dynascope_ds-7100_system_operation_manual_ver-11_se.pdf
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Ver.11
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This operation manual is for the DS-7100 Series Version 11.
This device bears the CE label in accordance with the
provisions of Medical Device Directive 93/42/EEC.
The above mark "CE" is applied to the product that operates on 230V, 50Hz.
The persons responsible for placing devices on the EC market under MDD 93/42/EEC
Fukuda Denshi UK
13 Westminster Court, Hipley Street Old Woking, Surrey, GU22 9LG, United Kingdom
CAUTION:
• 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 © 2012 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
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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·························································· v
Precautions for Safe Operation of Medical Electrical
Equipment···································································vii
Precautions for Safe Operation of Medical Telemetry
(DS-7141, DS-7141M, DS-7101LT, DS-7101LTM)····viii
Precautions about the Maintenance···························· ix
Precautions about the Pacemaker ······························· x
Non-Explosion Proof ···················································· x
Defibrillation Safety ······················································ x
Electrosurgery Safety·················································· xi
Precautions about Magnetic Resonance Imaging······· xi
Precautions about Connections to Peripheral Devicesxii
Precautions about the Fuse ········································xii
Accessories and Optional Accessories ·······················xii
Precautions about the DS-7100 System ····················xiii
Precautions about the Wired Network System
(DS-LANII/DS-LANIII) ···············································xxi
Precautions about the Wireless Network System ···· xxiii
Precautions about Ventilator Monitoring ··················xxiv
Precautions for Use of SpO2 Sensor························xxvi
Precautions for Masimo® SpO2 Unit·························xxvi
Precautions for Use of NIBP Cuff·····························xxvi
Disposing of Equipment, Accessories, or Components
·················································································xxvi
Precautions about Transportation ····························xxvi
Precautions about RTC or Data Backup ··················xxvi
Precautions for Use of Lithium-Ion Battery Pack····· xxvii
To Prepare for Emergency Use ····························· xxviii
Electromagnetic Compatibility ·································· xxix
Precautions for Safe Operation under Electromagnetic
Influence ··································································xxix
EMC Guidance·························································xxix
●Compliance to the Electromagnetic Emissions xxx
●Compliance to the Electromagnetic Immunity (1)
············································································xxx
●Compliance to the Electromagnetic Immunity (2)
···········································································xxxi
●Recommended Separation Distances between
Portable and Mobile RF Communications Equipment
and the DS-7100 System ·································· xxxii
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Safety Precautions
y Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the product.
y Be 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
DANGER injury, or complete failure of the equipment.
Failure to follow this message may result in death or serious injury, or complete
WARNING failure of the equipment.
CAUTION 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.
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DS-7100 System
DANGER
Risk of explosion if used in the presence of flammable anesthetics.
CAUTION
Before connecting, read instruction manual.
CAUTION
To reduce the risk of electric shock, do not remove the cover.
Refer servicing to qualified service personnel.
DANGER
• Use only the batteries specified for this
device.
• Do not disassemble or modify the battery.
The battery incorporates protection circuitry
for safety purposes.
WARNING
• Installation of the battery should be
performed only by our service
representative, to avoid any risk of electric
shock to the operator or malfunction of the
device.
CAUTION
• The life cycle of the battery is 1 year.
• The battery charges when the power cord is
connected to a hospital-grade outlet.
• It takes approximately 2.5 hours to fully
charge an empty battery.
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Measurement Unit for Each Parameter
The measurement units for this equipment are as follows.
Detail
Parameter
Heart Rate / Pulse
Rate *1
ST Level
VPC
Respiration Rate
*2
Apnea
Invasive Blood
Pressure
Non-Invasive Blood
Pressure
Arterial Oxygen
Saturation
Temperature
End-Tidal CO2
Concentration
Inspiratory CO2
Concentration
*1
*2
iv
Display
ECG
HR
Invasive Blood
Pressure
PR_BP
SpO2
PR_SpO2
ECG
ECG
Impedance
Respiration
ST
VPC
CO2
RR_CO2
Impedance
Respiration
CO2
Invasive Blood
Pressure
Non-Invasive Blood
Pressure
RR_IMP
Unit
bpm
(beats per minute)
bpm
(beats per minute)
bpm
(beats per minute)
mm, mv
beats / minute
Bpm
(breaths per minute)
Bpm
(breaths per minute)
Default
mv
APNEA
s (second)
APNEA
s (second)
BP
mmHg, kpa
mmHg
NIBP
mmHg, kPa
mmHg
SpO2
SpO2
%
Temperature
TEMP
°C / °F
°C
CO2
EtCO2
mmHg, kPa, %
mmHg
CO2
InspCO2
mmHg, kPa, %
mmHg
HR/PR will be displayed in the color selected for ECG/HR.
