DS-8007 System Service Manual Edition 2 Aug 2018.pdf
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Series
Patient Monitor
Service Manual
DS-8007 System
* Before installation/maintenance,
read this service manual thoroughly.
* After reading this service manual, store it in a safe place.
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This device bears the CE label in accordance with the provisions of Medical Device Directive
93/42/EEC.
This device bears the CE label in accordance with the provisions of RoHS Directive 2011/65/EU.
Fukuda Denshi UK
Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom
Fukuda Denshi Co., Ltd.
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
CAUTION
(For USA)
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION
●
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.
© 2017 Fukuda Denshi Co., Ltd.
No part of this document may be reproduced or transmitted in any form without the prior written
permission of Fukuda Denshi Co., Ltd.
If this manual has pages missing or out of order, contact Fukuda Denshi for replacement.
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Revision History
Model Name
DS-8007 System
Service Manual
Edition
Revised Items
1
－
Reason of the Revision
New Edition
Date
2017.06
Item code and remarks for the
The mechanical elements are
mechanical elements such as Micro
partly changed according to the
MediCO2, HCP-820 and HPD-820
design change of the
are changed.
MicroMediCO2.
The general assembly diagram of
the HCP-820 is changed.
2
The description is added that
DS-8007 needs to be updated
due to the MicroMediCO2
software update. (DS-8007
should be V03-04 or newer
when the MicroMediCO2 with
the new item code is used.)
The general assembly diagram of
the HPD-820 is changed.
As it is common with the
HPD-820.
Assembly of SpO2 Nellcor RR
License key (Optional software) is
changed.
Due to the DS-8007 software
update, the SpO2 Nellcor RR
License became royalty-free.
Alarms regarding the battery are
added in Troubleshooting.
To add alarms regarding the
battery.
2018.08
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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.
About the Safety Precautions ································ ii
The Meaning of Each Safety Precaution ················ ii
Warning Labels Attached to the Unit ····················· ii
Graphic Symbols ············································· iv
Precautions for Safe Operation of Medical Electrical
Equipment ······················································ v
Precautions about the Maintenance ······················ vii
Precautions about the Network System ················ viii
Medical Telemetry ··········································· viii
Bidirectional Wireless Communications Module
(TCON) (For USA Only) ···································· ix
Precautions when Using with Other Equipment ······· xi
Pacemaker ····················································· xi
Non-Explosion Proof ········································· xi
Defibrillator ····················································· xi
Electrosurgical Instrument ································ xii
MRI (Magnetic Resonance Imaging) ··················· xii
Precautions about Connections to Peripheral Devices
··································································· xiii
Precautions for Using the Equipment ··················· xiv
This System ··················································· xiv
Wired Network (DS-LANII/ DS-LANIII) ·················xxi
Wireless Network System ································ xxii
RTC and Data Backup ··································· xxiii
Precautions about the Ventilator Monitoring ········· xxiii
Precautions about the SpO2 Sensor ·················· xxiii
Precautions about the NIBP Cuff ······················ xxiii
Precautions about Disposing of the Equipment,
Accessories, or Components ··························· xxiv
Precautions about Transportation······················ xxiv
Monitoring after Power Failure ·························· xxiv
To Prepare for Emergency Use ························ xxiv
Electromagnetic Compatibility···························· xxv
Precautions for Safe Operation under Electromagnetic
Influence ······················································ xxv
EMC Guidance ············································· xxvi
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About the Safety Precautions
The Meaning of Each Safety Precaution
Read this manual thoroughly before use to ensure correct and safe use of the product.
Be sure to follow the precautions indicated below, as these are important messages related to safety.
Indicates an imminently hazardous situation which, if not avoided, will result in
D A N G E R death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in
W A R N I N G death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in
C A U T I O N minor or moderate injury.
NOTE
A note is not related to product safety, but provides information about the correct
use and operating procedures to prevent incorrect operation and malfunction of
the equipment.
Warning Labels Attached to the Unit
Make sure to read the warning label attached to the equipment and comply with the requirements while operating
the equipment.
CAUTION
Do not damage or erase the warning label attached to the equipment.
These warning labels contain important descriptions for handling and operating the
equipment properly and safely. A damaged label may compromise safe operation.
DS-8007 System Main Unit
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DSA-81 AC Unit
HR-800 Recorder Unit
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Graphic Symbols
Refer to the following for the meaning of the symbol indicated on the equipment.
Symbol
Description
Follow operating instructions (Warning); indicated in blue. Failure to follow operating instructions could
place the patient or operator at risk.
Follow operating instructions (Information);
Indicates the need to refer to the related accompanying documents before operation.
General precaution
Caution, refer to accompanying documents
Indicates the need to refer to the related accompanying documents before operation.
Potential Equalization Terminal
Indicates the terminal to equalize the potential difference when interconnecting the devices.
Protective Earth
Indicates the protective earth inside the equipment.
Alternating Current
(Main Power Input Indicator)
Indicates that the equipment is in normal operation.
Indicates that the equipment is in standby mode.
Electrostatic Sensitive Part
Directly touching this connector part with hands should be avoided.
Type CF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type CF Applied Part with defibrillationproof.
Type BF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type BF Applied Part with defibrillationproof.
Signal Output
Signal Input/Output
GAS Input Part
GAS Output Part
Battery
Alarm Silence
Name and Address of Manufacturer
Indicates the name and address of manufacturer.
Date of Manufacture
Indicates the date of manufacture.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic equipment.
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Precautions for Safe Operation of Medical Electrical Equipment
WARNING
Do not disassemble or remodel the equipment.
CAUTION
Users should have a thorough knowledge of the operation before using this equipment.
Do not use the equipment in an environment where protective earth and wiring is
questionable.
