Fukuda Denshi Co DS7100 Patient Monitor User Manual DS71v1 1 FA 001 Preface 001

Fukuda Denshi Co Ltd Patient Monitor DS71v1 1 FA 001 Preface 001

User manual 1

iPrefaceThank you for purchasing this product.Before using this product, read the following precautions to make sure the product isused correctly and safely.Safety Precautions ･････････････････････････････････iiLabels Attached to the Unit ･･･････････････････････iiMeasurement Unit for Each Parameter ････････････ ivGraphic Symbols ････････････････････････････････vPrecautions for Safe Operation of Medical ElectricalEquipment ････････････････････････････････････ viPrecautions for Safe Operation of Medical Telemetry(DS-7141, DS-7101LT)･･････････････････････････viiPrecautions about the Maintenance･･････････････ viiiPrecautions about the Pacemaker ････････････････ ixNon-Explosion Proof････････････････････････････ ixDefibrillation Safety･････････････････････････････ ixElectrosurgery Safety ････････････････････････････xPrecautions about Magnetic Resonance Imaging ････xPrecautions about Connections to Peripheral Devices xiPrecautions about the Fuse･･････････････････････ xiAccessories and Optional Accessories ････････････ xiPrecautions about the DS-7100 System ･･･････････xiiPrecautions for Use of SpO2 Sensor ････････････ xviiiPrecautions for Use of NIBP Cuff ･･･････････････ xviiiDisposing of Equipment, Accessories, or Components････････････････････････････････････････････ xviiiPrecautions about Transportation･･･････････････ xviiiPrecautions about RTC or Data Backup ･････････ xviiiPrecautions for Use of Lithium-Ion Battery Pack ･･･ xixTo Prepare for Emergency Use･･･････････････････xxElectromagnetic Compatibility ･･････････････････････ xxiPrecautions for Safe Operation under ElectromagneticInfluence ･････････････････････････････････････ xxiEMC Guidance ･･･････････････････････････････ xxi●Compliance to the Electromagnetic Emissions xxii●Compliance to the Electromagnetic Immunity (1)･･････････････････････････････････････････xxii●Compliance to the Electromagnetic Immunity (2)･････････････････････････････････････････ xxiii●Recommended Separation Distances betweenPortable and Mobile RF Communications Equipmentand the DS-7100 System･･･････････････････ xxiv
iiSafety Precautions? Read the “Safety Precautions” thoroughly before use to ensure correct and safe use of the product.? Be sure to follow the precautions indicated below, as these are important messages related to safety.DANGER Failure to follow this message may cause immediate threat of death or seriousinjury, or complete failure of the equipment.WARNING Failure to follow this message may result in death or serious injury, orcomplete 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 thecorrect use and operating procedures to prevent incorrect operation andmalfunction of the equipment.Labels Attached to the UnitMake sure to read the warning labels attached to the unit and comply with these requirements whileoperating the unit.CAUTIONDo not damage or erase the warning labels attached to the unit.These warning labels contain descriptions important for handling andoperating the unit properly and safely. A damaged label may compromisesafe operation.
iiiDS-7100 System DANGERRisk of explosion if used in the presence of flammable anesthetics. CAUTIONBefore connecting, read instruction manual. CAUTIONTo reduce the risk of electric shock, do not remove the cover.Refer servicing to qualified service personnel. DANGER? Use only the batteries specified for thisdevice.? Do not disassemble or modify the battery.The battery incorporates protection circuitryfor safety purposes. WARNING? Installation of the battery should beperformed only by our servicerepresentative, to avoid any risk of electricshock to the operator or malfunction of thedevice. CAUTION? The life cycle of the battery is 1 year.? The battery charges when the power cord isconnected to a hospital-grade outlet.? It takes approximately 2.5 hours to fullycharge an empty battery.
ivMeasurement Unit for Each ParameterThe measurement units for this equipment are as follows.Detail Parameter Display Unit DefaultECG HR bpm(beats per minute)Invasive BloodPressure PR_BP bpm(beats per minute)Heart Rate／PulseRate *1SpO2PR_SpO2bpm(beats per minute)ST Level ECG ST mm, mv mvVPC ECG VPC beats / hourImpedanceRespiration RR_IMP Bpm(breaths per minute)Respiration Rate*2 CO2RR_CO2Bpm(breaths per minute)ImpedanceRespiration APNEA s (second)ApneaCO2APNEA s (second)Invasive BloodPressure Invasive BloodPressure BP mmHg, kpa mmHgNon-Invasive BloodPressure Non-Invasive BloodPressure NIBP mmHg, kPa mmHgArterial OxygenSaturation SpO2SpO2%Temperature Temperature TEMP ?C / ?F?CEnd-Tidal CO2Concentration CO2EtCO2mmHg, kPa, % mmHgInspiratory CO2Concentration CO2InspCO2mmHg, kPa, % mmHg*1 HR/PR will be displayed in the color selected for ECG/HR.*2 RR will be displayed in the color selected for RESP.
vGraphic SymbolsThe following symbols are used for this equipment.DS-7100 System: Main UnitSymbol DescriptionCaution; refer to accompanying documentsIndicates the need to refer to related accompanying documents beforeoperation.Equipotential TerminalIndicates the terminal to equalize the potential difference wheninterconnecting the devices.DS-7100 System: Symbols displayed on the screenSymbol DescriptionBattery MarkIndicates battery capacity and remaining volume during battery operation.Alarm OFFIndicates the alarm is OFF.Heart Rate Synchronization MarkThis mark flashes synchronizing to the heartbeat.Respiration Synchronization MarkThis mark flashes synchronizing to the inspiration.Event Key MarkDisplayed when an alarm generates. ON/OFF of the display can beselected on the ward setup.Message MarkDisplayed in the parameter key when an alarm message is present forthat parameter.
viPrecautions for Safe Operation of Medical Electrical EquipmentCAUTIONRead the following precautions thoroughly to correctly operate the device.? Users should have a thorough knowledge of the operation before using thissystem.? Pay attention to the following when installing and storing the equipment.? Do not install or store in an area where the equipment will be subject tosplashing water.? 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.? Place the equipment on a stable surface where there is no inclination,vibration, or shock (including during transportation).? Do not install or store in an area where there are chemical or gassesstored.? Verify the power frequency, voltage and allowable current (or powerconsumption).? Ensure the grounding is proper by connecting the accompanying powercable to the hospital grade outlet.? Before operating the system, verify the following items? Verify the power voltage.? Check the cable connection and polarity to ensure proper operation ofthe equipment.? Make sure the power system has adequate earth ground.? Ensure that all cables are firmly and safely connected.? Pay special attention when the device is used in conjunction with otherequipment as it may cause erroneous judgement and danger.? Ensure all patient connections are proper and secure.? During operation of the system, verify the following items.? Always observe the system and patient to ensure safe operation of theequipment.? If any abnormality is found on the equipment or patient, take appropriatemeasures such as ceasing operation of the equipment in the safest wayfor the patient.? Do not allow the patient to come in contact with the device.? After using the system, verify the following items.? Unplug all the cables from the patient before turning off the power.? When unplugging the cables, do not apply excessive force by pulling onthe cord. Pull by the connector part of the cable.? Clean the accessories and cables, and keep them together in one place.? Keep the unit clean to ensure proper operation of the next use.? If the equipment is damaged and in need of repair, user should not attemptservice. Label the unit “OUT OF ORDER” and contact Fukuda Denshi.? Do not remodel the equipment.? Maintenance Check? Make sure to periodically check the equipment, accessories and cables.? Before reusing the device that has been left unused for a while, makesure that the device works normally and safely.? When using the electrosurgical knives or defibrillator with this equipment,verify proper attachment of patient ground plate, ECG electrode type for theelectrosurgical knives, and paste volume, output energy for the defibrillator.Also, verify that proper ground is selected.
