DynaScope DS-7300 System Operation Manual (Monitoring Operation) June 2006

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 NAME ADDRESS

: FUKUDA DENSHI UK : 13 WESTMINSTER COURT, HIPLEY STREET, OLD WOKING, SURREY GU22 9LG, U.K.

CAUTION: • This device for sale by or on the order of a physician. • The company and product names used in this manual are trademarks or registered trademarks. • If this manual has pages missing or out of order, contact Fukuda Denshi for replacement. • Only physician or persons instructed by physicians are allowed to use the equipment. • The information contained in this document is subject to change without notice due to improvement in the equipment.

Copyright © 2006 by Fukuda Denshi Co., Ltd. No part of this document may be copied or transmitted in any form without the prior written permission of Fukuda Denshi Co., Ltd. Printed in Japan

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.

Composition of This Operation Manual ･････････････ ii Safety Precautions ･･････････････････････････････ iii Labels Attached to the Unit ･･････････････････････ iii Measurement Unit for Each Parameter ･････････････ v Graphic Symbols ･･･････････････････････････････ vii Precautions for Safe Operation of Medical Electrical Equipment ････････････････････ viii Precautions for Safe Operation of Medical Telemetry ･･････････････････････････････ ix Precautions about the Maintenance ････････････････ x Precautions about the Pacemaker ････････････････ xi Non-Explosion Proof ････････････････････････････ xi Defibrillation Safety ･････････････････････････････ xi Electrosurgery Safety ･･･････････････････････････ xii Precautions about Magnetic Resonance Imaging ･･･ xii Precautions about Connections to Peripheral Devices ････････････････････････････ xiii Precautions about the Fuse ･････････････････････ xiii Accessories and Optional Accessories ･･･････････ xiii Precautions about the DS-7300 System ･･････････ xiv Precautions about the Wired Network System (DS-LAN II) ･･･････････････････････････････････ xxii Precautions about the Wired Network System (AU-5500N 1:N Network) ･･････････････････････ xxiii Precautions about the Wireless Network System ･･ xxiv Precautions about the Ventilator Monitoring ･･･････ xxv Precautions for Use of SpO2 Sensor ････････････ 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 To Prepare for Emergency Use ･････････････････ xxvi Electromagnetic Compatibility･･････････････････ xxvii Precautions for Safe Operation under Electromagnetic Influence ･････････････････････ xxvii EMC Guidance･･･････････････････････････････ xxvii ●Compliance to the Electromagnetic Emissions ･････････････････････････････ xxviii ●Compliance to the Electromagnetic Immunity (1) ･･･････････････････････････ xxviii ●Compliance to the Electromagnetic Immunity (2) ････････････････････････････ xxix ●Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the DS-7300 System ････････ xxx

i

Composition of This Operation Manual The DS-7300 System Operation Manual is composed of the following 3 sections. ≪General Description≫ This section is composed of the chapters stating the general description of the device and basic operation procedure. 1. General Description 2. Basic Operation 3. Vital Application

: : :

Describes the outline of this equipment. Describes the basic operation for monitoring. Describes the procedure for vital application, etc.

≪Monitoring Operation≫ This section is composed of the chapters explaining the detailed monitoring procedures and setup procedures. 4. Monitoring Setup

:

5. Admit / Discharge of a Patient : 6. Parameter Setup : 7. Function

:

8. System Configuration

:

Describes the procedures to set the monitor according to the monitoring purpose. Describes the procedure to admit or discharge a patient. Describes the procedure to set the measurement condition, size, scale, etc. for each parameter. Describes about the functions such as arrhythmia analysis, trend, recall, etc. Describes about the system configuration such as night mode, alarm mode, display mode, etc.

≪Maintenance≫ This section is composed of the chapters describing the installation procedure, maintenance, technical information, accessories, etc.

ii

9. Installation 10. Maintenance 11. Technical Information

: : :

12. Accessories

:

Describes about the environment for use, wireless system, etc. Describes about the maintenance, troubleshooting of this equipment.

Lists the specification, default settings, pin assignments of external connector, etc. Lists the accessories and optional accessories for this equipment.

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

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.

CAUTION

Do not damage or erase the warning labels attached to the unit. These warning labels contain descriptions important for handling and operating the unit properly and safely. A damaged label may compromise safe operation.

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DS-7300 System Main Unit (DSC-7300) 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.

DS-7300 System Super Module

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.

