HS-700 Series Operation Manual Ver.07 Oct 2009

Ver.07

0086

This operation manual is for the HS-700 Version 07.

This module conforms with the provisions of Medical Device Directive 93/42/EEC in connecting with the Fukuda Denshi monitoring equipment, labeled "CE". 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.

* 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 a physician or persons instructed by physicians are allowed to use this device. * The information contained in this document is subject to change without notice due to improvement in the device.

Copyright © 2009 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 Graphic Symbols·························································· ii Precautions for Safe Operation of Medical Electrical Equipment··································································· iv Precautions about the Maintenance····························· v Precautions about the Pacemaker ······························ vi Non-Explosion Proof ··················································· vi Defibrillation Safety ····················································· vi Precautions about the Mason-Likar Lead Configuration ·······························vii ●ECG Monitoring by the Mason-Likar Lead Configuration······················································vii ●Electrode Attachment Site ·································vii Electrosurgery Safety··················································vii Precautions about Magnetic Resonance Imaging·······vii Precautions about Connections to Peripheral Devices ···················································viii Precautions about the Fuse ·······································viii Accessories and Optional Accessories ······················viii Precautions about the HS-700 ···································· ix Precautions about the Ventilator Monitoring ··············xiv Precautions for Use of SpO2 Sensor·························· xv Precautions for Masimo® Unit: HS-710M, 710EM, 720M, 720EM, 702CM ··············· xv Precautions for Use of NIBP Cuff······························· xv Disposing of Equipment, Accessories, or Components·························································xvi Precautions about Transportation ······························xvi Precautions about Data Backup·································xvi To Prepare for Emergency Use ·································xvi

i

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

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.

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) Power ON This indicates that the main power switch is in the ON position. Power OFF This indicates that the main power switch is in the OFF position. 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.

ii

Symbol

Description Signal Output Part

GAS Output Part Signal Input Part TCP/IP Network Connector Connects to TCP/IP network. RS-232C Connector Connects the related device. Eject Indicates the switch to remove the recorder paper cassette.

iii

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.

CAUTION

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.

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 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 “5. 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; 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 HS-700 series 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 WARNING “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] 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 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.

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 by the discharged energy.

z 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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Precautions about the Mason-Likar Lead Configuration ●ECG Monitoring by the Mason-Likar Lead Configuration The Mason-Likar lead configuration which places the limb leads on the torso may generate waveforms different from the standard 12-lead ECG. The C A U T I O N waveforms may also differ depending on the patient’s supine or standing (sitting) position. Therefore, verify the waveform difference which may be caused by the lead configuration or patient’s body position before monitoring.

●Electrode Attachment Site NOTE

The waveform difference with the standard 12-lead ECG can be reduced by placing the R and L electrodes at the right and left infraclavicular fossa, as near as possible to the arm where myoelectric influence will not occur.

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:

WARNING

Location Locate the electrosurgical unit as far as possible from this unit and the patient cable. This will help reduce interference on the ECG through the monitor or cables. Power Supply Connect the electrosurgical unit to a power supply that is different from that of the monitor. This will help prevent interference through the power cable. Electrode Placement The amount of interference is considerably different depending on the 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 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.

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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 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. All the peripheral device connectors on the HS-700 series are isolated from the

C A U T I O N 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, 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 burns out, 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 Use only the cables specified by Fukuda Denshi.

WARNING

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y Use of other cables may result in increase in emission or decrease in immunity. y We are not liable of the performance if product other than specified is used.

Precautions about the HS-700 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. z Do not connect unit or cable not authorized by Fukuda Denshi to any I/O connector. If done so by mistake, the HS-700 cannot deliver its maximum performance and the connected units may be damaged, resulting in a safety hazard. 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. When connecting, do not use multitap. 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 If the HS-700 series 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. 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 Be cautious when setting the "SpO2 Averaging" duration as the SpO2 alarm is 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. WARNING ® (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 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 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 Use only the specified accessories. z For HS-710E, 710EM, 720E, 720EM, 702E, 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 Multigas Monitoring (HS-720C, 702C, 702CM: PHASEIN IRMA Probe) y The IRMA probe is intended for use by authorized and trained medical personnel only. y The IRMA probe must not be used with flammable anesthetic agents. ix

