmia detection is possible through the fixed
algorithm incorporated in this monitor. However, excessive waveform
morphology change, motion artifact, or the inability to determine the
waveform pattern may cause an error, or fail to make adequate detection.
Therefore, physicians should make final decisions using manual recording,
alarm recording and recall waveform for evaluation.
z The HR/PR alarm will not be generated unless the parameter key
corresponded to the selected HR/PR source is displayed. Make sure to
display the parameter key for the HR/PR source.
z The RR/APNEA alarm will not be generated unless the parameter key
corresponded to the selected RR/APNEA source is displayed. Make sure to
display the parameter key for the RR/APNEA source.
z When selecting Silence or Time Disp. Only for the night mode, pay
attention not to miss any important alarm by simultaneously monitoring the
WARNING
bed on other monitors such as central monitor.
z When lifting this device, hold the bottom part of the main unit and the
display unit.
z When attaching the display unit to the DSC main unit, place the display unit
facing down and slowly attach the main unit using the guide on the side of
the display unit. Then, secure it with the specified screws.
z About the Trolley
y When integrating and mounting a display unit + a main unit + an
exclusive stand to a trolley, make sure that they are fixed using the
screws (x4). Otherwise, the equipment may fall from the trolley, resulting
in injury to the operator or damage to the equipment.
y Use the trolley only with the equipment specified by Fukuda Denshi.
Otherwise, the monitor and trolley may fall down, resulting in injury or
damage to the monitor.
y Make sure to lock both casters when using or storing the trolley.
The trolley may move or fall down, resulting in injury or damage to the
monitor.
y Do not use or store the trolley where it will be subject to inclination of 10
degrees or more. The trolley or equipment may fall resulting in injury or
damage to the equipment.
xiv
Page 19
z Systems
y Use only the accessories specified for this device. Otherwise, proper
function cannot be executed.
y Do not use the touch panel with the film attached. Malfunction of the
touch panel or damage may result.
y Due to its material characteristic, the touch panel expands/contracts
depending on the temperature/humidity. When the touch panel is left
unused for a while, or when the ambient temperature is low, the surface
film of the touch panel may expand, but this is not an abnormal condition.
This expansion will be reduced in few hours or half a day after the power
is turned ON.
y For quality improvement, specifications are subject to change without
prior notice.
y The display panel utilizes exclusive fluorescent light for the backlight.
Since this fluorescent light deteriorates by the life cycle, the display may
become dark, scintillate, or may not light by the long term use. In such
case, contact your nearest service representative and replace the LCD
panel.
y This equipment is intended to be used for only one patient.
y The installation of this equipment and attaching the option unit should be
performed by a person who is well acquainted with this equipment.
y If it is not used for a long period, make sure to turn OFF the power of the
main unit.
z ECG Monitoring
y The indication for continuous use of the electrode is about one day.
y Replace the electrode if the skin contact gets loose due to perspiring,
etc.
y When an electrode is attached at the same location for a long time, some
patients may develop a skin irritation. Check the patient’s skin condition
periodically
and change the electrode site as required.
CAUTION
y For stable arrhythmia detection and ECG monitoring, verify proper
electrode placement, lead, waveform size, and filter mode selection. If
not properly selected, it may cause erroneous detection.
y The arrhythmia detection level is related with the displayed waveform
size. Set a proper waveform size for monitoring.
When the waveform size is ×1/4, ×1/2, or ×1, the detection threshold is
250µV. When the waveform size is ×2 or ×4, the detection threshold is
150µV.
y The QRS detection leads, arrhythmia detection leads, monitoring leads
on the central monitor, recording leads are fixed as ECG1 and ECG2.
