DS-8500 System Service Manual Edition 1 Aug 2011

Service manual Delivery Notice Service Manual (No.

): Q’ty 1

Please confirm your receipt of the above service manual by filling in and sending us back this sheet by return. Delivery of Service Manual

Please note that this service manual is a confidential document and needs to be kept with an utmost care under person in charge. If the technical drawing in the service manual is unreadable, you can request it to us by specifying a page or a part. When you have received this service manual, verify that there is no paging disorder or missing page. You are requested to kindly fill the underlined area below in this sheet and send it back to us after verification. Please be noted that photocopying of this manual is strictly prohibited. Also, for improvement of the future service manual, your comment and request will be appreciated. If you have any comment or request on usability, viewability, readability, or if you notice anything hard to understand on this service manual, please inform it to us. Fukuda Denshi Co., Ltd. Development & Production Support Dept. 2-35-8 Hongo Bunkyo-ku, Tokyo, 113-8420 Japan

Received by of (Company/Hospital) on the day of

Revision History Model Name DS-8500 System Edition 1

－

Service Manual Revised Items

Reason of the Revision New Edition

Revised Date 2011.8

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 Labels Attached to the Unit ·········································· ii Measurement Unit for Each Parameter ······················· iv Graphic Symbols ························································· vi Precautions for Safe Operation of Medical Electrical Equipment ·································································· vii Precautions for Safe Operation of Medical Telemetry (When using HLX-501) ·············································· viii Precautions about the Maintenance ···························· ix Precautions about Pacemaker ·····································x Non-Explosion Proof·····················································x Defibrillation Safety·······················································x Electrosurgery Safety ·················································· xi Precautions about Magnetic Resonance Imaging ······· xi Precautions about Connections to Peripheral Devices ····················································· xii Precautions about the Fuse········································ xii Accessories and Optional Accessories······················· xii Precautions about the DS-8500 System···················· xiii Precautions about the Wired Network System (DS-LAN ΙΙ/DS-LAN ΙΙΙ)·············································· xx Precautions about the Wireless Network System ······ xxi Precautions for Use of Bidirectional Wireless Communications (TCON) ········································· xxii Precautions about the Ventilator Monitoring·············xxiii Precautions for Use of SpO2 Sensor ······················· xxiv Precautions for Use of NIBP Cuff ···························· xxiv Disposing of Equipment, Accessories, or Components ······················································ xxiv Precautions about Transportation····························· xxv Precautions about RTC or Data Backup··················· xxv To Prepare for Emergency Use ································ xxv Electromagnetic Compatibility···································xxvi Precautions for Safe Operation under Electromagnetic Influence·································································· xxvi EMC Guidance ························································ xxvi Compliance to the Electromagnetic Emissions ··xxvii Compliance to the Electromagnetic Immunity (1) ·························xxvii Compliance to the Electromagnetic Immunity (2) ························xxviii Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the DS-8500 System ············· xxix

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Safety Precautions y Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the product. y Make 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 serious

D A N G E R injury, or complete failure of the equipment.

Failure to follow this message may result in death or serious injury, or

W A R N I N G complete failure of the equipment.

C A U T I O N Failure to follow this message may cause injury or failure to the equipment.

NOTE

A note is not related to product safety, but provides information about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment.

Labels Attached to the Unit Make sure to read the warning labels attached to the unit and comply with these requirements while operating the unit. Do not damage or erase the warning labels attached to the unit. These warning labels contain descriptions important for handling and CAUTION operating the unit properly and safely. A damaged label may compromise safe operation.

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DS-8500 System Main Unit (DSC-8500 Series)

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Measurement Unit for Each Parameter The measurement units for this equipment are as follows. Detail Heart Rate / Pulse Rate ST Level VPC

Respiration Rate

Apnea Invasive Blood Pressure Non-Invasive Blood Pressure Arterial Oxygen Saturation Temperature End-Tidal CO2 Concentration Inspiratory CO2 Concentration Cardiac Output Blood Temperature Injectate Temperature Airway Flow Airway Pressure Tidal Volume

Minute Ventilation Compliance

Airway Resistance

Airway Pressure Spontaneous Respiration Peak End Expiratory Pressure Fraction of Inspiratory Oxygen

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Parameter

Display

Unit bpm (beats per minute) bpm bpm mm, mv beat/minute Bpm (breaths per minute) Bpm Bpm Bpm s (second) s (second) s (second) mmHg, kPa cmH2O (CVP only)