＜HS-720E＞

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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

Parameter

Display

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

Default

ECG

HR

Invasive Blood Pressure

PR_IBP

SpO2

PR_SpO2

ECG ECG

ST VPC

Impedance Respiration

RR_IMP

CO2

RR_CO2

Ventilator

RR_VENT

Gas Module Impedance Respiration CO2 Ventilator

RR_GAS APNEA APNEA APNEA

Invasive Blood Pressure

BP

Non-Invasive Blood Pressure

NIBP

mmHg, kPa

SpO2

SpO2

%

Temperature

TEMP

°C / °F

°C

CO2

EtCO2

mmHg, kPa, %

mmHg

CO2

InspCO2

mmHg, kPa, %

mmHg

Cardiac Output Blood Temperature

CO Tb

L/minute °C / °F

°C

Injectate Temperature

Ti

°C / °F

°C

Airway Flow Airway Pressure Inspiratory Tidal Volume Expiratory Tidal Volume Tidal Volume Inspiratory/Expiratory Ratio Minute Ventilation Spontaneous Minute Ventilation Compliance Static Compliance Dynamic Compliance Inspiratory Resistance Expiratory Resistance Static Airway Resistance Dynamic Airway Resistance Mean Airway Pressure Maximum Airway Pressure Pause Airway Pressure Minimum Airway Pressure

AWF AWP I-TV E-TV TV I:E MV

L/minute cmH2O mL mL mL (none) L/minute

SMV

L/minute

COMP S_COMP D_COMP I－RES E－RES S-RES D-RES MEAN PEAK PAUSE P_Min

mL/cmH2O mL/cmH2O mL/cmH2O cmH2O/L/Sec cmH2O/L/Sec cmH2O/L/Sec cmH2O/L/Sec cmH2O cmH2O cmH2O cmH2O

mv

mmHg mmHg

v

Detail Spontaneous Respiration Peak End Expiratory Pressure Fraction of Inspiratory Oxygen Transcutaneous Partial Pressure

Vigilance Data ・Vigilance ・Vigilance CEDV ・VigilanceII ・Vigileo

Gas Module Data

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Parameter Spontaneous Respiration Peak End Expiratory Pressure Fraction of Inspiratory Oxygen Transcutaneous Oxygen Partial Pressure Transcutaneous Carbon Dioxide Partial Pressure 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

Unit

Default

S_RR

Bpm

PEEP

cmH2O

FIO2

%

tcpO2

mmHg, kPa

mmHg

tcpCO2

mmHg, kPa

mmHg

SvO2

%

ScvO2

%

SaO2 O2EI DO2 VO2 SV

% % mL/minute mL/minute mL

SV_STAT

mL

SVI

mL/m

2

SVI_STAT

mL/m

2

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 Expired Carbon Dioxide Inspired Carbon Dioxide Expired Oxygen Inspired Oxygen Expired Nitrous Oxide Inspired Nitrous Oxide Expired Agent gas Inspired Agent gas

MAP CVP CCO

bpm (beats per minute) mmHg mmHg L/minute

CCO_STAT

L/minute

CCI

L/minute/m

2

CCI_STAT

L/minute/m

2

SVR

dynes-sec/cm

5

SVRI

dynes-sec/cm

5

BT EF

°C %

EF_STAT

%

EDV

mL

EDV_STAT

mL

EDVI

mL/m

2

EDVI_STAT

mL/m

2

ESV ESVI SVV CO2-E CO2-I O2-E O2-I N2O-E N2O-I AGT-E AGT-I

mL mL % mmHg, kPa, % mmHg, kPa, % % % % % % %

mmHg mmHg

Detail BIS Monitor Data

Parameter Bispectral Index Signal Quality Index Electromyograph Suppression Ratio

Display BIS SQI EMG SR

Unit (no unit) % dB %

Default

Graphic Symbols The following symbols are used for this equipment. DS-7300 System: Main Unit 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.

DS-7300 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. Event Key Mark Displayed when an alarm generates. Whether or not to display this icon can be selected on the monitor setup menu. Device Configuration Icon Displayed when device configuration has changed. Whether or not to display this icon can be selected on the monitor setup menu. Message Icon Displayed in 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.

