Fukuda Denshi DS-7001 User manual

●●●●●●●●●●●●●●●●●●●●●●●●●●●●
Bedside Monitor
Service Manual
l Before using this device, read this manual thoroughly.
l
Keep this manual near the device for future reference.

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.
• Microsoft®and Windows®is a registered trademark or trademark of US Microsoft Corporation in
US and other countries.
• 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 ©2006 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.

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 iv
Symbols on the Main Unit iv
Symbols Displayed on the Screen v
Precautions for Safe Operation of Medical Electrical Equipment vi
Precautions for Safe Operation of Medical Telemetry vii
Precautions about the Maintenance viii
Safety Inspection and Maintenance viii
Maintenance, Modifications, and Repairs viii
Precautions about the Pacemaker viii
Non-Explosion Proof ix
Defibrillation Safety ix
Electrosurgery Safety ix
Precautions about Magnetic Resonance Imaging x
Precautions about the Fuse x
Precautions about the DS-7001 xi
Precautions for Use of SpO2Sensor xv
Precautions for Use of NIBP Cuff xv
Precautions for Ventilator Monitoring xvi
Disposing of Equipment, Accessories, or Components xix
Precautions about Transportation xix
Precautions about RTC or Data Backup xix
Precautions about the Cables xix
Precautions for Use of Ni-MH Battery xx
Electromagnetic Compatibility xxi
Precautions for Safe Operation under Electromagnetic Influence xxi
EMC Guidance xxii
Compliance to the Electromagnetic Emissions xxii
Compliance to the Electromagnetic Immunity (1) xxiii
Compliance to the Electromagnetic Immunity (2) xxiv
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the DS-7001 xxv
i

Safety Precautions
Read the “Safety Precautions” 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, or complete failure of the equipment.
WARNING Failure to follow this message may result in death or serious injury, or
complete failure of the equipment.
CAUTION Failure to follow this message may 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.
CAUTION
Do not damage or erase the warning labels attached to the unit. These
warning labels contain descriptions important for handling and operating
the unit properly and safely.
A damaged label may compromise safe operation.
ii

DANGER ・Do not operate the device where chemicals are stored, or in the presence of flammable anesthetics.
WARNING
・When using an electrosurgical knife, ensure proper attachment of patient plates.
・When using near an electrosurgical knife or other device generating high frequency, verify proper operation.
・Use the power cable with ground electrode and plug into a hospital-grade outlet.
CAUTION ・Read the operation manual thoroughly before use. ・Verify proper operation before use.
・Do not locate/store the device in an area vulnerable to high temperature/humidity. Avoid direct sunlight.
・Use only the batteries specified for this device.
・Do not disassemble or modify the battery.
・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.
・Replace the battery every 2 years.
・The battery charges when the power cable is connected to
a hospital-grade outlet. To fully charge an empty battery,
it takes approximately 2.5 hours by quick charging, and
approximately 16 hours by standard charging.
Charging will automatically stop when fully charged. The
guaranteed number of charge time is approximately 300
times.
Danger
Warning
Caution
iii

Measurement Unit for Each Parameter
The measurement units for this equipment are as follows.
Parameter
(Default Color) Description Display Unit
ECG (Green) Heart Rate HR bpm (beats per minute)
Respiration (White) Respiration Rate RR (RESP) Bpm (breaths per minute)
NIBP (White) Non-Invasive Blood
Pressure NIBP mmHg
Arterial Oxygen Saturation SpO2%
SpO2 (Yellow) Pulse Rate PR bpm (beats per minute)
Graphic Symbols
The following symbols are used for this equipment.
Symbols on the Main Unit
Symbol Description
Equipotential Terminal
Indicates the terminal to equalize the potential difference when
interconnecting the devices.
Caution; refer to accompanying documents
Indicates the need to refer to related accompanying documents before
operation.
Defibrillation-Proof Type CF Equipment
Indicates that the DS-7001 is a defibrillation-proof type CF equipment.
iv