Default

ECG

HR

Invasive Blood Pressure SpO2 ECG ECG

PR_IBP PR_SpO2 ST VPC

Impedance Respiration

RR_IMP

CO2 Ventilator Gas Module Impedance Respiration CO2 Ventilator

RR_CO2 RR_VENT RR_GAS APNEA APNEA APNEA

Invasive Blood Pressure

BP

Non-Invasive Blood Pressure

NIBP

mmHg, kPa

SpO2 Temperature

SpO2 TEMP

% °C

CO2

EtCO2

mmHg, kPa, %

mmHg

CO2

InspCO2

mmHg, kPa, %

mmHg

Cardiac Output Blood Temperature Injectate Temperature Airway Flow Airway Pressure Expiratory Tidal Volume Inspiratory Tidal Volume Tidal Volume Inspiratory/Expiratory Ratio Minute Ventilation Spontaneous Minute Ventilation Compliance Static Compliance Dynamic Compliance Expiratory Resistance Inspiratory Resistance Static Airway Resistance Dynamic Airway Resistance Mean Airway Pressure Maximum Airway Pressure Pause Airway Pressure Minimum Airway Pressure Spontaneous Respiration

CO Tb Ti AWF AWP E-TV I-TV TV I:E MV SMV COMP S_COMP D_COMP E-RES I-RES S-RES D-RES MEAN PEAK PAUSE P_Min S_RR

L/minute °C °C L/minute cmH2O mL mL mL (none) L/minute L/minute mL/cmH2O mL/cmH2O mL/cmH2O cmH2O/L/Sec cmH2O/L/Sec cmH2O/L/Sec cmH2O/L/Sec cmH2O cmH2O cmH2O cmH2O Bpm

Peak End Expiratory Pressure

PEEP

cmH2O

Fraction of Inspiratory Oxygen

FIO2

%

mv

mmHg mmHg

Detail

Vigilance Data ・Vigilance ・Vigilance CEDV ・VigilanceΙΙ ・Vigileo

Multigas Unit

BIS Monitor Data aepEX 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

SV_STAT

mL

SVI

mL/m2

SVI_STAT

mL/m2

Heart Rate

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 Et CO2 Concentration Insp CO2 Concentration End Tidal Oxygen Inspired Oxygen Expired Nitrous Oxide Inspired Nitrous Oxide End Tidal Anesthetic Gas Expired Agent gas Bispectral Index Signal Quality Index Electromyograph Suppression Ratio AEPIndex

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

dynes-sec/cm5

SVRI

dynes-sec/cm5

BT EF

°C %

EF_STAT

%

EDV

mL

EDV_STAT

mL

EDVI

mL/m2

EDVI_STAT

mL/m2

ESV ESVI SVV CO2-E CO2-I O2-E O2-I N2O-E N2O-I AGT-E AGT-I BIS SQI EMG SR aepEX

mL mL % mmHg, kPa, % mmHg, kPa, % % % % % % % (no unit) % dB % (no unit)

Default

mmHg mmHg

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Graphic Symbols Refer to the following for the meaning of the symbols indicated on the equipment. DS-8500 System Main Unit Symbol

Description Caution; refer to accompanying documents Indicates the need to refer to 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. Power ON Indicates that the main power switch is in the ON position. Power OFF Indicates that the main power switch is in the OFF position. Electrostatic Sensitive Part Directly touching this connector part with hands should be avoided.

DS-8500 System Symbols displayed on the screen Symbol

Description Alarm OFF Indicates the alarm is OFF. Heart Rate Synchronization Mark This mark flashes synchronizing to the heartbeat. Respiration Synchronization Mark This mark flashes synchronizing to the inspiration. Message Icon This mark will be displayed inside the parameter key when an alarm message is present for that parameter. Whether or not to display this icon can be selected on the monitor setup menu. TCON Mark Displays the Bidirectional Wireless Communication (TCON) connection status while in communication.

