Fukuda Denshi Dynascope 8000 Series User manual

1
Contents
Contents
Preface
Introduction..............................................................................................................................i
Important Notice......................................................................................................................i
For Safe Operation of the Equipment...................................................................................................i
Intended Use of this Equipment...........................................................................................................i
Copyright.............................................................................................................................................ii
Maintenance, Repair, Replacement....................................................................................................ii
Contact................................................................................................................................................ii
About This Manual ................................................................................................................iii
Expression Used in This Manual........................................................................................................iii
Composition of This Manual...............................................................................................................iv
Safety
About the Safety Precautions..................................................................................................i
The Meaning of Each Safety Precaution..............................................................................................i
Warning Labels Attached to the Unit....................................................................................................i
Graphic Symbols................................................................................................................................iii
Precautions for Safe Operation of Medical Electrical Equipment..........................................iv
Precautions about the Maintenance.......................................................................................v
Precautions about the Network System ................................................................................vi
Medical Telemetry..............................................................................................................................vi
Precautions when Using with Other Equipment...................................................................vii
Pacemaker........................................................................................................................................vii
Non-Explosion Proof .........................................................................................................................vii
Defibrillator........................................................................................................................................vii
Electrosurgical Instrument................................................................................................................viii
MRI (Magnetic Resonance Imaging)................................................................................................viii
Precautions about Connections to Peripheral Devices......................................................................ix
Precautions for Using the Equipment....................................................................................ix
This System........................................................................................................................................ix
Wired Network (DS-LANII/ DS-LANIII)............................................................................................xvii
Wireless Network System .............................................................................................................. xviii
RTC and Data Backup ................................................................................................................... xviii
Precautions about the Ventilator Monitoring........................................................................xix
Precautions about the SpO2 Sensor...................................................................................xix
Precautions about the NIBP Cuff.........................................................................................xix
Precautions about Disposing of the Equipment, Accessories, or Components...................xix
Precautions about Transportation ........................................................................................xx
Monitoring after Power Failure .............................................................................................xx
To Prepare for Emergency Use............................................................................................xx
Electromagnetic Compatibility..............................................................................................xx
Precautions for Safe Operation under Electromagnetic Influence ...................................................xxi
EMC Guidance.................................................................................................................................xxi

2
Contents
Chapter 1 Installation of the Unit
Precautions for Installing the Equipment............................................................................1-1
Operating Environment....................................................................................................................1-1
System Construction...........................................................................................................1-2
Inserting the SD Card......................................................................................................................1-2
Connecting the AC Unit and CO2 Gas Unit.....................................................................................1-3
Connecting the Recorder Unit (HR-800)..........................................................................................1-5
Connecting the HCP-820, HPD-820................................................................................................1-5
Connecting the HPD-810, HCP-810, HBX-800 ...............................................................................1-7
Power Source and Ground Connection..............................................................................1-8
Power Connection of the Main Unit.................................................................................................1-8
Equipotential Grounding..................................................................................................................1-9
Installing the Lithium-Ion Battery Pack (BTO-008) .............................................................1-9
Chapter 2 Network System Construction
Wired Network System.......................................................................................................2-1
DS-LAN Connection ........................................................................................................................2-1
DS-LAN Setup.................................................................................................................................2-2
Precautions about Printing/Display..................................................................................................2-4
Wireless Network................................................................................................................2-6
Example of Wireless Network Construction.....................................................................................2-6
Channel ID and Telemetry Wave Setup..........................................................................................2-6
Chapter 3 Using the External Media
Inserting the USB Memory/SD Card...................................................................................3-1
Data Backup/Copy Using the USB Memory/SD Card ........................................................3-1
Formatting the Full Disclosure Waveform Card..................................................................3-4
Chapter 4 Connection to the External Devices
Ventilator Alarm Input.........................................................................................................4-1
Connecting the Ventilator ................................................................................................................4-3
External Device Setup.....................................................................................................................4-4
BIS Data Input ....................................................................................................................4-5
Connecting the A-2000/A-3000 (Covidien)......................................................................................4-5
External Device Setup.....................................................................................................................4-5
Setup for the External Device Connection..........................................................................4-6
External Device Setup.....................................................................................................................4-6
Alarm Output Setup.........................................................................................................................4-7