Symbols Displayed on the Screen
Symbol Description
Alarm OFF
Indicates the alarm is OFF.
Heartbeat Synchronization Mark
This mark flashes synchronizing to the heartbeat.
Lead Off
Indicates the electrodes are detached.
Probe Off
Indicates the SpO2probe is disconnected.
Pacemaker Mark
Indicates that the patient is using a pacemaker. This mark will be
displayed when YES is selected for pacemaker on the admit menu.
Synchronized Tone Mark
Indicates that the heartbeat synchronized tone is set to either ECG or
SpO2.
Synchronized Lamp Mark
Indicates that the heartbeat synchronized lamp is set to either ECG or
SpO2.
AC Power Supply Mark
Indicates that the monitor is operated with AC power supply.
Battery Mark
Indicates the battery capacity during battery operation.
v

Precautions for Safe Operation of Medical Electrical Equipment
CAUTION
Read the following precautions thoroughly to correctly operate the
device.
l
l
l
l
Users should have a thorough knowledge of the operation before
using this system.
l Pay attention to the following when installing and storing the
equipment.
· Do not install or store in an area where the equipment will be subject to
splashing water.
· 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.
· Place the equipment on a stable surface where there is no inclination,
vibration, or shock (including during transportation).
· Do not install or store in an area where there are chemical or gasses
stored.
· Verify the power frequency, voltage and allowable current (or power
consumption).
· Ensure the grounding is proper by connecting the accompanying power
cable to the hospital grade outlet.
l Before operating the system, verify the following items.
· Verify the power voltage.
· Check the cable connection and polarity to ensure proper operation of the
equipment.
· Make sure the power system is properly grounded.
· Ensure that all cables are firmly and safely connected.
· Pay special attention when the device is used in conjunction with other
equipment as it may cause erroneous judgment and danger.
· Ensure all patient connections are proper and secure.
l During operation of the system, verify the following items.
· Always observe the system and patient to ensure safe operation of the
equipment.
· 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.
· Do not allow the patient to come in contact with the device.
l After using the system, verify the following items.
· Unplug all the cables from the patient before turning off the power.
· When unplugging the cables, do not apply excessive force by pulling on
the cord. Pull by the connector part of the cable.
· Clean the accessories and cables, and keep them together in one place.
· Keep the unit clean to ensure proper operation of the next use.
l 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
· Make sure to periodically check the equipment, accessories and cables.
· 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 instrument or defibrillator with this
equipment, verify proper attachment of patient ground plate, ECG
electrode type for the electrosurgical instrument, and paste volume,
output energy for the defibrillator. Also, verify that proper ground is
selected.
vi

Precautions for Safe Operation of Medical Telemetry
CAUTION
To operate the device correctly, read the following precautions carefully.
l
l
l
l
l
l
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).
l 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.
l When using telemetry which requires zone location, display and
identify each prepared zone in the equipment.
l When laying receiver antenna for each transmitter, the institution has
to be examined so as not to generate electronic interference.
Based on the above examination result, the institution places each
receiver antenna as required.
In managing, be sure to follow the precautions below.
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.
l Select a telemetry manager who understands the characteristics and
functionality of telemetry systems, and is skilled in operating
telemetry.
l When installing telemetry, the Overall Manager and the Zone
Manager have to understand the precautions for use of the telemetry
in advance.
The Overall Manager takes responsibility of wireless channel
management and transmitter storage for the whole medical institution
by giving proper instruction.
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.
l The Zone Manager assumes responsibility for managing the wireless
channels, storing, and managing telemetry.
l The Zone Manager assigns the transmitter to the user, and provides
enough education for use inside the zone.
l The telemetry user verifies operation of the transmitter/receiver
before use.
l 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.
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.
vii

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 ;
·the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
·the equipment was subjected to liquid spill.
·the monitoring function is interrupted or disturbed.
→
“4. Maintenance” ·parts of the equipment enclosure are cracked, removed, or lost.
·any connector or cable shows signs of deterioration.
WARNING Never open the housing while the equipment is in operation or
connected to hospital grade outlet as it may result in electric shock.
Maintenance, Modifications, and Repairs
Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if;
·Maintenance, modifications, and repairs are carried out by authorized personnel.
·Components are used in accordance with Fukuda Denshi operating instructions.
A full technical description of the DS-7001 is available from your local Fukuda Denshi
representative.
Precautions about the Pacemaker
WARNING
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”
FDA alerts health professionals that minute ventilation
rate-adaptive implantable pacemakers can occasionally
interact with certain cardiac monitoring and diagnostic
equipment, causing pacemakers to pace at their maximum
programmed rate.
[October 14, 1998 (Letter: www.fda.gov/cdrh/safety.html) -
FDA]
viii

