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Fukuda VaSera VS-2000 Series - User Manual

Fukuda VaSera VS-2000 Series
234 pages
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SphygmomanometerandSphygmograph
Series
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Before using the product,
please read this manual thoroughly.
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Store this manual where it can be
always referred to.
Ver. 03
OperationManual

Table of Contents

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Summary

Sphygmomanometer and Sphygmograph Operation Manual

Product Overview and Safety Instructions

Introduction to the VaSera VS-2000 Series operation manual and essential safety guidelines for product use.

Safety Precautions and Regulations

Details CAUTIONary notes, legal restrictions (physician's order), and copyright information.

Preface and Device Introduction

Manual Purpose and Device Identification

Explains the manual's purpose and identifies the VS-2000 as the covered device.

Safety Notations and Symbols

Understanding Safety Notations

Defines DANGER, WARNING, CAUTION, and NOTE notations used for safety.

Interpreting Safety Symbols

Explains the meaning of various safety symbols used in the manual.

Device Safety Labels and Symbols

Safety Labels on the Device

Highlights the importance of warning labels attached to the device for safe operation.

Symbols Used on the Device

Lists and explains symbols commonly found on the device interface.

General Safety and Design Specifications

Compliance with Medical Electrical Standards

Details compliance with ANSI/AAMI ES 60601-1 and classification of protection.

Preventive Maintenance Requirements

Outlines necessary preventive maintenance and inspection schedules.

Specific Safety Precautions

Non-Explosion Proof Safety

Details DANGER warnings related to flammable gases and environments.

MRI and Defibrillator Usage Warnings

Provides WARNINGs for using the device near MRI or during defibrillation.

Cardiac Application Caution

CAUTIONs that the device is not designed for direct cardiac application.

Usage Precautions with Other Devices

High Frequency Surgical Device Interaction

WARNINGs for using the device with high-frequency surgical equipment.

Accessory and Cable Usage Warnings

WARNINGs regarding the use of specified accessories and cables.

Device and Accessory Handling

General warnings on device and accessory handling, including power connection and modification.

Connection, Disposal, and Leakage Current

Connecting to Other Devices and Disposal

WARNINGs on connecting unauthorized devices and proper disposal procedures.

Power Cable and Leakage Current CAUTIONS

CAUTIONs for power cable connection and potential risks from leakage current.

Precautions for Safe Operation

General Medical Electrical Equipment Safety

CAUTIONs for safe operation, covering impact, water, LCD, and patient contact.

Handling Media and Cleaning Procedures

Precautions for SD/USB insertion, touch panel use, and cleaning with ethanol.

Battery and Stand Usage Precautions

Guidelines for using the specified battery pack and stand for safe operation.

Installation and Environmental Precautions

Environmental Condition CAUTIONS

CAUTIONs regarding installation environment (temperature, humidity, chemicals, impact).

Operation Verification and Patient Safety

Steps to verify during operation for patient safety and error handling.

Operational Precautions and Troubleshooting

Cable Handling and Media Precautions

Precautions for handling cables, SD card, USB memory, and media saving.

PCG Microphone Precautions

CAUTIONs for PCG microphone use, including noise and impact.

Electromagnetic Interference (EMC) Guidance

EMC Precautions for Safe Operation

CAUTIONs for safe operation under electromagnetic interference (EMC).

Interpreting Test Results

CAUTIONs regarding the interpretation of printed results and clinical diagnosis.

Electromagnetic Compatibility (EMC) Compliance

EMC Guidance Overview

General guidance on EMC compliance for the VS-2000 device.

Electromagnetic Emissions Compliance

Details compliance with RF emissions standards (CISPR 11).

Electromagnetic Immunity Standards

Immunity Compliance (Part 1)

Details compliance levels for ESD, transients, surges, voltage variations, and magnetic fields.

Immunity Compliance (Part 2)

Details compliance levels for conducted RF and radiated RF immunity.

Error Messages and Countermeasures

Error Messages A & B

Lists error messages related to measurements and battery status with countermeasures.

Error Messages C & E

Details errors related to communication, SD card, USB, BP zero, and measurement timeouts.

Error Messages F & I

Covers errors related to connection, data deletion, SD/USB format, and input height/length.

Error Messages L, N, O, P

Lists errors for BP measurement, data selection, and DMS communication timeouts.

Error Messages R, S, T, V

Details errors for DMS settings, safety operations, analysis range, battery voltage, and valve errors.

Chapter 1: Preface and Device Overview

Introduction to the VS-2000 Device

Describes the intended use of the VS-2000, including PCG and BPU-100 capabilities.