3
Contents
Analog Output Setup.......................................................................................................................4-7
Using the Magnetic Card Reader.......................................................................................4-9
Connecting the Magnetic Card Reader...........................................................................................4-9
Magnetic Card Reader Setup.......................................................................................................... 4-9
PC Communication...........................................................................................................4-13
Connection with the System.......................................................................................................... 4-13
External Device Setup................................................................................................................... 4-13
Connection with the Laser Printer ....................................................................................4-14
Laser Printer Setup ....................................................................................................................... 4-14
Chapter 5 Initial Settings
Initial Settings.....................................................................................................................5-1
Administrator Setup............................................................................................................5-2
Key Lock..........................................................................................................................................5-2
Password Setup.............................................................................................................................. 5-3
Alarm Related Setup .......................................................................................................... 5-5
Measurement Related Setup..............................................................................................5-8
User Label Setup.............................................................................................................................5-8
Measurement Unit........................................................................................................................... 5-9
Other Setup..................................................................................................................................... 5-9
User I/F.............................................................................................................................5-11
Display/Print Setup........................................................................................................................5-11
Power ON/Discharge.....................................................................................................................5-15
Shortcut Menu............................................................................................................................... 5-17
Key Mask....................................................................................................................................... 5-18
Operation Related Setup...............................................................................................................5-19
Quick Menu Setup......................................................................................................................... 5-21
Setup for the External Device Connection........................................................................5-21
System Setup...................................................................................................................5-21
User Mode Registration.................................................................................................... 5-22
About the User Mode .................................................................................................................... 5-22
To Program the User Mode........................................................................................................... 5-23
Chapter 6 Setup Item/Default Value
Setup Item..........................................................................................................................6-1
Initial Settings.................................................................................................................................. 6-1
External Connection (Pin Assignments)...........................................................................6-13
Serial Connector Output Signal..................................................................................................... 6-13
Status I/O Signal (Status II Connector).........................................................................................6-13
Analog Output Signal .................................................................................................................... 6-14

4
Contents
Chapter 7 Replacement Parts
Periodic Replacement.........................................................................................................7-1
To Check the Periodic Replacement Period....................................................................................7-1
Disposing the Equipment....................................................................................................7-2
Chapter 8 Cleaning/Disinfecting/Storing
After Usage/Handling the Equipment .................................................................................8-1
After Using the Equipment...............................................................................................................8-1
Display.............................................................................................................................................8-1
Storing the Equipment and Recording Paper.....................................................................8-1
Equipment........................................................................................................................................8-1
Recording Paper..............................................................................................................................8-2
Cleaning the Equipment and Sensors................................................................................8-2
Touch Panel.....................................................................................................................................8-2
Housing............................................................................................................................................8-3
NIBP Cuff and Air Hose...................................................................................................................8-3
BP Transducer.................................................................................................................................8-4
SpO2 Sensor...................................................................................................................................8-4
Temperature Probe..........................................................................................................................8-4
Cardiac Output Relay Cable............................................................................................................8-5
Airway Adapter for Capnostat 5.......................................................................................................8-5
BISx.................................................................................................................................................8-5
Chapter 9 Maintenance Check
Daily and Periodic Check....................................................................................................9-1
Maintenance Check.........................................................................................................................9-1
Daily Check Items and Procedures .................................................................................................9-2
Periodic Check Items and Procedures ............................................................................................9-4
Handling and Storage of Lithium-Ion Battery Pack (BTO-008)...........................................9-8
CO2 Calibration (HCP-810/HCP-820)................................................................................9-9
Program Version...............................................................................................................9-10
Software Install.................................................................................................................9-10