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Precautions for Safe Operation of Medical Electrical Equipment

CAUTION

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Read the following precautions thoroughly to correctly operate the device. l Users should have a thorough knowledge of the operation before using this system. l Pay attention to the following when installing and storing the equipment. Ÿ Do not install or store in an area where the equipment will be subject to splashing water. Ÿ 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. Ÿ Place the equipment on a stable surface where there is no inclination, vibration, or shock (including during transportation). Ÿ Do not install or store in an area where there are chemical or gasses stored. Ÿ Verify the power frequency, voltage and allowable current (or power consumption). Ÿ Ensure the grounding is proper by connecting the accompanying power cable to the hospital grade outlet. l Before operating the system, verify the following items. Ÿ Verify the power voltage. Ÿ Check the cable connection and polarity to ensure proper operation of the equipment. Ÿ Make sure the power system has adequate earth ground. Ÿ Ensure that all cables are firmly and safely connected. Ÿ Pay special attention when the device is used in conjunction with other equipment as it may cause erroneous judgment and danger. Ÿ Ensure all patient connections are proper and secure. l During operation of the system, verify the following items. Ÿ Always observe the system and patient to ensure safe operation of the equipment. Ÿ 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. Ÿ Do not allow the patient to come in contact with the device. l After using the system, verify the following items. Ÿ Unplug all the cables from the patient before turning off the power. Ÿ When unplugging the cables, do not apply excessive force by pulling on the cord. Pull by the connector part of the cable. Ÿ Clean the accessories and cables, and keep them together in one place. Ÿ Keep the unit clean to ensure proper operation of the next use. l 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. l Do not remodel the equipment. l Maintenance Check Ÿ Make sure to periodically check the equipment, accessories and cables. Ÿ Before reusing the device that has been left unused for a while, make sure that the device works normally and safely. l 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.

Precautions for Safe Operation of Medical Telemetry Precautions for Safe Operation of Medical Telemetry To operate the device correctly, read the following precautions carefully. l 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). l 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. l When using telemetry which requires zone location, display and identify each prepared zone in the equipment. l When laying receiver antenna for each transmitter, the institution has to be examined so as not to generate electronic interference. l Based on the above examination result, the institution places each receiver antenna as required.

CAUTION

In managing, be sure to follow the precautions below. l 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. l Select a telemetry manager who understands the characteristics and functionality of telemetry systems, and is skilled in operating telemetry. l When installing telemetry, the Overall Manager and the Zone Manager have to understand the precautions for use of the telemetry in advance. l The Overall Manager takes responsibility of wireless channel management and transmitter storage for the whole medical institution by giving proper instruction. l 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. l The Zone Manager assumes responsibility for managing the wireless channels, storing, and managing telemetry. l The Zone Manager assigns the transmitter to the user, and provides enough education for use inside the zone. l The telemetry user verifies operation of the transmitter/receiver before use. l 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. l 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 ; Ÿ the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall. Ÿ the equipment was subjected to liquid spill. Ÿ the monitoring function is interrupted or disturbed. Ÿ parts of the equipment enclosure are cracked, removed, or lost. Ÿ 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

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; Ÿ Maintenance, modifications, and repairs are carried out by authorized personnel. Ÿ Components are used in accordance with Fukuda Denshi operating instructions. A full technical description of the DS-7300 system is available from your local Fukuda Denshi representative.

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Precautions about the 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.) 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

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

WARNING

l 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 directly contact the electrodes or medicament, electrical shock may result by the discharged energy. l 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 by the discharged energy. l When defibrillating, do not touch the patient and the metal part of the device or cables. Electric shock may result by 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 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 l Do not operate this equipment in magnetic resonance imaging (MRI) environments. l When conducting MRI test, remove the electrodes and sensors connected WARNING 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.

xii

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 W A R N I N G 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

All the peripheral device connectors on the DS-7300 system are isolated from 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-7300 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, contact Fukuda Denshi Service Representative.

Do not

D A N G E R continue using it as internal damage to the equipment may be considered.