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Precautions for Safe Operation of Medical Electrical Equipment Read the following precautions thoroughly to correctly operate the device. z Users should have a thorough knowledge of the operation before using this system. z Pay attention to the following when installing and storing the equipment. y Do not install or store in an area where the equipment will be subject to splashing water. y Do not install or store in an area where the environmental conditions, such as atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, sodium, sulfur, will adversely affect the system. 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 there are chemical or gasses stored. 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 Before operating the system, verify the following items. y Verify the power voltage. 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 device is used in conjunction with other equipment as it may cause erroneous judgment and danger. y Ensure all patient connections are proper and secure. C A U T I O N z During operation of the system, verify the following items. y Always observe the system 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 device. y Make sure not to touch all Signal Input/Output parts in the device with the patient at the same time. z After using the system, verify the following items. y Unplug all the cables from the patient before turning off the power. y When unplugging the cables, do not apply excessive force by pulling on the cable. Pull from the connector part of the cable. 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 If the equipment is damaged and in need of repair, user should not attempt service. Label the unit “OUT OF ORDER” and contact our service representative. z Do not remodel the equipment. z Maintenance Check y Make sure to periodically check the equipment, accessories and cables. y Before reusing the device that has been left unused for a while, make sure that the device works normally and safely. z To prevent burn injury to the patient, verify proper attachment of patient ground plate or ECG electrode type when using the electrosurgical knife, and verify paste volume or output energy when using the defibrillator. Also, verify that proper ground is selected.

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Precautions for Safe Operation of Medical Telemetry (When using HLX-501) To operate the device correctly, read the following precautions carefully. z The medical institution (hereinafter referred to as the “Institution”) must decide the telemetry installation plan 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. z When using telemetry which requires zone location, the Institution is to set up the zones as an operation unit for each transmitter to prevent electronic interference between telemetry throughout the medical institution. z When using telemetry which requires zone location, display and identify each prepared zone in the equipment. z When laying receiver antenna for each transmitter, the Institution has to examine the installation so that electronic interference does not occur. z Based on the above examination result, the Institution should place each receiver antenna as required. In managing, make sure to follow the precautions below. z 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. CAUTION z Select a telemetry manager who understands the characteristics and functionality of telemetry systems, and is skilled in operating telemetry. z When installing telemetry, the Overall Manager and the Zone Manager have to understand the precautions for use of the telemetry in advance. z The Overall Manager takes responsibility of wireless channel management and transmitter storage for the whole medical institution by giving proper instruction. z The Overall Manager creates a management log, list of wireless channels, management status for the whole medical institution (hereinafter referred to as the “management log”. When changing a wireless channel, register it in the log and give proper instructions to the zone manager or to the user. z The Zone Manager assumes responsibility for managing the wireless channels, storing, and managing telemetry. z The Zone Manager assigns the transmitter to the user, and provides enough education for use inside the zone. z The telemetry user verifies operation of the transmitter/receiver before use. z 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. z 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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Precautions about the Maintenance Safety Inspection and Maintenance For safe operation of the equipment, regular inspection and maintenance is required. Once a year, check all cables, devices, and accessories for damage, earth impedance, earth and leakage currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of these safety inspections. Immediate maintenance has to be carried out if ; y the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall. y the equipment was subjected to liquid spill. y the monitoring function is interrupted or disturbed. y parts of the equipment enclosure are cracked, removed, or lost. y any connector or cable shows signs of deterioration. Reference

Refer to “12. Periodic Check” for details.

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.

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 Pacemaker z 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. WARNING For more details, contact FUKUDA DENSHI personnel, your institution’s professionals, or your pacemaker distributors. Reference “Minute Ventilation Rate-Adaptive Pacemakers” FDA alerts health professionals that minute ventilation rate-adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic equipment, causing pacemakers to pace at their maximum programmed rate. [October 14, 1998 (Letter: www.fda.gov/cdrh/safety.html) – FDA]

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.

Defibrillation Safety 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 from the discharged energy. W A R N I N G 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 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.

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Electrosurgery Safety 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.

WARNING

Power Supply Connect the electrosurgical unit to a power supply that is different from that of the monitor. This will help prevent interference through the power cable. Electrode Placement The amount of interference is considerably different depending on the electrode position and surgery site. Place the ECG electrodes as far away as possible from the surgery site. Do not place electrodes in the path between the surgery site and the ground plate. If the electrodes are placed in this path, the amount of interference will be quite large. Position (+) and (–) electrodes as close as possible to each other. Ground Plate When using electrosurgical instruments, make sure the contact between the patient and the ground plate is secure. If the connection is incomplete, the patient may suffer a burn at the electrode site.

Precautions about Magnetic Resonance Imaging z Do not operate this equipment in magnetic resonance imaging (MRI) environments. z When conducting MRI test, remove the electrodes and sensors WARNING connected to the patient (test subject). The local heating caused by the induced electromotive force may cause burn injury to the patient (subject). For details, refer to the operation manual for the MRI testing device.

