Fukuda Denshi Dynascope 8000 Series User manual

Series
Patient Monitor
ServiceManual
*
Before setting up/maintenance,
please read this “Service Manual” thoroughly.
*
After reading, keep this manual for future reference.

CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON
THE ORDER OF A PHYSICIAN.
This device bears the CE label in accordance with the provisions of Medical
Device Directive 93/42/EEC.
This device bears the CE label in accordance with the provisions of RoHS
Directive 2011/65/EU.
Fukuda Denshi UK
Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom
CAUTION:
•This device for sale by or on the order of a physician.
•The company and product names used in this manual are trademarks or registered
trademarks.
•If this manual has pages missing or out of order, contact Fukuda Denshi for
replacement.
•Only physician or persons instructed by physicians are allowed to use the equipment.
•The information contained in this document is subject to change without notice due to
improvement in the equipment.
Copyright © 2014 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

Revision History
Model Name
DS-8200 System Service Manual
Edition Revised Items Reason of the Revision Revised Date
1 － New Edition 2014.02

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Preface
Thank you for purchasing our product.
Before using this product, read the following precautions to make sure the
product is used correctly and safely.
Safety ··············································································· ii
About the Safety Precautions ·······································ii
The Meaning of Each Safety Precaution················· ii
Warning Labels Attached to the Unit······················· ii
Measurement Unit for Each Parameter ······················· iii
Graphic Symbols ··················································· vi
Precautions for Safe Operation of Medical Electrical
Equipment ································································· viii
Precautions about the Maintenance ···························· ix
Precautions about the Network System························x
Medical Telemetry···················································x
Bidirectional Wireless Communications Module
(TCON) (Only for USA)······································· xi
Precautions when Using with Other Equipment ········ xiii
Pacemaker··························································· xiii
Non-Explosion Proof ············································ xiii
Defibrillator··························································· xiii
Electrosurgical Instrument ··································· xiv
MRI (Magnetic Resonance Imaging)···················· xiv
Precautions about Connections to Peripheral
Devices······························································ xv
Precautions for Using the Equipment ························ xvi
This System ························································· xvi
Wired Network (DS-LANII/ DS-LANIII)··············· xxiv
Wireless Network System ··································· xxv
RTC and Data Backup ········································ xxv
Precautions about the Ventilator Monitoring············ xxvi
Precautions about the SpO2Sensor························ xxvi
Precautions about the NIBP Cuff····························· xxvi
Precautions about Disposing of the Equipment,
Accessories, or Components··································· xxvi
Precautions about Transportation····························xxvii
Monitoring after Power Failure ································xxvii
To Prepare for Emergency Use ·······························xxvii
Electromagnetic Compatibility ································xxviii
Precautions for Safe Operation under
Electromagnetic Influence ·····························xxviii
EMC Guidance ·················································xxviii
i

Safety
About the Safety Precautions
The Meaning of Each Safety Precaution
Read this manual thoroughly before use to ensure correct and safe use of the product.
Be 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.
CAUTION Failure to follow this message may cause injury or failure to the equipment.
Warning Labels Attached to the Unit
Make sure to read the warning label attached to the equipment and comply with the requirements
while operating the equipment.
CAUTION
Do not damage or erase the warning label attached to the equipment.
This warning label contains descriptions important for handling and
operating the equipment properly and safely. A damaged label may
compromise safe operation.
Super Unit (HS-8312M / HS-8312N)
Warning Label Attached to the Unit (HS-8312)
Warning Label
ii