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
WARNING
l
l
When defibrillating, keep away from the electrodes or medicament
applied to the patient chest. If this is not possible, remove the
electrodes or medicament before defibrillating.
If the defibrillator paddles directly contact the electrodes or
medicament, electrical shock may result by the discharged energy.
l When defibrillating, make sure that the electrodes, sensor cables, or
relay cables are firmly connected to the device.
Contacting the metal part of the disconnected cable may result in
electrical shock by the discharged energy.
When defibrillating, do not touch the patient and the metal part of the
device or cables.
Electric shock may result by the discharged energy.
Electrosurgery Safety
WARNING
The monitoring system contains protection against interference
generated by electrosurgical instruments. However, operating
conditions, surgery site with respect to the location of ECG electrodes,
or the type of instrument used, may cause noise on the ECG. 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 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.
ix

Precautions about Magnetic Resonance Imaging
WARNING
l Do not operate this equipment in magnetic resonance imaging (MRI)
environments.
l When conducting MRI test, remove the electrodes and sensors
connected to the patient (test subject).
The local heating caused by the induced electromotive force may
cause burn injury to the patient (subject). For details, refer to the
operation manual for the MRI testing device.
Precautions about the Fuse
DANGER
If the fuse blows, contact Fukuda Denshi Service Representative.
Do not continue using it as internal damage to the equipment may be
considered.
x

Precautions about the DS-7001
DANGER
When connecting to other device, contact Fukuda Denshi service
representative.
Danger such as electric shock may result to the patient and
operator.
WARNING
l
l
l
l
Do not connect unit or cable not authorized by Fukuda Denshi to
any I/O connector. If done so by mistake, the device can not
deliver its maximum performance and the connected units may be
damaged, resulting in a safety hazard.
l Use only the accompanying 3-way AC power cable. Use of other
cables may result in electric shock to the patient and the operator.
l The power cable must be plugged into 230V AC hospital grade
outlet.
Use only the accompanying 3-way AC power cable to assure
ground reliability. Use a power outlet that can supply sufficient
power to the device.
l When using multiple ME devices simultaneously, equipotential
grounding must be conducted to avoid electrical potential difference
between the devices. Presence of any electrical potential
difference may result in electric shock to the patient and the
operator.
The battery installation will be performed by our service
representative. Users should not attempt the procedure as it may
result in electric shock or malfunction to the equipment.
If the upper/lower alarm threshold is set to OFF, alarm will not
generate even if all alarm is set to ON. Pay attention when setting
the threshold OFF.
l Even if the individual parameter alarm is set to ON, all the alarm will
not generate during the alarm suspend time.
Check the patient’s condition frequently.
l When using electrosurgical instrument with this equipment, verify
ground plate attachment, electrode position, ground cable
connection, etc.
A high frequency energy generated by the electrosurgical
instrument may cause burn injury at the electrode site, damage the
equipment, or cause electric shock.
l Do not touch the DS-7001 during defibrillation.
Electric shock may result to the patient or the operator.
l Do not disassemble/remodel the equipment.
Electric shock may result.
l Set the correct patient type on the admit menu.
This selection will affect the measurement accuracy of QRS
detection, cuff inflation value of NIBP measurement, and respiration
filter.
l Set the pacemaker use (Yes/No) correctly on the admit menu.
This will affect accuracy of QRS detection. The pacemaker pulse
may be misdetected as QRS wave causing to overlook pacing
failure.
When measuring the SpO2of 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 2～3°C due to the sensor heat which may result in burn
injury.
xi