viiPrecautions for Safe Operation of Medical Telemetry (DS-7141, DS-7101LT)CAUTIONPrecautions for Safe Operation of Medical TelemetryTo operate the device correctly, read the following precautions carefully.? The medical institution (hereinafter referred as “Institution”) must decide thetelemetry installation plan for the medical institution in order to preventinterference and interference between transmitters (telemetry based ondestination country’s radio law).? When using telemetry which requires zone location, the institution is to setup the zones as an operation unit for each transmitter to prevent electronicinterference between telemetry throughout the medical institution.? When using telemetry which requires zone location, display and identifyeach prepared zone in the equipment.? When laying receiver antenna for each transmitter, the institution has to beexamined so as not to generate electronic interference.? Based on the above examination result, the institution places each receiverantenna as required.In managing, be sure to follow the precautions below.? The institution appoints a person to manage the wireless channels for thewhole medical institution. And when using telemetry which requires zonelocation, the institution nominates a person to manage the wirelesschannels in each zone (a “Zone Manager”). However, when using suchtelemetry in a local medical institution, one person can perform bothfunctions.? Select a telemetry manager who understands the characteristics andfunctionality of telemetry systems, and is skilled in operating telemetry.? When installing telemetry, the Overall Manager and the Zone Managerhave to understand the precautions for use of the telemetry in advance.? The Overall Manager takes responsibility of wireless channel managementand transmitter storage for the whole medical institution by giving properinstruction.? The Overall Manager creates a management log, list of wireless channels,management status for the whole medical institution (hereinafter referred toas the “management log”). When changing a wireless channel, register itin the log and give proper instructions to the zone manager or to the user.? The Zone Manager assumes responsibility for managing the wirelesschannels, storing, and managing telemetry.? The Zone Manager assigns the transmitter to the user, and providesenough education for use inside the zone.? The telemetry user verifies operation of the transmitter/receiver before use.? The telemetry user, if using the telemetry in a zone location, follows theinstructions of the zone manager for the zone and gives instructions to thepatient if required.? When interference or breakdown occurs in telemetry communication, theuser is required to inform the zone manager and the overall manager of theproblems. The zone manager and overall manager are to deal with theproblem properly and/or contact their nearest Fukuda Denshirepresentative for service.
viiiPrecautions about the MaintenanceSafety Inspection and MaintenanceFor 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 enclosure leakagecurrents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record ofthese safety inspections.Immediate maintenance has to be carried out if ;? the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.? the equipment was subjected to liquid spill.? the monitoring function is interrupted or disturbed.? parts of the equipment enclosure are cracked, removed, or lost.? any connector or cable shows signs of deterioration.ReferenceRefer to “10. Maintenance” for details.WARNING Never open the housing while the equipment is in operation or connected tohospital grade outlet as it may result in electric shock.Maintenance, Modifications, and RepairsFukuda Denshi is liable for the safety, reliability, and performance of its equipment only if;? Maintenance, modifications, and repairs are carried out by authorized personnel.? 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 Denshirepresentative.
ixPrecautions about the PacemakerWARNINGMinute ventilation rate-adaptive implantable pacemakers can occasionallyinteract with certain cardiac monitoring and diagnostic equipment, causingthe pacemakers to pace at their maximum programmed rate. The cardiacmonitoring and diagnostic equipment may possibly send wrong information.If such event occurs, please disconnect the cardiac monitoring anddiagnostic equipment, or follow the procedures described in the operationmanual of the pacemaker.(For more details, contact FUKUDA DENSHI personnel, your institution’sprofessionals, or your pacemaker distributors.)Reference“Minute Ventilation Rate-Adaptive Pacemakers”FDA alerts health professionals that minute ventilation rate-adaptive implantable pacemakers can occasionally interact withcertain cardiac monitoring and diagnostic equipment, causingpacemakers to pace at their maximum programmed rate.[October 14, 1998 (Letter: www .fda.gov/cdrh/safety.html) – FDA]Non-Explosion ProofDANGERNever operate the equipment in the presence of flammable anesthetics, highconcentration of oxygen, or inside hyperbaric chamber. Also, do notoperate the equipment in an environment in which there is a risk ofexplosion.Explosion or fire may result.Defibrillation SafetyWARNING? When defibrillating, keep away from the electrodes or medicamentapplied to the patient chest. If this is not possible, remove the electrodesor medicament before defibrillating.If the defibrillator paddles directly contact the electrodes or medicament,electrical shock may result by the discharged energy.? When defibrillating, make sure that the electrodes, sensor cables, or relaycables are firmly connected to the device.Contacting the metal part of the disconnected cable may result inelectrical shock by the discharged energy.? When defibrillating, do not touch the patient and the metal part of thedevice or cables. Electric shock may result by the discharged energy.
xElectrosurgery SafetyWARNINGThe monitoring system contains protection against interference generated byelectrosurgical instruments. However, operating conditions, surgery site withrespect to the location of ECG electrodes, or the type of instrument used, maycause noise on the ECG. The noise is generated at the tip of an electricalknife and is difficult to completely eliminate because of the frequencycomponents of the ECG. To reduce electrosurgical interference, take thefollowing precautions:LocationLocate the electrosurgical unit as far as possible from this unit and thepatient cable. This will help reduce interference on the ECG through themonitor or cables.Power SupplyConnect the electrosurgical unit to a power supply that is different from thatof the monitor. This will help prevent interference through the powercable.Electrode PlacementThe amount of interference is considerably different depending on theelectrode position and surgery site. Place the ECG electrodes as faraway as possible from the surgery site and the ground plate. Do notplace 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 bequite large. Position (+) and (–) electrodes as close as possible to eachother.Ground PlateWhen using electrosurgical instruments, make sure the contact betweenthe patient and the ground plate is secure. If the connection isincomplete, the patient may suffer a burn at the electrode site.Precautions about Magnetic Resonance ImagingWARNING? Do not operate this equipment in magnetic resonance imaging (MRI)environments.? When conducting MRI test, remove the electrodes and sensors connectedto the patient (test subject).The local heating caused by the induced electromotive force may causeburn injury to the patient (subject). For details, refer to the operationmanual for the MRI testing device.
xiPrecautions about Connections to Peripheral DevicesIn the interest of safe and sufficient performance of this equipment, the connection of othermanufacturers’ equipment to the monitor is not authorized, unless the connection is explicitly approvedby Fukuda Denshi. It is the user’s responsibility to contact Fukuda Denshi to determine thecompatibility and warranty status of any connection made to another manufacturer’s equipment.WARNINGFor the connector with mark, only the peripheral devices specified byFukuda Denshi should be connected with the given procedure. Use of anunspecified device may cause electric shock to the patient and/or operator dueto excessive leakage current.CAUTIONAll the peripheral device connectors on the DS-7100 system are isolated fromthe power supply, but the peripheral devices are not isolated. To preventdanger of electric shock, always position the peripheral devices away from thepatient.When connecting peripheral devices to DS-7100 system, it is the user’s responsibility to verify that theoverall system complies with IEC 60601-1-1, “Collateral Standard: Safety Requirements for MedicalElectrical Systems”.Precautions about the FuseDANGER If the fuse burns out, contact Fukuda Denshi Service Representative. Do notcontinue using it as internal damage to the equipment may be considered.Accessories and Optional AccessoriesWARNING Use only the cables specified by Fukuda Denshi.Use of other cables may result in increase in emission or decrease inimmunity.
xiiPrecautions about the DS-7100 SystemDANGER? When connecting to other device, contact Fukuda Denshi servicerepresentative.Danger such as electric shock may result to the patient and operator.? When monitoring a patient with wireless telemetry, make sure the patientdata is properly received at the central monitor. Pay special attentionwhen channel ID at the bedside monitor is changed.WARNING? Do not connect unit or cable not authorized by Fukuda Denshi to any I/Oconnector. If done so by mistake, the DS-7100 system can not deliver itsmaximum performance and the connected units may be damaged,resulting in a safety hazard.? Use only the accompanying 3-way AC power cable. Use of other cablesmay result in electric shock to the patient and the operator.? The power cable must be connected to AC 115V outlet.? When using multiple ME equipment simultaneously, perform equipotentialgrounding to prevent potential difference between the equipment. Even asmall potential difference may result in electric shock to the patient and theoperator.? The patient type selection influences the precision of the QRS detectionand NIBP measurement. Make sure the correct selection is made.? The pacemaker use selection influences the precision of the QRSdetection and arrhythmia analysis. Make sure the correct selection ismade.? When measuring the SpO2 of patient with high fever or peripheralcirculatory insufficiency, check the sensor attachment periodically andchange the attachment site. The temperature of attachment site will rise 2∼3?C due to the sensor heat which may result in burn injury.? For the following case, accurate measurement may not be possible.? Patient with excessive abnormal hemoglobin (HbCO, MetHb)? Patient with the pigment injected to the blood? Patient receiving CPR treatment? When measuring at site with venous pulse? Patient with body motion? Patient with small pulse? Before the 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.? Pay attention when measuring the NIBP of patient with bleeding disordersor hypercoagulation. The cuff inflation may cause petechia or circulatoryfailure by the blood clot.? Use the specified sampling tube and nasal prong manufactured by Oridion.? Always consider the circumference of the intubation tube when using theairway adapter. If inappropriate airway adapter is used for a patient withlow ventilation, CO2 may mix in to the inspired air resulting in incorrectmeasurement, or apnea detection may become difficult.? When measuring CO2 concentration of a patient treated with mouth-to-mouth resuscitation, Jackson-Rees circuit, Mapleson D circuit of which CO2gas may mix in, the value may be displayed lower than the actual value.? When the system alarm is suspended, all the alarm will be suspended evenif the parameter alarm is set to ON. Also, the alarm event will not bestored as recall.? If the upper/lower alarm limit of the parameter is set to OFF, or arrhythmiaalarm is set to OFF, alarm will not function even if the system alarm is set toON. Pay attention when setting them OFF.? If the QRS pace mask function is turned OFF, a decrease in heart rate maynot 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.