WARNING

y Disposable IRMA airway adapters shall not be reused. Used disposable airway adapters shall be disposed of in accordance with local regulations for medical waste. y Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors shall be disposed of in accordance with local regulations for batteries. y Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml dead space to the patient circuit. y Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow resistance. y Measurements can be affected by mobile and RF communications equipment. It should be assured that the IRMA probe is used in the electromagnetic environment specified. y Do not place the IRMA airway adapter between the ET tube and an elbow, as this may allow patient secretions to block the adapter windows. y To keep secretions and moisture from pooling on the windows or oxygen sensor port, always position the IRMA airway adapter with its windows in a vertical position and the IRMA oxygen sensor pointing upwards. y Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as this may affect the light transmission of the airway adapter windows. y Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable product and contains a caustic electrolyte and lead. y The IRMA probe is intended only as an adjunct in patient assessment. It must be used in conjunction with other assessments of clinical signs and symptoms. y Incorrect probe zero calibration will result in false gas readings. y Incorrect agent selection by the user for IRMA AX/OR (no automatic agent identification) will result in false agent readings. y Using IRMA AX/OR (no automatic agent identification) with gas mixtures containing more than one agent will result in false agent readings. y Replace the adapter if rainout/condensation occurs inside the airway adapter.

z Analog signal is a delay output. (about 35ms for ECG, BP) When connecting to a device using vital signs as trigger signals (ex. IABP), make sure the delay time fulfills the specifications of the connected device. z The delay time may differ depending on the waveform shape or artifact interference. z Be cautious not to touch the cooling fan. Fingers may be entangled in the fan causing serious injury. z 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. z The air filter must be attached. If the equipment is used with the air filter detached, it may damage the equipment. z Systems y This equipment is intended to be used for only one patient. 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 When the product is used in regions whose voltage is other than 220-240V, a cable appropriate to the regulations and voltage of the country in which the product is being used shall be used.

z ECG Monitoring

CAUTION

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y Use only the specified relay cables, lead cables, and electrodes. y The conductive parts of electrodes and associated connectors for applied parts, including the neutral electrode, should not contact other conductive parts including earth. 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 There are some cases when QRS is not automatically detected although the amplitude is above the threshold level. y QRS may not be automatically detected for the following ECG waveforms. ・ The amplitude is low and extremely wide. ・ Contains large amount of artifacts such as EMG or excessive body movement. ・ Contains excessive noise from 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 continuously detecting AC noise artifact as pacemaker pulses, QRS detection stops and heart rate is extremely degraded. Also arrhythmia cannot be detected.

z Arrhythmia Analysis 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.

z Respiration Monitoring y 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) 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

CAUTION

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. 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 input connector. Otherwise, the measurement data may be erroneously displayed by the ambient light. y Precautions for Reusable Type Sensors ・ 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. ・ 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. ・ 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-Use Type Sensors ・ Do not wind the tape too strong. It may obstruct the blood flow. ・ The sensor is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape. ® ・ The Nellcor sensor OXISENSORⅢ, 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. ® ・ 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. ・ For the Nellcor® single-use type sensors, the site must be inspected every 8 hours to ensure adhesion, skin integrity, and correct optical alignment. If skin integrity changes, move the sensor to another site. ・ Do not reuse the sensor by resterilizing it.

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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. Do not connect them to Nellcor® SpO2 unit. If connected, the unit will not function properly.

z NIBP Monitoring

CAUTION

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 hyper coagulation. The cuff inflation may cause petechia or circulatory failure by the blood clot. y When measuring the NIBP, make sure to display the NIBP numeric data box on the home display. Otherwise, the measurement result will not be displayed although the NIBP Start/Stop key is pressed. 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 310mmHg for adult, 210mmHg for child, 160mmHg for neonate.

z BP Monitoring y The zero balance procedure is required for the following case. ・ When starting the measurement. ・ When the position of the heart has changed due to body movement. ・ When measuring for a long period of time and there is a possibility of measurement error due to change in ambient temperature, etc. ・ When the connector is connected / disconnected, or transducer is replaced.

z CO2 Monitoring (HS-710E, 710EM, 720E, 720EM, 702E)

y Perform calibration after 20 minutes when the main power of the Super Module is turned ON. y Do not disconnect the sampling tube during calibration. If disconnected, calibration will cease. y Conduct CO2 calibration for the following case. ・ When 6 months has elapsed from the last calibration date. ・ When EtCO2 measurement is not stable or accuracy is degraded compared with other measuring device. ・ When the patient monitor was not used for a while, or when EtCO2 was not measured for a while. y If the HC-500 (CO2 Module) is simultaneously used, the CO2 measurement priority will be according to the setting on the patient monitor. With the default setting, the HC-500 will be prioritized. ®

z CO2 Monitoring (HS-720C, 702C, 702CM: RESPIRONICS Capnostat 5) y If the HC-500 (CO2 Module) is simultaneously used, the CO2 measurement priority will be according to the setting on the patient monitor. With the default setting, the HC-500 will be prioritized.