1-1
Contents
Preface
Introduction.......................................................................................i
Important Notice ...............................................................................i
For Safe Operation of the Equipment.................................................i
Intended Use of this Equipment .........................................................i
Copyright........................................................................................... ii
Maintenance, Repair, Replacement.................................................. ii
Contact.............................................................................................. ii
About This Manual..........................................................................iii
Expression Used in This Manual.......................................................iii
Composition of This Manual............................................................. iv

Contents

i
Preface Introduction
Preface
Introduction
Thank you for purchasing this product. Read the "Safety Precautions" thoroughly before use to ensure correct and
safe use of the product.
Before using or installing this product, read this manual thoroughly.
Important Notice
For Safe Operation of the Equipment
(1) Before using this equipment, read this operation manual.
(2) Fukuda Denshi cannot predict all the dangers which may be caused by misusage of this product or
environmental condition.
(3) For using this equipment, there are many items that "should be performed", "should not be performed", and
"cannot be performed". It is not possible to cover all these items in this manual or warning labels. Therefore, it
is necessary to also follow the general safety precaution other than the items described in this manual.
(4) To prevent accidents, usage other than intended, or usage, cleaning, and maintenance not described in this
manual should not be performed.
(5) When using this equipment, follow the respective regulation to minimize the probability of accidents.
Intended Use of this Equipment
This equipment is designed for the following <Intended Use>.
<Intended Use>
This equipment is intended for patient monitoring in surgery room, ICU, ward, emergency room or during
transportation in the medical facility by measuring parameters such as ECG, respiration, NIBP, pulse rate, SpO2,
SpCO, SpMet, SpHb, pulse wave, temperature, BP, CO, respiration gas (CO2concentration), BIS, SQI, SR, EMG,
EEG, and monitors patient condition by displaying/recording the measurement data on this equipment or central
monitor and generates alarm as required.
This equipment is intended for monitoring one patient. It is not intended for monitoring multiple patients.
The 12-lead ECG analysis function is intended for adult and pediatric patients.
For specification of this equipment, refer to "Chapter 14 Specification" of this manual.
This equipment is intended to be used by healthcare professionals. Users should have a thorough knowledge of the
function and operation before using this equipment. The maintenance of this equipment should be performed by
skilled personnel who received a training of possible hazards and measures to avoid those hazards. Also, your local
regulation must be followed. If this equipment is used for the purpose other than intended, or if the user does not
follow the safety instructions, the following hazard may result.
Hazard to the Life and Health of the Patient or the User

ii
Preface Important Notice
A Problem Related to Medical Practice
Damage to the Equipment
Copyright
(1) The copyright of this manual is owned by Fukuda Denshi. No part of this document may be copied or transmitted
in any form without the prior written permission of Fukuda Denshi Co., Ltd.
(2) This manual includes the description for the optional equipments that can be connected.
(3) The illustration in this manual may differ with the actual equipment.
(4) If you lose or damage this manual, contact your nearest sales representative. Using the equipment without this
manual may cause accidents.
(5) When handing over this equipment, make sure to also pass this manual to the next owner.
Maintenance, Repair, Replacement
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 or organization.
Components are used in accordance with Fukuda Denshi operating instructions.
A full technical description of the DS-8007 System is available from your local Fukuda Denshi sales representative.
Contact
If you need more detailed information, please contact following.
(1) Fukuda Denshi Co., Ltd., Head Office
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan
Phone:[phone] Fax:[phone]
E-mail: [email protected]
Home Page: http://www.fukuda.com
(2) Sales Representative
Write the name, address, phone, fax number of your local sales representative.
(Name of Sales Representative, Address, Phone/Fax)

iii
Preface About This Manual
About This Manual
Expression Used in This Manual
Meaning of the Symbols
Indications for the Screens and Keys
The keys displayed on the monitor screen are indicated by [ ].
(Ex.: [Display Config.], [Manual Printing], etc.)
The expressions displayed on the monitor screen are indicated by " " .
(Ex.: "Volume", "Admit/Discharge", etc.)
The messages displayed on the screen are indicated by < >.
(Ex: <Searching>, <Alarm Suspend>, etc.)
REFERENCE
There are 2 types of menu display for this equipment, menu list and simple menu.
(

