Fukuda Denshi HJ-500 User manual

H
HJ J- -5 50 00 0/ /H HC C- -5 53 30 0
Module
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Service Manual
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・Before setting up/maintenance, please read this service manual carefully.
・Keep this manual where it can be always referred to.

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.
Printed in Japan

Safety Messages
The following safety messages are used throughout this manual. These
notices have different meanings as described below. Read this section
carefully and become familiar with their meaning.
WARNING Failure to follow this message may result in
death or serious injury to the patient or
operator.
CAUTION Failure to follow this message may cause injury
to the patient or operator, or may cause damage
to the equipment.
NOTE
A note is not related to product safety. A note
provides information about the proper use and
operating methods to prevent incorrect
operation and trouble with the unit.
Symbol
Symbol Description
This symbol on the unit indicates that some hazard
might be present. Relevant information is supplied in
this operation manual.
Defibrillation-Proof Type CF Equipment
This indicates that this system is Defibrillation-Proof
Type CF Equipment.
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Precautions for safe operation of medical electrical equipment
CAUTION
Precautions for safe operation of medical electrical equipment
To operate the device correctly, read the following precautions carefully.
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Before using this system, become familiar with its operation.
On the installation and storage of the system:
· Do not install or store in an area where there is splashing water or excessive
humidity.
· Do not install or store in an area where the environmental conditions, such as
atmospheric pressure, temperature, sunlight, dust, sodium, sulfur, will adversely
affect the system.
· Do not install or store in an area that is subject to excessive vibration, shock or
where the instrument may fall.
· Do not install or store in an area where there are chemicals or gasses stored.
· When using this device near devices generating high-frequency interference, such
as mobile phones and electrosurgical knives, verify the recorder operation is normal.
· Verify the power voltage and frequency before connecting to the AC power source.
· Verify the power source can provide adequate current as indicated on the power
rating label on the device.
Before operating the system, verify the following items:
· Ensure all cables are connected firmly and the system works correctly.
· Make sure the power system has adequate Earth ground. If necessary, use the
accessory ground cable and connect it to the ground terminal.
· Pay special attention when the device is used in conjunction with other equipment.
· Ensure any patient connections are connected properly and securely.
During operation of the system, verify the following items:
· The system and patient should be continuously monitored to ensure safe and proper
operation.
· If a malfunction occurs, adequate measures should be immediately taken to cease
operation in the safest way for the patient.
· Do not allow the patient to touch the equipment.
After use of the system, verify the following items:
· Unplug all cables from patient before turning the power OFF.
· When unplugging any of the cables connected to the device, do not pull on the cable
itself. Always remove any cables by pulling on the connector.
· Always clean the unit and cables, if necessary to prepare for the next use.
If the equipment is broken and in need of repair, do not attempt service. Label the
unit “OUT OF ORDER” and contact Fukuda Denshi for service.
Do not remodel the equipment.
Maintenance checks.
· Make sure to periodically check the equipment and parts.
· Before reusing a device which has been left unused for a while, make sure that the
device works normally and safely.
When use electrosurgical knives or defibrillator while using device, verify the
followings so that patient may not burn.
· For electrosurgical knives, verify antipole board loading and ECG electrode modes.
· For defibrillator, verify paste volume and output energy. In addition, make sure each
device is firmly grounded.
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●Precautions about the Pacemakers
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.
òReference
“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]
●Precautions about the device
DANGER
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When connect this device to another device, contact Fukuda Denshi for service.
Electric shock or some dangerous consequence may result to patient and operator.
To avoid the risk of explosion, do not use in the presence of combustible of
flammable material such as flammable anesthetic gas, hydrogen.
Explosion or fire may result.
When using multiple devices together, make sure they are properly grounded to
achieve an equipotential ground.
Electric shock may result if proper grounding is not observed.
WARNING
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Do not connect to I/O connectors except with devices or wires authorized by
Fukuda Denshi.
If use unauthorized devices and wires, either of function and safety cannot be ensured
and damage may result to devices.
If use this device under insufficient condition, either of function and safety cannot
be ensured and damage may result to device.
Electrosurgical knives can not be used simultaneously with the HJ-500. When
using the electrosurgical knives, disconnect the cables from the HJ-500.
High radio frequency energy generated by electrosurgical knives may cause a burn
injury at the electrode sites, or may cause damage to the device. There is also a
danger of electric shock.
