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Preface
Thank you for purchasing this product.
Before using this product, read the following precautions to make sure the product is
used correctly and safely.
Safety Precautions ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ii
Labels Attached to the Unit ・・・・・・・・・・・・・・・・・・・・・・・ ii
Measurement Unit for Each Parameter ・・・・・・・・・・・・ iv
Graphic Symbols ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ v
Equipment ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ vi
(DS-7141, DS-7101LT)・・・・・・・・・・・・・・・・・・・・・・・・・・ vii
Precautions about the Maintenance ・・・・・・・・・・・・・・ viii
Precautions about the Pacemaker ・・・・・・・・・・・・・・・・ ix
Non-Explosion Proof ・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ix
Defibrillation Safety ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ix
Electrosurgery Safety ・・・・・・・・・・・・・・・・・・・・・・・・・・・・ x
Precautions about the Fuse ・・・・・・・・・・・・・・・・・・・・・・ xi
Accessories and Optional Accessories ・・・・・・・・・・・・ xi
Precautions about the DS-7100 System ・・・・・・・・・・・ xii
Precautions for Use of NIBP Cuff ・・・・・・・・・・・・・・・ xviii
Precautions about Transportation・・・・・・・・・・・・・・・ xviii
Precautions about RTC or Data Backup ・・・・・・・・・ xviii
To Prepare for Emergency Use・・・・・・・・・・・・・・・・・・・ xx
Electromagnetic Compatibility ・・・・・・・・・・・・・・・・・・・・・・ xxi
Influence ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ xxi
EMC Guidance ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ xxi
●Compliance to the Electromagnetic Emissions xxii
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ xxii
●Compliance to the Electromagnetic Immunity (2)
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ xxiii
and the DS-7100 System・・・・・・・・・・・・・・・・・・・ xxiv
Sensor ・・・・・・・・・・・・ xviii
2
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Summary of Contents for Fukuda Denshi Dynascope 7100

  • Page 1: Table Of Contents

    Preface Thank you for purchasing this product. Before using this product, read the following precautions to make sure the product is used correctly and safely. Safety Precautions ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ii Labels Attached to the Unit ・・・・・・・・・・・・・・・・・・・・・・・ ii Measurement Unit for Each Parameter ・・・・・・・・・・・・ iv Graphic Symbols ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・...
  • Page 2: Safety Precautions

    Safety 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. 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.
  • Page 3 DS-7100 System DANGER Risk of explosion if used in the presence of flammable anesthetics. CAUTION Before connecting, read instruction manual. CAUTION To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel. DANGER ? Use only the batteries specified for this device.
  • Page 4: Measurement Unit For Each Parameter

    Measurement Unit for Each Parameter The measurement units for this equipment are as follows. Detail Parameter Display Unit Default (beats per minute) Heart Rate/Pulse Invasive Blood PR_BP Pressure Rate *1 (beats per minute) PR_SpO (beats per minute) ST Level mm, mv beats / hour Impedance RR_IMP...
  • Page 5: Graphic Symbols

    Graphic Symbols The following symbols are used for this equipment. DS-7100 System: Main Unit Symbol Description Caution; refer to accompanying documents Indicates the need to refer to related accompanying documents before operation. Equipotential Terminal Indicates the terminal to equalize the potential difference when interconnecting the devices.
  • Page 6: Precautions For Safe Operation Of Medical Electrical Equipment

    ? 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 attempt service. Label the unit “OUT OF ORDER” and contact Fukuda Denshi. ? Do not remodel the equipment.
  • Page 7: Precautions For Safe Operation Of Medical Telemetry (Ds-7141, Ds-7101Lt)

    ? When interference or breakdown occurs in telemetry communication, the user is required to inform the zone manager and the overall manager of the problems. The zone manager and overall manager are to deal with the problem properly and/or contact their nearest Fukuda Denshi representative for service.
  • Page 8: Precautions About The Maintenance

