Fukuda 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) ............................................................................................. xxi
Wireless Network System ............................................................................................................... xxii
RTC and Data Backup ................................................................................................................... xxiii
Precautions about the Ventilator Monitoring...................................................................... xxiii
Precautions about the SpO2 Sensor ................................................................................. xxiii
Precautions about the NIBP Cuff....................................................................................... xxiv
Precautions about Disposing of the Equipment, Accessories, or Components................. xxiv
Precautions about Transportation ..................................................................................... xxiv
Monitoring after Power Failure .......................................................................................... xxiv
To Prepare for Emergency Use......................................................................................... xxiv
Electromagnetic Compatibility ............................................................................................ xxv
Precautions for Safe Operation under Electromagnetic Influence .................................................. xxv
EMC Guidance ............................................................................................................................... xxvi

2
Contents
Chapter 1 Installation of the Unit
Precautions for Installing the Equipment ............................................................................ 1-1
Operating Environment....................................................................................................................1-1
System Construction........................................................................................................... 1-2
Connection with the Display Unit ..................................................................................................... 1-2
Connecting the AC Unit and CO2 Gas Unit..................................................................................... 1-4
Connecting the Super Unit, Input Box, DS-8007 .............................................................................1-6
Connection of Multigas Unit...........................................................................................................1-12
Connecting the External Monitor ...................................................................................................1-15
Connecting the Extended Display Unit ..........................................................................................1-16
Connecting the Mouse (Optional) ..................................................................................................1-17
Power Source and Ground Connection ............................................................................ 1-18
Power Connection of the Main Unit ...............................................................................................1-18
Power Connection of the Super Unit .............................................................................................1-19
Power Connection of the Input Box ...............................................................................................1-19
Equipotential Grounding ................................................................................................................1-20
Chapter 2 Network System Construction
Wired Network System ....................................................................................................... 2-1
DS-LAN Connection ........................................................................................................................ 2-1
DS-LAN Setup ................................................................................................................................. 2-2
Precautions about the DS-LAN........................................................................................................ 2-5
Wireless Network................................................................................................................ 2-6
Example of Wireless Network Construction..................................................................................... 2-6
Module Attachment and Serial Communication Setup .................................................................... 2-7
Channel ID and Telemetry Wave Setup .......................................................................................... 2-8
Chapter 3 Using the CF card
Inserting the CF card ..........................................................................................................3-1
Data Backup/Copy Using the CF Card ............................................................................... 3-1
Formatting the CF Card ...................................................................................................... 3-4
Formatting the SD Card...................................................................................................... 3-5
Chapter 4 Connection to the External Devices
Ventilator Measurement and Alarm Input ........................................................................... 4-1
Ventilator Connection ...................................................................................................................... 4-3
External Device Setup .....................................................................................................................4-6
SvO2/CCO Monitor Connection.......................................................................................... 4-6

3
Contents
SvO2/CCO Monitor Connection ...................................................................................................... 4-7
External Device Setup..................................................................................................................... 4-8
CO2 Concentration Data Input ........................................................................................... 4-8
Connecting the MGU-800/MGU-810 ............................................................................................... 4-8
Connecting the Capnostat 5............................................................................................................ 4-9
Connecting the Sampling Line (Covidien) ....................................................................................... 4-9
CO2 Source Priority ...................................................................................................................... 4-10
Multigas Unit/ Spiro Unit Selection ................................................................................................ 4-10
BIS Data Input .................................................................................................................. 4-10
Connecting the A-2000/A-3000 (Covidien).................................................................................... 4-11
External Device Setup................................................................................................................... 4-11
Connecting the BISx (Covidien) .................................................................................................... 4-12
INVOS Data Input............................................................................................................. 4-12
Connecting to the INVOS.............................................................................................................. 4-12
External Device Setup................................................................................................................... 4-13
FLOW-i Data Input............................................................................................................ 4-13
Connection with the FLOW-i ......................................................................................................... 4-13
External Device Setup................................................................................................................... 4-14
Transcutaneous Blood Gas Monitor Data Input ............................................................... 4-14
Connecting the Transcutaneous Blood Gas Monitor..................................................................... 4-14
External Device Setup................................................................................................................... 4-15
Setup for the External Device Connection........................................................................ 4-16
External Device Setup................................................................................................................... 4-16
Unit Module Setup......................................................................................................................... 4-17
Status Output Setup ...................................................................................................................... 4-21
Analog Output Setup ..................................................................................................................... 4-22
Using the Magnetic Card Reader ..................................................................................... 4-24
Connecting the Magnetic Card Reader ......................................................................................... 4-24
Magnetic Card Reader Setup........................................................................................................ 4-24
PC Communication........................................................................................................... 4-28
Connection with the System.......................................................................................................... 4-28
External Device Setup................................................................................................................... 4-28
Connection with the Laser Printer .................................................................................... 4-29
Laser Printer Setup ....................................................................................................................... 4-29
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............................................................................................ 5-11
User Label Setup........................................................................................................................... 5-11
Measurement Unit ......................................................................................................................... 5-12
Other Setup ................................................................................................................................... 5-12
User I/F............................................................................................................................. 5-14
Display/Print Setup........................................................................................................................ 5-14