Do not touch this device during defibrillation.
Electric shock or some dangerous consequence may result to patient and operator.
Do not dismantle/remodel the equipment.
Electric shock may result.
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WARNING
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Do not cover the vent holes on the front panel.
The temperature rise inside the equipment may cause damage or malfunction of the
equipment.
If device gets wet with water or medicament, stop monitoring and unplug power
cable.
Before starting up the device again, make sure of its safety.
Set the pacemaker used/unused information correctly in the patient
admit/discharge setup.
This affects the measurement accuracy of QRS detection and arrhythmia analysis.
Arrhythmia detection is sometimes affected by excessive changes in waveform,
artifact, or lack of pattern recognition, which may cause an error in the detection.
Final decision should be made by the physician.
Cable connection of analog signal output should be performed only by trained
personnel.
Electric shock hazard may occur to the user, or a malfunction of the device may occur.
Analog signal of this device is output in delayed time.
The delay time of the waveform and QRS synchronized signal may vary depending on
the waveform shape and presence of artifact.
l Inside the calibration gas cylinder is applied pressure. Do not puncture.
Do not use or store in the presence of heat or open flame. If exposed to the
temperature above 54°C, leakage or explosion may result. Never discard the
cylinder into the fire or incinerator. (Printed on the gas cylinder.)
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WARNING
Long-term hyperthermia may blister skin. Also, when producing local
hyperaemia by means of hyperthermia, a certain risk of applying a heat exposure
that is harmful to the skin is always present. For special patients, e.g. patients in
shock, patients with low blood pressure, and patients with vascular constrictions,
particular care should be taken whenever hyperthermia is produced.
l During monitoring, electrodes need to be replaced at least every 4 hours to
avoid burn on patient’s skin.
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CAUTION
· This device is not intended for use with the IB-7006 of the polygraph system
(MCS-7000 System). Do not use polygraph system modules with the DS-5000
System. The device can be damaged and/or safety cannot be ensured.
· This device is not intended for use outside the hospital (including in ambulance),
under MRI environment, inside a hyperbaric chamber or in the presence of
flammable anesthetic gas.
· For quality improvement, specifications are subject to change without prior notice.
· Upgrading of the program, maintenance test, module install (upgrade), and
demonstration functions should be performed only by Fukuda Denshi authorized
personnel. Users should not attempt to perform any of these operations.
Malfunction may occur to the device.
· Do not open the external case of this device.
· Lead cables and amplifiers are galvanically isolated from other parts of the
equipment, but if the electrodes are touching other metal parts or patient’s limbs, the
galvanic isolation will not function. Electric shock may occur even if the equipment
is grounded.
· If the power cables for several equipments are connected to the same outlet, the
leakage current will increase and may cause hazardous condition to the patient.
12ECG/RESP Monitoring
· When using the HJ-500 and the HS-500 simultaneously, the measurements by the
HJ-500 will be given priority. Waveforms and measurements measured by the
HS-500 will not be displayed.
· The HJ-500 is a CF type equipment, but is not intended for use directly to the heart.
· Be especially cautious when monitoring ECG of a patient with pacemaker or other
electrical equipment connected.
· For stable monitoring, use the specified electrodes and leads.
· When applying ECG electrodes to the patient, follow the instruction of the physician.
· If ECG electrodes are located at the same place for a long time period, some
patients may experience a rash. Check the electrodes periodically and change
the placement if necessary.
· When using a defibrillator during ECG monitoring, the high-voltage discharge will
generate a polarization potential in the electrode, and may interrupt monitoring for a
few seconds.
· A pacemaker pulse is detected by hardware. Stable detection may not be acquired
if the pacemaker pulse signal gets small depending on the pacemaker type, output
pulse voltage, pulse width, electrode lead type (unipolar, bipolar), and lead position.
· If there is a device generating noise near the patient, this noise can be erroneously
detected and displayed as a pacemaker pulse.
· When a pacemaker pulse wave resembles the QRS wave, QRS detection (heart rate
counting) may not be performed.
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CAUTION
· Sometimes automatic QRS detection may not be performed, even though the QRS
amplitude value is above the threshold level.
· Automatic QRS detection may not be performed when the QRS amplitude is
extremely low and wide, or when noise is interfering.
