Service Manual
247 Pages
Preview
Page 1
Series
Patient Monitor
* Before setting up/maintenance, please read this “Service Manual” thoroughly. * After reading, keep this manual for future reference.
Service Manual
CAUTION
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
This device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC. This device bears the CE label in accordance with the provisions of RoHS Directive 2011/65/EU.
Fukuda Denshi UK Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom
CAUTION:
This device is for sale by or on the order of a physician.
CAUTION: • This device for sale by or on the order of a physician. • The company and product names used in this manual are trademarks or registered trademarks. • If this manual has pages missing or out of order, contact Fukuda Denshi for replacement. • Only physician or persons instructed by physicians are allowed to use the equipment. • The information contained in this document is subject to change without notice due to improvement in the equipment. Copyright © 2014 by Fukuda Denshi Co., Ltd. No part of this document may be copied or transmitted in any form without the prior written permission of Fukuda Denshi Co., Ltd. Printed in Japan
Revision History Model Name
DS-8100 System Service Manual Edition 1
Revised Items －
Reason of the Revision New Edition
Date 2014.02
Blank Page
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 The Meaning of Each Safety Precaution ······················ ii Warning Labels Attached to the Unit ··························· iii Measurement Unit for Each Parameter ······················· iv Graphic Symbols ························································· vi Precautions for Safe Operation of Medical Electrical Equipment ································································ vii Precautions about the Maintenance ·························· viii Precautions about the Network System······················· ix Medical Telemetry·················································· ix Bidirectional Wireless Communications Module (TCON) (Only for USA)········································x Precautions when Using with Other Equipment ········· xii Pacemaker···························································· xii Non-Explosion Proof ············································· xii Defibrillator···························································· xii Electrosurgical Instrument ··································· xiii MRI (Magnetic Resonance Imaging)···················· xiii Precautions about Connections to Peripheral Devices····························································· xiii Precautions for Using the Equipment ························ xiv This System ························································· xiv Wired Network (DS-LAN II / DS-LAN III) ············ xxii Wireless Network System ···································xxiii RTC and Data Backup ······································· xxiv Precautions about the Ventilator Monitoring············ xxiv Precautions about the SpO2 Sensor························· xxv Precautions about the NIBP Cuff······························ xxv Precautions about Disposing of the Equipment, Accessories, or Components···································· xxv Precautions about Transportation····························· xxv Monitoring after Power Failure ································· xxv To Prepare for Emergency Use ······························· xxvi Electromagnetic Compatibility··································xxvii Precautions for Safe Operation under Electromagnetic Influence ································································xxvii EMC Guidance ························································xxvii Compliance to the Electromagnetic Emissions ·xxviii Compliance to the Electromagnetic Immunity (1) ··················································xxviii Compliance to the Electromagnetic Immunity (2) ··················································· xxix Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the DS-8100 System ·············· xxx
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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. Failure to follow this message may cause immediate threat of death or
D A N G E R serious injury.
W A R N I N G Failure to follow this message may result in death or serious injury. C A U T I O N Failure to follow this message may cause injury or failure to the equipment. NOTE
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"Note" is used to emphasize important information.