Precautions about the Location of Installation and Storage of the Equipment
Set the monitor to the user's intended position where the user can easily recognize the visual and audible
monitoring conditions. Normally it is recommended to set at a distance of 1m from the user.
Install or store in a place where the equipment will not be exposed to splashing water.
Install or store in an area where environmental conditions such as atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust, sodium, and sulfur will not 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 chemicals are stored or gases are evolved.
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.
Make sure to secure the equipment using a trolley or stand.
Do not place the equipment or accessories in any position that might cause it to fall on the patient.
Precautions Before Using the Equipment
Verify the power voltage. Charge the battery pack fully before operating the system with the battery pack.
Check the cable connection and polarity to ensure proper operation of the equipment.
Make sure the power system has adequate earth ground.
Ensure that all cables are firmly and safely connected.
Pay special attention when the equipment is used in conjunction with other equipment as it may
cause erroneous diagnosis and danger.
Precautions During Using the Equipment
Always observe the equipment and patient to ensure safe operation of the equipment.
If any abnormality is found on the equipment or with the patient, take appropriate measures under the safe
conditions, such as ceasing operation of the equipment.
Do not allow the patient to come in contact with the equipment.
On start-up of the system, verify that the start-up tone generates and alarm indicator lights.
For the connectors which are not Type BF, CF applied part, do not touch them and the patient at the same time.
Precautions After Using the Equipment
Unplug all the cables from the patient before turning off the power.
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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 equipment clean to ensure proper operation for the next use.
Precaution when Equipment Failure Occurs
If the equipment is damaged and in need of repair, the user should not attempt service. Label the unit
"OUT OF ORDER" and contact our service representative.
Precaution about Disassembling/Remodeling the Equipment
Do not disassemble or remodel the equipment.
If water or other liquids enter the equipment, cease using the equipment and contact your nearest service
representative.
Precautions about Maintenance Check
Make sure to periodically check the equipment, accessories, and cables.
Before reusing the equipment that has been left unused for a while, make sure that the equipment operates
normally and safely.
Precautions when Using with Other Equipment
To prevent patient from burn injury, verify proper attachment of patient ground plate, ECG electrode type
when using the electrosurgical knife, and verify paste volume, output energy when using the defibrillator.
Also, verify that each equipment is properly grounded.
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Precautions about the Maintenance
WARNING
Never open the housing while the equipment is in operation or connected to hospital grade outlet as it may
result in electric shock.
CAUTION
Precautions about Safety Check
For safe operation of the equipment, regular inspection and maintenance are required. Once a year, check all
cables, devices, and accessories for damage, earth impedance, earth and leakage currents, and all alarm
functions. Also, ensure that all safety labels are legible. Maintain a record of these safety inspections.
Immediate maintenance has to be carried out for the following case.
When the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
When the equipment was subjected to liquid spill.
When the monitoring function is interrupted or disturbed.
When parts of the equipment enclosure are cracked, removed, or lost.
When any connector or cable shows signs of deterioration.
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Precautions about the Network System
Medical Telemetry
CAUTION
Precautions about the Installation
The medical institution (hereinafter referred as "Institution" ) must decide the telemetry installation plan for
the medical institution in order to prevent interference between transmitters (telemetry based on destination
country's radio law). When telemetry has already been installed and been used, radio format, frequency, and
antenna power are required to be examined to prevent interference.
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 Institution.
When using telemetry which requires zone location, display and identify each prepared zone in the equipment.
When laying receiver antenna for each transmitter, the Institution has to examine the installation so that electronic
interference does not occur.
Based on the above examination result, the Institution should place each receiver antenna as required.
CAUTION
Precautions about the Management
The institution appoints a person to manage the wireless channels for the whole medical institution. And when
using telemetry which requires zone location, the Institution should nominate a person to manage the wireless
channels in each zone (a "Zone Manager"). However, when using such telemetry in a local medical institution,
one person can perform both functions.
Select a telemetry manager who understands the characteristics and functionality of telemetry systems, and is
skilled in operating telemetry.
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 Institution by giving proper instruction.
The Overall Manager should create a management log (hereinafter referred to as the "log" ), which contains a
list of the management status of the wireless channels for the whole Institution. When changing a wireless
channel, register it in the log and give proper instructions to the Zone Manager or to the user.
The Zone Manager assumes responsibility for managing the wireless channels, storing, and managing
telemetry.
The Zone Manager assigns the transmitter to the user, and provides enough education for use inside the zone.
The telemetry user verifies operation of the transmitter/receiver before use.
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.
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Bidirectional Wireless Communications Module (TCON) (For USA Only)
CAUTION
Precautions about the Installation
The medical institution (hereinafter referred to as "Institution" must execute investigation required to prevent
interference including types of radio waves, frequencies, and antenna power if wireless equipment is already
installed and being used in the facility.
Even if this equipment is installed within the range of radio communication, the communication may not be
possible due to noise or multi-path phasing etc. This should be fully considered when using the TCON network.
If the TCON is installed in a line-of-sight distance where there are no obstacles or on the upper floors,
unexpected long distance transmission may occur which may cause interference with nearby medical
institution. Before using the TCON system, test the reception to make sure that it does not interfere with other
channels. If the channel is used by other medical institution, change the channel ID.
Do not install the TCON system in an area where it will be subject to splashing water. Water entering the
equipment may cause the equipment to malfunction or be damaged.
CAUTION
Precautions about the Management
The Institution should appoint a person (hereinafter referred as the "Overall Manager" to manage the wireless
devices for the whole facility. The ME engineer is appropriate for the Overall Manager.
When installing TCON, the Overall Manager has to receive an explanation of the precautions for use of the
TCON from the manufacturer or sales representative.