"Menu Configurations" P1-3)
In this manual, the operation procedure is explained for the case when menu list is displayed
(when simple menu setup is OFF).
If simple menu is displayed, press [Menu] > [Menu List] to follow the procedure explained in
this manual.
Type of Precaution Description
DANGER Failure to follow this message may cause immediate threat of death or serious injury.
WARNING Failure to follow this message may result in death or serious injury.
CAUTION Failure to follow this message may cause injury or failure to the equipment.
NOTE "Note" is used to emphasize important information.
REFERENCE "Reference" is used to provide useful information.
Indicates the reference page for the procedure and precaution.
* Used in a table which indicates that there is detailed explanation outside the table.

iv
Preface About This Manual
Composition of This Manual
The operation manual is composed of the following chapters.
The maintenance manual is composed of the following chapters.
Chapter Title Description
Preface Outline and purpose of this manual
(Important Notice, About This Manual)
Safety Warning, Precautions for Safety
1.General Description Composition, features, menu configuration of this equipment
2.Name of Parts and Their
Functions Name and function of each part, external appearance
3.OperationProcedureandScreen
Examples Operation procedure, home display, window, procedure to return the display, user key setup
4.Preparation Installing the recording paper, power ON/OFF, time/date, daily checks
5.Admit/Discharge Entering patient information (name, age, etc.) at admittance, discharging the patient, user
mode selection, suspend monitoring
6.Alarm Function General description of alarm function, alarm-related setups
7.Monitoring Measurement condition setup of the monitoring parameters, size/scale setup, etc.
Setup of the stopwatch, connector
8.Review Function Arrhythmia analysis, trend, recall, NIBP list, Tabular Trend, ST measurement,
hemodynamics, lung function, alarm history, other bed display, full disclosure waveform,
MPDR
9. Printing Recorder output function
10. System Configuration Setup of the display configuration, tone/volume, color, brightness, night mode
11. Troubleshooting Message list, maintenance and troubleshooting of this equipment
12. Setup Item/Default Value Setup item and default value
13. Accessories List of accessories and optional accessories of this equipment
14. Specification Specification and performance of this equipment
Chapter Title Description
Preface Outline and purpose of this manual
(Important Notice, About This Manual)
Safety Warning, Precautions for Safety
1.Installation of the Unit Precautions about the operating environment, system construction, power source and
ground connection, trolley usage
2.Network System Construction Network connection and setup
3.Using the External Media Procedure to use the USB memory and SD card.
4.Connection to the External
Devices External equipment connection and setup
5.Initial Settings Initial setup, administrator setup, alarm/measurement setup, user I/F, user mode
registration
6.Setup Item/Default Value Default and backup of setup items
7.Replacement Parts Precautions about the periodic replacement parts, consumable parts
8.Cleaning/Disinfecting/Storing Procedure to handle, clean, store this equipment
9. Maintenance Check Daily and periodic checks, self-diagnosis function, software version
software install

2-1
Contents
Safety
About the Safety Precautions...........................................................i
The Meaning of Each Safety Precaution............................................i
Warning Labels Attached to the Unit..................................................i
Graphic Symbols...............................................................................iii
Precautions for Safe Operation of Medical Electrical Equipment...iv
Precautions about the Maintenance................................................v
Precautions about the Network System..........................................vi
Medical Telemetry............................................................................ vi
Precautions when Using with Other Equipment ............................vii
Pacemaker .......................................................................................vii
Non-Explosion Proof.........................................................................vii
Defibrillator .......................................................................................vii
Electrosurgical Instrument...............................................................viii
MRI (Magnetic Resonance Imaging)...............................................viii
Precautions about Connections to Peripheral Devices .................... ix
Precautions for Using the Equipment.............................................ix
This System...................................................................................... ix
Wired Network (DS-LANII/ DS-LANIII) ...........................................xvii
Wireless Network System..............................................................xviii
RTC and Data Backup...................................................................xviii
Precautions about the Ventilator Monitoring.................................xix
Precautions about the SpO2 Sensor............................................xix
Precautions about the NIBP Cuff..................................................xix
Precautions about Disposing of the Equipment, Accessories, or
Components .................................................................................xix
Precautions about Transportation .................................................xx
Monitoring after Power Failure.......................................................xx
To Prepare for Emergency Use.....................................................xx
Electromagnetic Compatibility .......................................................xx
Precautions for Safe Operation under Electromagnetic Influence...xxi
EMC Guidance................................................................................xxi