Warning Labels Attached to the Unit Make sure to read the warning labels attached to the unit and comply with these requirements while operating the unit. Do not damage or erase the warning labels attached to the unit. These warning labels contain important descriptions for handling and C A U T I O N operating the equipment properly and safely. A damaged label may compromise safe operation. DS-8100 Series Main Unit Caution Label
Battery Caution Label Warning Labels Attached to the Unit
Warning Label
Warning Label
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Measurement Unit for Each Parameter The measurement units for this equipment are as follows. Detail
Parameter
Display
Impedance
RESP
Ventilator CO2 SpO2 Impedance CO2 Ventilator
RR_VENT RR_CO2 RR_SpO2 APNEA APNEA APNEA
BP
BP
BP
Non-Invasive Blood Pressure Arterial Oxygen Saturation
Non-Invasive Blood Pressure SpO2 Perfusion Index Pleth Variability Index SpHb
NIBP SpO2 PI PVI SpHb
Unit bpm (beats per minute) bpm bpm bpm mm, mv beat/minute beat/minute Bpm (breaths per minute) Bpm Bpm Bpm s (second) s (second) s (second) mmHg, kPa cmH2O (CVP only) mmHg, kPa % % % g/dL
SpCO
SpCO
%
SpMet
SpMet
%
SpOC TEMP CO2
SpOC TEMP EtCO2
mL/dL °C mmHg, kPa, %
mmHg
CO2
InspCO2
mmHg, kPa, %
mmHg
CO Blood Temperature Injectate Temperature Airway Flow Airway Pressure Ventilatory Volume Expiratory Tidal Volume Inspiratory Tidal Volume Ventilatory Volume per second Minute Ventilation Volume Spontaneous Minute Volume Compliance Expiratory Resistance Inspiratory Resistance Mean Airway Pressure Peak Airway Pressure Pause Airway Pressure Plateau Pressure
CO Tb Ti AWF AWP AWV E-TV I-TV TV/1Sec MV SMV COMP E-RES I-RES MEAN PEAK PAUSE PLATEAU
L/minute °C °C L/minute cmH2O mL mL mL % L/minute L/minute mL/cmH2O cmH2O/L/Sec cmH2O/L/Sec cmH2O cmH2O cmH2O cmH2O
Peak End Expiratory Pressure
PEEP
cmH2O
ECG
HR
ST Level
BP Non-Invasive Blood Pressure SpO2 ECG
VPC
ECG
PR_IBP PR_NIBP PR_SpO2 ST VPC PACE
Heart Rate/Pulse Rate
Respiration Rate
Apnea
Perfusion Index Total Hemoglobin Carboxyhemoglobin Concentration Methemoglobin Concentration Arterial Oxygen Saturation TEMP End-Tidal CO2 Concentration Inspiratory CO2 Concentration CO Blood Temperature Injectate Temperature Airway Flow Airway Pressure Ventilatory Volume Tidal Volume Minute Ventilation Volume Compliance Airway Resistance
Airway Pressure Peak End Expiratory Pressure
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Default
mm
mmHg mmHg
Detail
Vigilance Data Vigilance Vigilance CEDV Vigilance II Vigileo
BIS Monitor Data AEP Monitor Data INVOS 5100C Monitor Data
Parameter Mixed Venous Oxygen Saturation Central Venous Oxygen Saturation Arterial Oxygen Saturation Oxygen Uptake Index Oxygen Transport Oxygen Consumption Stroke Volume Stroke Volume (STAT Mode) Stroke Volume Index Stroke Volume Index (STAT Mode)
Display SvO2
%
Unit
ScvO2
%
SaO2 O2EI DO2 VO2 SV
% % mL/minute mL/minute mL/beat
SV_STAT
mL
SVI
mL/m2
SVI_STAT
mL/m2
HR
HR
Mean Arterial Pressure Central Venous Pressure Continuous Cardiac Output Continuous Cardiac Output (STAT Mode) Continuous Cardiac Index Continuous Cardiac Index (STAT Mode) Systemic Vascular Resistance Systemic Vascular Resistance Index Blood Temperature Ejection Fraction Ejection Fraction (STAT Mode) End-Diastolic Volume End-Diastolic Volume (STAT Mode) End-Diastolic Volume Index End-Diastolic Volume Index (STAT Mode) End-Systolic Volume End-Systolic Volume Index Stroke Volume Variance Bispectral Index Signal Quality Index Electromyograph Suppression Ratio AEP Index regional cerebral oxygen saturation (Left) regional cerebral oxygen saturation (Right)
MAP CVP CCO
bpm (beats per minute) mmHg mmHg L/minute
CCO_STAT
L/minute
CCI
L/minute/m2
CCI_STAT
L/minute/m2
SVR
dyn-sec-cm-5
SVRI
(dyn-sec-cm-5-m2)
BT RVEF RVEF_STAT EDV
°C % % mL
EDV_STAT
mL
EDVI
mL/m2
EDVI_STAT
mL/m2
ESV ESVI SVV BIS SQI EMG SR AEP
mL mL/m2 % (no unit) % dB % (no unit)
Lt-rSO2
%
Rt-rSO2
%
Default
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Graphic Symbols Refer following for the meaning of the symbols indicated on the equipment.
