DynaScope DS-7100 System Operation Manual Ver.11 Sept 2012

This operation manual is for the DS-7100 Series Version 11.

This device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC. The above mark "CE" is applied to the product that operates on 230V, 50Hz.

The persons responsible for placing devices on the EC market under MDD 93/42/EEC Fukuda Denshi UK 13 Westminster Court, Hipley Street Old Woking, Surrey, GU22 9LG, United Kingdom

CAUTION: • 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 © 2012 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

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·························································· v Precautions for Safe Operation of Medical Electrical Equipment···································································vii Precautions for Safe Operation of Medical Telemetry (DS-7141, DS-7141M, DS-7101LT, DS-7101LTM)····viii Precautions about the Maintenance···························· ix Precautions about the Pacemaker ······························· x Non-Explosion Proof ···················································· x Defibrillation Safety ······················································ x Electrosurgery Safety·················································· xi Precautions about Magnetic Resonance Imaging······· xi Precautions about Connections to Peripheral Devicesxii Precautions about the Fuse ········································xii Accessories and Optional Accessories ·······················xii Precautions about the DS-7100 System ····················xiii Precautions about the Wired Network System (DS-LANII/DS-LANIII) ···············································xxi Precautions about the Wireless Network System ···· xxiii Precautions about Ventilator Monitoring ··················xxiv Precautions for Use of SpO2 Sensor························xxvi Precautions for Masimo® SpO2 Unit·························xxvi Precautions for Use of NIBP Cuff·····························xxvi Disposing of Equipment, Accessories, or Components ·················································································xxvi Precautions about Transportation ····························xxvi Precautions about RTC or Data Backup ··················xxvi Precautions for Use of Lithium-Ion Battery Pack····· xxvii To Prepare for Emergency Use ····························· xxviii Electromagnetic Compatibility ·································· xxix Precautions for Safe Operation under Electromagnetic Influence ··································································xxix EMC Guidance·························································xxix ●Compliance to the Electromagnetic Emissions xxx ●Compliance to the Electromagnetic Immunity (1) ············································································xxx ●Compliance to the Electromagnetic Immunity (2) ···········································································xxxi ●Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the DS-7100 System ·································· xxxii

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

DANGER injury, or complete failure of the equipment.

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

WARNING failure of the equipment.

CAUTION 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-7100 System

DANGER Risk of explosion if used in the presence of flammable anesthetics. CAUTION Before connecting, read instruction manual. CAUTION To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel.

DANGER • Use only the batteries specified for this device. • Do not disassemble or modify the battery. The battery incorporates protection circuitry for safety purposes.

WARNING • Installation of the battery should be performed only by our service representative, to avoid any risk of electric shock to the operator or malfunction of the device.

CAUTION • The life cycle of the battery is 1 year. • The battery charges when the power cord is connected to a hospital-grade outlet. • It takes approximately 2.5 hours to fully charge an empty battery.

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Measurement Unit for Each Parameter The measurement units for this equipment are as follows. Detail

Parameter

Heart Rate / Pulse Rate *1

ST Level VPC Respiration Rate *2

Apnea Invasive Blood Pressure Non-Invasive Blood Pressure Arterial Oxygen Saturation Temperature End-Tidal CO2 Concentration Inspiratory CO2 Concentration *1 *2

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Display

ECG

HR

Invasive Blood Pressure

PR_BP

SpO2

PR_SpO2

ECG ECG Impedance Respiration

ST VPC

CO2

RR_CO2

Impedance Respiration CO2 Invasive Blood Pressure Non-Invasive Blood Pressure

RR_IMP

Unit bpm (beats per minute) bpm (beats per minute) bpm (beats per minute) mm, mv beats / minute Bpm (breaths per minute) Bpm (breaths per minute)

Default

mv

APNEA

s (second)

APNEA

s (second)

BP

mmHg, kpa

mmHg

NIBP

mmHg, kPa

mmHg

SpO2

SpO2

%

Temperature

TEMP

°C / °F

°C

CO2

EtCO2

mmHg, kPa, %

mmHg

CO2

InspCO2

mmHg, kPa, %

mmHg

HR/PR will be displayed in the color selected for ECG/HR. RR will be displayed in the color selected for RESP.