WARNING
l
l
l
For the following case, accurate measurement may not be possible.
· Patient with excessive abnormal hemoglobin (HbCO, MetHb)
· Patient with the pigment injected to the blood
· Patient receiving CPR treatment
· When a sensor is applied to a limb with NIBP cuff, arterial catheter, or
intracatheter
· When measuring at site with venous pulse
· Patient with body motion
· Patient with small pulse
l To see the waveform on the PC, use the application
software, ”Microsoft®Paint” on a PC with OS of Microsoft®Windows®
95, 98, XP, or 2000 loaded. Other application may not properly
display the waveform.
l The BMP file recorded on the CF card is read only file.
· Do not edit the file.
· Do not perform procedure such as “Save as” on the “Paint” software.
l If the channel ID is changed without notifying, it may result in
monitoring a different patient. Make sure the correct channel ID is
set for the patient.
l Some wireless combinations of telemetry transmitters may generate
interference with other devices.
Before selecting the channel, verify it will not interfere with other
channels.
l Make sure the telemetry manager of your system is aware of any
changes to the telemetry channels.
l 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.
l Do not cover the vent hole located at the rear side of the monitor.
l If this device is used under adverse environmental conditions, not
only that the device can not deliver its maximum performance, the
device may be damaged and safety cannot be ensured.
If using the device under condition other than specified above, contact
our service representative.
CAUTION
System
· The DS-7001 is intended for patient monitoring in the general ward, ICU,
CCU, OR and during in-hospital transportation. Do not use in the MRI
environment, inside hyperbaric chamber, flammable anesthetic gas and
outside hospital (including inside ambulance).
· When not using the DS-7001, always turn the power OFF.
When not charging the battery, disconnect the power cable from the
hospital grade outlet.
· For a brief time period after the power is turned ON, or when the ambient
temperature is low, the display may be indistinct and the waveforms and
measured value display may be unclear.
· Before monitoring, make sure that the correct time and date is set. If the
time/date is not correctly set, or changed during monitoring, erroneous
condition may occur to NIBP measurement, CF card periodic recording and
alarm list data.
· For battery installation, channel ID / group ID setup, DIP switch setup,
program upgrading, maintenance test, please contact Fukuda Denshi.
Users should not attempt these operations as malfunction or trouble may
result.
· When upgrading the software program, all prior memory will be erased.
· To ensure that system performs to specification, use the accessories
specified by Fukuda Denshi. Otherwise, its proper functions may not be
executed.
· For quality improvement, specifications are subject to change without prior
notice.
· When connecting the units, make sure the power is OFF.
xii

CAUTION
· AC filter will not function properly unless the correct frequency is selected.
· The display OFF function will inactivate the alarm generation and lamp
function.
· The maintenance test will be performed by our service representative.
Users should not attempt the procedure as malfunction to the equipment
may occur.
Battery
· The battery operating time will shorten depending on the number of NIBP
measurement times, etc.
· When using a new battery, or a battery which was stored for a long period
of time, the operation time may be short at beginning of usage. In such
case, repeating charging and battery operation for 2 or 3 times will bring out
the original performance.
· When the battery charging duration becomes short, the battery needs to be
replaced. (Indication for battery replacement is about 2 years, or 300 times
of charging/discharging.)
· When the battery operation duration becomes short, the battery needs to be
replaced.
· Repeated charging within short duration will cause the battery temperature
to rise and may stop the charging procedure for safety purpose until the
battery temperature decreases.
· Repeated charging of fully charged battery within short duration will cause
the battery temperature to rise and degrade the battery.
Alarm
· If the alarm of the same level occurs at the same time, the alarm message
for the newer alarm will be generated.
· While the “LEAD OFF” message is displayed, the HR alarm will not
generate. Leaving this condition unresolved may result in missing a
sudden change of the patient. Promptly check the electrodes when this
message is displayed.
ECG Monitoring
· For stable monitoring, use the specified lead cables and electrodes. Use
of other cables or electrodes may prevent proper monitoring during
defibrillation or eletrosurgery, and may cause a drift in the waveform
baseline.
· Follow the instruction of the physician for electrode attachment position.
· The electrode colors should be corresponded to the colors of the
accompanying lead cables.
· The indication for continuous use of the electrode is about one day.
· Replace the electrode if the skin contact gets loosen due to perspiring, etc.
· 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.
· When using a defibrillator during ECG monitoring, a polarizing potential
may interrupt monitoring for a few seconds.
· To display the pacemaker pulse on the monitor, select
Yes for “Pacemaker”, and ON or Color for “Pace. Pulse” on the
admit menu.
· There are some cases when pacemaker pulse can not be detected
depending on the pacemaker type, pulse voltage, pulse width, lead cable
(unipolar, bipolar), electrode site, or lead type which causes the pacemaker
pulse amplitude to decrease and disables pacemaker pulse detection.
· 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.
· During telemetry transmission, a noise may interfere depending on the
transmission condition and be erroneously detected and displayed as a
pacemaker pulse.
· When the spontaneous QRS and pacemaker pulse overlaps (as in a fusion
beat), QRS detection will be disabled which will reduce the heart rate.
· If a pacemaker pulse is continuously detected due to AC frequency
interference, QRS detection will remain suspended which will reduce the
heart rate.
xiii