RR will be displayed in the color selected for RESP.
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Graphic Symbols
Refer following for the meaning of the symbols indicated on the equipment.
Symbols indicated on the equipment
Symbol
Description
Caution; refer to accompanying documents
Indicates the need to refer to related accompanying documents before
operation.
Equipotential 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)
Direct Current
“OFF” for a Part of an Equipment
Indicates the “OFF” condition for a part of an equipment.
“ON” for a Part of an Equipment
Indicates the “ON” condition for a part of an equipment.
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.
Type BF Applied Part
Indicates the degree of protection against electric shock is Type BF
Applied Part.
Signal Output Part
GAS Output Part
Signal Input Part
Manufactured Date
TCP/IP Network Connector
Connects to TCP/IP network.
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Symbol
Description
RS-232C Connector
Connects the related device.
Eject
Indicates the switch to remove the recorder paper cassette.
Symbols displayed on the screen
Symbol
Description
Battery Mark
Indicates battery capacity and remaining volume during battery operation.
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.
Event Key Mark
Displayed when an alarm generates. ON/OFF of the display can be
selected on the ward setup.
Message Mark
Displayed in the parameter key when an alarm message is present for
that parameter.
Record Start/Stop
Starts/stops the recording.
SEC Alarm Display
Indicates the SEC alarm status.
Scroll Keys
These keys will allow to scroll the screen.
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Precautions for Safe Operation of Medical Electrical Equipment
z
z
z
CAUTION
z
z
z
z
z
z
Read the following precautions thoroughly to correctly operate the device.
Users should have a thorough knowledge of the operation before using this
system.
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.
y Do not install the equipment in a location where it is difficult to unplug the
power cable.
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.
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.
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 cord. Pull by 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 of the next use.
If the equipment is damaged and in need of repair, user should not attempt
service. Label the unit “OUT OF ORDER” and contact Fukuda Denshi.
Do not remodel the equipment.
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.
When using the electrosurgical knives or defibrillator with this equipment,
verify proper attachment of patient ground plate, ECG electrode type for the
electrosurgical knives, and paste volume, output energy for the defibrillator.
Also, verify that proper ground is selected.
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Precautions for Safe Operation of Medical Telemetry
(DS-7141, DS-7141M, DS-7101LT, DS-7101LTM)
Precautions for Safe Operation of Medical Telemetry
To operate the device correctly, read the following precautions carefully.
z The 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).
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 be
examined so as not to generate electronic interference.
z Based on the above examination result, the institution places each receiver
antenna as required.
In managing, be 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 nominates 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.
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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 “10. Maintenance” for details.
Never open the housing while the equipment is in operation or connected to
WARNING 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.
A full technical description of the DS-7100 system is available from your local Fukuda Denshi
representative.
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Precautions about the 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.
(For more details, contact FUKUDA DENSHI personnel, your institution’s
professionals, or your pacemaker distributors.)
Reference
“Minute Ventilation Rate-Adaptive Pacemakers”
WARNING
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]
z Rate 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 “11
Technical Information” for disclosure of the pacemaker pulse rejection
capability of this equipment.
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.
Defibrillation Safety
z When using the defibrillator, keep away from the electrodes or medicament
applied to the patient chest. If this is not possible, remove the electrodes or
medicament before using it.
If the defibrillator paddles are directly in contact with the electrodes or
medicament, electrical shock may result by the discharged energy.
z When using the defibrillator, 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
WARNING
shock by the discharged energy.
z When using the defibrillator, do not touch the patient and the metal part of the
device or cables. Electric shock may result by the discharged energy.
z This equipment will return to standard operating mode within 10 seconds.