Graphic Symbols Refer following for the meaning of the symbols indicated on the equipment. Symbols indicated on the equipment Symbol

Description Caution; refer to accompanying documents Indicates the need to refer to related accompanying documents before operation. Equipotential 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) Direct Current “OFF” for a Part of an Equipment Indicates the “OFF” condition for a part of an equipment. “ON” for a Part of an Equipment Indicates the “ON” condition for a part of an equipment. 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 defibrillation-proof. Type BF Applied Part with Defibrillation-Proof Indicates the degree of protection against electric shock is Type BF Applied Part with defibrillation-proof. Type BF Applied Part Indicates the degree of protection against electric shock is Type BF Applied Part. Signal Output Part

GAS Output Part

Signal Input Part

Manufactured Date TCP/IP Network Connector Connects to TCP/IP network. v

Symbol

Description RS-232C Connector Connects the related device. Eject Indicates the switch to remove the recorder paper cassette.

Symbols displayed on the screen Symbol

Description

Battery Mark Indicates battery capacity and remaining volume during battery operation.

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. Event Key Mark Displayed when an alarm generates. ON/OFF of the display can be selected on the ward setup. Message Mark Displayed in the parameter key when an alarm message is present for that parameter. Record Start/Stop Starts/stops the recording. SEC Alarm Display Indicates the SEC alarm status. Scroll Keys These keys will allow to scroll the screen.

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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. y Do not install the equipment in a location where it is difficult to unplug the power cable. 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 CAUTION equipment as it may cause erroneous judgment and danger. y Ensure all patient connections are proper and secure. 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. 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 cord. Pull by 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 of 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 Fukuda Denshi. 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 When using the electrosurgical knives or defibrillator with this equipment, verify proper attachment of patient ground plate, ECG electrode type for the electrosurgical knives, and paste volume, output energy for the defibrillator. Also, verify that proper ground is selected.

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Precautions for Safe Operation of Medical Telemetry (DS-7141, DS-7141M, DS-7101LT, DS-7101LTM) Precautions for Safe Operation of Medical Telemetry To operate the device correctly, read the following precautions carefully. z 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). 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 be examined so as not to generate electronic interference. z Based on the above examination result, the institution places each receiver antenna as required. In managing, be 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 nominates 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 “10. Maintenance” for details.

Never open the housing while the equipment is in operation or connected to

WARNING 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. A full technical description of the DS-7100 system is available from your local Fukuda Denshi representative.

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Precautions about the 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. (For more details, contact FUKUDA DENSHI personnel, your institution’s professionals, or your pacemaker distributors.) Reference “Minute Ventilation Rate-Adaptive Pacemakers” WARNING 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] z 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. See “11 Technical Information” for disclosure of the pacemaker pulse rejection capability of this equipment.

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.

Defibrillation Safety z When using the defibrillator, keep away from the electrodes or medicament applied to the patient chest. If this is not possible, remove the electrodes or medicament before using it. If the defibrillator paddles are directly in contact with the electrodes or medicament, electrical shock may result by the discharged energy. z When using the defibrillator, 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 WARNING shock by the discharged energy. z When using the defibrillator, do not touch the patient and the metal part of the device or cables. Electric shock may result by the discharged energy. z This equipment will return to standard operating mode within 10 seconds. 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.

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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 an 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 WARNING 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 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 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 connected to WARNING 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 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. For the connector with mark, only the peripheral devices specified by WARNING 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. All the peripheral device connectors on the DS-7100 system are isolated from

CAUTION the power supply, but the peripheral devices are not isolated. To prevent danger of electric shock, always position the peripheral devices away from the patient.

When connecting peripheral devices to DS-7100 system, it is the user’s responsibility to verify that the overall system complies with EN 60601-1-1, “Collateral Standard: Safety Requirements for Medical Electrical Systems”.

Precautions about the Fuse If the fuse blows, contact Fukuda Denshi Service Representative. Do not

DANGER continue using it as internal damage to the equipment may be considered.

Accessories and Optional Accessories WARNING

xii

Use only the cables specified by Fukuda Denshi. Use of other cables may result in increase in emission or decrease in immunity.