The Overall Manager is responsible for the maintenance and storage of the equipment.
The Overall Manager should create a management log (hereinafter referred to as the "log"), which contains a
list of the management status of the wireless channels for the whole Institution. When changing a wireless
channel, register it in the log and give proper instructions to the Zone Manager or to the user.
The user needs to verify the transmitting/receiving operation before use.
If interference or breakdown occurs in the communication, the TCON user is required to stop using the TCON
and to inform the Overall Manager of the problem. The Overall Manager is to deal with the problem properly
and/or contact the nearest Fukuda Denshi representative for service.
CAUTION
Precautions for Operation
The Bidirectional Wireless Communications Module (TCON) uses radio waves to transmit data. Therefore,
necessary precautions need to be taken for the characteristics and difficulties of using the device that emits radio
waves. The TCON user should fully understand these precautions beforehand, and use the TCON device safely.The
TCON communication status can be verified by the messages and symbols (
) displayed on the screen. If
TCON communication is interrupted by other wireless devices, a mark indicating the communication status and
technical messages, <TCON Interference>, <Chk TCON Reception> will be displayed. For details, refer to the HTC702 (FA) Operation Manual.
Furthermore, situations in which interference may occur are outlined below. In such cases, pay special attention to
the condition of the patient connected to the bedside monitor, and eliminate the cause of interference.
When the patient’s data become mixed with a different patient's data due to interference.
When there are multiple TCON devices set to the same TCON ID and channel (group).
When communication failure, unstable communication, or poor reception occur.
When the radio communication is poor as there are metal, concrete, or other such obstacles between the
Bidirectional Wireless Communications Modules (TCON).
When a different wireless device is using the same frequency (channel).
When there are other TCON devices nearby using different channels (groups).
When a cell telephone or other wireless device is being used nearby.
When citizens broadcast bands such as amateur radio or truck radios are used in the vicinity of the
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TCON operating area.
When a computer or word processor, or electrical device that has an internal computer, is used near the TCON
device antenna.
When the TCON device is installed or moved to a location that is outside the radio communication range.
When the channel settings for the two TCON groups are close to each other.
CAUTION
Precautions about the Setting
Follow the instructions from the Overall Manager for the wireless channel when setting the TCON and
channel IDs to prevent interference within the same institution.
If the TCON is set to [OFF], all TCON messages such as <Check TCON Comm.> will not be displayed.
Even if [ON] is set for "Start NIBP Auto Mode with Start/Stop key" ([Initial Settings]>[User I/F]>[Power ON/
Discharge]), "Backup at Discharge (NIBP Auto Mode)" setting will be [ON] since the central monitor will not
be in standby mode during TCON communication.
Make sure that three antenna bar marks (
) are displayed.
Make sure that the TCON channels of the bedside monitor and central monitor are the same.
When using the TCON network, do not move the equipment. The radio waves may not be transmitted.
There are following restrictions when connecting the DS-8007 System to the TCON network.
When the measurement unit of BP is [kPa], the central monitor will not receive the numeric data of NIBP,
BP1, and BP2. Also, the alarm setting of NIBP, BP1, and BP2 cannot be changed from the central monitor.
The NIBP measurement cannot be started from the central monitor via TCON system if the NIBP
measurement interval is set to [5 min] or less, or during the 1-minute or continuous measurement. However,
it can be stopped.
When the measurement unit of CO2 concentration is [mmHg], the CO2 value of 100 mmHg or above will be
transmitted as 99 mmHg.
On the DS-8007 system, the TCON settings are saved on the AC Unit (DSA-81).
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Precautions when Using with Other Equipment
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.
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.
Reference
"Minute Ventilation Rate-Adaptive Pacemakers"
FDA alerts health professionals that minute ventilation rate-adaptive implantable pacemakers can
occasionally interact with certain cardiac monitoring and diagnostic equipment, causing pacemakers to pace
at their maximum programmed rate.
[Based on a safety bulletin issued by FDA Center for Devices and Radiological Health on October 14, 1998]
Non-Explosion Proof
DANGER
Never operate the equipment in the presence of flammable anesthetics, high concentration of oxygen, or inside
hyperbaric chamber. Also, do not operate the equipment in an environment in which there is a risk of explosion.
Explosion or fire may result.
Defibrillator
WARNING
When defibrillating, keep away from the electrodes or medicament applied to the patient chest. If this is
not possible, remove the electrodes or medicament before defibrillating.
If the defibrillator paddles are directly in contact with the electrodes or medicament, an electrical shock may
result by the discharged energy.
When defibrillating, make sure that the electrodes, sensor cables, or relay cables are firmly connected to
the device.
Contacting the metal part of the disconnected cable may result in electrical shock from the discharged energy.
When defibrillating, do not touch the patient and the metal part of the device or cables.
Electric shock may result from the discharged energy.
This equipment will return to standard operating mode within 10 seconds after defibrillating. However, when in
diagnosis mode, it may require 10 seconds or more after defibrillation to display the normal ECG waveform as the
time constant setting is large.
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.
The QRS synchronized signal is not intended to be used as synchronized signal for defibrillator.
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Electrosurgical Instrument
WARNING
The monitoring system contains protection against interference generated by electrosurgical instruments.
However, depending on the operating conditions, surgery site with respect to the location of ECG electrodes,
ground plate attachment condition, or the type of instrument used, it may cause burn injury at the electrode
site or noise on the ECG. The noise is generated at the tip of the electrosurgical 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 equipment 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 this equipment. This will help
prevent interference through the power cable.