xiiiWARNING? Objective and constant arrhythmia detection is possible through the fixedalgorithm incorporated in this monitor.However, excessive waveform morphology change, motion artifact, or theinability to determine the waveform pattern may cause an error, or fail tomake adequate detection. Therefore, physicians should make finaldecisions using manual recording, alarm recording and recall waveform forevaluation.? When setting the monitor on a trolley, use 2 fixing screws to ensure safety.Otherwise, the monitor may fall off the trolley, resulting in injury or damageto the monitor.? Use the trolley only with the equipment specified by Fukuda Denshi.Otherwise, the monitor and trolley may fall down, resulting in injury ordamage to the monitor.? 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 themonitor.? Do not use or store the trolley where it will be subject to inclination of 10degrees or more. The trolley or defibrillator may fall resulting in injury ordamage to the monitor.? Some wireless combinations of telemetry transmitters may generateinterference with other devices.? Before selecting the channel, verify it will not interfere with other channels.? Make sure the telemetry manager of your system is aware of any changesto the telemetry channels.? If transmitters are used in a neighboring medical facility, your facility andneighboring facility must make agreements on the setting of telemetrychannels to prevent telemetry interference.? The purpose of this respiration alarm is to alert the user to evaluate for thepossible occurrence of apnea events by identifying the absence ofrespiration. It is not intended to be classified as an “Apnea Monitor” and willnot identify the condition creating the possible event. (Central, Obstructiveor Mixed.)CAUTION? Systems? The monitor should be kept apart at least 20cm from the head of patientor operator.? Use only the accessories specified for this device. Otherwise, properfunction cannot be executed.? For quality improvement, specifications are subject to change withoutprior notice.? The battery deteriorates with the repeated use, which shortens theusable time.? The arrhythmia detection level corresponds with the displayed waveformsize. Select an appropriate size for monitoring.? The display panel utilizes exclusive fluorescent light for the backlight.Since this fluorescent light deteriorates by the life cycle, the display maybecome dark, scintillate, or may not light by the long term use. In suchcase, contact your nearest service representative.? Always operate the touch screen with fingers or touch screen pen. Donot touch with a pen-point or other hard-edged instruments.Malfunction of the touch screen or damage may result.? ECG Monitoring? The indication for continuous use of the electrode is about one day.? Replace the electrode if the skin contact gets loosen due to perspiring,etc.? When an electrode is attached at the same location for a long time, somepatients may develop a skin irritation. Check the patient’s skin conditionperiodically and change the electrode site as required.
xivCAUTION? The threshold level for arrhythmia detection changes with ECGwaveform size. Set a proper waveform size for monitoring.When the waveform size is ?1/4, ?1/2, or ?1, the detection threshold is250 µV.When the waveform size is ?2 or ?4, the detection threshold is 150 µV.? Automatic size/position of the ECG is effective only at the time the AUTO key is pressed. This does not continually adjust size andposition.? There are some cases when pacemaker pulse can not be detecteddepending on the pacemaker type, pulse voltage, pulse width, electrodelead type (unipolar, bipolar), or electrode placement which causes thepacemaker pulse amplitude to decrease and disables pacemaker pulsedetection.? If signals similar to a pacemaker pulse are present, such as electricblanket noise or excessive AC frequency noise, these may beerroneously detected and displayed as a pacemaker pulse.? When automatic QRS and pacemaker pulse overlap (ex. fusion beat,etc.), QRS detection cannot be performed properly. In this case, theheart rate is degraded.? When continuously detecting AC noise artifact as pacemaker pulses,QRS detection stops and heart rate is extremely degraded. Alsoarrhythmia cannot be detected.? Respiration Monitoring? When the following relay cables are used, respiration can not bemeasured.・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)? When a defibrillator is used during respiration monitoring, a large offsetvoltage will be placed on the ECG electrodes, which may causeinterruption of monitoring for a few seconds.? When the following lead cables are used, respiration cannot bemeasured.・Lead Cable #3380.0648.16 (Electrosurgery-proof, 3-electrode)・Lead Cable #3380.0661.16 (Electrosurgery-proof, 5-electrode)? SpO2 Monitoring? If the nail is rough, dirty, or manicured, accurate measurement will not bepossible. Change the finger or clean the nail before attaching the probeand sensor.? If irritation such as skin reddening or skin fit appears with the sensor use,change the attachment site or stop using the sensor.? When fixing the sensor with a tape, do not wind the tape too tighｔ. Atthe same time, check the blood flow constantly so that congestion is notgenerated at the peripheral.? Even a short duration of attachment may inhibit the blood flow andgenerate compression necrosis and burn injury? Change the sensor attachment site constantly (every 4 hours). As thetemperature of sensor attachment site normally rises 2∼3?C,compression necrosis and burn injury may generate.? As skin for neonate / low birth weight infant is immature, change thesensor attachment site more frequently depending on the condition.? Direct sunlight to the sensor area can cause a measurement error.Place a black or dark cloth over the sensor.? When not performing the measurement, unplug the relay cable andsensor from the SpO2 connector. Otherwise, the measurement datamay be erroneously displayed by the ambient light.? NIBP Monitoring? If the air hose is twisted, or weighed down, the cuff air can not beexhausted. Properly arrange the cuff and air hose.
xvCAUTION? For the following situation, measurements will be terminated.When the measurement time has exceeded 120 seconds for adult, 90seconds for child, 60 seconds for neonate.When the inflation value has exceeded 300mmHg for adult, 200mmHgfor child, 150mmHg for neonate.? If used with the incorrect patient type, it will not only cause erroneousmeasurement, but the inflating level for the adult may be applied to childor neonate causing dangerous situation to the patient.? The 1-minute interval measurement will always start from 00 second.Pressing the 1min start key will start the measurement from the next00 second.? The 1-minute interval measurement will automatically stop after 10minutes or 20 minutes and returns to the previous interval mode setup.The selection of 10min / 20min can be made on the NIBPconfiguration menu.? The alarm function will be ineffective for the BP value measured by QuickSYS regardless of the ON/OFF selection of NIBP alarm.? BP Monitoring? If the SYS value is abnormally high, or DIA is abnormally low, aresonance may be the cause. If the resonance can not be eliminated byadjusting the blood pressure filter, check the BP line and use a thick,short, and hard catheter.? When the main power is turned ON, the BP value will not be displayeduntil zero balance is performed. Make sure to perform the zerobalance.? Each time the blood pressure transducer or tubing is replaced, the zerobalance procedure is required to ensure accurate measurements.? 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 the position of the transducer has changed.? When measuring for a long period of time and there is a possibility ofmeasurement error due to change in ambient temperature, etc.? When the connector is connected / disconnected, or transducer isreplaced.? If the mean BP display is set to OFF, the mean BP alarm will not begenerated. Also, the mean BP will not be displayed on the tabulartrend. Be cautious when setting the mean BP display OFF.? CO2 Monitoring? Perform calibration after 20 minutes when the main power of theDS-7100 system is turned ON.? Do not disconnect the sampling tube during calibration.If disconnected, calibration will cease.? 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 degradedcompared with other measuring device.? When the patient monitor was not used for a while, or when EtCO2was not measured for a while.? CO2 monitoring will cease when the ventilation connector is covered.? Use only the specified sampling tube for CO2 monitoring.? Alarm? A faint sound will be generated when setting a minimum volume for thealarm sound, but be cautious not to miss any alarm. Adjust the volumeto a recognizable level.? Alarm messages will be displayed according to the priority. (Level 1 →Level 2 → Level 3 → Level 4)? For the same alarm level, the alarm message for the newer alarm will bedisplayed.? The alarm message for the arrhythmia alarm will continue to bedisplayed for 30 seconds after the alarm is resolved.
