Service Manual
266 Pages
Preview
Page 1
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.
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.
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
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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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. v
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 ix
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 xiv
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. xvi
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. xvii
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 xviii