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.
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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 an 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
WARNING
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 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 connected to
WARNING
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.
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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.
For the connector with
mark, only the peripheral devices specified by
WARNING 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.
All the peripheral device connectors on the DS-7100 system are isolated from
CAUTION 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 DS-7100 system, it is the user’s responsibility to verify that the
overall system complies with EN 60601-1-1, “Collateral Standard: Safety Requirements for Medical
Electrical Systems”.
Precautions about the Fuse
If the fuse blows, contact Fukuda Denshi Service Representative. Do not
DANGER continue using it as internal damage to the equipment may be considered.
Accessories and Optional Accessories
WARNING
xii
Use only the cables specified by Fukuda Denshi.
Use of other cables may result in increase in emission or decrease in
immunity.
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Precautions about the DS-7100 System
When connecting to other device, contact Fukuda Denshi service
DANGER representative. Danger such as electric shock may result to the patient and
operator.
z Do not connect unit or cable not authorized by Fukuda Denshi to any I/O
connector. If done so by mistake, the DS-7100 system cannot deliver its
maximum performance and the connected units may be damaged, resulting
in a safety hazard.
z The equipment should be installed by a professional person. Otherwise, it
may result in damage to the equipment 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 type selection influences the precision of the QRS detection and
NIBP measurement. Make sure the correct selection is made.
z The pacemaker selection influences the precision of the QRS detection and
arrhythmia analysis. Make sure the correct selection is made.
z When a ventilator is connected to the DS-7100, verify that ”Vent. Online”
message is displayed for the connection status. The DS-7100 will not detect
the ventilator alarm unless the ”Vent. Online” condition is achieved.
z If the QRS pace 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. Select OFF , 10ms , or 20ms only if you
are sure that pacing failure will not occur, or when the patient can be
constantly monitored.
z Be cautious when setting the "SpO2 Averaging" duration as the SpO2 alarm is
WARNING
based on the displayed SpO2 value which is averaged from the duration set
in "SpO2 Averaging". The alarm occurrence time will be affected or may not
occur for the transient value of SpO2 depending on the set duration. (For
®
Masimo SpO2 unit)
z When measuring the SpO2 of patient with high fever or peripheral 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 compression necrosis and burn injury.
z For the following case, accurate SpO2 measurement may not be possible.
y Patient with excessive abnormal hemoglobin (COHb, MetHb)
y Patient with the pigment injected to the blood
y Patient receiving CPR treatment
y When measuring at site with venous pulse
y Patient with body motion
y Patient with small pulse
z Before the NIBP measurement, make sure the patient type ( Adult / Child /
Neonate ) is properly selected. Otherwise, correct measurement cannot be
performed, and congestion or other injury may result.
z Pay attention when measuring the NIBP of patient with bleeding disorders or
hypercoagulation. The cuff inflation may cause petechia or circulatory failure
by blood clot.
z Use the specified sampling tube and nasal prong manufactured by Oridion.
z 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.
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z When performing expectoration treatment to the patient with ventilator
connected, make sure to suspend the CO2 measurement before the
treatment. Otherwise, water may enter into the pump causing the equipment
to be damaged.
z The HR/PR alarm will not be generated unless the parameter key
corresponded to the selected HR/PR source is displayed. Be sure to display
the parameter key for the HR/PR source.
z The alarm for the parameter not selected for the “HR/PR Alarm Source”
(ECG/SpO2/BP) will be set to OFF on the DS-7600 Central Monitor.
y The “HR/PR Alarm Source” setting will synchronize between the bedside
monitor and the central monitor.
y For example, if PR is set as the HR/PR alarm source on the DS-7100, HR
alarm will be set to OFF on the central monitor.
z The RR/APNEA alarm will not be generated unless the parameter key
corresponded to the selected RR/APNEA source is displayed. Be sure to
display the parameter key for the RR/APNEA source.
z When performing expectoration treatment to the patient with a ventilator
connected, make sure to suspend the CO2 measurement before the
treatment. Otherwise, water may enter into the pump causing the equipment
to be damaged.