Especially for arrhythmia detection, set the most appropriate leads with
high QRS for ECG1 and ECG2.
y Automatic size/position of the ECG is effective only at the time the
AUTO key is pressed. This does not continually adjust size and
position.
y The ESIS mode can largely reduce the artifact such as electrosurgery
noise and EMG, but it may also reduce the QRS amplitude. Using the
ESIS mode may erroneously detect the pacemaker spike. The ESIS
mode should be selected only during electrosurgery.
y There are some cases when 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 pacemaker pulse
detection.
y If 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.
y When spontaneous QRS and pacemaker pulse overlap (ex. fusion beat,
etc.), QRS detection cannot be performed properly. In this case, the
heart rate is degraded.
xv
Page 20
z
z
CAUTION
z
z
xvi
y When continuously detecting AC noise artifact as pacemaker pulses,
QRS detection stops and heart rate is extremely degraded. Also
arrhythmia cannot be detected.
Respiration Monitoring
y When 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.
SpO2 Monitoring
y If the nail is rough, dirty, or manicured, accurate measurement will not be
possible. Select a different finger or clean the nail before attaching the
sensor.
y If irritation such as skin reddening or rash appears with the sensor use,
change the attachment site or stop using the sensor.
y When fixing the sensor with tape, do not wind the tape too tight. At the
same time, check the blood flow constantly so that congestion is not
generated at the peripheral.
y Even a short duration of attachment may inhibit the blood flow and
generate compression necrosis and burn injury.
y Change the sensor attachment site constantly (every 4 hours). As the
temperature of the sensor attachment site normally rises 2 to 3°C
y As skin for neonate / low birth weight infant is immature, change the
sensor attachment site more frequently depending on the condition.
y Direct sunlight to the sensor area can cause a measurement error.
Place a black or dark cloth over the sensor.
y When not performing measurement, unplug the relay cable and sensor
from the SpO2 connector. Otherwise, the measurement data may be
erroneously displayed by the ambient light.
y The DS-100A is intended for use on finger of adults weighing over 40 kg
(approximate). Do not use them on children or neonates. Also do not
apply them on the thumb or foot.
y The light-emitting part of the sensor should be over the root of the
fingernail. Do not insert the finger too far into the sensor as it may hurt the
patient.
y Measuring on a limb with NIBP cuff, arterial catheter, or intracatheter may
result in incorrect measurement.
NIBP Monitoring
y Pay attention when measuring the NIBP of patient with bleeding disorders
or hyper coagulation. The cuff inflation may cause petechia or circulatory
failure by the blood clot.
y For the following situation, measurements will be terminated.
When the measurement time has exceeded 160 seconds for adult and
child, 60 seconds for neonate.
When the inflation value has exceeded 300mmHg for adult, 210mmHg for
child, 150mmHg for neonate.
y If used with the incorrect patient classification, it will not only cause
erroneous measurement, but the inflating level for the adult may be
applied to child or neonate causing dangerous situation to the patient.
y The 1-minute interval measurement will always start from 00 second.
Pressing the 1min start key will start the measurement from the next 00
second.
y The alarm function will be ineffective for the BP value measured by Quick
SYS regardless of the ON/OFF selection of NIBP alarm.
y If the mean display is set to OFF, the mean BP will not be generated.
Also the mean BP will not be displayed inside the tabular trend or the
NIBP list function if the display is set to OFF.
BP Monitoring
y When the main power is turned ON, the BP value will not be displayed
until zero balance is performed. However, if the power is turned ON within
5 minutes after the power is turned OFF, the previous zero balance
information will be maintained, and BP value will be displayed.
Page 21
y Each time the blood pressure transducer or tubing is replaced, the zero
balance procedure is required to ensure accurate measurements.
y “Perform zero balance” message will not be displayed unless the
three-way valves of all pressure transducers are opened to air. If the
status is not displayed, or if “Open stop cock to air” message is
displayed, check if the three-way valve of pressure transducers is
opened to air.
y The zero balance procedure is required for the following case.
・ When starting the measurement.
・ When the position of the heart has changed due to body movement.
・ When the position of the transducer has changed.
・ When measuring for a long period of time and there is a possibility of
measurement error due to change in ambient temperature, etc.
・ When the connector is connected / disconnected, or transducer is
replaced.