xviCAUTION? While the “LEAD OFF” message is displayed, HR alarm and arrhythmiaalarm will not function. Leaving this condition unresolved may result inmissing a sudden change of the patient. Promptly check the electrodeswhen this message is displayed.? If the alarm with the higher priority occurs during alarm recording, therecording in process will be ceased and starts the alarm recording withthe higher priority.? Whether to use the SEC alarm function and its threshold selection shouldbe based on the patient’s clinical indication portent and medicalevaluation.? If the SpO2 alarm and SEC alarm setup is set to OFF, the SEC alarmintegral value will be set to 0.? System Configuration? When performing telemetry transmission, the numeric datacorresponding to the waveform should be selected for display.Otherwise, the displayed waveform or numeric data may not betransmitted.? If the time/date is not correctly set, or changed during monitoring,erroneous condition may occur to NIBP measurement, periodicrecording, trend and NIBP list data.? If the time/date is changed during monitoring, patient’s age will not berecalculated.? When connected to a wired network, the same time/date with the centralmonitor will be set.? The alarm ON/OFF setup will remain effective even when the power isturned OFF. Be cautious not to miss any important alarm by leaving thealarm silenced.? When performing telemetry transmission, the numeric datacorresponding to the waveform should be selected for display.Otherwise, the displayed waveform or numeric data may not betransmitted.? The setup of channel ID and group ID should be performed only by ourservice representative. Users should not perform this procedure asmalfunction to the equipment may occur.? The Bed ID is factory set to 000. If connected to the wired network withthe ID unchanged, monitoring on the central monitor will not be possible.? When connecting to the wired network, verify that the Bed ID does notduplicate with other bedside monitors. Otherwise, monitoring on thecentral monitor for both bedside monitors will not be possible.? To connect to the wired network, set the Bed ID in the range from 001 to048.? There are following restrictions when connecting the DS-7100 system tothe DS-LANⅡnetwork.? The DS-7100 system is not corresponded to the AU-5500N 8-channel recorder. The data for the DS-7100 system can not berecorded on the AU-5500N.? When the measurement unit of BP is kPa, BP waveform, BP numericdata, NIBP numeric data, NIBP list will not be transmitted. Thesewill be treated as not measured data, and will not be displayed on thecentral monitor. Also, alarm limit setup on the central monitor cannot be performed.? When the temperature unit is ?F, the temperature data will not betransmitted. It will be treated as not measured data, and will not bedisplayed on the central monitor. Also, alarm limit setup on thecentral monitor can not be performed.? Arrhythmia alarm of TACHY, BRADY, SLOW_VT, COUPLET,PAUSE will not be transmitted.? For numeric data displayed as “×××”, maximum or minimum valueof measurable range will be transmitted.? The numeric data displayed as “−−−” will be treated as notmeasured data.? For QRS classification, the “S” printed on the built-in recorder will beprinted as “N” on the HR-500 Recorder.
xviiCAUTION? When DS-5800N/NX/NXMB is used as a central monitor, recall,graphic trend, tabular trend, and ST measurement function will notbe displayed.? When DS-5700 is used as a central monitor, ST measurement functionwill not be displayed? A delay will occur for the communication with the central monitor. Thedelay is about 1.5 seconds for the waveform, about 1.5~4.0 seconds forthe numeric data, and about 1.5~2.0 seconds for the alarm.? When waveform and numeric data display is set to OFF, the alarmgeneration and tabular/graphic trend will be also set to OFF.? Patient Admit / Discharge? If you start monitoring a new patient without performing a dischargeprocedure for the previous patient, new data will be added to theprevious data which will result in inaccuracy.? The setup for the alarm mode and display mode remains stored evenwhen the power is turned off or when discharging procedure isperformed. Before monitoring, make sure the current monitoring modeis suitable for the patient’s condition.? Resuming monitoring will resume the alarm in suspension.? Arrhythmia Analysis? For proper arrhythmia detection and ECG monitoring, verify properelectrode placement, lead selection, and ECG waveform size. Ifnecessary, turn ON the AC filter. Improper electrode placement, leadselection, and ECG waveform size can cause errors in detection.? IC Card? Use only the specified IC card.? Restart the system after reading the setup data from the IC card.The setup data will become effective after the system is restarted.? Maintenance? Always operate the touch screen with fingers or touch screen pen. Donot touch with a pen-point or other hard-edged instruments.Malfunction of the touch screen or damage may result.? Do not clean the touch panel using strong acid? A special coating is applied to the surface of the touch panel. Wipe thesurface with the soft cleaning cloth provided as optional accessory orwith commercially available eyeglass cleaning cloth.? Clean the equipment frequently so stains can be removed easily.? To prevent injury, it is recommended to wear gloves when cleaning theequipment.? Do not allow liquids such as alcohol or cleaning solution enter themonitor or connectors.? Do not use organic solvents, thinner, toluene and benzene to avoiddamaging the resin case.? Do not polish the housing with abrasive or chemical cleaner.? When sterilizing the entire room using a spray solution, pay closeattention not to have liquids get into the monitor or connectors.? Use only neutral detergent to clean the housing. Do not use chemicalcloth, scrub brush, abrasive, polishing powder, hot water, volatile solventand chemicals (cleanser, thinner, toluene, benzine, benzol, and syntheticdetergent for house and furniture), or sharp-edged tools. The surfaceresin coating may be damaged, resulting in discoloration, scratches, andother problems.? Do not open the housing.? Replace the components periodically as specified.
xviiiPrecautions for Use of SpO2 SensorDANGERBurn Risk in Using SpO2 SensorIn SpO2 monitoring, always use the sensor/relay cable specified by FukudaDenshi. If any other sensor/relay cable is used, a high temperature rise ofthe sensor may place the patient in danger of burns.If there are any questions regarding the sensor/relay cable use for SpO2measurements of this device, please contact Fukuda Denshi servicerepresentative.Precautions for Use of NIBP CuffCAUTION This product contains natural rubber latex which may cause allergic reactions.Disposing of Equipment, Accessories, or ComponentsCAUTION When disposing of the equipment, accessories, or components, use anindustrial waste distributor. Do not dispose of as ordinary waste.Precautions about TransportationFor transporting the DS-7100 system, pack with specified packing materials.ReferenceRefer to “11. Technical Information Specification / Performance” for environmental conditionduring transportation.Precautions about RTC or Data BackupCAUTION? The DS-7100 system is equipped with a built-in clock. When the power ofthe DS-7100 system is turned off, this clock is backed up by a lithium primarybattery.If incorrect time is displayed when turning on the power, a low battery may bethe cause. In such case, contact Fukuda Denshi service representative forreplacing the battery.? To protect the data during voltage dip, short interruptions and voltagevariations on power supply input lines or during short duration of powerturned OFF, this monitor performs 5-minute (approx.) data backup using thesecondary battery. The data may not be protected if the power is turned offwithin 30 minutes from power on.
xixPrecautions for Use of Lithium-Ion Battery PackDANGER? This battery pack is intended for exclusive use with the DS-7100 system (orother specified equipment). Do not use with other equipment. If chargedon unspecified equipment, the performance and life cycle of the batterypack deteriorates or abnormal current flows causing damage, leakage,heating, fuming, explosion, ignition of the battery.? Do not disassemble or remodel the equipment. If the security apparatusor protector inside the battery gets damaged, it may cause heating, fuming,explosion, ignition of the battery.? Do not use the battery if leaked or transformed. If the security apparatusinside the battery is damaged, it may cause heating, fuming, explosion,ignition of the battery.? When installing the battery to the monitor, verify the polarity direction iscorrect. If not, it may cause leakage, heating, fuming, explosion, ignition.? If the leaked solution of the battery gets into the eyes, do not rub the eyes.Wash thoroughly with clean water and immediately receive medicaltreatment from the doctor. If not treated soon, it may cause serious injury.WARNING? If the leaked solution of the battery gets on to the skin or clothes,immediately wash down with rinse water. If not treated soon, it may causeserious injury.? If charging does not complete within the specified charging time, removethe battery and disconnect the power supply cable from the outlet.Otherwise, it may result in leakage or heating of the battery.? Do not throw into fire or heat the battery. The insulator may melt, gasexhaust vent or security apparatus may get damaged, or electrolyte mayignite causing heating, fuming, explosion, ignition of the battery.? Do not connect the (+) and (--) terminals of the battery with a wire or anyother metal. Also, do not carry or store the battery with any metal such asnecklace, hairpins, etc. The battery may short causing excessive currentflow which may result in heating, fuming, explosion, ignition of the battery orheating of the metal (wire, necklace, hairpin, etc.)? Do not solder the battery directly. The heat may melt the insulator ordamage the security apparatus which may result in heating, fuming,explosion, ignition of the battery.? Do not put the battery in microwave oven or a pressure cooker.If heated suddenly or if sealed condition breaks, it may result in leakage,heating, fuming, explosion, ignition of the battery.? Do not drive a nail in, hit with a hammer, or step on the battery. Thebattery may explode and transform causing a short out which may result inheating, fuming, explosion, ignition of the battery.? Do not apply strong impact or throw the battery. This may result inleakage, heating, fuming, breakage, ignition of the battery. Also, if thesecurity apparatus incorporated in the battery gets damaged, the batterycharges with abnormal current and voltage which results in leakage,heating, fuming, explosion, or ignition.? Do not get the battery wet with water, sea water or chemicals. If thesecurity apparatus incorporated in the battery gets damaged, it may resultin heating, fuming, explosion, ignition of the battery.? Do not connect the battery directly to power outlet or cigarette heatersocket in a car. A high voltage application will cause excessive currentflow and abnormal chemical reaction inside the battery causing abnormalcurrent flow during discharging. This may result in heating, fuming,explosion, ignition of the battery.? Do not use or leave the battery in a high temperature (80 ?C or over) suchas near the fire or heater. If the resin separator gets damaged by heat,the battery shorts causing heating, fuming, explosion, ignition.? If the battery is leaking or generating an abnormal odor, immediatelyremove the battery away from the fire. The leaked electrolyte may causeheating, fuming, explosion, ignition.