WARNING 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 When a parameter is in a connector-off condition, the alarm will be generated
only on the bedside monitor and not on the central monitor. Make sure that
the connector is securely connected. If the waveform/numeric data is not
displayed for a monitored parameter, check the patient’s condition and pay
attention not to miss the connector-off condition.
z If the QRS pace mask function is turned OFF, a decrease in heart rate may
not generate HR or ASYSTOLE alarms due to erroneously detected QRS.
Turn this function OFF only if you are sure that pacing failure will not occur, or
when the patient can be constantly monitored.
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 Systems
y This equipment is intended to be used for only one patient.
y The monitor should be kept apart at least 20cm from the head of patient or
operator.
y Use only the accessories specified for this device. Otherwise, proper
function cannot be executed.
y For quality improvement, specifications are subject to change without prior
notice.
y The battery deteriorates with repeated use, which shortens the usable
time. When the DS-7100 system is operated by battery, and if empty mark
CAUTION
is displayed for the battery condition, IC card format, read/write process
cannot be performed.
y The arrhythmia detection level corresponds with the displayed waveform
size. Select an appropriate size for monitoring.
y The touch 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.
y Do not use the touch panel with the film attached. Malfunction of the touch
panel or damage may result.
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z Systems (Continued)
y As the touch panel is made of glass, a strong impact may cause damage.
Pay attention not to hit or drop the touch panel.
y Always operate the touch panel with fingers or a touch panel pen. Do not
touch with a pen-point or other hard-edged instruments. It may cause
malfunction or damage the touch panel.
y Do not press the touch panel with strength or twist your finger on the
panel. It may cause malfunction or damage the touch panel.
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.
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 loosen 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.
y If 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.
y The threshold level for arrhythmia detection changes with ECG 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 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.
CAUTION
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 automatic QRS and pacemaker pulse overlap (ex. fusion beat, etc.),
QRS detection cannot be performed properly. In this case, the heart rate is
degraded.
y When continuously detecting AC noise artifact as pacemaker pulses, QRS
detection stops and heart rate is extremely degraded. Also arrhythmia
cannot be detected.
z Respiration Monitoring
y When the following relay cables are used, respiration cannot be
measured.
・Relay Cable CI‐700E-3 (defibrillation / electrosurgery-proof, 3-electrode)
・Relay Cable CI‐700E-4 (defibrillation / electrosurgery-proof, 4-electrode)
・Relay Cable CI‐700E-5 (defibrillation / electrosurgery-proof, 5-electrode)
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.
z SpO2 Monitoring
y If the sensor site is too thick, thin, deeply pigmented, or deeply colored (ex.
nail polish, dye, or pigmented cream), it may lead to inaccurate
measurements. In such case, reposition the sensor or choose an alternate
sensor for use on a different site.
y If irritation such as skin reddening or skin fit appears with the sensor use,
change the attachment site or stop using the sensor.
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z SpO2 Monitoring (Continued)
y When fixing the sensor with a 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 at regular time intervals (about 4
hours). The temperature of attachment site will rise 2 to 3°C due to the
sensor heat which may result in compression necrosis and burn injury.
y As skin for neonate / low birth weight infant is immature, change the
sensor attachment site more frequently depending on the condition.
y Excessive light may cause inaccurate measurements. In such cases,
cover the sensor with opaque material.
y When not performing the measurement, unplug the relay cable and sensor
from the SpO2 connector. Otherwise, the measurement data may be
erroneously displayed by the ambient light.
y Precautions for Reusable Type Sensors
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 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 toe.
y The DS-100A must be moved to a new site at least every 4 hours.
Because individual skin condition affects the ability of the skin to
tolerate sensor placement, it may be necessary to change the sensor
site more frequently with some patients. If skin integrity changes, move
the sensor to another site.
y Precautions for Single-Patient-Use Type Sensors
y Do not wind the tape too strong. It may obstruct the blood flow.
y The sensor is contraindicated for use on patients who exhibit allergic
CAUTION
reactions to the adhesive tape.
