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 ?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. Failure to follow this message may result in death or serious injury, or W A R N I N G complete failure of the equipment.
DS-7100 System DANGER Risk of explosion if used in the presence of flammable anesthetics. CAUTION Before connecting, read instruction manual. CAUTION To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel. DANGER ? Use only the batteries specified for this device. ? Do not disassemble or modify the battery. The battery incorporates protection circuitry for safety purposes.
Measurement Unit for Each Parameter The measurement units for this equipment are as follows.
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. DS-7100 System: Symbols displayed on the screen Symbol Description Battery Mark Indicates battery capacity and remaining volume during battery operation.
Precautions for Safe Operation of Medical Electrical Equipment ? ? ? CAUTION ? ? ? ? ? ? vi Read the following precautions thoroughly to correctly operate the device. Users should have a thorough knowledge of the operation before using this system. 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 to splashing water.
Precautions for Safe Operation of Medical Telemetry (DS-7141, DS-7101LT) Precautions for Safe Operation of Medical Telemetry To operate the device correctly, read the following precautions carefully. ? The medical institution (hereinafter referred as “Institution”) must decide the telemetry installation plan for the medical institution in order to prevent interference and interference between transmitters (telemetry based on destination country’s radio law).
Precautions about the Maintenance Safety Inspection and Maintenance For safe operation of the equipment, regular inspection and maintenance is required. Once a year, check all cables, devices, and accessories for damage, earth impedance, earth and enclosure leakage currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of these safety inspections. Immediate maintenance has to be carried out if ; ?the equipment was subjected to extreme mechanical stress, e.g.
Precautions about the Pacemaker WARNING Minute ventilation rate-adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic equipment, causing the pacemakers to pace at their maximum programmed rate. The cardiac monitoring and diagnostic equipment may possibly send wrong information. If such event occurs, please disconnect the cardiac monitoring and diagnostic equipment, or follow the procedures described in the operation manual of the pacemaker.
Electrosurgery Safety WARNING 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.
Precautions about Connections to Peripheral Devices In the interest of safe and sufficient performance of this equipment, the connection of other manufacturers’ equipment to the monitor is not authorized, unless the connection is explicitly approved by Fukuda Denshi. It is the user’s responsibility to contact Fukuda Denshi to determine the compatibility and warranty status of any connection made to another manufacturer’s equipment.
Precautions about the DS-7100 System DANGER WARNING xii ? When connecting to other device, contact Fukuda Denshi service representative. Danger such as electric shock may result to the patient and operator. ? When monitoring a patient with wireless telemetry, make sure the patient data is properly received at the central monitor. 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.
WARNING ? Objective and constant arrhythmia detection is possible through the fixed algorithm incorporated in this monitor. However, excessive waveform morphology change, motion artifact, or the inability to determine the waveform pattern may cause an error, or fail to make adequate detection. Therefore, physicians should make final decisions using manual recording, alarm recording and recall waveform for evaluation. ? When setting the monitor on a trolley, use 2 fixing screws to ensure safety.
CAUTION xiv ?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. This does not continually adjust size and position.
CAUTION ?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.
CAUTION xvi ?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.
? ? ? CAUTION ? ?When DS-5800N/NX/NXMB 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.
Precautions for Use of SpO2 Sensor DANGER Burn Risk in Using SpO2 Sensor In SpO2 monitoring, always use the sensor/relay cable specified by Fukuda Denshi. If any other sensor/relay cable is used, a high temperature rise of the sensor may place the patient in danger of burns. If there are any questions regarding the sensor/relay cable use for SpO2 measurements of this device, please contact Fukuda Denshi service representative.
Precautions for Use of Lithium-Ion Battery Pack DANGER ? 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. ? Do not disassemble or remodel the equipment.
CAUTION NOTE ? 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. ? 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 power and unplug the power cable from the outlet. Otherwise it may result in battery leakage.
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.
● Compliance to the Electromagnetic Emissions The DS-7100 system is intended for use in the electromagnetic environment specified below. Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Compliance Electromagnetic Environment - Guidance Group 1 The equipment uses RF energy that is necessary for the internal functioning of the equipment itself. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
● Compliance to the Electromagnetic Immunity (2) The DS-7100 system is intended for use in the electromagnetic environment specified below. should be assured that the DS-7100 system is used in such an environment. Immunity Test Radiated RF IEC61000-4-3 IEC60601-1-2 Test Level Compliance Level 3V/m 3V/m 26MHz 〜 1.0GHz It Electromagnetic Environment Guidance Recommended Separation Distance d = 1.2 P d = 1.2 P 80MHz〜800MHz d = 2.3 P 800MHz〜2.
● 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.
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.
Blank Page xxvi
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. 4. Monitoring Setup Describes the procedures to set the monitor according to the monitoring purpose. 5. Admit / Discharge of a Patient Describes the procedure to admit or discharge a patient. 6.