Measurement Unit for Each Parameter
The measurement units for this equipment are as follows.
Details Parameter Display Unit Default
ECG HR
bpm
(beats per minute)
BP PR_IBP bpm
Heart Rate / Pulse
Rate
SpO2PR_SpO2bpm
ST Level ECG ST mm, mv mm
VPC beat/minute
VPC ECG PACE beat/minute
Impedance RR_IMP
Bpm
(breaths per minute)
Ventilator RR_VENT Bpm
Respiration Rate
CO2, Gas Module RR_GAS Bpm
Impedance APNEA s (second)
CO2APNEA s (second)
Apnea
Ventilator APNEA s (second)
BP BP BP
mmHg, kPa
cmH2O (CVP only) mmHg
Non-Invasive Blood
Pressure
Non-Invasive Blood
Pressure NIBP mmHg, kPa mmHg
Arterial Oxygen
Saturation SpO2SpO2%
Perfusion Index PI %
Perfusion Index Pleth Variability Index PVI %
Carboxyhemoglobin
Concentration SpCO SpCO %
Methemoglobin
Concentration SpMet SpMet %
Total Hemoglobin
Concentration SpHb SpHb g/dL
TEMP TEMP TEMP °C, °F °C
End Tidal CO2
Concentration CO2EtCO2mmHg, kPa, % mmHg
Inspiratory CO2
Concentration CO2InspCO2mmHg, kPa, % mmHg
CO CO CO L/minute
Blood Temperature Blood Temperature Tb °C
Injectate
Temperature
Injectate
Temperature Ti °C
Airway Flow Airway Flow AWF L/minute
Airway Pressure Airway Pressure AWP cmH2O
Ventilatory Volume Ventilatory Volume AWV mL
Expiratory Tidal
Volume E-TV mL
Inspiratory Tidal
Volume I-TV mL
Tidal Volume
Ventilatory Volume
per second TV/1Sec %
Minute Ventilation
Volume MV L/minute
Minute Ventilation
Volume Spontaneous Minute
Volume SMV L/minute
Compliance Compliance COMP mL/cmH2O
iii

Details Parameter Display Unit Default
Expiratory
Resistance E-RES cmH2O/L/Sec
Airway Resistance Inspiratory
Resistance I-RES cmH2O/L/Sec
Mean Airway
Pressure MEAN cmH2O
Peak Airway
Pressure PEAK cmH2O
Pause Airway
Pressure PAUSE cmH2O
Airway Pressure
Plateau Pressure PLATEAU cmH2O
Peak End Expiratory
Pressure
Peak End Expiratory
Pressure PEEP cmH2O
Inspired Oxygen Inspired Oxygen FIO2%
Details Parameter Display Unit Default
Mixed Venous
Oxygen Saturation SvO2%
Central Venous
Oxygen Saturation ScvO2%
Arterial Oxygen
Saturation SaO2%
Oxygen Uptake Index O2EI %
Oxygen Transport DO2mL/minute
Oxygen Consumption VO2mL/minute
Stroke Volume SV mL/beat
Stroke Volume
(STAT Mode) SV_STAT mL
Stroke Volume Index SVI mL/m2
Stroke Volume Index
(STAT Mode) SVI_STAT mL/m2
HR HR
bpm
(beats per minute)
Mean Arterial
Pressure MAP mmHg
Central Venous
Pressure CVP mmHg
Continuous Cardiac
Output CCO L/minute
Continuous Cardiac
Output (STAT Mode) CCO_STAT L/minute
Continuous Cardiac
Index CCI L/minute/m2
Continuous Cardiac
Index (STAT Mode) CCI_STAT L/minute/m2
Systemic Vascular
Resistance SVR dyn-sec-cm-5
Systemic Vascular
Resistance Index SVRI (dyn-sec-cm-5-m2)
Blood Temperature BT °C
Ejection Fraction RVEF %
Ejection Fraction
(STAT Mode) RVEF_STAT %
End-Diastolic Volume EDV mL
Vigilance Data
Vigilance
Vigilance CEDV
Vigilance II
Vigileo
End-Diastolic Volume
(STAT Mode) EDV_STAT mL
iv

Details Parameter Display Unit Default
End-Diastolic Volume
Index EDVI mL/m2
End-Diastolic Volume
Index (STAT Mode) EDVI_STAT mL/m2
End-Systolic Volume ESV mL
End-Systolic Volume
Index ESVI mL/m2
Vigilance Data
Vigilance
Vigilance CEDV
Vigilance II
Vigileo
Stroke Volume
Variance SVV %
Bispectral Index BIS (no unit)
Signal Quality Index SQI %
Electromyograph EMG dB
Suppression Ratio SR %
Spectral Edge
Frequency SEF Hz
Total Power TOTPOW dB
BIS Data
Impedance IMP kohms
AEP Monitor Data AEP Index AEP (no unit)
Regional Cerebral
Oxygen Saturation
(Left)
Lt-rSO2%
INVOS 5100C
Monitor Data Regional Cerebral
Oxygen Saturation
(Right)
Rt-rSO2%sy
v