CAUTION
Respiration Monitoring
· The electrode position appropriate for ECG monitoring may not be always
appropriate for respiration monitoring.
· When using the ＃3382.0654.11 lead cable (for electrosurgical instrument,
3-electrodes) and CI-164 relay cable (for electrosurgical instrument,
3-electrodes), the respiration measurement can not be performed.
· When using a defibrillator during respiration monitoring, a polarizing
potential may interrupt monitoring for a few seconds.
NIBP Monitoring
· Do not apply cuff to the arm or leg with vein cannulation. The blood may
backflow and cease the drug injection.
· The cuff should be basically applied to a bare arm. Align the cuff height to
heart position. If the cuff is pressurized over the clothing, a measurement
error may be caused.
· Have the patient stay still during the measurement. Body motion such as
moving the arm, laying stress on the arm, or talking may cause
measurement error. Vibration and strong impact to the equipment should
be also avoided.
· After applying the cuff to the patient, always check that the air hose is not
bent or compressed. Otherwise, cuff pressure detection or depressurizing
control can not be performed which disables the measurement.
· Pay attention when measuring the NIBP of patient with bleeding disorders
or hypercoagulation. The cuff inflation may cause petechia or circulatory
failure by the blood clot.
· 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 310mmHg for adult, 210mmHg for
child, 160mmHg for neonate.
· 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.
· If 1-minute interval measurement (1min Start) is set, the measurement will
automatically stop after 10 minutes or 20 minutes depending on the setup.
· When performing long term measurement with the interval of 2.5 seconds
or less, constantly check the patient’s condition. Also, when performing
automatic measurement for long duration, constantly check the patient’s
blood circulation. Congestion may be caused at the measurement site.
· The 1-minute periodic measurement setup cannot be backed up. It will be
always turned OFF when the power is turned ON again.
SpO2Monitoring
· To ensure correct measurement and safe operation, Nellcor® sensor must
be used.
Use of unspecified sensor may not only cause inaccurate measurement but
also burn injury to the patient.
· If the nail is rough, dirty, or manicured, accurate measurement will not be
possible. Change the finger or clean the nail before attaching the probe
and sensor.
· If irritation such as skin reddening or skin fit appears with the sensor use,
change the attachment site or stop using the sensor.
· When fixating the sensor with a tape, do not apply the tape too strong. At
the same time, check the blood flow constantly so that congestion is not
generated at the peripheral.
· Even a short duration of attachment may inhibit the blood flow and generate
compression necrosis and burn injury.
· Change the sensor attachment site constantly (every 4 hours). As the
temperature of sensor attachment site normally rises 2 ~3°C, compression
necrosis and burn injury may generate.
· As the skin of neonate / low birth weight infant is immature, change the
sensor attachment site more frequently depending on the condition.
· Direct sunlight to the sensor area can cause a measurement error. Place
a black or dark cloth over the sensor.
· 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.
xiv