®
®
y The Nellcor sensor OxiMax , MAX-FAST can be reused on the same
patient as long as the adhesive tape attaches without slippage. But do
not reuse it on other patients. It is intended for single patient use only.
y The Masimo ®LNOP sensor can be reused on the same patient as
long as the light emitting and receiving part is clean, and if it is still
adhesive to the skin. But do not reuse it on other patients. It is intended
for single patient use only.
y For the Nellcor® single patient use type sensors, the site must be
inspected every 8 hours (MAX-FAST: 12 hours) to ensure adhesion,
skin integrity, and correct optical alignment. If skin integrity changes,
move the sensor to another site.
y Do not reuse the sensor by resterilizing it.
y Dispose the sensor after use. In the event of damage to the sterile
packaging, do not use it.
y For Masimo® sensor, change the sensor attachment site every 4 hours for
the reusable sensor, and every 8 hours for the disposable sensor.
Exercise extreme caution with poorly perfused patients; skin erosion and
pressure necrosis can be caused when the sensor is not frequently
moved. Assess site at least every 2 hours with poorly perfused patients.
y The SpO2 patient cables (PC04, PC08, PC12) are intended for Masimo®
SpO2 unit only. When connecting these cables to the DS-7100 system,
make sure that MASIMO® label is present on the DS-7100 system SpO2
connector. If connected to the unit without MASIMO® label, it will not
function properly.
y For Masimo® SpO2 unit, if High is selected for “Pulse Sens.”, sensor-off
detection will become somewhat inaccurate.
y For Masimo® SpO2 unit, if OFF is selected for “PI Display” under the
SpO2 configuration setup, “SpO2 Low Perfusion” alarm will be indicated by
message display only. The alarm sound will not be generated.
y For additional warnings, cautions or contraindications when using the
SpO2 sensors, refer to each SpO2 sensor instruction manual.
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z NIBP Monitoring
y Select the appropriate cuff size which best fits the arm circumference.
If the cuff size is inappropriate, it may cause measurement error.
y Do not use a cuff which is worn out. The cuff may burst during inflation.
y If there is any air leakage, correct NIBP measurement cannot be
performed. Make sure that the connection is secure.
y Correct NIBP measurement cannot be performed if artificial heart lung
machine is used or if the pulse is difficult to detect.
y Pay attention when measuring the NIBP of patient with bleeding disorders
or hypercoagulation. The cuff inflation may cause petechia or circulatory
failure by blood clot.
y Do not apply the cuff to the arm or thigh where vein is secured. The blood
may backflow causing the chemical injection to cease.
y Check the condition of cuff-applied part on the patient during
measurement so that the blood circulation will not be blocked over long
period of time by the squashed or bent cuff hose.
y If the air hose is twisted, or weighed down, the cuff air cannot be
exhausted. Properly arrange the cuff and air hose.
y Check the patient’s condition constantly while measuring over long period
of time with interval of 2.5 minutes or less. Also, periodically check the
blood circulation while performing periodic measurement over long period
of time. Congestion may occur at the measuring site.
y The following factors may affect the NIBP value.
・Body motion, arrhythmia, convulsion
・Continuous noise such as cardiac massage
・Periodic electromagnetic noise
y For the following situation, measurements will be terminated.
When the measurement time has exceeded 120 seconds for adult, 90
seconds for child, 60 seconds for neonate.
When the inflation value has exceeded 300mmHg for adult, 200mmHg for
CAUTION
child, 150mmHg for neonate.
y If used with the incorrect patient type, 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 1-minute interval measurement will automatically stop after 10
minutes and returns to the previous interval mode setup.
y The alarm function will be ineffective for the BP value measured by Quick
SYS regardless of the ON/OFF selection of NIBP alarm.
z BP Monitoring
y If the SYS value is abnormally high, or DIA is abnormally low, a resonance
may be the cause. If the resonance can not be eliminated by adjusting the
blood pressure filter, check the BP line and use a thick, short, or hard
catheter.
y When the main power is turned ON, the BP value will not be displayed
until zero balance is performed. Make sure to perform the zero balance.
y During IABP treatment, the displayed BP value may differ from actual
value.
y Each time the blood pressure transducer or tubing is replaced, the zero
balance procedure is required to ensure accurate measurements.
y The zero balance procedure is required for the following case.
y When starting the measurement.
y When the position of the heart has changed due to body movement.
y When the position of the transducer has changed.
y When measuring for a long period of time and there is a possibility of
measurement error due to change in ambient temperature, etc.
y When the connector is connected / disconnected, or transducer is
replaced.
y When the power has been turned OFF for more than 5 minutes.