xxCAUTION? Do not peel off or scratch the exterior tubing.? Do not use or leave the battery in high temperature. It may result inleakage or deterioration of the performance / life cycle of the battery.? Immediately stop using the battery if any abnormality is found during use.? Do not use / store the battery in reach of infants.? If the monitor is expected not to be used for a long time, turn off the powerand unplug the power cable from the outlet. Otherwise it may result inbattery leakage.NOTE Users should not attempt to install or replace the battery pack.For installation and replacement of the battery pack, contact our servicerepresentative.To Prepare for Emergency Use1.Battery Pack(1) The battery self-discharges even when not in use. If there is any possibility to use thebattery in emergency, the power cable should be always connected to the power receptacle.To fully charge the empty battery, it takes approximately 2.5 hours when the monitor is notoperating, and approximately 13 hours when the monitor is operating.ReferenceRefer to “2. Basic Operation To Use with the Battery Pack”(2) The performance of the battery deteriorates with the repeated use. To maintain the initialperformance, replace the battery at least once a year. It is recommended to indicate thestart usage date on the battery so that replacing date can be easily recognized.2. Accessories / Optional Accessories(1) The ECG electrodes are consumables. Always prepare extra supplies of electrodes.(2) Check if any wire break on the patient cables once a week.
xxiElectromagnetic CompatibilityThe performance of this device under electromagnetic environment complies with IEC60601-1-2(1993).Precautions for Safe Operation under Electromagnetic InfluenceCAUTIONIf any sorts of electromagnetic wave, magnetic field, or static electricity existaround the device, noise interference or malfunction of the device may occur.If any unintended malfunction or noise occurs during monitoring, check themagnetic influence and take appropriate countermeasures.The following are examples of the common cause and countermeasures.? Cellular PhoneThe radio wave may cause malfunction to the device.Cellular phones and radio sets should be turned off in the room (building)where medical device is located.? Static ElectricityIn a dry environment (room), static electricity is likely to occur. Take thefollowing countermeasures.? Both operator and patient should remove any static electricity beforeentering the room.? Humidify the room.? Lightning? A lightning nearby may induce excessive voltage to the equipment. If anydanger is suspected, use the uninterruptible power supply system.? High frequency noise interference from other device through the power outlet? Check where the noise is originated and remove it using filtering device,etc.? Stop using the device that is originating the noise.? Use other power outlet.EMC GuidanceThis equipment complies with IEC60601-1-2 (1993). However, if portable transmitter or wireless LANequipment is used extremely nearby, the electromagnetic influence may largely exceed the compliancelevel and may cause unexpected phenomenon such as noise interference on the waveform, etc.Therefore, this equipment should be used in a location specified by each medical institution.If any unexpected noise interference on the waveform or failure to the peripheral device occurs, stopusing the equipment and follow the instruction of the technician.The following is the information relating to EMC (Electromagnetic Compatibility).(When using this equipment, verify that it is used within the environment specified below.)
xxii●Compliance to the Electromagnetic EmissionsThe DS-7100 system is intended for use in the electromagnetic environment specified below.Emissions Test Compliance Electromagnetic Environment - GuidanceRF EmissionsCISPR 11 Group 1The equipment uses RF energy that is necessary for the internalfunctioning of the equipment itself. Therefore, its RF emissionsare very low and are not likely to cause any interference in nearbyelectronic equipment.RF EmissionsCISPR 11 Class AThis equipment is suitable for use in all establishments other thandomestic and those directly connected to a low-voltage powersupply network which supplies buildings used for domesticpurposes.●Compliance to the Electromagnetic Immunity (1)The DS-7100 system is intended for use in the electromagnetic environment specified below. Itshould be assured that the DS-7100 system is used in such an environment.Immunity Test IEC60601-1-2Test Level Compliance Level Electromagnetic Environment -GuidanceElectrostaticDischarge (ESD)IEC61000-4-2?3kV contact?8kV air?3kV contact?8kV airFloors should be wood, concreteor ceramic tile. If floors arecovered with synthetic material,the relative humidity should be atleast 30%.Electrical fasttransient / burstIEC61000-4-4?1kV for power supplylines?0.5kV for input/outputlines?1kV for power supplylines?0.5kV input/outputlinesPower supply quality should be atlevels characteristic of a typicallocation in a typical commercial orhospital environment.SurgeIEC61000-4-5?2kV:line to ground?1kV:line to line?2kV:line to ground?1kV:line to linePower supply quality should be atlevels characteristic of a typicallocation in a typical commercial orhospital environment.
xxiii●Compliance to the Electromagnetic Immunity (2)The DS-7100 system is intended for use in the electromagnetic environment specified below. Itshould be assured that the DS-7100 system is used in such an environment.Immunity Test IEC60601-1-2Test Level Compliance Level Electromagnetic Environment -GuidanceRadiated RFIEC61000-4-3 3V/m26MHz ∼ 1.0GHz 3V/m Recommended Separation Distanced = 1.2 Pd = 1.2 P 80MHz∼800MHzd = 2.3 P 800MHz∼2.5GHzWhere P is the maximum outputpower rating of the transmitter in watts(W) according to the transmittermanufacturer and d is therecommended separation distance inmeters (m).Field strengths from fixed RFtransmitters, as determined by anelectromagnetic site survey, should beless than the compliance level in eachfrequency range.Interference may occur in the vicinityof equipment marked with thefollowing symbol:Note 1 :At 80Mhz and 800MHz, the higher frequency range applies.Note 2 :These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephonesand land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can not bepredicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RFtransmitters, an electromagnetic site survey should be considered. If the measured field strengthin the location in which this monitor should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as reorienting or relocatingthis monitor.bOver the frequency range 150MHz to 80MHz, field strength should be less than 3V/m.
xxiv●Recommended Separation Distances between Portable and Mobile RFCommunications Equipment and the DS-7100 SystemThe DS-7100 system is intended for use in an environment in which radiated RF disturbances arecontrolled. The electromagnetic interference can be prevented by maintaining a minimum distancebetween portable and mobile RF communications equipment (transmitters) and the DS-7100 system asrecommended below, according to the maximum output power of the communications equipment.Separation Distance according to Frequency of Transmitter (m)Rated MaximumOutput Power ofTransmitter（W）26MHz ∼ 80MHzd = 1.2 P80MHz ∼ 800MHzd = 1.2 P800MHz ∼ 1GHzd = 2.3 P0.01 0.12 0.12 0.230.1 0.38 0.38 0.7311.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separationdistance d in meters (m) can be determined using the equation applicable to the frequency of thetransmitter, where P is the maximum output power rating of the transmitter in watts (W) according to thetransmitter manufacturer.Note 1 :At 80MHz and 800MHz, the separation distance for the higher frequency range applies.Note 2 :These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.
xxvWARNINGFCC Radiation Exposure Statement:This equipment with a built-in telemeter complies with FCCradiation exposure limits set forth for an uncontrolledenvironment. This equipment should be installed andoperated with minimum distance 20cm between the radiatorand your body (excluding extremities: hands, wrists, and feet)and must not be co-located or operated with any other antennaor transmitter.WARNINGOperation of this equipment requires the prior coordination witha frequency coordinator designated by the FCC for theWireless Medical Telemetry Service.CAUTIONFEDERAL LAW RESTRICTS THIS DEVICE TO SALEBY OR ON THE ORDER OF A PHYSICIAN.