CAUTION
Patient Admit / Discharge
· 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. Before monitoring, make sure the
current patient information is suitable for the patient’s condition.
CF Card
· Use only the specified IC card (FCF-32/FCF-64/FCF-128).
· When recording the waveform data on the CF card, use the CF card
formatted on the DS-7001.
· Never remove the CF card when the background color of the CF display is
red.
· When the CF card status is “ERR.” or “FULL”, format the CF card.
· When deleting the data on the CF card, format the CF card. The file can
not be completely deleted by the delete process on the PC.
· Do not delete the REC folder.
· Do not create other folder or file in the CF card.
· When removing the CF card (media) from the PC, refer to the operation
manual of the PC, OS, card reader, and follow the correct procedure.
Sleep Function
· When using the sleep function on the DS-7001, perform monitoring on the
central monitor. During the sleep mode, tone and lamp will not function,
and all alarm sound will not be generated on the DS-7001.
Maintenance
· Clean the equipment frequently so stains can be removed easily.
· To prevent injury, it is recommended to wear gloves when cleaning the
equipment.
· Do not allow liquids or cleaning solution to enter the monitor or connectors.
· Do not use organic solvents, thinner, toluene and benzene to avoid
damaging the resin case.
· Do not polish the housing with abrasive or chemical cleaner.
· When sterilizing the entire room using a spray solution, pay close attention
not to have liquids get into the monitor or connectors.
· 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, benzine, benzol, and synthetic detergent
for house and furniture), or sharp-edged tools. The surface resin coating
may be damaged, resulting in discoloration, scratches, and other problems.
· Do not open the housing of this device.
· Avoid alcohol or other liquids from getting into the equipment.
· The time-change components must be replaced at specified period.
Precautions for Use of SpO2Sensor
DANGER
Burn Risk in Using SpO2Sensor
In SpO2monitoring, always use the sensor/relay cable specified by
Fukuda Denshi. If any other sensor/relay cable is used, a high
temperature rise of the sensor may place the patient in danger of
burns.
If there are any questions regarding the sensor/relay cable use for
SpO2 measurements of this device, please contact Fukuda Denshi
service representative.
Precautions for Use of NIBP Cuff
CAUTION This product contains natural rubber latex which may cause allergic
reactions.
xv

Precautions for Ventilator Monitoring
WARNING
l The DS-7001 may not be able to properly receive the alarm
information from the ventilator due to causes such as communication
error, using environment, usage procedure, etc. Therefore, always
check the devices (ventilator, communication status of ventilator and
DS-7001, etc.) and safety of the patient. If any abnormality is found
on the devices or patient, take appropriate actions such as ceasing
the operation of the devices in the safest way for the patient.
l The ventilator operation should be performed by well-trained and
authorized personnel.
l If the DS-7001 does not generate an alarm even though the
ventilator is generating an alarm, or if any other malfunction occurs,
immediately check the ventilator, monitor, and the cable, and replace
the cable if necessary.
If malfunction persists, cease using the monitor.
l The alarm generation on the DS-7001 is not assured if the alarm
other than specified generates at the ventilator （SV-900, SV-300,
Servo-i/s, PB-740/760/860, VELA）.
See For details of “specified alarm”, refer to WARNING on the
operation manual, P3-29 “Ventilator Monitoring”.
l When connecting the ventilator to the monitor, using them under
adverse environmental condition will not only disallow the devices to
deliver their maximum performance, but also the devices may be
damaged and safety cannot be ensured.
l When transmitting the ventilator information to the central monitor
using the medical telemetry, read the “Precautions for Safe
Operation of Medical Telemetry” in the Preface.
l
l
l
When monitoring the ventilator information on the central monitor, use
the DS-7600 system or DS-5700 Central Monitor. Do not use the
DS-5800N/NX/NXMB Central Monitor. For use of other central
monitors, contact our service representative.
l When monitoring ventilator information, pulse oximetry (SpO2) can
be also simultaneously monitored.
l For connecting the DS-7001 and ventilator, use only the specified
connection cable.
Precautions about Evita2dura / Evita4 / EvitaXL
· The Evita2dura / Evita4 / EvitaXL acquires alarm information from the
serial port. The ventilator alarm that cannot be acquired from the serial
port is not guaranteed.
For corresponding alarm, refer to the service representative of the
ventilator manufacturer.
The DS-7001 will not correspond to the following alarm generated at
Evita2dura / Evita4 / EvitaXL.
O
2monitoring disabled alarm
CO
2alarm disabled alarm
Oximeter alarm disabled alarm
Neo. volume measurement inoperable alarm
Minute volume alarm disabled alarm
Minute volume alarm low off alarm
Tidal volume alarm high off alarm
Apnea alarm off alarm
Nebulizer active alarm
xvi