Electrode Placement
The amount of noise interference is considerably different depending on the electrode position and surgery
site. Place the ECG electrodes as far away as possible from the surgery site and the ground plate. Do not
place electrodes in the path between the surgery site and the ground plate. If the electrodes are placed in
this path, the amount of interference will be quite large. Position (+) and (–) electrodes as close as possible
to each other.
Ground Plate
When using electrosurgical instruments, make sure the contact between the patient and the ground plate is
secure. If the connection is incomplete, the patient may suffer from burn at the electrode site.
The stored data will not be affected. The measurement accuracy will temporarily decrease during
electrosurgery, but it will not compromise the safety of patient and the equipment.
When using the electrosurgery-proof type ECG relay cable, the impedance respiration cannot be measured, and
its numeric data and waveform will not be displayed. When measuring in an environment where electrosurgery
is not performed, make sure to use the standard ECG relay cable.
As this equipment utilizes capacitive touch panel, the energy from the electrosurgical knife may pass through
the cable to the touch panel causing unintentional touch panel control. Locate the cables as far away as possible
from the touch panel.
MRI (Magnetic Resonance Imaging)
WARNING
MR Unsafe-Keep away from magnetic resonance imaging (MRI) equipment.
Do not use this equipment in magnetic resonance imaging (MRI) environments.
When conducting MRI test, remove the electrodes and sensors connected to the patient (test subject). This
equipment may be pulled towards the MRI device. Also, the local heating caused by the induced electromotive
force may cause burn injury to the patient or performance degradation, failure, damage of this equipment.
For details, refer to the operation manual for the MRI testing device.
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Precautions about Connections to Peripheral Devices
For safety and good performance of this equipment, connection of other manufacturers’ equipment to the monitor is
not authorized, unless the connection is explicitly approved by Fukuda Denshi. It is the user's responsibility to
contact Fukuda Denshi to determine the compatibility and warranty status of any connection made to another
manufacturer's equipment.
WARNING
When multiple equipments are connected to the patient, it may be necessary to take measures for connection
(use of separation device), power supply (use of isolation power), grounding (additional protective earth). If
these measures are not properly taken, a leakage current may flow between the equipments, or the total amount
of leakage current may exceed the limit specified on IEC 60601-1.
Only the peripheral devices specified by Fukuda Denshi should be connected with the given procedure. Use
of an unspecified device may cause electric shock to the patient and/or operator due to excessive leakage
current.
CAUTION
Although the peripheral device connectors on the DS-8007 System are, with some exceptions, isolated from
the power supply, the connecting peripheral devices should comply with IEC 60601-1. It is the user's
responsibility to verify that the overall system complies with IEC 60601-1 or IEC 60601-1-1.
To prevent danger of electric shock, always position the peripheral devices away from the patient.
Network equipment including printer and hub should be located outside the "Patient Environment". If
located inside the "Patient Environment", it may result in electric shock to the patient or the operator.
Combinations of medical equipment with non-medical equipment must comply with IEC 60601-1 or IEC
60601-1-1. Never use a multiple portable socket-outlet or extension cable when connecting the equipments
unless it is supplied specifically for use with that equipment.
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Precautions for Using the Equipment
This System
DANGER
When connecting to other equipments, contact your nearest representative.
Danger such as electric shock may result to the patient and operator.
WARNING Warnings about the System
Do not connect any damaged/unspecified equipment or cable to any I/O connector. Otherwise, the equipment
cannot deliver its maximum performance and the connected equipments may be damaged, resulting in a safety
hazard.
If this equipment is used under an environment not fulfilling the specified condition, not only that the
equipment cannot deliver its maximum performance, the equipment may be damaged and safety cannot be
ensured. If using the equipment under condition other than specified, contact your nearest representative.
Use only the supplied 3-way AC power cable. Use of other cables may result in electric shock to the
patient and the operator.
The power cable must be connected to a hospital grade outlet.
When using multiple ME equipment simultaneously, perform equipotential grounding to prevent potential
difference between the equipments. Even a small potential difference may result in electric shock to the patient
and the operator.
Carefully route cables to reduce the possibility of patient entanglement and strangulation.
When lifting this equipment, hold it by the handle or the bottom part of the main unit.
When using this equipment, the operator should stay in a distance close enough to recognize an alarm sound.
Do not move too far away from the equipment where an alarm sound cannot be recognized.
WARNING Warnings about the Monitoring
The patient classification selection influences the precision of the QRS detection and NIBP measurement.
Make sure the proper selection is made.
The pacemaker usage setting influences the precision of the QRS detection and arrhythmia analysis. Make
sure the correct selection is made.
If the QRS pace mask function is set to [OFF], [10ms]/[20ms], the pace pulse may be erroneously detected as
a QRS complex and HR alarm or asystole alarm may not generate due to incorrect HR (counting pace pulse
as QRS complex). Select [OFF], [10ms]/[20ms] only if you are sure that pacing failure will not occur, or
when the patient can be constantly monitored.
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 the attachment site will rise due to
the sensor heat which may result in burn injury.
For the following case, accurate measurement of SpO2 may not be possible.
Patient with excessive abnormal hemoglobin (COHb, 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
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When a patient is receiving a photodynamic therapy, measuring SpO2 on a same site for a long duration may
cause blisters from the irradiation light of the SpO2 sensor. Make sure to periodically change the sensor
attachment site.
Before the measurement, make sure the patient classification (Adult/Child/Neonate) is properly selected.
Otherwise, correct measurement cannot be performed, and congestion or other injury may result.
When the system alarm is suspended, all the alarm will be suspended even if the parameter alarm is set to [ON].
Also, the alarms will not be stored as recall events.
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 individual alarm is set to [ON]. Pay attention when setting them [OFF].
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 printing, alarm printing and recall waveform for evaluation.