Graphic Symbols
Refer to the following for the meaning of the symbol indicated on the equipment.
DS-8200 System Main Unit
Symbol Description
Follow operating instructions (Warning); indicated in blue. Failure to
follow operating instructions could place the patient or operator at
risk.
Follow operation instractions (Information).
Indicates the need to refer to the related accompanying documents
before operation.
General precaution
Potential Equalization Terminal
Indicates the terminal to equalize the potential difference when
interconnecting the devices.
Protective Earth
Indicates the protective earth inside the equipment.
Alternating Current
(Main Power Input Indicator)
Indicates that the equipment is in normal operation.
Indicates that the equipment is in standby mode.
Electrostatic Sensitive Part
Directly touching this connector part with hands should be avoided.
Type CF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type CF
Applied Part with defibrillation-proof.
Type BF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type BF
Applied Part with defibrillation-proof.
Signal Output
GAS Input
GAS Output
Signal Input/Output
Battery
vi

Symbol Description
Waterproof Standard
Indicates this equipment complies with IPX1.
(Combination of LC-8210, HSB-80, HS-8000 and BS-8210: IPX1,
Other situation: IPX0)
Year of Manufacture
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic
equipment.
Indicates that this device bears the CE label in accordance with the
provisions of Medical Device Directive 93/42/EEC. The 0086
represents the number of the notified body.
Symbols displayed on the screen
Symbol Description
Alarm OFF
Indicates the alarm is OFF.
Pulse Tone
This mark flashes synchronizing to the heartbeat.
RR Sync. Indicator
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 Initial Settings.
TCON (Only for USA)
Displays the Bidirectional Wireless Communication (TCON)
connection status while in communication.
Key Lock Mark
Indicates that the item requires password input when changing its
setting.
Key Unlocked Mark
Indicates that the key is unlocked
Indicates that AC power is connected.
Displays the remaining battery level.
This icon (full green) indicates that the battery is fully charged.
*The icon flashes while charging and the flashing icon varies
depending on the remaining battery level.
This icon (2/3 green) indicates that the battery is less than full, but
still usable.
vii

Symbol Description
This icon (1/3 yellow) indicates that the battery is low and needs to
be charged.
This icon (1/3 red) indicates that the battery is very low and flashes
to alert the low battery status.
Immediate battery charge is required.
Technical alarm will generate.
This icon (red frame) indicates that the battery is very low and it
flashes for alert to charge. Make sure to charge the battery at the
point when this icon appears.
The remaining operable time is about 5 minutes.
The remaining operable time is based on when measurement of
NIBP 15 minutes interval, ECG, SpO2is performed with a new
battery pack. It will vary depending on the optional unit composition,
NIBP measurement interval, recorder operating condition, etc.
This icon (black frame with a slash) indicates that the battery is not
installed. Pay attention as power will not be supplied if AC power
cable is disconnected during this state.
Precautions for Safe Operation of Medical Electrical Equipment
CAUTION
zUsers should have a thorough knowledge of the operation before using this
equipment.
zPrecautions about the Location of Installation and Storage of the Equipment
ySet the monitor to the user's intended position where the user can easily
recognize the visual and audible monitoring conditions. Normally it is
recommended to set at a distance of 1m from the user.
yInstall or store in a place where the equipment will not be exposed to
splashing water.
yInstall or store in a place where the equipment will not be adversely affected
by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust
or atmosphere containing salt or sulfur.
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.
zPrecautions Before Using the Equipment
yVerify the power voltage. Charge the battery pack fully before operating the
system with the battery pack.
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 equipment is used in conjunction with other
equipment as it may cause erroneous diagnosis and danger.
viii

CAUTION
zPrecautions During Using the Equipment
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.
yOn start-up of the system, verify that the start-up tone generates and alarm
indicator lights.
yFor the connectors which is not Type BF, CF applied part, do not touch
them and the patient at the same time.
zPrecautions After Using the Equipment
yUnplug all the cables from the patient before turning off the power.
yWhen unplugging the cables, make sure to pull from the connector part of
the cable and avoid applying excessive force.
yClean the accessories and cables, and keep them together in one place.
yKeep the equipment clean to ensure proper operation for the next use.
zPrecaution when Equipment Failure Occurs
yIf the equipment is damaged and in need of repair, user should not attempt
service. Label the unit "OUT OF ORDER" and contact Fukuda Denshi.
zPrecaution about Disassembling/Remodeling the Equipment
yDo not disassemble or remodel the equipment.
yIf water or other liquids enter the equipment, cease using the equipment and
contact Fukuda Denshi.
zPrecautions about Maintenance Check
yMake sure to periodically check the equipment, accessories and cables.
yWhen reusing the equipment which was left unused for a while, always
check that the equipment operates properly and safely before use.
zPrecautions when Using with Other Equipment
yTo 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 each equipment is properly grounded.
Precautions about the Maintenance
WARNING Never open the housing while the equipment is in operation or connected to
hospital grade outlet as it may result in electric shock.
CAUTION
Precautions about Safety Check
zFor 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.
zImmediate maintenance has to be carried out for the following case.
yWhen the equipment was subjected to extreme mechanical stress, e.g. after
a heavy fall.
yWhen the equipment was subjected to liquid spill.
yWhen the monitoring function is interrupted or disturbed.
yWhen parts of the equipment enclosure are cracked, removed, or lost.
yWhen any connector or cable shows signs of deterioration.
ix