Contents

i
Safety About the Safety Precautions
Safety
About the Safety Precautions
The Meaning of Each Safety Precaution
Read this manual 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.
Warning Labels Attached to the Unit
Make sure to read the warning label attached to the equipment and comply with the requirements while operating
the equipment.
CAUTION
Do not damage or erase the warning label attached to the equipment.
These warning labels contain important descriptions for handling and operating the
equipment properly and safely. A damaged label may compromise safe operation.
DS-8007 System Main Unit
Type of Precaution Description
Indicates an imminently hazardous situation which, if not avoided, will result in death
or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in death
or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in minor
or moderate injury.
DANGER
WARNING
CAUTION

ii
Safety About the Safety Precautions
DSA-81 AC Unit
HR-800 Recorder Unit

iii
Safety About the Safety Precautions
Graphic Symbols
Refer to the following for the meaning of the symbol indicated on the equipment.
Symbol Description
Follow operating instructions (Warning); indicated in blue. Failure to follow operating instructions could
place the patient or operator at risk.
Follow operating instructions (Information);
Indicates the need to refer to the related accompanying documents before operation.
General precaution
Caution, refer to accompanying documents
Indicates the need to refer to the related accompanying documents before operation.
Potential Equalization Terminal
Indicates the terminal to equalize the potential difference when interconnecting the devices.
Protective Earth
Indicates the protective earth inside the equipment.
Alternating Current
(Main Power Input Indicator)
Indicates that the equipment is in normal operation.
Indicates that the equipment is in standby mode.
Electrostatic Sensitive Part
Directly touching this connector part with hands should be avoided.
Type CF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type CF Applied Part with defibrillation-
proof.
Type BF Applied Part with Defibrillation-Proof
Indicates the degree of protection against electric shock is Type BF Applied Part with defibrillation-
proof.
Signal Output
Signal Input/Output
GAS Input Part
GAS Output Part
Battery
Alarm Silence
Name and Address of Manufacturer
Indicates the name and address of manufacturer.
Date of Manufacture
Indicates the date of manufacture.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic equipment.

iv
Safety Precautions for Safe Operation of Medical Electrical Equipment
Precautions for Safe Operation of Medical Electrical Equipment
WARNING
Do not disassemble or remodel the equipment.
CAUTION
Users should have a thorough knowledge of the operation before using this equipment.
Do not use the equipment in an environment where protective earth and wiring is
questionable.
Precautions about the Location of Installation and Storage of the Equipment
Set the monitor to the user's intended position where the user can easily recognize the visual and audible
monitoring conditions. Normally it is recommended to set at a distance of 1m from the user.
Install or store in a place where the equipment will not be exposed to splashing water.
Install or store in an area where environmental conditions such as atmospheric pressure, temperature,humidity,
ventilation, sunlight, dust, sodium, and sulfur will not 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 chemicals are stored or gases are evolved.
Verify the power frequency, voltage and allowable current (or power consumption).
Ensure the grounding is proper by connecting the accompanying power cable to the hospital grade outlet.
Make sure to secure the equipment using a trolley or stand.
Do not place the equipment or accessories in any position that might cause it to fall on the patient.
Precautions Before Using the Equipment
Verify the power voltage. Charge the battery pack fully before operating the system with the battery pack.
Check the cable connection and polarity to ensure proper operation of the equipment.
Make sure the power system has adequate earth ground.
Ensure that all cables are firmly and safely connected.
Pay special attention when the equipment is used in conjunction with other equipment as it may cause
erroneous diagnosis and danger.
Precautions During Using the Equipment
Always observe the equipment and patient to ensure safe operation of the equipment.
If any abnormality is found on the equipment or with the patient, take appropriate measures under the safe
conditions, such as ceasing operation of the equipment.
Do not allow the patient to come in contact with the equipment.
On start-up of the system, verify that the start-up tone generates and alarm indicator lights.
For the connectors which are not Type BF, CF applied part, do not touch them and the patient at the same time.
Precautions After Using the Equipment
Unplug all the cables from the patient before turning off the power.
When unplugging the cables, do not apply excessive force by pulling on the cord. Pull by the connector part
of the cable.