The RR/APNEA alarm will not be generated unless the numeric data box corresponded to the selected RR/
APNEA alarm source is displayed.Make sure to display the numeric data box for the RR/APNEA alarm source.
When selecting [0] for "Volume" or [Timer] for "Display" for the Night Mode, pay attention not to miss
any important alarm by simultaneously monitoring the patient on central monitor or other monitors.
When the alarm sound is suspended, the alarm sound will not generate for the fixed amount of time. Pay
attention not to miss any important alarm by simultaneously monitoring the patient on central monitor or
other monitors.
If the safety of the patient cannot be ensured, do not suspend the alarm or decrease the alarm volume.
WARNING Precautions about the CO2 Monitoring (HCP-810/HCP-820, HPD-810/HPD-820)
Only one of either HCP-810/HCP-820/HPD-810/HPD-820 can be connected.
When using a sampling line for intubated patients with a closed suction system, do not place the airway adapter
between the suction catheter and endotracheal tube. This is to ensure that the airway adapter does not interfere
with the functioning of the suction catheter.
To prevent cross-infection, do not allow the sampling gas to return to the breathing system.
To protect the hospital staffs from unnecessary anesthetic agent when using the HCP-810/HCP-820, it is
strongly recommended to connect the exhaust hole to the gas exhaust system in the hospital.
Loose or damaged connections of the sampling line may compromise ventilation or cause an inaccurate
measurement of respiratory gases. Securely connect all components and check connections for leaks according
to standard clinical procedures.
Do not cut or remove any part of the sampling line. It could lead to erroneous readings.
If too much moisture enters the sampling line (i.e., from ambient humidity or breathing of unusually humid air)
when using the HCP-810/HCP-820, <Check Sample Line> will be displayed in the message area. Replace the
sampling line once this message is displayed.
Carefully route the sampling line to reduce the possibility of patient entanglement or strangulation.
Do not lift the HCP-810/HCP-820 by the sampling line, as the sampling line could disconnect from the
equipment, causing the equipment to fall on the patient.
CO2 readings and respiratory rate can be affected by sensor application errors, certain ambient environmental
conditions, and certain patient conditions.
CAUTION
Precautions for Installing the Monitor
Make sure to secure the equipment using a specified trolley or stand. Otherwise, the equipment may fall down,
resulting in injury to the operator or damage to the equipment.
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CAUTION
Precautions about the Trolley
When attaching the monitor to the specified trolley, make sure that it is securely fixed on. Otherwise, the
equipment may fall off from the trolley, resulting in injury to the operator or damage to the equipment.
Make sure to use only the specified trolley. Otherwise, the trolley may fall down, resulting in injury to the
operator or damage to the equipment.
When using or storing the trolley, make sure that the casters are locked. Otherwise, the trolley may fall down,
resulting in injury to the operator or damage to the equipment.
Do not use or store the trolley where it will be subject to inclination of 10 degrees or more. The trolley or
equipment may fall resulting in injury to the operator or damage to the equipment.
CAUTION
Precautions about the System
Use only the spare parts specified for this equipment. Otherwise, proper function cannot be executed.
Do not use the touch panel with the film attached. It may cause malfunction or damage the touch panel.
For quality improvement, specifications are subject to change without prior notice.
This equipment utilizes LED for the backlight. Since this LED 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.
This equipment is intended to be used for only one patient.
The installation of this equipment should be performed by our service representative or a person who is
well acquainted with this equipment.
If not using the equipment for a long period, disconnect the power cable, module connection cable and lithiumion battery.
The lithium-ion battery can only be charged in the specified operational temperatures of the equipment. Refer
to the operation manual of the lithium-ion battery (BTO-008) for details.
CAUTION
Precautions about the ECG Monitoring
If any electrodes get detached from the patient after being connected to the lead cable and patient monitor, pay
attention that the metal part of the electrode does not get in touch with any metal parts of the bed or any
conductive parts. Also, the operator should not touch any conductive parts with bare hands. Otherwise, it may
cause electric shock to the patient and/or operator due to excessive leakage current.
The indication for continuous use of the electrode is about one day.
Replace the electrode if the skin contact gets loosen due to perspiration, etc.
When an electrode is attached to the same location for a long period, some patients may develop skin irritation.
Check the patient's skin condition periodically and change the electrode site as required.
For stable arrhythmia detection and ECG monitoring, verify proper electrode placement, lead, waveform size,
and filter mode selection. If not properly selected, it may cause erroneous detection.
The threshold level for arrhythmia detection changes with ECG waveform size. Set a proper waveform size
for monitoring.
When the ECG waveform size is x1/4, x1/2, or x1, the arrhythmia detection level is 250 μV.
When the ECG waveform size is x2 or x4, the arrhythmia detection level is 150 μV.
The leads for arrhythmia detection, central monitor display, printing are fixed as ECG1 and ECG2. Set the
most appropriate leads with high QRS for ECG1 and ECG2, especially for arrhythmia detection.If the QRS
amplitude for the set lead is low, it may cause erroneous arrhythmia detection.
In ESIS Mode, artifacts such as electrosurgical noise or EMG can be largely reduced, but QRS amplitude
attenuation, waveform distortion, or ST segment change may occur compared with other filter modes.
The ESIS mode cannot completely reduce the electrical noise, and may erroneously detect the pacemaker
spike. This mode should be selected only when a high frequency noise largely affects the HR measurement.
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There are some cases when the pacemaker pulse cannot be detected depending on the pacemaker type,
pulse voltage, pulse width, electrode lead type (unipolar, bipolar), or electrode placement which causes the
pacemaker pulse amplitude to decrease, and disables the pacemaker pulse detection.
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.