WARNING
l Precautions about E200
· When connecting the cable, the power of the E200 should be turned
OFF. It should be also turned OFF when performing ventilator setup on
the DS-7001. Otherwise, proper alarm monitoring cannot be performed.
· The E200 acquires alarm information from serial port.
The ventilator alarm that cannot be acquired from serial port is not
guaranteed. For corresponding alarm, refer to the service representative
of the ventilator manufacturer.
· The ventilator alarm display on the DS-7001 is not assured if the alarm
other than the following generates at the ventilator.
Upper and lower airway pressure alarm
Upper and lower minute ventilation alarm
· The “gas supply source failure” alarm generated on the E200 will not be
generated on the DS-7001.
· The apnea alarm (30 seconds of apnea) generated on the E200 will be
also generated on the DS-7001.
· When monitoring the alarm of the E200, verify that the power of the E200
is OFF before turning ON the power of the DS-7001. Otherwise,
confirmation screen will be displayed on the DS-7001. In such case,
check that the ventilator is not in alarm condition before monitoring the
alarm.
· When selecting E200 on the ventilator setup menu, the power of the
E200 ventilator should be turned OFF. Proper alarm monitoring will not
be performed if installing or setup of the E200 is performed without the
power being turned OFF.
· If "Compass VM200"(optional accessory of E200) is connected to the
E200, do not use the DS-7001. The alarm generated on the VM200 will
not be transmitted to the DS-7001.
l If OFF is selected for the ventilator, ventilator message will not be
displayed on the screen and ventilator alarm will not be generated.
A proper selection should be made when connecting a ventilator.
l The DS-7001 acquires alarm information by communicating with the
ventilator. The alarm information that cannot be acquired from the
ventilator will not be guaranteed.
CAUTION
l
l
As ventilator message will be displayed at the upper right of the
screen during ventilator monitoring, synchronized tone and
synchronized lamp information will not be displayed. Verify each
setup on the tone setup and lamp setup menu.
l For the SV-900, PB, VELA, Evita, E200 ventilator, ventilator alarm
factor cannot be transmitted to the central monitor.
l Depending on the central monitor type and software version,
ventilator alarm factor may not be displayed. For details, refer to our
service representative.
l The ventilator alarm will continue for 5 seconds even after the alarm
cause is resolved.
l When the 2min alarm silence button on the SV-900 is pressed, the
ventilator alarm on the DS-7001 will be also silenced. However,
airway pressure upper limit alarm will be generated even when the
2min alarm silence button is pressed.
l The tone and volume of the ventilator alarm cannot be changed.
When the SV-300, Servo-i, Servo-s is operated by battery,
will be displayed for the ventilator message on the DS-7001. Do not
use the DS-7001 when the ventilator is operated by battery.
xvii

CAUTION
l The ventilator display will be displayed until the proper communication
with the ventilator is resumed. When the communication is resumed,
the screen will automatically return to the home display.
However, if the ventilator display was accessed by selecting
Ventilator key on the menu display, the screen will not automatically
return to the home display unless the key is not pressed for 30 seconds.
l When condition is detected during the sleep mode, the sleep
mode will be cancelled, and ventilator display will be shown.
l For connecting the DS-7001 and ventilator, use only the specified
connection cable.
l Verify that the DS-7001 and the ventilator are properly connected.
l When connecting the cable, verify that the main power of the DS-7001
and the ventilator is OFF.
l When connecting the PURITAN-BENNETT ventilator, follow the
precautions below.
· The serial port (RS-232C) of the ventilator should be set as follows. Refer
to the service representative of the ventilator manufacturer.
Baud Rate : 9600bit/s
Data Bit : 8bit
Parity Bit : none
(Stop Bit) : (1bit)
· The DS-7001 detects the “ventilator alarm” when the nurse call port on the
ventilator outputs the alarm signal. For details of ventilator setup and
alarm signal output condition from the nurse call port, refer to the service
representative of the ventilator manufacturer.
l When connecting the VELA, the cable must be connected to the “nurse
call connector” on the rear side of VELA. Do not connect to the
“PATIENT ASSIST CALL”.
l When connecting the E200 ventilator, follow the precautions below.
· The PRINT INTERVAL should be set to 1 minute on the ventilator. Refer
to the service representative of the ventilator manufacturer.
· The DS-7001 detects the “Ventilator Alarm” when the alarm signal is output
from the serial port of the E200. For output condition of the alarm signal,
refer to the service representative of the ventilator manufacturer.
l If OFF is selected, the “VENT” message will not be displayed at the
alarm message area even if the ventilator alarm is generated.
l When turning ON the power of the SV-300, it will take about 30
seconds to start communication.
l When the ventilator is in alarm condition, will be displayed
for the ventilator message.
l During monitoring, always verify the proper communication of the
DS-7001 and the ventilator. Check that the alarm is not generated at
the ventilator, and is displayed for the ventilator message on
the DS-7001.
xviii