v
Safety Precautions about the Maintenance
Clean the accessories and cables, and keep them together in one place.
Keep the equipment clean to ensure proper operation for the next use.
Precaution when Equipment Failure Occurs
If the equipment is damaged and in need of repair, the user should not attempt service. Label the unit "OUT
OF ORDER" and contact our service representative.
Precaution about Disassembling/Remodeling the Equipment
Do not disassemble or remodel the equipment.
If water or other liquids enter the equipment, cease using the equipment and contact your nearest service
representative.
Precautions about Maintenance Check
Make sure to periodically check the equipment, accessories, and cables.
Before reusing the equipment that has been left unused for a while, make sure that the equipment operates
normally and safely.
Precautions when Using with Other Equipment
Toprevent patient from burn injury,verify properattachment of patient ground plate, ECG electrode type when
using the electrosurgical knife, and verify paste volume, output energy when using the defibrillator. Also,
verify that each equipment is properly grounded.
Precautions about the Maintenance
Never open the housing while the equipment is in operation or connected to hospital grade outlet as it may
result in electric shock.
Precautions about Safety Check
For safe operation of the equipment, regular inspection and maintenance are required. Once a year, check all
cables, devices, and accessories for damage, earth impedance, earth and leakage currents, and all alarm
functions. Also, ensure that all safety labels are legible. Maintain a record of these safety inspections.
Immediate maintenance has to be carried out for the following case.
When the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall.
When the equipment was subjected to liquid spill.
When the monitoring function is interrupted or disturbed.
When parts of the equipment enclosure are cracked, removed, or lost.
When any connector or cable shows signs of deterioration.
WARNING
CAUTION

vi
Safety Precautions about the Network System
Precautions about the Network System
Medical Telemetry
Precautions about the Installation
The medical institution (hereinafter referred as "Institution" ) must decide the telemetry installation plan for
the medical institution in order to prevent interference between transmitters (telemetry based on destination
country's radio law). When telemetry has already been installed and been used, radio format, frequency, and
antenna power are required to be examined to prevent interference.
When using telemetry which requires zone location, the institution is to set up the zones as an operation unit
for each transmitter to prevent electronic interference between telemetry throughout the Institution.
When using telemetry which requires zone location, display and identify each prepared zone in the equipment.
When laying receiver antenna for each transmitter, the Institution has to examine the installation so that
electronic interference does not occur.
Based on the above examination result, the Institution should place each receiver antenna as required.
Precautions about the Management
The institution appoints a person to manage the wireless channels for the whole medical institution. And when
using telemetry which requires zone location, the Institution should nominate a person to manage the wireless
channels in each zone (a "Zone Manager" ). However, when using such telemetry in a local medical institution,
one person can perform both functions.
Select a telemetry manager who understands the characteristics and functionality of telemetry systems, and is
skilled in operating telemetry.
When installing telemetry, the Overall Manager and the Zone Manager have to understand the precautions for
use of the telemetry in advance.
The Overall Manager takes responsibility of wireless channel management and transmitter storage for the
whole Institution by giving proper instruction.
The Overall Manager should create a management log (hereinafter referred to as the "log" ), which contains a
list of the management status of the wireless channels for the whole Institution. When changing a wireless
channel, register it in the log and give proper instructions to the Zone Manager or to the user.
The Zone Manager assumes responsibility for managing the wireless channels, storing, and managing
telemetry.
The Zone Manager assigns the transmitter to the user, and provides enough 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 the instructions of the Zone Manager for
the zone and gives instructions to the patient if required.
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.
CAUTION
CAUTION