    Maintenance, Modifications, and Repairs Fukuda Denshi is liable for the safety, reliability, and performance of its equipment only if; ? Maintenance, modifications, and repairs are carried out by authorized personnel.
  • Page 9: Precautions About The Pacemaker

    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 W A R N I N G professionals, or your pacemaker distributors.) Reference “Minute Ventilation Rate-Adaptive Pacemakers”...
  • Page 10: Electrosurgery Safety

    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.
  • Page 11: Precautions About Connections To Peripheral Devices

    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.
  • Page 12: Precautions About The Ds-7100 System

    Pay special attention when channel ID at the bedside monitor is changed. ? Do not connect unit or cable not authorized by Fukuda Denshi to any I/O connector. If done so by mistake, the DS-7100 system can not deliver its maximum performance and the connected units may be damaged, resulting in a safety hazard.
  • Page 13 Otherwise, the monitor may fall off the trolley, resulting in injury or damage to the monitor. ? Use the trolley only with the equipment specified by Fukuda Denshi. Otherwise, the monitor and trolley may fall down, resulting in injury or damage to the monitor.
  • Page 14 ? The threshold level for arrhythmia detection changes with ECG waveform size. Set a proper waveform size for monitoring. When the waveform size is ? 1/4, ? 1/2, or ? 1, the detection threshold is 250 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.
  • Page 15 ? For the following situation, measurements will be terminated. When the measurement time has exceeded 120 seconds for adult, 90 seconds for child, 60 seconds for neonate. When the inflation value has exceeded 300mmHg for adult, 200mmHg for child, 150mmHg for neonate. ? If used with the incorrect patient type, it will not only cause erroneous measurement, but the inflating level for the adult may be applied to child or neonate causing dangerous situation to the patient.
  • Page 16 ? While the “LEAD OFF” message is displayed, HR alarm and arrhythmia alarm will not function. Leaving this condition unresolved may result in missing a sudden change of the patient. Promptly check the electrodes when this message is displayed. ? If the alarm with the higher priority occurs during alarm recording, the recording in process will be ceased and starts the alarm recording with the higher priority.
  • Page 17 ? When DS-5800N/NX/NX is used as a central monitor, recall, graphic trend, tabular trend, and ST measurement function will not be displayed. ? When DS-5700 is used as a central monitor, ST measurement function will not be displayed ? A delay will occur for the communication with the central monitor. The delay is about 1.5 seconds for the waveform, about 1.5~4.0 seconds for the numeric data, and about 1.5~2.0 seconds for the alarm.
  • Page 18: Precautions For Use Of Spo Sensor

    DS-7100 system is turned off, this clock is backed up by a lithium primary battery. If incorrect time is displayed when turning on the power, a low battery may be the cause. In such case, contact Fukuda Denshi service representative for C A U T I O N replacing the battery.
  • Page 19: Precautions For Use Of Lithium-Ion Battery Pack

    Precautions for Use of Lithium-Ion Battery Pack ? This battery pack is intended for exclusive use with the DS-7100 system (or other specified equipment). Do not use with other equipment. If charged on unspecified equipment, the performance and life cycle of the battery pack deteriorates or abnormal current flows causing damage, leakage, heating, fuming, explosion, ignition of the battery.
  • Page 20: To Prepare For Emergency Use

    ? Do not peel off or scratch the exterior tubing. ? Do not use or leave the battery in high temperature. It may result in leakage or deterioration of the performance / life cycle of the battery. ? Immediately stop using the battery if any abnormality is found during use. C A U T I O N ? Do not use / store the battery in reach of infants.
  • Page 21: Electromagnetic Compatibility

    Electromagnetic Compatibility The performance of this device under electromagnetic environment complies with IEC60601-1-2 (1993). Precautions for Safe Operation under Electromagnetic Influence If any sorts of electromagnetic wave, magnetic field, or static electricity exist around the device, noise interference or malfunction of the device may occur. If any unintended malfunction or noise occurs during monitoring, check the magnetic influence and take appropriate countermeasures.
  • Page 22 ●Compliance to the Electromagnetic Emissions The DS-7100 system is intended for use in the electromagnetic environment specified below. Emissions Test Compliance Electromagnetic Environment - Guidance The equipment uses RF energy that is necessary for the internal RF Emissions functioning of the equipment itself. Therefore, its RF emissions Group 1 are very low and are not likely to cause any interference in nearby CISPR 11...
  • Page 23: Compliance To The Electromagnetic Immunity