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xxviiContentsPreface1. General Description Describes the outline of this equipment.12. Basic Operation Describes the basic operation for monitoring.23. Vital Application Describes the procedure for vital application, etc.34. Monitoring Setup Describes the procedures to set the monitoraccording to the monitoring purpose.45. Admit / Discharge of a Patient Describes the procedure to admit or discharge apatient.56. Parameter Setup Describes the procedure to set the measurementcondition, size, scale, etc. for each parameter.67. Function Describes about the functions such as arrhythmiaanalysis, trend, recall, etc.78. System Configuration Describes about the system configuration such asnight mode, alarm mode, display mode, etc.89. Installation Describes about the environment for use,wireless system, etc.910. Maintenance Describes about the maintenance,troubleshooting of this equipment.1011. Technical Information Lists the specification, default settings, pinassignments of external connector, etc.1112. Accessories Lists the accessories and optional accessories forthis equipment.12
xxviiiPrefaceSafety Precautions･･････････････････････････････････iiLabels Attached to the Unit ･･･････････････････････iiMeasurement Unit for Each Parameter ････････････ ivGraphic Symbols ･･･････････････････････････････ vPrecautions for Safe Operation of Medical ElectricalEquipment･････････････････････････････････････ viPrecautions for Safe Operation of Medical Telemetry(DS-7141, DS-7101) ････････････････････････････viiPrecautions about the Maintenance ･･････････････ viiiPrecautions about the Pacemaker ････････････････ ixNon-Explosion Proof ････････････････････････････ ixDefibrillation Safety ･････････････････････････････ ixElectrosurgery Safety ･･･････････････････････････ xPrecautions about Magnetic Resonance Imaging････ xPrecautions about Connections to Peripheral Devices xiPrecautions about the Fuse ･･････････････････････ xiAccessories and Optional Accessories･････････････ xiPrecautions about the DS-7100 System ･･･････････xiiPrecautions for Use of SpO2 Sensor･････････････ xviiiPrecautions for Use of NIBP Cuff ･･･････････････ xviiiDisposing of Equipment, Accessories, or Components････････････････････････････････････････････ xviiiPrecautions about Transportation ･･･････････････ xviiiPrecautions about RTC or Data Backup ･･････････xviiPrecautions for Use of Lithium-Ion Battery Pack･･･xviiiiTo Prepare for Emergency Use･･････････････････ xxElectromagnetic Compatibility ･･････････････････････ xxiPrecautions for Safe Operation under ElectromagneticInfluence ･････････････････････････････････････ xxiEMC Guidance････････････････････････････････ xxi●Compliance to the Electromagnetic Emissions xxi●Compliance to the Electromagnetic Immunity (1)･･････････････････････････････････････････xxii●Compliance to the Electromagnetic Immunity (2)･････････････････････････････････････････ xxiii●Recommended Separation Distances betweenPortable and Mobile RF Communications Equipmentand the DS-7100 System ･･･････････････････ xxivChapter 1 General DescriptionGeneral Description ････････････････････････････････2Features ･･･････････････････････････････････････3Names of Parts and Their Functions ･･････････････････4【Front Side】･･･････････････････････････････4【Rear Side】･･･････････････････････････････4【Right Side】･･･････････････････････････････5【Left Side】････････････････････････････････5
xxixChapter 2 Basic Operation− Before Use − Basic Operation for Monitoring･･ 2Touch Keys････････････････････････････････････ 2●General Key Control ･･･････････････････････ 2●Key Control for Each Parameter ･････････････ 2− Before Use − About the Home Display ･･･････ 3About the Home Display･････････････････････････ 3The Description of the Display････････････････････ 4●Numeric Data, Waveform, Patient Name, etc.･･ 4●Alarm Message for Numeric Data / Arrhythmia･4●Equipment Status Alarm Message ･･･････････ 5●Other Bed Alarm Message･･････････････････ 5To Return the Display ･･･････････････････････････ 6− Preparation for Monitoring −To Turn On the Power･･･････････････････････････ 7Connecting the Power Cable ･････････････････････ 7To Turn On the Power Switch ････････････････････ 8To Use with the Battery Pack･････････････････････ 9− To Start Monitoring −･････････････････････････ 10Discharge Confirmation at Power ON･････････････ 10To Admit a Patient ･････････････････････････････ 10− Basic Operation −････････････････････････････ 12Scale, Lead, Baseline Position Setup(Parameter Key)･･･････････････････････････････ 12Scale, Lead, Baseline Position Setup (User Key)･･･ 14Alarm Setup for Each Parameter･････････････････ 15ON/OFF of Parameter DisplayWaveform/Numeric Data Display ････････････････ 16Recording ････････････････････････････････････ 17●Start / Stop of Waveform Recording ･････････ 17To Install the Paper ････････････････････････････ 18To Suspend Monitoring･････････････････････････ 19Discharging Procedure ･････････････････････････ 20− Operation Flow −･････････････････････････････ 21Chapter 3 Vital Application− To Acquire ECG Waveform −････････････････････2Before Attaching the Electrodes ･･･････････････････2Electrode Placement･････････････････････････････3Connection to the Patient Monitor･･････････････････4About the Arrhythmia Analysis ････････････････････5●QRS Classification ･････････････････････････5●Arrhythmia Type ･･･････････････････････････5Filter Selection･･････････････････････････････････6●Filter Mode Setup ･･････････････････････････6●Procedure for Filter Mode Selection･･･････････7●AC Filter ･･････････････････････････････････7Lead Cable Types･･･････････････････････････････7− Respiration (Impedance Measurement) −･･････････8− To Measure the SpO2 −･････････････････････････9●Functional and Fractional Saturation ････････ 12●Measured Versus Calculated Saturation ･････ 12− To Measure the NIBP−････････････････････････ 13Procedure for Periodic Measurement･････････････ 15− To Measure the BP −･････････････････････････ 16−To Measure the CO2 Concentration −(DS-7141) ･･･ 20Patient Application and Display･･････････････････ 20Procedure for Calibration (Every 6 Months) ･･･････ 21− To Measure the Temperature −････････････････ 23
xxxChapter 4 Monitoring Setup− Display Configuration − For Easier View･･････････ 2To Configure the Display ････････････････････････ 2●To Enlarge the Numeric Data ･･･････････････ 2●To Configure the Display ･･･････････････････ 3●To Display the Short Trend ･････････････････ 5Description of the Display････････････････････････ 6●ECG1, ECG2, BP, SpO2, Impedance RESP,CO2 Waveform Display･･･････････････････････ 6●HR, BP, VPC/ST, BP1, BP2, NIBP, SpO2, TEMP,RR, CO2 Numeric Display･････････････････････ 8●HR, BP, NIBP, SpO2, TEMP, RR, CO2 EnlargedNumeric Data Display ･･･････････････････････ 10●HR, BP, NIBP, SpO2, TEMP, RR, CO2 AlarmLimit Display･･･････････････････････････････ 10●HR, BP, NIBP, SpO2, TEMP, RR, CO2 ShortTrend Display･･････････････････････････････ 11Parameter Key Frame Display･･･････････････････ 11Description of Alarm Message and Alarm Sound ･･･ 12●Vital Alarm Message ･･････････････････････ 12●Equipment Status Alarm Message ･･････････ 14●Lead-Off Message････････････････････････ 15− Key Setup −For Easier Use ････････････････････････････････ 16To Set the User Keys ･･････････････････････････ 17To Set the Menu Keys･･････････････････････････ 19− Recording Setup −To Record the Waveform and Numeric Data･･･････ 20Manual Recording ･････････････････････････････ 20●To Start / Stop the Recording ･･････････････ 20●To Set the Manual Recording ･･････････････ 20Periodic Recording ････････････････････････････ 21Alarm Recording ･･････････････････････････････ 22Freeze Recording ･････････････････････････････ 24Graphic Recording (Graphic/Tabular Trend, etc.)･･･ 25Recorder Operation (QRS Symbol, etc.) ･･････････ 26− Volume Setup −Pulse Tone, Alarm Sound, etc. ･･････････････････ 27− Color / Brightness Setup −･････････････････････ 28Color Setup (Numeric Data, Waveform)･･･････････ 28Brightness Setup ･･････････････････････････････ 29− Telemetry Setup −（DS-7141, DS-7101LT）･････ 30Transmitting Waveform Setup ･･･････････････････ 32− Wired Network Connection −(LAN Communication)･･････････････････････････ 33Room / Bed ID Setup ･･････････････････････････ 33− Alarm Pole Setup −Notifying the Alarm by Light ･････････････････････ 35Alarm Level Setup ･････････････････････････････ 35Alarm Pole Flash Pattern Setup ･････････････････ 38− Alarm Setup −To Set the Alarm Condition ･････････････････････ 39To Set the System Alarm ･･･････････････････････ 39To Turn ON the System Alarm･･･････････････････ 40To Suspend the System Alarm ･･････････････････ 40To Silence the System Alarm････････････････････ 40●Precautions about Silencing the Alarm･･･････ 40Alarm Setup for Each Parameter･････････････････ 41Arrhythmia Alarm Setup ････････････････････････ 43●To Set ON/OFF of Arrhythmia Alarm ････････ 44●To Set the Arrhythmia Detection Level･･･････ 44●Alarm Limit for TACHY, BRADY ････････････ 45SpO2 SEC Alarm Setup ････････････････････････ 45Alarm Suspend / Alarm Silence Time･････････････ 47ON / OFF of Alarm Limit Display･････････････････ 48