Key Features of the VS-2000

Highlights main features like CAVI, Four-Limb BP, and BP Balance.

Measurement Indices and Functions

Explains ABI, TBI, CAVI measurement without ECG, and other functions like Color Printing.

Product Configuration and Options

Details the product configuration of the VS-2000 with optional items.

Included Accessories

Lists accessories included with the VS-2000, such as power cable and NIBP cuffs.

Optional Accessory Packages

Details optional packages like BPU-100 and limb/toe BP measurement kits.

Chapter 1: Device Components and Interface

Main Unit Components

Identifies and describes the parts of the main unit (front, rear, bottom views).

Main Unit Control Keys and Ports

Explains functions of control keys, power indicator, vents, and various ports.

Display Unit Interface

Details the front and rear views of the display unit and its control keys.

Screen Description for Examinations

Explains the layout and elements of the examination screen.

How to View Device Icons

Provides a guide to understanding the icons displayed on the screen for device status.

Chapter 2: Device Installation and Setup

Installation Location Cautions

Precautions for selecting an appropriate installation location, avoiding interference and noise.

Installing and Using the Battery

Instructions for optional battery installation, charging, and usage precautions.

Device Charging Procedures

Details the steps for charging the device's battery.

Operating on Battery Power

Guidance on operating the device using battery power and checking battery status.

Mounting the Device on a Stand

Step-by-step instructions for installing the main unit and display on the optional stand.

Connecting Cables and Peripherals

Instructions for connecting power cables, hoses, cuffs, and PCG microphone.

Connecting Cuffs for Examinations

Procedure for connecting cuffs for 2-channel and 4-channel examinations.

Connecting the PCG Microphone

Instructions on how to connect the PCG microphone to the device.

Installing Optional Devices

Guidance on installing optional devices like BPU-100 NIBP/Pulse Wave Units.

Turning the Device Power On and Off

Detailed steps for powering the device on and off, including initial boot-up.

Acquiring and Setting Date and Time

Procedure for setting the device's date and time, including UTC synchronization.

Basic Operations: Changing Examination Type

How to change the type of examination being performed.

Displaying the Menu

Steps to access and navigate the device's menu system.

Connecting the Device to a Network

Instructions for network configuration, including wired and wireless LAN setup.

Network Settings Configuration

Detailed steps for configuring wired LAN network settings on the device.

External Printer Output Settings

Guidance on connecting and configuring external network printers.

Saving Examination Reports to PDF

Instructions for saving reports as PDF files to media or shared folders.

Chapter 3: Pre-Examination Preparations

Attaching Cuffs for Standard Examination

Guides on attaching brachial and ankle cuffs, including size and color coding.

Attaching Cuffs for 4-Channel Exam

Details on attaching cuffs for 4-channel examinations, including color coding.

Using Limb Cushions (Optional)

Instructions on using limb cushions for improved waveform stability.

Attaching the PCG Microphone

Procedure for attaching the PCG microphone using adhesive tape.

Attaching Toe Cuffs for 6-Channel Exam

Steps for attaching toe cuffs, including size and color information.

Chapter 4: Entering Patient Information

Patient Data Categories and Input Methods

Details patient data fields and available input methods (manual, DMS, SD card).

Entering Basic Patient Information

Step-by-step guide for entering ID, birth date, gender, name, height, and weight.

Entering Abdominal Circumference and Medical Info

Instructions for inputting abdominal circumference, medicine, symptoms, and comments.

Entering Blood Pressure and Department

Procedure for entering blood pressure values and selecting department codes.

Loading Patient Information from DMS

Steps to load patient data from the Data Management System using Master ID.

Using SD Card for Patient Data

Guidance on registering and loading patient information using an SD card.

Searching Patient Information

Methods for searching patient data by ID, name, or examination date.

Deleting Unnecessary Patient Information

Procedure for deleting patient information from the SD card.

Loading Past Examination Data

Steps to load patient information from saved examination data on media.

Chapter 5: Blood Pressure and Pulse Wave Examinations

Patient Precautions and Basic Safety

Important precautions for patient care and basic safety during examinations.

Measurement Preparations Checklist

Ensuring appropriate examination environment and patient condition.

Home Display Overview

Explanation of the main screen layout and its components.

Function Buttons During Examinations

Description of function buttons available before, during, and after examinations.

Measuring CAVI;ABI (Standard 2-Channel)

Procedure for performing standard 2-channel CAVI and ABI measurements.

Measuring CAVI;ABI;TBI (4;6-Channel)

Procedure for performing 4 or 6-channel CAVI, ABI, and TBI measurements.