Preface Safety Precautions･･････････････････････････････････ii Labels Attached to the Unit ･･･････････････････････ii Measurement Unit for Each Parameter ････････････ iv Graphic Symbols ･･･････････････････････････････ v Precautions for Safe Operation of Medical Electrical Equipment･････････････････････････････････････ vi Precautions for Safe Operation of Medical Telemetry (DS-7141, DS-7101) ････････････････････････････vii Precautions about the Maintenance ･･････････････ viii Precautions about the Pacemaker ･
Chapter 2 Basic Operation − Before Use − Basic Operation for Monitoring･･ Touch Keys････････････････････････････････････ ● General Key Control ･･･････････････････････ ● Key Control for Each Parameter ･････････････ Chapter 3 2 2 2 2 − Before Use − About the Home Display ･･･････ 3 About the Home Display ･････････････････････････ 3 The Description of the Display ････････････････････ 4 ● Numeric Data, Waveform, Patient Name, etc.
Chapter 4 Monitoring Setup − Display Configuration − For Easier View･･････････ 2 To Configure the Display ････････････････････････ 2 ● To Enlarge the Numeric Data ･･･････････････ 2 ● To Configure the Display ･･･････････････････ 3 ● To Display the Short Trend ･････････････････ 5 Description 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･････････････････････
Chapter 5 Admit / Discharge of a Patient − Admit / Discharge of a Patient− ･･････････････････ 2 − Admitting a Patient − Entering Name, Sex, and Age ･･･････････････ 3 Patient Name ･･････････････････････････････････ 3 Patient ID ･････････････････････････････････････ 4 Patient Type ･･･････････････････････････････････ 4 Patient Sex ････････････････････････････････････ 5 Pacemaker Use ････････････････････････････････ 6 ● Pacemaker Use Selection ･･････････････････ 6 ● Impedance Respiration Measurement ････････
CO2 Scale ････････････････････････････････････ EtCO2 (End-Tidal CO2) Alarm ･･･････････････････ InspCO2 (Inspiratory CO2) Alarm ･････････････････ EtCO2 Average Duration ････････････････････････ Measurement Unit ･････････････････････････････ CO2 Calibration ･･･････････････････････････････ Restarting the CO2 Unit･････････････････････････ ON/OFF of Parameter Display･･･････････････････ 38 38 39 40 40 41 42 42 Chapter 7 Function − Arrhythmia Analysis − Definition, etc.
Chapter 8 Chapter 9 System Configuration − Night Mode − Night Mode Monitoring ･･････････ About the Night Mode ･･･････････････････････････ To Set the Night Mode ･･････････････････････････ ● To Start/Stop the Night Mode ･･･････････････ ● Night Mode Display Setup ･･････････････････ 2 2 4 4 5 − Alarm Mode Setup − Programming the Alarm Mode ･･････････････････ 6 About the Alarm Mode ･･････････････････････････ 6 To Program the Alarm Mode ･････････････････････ 7 − Monitor Setup − Setup for Each Monitor ････ 8
Chapter 10 Maintenance − Handling − After Use / Display Panel ･･･････ 2 Handling After Use･･････････････････････････････ 2 Handling the Display Panel ･･････････････････････ 2 − Storage − Device / Recording Paper･･････････ 3 Storing the Device ･･････････････････････････････ 3 Storing the Recording Paper ･････････････････････ 3 − Cleaning − Display Panel and Housing ････････ 4 Cleaning the Display Panel ･･････････････････････ 4 Cleaning the Housing ･･･････････････････････････ 5 Disinfecting the Blood Pressu
Chapter 12 Accessories − Accessories − ･････････････････････････････････ 2 − Optional Accessories − ･････････････････････････ ECG, Impedance Respiration Measurement ････････ Invasive Blood Pressure Measurement ････････････ Non-Invasive Blood Pressure Measurement ････････ Temperature Measurement ･･････････････････････ SpO2 Measurement ･････････････････････････････ CO2 Concentration Measurement ･････････････････ Others ････････････････････････････････････････ 3 3 3 3 4 4 4 5 xxxv
Blank Page xxxvi
Chapter 1 General Description This chapter explains the general description of this equipment.
General Description The 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, telemetry transmission, and Ethernet LAN connection are also possible.
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. data display can be enlarged for easier view. Also, the numeric ?The alarm pole provided as standard indicates the alarm by 9 flashing patterns corresponding to the alarm level.
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 Indicates the charge status. Orange: Charging in process Green: Charging complete SpO2 Input Connector SpO2 relay cable (DOC-10) is connected here. ECG Input Connector ECG relay cable is connected here. Ambient Light Sensor Detects the ambient light.
【Right Side】 Serial Connector Connect only the specified device here. Status Input Connector Connect only the specified device here. LAN Connector Branch cable (CJ-522) is connected here for wired network. 1 Names of Parts and Their Function Speaker Generates synchronous sound, key sound, alarm sound. Power Supply Switch Turns the monitor power ON or OFF. 【Left Side】 PC Card Access Lamp Indicates the PC card access status. PC Card Slot Insert only the specified PC card here.
Blank Page 1− 6