xxxiChapter 5 Admit / Discharge of a Patient− Admit / Discharge of a Patient−･･････････････････ 2− Admitting a Patient −Entering Name, Sex, and Age ･･･････････････ 3Patient Name ･･････････････････････････････････ 3Patient ID ･････････････････････････････････････ 4Patient Type ･･･････････････････････････････････ 4Patient Sex ････････････････････････････････････ 5Pacemaker Use ････････････････････････････････ 6●Pacemaker Use Selection ･･････････････････ 6●Impedance Respiration Measurement ････････ 6Patient Age ････････････････････････････････････ 7− Discharging a Patient −Erasing Name, Data, etc. ･･･････････････････ 8Discharging Procedure ･･････････････････････････ 8− Monitoring Mode Selection −Alarm and Display Mode････････････････････ 9Mode Selection ････････････････････････････････ 9●Display Modes ･･･････････････････････････ 11●Alarm Modes ････････････････････････････ 12− Suspend Monitoring −Suspend and Resume Monitoring･･･････････ 13To Suspend Monitoring･････････････････････････ 13To Resume Monitoring ･････････････････････････ 14− Room / Bed ID Setup −for LAN Communication ･･･････････････････ 15Room / Bed ID Setup ･･････････････････････････ 15Chapter 6 Parameter Setup− Parameter Setup −Setting the Monitoring Condition ･･･････････････2To Display the Parameter Setup Menu ･････････････2Zero Balance of All Pressure Lines (BP1, BP2) ･･････3− ECG −････････････････････････････････････････4ECG Waveform Size and Lead ････････････････････4HR Alarm ･･････････････････････････････････････6Arrhythmia Alarm････････････････････････････････6Filter Mode Selection ････････････････････････････7HR Average Selection ･･･････････････････････････8HR Synchronized Indicator(ON/OFF of HR Synchronized Tone) ･･･････････････8ECG Source････････････････････････････････････9Automatic Lead Switching ････････････････････････9Pacemaker Pulse ･････････････････････････････ 10QRS Pace Mask ･･････････････････････････････ 11ECG Drift Filter ･･･････････････････････････････ 12ON/OFF of Parameter Display ･･････････････････ 13− Respiration −････････････････････････････････ 14Respiration Waveform Size ･････････････････････ 14RR Alarm ････････････････････････････････････ 15Apnea Alarm ･････････････････････････････････ 15CVA Detection ････････････････････････････････ 16Respiration Source ････････････････････････････ 17Impedance Respiration Measurement ････････････ 17RR Synchronization Mark ･･････････････････････ 18ON/OFF of Parameter Display ･･････････････････ 19− Invasive Blood Pressure (BP1, BP2)−･･･････････ 20BP Scale (BP1, BP2) ･･････････････････････････ 20BP Alarm (BP1, BP2) ･･････････････････････････ 21Zero Balance of Pressure Lines (BP1, BP2)･･･････ 21Filter Selection (BP1, BP2) ･････････････････････ 22Mean BP Display (BP1, BP2) ･･･････････････････ 22ECG Source (BP1) ････････････････････････････ 23ON/OFF of Parameter Display ･･････････････････ 24− SpO2 −･････････････････････････････････････ 25SpO2 Waveform Size ･･････････････････････････ 26SpO2 Alarm･･･････････････････････････････････ 26ECG Source･･････････････････････････････････ 27SpO2 Alarm during NIBP Measurement(Ignore NIBP)･････････････････････････････････ 27ON/OFF of Parameter Display ･･････････････････ 28− Non-Invasive Blood Pressure −････････････････ 29NIBP Automatic Measurement ･･････････････････ 29NIBP 1-Minute Interval Measurement ････････････ 30Quick SYS Start･･･････････････････････････････ 31NIBP Alarm･･･････････････････････････････････ 31Quick SYS Measurement Duration･･･････････････ 32End of Measurement Tone ･････････････････････ 33Quick SYS List････････････････････････････････ 33PR Display ･･･････････････････････････････････ 34Mean BP Display･･････････････････････････････ 341-Minute Measurement Duration･････････････････ 35NIBP Speed ･･････････････････････････････････ 35− Temperature −･･･････････････････････････････ 36Temperature Alarm ････････････････････････････ 36ON/OFF of Parameter Display ･･････････････････ 37− CO2 Concentration − (DS-7141) ･･････････････ 38
xxxiiCO2 Scale ････････････････････････････････････ 38EtCO2 (End-Tidal CO2) Alarm ･･･････････････････ 38InspCO2 (Inspiratory CO2) Alarm ･････････････････ 39EtCO2 Average Duration････････････････････････ 40Measurement Unit ･････････････････････････････ 40CO2 Calibration ･･･････････････････････････････ 41Restarting the CO2 Unit･････････････････････････ 42ON/OFF of Parameter Display･･･････････････････ 42Chapter 7 Function− Arrhythmia Analysis −Definition, etc. ･･･････2Arrhythmia Definition･････････････････････････････2●QRS Classification ･････････････････････････2●Arrhythmia Type ･･･････････････････････････2To Set the Arrhythmia Alarm ･･････････････････････3To Perform Arrhythmia Learning･･･････････････････4− Graphic Trend Data−Display / Record ･･･････6To Display the Graphic Trend ･････････････････････6The Description of the Display･･･････････････････ 10− Tabular Trend −Display / Record ･･････････ 11To Display the Tabular Trend ･･･････････････････ 11The Description of the Display･･･････････････････ 12Parameter Setup for Tabular Trend ･･････････････ 13− Recall Data−Display / Record ･･････････････ 14To Display the Recall Menu･････････････････････ 14●Recall List Display････････････････････････ 14●To Display and Record the Enlarged RecallWaveform･････････････････････････････････ 15To Set the Recall Condition･････････････････････ 17− OCRG −Display ････････････････････････ 19− ST Display − ST Display, Alarm Setup, etc. ･20To Display the ST Measurement Menu ･･･････････ 20●To Set the Reference Waveform ･･･････････ 21●ST Alarm Setup ･･････････････････････････ 22− NIBP List −Display / Record･･･････････････ 23To Display the NIBP List ･･･････････････････････ 23The Description of the Display･･･････････････････ 24− Other Bed ―Display / Alarm････････････････ 25Other Bed Display･････････････････････････････ 25Other Bed Alarm Setup ････････････････････････ 26
xxxiiiChapter 8 System Configuration− Night Mode − Night Mode Monitoring ･･････････ 2About the Night Mode ･･･････････････････････････ 2To Set the Night Mode ･･････････････････････････ 4●To Start/Stop the Night Mode ･･･････････････ 4●Night Mode Display Setup ･･････････････････ 5− Alarm Mode Setup −Programming the Alarm Mode ･･････････････････ 6About the Alarm Mode ･･････････････････････････ 6To Program the Alarm Mode ･････････････････････ 7− Monitor Setup − Setup for Each Monitor ････ 8About the Monitor Setup･････････････････････････ 8●Battery Operation･･････････････････････････ 8●Message Icon･････････････････････････････ 8●Time/Date Setup ･･････････････････････････ 9●Password Setup･･･････････････････････････ 9●Program Version ･･････････････････････････ 9●Status Output Setup ･･･････････････････････ 9●Parameter Key Frame･････････････････････ 11●Wide AC Filter ･･･････････････････････････ 11●Check Discharge at Power ON ･････････････ 11●Backup at Discharge･･････････････････････ 12− Display Mode −Programming the Display Mode ･････････････････ 14About the Display Mode ････････････････････････ 14To Program the Display Mode ･･･････････････････ 15− Sweep Speed −Waveform Display Speed/Time17To Set the Sweep Speed ･･･････････････････････ 17− Hospital Setup − Setup for Each Hospital ･･ 18About the Hospital Setup ･･･････････････････････ 18●AC Filter ････････････････････････････････ 18●Date Format ･････････････････････････････ 18●Alarm Mute ･･････････････････････････････ 18●Telemetry Channel Setup(DS-7141, DS-7101LT) ････ 19●Measurement Unit Setup ･･････････････････ 19●Home Key Function･･･････････････････････ 19●Night Mode Cancel ･･･････････････････････ 19●Asystole, VF, VT ･････････････････････････ 20− Ward Setup −Setup for Each Ward ･････････ 21About the Ward Setup･･････････････････････････ 21●Trend Clip ･･･････････････････････････････ 21●BP Recording Scale ･･････････････････････ 21●Key Mask ･･･････････････････････････････ 22●User Key Setup ･･････････････････････････ 22●Alarm Pole Setup･････････････････････････ 23●NIBP Data Erase Time ････････････････････ 24●HR Lower Limit for VT･････････････････････ 24●Password ･･･････････････････････････････ 24●Monitoring Condition after Discharge ････････ 25●Event Key ･･･････････････････････････････ 25●MEAN Calculation (BP1, NIBP)･････････････ 25− IC Card − Data Transfer ･･････････････････ 26Data Transfer (DS-7100 → IC Card)･････････････ 26Data Transfer (IC Card → DS-7100)･････････････ 27IC Card Format ･･･････････････････････････････ 28Data for Transfer ･･････････････････････････････ 28Error Message ････････････････････････････････ 29Chapter 9 Installation− Precautions for Installing the Equipment −･････････2Precautions about the Operating Environment･･･････2− Telemetry System −････････････････････････････3Channel ID Setup ･･･････････････････････････････4− Wired Network System−･････････････････････････6Room / Bed ID Setup ････････････････････････････7