When a spontaneous QRS and pacemaker pulse overlap (ex. fusion beat, etc.), QRS detection cannot be
performed properly. In this case, the heart rate is degraded.
If a pacemaker pulse is continuously detected due to AC frequency interference, QRS detection will be
suspended and the heart rate will be reduced. Arrhythmia will not be detected either.
CAUTION
Precautions about the ST Measurement
The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment
changes need to be determined by a clinician.
For the lead which the electrode is detached, the reference waveform setup cannot be performed. Check if the
electrode is appropriately attached, and perform the setup again.
CAUTION
Precautions about the SpO2 Monitoring
Use only the sensor/relay cable specified by Fukuda Denshi. Otherwise, it may cause measurement error.If
the sensor is damaged, stop using it.
If the nail is rough, dirty, or manicured, accurate measurement will not be possible. Change the finger or clean
the nail before attaching the sensor.
If irritation such as skin reddening appears with the sensor use, change the attachment site or stop using the
sensor.
Do not apply the sensor too tight. At the same time, check the blood flow constantly so that congestion is not
generated at the peripheral site.
Do not use tape to attach the sensor.
Even attachment for a short duration may inhibit the blood flow and generate compression necrosis or burn
injury. Also, blood flow inhibition may prevent correct measurements.
Check the sensor attachment site constantly in every 4 hours when probes or reusable sensor are used, and at
least every 8 hours when single patient use sensors are used. Be especially careful of a patient with bad
perfusion. If the sensor attachment position is not changed constantly, skin irritation or skin necrosis due to
compression may be developed. For the patient with bad perfusion, check the sensor attachment position at
least every 2 hours.
As skin for neonate, premature 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 if
using in direct sunlight.
When not measuring, unplug the relay cable and sensor from the SpO2 connector. Otherwise, the outside light
may affect to falsely display measurements.
The pulse wave is normalized for SpO2 measurement, and does not indicate perfused blood volume. Check
proper probe attachment by observing the pulse wave.
Precautions for Reusable Sensors
The light-emitting part of the sensor should be over the root of the fingernail or as instructed per the related
sensor instruction manual. Do not insert the finger too far into the sensor as it may hurt the patient. For details,
refer to the SpO2 sensor instruction manual.
Precautions for Single-Patient-Use Type Sensors
The sensor can be reused on the same patient as long as the adhesive tape attaches without slippage. But do not
reuse on other patients to avoid cross contamination. It is intended for single patient use only. For details, refer
to the SpO2 sensor instruction manual.
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If "---" is displayed for the SpO2 numeric data, make sure that the sensor is properly attached.
Measuring on a limb with NIBP cuff, arterial catheter, or intracatheter may result in incorrect measurement.
Venous congestion may cause under reading of actual oxygen saturation. Therefore, assure proper venous
outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed
with arm dangling to the floor).
CAUTION
Precautions about the NIBP Monitoring
Do not apply the NIBP cuff to site of injury. An injury may be worsened by the measurement.
Do not apply the NIBP cuff to the arm on side treated axillary lymph nodes dissection. It may lead to
lymphatic edema by the cuff pressure.
Measuring on a limb with SpO2 sensor, arterial catheter, or intracatheter may result in incorrect measurement.
An operator must not get away from a patient during the NIBP measurement. However, when getting away
from the patient is necessary, do not activate the Alarm Suspend and Silence functions in order not to miss any
sudden changes in the patient's condition.
Pay attention when measuring the NIBP of patient with bleeding disorders or hyper coagulation. The cuff
inflation may cause petechia or circulatory failure by the blood clot.
For the following situation, measurements will be terminated.
When the measurement time has exceeded 160 seconds for adult and child, 80 seconds for neonate.
When the inflation value has exceeded 300mmHg for adult, 210mmHg for child, and 150mmHg for neonate.
If used with the incorrect patient classification, it will not only cause erroneous measurement, but the inflating
level for the adult may be applied to child or neonate causing dangerous situation to the patient.
The continuous measurement and 1-minute interval measurement will automatically stop after 12 minutes
(maximum 15 minutes).
If the mean MAP display is set to OFF, the MAP alarm will not be generated. Also the MAP data will not be
displayed for the tabular trend or the NIBP list.
CAUTION
Precautions about the BP Monitoring
Do not reuse / re-sterilize the disposable type transducers.
If using a reusable blood pressure transducer, disinfect it according to the manufacturer's guidelines.
The long-term use of the blood pressure transducer, tube and catheter may increase the risk of infection.
Perform periodic replacement with new one. The guidelines of the CDC (Disease Control and Prevention)
recommend replacing within 96 hours.
If the ambient temperature of the blood pressure transducer has changed greatly, the zero balance may cause
the drift. Perform the zero balance again.
An operator must not get away from a patient during the BP measurement. However, when getting away from
the patient is necessary, do not activate the Alarm Suspend and Silence functions in order not to miss any
sudden changes in the patient's condition.
Be sure to perform Daily Check. Use of faulty equipment might harm the patient or operator.
If the Equipment Status Alarm occurs or if you feel the unusual operation of the equipment, perform the
inspections to confirm the safety or contact our service representative.
If the transducer get disconnected, pay attention that the metal part of the transducer does not get in touch
with any metal parts of the bed or any conductive parts. Also, the operator should not touch the conductive
parts with bare hands. Otherwise, it may result in electric shock to the patient and/or operator.
When the power is turned ON, the BP value will not be displayed until zero balance is performed. Make sure
to perform the zero balance. Once the zero balance is performed, the zero balance information will be
maintained, and the BP value will be displayed.
Each time the blood pressure transducer or tubing is replaced, the zero balance procedure is required to
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ensure accurate measurements.
The zero balance procedure is required for the following case.
When starting the measurement.