・ When the power has been turned OFF for more than 5 seconds.
y Note that Systolic Pressure (SYS) = Peak Systolic Pressure (PSP) for
the graphic trend, data base, and alarm setup.
y When ECG is not measured, PDP cannot be calculated.
y The BP data (SYS/DIA/Mean) not displayed will not generate the BP
alarm or be displayed for the tabular trend function.
z CO2 Monitoring (MGU-800 Series)
y When using the MGU-800 series Gas Unit, CO2 measurement by the
HPD-800 Gas Unit I/F and HCP-800 CO2 Gas Unit will not be
performed.
y Do not disconnect the sampling tube during calibration. If disconnected,
calibration will cease..
y Conduct CO2 calibration for the following case.
・ After 12 months after the last calibration
CAUTION
・ When EtCO2 measurement is not stable or accuracy is degraded
compared with other measuring device.
・ When the patient monitor was not used for a while, or when EtCO2
was not measured for a while.
y The disposable airway adapter should be opened just before use. Do
not sterilize it.
y Do not reuse the disposable airway adapter.
y Do not sterilize the reusable airway adapter using autoclave methods.
z CO2 Monitoring (HCP-800)
y Conduct CO2 calibration for the following case.
・ When 12 months has elapsed from first use, or the accumulated
measurement time exceeds 1200 hours.
・When 12 months has elapsed from the last calibration date, or the
accumulated measurement time exceeds 4000 hours.
・When EtCO2 measurement is not stable or accuracy is degraded
compared with other measuring device.
・When the patient monitor was not used for a while, or when EtCO2
was not measured for a while.
y Perform calibration after 5 minutes since the power is turned ON for
HCP-800.
y Do not disconnect the sampling tube during calibration. If disconnected,
calibration will cease.
y Dispose of calibration gas according to the regulation of each medical
institution.
y Microstream® EtCO2 sampling lines are designed for single patient use,
and are not to be reprocessed. Do not attempt to clean, disinfect,
sterilize or flush any part of the sampling line as this can cause damage
to the monitor.
xvii
Page 22
z
z
CAUTION
z
z
xviii
y Dispose of sampline lines according to standard operating procedures or
local regulations for the disposal of contaminated medical waste.
y Before use, carefully read the Microstream® EtCO2 sampling lines
Directions for Use.
y Only use Microstream® EtCO2 sampline lines to ensure the monitor
functions properly.
CO2 Monitoring (HPD-800 Gas Unit I/F)
y The airway adapter should be attached with the thicker side facing to the
patient. If attached oppositely, it may damage the CO2 sensor or airway
adapter.
Alarm
y Alarm messages will be displayed according to the priority. (Level S →
Level H → Level M → Level L → Level N)
y For the same alarm level, the alarm message for the newer alarm will be
displayed.
y The alarm message for the arrhythmia alarm will continue to be
displayed for 30 seconds after the alarm is resolved.
y While the “LEAD OFF” message is displayed, HR alarm and arrhythmia
alarm will not function. Leaving this condition unresolved may result in
missing a sudden change of the patient. Promptly check the electrodes
when this message is displayed.
y When using the HPD-800 Gas Unit I/F series Super Unit, the upper
EtCO2 alarm will not generate if the upper limit is set to
100mmHg/13.4kPa and above as the measurement range is 0–99mmHg
/ 0–13.3kPa.
y Whether to use the SEC alarm function and its threshold selection should
be based on the patient’s clinical indication portent and medical
evaluation.
y If the SpO2 alarm and SEC alarm setup is set to OFF, the SEC alarm
integral value will be set to 0.
y Be cautious not to miss any important alarm by leaving the alarm
silenced.
System Configuration
y When the waveform and numeric data display for each parameter is set
to OFF, the alarm and tabular/graphic trend will be also set to OFF.
y When the waveform and numeric data display is set to OFF, the
respiration rate measured by CO2 will not be displayed either.
y If the RR source is set to the multigas unit, and if GAS waveform/numeric
data display is set to OFF, the RR value will not be displayed.
y Do not set the same remote control bed ID to more than one monitors on
the same floor.