Precautions about the DS-7100 System When connecting to other device, contact Fukuda Denshi service

DANGER representative. Danger such as electric shock may result to the patient and operator.

z Do not connect unit or cable not authorized by Fukuda Denshi to any I/O connector. If done so by mistake, the DS-7100 system cannot deliver its maximum performance and the connected units may be damaged, resulting in a safety hazard. z The equipment should be installed by a professional person. Otherwise, it may result in damage to the equipment 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 type selection influences the precision of the QRS detection and NIBP measurement. Make sure the correct selection is made. z The pacemaker selection influences the precision of the QRS detection and arrhythmia analysis. Make sure the correct selection is made. z When a ventilator is connected to the DS-7100, verify that ”Vent. Online” message is displayed for the connection status. The DS-7100 will not detect the ventilator alarm unless the ”Vent. Online” condition is achieved. z If the QRS pace 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. Select OFF , 10ms , or 20ms only if you are sure that pacing failure will not occur, or when the patient can be constantly monitored. z Be cautious when setting the "SpO2 Averaging" duration as the SpO2 alarm is WARNING based on the displayed SpO2 value which is averaged from the duration set in "SpO2 Averaging". The alarm occurrence time will be affected or may not occur for the transient value of SpO2 depending on the set duration. (For ® Masimo SpO2 unit) z 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 compression necrosis and burn injury. z For the following case, accurate SpO2 measurement may not be possible. y Patient with excessive abnormal hemoglobin (COHb, MetHb) y Patient with the pigment injected to the blood y Patient receiving CPR treatment y When measuring at site with venous pulse y Patient with body motion y Patient with small pulse z Before the NIBP measurement, make sure the patient type ( Adult / Child / Neonate ) is properly selected. Otherwise, correct measurement cannot be performed, and congestion or other injury may result. z Pay attention when measuring the NIBP of patient with bleeding disorders or hypercoagulation. The cuff inflation may cause petechia or circulatory failure by blood clot. z Use the specified sampling tube and nasal prong manufactured by Oridion. z 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.

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z When performing expectoration treatment to the patient with ventilator connected, make sure to suspend the CO2 measurement before the treatment. Otherwise, water may enter into the pump causing the equipment to be damaged. z The HR/PR alarm will not be generated unless the parameter key corresponded to the selected HR/PR source is displayed. Be sure to display the parameter key for the HR/PR source. z The alarm for the parameter not selected for the “HR/PR Alarm Source” (ECG/SpO2/BP) will be set to OFF on the DS-7600 Central Monitor. y The “HR/PR Alarm Source” setting will synchronize between the bedside monitor and the central monitor. y For example, if PR is set as the HR/PR alarm source on the DS-7100, HR alarm will be set to OFF on the central monitor. z The RR/APNEA alarm will not be generated unless the parameter key corresponded to the selected RR/APNEA source is displayed. Be sure to display the parameter key for the RR/APNEA source. z When performing expectoration treatment to the patient with a ventilator connected, make sure to suspend the CO2 measurement before the treatment. Otherwise, water may enter into the pump causing the equipment to be damaged. WARNING 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 When a parameter is in a connector-off condition, the alarm will be generated only on the bedside monitor and not on the central monitor. Make sure that the connector is securely connected. If the waveform/numeric data is not displayed for a monitored parameter, check the patient’s condition and pay attention not to miss the connector-off condition. z If the QRS pace mask function is turned OFF, a decrease in heart rate may not generate HR or ASYSTOLE alarms due to erroneously detected QRS. Turn this function OFF only if you are sure that pacing failure will not occur, or when the patient can be constantly monitored. 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 Systems y This equipment is intended to be used for only one patient. y The monitor should be kept apart at least 20cm from the head of patient or operator. y Use only the accessories specified for this device. Otherwise, proper function cannot be executed. y For quality improvement, specifications are subject to change without prior notice. y The battery deteriorates with repeated use, which shortens the usable time. When the DS-7100 system is operated by battery, and if empty mark CAUTION is displayed for the battery condition, IC card format, read/write process cannot be performed. y The arrhythmia detection level corresponds with the displayed waveform size. Select an appropriate size for monitoring. y The touch 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. y Do not use the touch panel with the film attached. Malfunction of the touch panel or damage may result. xiv

z Systems (Continued) y As the touch panel is made of glass, a strong impact may cause damage. Pay attention not to hit or drop the touch panel. y Always operate the touch panel with fingers or a touch panel pen. Do not touch with a pen-point or other hard-edged instruments. It may cause malfunction or damage the touch panel. y Do not press the touch panel with strength or twist your finger on the panel. It may cause malfunction or damage the touch panel. 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. 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 loosen 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. y If different types of electrodes are used at the same time, the difference between the polarization potential from each electrode may interfere monitoring. Make sure to use electrodes of the same type. y The threshold level for arrhythmia detection changes with ECG 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 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. CAUTION 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 automatic QRS and pacemaker pulse overlap (ex. fusion beat, etc.), QRS detection cannot be performed properly. In this case, the heart rate is degraded. 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 the following relay cables are used, respiration cannot be measured. ・Relay Cable CI-700E-3 (defibrillation / electrosurgery-proof, 3-electrode) ・Relay Cable CI-700E-4 (defibrillation / electrosurgery-proof, 4-electrode) ・Relay Cable CI-700E-5 (defibrillation / electrosurgery-proof, 5-electrode) 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 sensor site is too thick, thin, deeply pigmented, or deeply colored (ex. nail polish, dye, or pigmented cream), it may lead to inaccurate measurements. In such case, reposition the sensor or choose an alternate sensor for use on a different site. y If irritation such as skin reddening or skin fit appears with the sensor use, change the attachment site or stop using the sensor.