When the position of the heart has changed due to body movement.
When the position of the transducer has changed.
When measuring for a long period of time and there is a possibility of measurement error due to change in
ambient temperature, etc.
When a connector is connected/disconnected, or a transducer is replaced.
Note that Systolic Pressure (SYS) = Peak Systolic Pressure (PSP) for the graphic trend, data base, and alarm
setup.
When ECG is not measured, Peak Diastolic Pressure (PDP) cannot be calculated.
The undisplayed BP data (SYS/DIA/Mean) will not generate a BP alarm or be displayed in the tabular trend.
Select the appropriate display type according to the monitoring purpose.
CAUTION
Precautions about the CO2 Monitoring (HCP-810/HCP-820)
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.
When the accumulated measurement time exceeds 1,200 hours from the first use.
However, if the first calibration was performed before the accumulated measurement time reaches 720 hours,
another calibration is required when the accumulated measurement time exceeds 1,200 hours from the first
calibration.
When 12 months has elapsed or the accumulated measurement time has exceeded 4,000 hours from the previous
calibration.
When EtCO2 measurement is not stable or accuracy is degraded compared with other measuring device.
When the patient monitor was not used for a while, or when EtCO2 was not measured for a while.
Perform the calibration 5 minutes after turning ON the power on the HCP-810/HCP-820.
Do not disconnect the sampling tube during calibration. If disconnected, calibration will cease.
Dispose of calibration gas according to the regulation of each medical institution.
Microstream® EtCO2 sampling tubes are designed for single patient use, and are not to be reused. Do not
attempt to clean, disinfect, sterilize or flush any part of the sampling tube as this can cause damage to the
monitor or lead to cross-infection.
Dispose of sampling tubes according to standard operating procedures or local regulations for the disposal of
contaminated medical waste.
Before use, carefully read the Directions for Use for the Microstream® EtCO2 sampling tube.
Only use Microstream® EtCO2 sampling lines to ensure the monitor functions properly.
CAUTION
Precautions about the CO2 Monitoring (HCP-810/HCP-820)
The airway adapter should be attached with the thicker side facing to the patient. If attached oppositely, it
may damage the CO2 sensor or airway adapter.
Dispose of calibration gas according to the regulation of each medical institution.
CAUTION
Precautions about the Alarm
Alarm messages will be displayed according to the priority. (Level S > Level H > Level M > Level L> Level N)
For the same alarm level, the alarm message for the newer alarm will be displayed.
The arrhythmia alarm message other than Tachy, Brady, Ext Tachy, Ext Brady will continue to be
displayed for 30 seconds after the alarm is resolved.
When "LEAD OFF", "Check Electrodes" is displayed, HR alarm or arrhythmia alarm will not function. If this
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condition is left unresolved, a sudden change of the patient may not be noticed. Take prompt action when the
lead-off condition is detected.
For the HPD-810/HPD-820 and HCP-810/HCP-820, the CO2 measurement range is 0 to 99 mmHg/0 to 13.3
kPa, and the upper EtCO2 alarm will not generate if the upper alarm limit is set to 100 mmHg/13.4 kPa and
above.
Whether to use the SpO2 second alarm function and its threshold selection should be based on the
patient's clinical indication/portent and medical evaluation.
If the SpO2 alarm and second alarm setup is set to [OFF], the second alarm integral value will be set to 0.
Pay attention not to set the alarm volume too low to avoid missing any important alarms.
On a wired network, the alarm generated on the bedside monitor will be output to the network with a
maximum delay of 1 second, and to the central monitor with a total delay of 2.5 seconds.
On a wireless network, the alarm generated on the bedside monitor will be output to the network with
a maximum delay of 2 seconds, and to the central monitor with a total delay of 3 seconds to 12
seconds.
If the same or similar equipments with different alarm settings are used in the same facility or same department,
pay attention not to misjudge the alarms.
CAUTION
Precautions about the System Setup
When the waveform and numeric data display for each parameter is set to OFF, the alarm and trend input will
be also suspended.
If the HR/PR source is set to [BP], and if BP waveform/numeric data is set to [Disp.OFF], the PR value will
not be displayed.
If the HR/PR source or RR source is set to [SpO2], and if SpO2 parameter is set to [Disp. OFF], the HR and
RR parameter will not be displayed.
If the RR source is set to [CO2/GAS], and if CO2 waveform/numeric data is set to [Disp. OFF], the RR value
will not be displayed.
If the time/date is not correctly set, or changed during monitoring, malfunction may occur with NIBP
measurement, periodic printing, trend, NIBP list data, and age calculation from the birth date.
CAUTION
Precautions about the Patient Admit/Discharge
If monitoring of a new patient is started without discharging the previous patient, data of the new patient will
be added to the data of the previous patient which will result in inaccuracy.
The user mode setting (alarm/display configuration) will remain effective even when the power is turned OFF
or when the patient is discharged. Before monitoring, make sure the current user mode is suitable for the
patient's condition.
Resuming monitoring will also resume the alarm in suspension.
CAUTION
Precautions about the SD Card
Use only the specified SD card.
Use only the SD card formatted on this equipment.
Make sure to power cycle the system after the setup data is read from the SD card.
By power cycling the system, the read data will become effective.
Do not leave the SD card in reach of patients or infants.
CAUTION
Precautions about the Maintenance
When cleaning the touch panel, never use strong-acidic cleaning solution.
To clean the touch panel, use an optional cleaning cloth, eyeglass cleaning cloth, soft cotton cloth, or nonwoven cloth (pulp, rayon, polyethylene, etc.).
Clean the equipment frequently so stains can be removed easily.
To prevent injury, it is recommended to wear gloves when cleaning the equipment.