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Precautions for Safe Operation of Medical Electrical Equipment Users should have a thorough knowledge of the operation before using this equipment. z Precautions about the Location of Installation and Storage of the Equipment y 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. y Install or store in a place where the equipment will not be exposed to splashing water. y Install or store in a place where the equipment will not be adversely affected by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust or atmosphere containing salt or sulfur. y Place the equipment on a stable surface where there is no inclination, vibration, or shock (including during transportation). y Do not install or store in an area where chemicals are stored or gasses are evolved. y Verify the power frequency, voltage and allowable current (or power consumption). y Ensure the grounding is proper by connecting the accompanying power cable to the hospital grade outlet. z Precautions Before Using the Equipment y Verify the power voltage. Charge the battery pack fully before operating the system with the battery pack y Check the cable connection and polarity to ensure proper operation of the equipment. y Make sure the power system has adequate earth ground. y Ensure that all cables are firmly and safely connected. y Pay special attention when the equipment is used in conjunction with CAUTION other equipment as it may cause erroneous diagnosis and danger. z Precautions During Using the Equipment y Always observe the equipment and patient to ensure safe operation of the equipment. y If any abnormality is found on the equipment or patient, take appropriate measures such as ceasing operation of the equipment in the safest way for the patient. y Do not allow the patient to come in contact with the equipment. y On start-up of the system, verify that the start-up tone generates and alarm indicator lights. z Precautions After Using the Equipment y Unplug all the cables from the patient before turning off the power. y When unplugging the cables, make sure to pull from the connector part of the cable and avoid applying excessive force. y Clean the accessories and cables, and keep them together in one place. y Keep the unit clean to ensure proper operation for the next use. z Precaution when Equipment Failure Occurs y 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. z Precaution about Disassembling/Remodeling the Equipment y Do not disassemble or remodel the equipment. y If water or other liquids enter the equipment, cease using the equipment and contact Fukuda Denshi. z Precautions about Maintenance Check y Make sure to periodically check the equipment, accessories and cables. y When reusing the equipment which was left unused for a while, always check that the equipment operates properly and safely before use.
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z Precautions when Using with Other Equipment y To prevent patient from burn injury, verify proper attachment of patient ground plate, ECG electrode type when using the CAUTION electrosurgical knife, and verify paste volume, output energy when using the defibrillator. Also, verify that each equipment is properly grounded.
Precautions about the Maintenance Never open the housing while the equipment is in operation or connected to
W A R N I N G hospital grade outlet as it may result in electric shock.
z Precautions about Safety Check y 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. y Immediate maintenance has to be carried for the following case. CAUTION ・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. Reference
Refer to “11. Periodic Check” for details.
Maintenance, Modifications, and Repairs Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if; y Maintenance, modifications, and repairs are carried out by authorized personnel. y Components are used in accordance with Fukuda Denshi operating instructions.
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Precautions about the Network System Medical Telemetry z Precautions about the Installation y 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). When telemetry has already been installed and been used, radio format, frequency, and antenna power are required to be examined to prevent interference. y 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. y When using telemetry which requires zone location, display and identify each prepared zone in the equipment. y When laying receiver antenna for each transmitter, the Institution has to examine the installation so that electronic interference does not occur. y Based on the above examination result, the Institution should place each receiver antenna as required. z Precautions about the Management y 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. y Select a telemetry manager who understands the characteristics and CAUTION functionality of telemetry systems, and is skilled in operating telemetry. y When installing telemetry, the Overall Manager and the Zone Manager have to understand the precautions for use of the telemetry in advance. y The Overall Manager takes responsibility of wireless channel management and transmitter storage for the whole Institution by giving proper instruction. y 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. y The Zone Manager assumes responsibility for managing the wireless channels, storing, and managing telemetry. y The Zone Manager assigns the transmitter to the user, and provides enough education for use inside the zone. y The telemetry user verifies operation of the transmitter/receiver before use. y 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. y 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) (Only for USA)
CAUTION
x
z Precautions about the Installation y 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. y Even if this device is installed within the range of radio communication, the communication may not be possible due to noise or multi-path phasing etc. y 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, changes the channel ID. y Do not install this device in an area where it will be subject to splashing water. Water entering the equipment may cause the equipment to malfunction or be damaged. z Precautions about the Management y The Institution should appoint a person (hereinafter referred as the "Overall Manager" to manage the wireless devices for the whole facility. y 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. y The Overall Manager is responsible for the maintenance and storage of the equipment. y 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 facility. When assigning or changing wireless channels, register it in the log, and give proper instructions to the TCON user. y The user needs to verify the transmitting/receiving operation before use. y 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. z Precautions for Operation The Bidirectional Wireless Communications Module (TCON) uses radio waves to transmit data. Therefore, necessary precautions need to be taken for the characteristics and difficulties of using the device that emits radio waves. The TCON user should fully understand these precautions beforehand, and use the TCON device safely. For details, please refer to the HTC-702 Instruction Manual. Furthermore, situations in which interference may occur are outlined below. In such cases, pay special attention to the condition of the patient connected to the bedside monitor, and eliminate the cause of interference. y When the patient's data may become mixed with a different patient's data due to interference. ・When there are multiple TCON communication devices set to the same TCON ID and channel (group). y When symptoms such as being unable to communicate, unstable communication, or poor reception may occur. ・When the radio communication is bad because there are metal, concrete, or other such obstacles between the Bidirectional Wireless Communications Modules (TCON).