Precautions about the Network System
Medical Telemetry
CAUTION
Precautions about the Installation
zThe 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.
zWhen 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 Institution.
zWhen using telemetry which requires zone location, display and identify each
prepared zone in the equipment.
zWhen laying receiver antenna for each transmitter, the Institution has to examine
the installation so that electronic interference does not occur.
zBased on the above examination result, the Institution should place each receiver
antenna as required.
Precautions about the Management
zThe 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.
zSelect a telemetry manager who understands the characteristics and functionality
of telemetry systems, and is skilled in operating telemetry.
zWhen installing telemetry, the Overall Manager and the Zone Manager have to
understand the precautions for use of the telemetry in advance.
zThe Overall Manager takes responsibility of wireless channel management and
transmitter storage for the whole Institution by giving proper instruction.
zThe 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.
zThe Zone Manager assumes responsibility for managing the wireless channels,
storing, and managing telemetry.
zThe Zone Manager assigns the transmitter to the user, and provides enough
education for use inside the zone.
zThe telemetry user verifies operation of the transmitter/receiver before use.
zThe 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.
zWhen 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.
x

Bidirectional Wireless Communications Module (TCON) (Only for USA)
CAUTION
z
Precautions about the Installation
zThe 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.
zEven 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.
zIf 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.
zDo not install this device in an area where it will be subject to splashing water.
Water entering the equipment may cause the equipment to malfunction or be
damaged.
Precautions about the Management
zThe Institution should appoint a person (hereinafter referred as the "Overall
Manager" to manage the wireless devices for the whole facility.
When installing TCON, the Overall Manager has to receive an explanation of the
precautions for use of the TCON from the manufacturer or sales representative.
zThe Overall Manager is responsible for the maintenance and storage of the
equipment.
zThe 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.
zThe user needs to verify the transmitting/receiving operation before use.
zIf 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.
Precautions 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. For details, please refer to the HTC-702 Instruction Manual.
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.
xi

CAUTION
z
zWhen the patient's data may 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).
zWhen symptoms such as being unable to communicate, unstable
communication, or poor reception may occur.
yWhen the radio communication is bad because there are metal, concrete, or
other such obstacles between the Bidirectional Wireless Communications
Modules (TCON).
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.
Precautions about the Setting
Follow the instructions from the Overall Manager for the wireless channel when
setting the TCON and channel IDs to prevent interference within the same
institution.
zIf the TCON is set to [OFF], all TCON messages such as "Check TCON Comm."
will not be displayed.
zWhen TCON is used, even if [ON] is set for "Start NIBP Auto Mode with
Start/Stop key."([Initial Settings]>[User I/F]>[Power ON/Discharge]), Backup at
Discharge (NIBP Auto Mode) function will be [ON] since the central monitor will
not be on Standby mode.
zCheck that three antenna bar marks ( ) are displayed.
zMake sure that the TCON group number between the bedside monitor and
central monitor is the same.
zIf the equipment is moved during TCON operation, the radio waves signal may
become interrupted.
zThere are following restrictions when connecting the DS-8200 System to the
TCON network.
yWhen the BP measurement unit is [kPa], the central monitor does not receive
the NIBP/BP1/BP2 Data. Also, the NIBP/BP1/BP2 Alarm Setup cannot be
changed on the central monitor.
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 or continuous measurement. However, it can be stopped.
yIf the measurement unit of CO2concentration is [mmHg], the CO2value of
100mmHg or above will be transmitted as 99mmHg.
xii