· Manual QRS detection is always performed on the absolute level and may cause
erroneous detection in cases where there is excessive baseline drift of the ECG
waveform. 180ms after the detection of the peak of the R-wave will be a T-Wave
Lock Out Time to prevent detecting the T-wave as QRS (double counting).
· When turning on the AC filter or when Monitor Mode is selected, the amplitude of the
ECG waveform might become small or distorted.
· If “LEAD OFF” condition continues when automatic lead switching is set to ON, the
ECG lead will automatically switch to another lead, and when “LEAD OFF” condition
is resolved, it will return to the original lead.
· For using the HJ-500, proper setting on the DS-5300 bedside monitor is necessary.
Set the “HJ-500” to ON for the “MODULE CONFIG.” in the preset menu. (Refer to
the DS-5300 operation manual.)
· When monitoring with the 3-electrode lead, proper setting on the DS-5300 bedside
monitor is necessary. Set the “HJ-500 3LEAD” to ON in the ECG configuration
menu. (Refer to the DS-5300 operation manual.)
· Manual respiration detection is always performed on the absolute level and may
cause erroneous detection in cases where there is excessive baseline drift.
TcpO2/pO Monitoring
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· Use electrodes and accessories specified by Fukuda Denshi. If not, the unit may
not perform its function fully and may result in skin burns.
· Improper cleaning of the electrodes adversely affects the calibration value.
· Electrodes need to be calibrated. Perform calibration correctly.
· Set the calibrated value, temperature of electrodes and monitoring time on the
monitor in advance. For the setting procedure, refer to the operation manual for the
patient monitor.
· If electrodes are not removed from the socket within 30 minutes after the Ready LED
turns ON, electrode heating stops automatically (Ready LED turns OFF) to prevent
drying of the electrolyte. Electrodes will need to be recalibrated.
· TcpO2 and tcpCO monitoring should be used as an auxiliary for measuring pCO in
the artery. Do not use for patients with critical blood circulation.
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· If electrodes are not removed from the socket within 30 minutes after calibration,
electrode heating stops automatically to prevent drying of the electrolyte. When
used later for measurement, electrodes need to be recalibrated.
· The electrode may be rejected because of an incorrect preset calibration value.
Maintenance
· Do not allow alcohol or other liquids to enter the equipment and connectors.
· Do not use organic solvents, thinner, toluene and benzene to avoid damaging the
resin cabinet.
· Do not polish the case with abrasive or chemical cleaner.
· When sterilizing the entire room by using a spray, be cautious not to allow chemicals
to enter the device or the connector.
· Use only the accessories specified for this equipment. Failure to use the specified
accessories may result in improper function or operation.
●Disposing of Equipment, Accessories, or Components
When disposing of the equipment, accessories, or components, use
an industrial waste distributor. Do not dispose of as an ordinary
waste.
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Safety
Only persons familiar with the operational procedure for monitoring
12ECG/RESP and tcpO /CO measurements should be authorized to use this
equipment.
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●Design and Construction
These modules are designed to be classified as IEC 60601-1 type CF.
●Preventive Maintenance
The purpose of preventive maintenance is to eliminate potential problems and
to keep the instrument in a condition providing completely safe, satisfactory
operation.
Preventive maintenance should be carried out at least once a year as
prescribed in the Service Manual for these modules.
Before using the instrument, always ensure that the unit shows no signs of
damage.
Immediate maintenance has to be carried out:
· If the instrument was subject to extreme mechanical stress, e.g. after a
heavy fall.
· If the instrument was subject to spill of liquids.
· If the function of the instrument seems to be interrupted or disturbed.
· If parts of the enclosure of the instrument are cracked, removed, or lost.
· If any connector or cord shows signs of deterioration.
●Leakage Current
The system is designed to meet the standards for safe electrical current per
IEC 601-1.
●Non-explosion Proof
These modules are not designed to for operation in areas in which there is a
risk of explosion.
●Cleaning and Disinfection
Cables
For disinfection, the cables should be rubbed with a swab or cloth moistened
with a formaldehyde solution, such as Cidex 5%.
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Module
The instrument cabinet may be cleaned and disinfected in the following
manner,
Cleaning:
Rub the unit with a cleaning cloth moistened with water to which an ordinary
household cleaning agent can be added if necessary. Never use ether or
benzene.
Disinfection:
Thoroughly spray the cabinet with 5% Cidex or a similar product.
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