CAUTION
・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 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. ・If a nearby different group is set with a TCON channel frequency that is too close to the channel frequency set for the current TCON group. z Precautions about the Setting y 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. y If the TCON is set to [OFF], all TCON messages such as "Check TCON Comm." will not be displayed. y When TCON is used, even if [ON] is set for "Start NIBP Auto Mode with Start/Stop key."([Initial Settings] > [User I/F] > [Power ON/Discharge]), Backup at Discharge (NIBP Auto Mode) function will be [ON] since the central monitor will not be on Standby mode. y Check that three antenna bar marks ( ) are displayed. y Make sure that the TCON group number between the bedside monitor and central monitor is the same. y If the equipment is moved during TCON operation, the radio waves signal may become interrupted. y There are following restrictions when connecting the DS-8100 System to the TCON network. ・When the BP measurement unit is [kPa], the central monitor does not receive the NIBP/BP1/BP2 Data. Also, the NIBP/BP1/BP2 Alarm Setup cannot be changed on the central monitor. ・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. y If the measurement unit of CO2 concentration is [mmHg], the CO2 value of 100mmHg or above will be transmitted as 99mmHg.
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Precautions when Using with Other Equipment Pacemaker
WARNING
y 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. y 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 Never operate the equipment in the presence of flammable anesthetics, high concentration of oxygen, or inside hyperbaric chamber. Also, do not D A N G E R operate the equipment in an environment in which there is a risk of explosion. Explosion or fire may result.
Defibrillator z 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. z 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 W A R N I N G shock from the discharged energy. z When defibrillating, do not touch the patient and the metal part of the device or cables. Electric shock may result from the discharged energy. z This equipment will return to standard operating mode within 10 seconds after defibrillating. The stored data will not be affected. The measurement accuracy will temporarily decrease during defibrillation, but it will not compromise the safety of patient and the equipment. z The QRS synchronized signal is not intended to be used as synchronized signal for defibrillator.
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Electrosurgical Instrument z 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 the electrical knife and is difficult to completely eliminate because of the frequency components of the ECG. To reduce electrosurgical interference, take the following precautions: Location Locate the electrosurgical unit as far as possible from this unit and the patient cable. This will help reduce interference on the ECG through the monitor or cables. Power Supply Connect the electrosurgical unit to a power supply that is different from that of the monitor. This will help prevent interference through the power cable. Electrode Placement The amount of interference is considerably different depending on the W A R N I N G 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. z 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. z 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.
MRI (Magnetic Resonance Imaging) z Do not use this equipment in magnetic resonance imaging (MRI) environments. z When conducting MRI test, remove the electrodes and sensors connected to the patient (test subject). This equipment may be pulled WARNING towards the MRI device. Also, the local heating caused by the induced electromotive force may cause burn injury to the patient (subject) or performance degradation of this equipment. For details, refer to the operation manual for the MRI testing device.
Precautions about Connections to Peripheral Devices In the interest of safe and sufficient performance of this equipment, the connection of other manufacturers' equipment to the monitor is not authorized, unless the connection is explicitly approved by Fukuda Denshi. It is the user's responsibility to contact Fukuda Denshi to determine the compatibility and warranty status of any connection made to another manufacturer's equipment.
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z When multiple equipments are connected to the patient, the total amount of leakage current may exceed the limit specified on EN 60601-1.
W A R N I N G z For the connector with
mark, only the peripheral devices specified by Fukuda Denshi should be connected with the given procedure. Use of an unspecified device may cause electric shock to the patient and/or operator due to excessive leakage current.
z Although the peripheral device connectors on the DS-8100 System are isolated from the power supply, the connecting peripheral devices should comply with EN 60601-1 inside the patient environment. In other cases, to maintain operator and patient safety, consider the requirements of EN 60601-1. It is the user's responsibility to ensure that the overall system provides a level of safety in compliance with EN 60601-1. z To prevent danger of electric shock, always position the peripheral devices away from the patient. CAUTION z 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. z Combinations of medical equipment with non-medical equipment must comply with IEC60601-1-1. Never use a multiple portable socket-outlet or extension cord when combining equipment unless the socket outlet is supplied specifically for use with that equipment.