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y The disposable airway adapter should be opened just before use. Do not sterilize it. y Do not reuse the disposable airway adapter. y The airway adapter should be attached with the thicker side facing to the patient. If attached oppositely, it may damage the CO2 sensor or airway adapter. y Do not sterilize the airway adapter using autoclave method.

z Temperature Monitoring y Do not reuse the probe cover. It is intended for single patient use only. ®

z Multigas Monitoring (HS-720C, 702C, 702CM: PHASEIN IRMA Probe) y Never sterilize or immerse the IRMA probe in liquid. y The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will damage them. y Do not apply tension to the probe cable. y Do not operate the IRMA probe outside the specified operating temperature environment. y Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe is not in use. y The O2 sensor needs to be replaced every 4 months. Replace within 4 months after opening the package even if it is not used. When the “Replace O2 sensor” message is displayed, O2 measurement cannot be performed. Make sure to use the sensor before the expiration date indicated on the package. y The disposable airway adapter should be opened just before use. Do not sterilize it. y Do not reuse the disposable airway adapter. y The airway adapter should be attached with the thicker side facing to the patient. If attached oppositely, it may damage the IRMA probe or airway adapter. y If the O2 concentration is low (in such case if the airway adapter is removed near the nose/mouse where it is affected by expired gas), O2 sensor calibration will not be properly performed. After removing the airway adapter, locate it away where it will not be affected by expired gas.

z Multigas Monitoring (Poet IQ 8500A)

CAUTION

y When performing the O2 cell drift check and calibration, check the label of calibration gas cylinder. Do not use the calibration gas if the validity date is expired. y Use only the specified calibration gas. Proper calibration is not possible if unapproved calibration gas is used. y Make sure to restart the Poet IQ 8500A after the calibration. Otherwise, Poet IQ 8500A will not function properly. y If O2 gain adjustment is started without supplying the calibration gas, the message, “Check calibration gas.” will be displayed and O2 gain adjustment will cease. y If O2 offset adjustment is started without opening to air, the message, “Check calibration gas.” will be displayed and O2 offset adjustment will cease. y If O2 offset is adjusted, it is necessary to readjust the O2 gain. If O2 offset adjustment was not necessary, O2 gain readjusting screen will not be displayed.

z Maintenance y Clean the equipment frequently so stains can be removed easily. y To prevent injury, it is recommended to wear gloves when cleaning the equipment. y Do not allow liquids such as alcohol or cleaning solution enter the equipment or connectors. y Do not use organic solvents, thinner, toluene and benzene to avoid damaging the resin case. y Do not polish the housing with abrasive or chemical cleaner. y When sterilizing the entire room using a spray solution, pay close attention not to have liquids get into the equipment or connectors. y Use only neutral detergent to clean the housing. Do not use chemical cloth, scrub brush, abrasive, polishing powder, hot water, volatile solvent and chemicals (cleanser, thinner, toluene, benzine, benzol, and synthetic detergent for house and furniture), or sharp-edged tools. The surface resin coating may be damaged, resulting in discoloration, scratches, and other problems. y Do not open the housing. y Do not allow alcohol or other liquids to enter the equipment. y If you accidentally wet the device, dry it completely and verify it operates safely before usage. y Replace the components periodically as specified.

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Precautions about the Ventilator Monitoring z The ventilator alarm on this monitor should be used as supplementary function. Check the patient’s condition, ventilator alarm sound and message occasionally. z If the DS-7300 system does not generate an alarm even though the ventilator is generating an alarm, or if any other malfunction occurs, immediately check the ventilator, DS-7300 system, cable, and replace the cable if necessary. If the malfunction persists, stop using the device. z The alarm generation on the DS-7300 system is not assured if the alarm other than specified generates at the ventilator. See