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z SpO2 Monitoring (Continued) y When fixing the sensor with a 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 at regular time intervals (about 4 hours). The temperature of attachment site will rise 2 to 3°C due to the sensor heat which may result in compression necrosis and burn injury. y As skin for neonate / low birth weight infant is immature, change the sensor attachment site more frequently depending on the condition. y Excessive light may cause inaccurate measurements. In such cases, cover the sensor with opaque material. y When not performing the measurement, unplug the relay cable and sensor from the SpO2 connector. Otherwise, the measurement data may be erroneously displayed by the ambient light. y Precautions for Reusable Type Sensors 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 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 toe. y The DS-100A must be moved to a new site at least every 4 hours. Because individual skin condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently with some patients. If skin integrity changes, move the sensor to another site. y Precautions for Single-Patient-Use Type Sensors y Do not wind the tape too strong. It may obstruct the blood flow. y The sensor is contraindicated for use on patients who exhibit allergic CAUTION reactions to the adhesive tape. ® ® y The Nellcor sensor OxiMax , MAX-FAST can be reused on the same patient as long as the adhesive tape attaches without slippage. But do not reuse it on other patients. It is intended for single patient use only. y The Masimo ®LNOP sensor can be reused on the same patient as long as the light emitting and receiving part is clean, and if it is still adhesive to the skin. But do not reuse it on other patients. It is intended for single patient use only. y For the Nellcor® single patient use type sensors, the site must be inspected every 8 hours (MAX-FAST: 12 hours) to ensure adhesion, skin integrity, and correct optical alignment. If skin integrity changes, move the sensor to another site. y Do not reuse the sensor by resterilizing it. y Dispose the sensor after use. In the event of damage to the sterile packaging, do not use it. y For Masimo® sensor, change the sensor attachment site every 4 hours for the reusable sensor, and every 8 hours for the disposable sensor. Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently moved. Assess site at least every 2 hours with poorly perfused patients. y The SpO2 patient cables (PC04, PC08, PC12) are intended for Masimo® SpO2 unit only. When connecting these cables to the DS-7100 system, make sure that MASIMO® label is present on the DS-7100 system SpO2 connector. If connected to the unit without MASIMO® label, it will not function properly. y For Masimo® SpO2 unit, if High is selected for “Pulse Sens.”, sensor-off detection will become somewhat inaccurate. y For Masimo® SpO2 unit, if OFF is selected for “PI Display” under the SpO2 configuration setup, “SpO2 Low Perfusion” alarm will be indicated by message display only. The alarm sound will not be generated. y For additional warnings, cautions or contraindications when using the SpO2 sensors, refer to each SpO2 sensor instruction manual. xvi