Precautions for Using the Equipment This System When connecting to other equipments, contact Fukuda Denshi. Danger such
D A N G E R as electric shock may result to the patient and operator.
z Warnings about the System y Do not connect any damaged/unspecified equipment or cable to any I/O connector. If done so by mistake, the device cannot deliver its maximum performance and the connected units may be damaged, resulting in a safety hazard. y 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. y Use only the supplied 3-way AC power cable. Use of other cables WARNING may result in electric shock to the patient and the operator. y The power cable must be connected to a hospital grade outlet. y 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. y Carefully route cables to reduce the possibility of patient entanglement and strangulation. y When lifting this equipment, hold it by the handle or the bottom part of the main unit.
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z Warnings about the Monitoring y The patient classification selection influences the precision of the QRS detection and NIBP measurement. Make sure the correct selection is made. y The pacemaker use selection influences the precision of the QRS detection and arrhythmia analysis. Make sure the correct selection is made. y If the QRS pace mask function is set to [OFF], [10ms] or [20ms], the pace pulse may be erroneously be detected as a QRS complex and HR, Asystole alarms may not generate due to incorrect HR (counting pace pulse as QRS complex). Select [OFF], 10ms or [20ms] only if you are sure that pacing failure will not occur, or when the patient can be constantly monitored. y When measuring the SpO2 of patient with high fever or peripheral circulatory insufficiency, check the sensor attachment periodically and change the attachment site. The temperature of attachment site will rise 2 to 3°C due to the sensor heat which may result in burn injury. y 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 WARNING y Before the NIBP measurement, make sure the patient classification ([Adult] / [Child] / [Neonate]) is properly selected. Otherwise, correct measurement cannot be performed, and congestion or other injury may result. y When the system alarm is suspended, all the alarms will be suspended even if the parameter alarm is set to [ON]. Also, the alarms will not be stored as recall events. y If the upper/lower alarm limit of the parameter is set to [OFF], or arrhythmia alarm is set to [OFF], alarm will not function even if the system alarm is set to [ON]. Pay attention when setting them [OFF]. y Objective and constant arrhythmia detection is possible through the fixed algorithm incorporated in this monitor. However, excessive waveform morphology change, motion artifact, or the inability to determine the waveform pattern may cause an error, or fail to make adequate detection. Therefore, physicians should make final decisions using manual recording, alarm recording and recall waveform for evaluation. y The RR/APNEA alarm will not be generated unless the parameter key (Numeric Data Box) corresponded to the selected RR/APNEA source is displayed. Make sure to display the parameter key (Numeric Data Box) for the RR/APNEA source. y 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. y 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.
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z Warnings about the CO2 Monitoring (HPD-800/HPD-810, HCP-800/HCP-810) y For HPD-800/HPD-810 with Capnostat 5; ・Use only the specified airway adapter manufactured by Respironics Novametrix, LLC. Refer to the section on "Optional Accessories" for list of specified airway adapters. (
WARNING
xvi
Reference
Operation Manual "CO2 Concentration Measurement (Respironics)") These accessories may be purchased from Fukuda Denshi or any authorized Respironics Novametrix, LLC distributor.
・Always consider the circumference of the intubation tube when using the airway adapter. If inappropriate airway adapter is used for a patient with low ventilation, CO2 may mix in to the inspired air resulting in incorrect measurement, or apnea detection may become difficult. y For HCP-800/HCP-810; ・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. ・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. Cutting the sample line could lead to erroneous readings. ・If too much moisture enters the sampling line (i.e. from ambient humidity or breathing of unusually humid air), the message "Check Sample Line" will appear in the message area. Replace the sampling line once the "Check Sample Line" message appears. ・Carefully route the sampling line to reduce the possibility of patient entanglement or strangulation. ・Do not lift the HCP-800/HCP-810 by the sampling line, as the sampling line could disconnect from the equipment, causing the equipment to fall on the patient. y ・CO2 readings and respiratory rate can be affected by sensor application errors, certain ambient environmental conditions, and certain patient conditions.