For details of the specified alarms, refer to WARNING on “2. Basic Operation Ventilator Alarm Input” on the DS-7300 System Operation Manual

z The Evita 2 dura / Evita 4 / Evita XL / Savina acquires alarm information from the serial port. The ventilator alarm that cannot be acquired from the serial port is not guaranteed. For corresponding alarm, refer to the service representative of the WARNING ventilator manufacturer. z The DS-7300 system will not correspond to the following alarms generated on the Evita 4 / Evita XL / Evita 2 dura. y O2 monitoring disabled alarm, CO2 alarm disabled alarm, Oximeter alarm disabled alarm, Neo. volume measurement inoperable alarm, Minute volume alarm disabled alarm, Minute volume alarm low off alarm, Tidal volume alarm high off alarm, Apnea alarm off alarm, Nebulizer active alarm

z The DS-7300 system will not correspond to the following alarms generated on the Savina. y O2 monitoring disabled alarm, Minute volume alarm disabled alarm, Minute volume alarm low off alarm, Tidal volume alarm high off alarm, Apnea alarm off alarm, Nebulizer active alarm

z There is a communication delay of 3 seconds between the DS-7300 system and the Evita 4／Evita XL／Evita 2 dura／Savina ventilator. Therefore, if the alarm generated at the ventilator is resolved within 3 seconds, the ventilator alarm may not be generated at the DS-7300 system.

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z The ventilator operation should be performed by well-trained and authorized personnel. z For connecting the DS-7300 system and ventilator, use only the specified connection cable. z Verify that the DS-7300 system and the ventilator are properly connected. z When connecting the cable, verify that the main power of the DS-7300 system and the ventilator is OFF. z When connecting the PURITAN-BENNETT ventilator, follow the precautions below.

CAUTION

y The serial port (RS-232C) of the ventilator should be set as follows. Refer to the service representative of the ventilator manufacturer. Baud Rate : 9600bps Data Bit : 8bit Parity Bit : none (Stop Bit) : (1bit) y The DS-7300 system detects the “ventilator alarm” when the nurse call port on the ventilator outputs the alarm signal. For details of ventilator setup and alarm signal output condition from the nurse call port, refer to the service representative of the ventilator manufacturer.

z When connecting the Evita 4 / Evita XL / Evita 2 dura / Savina ventilator, the serial port (RS-232C) setup of the ventilator should be as follows. Refer to the service representative of the ventilator manufacturer. For Evita2dura / Evita4 / Evita XL Protocol Baud Rate Data Bit Parity Bit Stop Bit For Savina Protocol Baud Rate Data Bit Parity Bit Stop Bit

: Medibus : 19200bps : 8bit : Even : 1bit : Medibus : 9600bps : 8bit : None : 1bit

Precautions for Use of SpO2 Sensor Burn Risk in Using SpO2 Sensor

DANGER

In SpO2 monitoring, always use the sensor/relay cable specified by Fukuda Denshi. If any other sensor/relay cable is used, a high temperature rise of the sensor may place the patient in danger of burns. If there are any questions regarding the sensor/relay cable use for SpO2 measurements of this device, please contact Fukuda Denshi service representative.

Precautions for Masimo® Unit: HS-710M, 710EM, 720M, 720EM, 702CM No Implied License

CAUTION

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Precautions for Use of NIBP Cuff C A U T I O N This product contains natural rubber latex which may cause allergic reactions.

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Disposing of Equipment, Accessories, or Components When disposing of the equipment, accessories, or components, use an

C A U T I O N industrial waste distributor. Do not dispose of as ordinary waste.

Precautions about Transportation For transporting this device, pack with specified packing materials. Reference

Refer to “6. Technical Information Specification / Performance” for environmental condition during transportation.

Precautions about Data Backup To protect the data during voltage dip, short interruptions and voltage variations on power supply input lines or during short duration of power turned C A U T I O N OFF, this monitor performs 5-minute (approx.) data backup using the secondary battery. The data may not be protected if the power is turned off within 30 minutes from power on.

To Prepare for Emergency Use Accessories / Optional Accessories (1) The ECG electrodes are consumables. Always prepare extra supplies of electrodes. (2) Check if any wire break is present on the patient cable once a week.

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Contents

Preface 1. General Description

Describes the outline of this module.

2. Basic Operation

Describes the procedure for power supply connection and recorder operation.

3. Preparation

Describes the procedure to measure each parameter and to connect external equipment.

4. Installation

Describes the operating environment of this module.

5. Maintenance

Describes the maintenance and troubleshooting of this module.

6. Technical Information

List the specification and pin assignment of the external connector.

7. Accessories

Lists the accessories and optional accessories for this module.

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