z NIBP Monitoring y Select the appropriate cuff size which best fits the arm circumference. If the cuff size is inappropriate, it may cause measurement error. y Do not use a cuff which is worn out. The cuff may burst during inflation. y If there is any air leakage, correct NIBP measurement cannot be performed. Make sure that the connection is secure. y Correct NIBP measurement cannot be performed if artificial heart lung machine is used or if the pulse is difficult to detect. y Pay attention when measuring the NIBP of patient with bleeding disorders or hypercoagulation. The cuff inflation may cause petechia or circulatory failure by blood clot. y Do not apply the cuff to the arm or thigh where vein is secured. The blood may backflow causing the chemical injection to cease. y Check the condition of cuff-applied part on the patient during measurement so that the blood circulation will not be blocked over long period of time by the squashed or bent cuff hose. y If the air hose is twisted, or weighed down, the cuff air cannot be exhausted. Properly arrange the cuff and air hose. y Check the patient’s condition constantly while measuring over long period of time with interval of 2.5 minutes or less. Also, periodically check the blood circulation while performing periodic measurement over long period of time. Congestion may occur at the measuring site. y The following factors may affect the NIBP value. ・Body motion, arrhythmia, convulsion ・Continuous noise such as cardiac massage ・Periodic electromagnetic noise y For the following situation, measurements will be terminated. When the measurement time has exceeded 120 seconds for adult, 90 seconds for child, 60 seconds for neonate. When the inflation value has exceeded 300mmHg for adult, 200mmHg for CAUTION child, 150mmHg for neonate. y If used with the incorrect patient type, 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 1-minute interval measurement will automatically stop after 10 minutes and returns to the previous interval mode setup. y The alarm function will be ineffective for the BP value measured by Quick SYS regardless of the ON/OFF selection of NIBP alarm. z BP Monitoring y If the SYS value is abnormally high, or DIA is abnormally low, a resonance may be the cause. If the resonance can not be eliminated by adjusting the blood pressure filter, check the BP line and use a thick, short, or hard catheter. y When the main power is turned ON, the BP value will not be displayed until zero balance is performed. Make sure to perform the zero balance. y During IABP treatment, the displayed BP value may differ from actual value. y Each time the blood pressure transducer or tubing is replaced, the zero balance procedure is required to ensure accurate measurements. y The zero balance procedure is required for the following case. y When starting the measurement. y When the position of the heart has changed due to body movement. y When the position of the transducer has changed. y When measuring for a long period of time and there is a possibility of measurement error due to change in ambient temperature, etc. y When the connector is connected / disconnected, or transducer is replaced. y When the power has been turned OFF for more than 5 minutes.

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z BP Monitoring (Continued) y If the mean BP display is set to OFF, the mean BP alarm will not be generated. Also, the mean BP will not be displayed on the tabular trend. Be cautious when setting the mean BP display OFF. y For telemetry transmission, BP waveform with a scale above the programmed scale can not be properly transmitted. Set the appropriate scale. y The alarm for any BP not displayed will not be generated. Also, any BP not selected for the display type will not be added to the trending list function. Select the appropriate display type according to the monitoring purpose. y When the BP label is CVP, the display type is fixed as M , and cannot be changed. z CO2 Monitoring y Perform calibration 20 minutes after the patient monitor was turned ON. y Do not disconnect the sampling tube during calibration. Calibration will cease when the sampling tube is disconnected. y Conduct CO2 calibration for the following case. If the CO2 gas calibration is not performed at a specified interval, CO2 measurement accuracy may be affected and also subsequent gas calibration may not be possible. y When 1 year has elapsed from the last calibration. y When EtCO2 measurement is not stable or accuracy is degraded compared with other measuring device. y When the patient monitor was not used for a while, or when EtCO2 was not measured for a while. y CO2 monitoring will cease when the ventilation connector is covered. y Use only the specified sampling tube for CO2 monitoring. y When the measurement is suspended, the alarm generation and trend input will be also suspended. z Temperature Monitoring y Do not reuse the probe cover. It is intended for single patient use only. CAUTION z Alarm y A faint sound will be generated when setting a minimum volume for the alarm sound, but be cautious not to miss any alarm. Adjust the volume to a recognizable level. y Alarm messages will be displayed according to the priority. (Level 1 → Level 2 → Level 3 → Level 4) y For the same alarm level, the alarm message for the newer alarm will be displayed. y The alarm message for the arrhythmia alarm will continue to be displayed for 30 seconds after the alarm is resolved. y While the “LEAD OFF” message is displayed, HR alarm and arrhythmia alarm will not function. Leaving this condition unresolved may result in missing a sudden change of the patient. Promptly check the electrodes when this message is displayed. y The settings for the “HR Low Limit for VT” and “HR Low Limit for RUN” will be compared with the average HR of continuous VPC. Therefore, the displayed HR value at alarm generation may be lower than the settings if it is just after the VT detection, or if RUN with few continuous VPC is detected. y If the alarm with the higher priority occurs during alarm recording, the recording in process will cease and the alarm recording with the higher priority will start. y For the SpO2 measurement, whether to use the SEC alarm function and its threshold selection should be based on the patient’s clinical indication portent and medical evaluation. (For Nellcor® SpO2 unit) y If the SpO2 alarm and SEC alarm setup is set to OFF, the SEC alarm integral value will be set to 0. (For Nellcor® SpO2 unit) y The alarm ON/OFF setup will remain effective even when the power is turned OFF. Be cautious not to miss any important alarm by leaving the alarm silenced.

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