Accessories and Optional Accessories WARNING

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

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Precautions about the DS-7300 System When connecting to other device, contact Fukuda Denshi service

D A N G E R representative. Danger such as electric shock may result to the patient and operator. l Do not connect unit or cable not authorized by Fukuda Denshi to any I/O connector. If done so by mistake, the DS-7300 system cannot deliver its maximum performance and the connected units may be damaged, resulting in a safety hazard. l If the DS-7300 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. If using the equipment under condition other than specified, contact our service representative. l Use only the accompanying 3-way AC power cable. Use of other cables may result in electric shock to the patient and the operator. l The power cable must be connected to AC 100~230V outlet. l 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. l The patient type selection influences the precision of the QRS detection and NIBP measurement. Make sure the correct selection is made. l The pacemaker use selection influences the precision of the QRS detection and arrhythmia analysis. Make sure the correct selection is made. l 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. WARNING l 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 ～3°C due to the sensor heat which may result in burn injury. l For the following case, accurate measurement may not be possible. Ÿ Patient with excessive abnormal hemoglobin (HbCO, MetHb) Ÿ Patient with the pigment injected to the blood Ÿ Patient receiving CPR treatment Ÿ When a sensor is applied to a limb with NIBP cuff, arterial catheter, or intracatheter Ÿ When measuring at site with venous pulse Ÿ Patient with body motion Ÿ Patient with small pulse l Before the measurement, make sure the patient type ( Adult / Child / Neonate ) is properly selected. Otherwise, correct measurement can not be performed, and congestion or other injury may result. l Use the specified sampling tube and nasal prong manufactured by Oridion. l For HS-710E, 720E, 702E, and HC-500, 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. l For HS-710E, 720E, 702E, and HC-500, 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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l During tcpO2/pCO2 monitoring, long-term hyperthermia may blister skin. Also, when producing local hyperemia by means of hyperthermia, a certain risk of applying a heat exposure that is harmful to the skin is always present. For special patients, e.g. patients in shock, patients with low blood pressure, and patients with vascular constrictions, particular care should be taken whenever hyperthermia is produced. l During tcpO2/pCO2 monitoring, select the appropriate attachment site, electrode temperature, and attachment duration according to the patient’s condition. To avoid burn injury, it is recommended to change the electrode site every 4 hours. l 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. l 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. l 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. l 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. l If PURITAN-BENNETT Ventilator is used, APNEA alarm will not generate when ventilator is the RR/APNEA alarm source. l 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. l 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. l Fix the monitor on an adapter before setting on the trolley. Verify it is securely locked. Fixing on with 2 screws will ensure more safe use. If not securely fixed, the monitor may fall off the trolley which may damage the monitor or cause injury. l When lifting this device, hold the bottom part of the main unit and not the display unit. l When attaching the display unit to the main unit, insert the display unit to the attaching guide on the main unit from top and push in until a click sound can be heard. Verify that it is securely locked. l About the Trolley Ÿ 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. Ÿ Be 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. Ÿ 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. l About the Air Filter for Cooling Fan (Super Module, Input Box) Ÿ When the air filter is washed with neutral detergent, dry it completely before reattaching. If the moisture is remained on the air filter, it may damage the equipment. Ÿ The air filter must be attached. If the equipment is used with the air filter detached, it may damage the equipment.

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l Systems Ÿ This equipment is intended to be used for only one patient. Ÿ The installation of this equipment should be performed by our service representative or a person who is well acquainted with this equipment. Ÿ Use only the accessories specified for this device. Otherwise, proper function cannot be executed. Ÿ For quality improvement, specifications are subject to change without prior notice. Ÿ 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. Ÿ Always operate the touch panel with fingers or touch panel pen. Do not touch with a pen-point or other hard-edged instruments. Malfunction or damage may result. Ÿ Do not attach a film on the touch panel. Malfunction or damage may result. Ÿ 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. Ÿ Turning off the power of the LC-7315T Display Unit will also turn off the power of the Input Box. Ÿ As the Super Module and DSC-7300 communicates via Input Box, the power of the Input Box must be always turned ON even if the module is not inserted in the Input Box. Ÿ There are following restrictions when recording on the HR-500 Recording Module. ・ Only manual recording, periodic recording, alarm recording, recall recording can be performed on the HR-500. ・ If the measurement unit of BP is “kPa”, BP waveform, BP numeric data, and NIBP numeric data will be treated as non-measured data. ・ If the TEMP measurement unit is “°F”, the TEMP numeric data will be treated as non-measured data. ・ For the non-measured parameter, the waveform will not be printed, and numeric data will be printed as “- - -” or left blank. ・ The numeric data displayed as “×××” will be printed as “－－－”. ・ The QRS classification symbol of “S” will be printed as “N” on the HR-500. ・ The waveform recording is not possible for some scale depending on the parameter. ・ If the HR alarm source is BP, ECG will not be recorded. PR_IBP data will be printed for the HR data instead. ・ If the RR/APNEA alarm source is other than impedance respiration, the respiration waveform will not be recorded. ・ If the RR/APNEA alarm source is other than CO2/GAS, the CO2 waveform will not be recorded. l ECG Monitoring Ÿ The indication for continuous use of the electrode is about one day. Ÿ Replace the electrode if the skin contact gets loosen due to perspiring, etc. Ÿ 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. Ÿ 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.