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z BP Monitoring (Continued)
y If the mean BP display is set to OFF, the mean BP alarm will not be
generated. Also, the mean BP will not be displayed on the tabular trend.
Be cautious when setting the mean BP display OFF.
y For telemetry transmission, BP waveform with a scale above the
programmed scale can not be properly transmitted. Set the appropriate
scale.
y The alarm for any BP not displayed will not be generated. Also, any BP not
selected for the display type will not be added to the trending list function.
Select the appropriate display type according to the monitoring purpose.
y When the BP label is CVP, the display type is fixed as M , and cannot be
changed.
z CO2 Monitoring
y Perform calibration 20 minutes after the patient monitor was turned ON.
y Do not disconnect the sampling tube during calibration. Calibration will
cease when the sampling tube is disconnected.
y Conduct CO2 calibration for the following case. If the CO2 gas calibration is
not performed at a specified interval, CO2 measurement accuracy may be
affected and also subsequent gas calibration may not be possible.
y When 1 year has elapsed from the last calibration.
y When EtCO2 measurement is not stable or accuracy is degraded
compared with other measuring device.
y When the patient monitor was not used for a while, or when EtCO2 was
not measured for a while.
y CO2 monitoring will cease when the ventilation connector is covered.
y Use only the specified sampling tube for CO2 monitoring.
y When the measurement is suspended, the alarm generation and trend
input will be also suspended.
z Temperature Monitoring
y Do not reuse the probe cover. It is intended for single patient use only.
CAUTION z Alarm
y A faint sound will be generated when setting a minimum volume for the
alarm sound, but be cautious not to miss any alarm. Adjust the volume to a
recognizable level.
y Alarm messages will be displayed according to the priority. (Level 1 →
Level 2 → Level 3 → Level 4)
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 The settings for the “HR Low Limit for VT” and “HR Low Limit for RUN” will
be compared with the average HR of continuous VPC. Therefore, the
displayed HR value at alarm generation may be lower than the settings if it
is just after the VT detection, or if RUN with few continuous VPC is
detected.
y If the alarm with the higher priority occurs during alarm recording, the
recording in process will cease and the alarm recording with the higher
priority will start.
y For the SpO2 measurement, whether to use the SEC alarm function and its
threshold selection should be based on the patient’s clinical indication
portent and medical evaluation. (For Nellcor® SpO2 unit)
y If the SpO2 alarm and SEC alarm setup is set to OFF, the SEC alarm
integral value will be set to 0. (For Nellcor® SpO2 unit)
y The alarm ON/OFF setup will remain effective even when the power is
turned OFF. Be cautious not to miss any important alarm by leaving the
alarm silenced.
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z System Configuration
y If the time/date is not correctly set, or changed during monitoring,
erroneous condition may occur to NIBP measurement, periodic recording,
trend, NIBP list data.
y If the time/date is changed during monitoring, patient’s age will not be
recalculated.
y When waveform and numeric data display is set to OFF, the alarm
generation and tabular/graphic trend data input will also cease.
y If BP display is set to OFF, pulse rate will not be displayed if HR/PR source
is set to BP1.
y If SpO2 display is set to OFF, pulse rate will not be displayed if HR/PR
source is set to SpO2.
y If CO2 display is set to OFF, RR will not be displayed if RR source is set to
CO2.
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.
z Patient Admit / Discharge
y If you start monitoring a new patient without performing a discharge
procedure for the previous patient, new data will be added to the previous
data which will result in inaccuracy.
y The setup for the alarm mode and display mode remains stored even
when the power is turned off or when discharging procedure is performed.