Pulse Wave and CAVI Check Details

Information on waveform length, real-time CAVI check, and auto extension.

CAVI Check and Result Display

Explains the CAVI indicator, measurement data, and result display interpretation.

Examination Result Display Options

Details on viewing summary, wave, BP, and trend results.

Manual Measurement Adjustments

How to change measurement items, sites, and manually set blood pressure.

Setting Waveform Sensitivity and Length

Adjusting sensitivity manually and entering blood vessel length.

Ensuring Accurate Measurements

Points to check for accurate measurements, including waveform quality.

Manual CAVI Measurement

Procedure for manually capturing and measuring waveforms for CAVI analysis.

Simple CAVI Measurement Procedure

Streamlined procedure for measuring CAVI only, reducing examination time.

Understanding Report Types

Overview of different report types available for printing.

Standard Report Content

Details the information included in the standard report.

Patient Report and Trend Analysis

Explains the patient-specific report and trend graphs for monitoring health.

Chapter 6: Blood Pressure and Pulse Wave Examination (Simple Mode)

Simple Mode Patient and Safety Precautions

Safety precautions specific to simple mode and patient care.

Simple Mode Measurement Content and Procedure

Details the measurements and step-by-step procedure for simple mode.

Simple Mode Examination Steps

Guided walkthrough for performing a simple mode examination.

Simple Mode Examination Result Display

Explains how to view results and interpret data in simple mode.

Interpreting Color Reports in Simple Mode

Guide to interpreting color reports generated in simple mode.

Report Preview in Simple Mode

Procedure for previewing examination reports before printing.

Chapter 7: Other Functions for BP;PW Examinations

Correcting Patient Information

Procedure for editing patient information after an examination.

Correcting CAVI Measurement Boundaries

Manual adjustment of boundaries for accurate CAVI calculation.

Comparing Waveforms Function

Using the function to compare past and current waveforms.

Recalculating ABI and TBI

Steps to recalculate ABI/TBI by changing measurement sites.

Series Examination Setup and Procedure

How to register and perform a series of up to three examinations.

Chapter 8: Brachial Blood Pressure Examinations

Brachial BP Patient and Safety Precautions

Important precautions for patients and safety during brachial BP measurements.

Brachial BP Measurement Preparations

Checking the examination environment and patient readiness for brachial BP measurement.

Home Display for Brachial BP

Overview of the home display screen relevant to brachial BP measurements.

Function Buttons for Brachial BP

Explanation of function buttons used during brachial BP examinations.

Measuring Brachial Blood Pressure

Detailed steps for performing brachial blood pressure measurements (manual/auto).

Interpreting Brachial BP Results

Guidance on understanding and interpreting brachial BP measurement results.

Brachial BP Report Interpretation

How to interpret different sections of the Brachial BP report.

Brachial BP Report Preview

Procedure for previewing brachial BP reports before printing.

Entering BP Results into Patient Information

Automatically entering BP measurement results into patient records.

Convenient Functions for BP Measurement

Highlights graphic simulation and pulse amplitude graph display features.

Chapter 9: File Transfers and Media Handling

Device Functions and Supported Media

Overview of file transfer functions and supported media (SD, USB, DMS).

Precautions for SD Card and USB Memory

CAUTIONs for handling and using SD cards and USB memory devices.

File and Folder Management

Information on organizing files using folders and inserting SD cards.

Function Buttons for File Operations

Details the function buttons for file list, trash box, and folder management.

Media Initialization (Formatting)

Steps for formatting SD cards and USB memory devices before use.

Saving Examination Data

Methods for saving data: auto save, manual simple, and file utility operations.

Loading Examination Data

Procedure for reading and reviewing examination data from media.

Searching Data with Specific Conditions

How to search data using ID, name, date, or folder number.

Printing Reports from Data

Instructions for selecting data and printing reports.

Media and Data Selection Operations

Changing media, printing data lists, and clearing selections.

Deleting and Restoring Examination Data

Procedure for deleting data from the list and restoring it from the trash box.

Correcting and Copying Examination Data

Editing existing data and copying data between different media.

Naming and Managing Folders

Steps for naming folders on SD cards and USB memory devices.

Changing the Data Save Folder

Procedure for selecting a different folder for saving data.

Communication History Management

Printing and managing the communication history with DMS and media.

Selecting Communication History for Printing

Specifying conditions to select communication history items for printing.

Chapter 10: Recording Daily Reports

Content of Daily Reports

Details the information included in daily reports, like date, time, and patient data.

Function Buttons for Daily Reports

Explains function buttons for saving, printing, and navigating daily reports.