Otherwise, it may cause to remote control more than one monitors at the
same time.
y After the remote control setup, check that the remote control unit is
properly operating.
y If the time/date is not correctly set, or changed during monitoring,
malfunction may occur with NIBP measurement, periodic recording,
trend, NIBP list data, and age calculation from the birth date.
The multigas unit data monitoring
y The gas calibration will be performed when the multigas unit is
connected.
y Warm up the multigas unit sufficiently before the gas calibration. To
acquire maximum measurement accuracy, 30 minutes of warm up is
required after the power is turned ON.
y If the calibration is performed using a low pressure gas, the accuracy of
gas measurement will be reduced. Make sure to perform the calibration
using the specified calibration gas which is before its expiration date.
y If the multigas unit is not zeroed, “Zeroing Error will be displayed and
previous calibration data will be reset. Perform the calibration again.
Page 23
z
z
z
CAUTION
z
y Make sure to firmly connect the calibration gas cylinder and the regulator.
y Make sure to connect the regulator and the regulator tube so that the
calibration gas will not leak.
y To prevent the gas cylinder to become empty, make sure to disconnect
the regulator when not using it.
y If calibration fails for some parameter due to sampling error, "Sampling
Error” will be displayed and “ERR” will be displayed next to the
corresponding parameter. Pressing YES will start the calibration for the
parameter without the sampling error.
Patient Admit / Discharge
y If you start monitoring a new patient without performing a discharge
procedure of the previous patient, new data will be added to the previous
data which will result in inaccuracy.
y The mode setting (alarm/display configuration) will remain effective even
when the power is turned OFF or when the patient is discharged. Before
monitoring, make sure the current user mode is suitable for the patient’s
condition.
y Resuming monitoring will also resume the alarm in suspension.
ST Measurement
y For the lead which the electrode is detached, the reference waveform
setup cannot be performed. Check if the electrode is correctly attached,
and perform the setup again.
CF Card
y Use only the specified CF card.
y Use only the CF card formatted with this device.
y Restart the system after reading the setup data from the CF card.
The setup data will become effective after the system is restarted.
y Reading the patient data from the CF card will erase all previous patient
data stored in the patient monitor.
Maintenance
y When cleaning the touch panel, never use strong-acidic cleaning solution.
y A special coating is applied to the surface of the touch panel. Do not wipe
the surface with a cloth or gauze with coarse texture. Wipe the surface
with a soft cleaning cloth provided as optional accessory or with an
eyeglass cleaning cloth.
y Clean the unit frequently so stains can be removed easily.
y To prevent injury, it is recommended to wear gloves when cleaning the
equipment.
y Do not allow liquids or cleaning solution to enter the equipment or
connectors.
y Do not use organic solvents, thinner, toluene and benzene to avoid
damaging the resin case.
y Do not polish the housing with abrasive or chemical cleaner.
y When sterilizing the entire room using a spray solution, pay close
attention not to have liquids get into the equipment or connectors.
y The surface resin coating may be damaged, resulting in discoloration,
scratches, or other problems.
Example:
Do not use chemical cloth, scrub brush, abrasive, polishing powder, hot
water,
volatile solvent and chemicals (cleanser, thinner, benzine, benzol, and
synthetic
detergent for house and furniture), or sharp-edged tools.
y Do not open the housing.
y Make sure that alcohol and other liquids do not enter inside the unit.
y Replace the periodic replacement parts periodically as specified.
xix
Page 24
Precautions about the Wired Network System (DS-LAN ΙΙ/DS-LAN ΙΙΙ)
W A R N I N G Do not connect unspecified device to a wired network.
z If performing wired network transmission, configure the display so that the
numeric data corresponded to the waveform is displayed. If not, the
displayed waveform or numeric data may not be transmitted.
z The Bed ID is factory set to 000. If connected to the wired network with the
ID unchanged, monitoring on the central monitor will not be possible.
z When connected to the wired network, verify that the Bed ID is not duplicate
with other bedside monitors. Otherwise, monitoring on the central monitor
for both bedside monitors will not be possible.
z When connected to the DS-LAN ΙΙ network, set the Bed ID in the range from
001 to 048.
z When connected to the DS-LAN ΙΙΙ network, set the Bed ID in the range
from 001 to 100.
z When using the DS-8500 on the wired network, the measurement unit
should be “mmHg” for BP.
z There are some restrictions when connecting the DS-8500 system to the
wired network, and they are:
y When the measurement unit of BP is kPa, BP waveform, BP numeric data,
NIBP numeric data, NIBP list will not be transmitted. These will be treated
as not measured data, and will not be displayed on the central monitor.