Before monitoring, make sure the current monitoring mode is suitable for
the patient’s condition.
y Resuming monitoring will resume the alarm in suspension.
z Arrhythmia Analysis
y For proper arrhythmia detection and ECG monitoring, verify proper
CAUTION
electrode placement, lead selection, and ECG waveform size. If
necessary, turn ON the AC filter. Improper electrode placement, lead
selection, and ECG waveform size can cause errors in detection.
z IC Card
y Use only the specified IC card.
y Use the IC card formatted with this device.
y Do not transfer the setup data from the newer to older software version
device. The operation of the device may become unstable and proper
monitoring may not be possible.
y When the DS-7100 system is operated by battery, and if empty mark is
displayed for the battery condition, IC card format, read/write process
cannot be performed.
y Restart the system after reading the setup data from the IC card.
The setup data will become effective after the system is restarted.
y Before reading the patient data from the IC card, all the patient data stored
in the patient monitor will be erased.
z Maintenance
y If stains cannot be removed from the touch panel surface, wipe softly with
a dry or ethanol dampened cleaning cloth. Never use strong acidic
solution. Neither is it recommended that mild acidic or alkaline cleaning
solution to be used.
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 the soft cleaning cloth provided as optional accessory or with an
eyeglass cleaning cloth.
y Clean the equipment 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 such as alcohol or cleaning solution enter the monitor
or connectors.
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z Maintenance (Continued)
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 monitor or connectors.
y Use only neutral detergent to clean the housing. Do not use chemical
cloth, scrub brush, abrasive, polishing powder, hot water, volatile solvent
and chemicals (cleanser, thinner, toluene, benzine, benzol, and synthetic
CAUTION
detergent for house and furniture), or sharp-edged tools. The surface resin
coating may be damaged, resulting in discoloration, scratches, and other
problems.
y Do not open the housing.
y Replace the components periodically as specified.
z Synchronized Signal
y As the synchronous detection is performed after filtering the input signal,
the synchronized signal is delayed from the actual synchronization.
If HR is selected for “Signal to output”, and ECG is selected as HR source,
the delay time is 100 to 132ms (standard approx. 100ms) for adult.
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Precautions about the Wired Network System (DS-LANII/DS-LANIII)
z Do not connect unspecified device to a wired network.
z Do not mix devices with DS-LANII and DS-LANIII setting in the same wired
network. The network may cease and proper monitoring may not be possible.
WARNING z Before setting the bed ID, make sure the DS-LAN (DS-LANII/DS-LANIII) is
correctly set on the Monitor Setup menu. If not correctly set, the network may
cease which may lead to accidents such as not transmitting important alarms
to the central monitor.
z When connecting to the DS-LAN network, perform “DS-LAN Setup” in the
Monitor Setup menu and restart the system before connecting the LAN cable.
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 connecting to the wired network, verify that the Bed ID does not
duplicate with other bedside monitors. Otherwise, monitoring on the central
monitor for both bedside monitors will not be possible.
z Make sure to set the bed ID in the following range.
y For DS-LANII network: 001 to 048
y For DS-LANIII network: 001 to 100
z When 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-7100 system, it
will be corrected to the time/date of the central monitor.
z On some central monitors depending on the model type or software version,
the setups for “HR Low Limit for VT” and “HR Low Limit for Run” cannot be
performed.
z For the alarm generation on the bedside monitor, maximum of 2.5 seconds
delay will occur for the alarm generation on the central monitor.
z In case of DS-LANII network, if BP1 is selected for “HR/PR source” (Or,
if Auto selects BP1 for HR/PR source), ECG waveform will not be
transmitted on the network. On the central monitor, PR_BP value will be
displayed instead of HR. However, on some central monitor depending on the
CAUTION
model type, the HR value from ECG will be displayed on ST measurement
list, etc. Refer to the operation manual for the respective central monitor.
In case of DS-LANIII network, refer to the operation manual for the central
monitor.
z There are following restrictions when connecting the DS-7100 system to the
DS-LANII network.
y When DS-5800N/NX/NXMB is used as a central monitor, recall, graphic
trend, and tabular trend will not be displayed.
y On the ST display of the DS-5800N/NX/NXMB, the overlap waveform will
not be displayed until 15 minutes have elapsed after the reference
waveform has been set on the DS-7100.
y The DS-7100 system will not communicate to the AU-5500N 8-channel
recorder. The data for the DS-7100 system cannot be recorded on the
AU-5500N.
y If the measurement unit for BP (mmHg/kPa) is different between the
bedside monitor and the central monitor, the corresponding waveform and
numeric data will not be displayed on the central monitor.
y When the temperature unit is °F, the temperature data will not be
transmitted. It 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 “SLOW_VT” will be transmitted as “VT”.
y For numeric data displayed as “×××”, maximum or minimum value of
measurable range will be transmitted.