4
Contents
Power ON/Discharge.....................................................................................................................5-17
Menu Setup ...................................................................................................................................5-20
Key Mask.......................................................................................................................................5-21
Remote Control Setup ...................................................................................................................5-22
Operation Related Setup ...............................................................................................................5-25
Drug Calculation ............................................................................................................................5-26
System Setup ...................................................................................................................5-27
User Mode Registration .................................................................................................... 5-29
About the User Mode.....................................................................................................................5-29
To Program the User Mode ...........................................................................................................5-30
Chapter 6 Setup Item/Default Value
Setup Item .......................................................................................................................... 6-1
Initial Settings ..................................................................................................................................6-1
External Connection (Pin Assignments) ........................................................................... 6-37
RS-232C Connector Output Signal................................................................................................6-37
Status I/O Signal (Status II Connector).......................................................................................... 6-38
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 Unit...................................................................................................................................... 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
Fan Filter..........................................................................................................................................8-4
NIBP Cuff and Air Hose................................................................................................................... 8-4
BP Transducer................................................................................................................................. 8-4
SpO2 Sensor ................................................................................................................................... 8-4
Temperature Probe..........................................................................................................................8-5
Cardiac Output Relay Cable............................................................................................................8-5
Airway Adapter for Capnostat 5.......................................................................................................8-5

5
Contents
Water Trap (Multigas Unit) .............................................................................................................. 8-5
BISx................................................................................................................................................. 8-7
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
Gas Measurement Accuracy Check Procedure (MGU-800/MGU-810).............................. 9-8
CO2 Calibration (HCP-800/HCP-810) .............................................................................. 9-10
Program Version............................................................................................................... 9-11
Software Install ................................................................................................................. 9-12

6
Contents

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 measuring parameters such as ECG, respiration, NIBP, pulse rate, SpO2, SpCO,
SpMet, pulse wave, temperature, BP, CO, respiration gas (concentration of CO2, N2O, volatile anesthetic agent, O2),
spirometry, BIS, brain wave, and monitors patient condition by displaying/printing 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
A Problem Related to Medical Practice
Damage to the Equipment

ii
Preface Important Notice
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-8500 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: [e-mail]
Home Page: http://www.fukuda.com
(2) Fukuda Denshi USA, Inc.
17725-C NE 65th Street Redmond, WA 98052 USA
Toll Free: [phone]
Local: [phone]
Fax: [phone]
Home Page: http://www.fukuda.com/index_usa.html

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.)
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.Operation Procedure and Screen
Examples
Operation procedure, home display, window, procedure to return to the previous 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 stop watch, connector
8.Review Function Arrhythmia analysis, 12-lead analysis, trend, recall, NIBP list, ST measurement,
hemodynamics, lung function, alarm history, other bed display, full disclosure waveform
9. Printing Recorder output function
10. System Configuration Setup of the display configuration, tone/volume, color, etc.
11. Troubleshooting Message list, maintenance and troubleshooting of this equipment
12. Setup Item/Default Value Setup details 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, mouse connection
2.Network System Construction Network connection and setup
3.Using the CF card Procedure to use the CF 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) ............................................xxi
Wireless Network System...............................................................xxii
RTC and Data Backup................................................................... xxiii
Precautions about the Ventilator Monitoring............................... xxiii
Precautions about the SpO2 Sensor .......................................... xxiii
Precautions about the NIBP Cuff................................................ xxiv
Precautions about Disposing of the Equipment, Accessories, or
Components ............................................................................... xxiv
Precautions about Transportation .............................................. xxiv
Monitoring after Power Failure.................................................... xxiv
To Prepare for Emergency Use .................................................. xxiv
Electromagnetic Compatibility ..................................................... xxv
Precautions for Safe Operation under Electromagnetic Influence..xxv
EMC Guidance ..............................................................................xxvi

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 labels attached to the unit and comply with these requirements while operating the
unit.
CAUTION
Do not damage or erase the warning labels attached to the unit.
These warning labels contain important descriptions for handling and operating the unit
properly and safely. A damaged label may compromise safe operation.
DS-8500 System Main Unit (DSC-8500 Series)
Warning Labels Attached to the 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
Warning Label
DS-8500 System Super Unit (HS-8000 Series)
Warning Labels Attached to the Unit (HS-8312)
Warning Label

iii
Safety About the Safety Precautions
Graphic Symbols
Refer following for the meaning of the symbols 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.
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)
Power ON
Indicates that the main power switch is in the ON position.
Power OFF
Indicates that the main power switch is in the OFF position.
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
Gas Input
GAS Output
Signal Input
TCP/IP Network Connector
RS-232C Connector
Eject: Indicates the switch to remove the recorder paper cassette.
Date of Manufacture
Indicates the date of manufacture.
Name and Address of Manufacturer
Indicates the name and address of manufacturer.
WEEE (Waste Electrical and Electronics Equipment)
Indicates a separate collection for electrical and electronic equipment.
Indicates that this device bears the CE label in accordance with the provisions of Medical Device Directive
93/42/EEC. The 0086 represents the number of the notified body.
Alarm Silence Key: Silences the alarm.
NIBP Start/Stop Key
Starts/stops the NIBP measurement.Stops the measurement if pressed while measurement is in progress.

iv
Safety Precautions for Safe Operation of Medical Electrical Equipment
Precautions for Safe Operation of Medical Electrical Equipment
CAUTION
Users should have a thorough knowledge of the operation before using this system.
Precautions about the Location of Installation and Storage of the Equipment
Do not install or store in an area where the unit will be subject to splashing 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 equipment.
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.
Do not install the equipment in a location where it is difficult to unplug the power cable.
Precautions Before Using the Equipment
 Verify the power voltage.
Check the cable connection and polarity to ensure proper operation of the unit.
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 other equipment as it may cause erroneous
judgment 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 patient, take appropriate measures such as ceasing operation
of the equipment in the safest way for the patient.
Do not allow the patient to come in contact with the equipment. Also, the operator should not contact the patient
and the equipment at the same time.
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 cable. Pull from the connector part
Home Key: Displays the home display.
Menu Key: Displays the menu screen.
Previous Display: Displays the previous display.
Symbol Description