Recording Daily Reports

Procedure for recording daily reports by date or all records.

Chapter 11: Device Settings Configuration

Overview of Device Settings

Lists categories of settings available for equipment, patient info, file, and communication.

Setting the Examination Method

How to configure and change the device's examination methods and parameters.

Equipment Control Settings

Configures general settings like examination mode, terminal number, and auto power-off.

Buzzer Control Settings

Adjusts volumes and tones for various buzzer alerts and key sounds.

Print and Localization Settings

Configures print options, paper size, output targets, and language settings.

Patient Information Input Settings

Configures how patient information is entered, referenced, and displayed.

ID Number, Age, and Name Settings

Settings for ID number format, auto-increment, and backup options for patient data.

Height, Weight, BMI, Department Settings

Configuration for entering and displaying physical measurements and department info.

Medicine, Symptoms, and BP Settings

Settings for inputting medicine, symptoms, comments, and BP measurement parameters.

Doctor and Technician Name Settings

Configuration for entering and managing doctor and technician names.

File Saving and Loading Settings

Configures settings for saving data to media and loading files.

Communication Settings

Configures device communication settings, including LAN and DMS connections.

Printer and Network Settings

Settings for connecting and configuring printers and network parameters.

Blood Pressure and Pulse Wave Settings

Configuration for pulse wave and BP examination parameters.

Pulse Wave Examination Settings

Detailed settings for pulse wave analysis, including PCG, wave sensitivity, and CAVI check.

BP Examination Specific Settings

Settings related to BP re-inflation, measurement pauses, and ABI/TBI judgment.

Print Settings Configuration

Configures printing items, paper speed, and automatic print copies.

Brachial BP Examination Settings

Settings for brachial BP anonymous mode, buzzers, auto save, and thresholds.

Registering and Managing Examinations

How to register new examinations, change order, and delete/copy existing ones.

Saving and Initializing Device Settings

Procedures for saving settings to SD card and initializing common settings.

Chapter 12: Maintenance and Inspection

Daily Inspection Procedures

Guidelines for daily visual and accessory checks to ensure device functionality.

Periodic Inspection Procedures

Annual inspections for device components, operation, and maintenance tests.

Performance Checks

Details performance tests for blood pressure and PCG filter characteristics.

Electrical Safety Inspection Methods

Procedures and allowable values for electrical safety testing.

Consumable Parts Replacement

Information on replacement periods for consumable parts like batteries and cuffs.

Cleaning and Disinfection Procedures

Instructions for cleaning and disinfecting the device, display, and accessories.

Replacing Built-in and Clock Batteries

Guidance on replacing the built-in battery and clock battery.

Handling System Error Messages

Describes system error messages and appropriate actions to take.

Chapter 13: Appendix

Main Device Specifications

Technical specifications for display, PCG, NIBP, power, and dimensions.

Blood Pressure and Pulse Wave Measurements Explained

Details on CAVI calculation, stiffness parameters, and Bramwell-Hill equation.

Vascular Length and Measurement Indices

Explains vascular length calculation, Oscillometric Method, ABI, and TBI.

BMI, UT, %MAP, AI, and BPB Calculations

Formulas and explanations for BMI, UT, %MAP, AI, and Blood Pressure Balance.

Printed Messages and Interpretation Criteria

Details messages and criteria for interpreting test results like ABI and TBI.

Optional Accessories List

Comprehensive list of optional accessories available for the VS-2000.

Peripheral Devices for System Integration

Lists peripheral devices like Ethernet hubs and printers compatible with the system.

Medical and Non-Medical Device Combinations

Guidance on combining medical and non-medical devices safely.

Inspection Lists for Maintenance

Checklists for daily and periodic inspections of the device.

Fukuda VaSera VS-2000 Series Specifications

General IconGeneral
ModelVS-2000 Series
PrinterBuilt-in thermal printer
Power SupplyAC 100-240V, 50/60 Hz
Measurement ItemsBlood Pressure, Heart Rate
Measurement MethodOscillometric method (Blood Pressure)
Measurement RangeBlood Pressure: 0-300 mmHg
AccuracyBlood Pressure: ±3 mmHg
Cuff Size (Arm)S: 17 - 22 cm, M: 22 - 32 cm, L: 32 - 42 cm
DisplayLCD touch screen
DimensionsApprox. 400(W) x 300(D) x 150(H) mm
Operating Environment Humidity30% - 85% RH (non-condensing)
Storage Environment Humidity10-90% RH (non-condensing)
ConnectivityUSB
Operating Environment Temperature10°C - 40°C

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