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y The numeric data displayed as “－－－” will be treated as not measured
data.
y For QRS classification, the “S” (Supraventricular Extrasystole) printed on
the built-in recorder will be printed as “N” (Normal QRS beat) on the
HR-500 Recorder.
y Some central monitors cannot set the periodic recording interval time to
1min, 2min, or 3min.
y When DS-5800N/NX/NXMB or DS-5700 is used as a central monitor, ST
measurement cannot be recorded.
y If BP1 is selected for “HR/PR source” (Or, if Auto selects BP1 for
HR/PR source), ECG will not be printed on the central recorder. PR_BP
value will be printed instead of HR.
y If the “RR source” is other than impedance respiration (Or, if Auto
selects the RR source other than impedance respiration), respiration
waveform will not be transmitted on a wired network and will not be
recorded on the central recorder.
y If the SpO2 (PR_SpO2) lower alarm limit is set, and “– – –“ is displayed for
the SpO2 (PR_SpO2) value due to a cause such as SpO2 sensor off, etc.
on the DS-7100, it will be notified as SpO2 (PR_SpO2) lower alarm on
some central monitors even if the alarm is not generated on the DS-7100.
y If using a HUB for the DS-LANII network construction, make sure to use a
repeater HUB recommended by Fukuda Denshi.
z There are following restrictions when connecting the DS-7100 system to the
DS-LANIII network.
y In order to connect to the DS-LANIII network, a special LAN board needs
CAUTION
to be mounted on the DS-7100. The software version also needs to be the
version which supports the DS-LANIII. For details, refer to our service
representative.
y If the measurement unit for BP (mmHg/kPa) and temperature (°C/°F) is
different between the bedside monitor and the central monitor, the
corresponding waveform and numeric data will not be displayed on the
central monitor.
y If using a HUB for the DS-LANIII network construction, make sure to use a
switching HUB recommended by Fukuda Denshi.
y If the same lead is set for ECG1 and ECG2, it will function as follows.
- The waveform size setting for ECG1 will be transmitted.
- ST alarm setting for only ECG1 will be transmitted. Therefore ST2 alarm
will not generate.
y For numeric data displayed as “×××”, maximum or minimum value of
measurable range will be transmitted.
y For QRS classification, the “S” (Supraventricular Extrasystole) printed on
the built-in recorder will be printed as “N” (Normal QRS beat) on the
HR-500 Recorder.
y Some central monitors cannot set the periodic recording interval time to
1min, 2min, or 3min.
y If Center is selected for the recorder and recording is started on the
DS-7100, the central monitor recorder will print patient ID of only up to 10
digits. If the recording is started on the central monitor, all 20 digits can be
printed.
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Precautions about the Wireless Network System
When monitoring a patient with wireless telemetry, make sure the patient data is
DANGER properly received at the central monitor. Pay special attention when channel ID
at the bedside monitor is changed.
z Some wireless combinations of telemetry transmitters may generate
interference with other devices.
z Before selecting the channel, verify it will not interfere with other channels.
z Make sure the telemetry manager of your system is aware of any changes to
WARNING
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 When performing telemetry transmission, the numeric data corresponding
to the waveform should be selected for display. Otherwise, the displayed
waveform or numeric data may not be transmitted.
y The setup of channel ID and group ID should be performed only by our
service representative. Users should not perform this procedure as
malfunction to the equipment may occur.
CAUTION
y If the measurement unit is “°F” and “kPa” on the DS-7100 system, it will be
converted to “°C” and “mmHg” respectively when transmitted to the central
monitor. If the measurement unit “°F” and “kPa” are set on the central
monitor, it will be reconverted to the value in “°F” and “kPa” after
transmitted to the central monitor.
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.
xxiii