Also, alarm limit setup on the central monitor cannot be performed.
y Arrhythmia alarm of TACHY, BRADY, COUPLET, PAUSE, TRIGEMINY
will not be transmitted.
y Arrhythmia alarm of “SLOW_VT” will be transmitted as “VT”.
y On a wired network, waveform, numeric data, alarm of BP7, 8, and
TEMP3-8 will not be transmitted. Also, the displayable waveform, numeric
data, alarm differs depending on the connected central monitor. Refer to
the operation manual for the respective central monitor.
y
The
PR_IBP Alarm will not be transmitted to the central monitor.
CAUTION
y If the RR/APNEA alarm source is other than Impedance (Or, if Auto
selects a setting other than impedance for RR/APNEA alarm source), the
respiration waveform will not be transmitted on the network.
y If the “RR/APNEA alarm source” is other than CO2/GAS (Or, if Auto
selects other than CO2/GAS), CO2 waveform will not be transmitted on a
wired network.
y For numeric data displayed as “×××”, maximum or minimum value of
measurable range will be transmitted.
y The numeric data displayed as “− − −” will be treated as not measured
data.
y If the measurement unit of CO2 concentration is “mmHg”, and
99mmHg is selected for “CO2 (mmHg) Upper Limit for LAN, Telemetry”
on the monitor setup menu, the CO2 value of 100mmHg or above will be
transmitted as 99mmHg.
z As the DS-8500 do not have the arrhythmia template display and 12-lead ST
display function, these displays on the central monitor will not be
corresponded.
z If connected to a wired network, time/date will be the same with the central
monitor. Even if the time/date is changed on the DS-8500 system, it will be
corrected to the time/date of the central monitor.
z If ECG lead (ECG1 or ECG2) is changed on the DS-8500 while monitoring
ST display on the central monitor, the ST display will be distorted.
Redrawing the ST display will return the display to normal.
z The respiration waveform and RR value based on the RR/APNEA alarm
source selected on the DS-8500 will be displayed on the central monitor.
The monitoring RR and APNEA will be the same as the one monitored on
the DS-8500.
xx
Page 25
Precautions about the Wireless Network System
When monitoring a patient using wireless telemetry, make sure the patient
D A N G E R data is properly received at the central monitor. Pay special attention when the
channel ID at the bedside monitor is changed.
z A password can be set to access the channel ID setup menu to allow only
the telemetry channel administrator to change the channel ID.
z Some wireless combinations of telemetry transmitters may generate
interference with other devices.
z Before selecting a channel, verify it will not interfere with other channels.
W A R N I N G z Make sure the telemetry manager of your system is aware of any changes
to the telemetry channels.
z If 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.
z Telemetry Transmission
y If performing telemetry transmission, configure the display so that the
numeric data corresponded to the waveform is displayed. If not, the
displayed waveform or numeric data may not be transmitted.
y Users should not set up channel ID and Group ID as malfunction of the
equipment may occur.
y When the BP measurement unit is kPa, the corresponded waveform and
numeric data will not be transmitted. When performing telemetry
CAUTION
transmission, use °C for temperature unit and mmHg for BP unit.
y BP waveform with a scale above the programmed scale can not be
properly transmitted. When transmitting the BP waveform, check the
displayed BP waveform scale.
y If the measurement unit of CO2 concentration is mmHg and 99mmHg is
selected for “CO2 (mmHg) Upper Limit” for [Initial Settings], [System],
[Telemetry], the CO2 value of 100mmHg or above will be transmitted as
99mmHg.
xxi