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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. For the connector with mark, only the peripheral devices specified by Fukuda Denshi should be connected with the given procedure. Use of an WARNING unspecified device may cause electric shock to the patient and/or operator due to excessive leakage current. All the peripheral device connectors on the DS-8500 system are isolated from the power supply, but the peripheral devices are not isolated. To C A U T I O N prevent danger of electric shock, always position the peripheral devices away from the patient. When connecting peripheral devices to DS-8500 system, it is the user’s responsibility to verify that the overall system complies with IEC 60601-1-1, “Collateral Standard: Safety Requirements for Medical Electrical Systems”.

Precautions about the Fuse If the fuse blows, do not continue using it as internal damage to the

D A N G E R equipment may be considered.

Accessories and Optional Accessories Use only the cables specified by Fukuda Denshi. Use of other cables may result in increase in emission (unnecessary WARNING generation of electromagnetic energy from this unit) or decrease in immunity (resistance characteristics to electromagnetic interference generating from other device).

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Precautions about the DS-8500 System Be cautious when connecting to other device.

D A N G E R Danger such as electric shock may result to the patient and operator. z Do not connect a unit or cable not authorized by Fukuda Denshi to any I/O connector. If done so by mistake, the DS-8500 system cannot deliver its maximum performance and the connected units may be damaged, resulting in a safety hazard. z If the DS-8500 system 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. z Use only the accompanying 3-way AC power cable. Use of other cables may result in electric shock to the patient and the operator. z The power cable must be connected to hospital grade outlet. z When using multiple ME equipment simultaneously, perform equipotential grounding to prevent potential difference between the equipment. Even a small potential difference may result in electric shock to the patient and the operator. z The patient classification selection influences the precision of the QRS detection and NIBP measurement. Make sure the correct selection is made. z The pacemaker use selection influences the precision of the QRS detection and arrhythmia analysis. Make sure the correct selection is made. z If the QRS pace pulse mask function is set to OFF , 10ms or 20ms , a decrease in heart rate may not generate HR or ASYSTOLE alarms due to erroneously detected QRS. Set this function to OFF , 10ms or 20ms only if you are sure that pacing failure will not occur, or when the patient can be constantly monitored. z When measuring the SpO2 of patient with high fever or peripheral WARNING 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. z For the following case, accurate measurement may not be possible. y Patient with excessive abnormal hemoglobin (HbCO, MetHb) y Patient with the pigment injected to the blood y Patient receiving CPR treatment y When a sensor is applied to a limb with NIBP cuff, arterial catheter, or intracatheter y When measuring at site with venous pulse y Patient with body motion y Patient with small pulse z 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. z Use the specified sampling tube and nasal prong manufactured by Oridion. z For CO2 concentration measurement, 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. z When measuring CO2 concentration of a patient treated with mouth-to-mouth resuscitation, Jackson-Rees circuit, Mapleson D circuit of which CO2 gas may mix in, the value may be displayed lower than the actual value.

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z When the system alarm is suspended, all the alarm will be suspended even if the parameter alarm is set to ON. Also, the alarm event will not be stored as recall. z 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. z 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. z The HR/PR alarm will not be generated unless the parameter key corresponded to the selected HR/PR source is displayed. Make sure to display the parameter key for the HR/PR source. z The RR/APNEA alarm will not be generated unless the parameter key corresponded to the selected RR/APNEA source is displayed. Make sure to display the parameter key for the RR/APNEA source. z When selecting Silence or Time Disp. Only for the night mode, pay attention not to miss any important alarm by simultaneously monitoring the WARNING bed on other monitors such as central monitor. z When lifting this device, hold the bottom part of the main unit and the display unit. z When attaching the display unit to the DSC main unit, place the display unit facing down and slowly attach the main unit using the guide on the side of the display unit. Then, secure it with the specified screws. z About the Trolley y When integrating and mounting a display unit + a main unit + an exclusive stand to a trolley, make sure that they are fixed using the screws (x4). Otherwise, the equipment may fall from the trolley, resulting in injury to the operator or damage to the equipment. y Use the trolley only with the equipment specified by Fukuda Denshi. Otherwise, the monitor and trolley may fall down, resulting in injury or damage to the monitor. y Make sure to lock both casters when using or storing the trolley. The trolley may move or fall down, resulting in injury or damage to the monitor. y 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 or damage to the equipment.