CAUTION

Ÿ The threshold level for arrhythmia detection and QRS 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 250 µV. When the waveform size is ´2 or ´4, the detection threshold is 150 µV. Ÿ 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. Ÿ 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. Ÿ The electric blanket mode cannot fully attenuate electric blanket noise, and may still erroneously detect pacemaker spike. Use this mode only when high frequency noise is too large and generates error on HR measurement. Ÿ 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. Ÿ 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. Ÿ 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. Ÿ When continuously detecting AC noise artifact as pacemaker pulses, QRS detection stops and heart rate is extremely degraded. Also arrhythmia cannot be detected. l Respiration Monitoring Ÿ When the following relay cables are used, respiration cannot be measured. ・Relay Cable CI-700E_3 (Electrosurgery-proof, 3-electrode) ・Relay Cable CI-700E_4 (Electrosurgery-proof, 4-electrode) ・Relay Cable CI-700E_5 (Electrosurgery-proof, 5-electrode) Ÿ 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. l SpO2 Monitoring Ÿ If the nail is rough, dirty, or manicured, accurate measurement will not be possible. Change the finger or clean the nail before attaching the probe and sensor. Ÿ If irritation such as skin reddening or skin fit appears with the sensor use, change the attachment site or stop using the sensor. Ÿ 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. Ÿ Even a short duration of attachment may inhibit the blood flow and generate compression necrosis and burn injury. Ÿ Change the sensor attachment site constantly (every 4 hours). As the temperature of sensor attachment site normally rises 2～3°C, compression necrosis and burn injury may generate. Ÿ As skin for neonate / low birth weight infant is immature, change the sensor attachment site more frequently depending on the condition. Ÿ Direct sunlight to the sensor area can cause a measurement error. Place a black or dark cloth over the sensor. Ÿ 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.

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Ÿ 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. Ÿ 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. Ÿ Measuring on a limb with NIBP cuff, arterial catheter, or intracatheter may result in incorrect measurement. l NIBP Monitoring Ÿ 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. Ÿ 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 310mmHg for adult, 210mmHg for child, 160mmHg for neonate. Ÿ 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. Ÿ 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. Ÿ The 1-minute interval measurement will automatically stop after 10 minutes or 20 minutes and returns to the previous interval mode setup. The selection of 10min / 20min can be made on the NIBP configuration menu. Ÿ The alarm function will be ineffective for the BP value measured by Quick SYS regardless of the ON/OFF selection of NIBP alarm. Ÿ 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 for the tabular trend or the NIBP list function if the display is set to OFF. l BP Monitoring Ÿ 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. If HB-500 BP Module is used, the balance information will be maintained for 1 minute. Ÿ Each time the blood pressure transducer or tubing is replaced, the zero balance procedure is required to ensure accurate measurements. Ÿ “Perform zero balance” message will not be displayed unless the three-way cocks of all pressure transducers are opened to air. If the status is not displayed, or if “Open stop cock to air” message is displayed, check if the three-way cock of pressure transducers are opened to air. Ÿ The zero balance procedure is required for the following case. Ÿ When starting the measurement. Ÿ When the position of the heart has changed due to body movement. Ÿ When the position of the transducer has changed. Ÿ When measuring for a long period of time and there is a possibility of measurement error due to change in ambient temperature, etc. Ÿ When the connector is connected / disconnected, or transducer is replaced. Ÿ When the power has been turned OFF for more than 5 seconds. Ÿ Note that Systolic Pressure (SYS) = Peak Systolic Pressure (PSP) for the graphic trend, data base, and alarm setup. Ÿ When ECG is not measured, PDP cannot be calculated. Ÿ When HB-500 is used, do not set the BP label to IAP. PDP will not be calculated and displayed as “- - -”. S/D/M will not be displayed either. Ÿ The BP data (SYS/DIA/Mean) not displayed will not generate the BP alarm or be displayed for the tabular trend function. Select the appropriate display type according to the monitoring purpose.