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Pay attention not to allow chemical solution to enter the equipment or connectors.
Do not use organic solvents, thinner, toluene or benzene to avoid damaging the resin case.
Do not polish the equipment with abrasive or chemical cleaner.
When disinfecting the entire room using a spray solution, pay close attention not to get any solution into the
equipment or connectors.
Use only neutral detergent to clean the equipment. The surface resin coating may damage, resulting in
discoloration, scratches, and malfunction.
Example:
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
Do not open the housing.
Do not allow alcohol or other liquids to enter the equipment.
Replace the periodic replacement parts periodically as specified.
Wired Network (DS-LANII/ DS-LANIII)
WARNING
Do not connect unspecified device to the wired network.
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.
CAUTION
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.
On the DS-8007 system, the following settings are saved on the AC Unit (DSA-81).
Room ID, Bed ID, DS-LAN II/III Setup, Pat. ID Transmission Start Position, Hemodynamic Data
Synchronization, CO2(mmHg) Upper Limit of Transmission
On the AC Unit (DSA-81), the default setting of Bed ID is "000". If connected to a wired network with the
bed ID unchanged, monitoring on the central monitor will not be possible.
When connecting to a wired network, make sure that there are no other bedside monitors with the same ID. If
there is more than one bedside monitor with the same bed ID, the duplicated bedside monitors cannot be
monitored on the central monitor.
When connected to the DS-LAN II network, set the Bed ID in the range from "001" to "048" .
When connected to the DS-LAN III network, set the Bed ID in the range from "001" to "100" .
There are following restrictions when connecting the DS-8007 System to the wired network.
The BP measurement unit setting should be the same for all central monitors and bedside monitors. If the
setting is different among the monitors, data such as BP waveform, BP numeric data, NIBP numeric data,
NIBP list will not be transmitted.It will be treated as not measured data, and will not be displayed on the
central monitor.The alarm limit setup from the central monitor cannot be performed either.
On the DS-LAN II network, the arrhythmia alarm of Tachy, Brady, Couplet, Pause, Trigeminy, ExtTachy,
ExtBrady, RR IREG, Prolong RR, Triplet, Multiform, VENT Rhythm, Not Capt, Not Pacing, S Couplet,
SVT, SVPC, S Frequent will not be transmitted.
On the DS-LAN II network, arrhythmia alarm of "SLOW VT" will be transmitted as "VT" .
On the wired network, measurement data and alarm of TEMP3 to 6 will not be transmitted. Also, the
displayable waveform, numeric data, alarm differs depending on the connected central monitor.Refer also to
the operation manual for the respective central monitor.
The PR_IBP alarm will not be transmitted to the central monitor.
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If the "RR/APNEA alarm source" is other than [Impedance] (or, if [Auto] selects a setting other than
[Impedance]), the RESP waveform will not be transmitted on a wired network.
If the "RR/APNEA Alarm Source" setting is other than [CO2] (Or, if [Auto] selects a setting other than
[CO2]), the CO2 waveform will not be transmitted on a wired network.
For the numeric data displayed as "xxx", maximum or minimum value of measurable range will be
transmitted.
The numeric data displayed as "--- " will be treated as not measured data.
If the measurement unit of CO2 concentration is mmHg and [99mmHg] is selected for "CO2 (mmHg) Upper
Limit of Transmission" ([Initial Settings]>[System]>[DS-LAN]), the CO2 value of 100mmHg or above will
be transmitted as 99mmHg.
As the DS-8007 System do not have the arrhythmia template display and 12-lead ST display function,
waveforms and other data will not be displayed for these displays on the central monitor connected to the DSLAN network.
When connected to the wired network, the time/date will synchronize with the central monitor.Even if the time/
date is changed on the DS-8007 System, it will be corrected to the time/date of the central monitor.
Depending on the central monitor model type, the ST display will be distorted if the ECG lead (ECG1 or ECG
2) is changed on the DS-8007 System system. Redrawing the ST display will return the display to normal.
On the central monitor, the respiration waveform and RR value based on the "RR/APNEA Alarm Source"
selected on this monitor will be displayed. The same parameter for the RR and apnea will be monitored on
this monitor and the central monitor. However, the DS-7000 series central monitors do not support
RR_SpO2 measurement, and if RR/APNEA source is set to [SpO2], RR value and APNEA condition will
not be displayed.
Wireless Network System
DANGER
When monitoring a patient using wireless telemetry, make sure the patient data is properly received at the
central monitor. Pay special attention when the channel ID at the bedside monitor is changed.
WARNING
A password can be set to access the channel ID setup menu to allow only the telemetry channel
administrator to change the channel ID.
Some type of wireless combinations may generate interference with other telemetry.
Before selecting a channel, verify it will not interfere with other channels.
Inform the supervisor of the use of telemetry channels to avoid interference with other telemetry.
If transmitters are used in a neighboring medical facility, your facility and the neighboring facility must make
agreements on the setting of the telemetry channels to prevent telemetry interference.
CAUTION
Precautions about the Telemetry
When performing telemetry transmission, configure the display so that the numeric data corresponded to
the waveform is displayed. If not, the displayed waveform or numeric data may not be transmitted.
The setup of channel ID and group ID should be performed only by the telemetry channel administrator or our
service representative. Users should not perform this procedure as malfunction may occur.
When the measurement unit of BP is "kPa", corresponding waveform and numeric data will not be transmitted.
When using a wireless network, use "mmHg" for the BP measurement unit.
BP waveform with a scale above the set scale cannot be properly transmitted. When transmitting the BP
waveform, pay attention to the displayed BP scale.
If the measurement unit of CO2 concentration is mmHg and [99mmHg] is selected for "CO2 (mmHg) Upper
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