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z Systems y Use only the accessories specified for this device. Otherwise, proper function cannot be executed. y Do not use the touch panel with the film attached. Malfunction of the touch panel or damage may result. y Due to its material characteristic, the touch panel expands/contracts depending on the temperature/humidity. When the touch panel is left unused for a while, or when the ambient temperature is low, the surface film of the touch panel may expand, but this is not an abnormal condition. This expansion will be reduced in few hours or half a day after the power is turned ON. y For quality improvement, specifications are subject to change without prior notice. y The display panel utilizes exclusive fluorescent light for the backlight. Since this fluorescent light 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 and replace the LCD panel. y This equipment is intended to be used for only one patient. y The installation of this equipment and attaching the option unit should be performed by a person who is well acquainted with this equipment. y If it is not used for a long period, make sure to turn OFF the power of the main unit. z ECG Monitoring y The indication for continuous use of the electrode is about one day. y Replace the electrode if the skin contact gets loose due to perspiring, etc. y When an electrode is attached at the same location for a long time, some patients may develop a skin irritation. Check the patient’s skin condition periodically and change the electrode site as required. CAUTION y 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. y The arrhythmia detection level is related with the displayed waveform size. Set a proper waveform size for monitoring. When the waveform size is ×1/4, ×1/2, or ×1, the detection threshold is 250µV. When the waveform size is ×2 or ×4, the detection threshold is 150µV. y The QRS detection leads, arrhythmia detection leads, monitoring leads on the central monitor, recording leads are fixed as ECG1 and ECG2. Especially for arrhythmia detection, set the most appropriate leads with high QRS for ECG1 and ECG2. y Automatic size/position of the ECG is effective only at the time the AUTO key is pressed. This does not continually adjust size and position. y The ESIS mode can largely reduce the artifact such as electrosurgery noise and EMG, but it may also reduce the QRS amplitude. Using the ESIS mode may erroneously detect the pacemaker spike. The ESIS mode should be selected only during electrosurgery. y There are some cases when pacemaker pulse can not 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 pacemaker pulse detection. y 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. y When spontaneous QRS and pacemaker pulse overlap (ex. fusion beat, etc.), QRS detection cannot be performed properly. In this case, the heart rate is degraded.

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y When continuously detecting AC noise artifact as pacemaker pulses, QRS detection stops and heart rate is extremely degraded. Also arrhythmia cannot be detected. z Respiration Monitoring y When a defibrillator is used during respiration monitoring, a large offset voltage will be placed on the ECG electrodes, which may cause interruption of monitoring for a few seconds. z SpO2 Monitoring y If the nail is rough, dirty, or manicured, accurate measurement will not be possible. Select a different finger or clean the nail before attaching the sensor. y If irritation such as skin reddening or rash appears with the sensor use, change the attachment site or stop using the sensor. y When fixing the sensor with tape, do not wind the tape too tight. At the same time, check the blood flow constantly so that congestion is not generated at the peripheral. y Even a short duration of attachment may inhibit the blood flow and generate compression necrosis and burn injury. y Change the sensor attachment site constantly (every 4 hours). As the temperature of the sensor attachment site normally rises 2 to 3°C y As skin for neonate / low birth weight infant is immature, change the sensor attachment site more frequently depending on the condition. y Direct sunlight to the sensor area can cause a measurement error. Place a black or dark cloth over the sensor. y When not performing measurement, unplug the relay cable and sensor from the SpO2 connector. Otherwise, the measurement data may be erroneously displayed by the ambient light. y The DS-100A is intended for use on finger of adults weighing over 40 kg (approximate). Do not use them on children or neonates. Also do not apply them on the thumb or foot. CAUTION y The light-emitting part of the sensor should be over the root of the fingernail. Do not insert the finger too far into the sensor as it may hurt the patient. y Measuring on a limb with NIBP cuff, arterial catheter, or intracatheter may result in incorrect measurement. z NIBP Monitoring y 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. y For the following situation, measurements will be terminated. When the measurement time has exceeded 160 seconds for adult and child, 60 seconds for neonate. When the inflation value has exceeded 300mmHg for adult, 210mmHg for child, 150mmHg for neonate. y 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. y The 1-minute interval measurement will always start from 00 second. Pressing the 1min start key will start the measurement from the next 00 second. y The alarm function will be ineffective for the BP value measured by Quick SYS regardless of the ON/OFF selection of NIBP alarm. y If the mean display is set to OFF, the mean BP will not be generated. Also the mean BP will not be displayed inside the tabular trend or the NIBP list function if the display is set to OFF. z BP Monitoring y When the main power is turned ON, the BP value will not be displayed until zero balance is performed. However, if the power is turned ON within 5 minutes after the power is turned OFF, the previous zero balance information will be maintained, and BP value will be displayed.

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