Precautions when Using with Other Equipment
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.
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.
[Based on a safety bulletin issued by FDA Center for Devices and
Radiological Health on October 14, 1998]
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.
Defibrillator
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.
zThis equipment will return to standard operating mode within 10 seconds after
defibrillating. The stored data will not be affected. The measurement accuracy
will temporarily decrease during defibrillation, but it will not compromise the
safety of patient and the equipment.
zThe QRS synchronized signal is not intended to be used as synchronized
signal for defibrillator.
xiii

Electrosurgical Instrument
WARNING
zThe 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.
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.
zThe stored data will not be affected. The measurement accuracy will temporarily
decrease during electrosurgery, but it will not compromise the safety of patient
and the equipment.
zWhen using the electrosurgery-proof type ECG relay cable, the impedance
respiration cannot be measured, and its numeric data and waveform will not be
displayed. When measuring in an environment where electrosurgery is not
performed, make sure to use the standard ECG relay cable.
MRI (Magnetic Resonance Imaging)
WARNING
zDo not use this equipment in magnetic resonance imaging (MRI)
environments.
zWhen conducting MRI test, remove the electrodes and sensors connected to
the patient (test subject).
This equipment may be pulled towards the MRI device. Also, the local heating
caused by the induced electromotive force may cause burn injury to the patient
(subject) or performance degradation of this equipment.
For details, refer to the operation manual for the MRI testing device.
xiv

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
zWhen multiple equipments are connected to the patient, the total amount of
leakage current may exceed the limit specified on EN 60601-1 (for Europe) /
IEC 60601-1 (for USA).
zFor the connector with 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
zAlthough the peripheral device connectors on the DS-8200 System are
isolated from the power supply, the connecting peripheral devices should
comply with EN 60601-1 (for Europe) / IEC 60601-1 (for USA) inside the patient
environment. In other cases, to maintain operator and patient safety, consider
the requirements of EN 60601-1 (for Europe) / IEC 60601-1 (for USA). It is the
user's responsibility to ensure that the overall system provides a level of safety
in compliance with EN 60601-1 (for Europe) / IEC 60601-1 (for USA).
zTo prevent danger of electric shock, always position the peripheral devices
away from the patient.
zNetwork equipment including printer and hub should be located outside the
"Patient Environment". If located inside the "Patient Environment", it may
result in electric shock to the patient or the operator.
zCombinations of medical equipment with non-medical equipment must comply
with EN 60601-1-1 (for Europe) / IEC 60601-1-1 (for USA). Never use a
multiple portable socket-outlet or extension cord when combining equipment
unless the socket outlet is supplied specifically for use with that equipment.
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Precautions for Using the Equipment
This System
DANGER When connecting to other equipments, contact Fukuda Denshi.
Danger such as electric shock may result to the patient and operator.
WARNING
Warnings about the System
zDo not connect any damaged / unspecified equipment or cable 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 this equipment 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. If
using the equipment under condition other than specified, contact Fukuda
Denshi.
zUse only the supplied 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.
zCarefully route cables to reduce the possibility of patient entanglement and
strangulation.
zWhen lifting this equipment, hold it by the handle or the bottom part of the
main unit.
Warnings about the Monitoring
zThe patient classification selection influences the precision of the QRS
detection and NIBP measurement. Make sure the correct selection is made.
zThe pacemaker use selection influences the precision of the QRS detection
and arrhythmia analysis. Make sure the correct selection is made.
zIf the QRS pace mask function is set to [OFF], [10ms] or [20ms], the pace
pulse may be erroneously be detected as a QRS complex and HR, Asystole
alarms may not generate due to incorrect HR (counting pace pulse as QRS
complex). Select [OFF], [10ms], or [20ms] only if you are sure that pacing
failure will not occur, or when the patient can be constantly monitored.
zWhen measuring the SpO2of 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 rise 2 to 3°C due to
the sensor heat which may result in burn injury.
zFor the following case, accurate measurement of SpO2may not be possible.
yPatient with excessive abnormal hemoglobin (COHb, MetHb)
yPatient with the pigment injected to the blood
yPatient receiving CPR treatment
yWhen a sensor is applied to a limb with NIBP cuff, arterial catheter, or
intracatheter
yWhen measuring at site with venous pulse
yPatient with body motion
yPatient with small pulse
zBefore 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.
zWhen the system alarm is suspended, all the alarms will be suspended even if
the parameter alarm is set to [ON]. Also, the alarms will not be stored as recall
events.
xvi