    ●Compliance to the Electromagnetic Immunity (2) The DS-7100 system is intended for use in the electromagnetic environment specified below. It should be assured that the DS-7100 system is used in such an environment. IEC60601-1-2 Electromagnetic Environment - Immunity Test Compliance Level Test Level Guidance Radiated RF...
  • Page 24: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Ds-7100 System

    ●Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the DS-7100 System The DS-7100 system is intended for use in an environment in which radiated RF disturbances are controlled. The electromagnetic interference can be prevented by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DS-7100 system as recommended below, according to the maximum output power of the communications equipment.
  • Page 25 WARNING FCC Radiation Exposure Statement: This equipment with a built-in telemeter complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator and your body (excluding extremities: hands, wrists, and feet) and must not be co-located or operated with any other antenna or transmitter.
  • Page 26 Blank Page xxvi...
  • Page 27 Contents Preface 1. General Description Describes the outline of this equipment. 2. Basic Operation Describes the basic operation for monitoring. 3. Vital Application Describes the procedure for vital application, etc. Describes the procedures to set the monitor 4. Monitoring Setup according to the monitoring purpose.
  • Page 28: Preface

    Preface Chapter 1 General Description General Description ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・2 Safety Precautions・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ii Labels Attached to the Unit ・・・・・・・・・・・・・・・・・・・・・・・ii Features ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・3 Measurement Unit for Each Parameter ・・・・・・・・・・・・ iv Names of Parts and Their Functions ・・・・・・・・・・・・・・・・・・4 【Front Side】・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・4 Graphic Symbols ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ v 【Rear Side】 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・4 Precautions for Safe Operation of Medical Electrical 【Right Side】・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・5 Equipment・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・...
  • Page 29: Basic Operation

    Chapter 2 Basic Operation Chapter 3 Vital Application − Before Use − − To Acquire ECG Waveform − ・・・・・・・・・・・・・・・・・・・・2 Basic Operation for Monitoring・・ 2 Before Attaching the Electrodes ・・・・・・・・・・・・・・・・・・・2 Touch Keys・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2 ●General Key Control ・・・・・・・・・・・・・・・・・・・・・・・ 2 Electrode Placement・・・・・・・・・・・・・・・・・・・・・・・・・・・・・3 ●Key Control for Each Parameter ・・・・・・・・・・・・・ 2 Connection to the Patient Monitor・・・・・・・・・・・・・・・・・・4 −...
  • Page 30: Monitoring Setup

    Chapter 4 Monitoring Setup ●Alarm Limit for TACHY, BRADY ・・・・・・・・・・・・ 45 − Display Configuration − For Easier View・・・・・・・・・・ 2 SEC Alarm Setup ・・・・・・・・・・・・・・・・・・・・・・・・ 45 To Configure the Display ・・・・・・・・・・・・・・・・・・・・・・・・ 2 Alarm Suspend / Alarm Silence Time・・・・・・・・・・・・・ 47 ●To Enlarge the Numeric Data ・・・・・・・・・・・・・・・ 2 ON / OFF of Alarm Limit Display・・・・・・・・・・・・・・・・・...
  • Page 31: Admit / Discharge Of A Patient

    Chapter 5 Admit / Discharge of a Patient Chapter 6 Parameter Setup − Admit / Discharge of a Patient− ・・・・・・・・・・・・・・・・・・ 2 − Parameter Setup − Setting the Monitoring Condition ・・・・・・・・・・・・・・・2 − Admitting a Patient − To Display the Parameter Setup Menu ・・・・・・・・・・・・・2 Entering Name, Sex, and Age ・・・・・・・・・・・・・・・...
  • Page 32: Function