xxxivChapter 10 Maintenance− Handling − After Use / Display Panel ･･･････ 2Handling After Use･･････････････････････････････ 2Handling the Display Panel ･･････････････････････ 2− Storage −Device / Recording Paper･･････････ 3Storing the Device ･･････････････････････････････ 3Storing the Recording Paper ･････････････････････ 3− Cleaning −Display Panel and Housing ････････ 4Cleaning the Display Panel ･･････････････････････ 4Cleaning the Housing ･･･････････････････････････ 5Disinfecting the Blood Pressure Transducers ･･･････ 5Disinfecting the Temperature Probes ･･････････････ 5Disinfecting the CO2 Filter Line ･･･････････････････ 5Cleaning and Disinfecting the SpO2 Transducer･････ 5Cleaning and Disinfecting the NIBP Cuff ･･･････････ 5Cleaning and Disinfecting the ECG Lead Cable ･････ 5− Battery −Handling the Battery Pack ･････････ 6Handling the Battery ････････････････････････････ 6Storing the Battery･･････････････････････････････ 6− Maintenance Check −Daily and Periodic Check ････････････････････････ 7About the Maintenance Check････････････････････ 7●Daily Check ･･････････････････････････････ 7●Periodic Check････････････････････････････ 7Time-Change Components ･･････････････････････ 7− Troubleshooting −･････････････････････････････ 9ECG ･･････････････････････････････････････････ 9Respiration ･･･････････････････････････････････ 11Invasive Blood Pressure････････････････････････ 11SpO2････････････････････････････････････････ 12Non-Invasive Blood Pressure････････････････････ 13Temperature ･･････････････････････････････････ 14CO2 Concentration･････････････････････････････ 15Recorder ･････････････････････････････････････ 16Telemetry ････････････････････････････････････ 16General ･･････････････････････････････････････ 17Battery ･･･････････････････････････････････････ 18Chapter 11 Technical Information− Specification/Performance −･････････････････････2Specification････････････････････････････････････2Performance････････････････････････････････････3− Setup Item −Default and Backup･････････････5Patient Admit / Discharge･････････････････････････5Alarm Setup ････････････････････････････････････5Parameter Setup ････････････････････････････････6Review Function Setup･･･････････････････････････7System Configuration Setup ･･････････････････････8Display Mode Setup ･･･････････････････････････ 12Alarm Mode Setup ････････････････････････････ 13− External Connection −Pin Assignments ･･･ 14Serial Connector Output Signal･･････････････････ 14Status I/O Signal ･･････････････････････････････ 14
xxxvChapter 12 Accessories− Accessories −･････････････････････････････････ 2− Optional Accessories −･････････････････････････ 3ECG, Impedance Respiration Measurement････････ 3Invasive Blood Pressure Measurement ････････････ 3Non-Invasive Blood Pressure Measurement ････････ 3Temperature Measurement ･･････････････････････ 4SpO2 Measurement ･････････････････････････････ 4CO2 Concentration Measurement ･････････････････ 4Others ････････････････････････････････････････ 5
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1−1General DescriptionThis chapter explains the general description of this equipment.Chapter 1General Description ･････････････････････････････ 2Features ････････････････････････････････････ 3Names of Parts and Their Functions ･･･････････････ 4【Front Side】･･･････････････････････････････4【Rear Side】･･･････････････････････････････4【Right Side】･･･････････････････････････････5【Left Side】････････････････････････････････51General Description
1−2General DescriptionThe DS-7100 system utilizes 8.4-inch color LCD display for monitoring ECG, RESP, SpO2, BP,NIBP, TEMP measurements. Depending on the model type, CO2 measurement, telemetrytransmission, and Ethernet LAN connection are also possible.＜DS-7141＞FunctionModel Type BasicMeasurement CO2Measurement BP TelemetryTransmission EthernetLANDS-7141 ○ ○ 2 channels ○ ○DS-7101LT ○ × 2 channels ○ ○DS-7101L ○ × 2 channels × ○NOTEThe display illustration on this operation manual includes CO2measurement, but note that CO2 measurement function is not supportedfor the DS-7101L and DS-7101LT.DS-7141 is not currently available for sales in theUnited States.
1−3Features? Completely self-contained, the monitor includes display part, recording part, measuring part in acompact and lightweight package. A battery pack (optional) operation is also possible whichallows the monitor to be used as a portable monitor.? On the 8.4-inch color LCD display, up to 6 waveforms can be displayed. Also, the numericdata display can be enlarged for easier view.? The alarm pole provided as standard indicates the alarm by 9 flashing patterns corresponding tothe alarm level.? All the operations are performed through the touch screen controls, and up to 4 frequently usedkeys can be programmed as user key.? For the CO2 measurement, a microstream method is adopted which is less influenced by theanesthetic gas. (DS-7141)? Through the use of telemetry transmission unit, a wireless network formation is possible.(DS-7141,DS-7101LT)? Through the use of Ethernet LAN unit, a wired network formation is possible.(DS-7141,DS-7101LT,DS-7101L)? No cooling fan is used, ensuring clean and quiet monitoring.1General Description
1−4Names of Parts and Their Functions【Front Side】【Rear Side】NIBP Cuff ConnectorAir hose is connected here.SpO2 Input ConnectorSpO2 relay cable (DOC-10) isconnected here.ECG Input ConnectorECG relay cable is connected here.BP 2ch conversion Connector2ch BP conversion cable isconnected here.Temperature Input ConnectorTemperature probe is connected here.CO2 Connector（DS-7141）CO2 sampling tube or nasal prong is connected here.Paper MagazineRecording paper is installed here.Power Supply Connector(with fuse holder)Power cable is connected here.(Fuse is installed in the holder.)Equipotential Ground TerminalEquipotential ground terminal isconnected here.HandleHold this part when carrying.Battery Pack HolderBattery is installed here.※We recommend the battery to bereplaced annually.Power Supply LampIndicates the main power supply.Alarm PoleLights when the alarm generates.Charge LampIndicates the charge status.Orange: Charging in processGreen: Charging completeAmbient Light SensorDetects the ambient light.Magazine Release ButtonPressing this button will release themagazine.Exhaust Connector (DS-7141)Connects the gas exhaustingdevice and exhausts sampling gas.
1−5【Right Side】【Left Side】WARNINGDo not connect unit or cable not authorized by Fukuda Denshi to any I/Oconnector. If done so by mistake, the device can not deliver its maximumperformance and the connected units may be damaged, resulting in asafety hazard.NOTEThe display panel utilizes exclusive fluorescent light for the backlight.Since this fluorescent light deteriorates by the life cycle, the display maybecome dark, scintillate, or may not light by the long term use. In suchcase, contact your nearest service representative.PC Card Access LampIndicates the PC card access status.PC Card SlotInsert only the specified PC card here.Serial ConnectorConnect only the specified device here.Status Input ConnectorConnect only the specified device here.SpeakerGenerates synchronous sound, key sound, alarmsound.Power Supply SwitchTurns the monitor power ON or OFF.LAN ConnectorBranch cable (CJ-522) is connected here forwired network.1Names of Parts and Their FunctionSide Cover (for maintenance)Do not open this cover. This cover is formaintenance only, which is to be performed byour service representative.
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