    Scale ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 38 Chapter 7 Function ) Alarm ・・・・・・・・・・・・・・・・・・・ 38 EtCO (End-Tidal CO − Arrhythmia Analysis − Definition, etc. ・・・・・・・2 ) Alarm ・・・・・・・・・・・・・・・・・ 39 InspCO (Inspiratory CO Average Duration ・・・・・・・・・・・・・・・・・・・・・・・・ 40 Arrhythmia Definition・・・・・・・・・・・・・・・・・・・・・・・・・・・・・2 EtCO ●QRS Classification ・・・・・・・・・・・・・・・・・・・・・・・・・2 Measurement Unit ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 40 ●Arrhythmia Type ・・・・・・・・・・・・・・・・・・・・・・・・・・・2 Calibration ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・...
  • Page 33: System Configuration

    Chapter 9 Installation Chapter 8 System Configuration − Precautions for Installing the Equipment − ・・・・・・・・・2 − Night Mode − Night Mode Monitoring ・・・・・・・・・・ 2 Precautions about the Operating Environment ・・・・・・・2 About the Night Mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2 − Telemetry System − ・・・・・・・・・・・・・・・・・・・・・・・・・・・・3 To Set the Night Mode ・・・・・・・・・・・・・・・・・・・・・・・・・・...
  • Page 34: Maintenance

    Chapter 10 Maintenance Chapter 11 Technical Information − Handling − After Use / Display Panel ・・・・・・・ 2 − Specification/Performance − ・・・・・・・・・・・・・・・・・・・・・2 Handling After Use・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2 Specification・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・2 Handling the Display Panel ・・・・・・・・・・・・・・・・・・・・・・ 2 Performance・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・3 − Storage − − Setup Item − Default and Backup ・・・・・・・・・・・・・5 Device / Recording Paper・・・・・・・・・・...
  • Page 35: Accessories

    Chapter 12 Accessories − Accessories −・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2 − Optional Accessories − ・・・・・・・・・・・・・・・・・・・・・・・・・ 3 ECG, Impedance Respiration Measurement ・・・・・・・・ 3 Invasive Blood Pressure Measurement ・・・・・・・・・・・・ 3 Non-Invasive Blood Pressure Measurement ・・・・・・・・ 3 Temperature Measurement ・・・・・・・・・・・・・・・・・・・・・・ 4 Measurement ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 4 Concentration Measurement ・・・・・・・・・・・・・・・・・ 4 Others ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・...
  • Page 36 Blank Page xxxvi...
  • Page 37 Chapter 1 General Description This chapter explains the general description of this equipment. General Description ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2 Features ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 3 Names of Parts and Their Functions ・・・・・・・・・・・・・・・ 4 【Front Side】・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・4 【Rear Side】 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・4 【Right Side】・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・5 【Left Side】 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・5 1−1...
  • Page 38: General Description

    General Description The DS-7100 system utilizes 8.4-inch color LCD display for monitoring ECG, RESP, SpO , BP, NIBP, TEMP measurements. Depending on the model type, CO measurement, telemetry transmission, and Ethernet LAN connection are also possible. <DS-7141> Function Model Type Basic Telemetry Ethernet...
  • Page 39: Features

    Features ? Completely self-contained, the monitor includes display part, recording part, measuring part in a compact and lightweight package. A battery pack (optional) operation is also possible which allows 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 numeric data display can be enlarged for easier view.
  • Page 40: Names Of Parts And Their Functions

    Names of Parts and Their Functions 【Front Side】 Alarm Pole Lights when the alarm generates. NIBP Cuff Connector Air hose is connected here. Power Supply Lamp Indicates the main power supply. Charge Lamp Input Connector Indicates the charge status. relay cable (DOC-10) is Orange: Charging in process connected here.
  • Page 41: Right Side】・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・5

    Do not connect unit or cable not authorized by Fukuda Denshi to any I/O connector. If done so by mistake, the device can not deliver its maximum W A R N I N G performance and the connected units may be damaged, resulting in a safety hazard.
  • Page 42 Blank Page 1−6...

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