Page 1 Sphygmomanometer and Sphygmograph Series Ver. 03 Operation Manual * Before using the product, please read this manual thoroughly. * Store this manual where it can be always referred to.
Page 2 2015 Fukuda Denshi Co., Ltd. © No part of this document may be reproduced or transmitted in any form without the prior written permission of Fukuda Denshi Co., Ltd. If this manual has pages missing or out of order, contact Fukuda Denshi for replacement.
Page 3 Thank you for purchasing our product. This operation manual is a guide to the correct and safe use of the VaSera VS-2000 series. Read this operation manual carefully and make sure that you understand the instructions before using this device. It is recommended to keep this operation manual nearby at all times when operating this device.
Page 5: An Example Of Safety Symbol
Components are used in accordance with Fukuda Denshi operating instructions. If the device is used incorrectly and becomes unusable as a result, Fukuda Denshi is not liable for the malfunction. Use the device only for the purposes specified in this manual.
Page 6: Safety Labels
Safety Labels Warning (safety) labels are attached to this device to indicate precautions that need to be followed to ensure proper and safe use of the device. Make sure to follow the instructions of the warning labels attached to this device when operating the device. The positions of the labels attached to this device are indicated below.
Page 7: Safety
Safety ●Design Specifications This device complies with ANSI/AAMI ES 60601-1: "Medical Electrical Equipment - Part1: General Requirements for Basic Safety and Essential Performance" and is classified as follows: 1. Protection against electrical shock Class I, Internally Powered Device. 2. Degree of protection against electrical shock Type CF applied part.
Page 8: Non-Explosion Proof
Non-Explosion Proof DANGER • Never operate the equipment where flammable gas or fluid such as anesthetic, oxygen and hydrogen are used. Explosion or fire may result. • Never operate the equipment in the presence of flammable anesthetics, high concentration of oxygen. This may cause an explosion or fire.
Page 9: Using With High Frequency Surgical Devices
• Use only the cables specified by Fukuda Denshi. Use of other cables may result in increase in emission or decrease in immunity. • Contact your local Fukuda Denshi service representative for more information on connecting the cables. Device and Accessories WARNING •...
Page 10: Connection To Other Devices
Connection to Other Devices WARNING • Do not connect any unauthorized devices. Disposal WARNING • When disposing of this product and accessories, contact a specialized waste disposal company Connecting the Power Cable WARNING • When operating this device using an AC power supply, make sure to connect the power cable to a hospital grade outlet.
Page 11: Precautions For Safe Operation Of Medical Electrical Equipment
• Do not drop the device or subject it to strong impact or vibration. This may result in electric shock or a fire hazard. Contact your local Fukuda Denshi service representative if this device is dropped or otherwise damaged. • Do not subject the LCD screen to strong impact.
Page 12 This may result in overheating or a fire hazard. • Do not drop the device or subject it to strong impact or vibration. This may result in electric shock or a fire hazard. Contact your local Fukuda Denshi service representative if this device is dropped or damaged.
Page 13: Precautions Concerning The Pcg Microphone
ON, make sure that the icon indicating the media status has changed before operating the device. • Use only the media specified by Fukuda Denshi. Using unspecified media may cause failure to the device, such as damage or loss of waveform data.
Page 14: Precautions Concerning The Cuffs
Precautions Concerning the Cuffs CAUTION • Wash only the cuff cover in water, and clean only the surface of the cuff. Washing the cuff in water may cause water to get inside the cuff, which may damage the cuff or cause deterioration in performance.
Page 15: Precautions Concerning The Lan
• The devices to be connected to the network must be located outside the patient environment. (IEC 60601-1-1: 2000 / EN 60601-1-1: 2001) • Use only Ethernet hubs specified by Fukuda Denshi when connecting this device to the network (LAN).
Page 16: Storage And Cleaning
• Do not allow alcohol or other liquids to enter the device. • If the optional software is installed, make sure to keep the software (SD card). If the main unit needs to be repaired, send the optional software (SD card) to Fukuda Denshi along with the main unit.
Page 17: Cleaning The System Devices
Cleaning the System Devices CAUTION • Clean the connected devices according to the instructions in their respective manuals. Precautions for Safe Operation under Electromagnetic Interference (EMC) CAUTION ■ Malfunctions Due to EMC While this device complies with the IEC 60601-1-2 (2004) and JIS T 0601-2-25 (2006) safety standards, malfunctions may occur if there are strong electromagnetic (radio) waves nearby that exceed the limit.
Page 18: Emc Guidance
●EMC Guidance This device complies with the Safety Standard IEC 60601-1-2 (2004). However, if portable transmitter or wireless LAN equipment is used extremely nearby, the electromagnetic influence may largely exceed the compliance level and may cause unexpected phenomenon such as noise interference on the waveform, etc. This device should be used in a location specified by each medical institution.
Page 19 ●Compliance to the Electromagnetic Immunity (1) The VS-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the VS- 2000 should assure that it is used in such an environment. Immunity Test IEC 60601-1-2 Compliance Level Electromagnetic Environment/Guidance Test Level...
Page 20 ●Compliance to the Electromagnetic Immunity (2) The VS-2000 is intended for use in the electromagnetic environments specified below. The customer or the user of the VS- 2000 should assure that it is used in such an environment. Immunity Test IEC 60601-1-2 Compliance Level Electromagnetic Environment/Guidance Test Level...
Page 21 Recommended Separation Distance between Portable and Mobile RF Communications Equipment and the VS-2000 The VS-2000 is intended for use in electromagnetic environments where radiated RF interference is controlled. The customer or the user of the VS-2000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VS-2000 as recommended below, according to the maximum output power of the communications equipment.
Page 23: Messages And Countermeasures
Messages and Countermeasures The displayed error messages along with the countermeasures are listed below. If the error message is still displayed even after trying the countermeasure, stop the examination and contact your local Fukuda Denshi service representative. Message Cause Countermeasure Abnorm BP Meas.
Page 24 DMS (Data Management System). Check the communication settings. If no problem can be found on the communication settings, contact your local Fukuda Denshi service representative. Cannot write due to The data could not be saved on the SD card...
Page 25 Failed to load the settings from the SD card. Make sure that the correct SD card is used which the settings are saved. If the correct SD card is used, a failure of the SD card can be considered. Contact your local Fukuda Denshi service representative. Failed to retrieve patient The patient information could not be Make sure that the correct media is used.
Page 26 Message Cause Countermeasure Operation has timed out. The time limit for communication with the Check the connection and start the connection DMS (Data Management System) was again. exceeded. If this message appears frequently, contact your local Fukuda Denshi service representative.
Page 27 Message Cause Countermeasure Please set DMS. DMS is not set. Set the DMS. Please set SD card. SD card is not inserted. Insert an SD card. Please set USB mem. USB memory is not inserted. Insert a USB memory. Message Cause Countermeasure Replace the backup...
Page 28 Message Cause Countermeasure There is not enough space There is not enough space on the USB Replace with a USB memory with enough capacity. on USB mem. Please memory to save the data. replace the media with another one. To not run out of battery, During battery operation, the power will Turn ON the power again.
Page 29: Table Of Contents
Table of Contents Safety Notations ........................1 An Example of Safety Symbol .................... 1 Safety Labels ........................2 Symbols on the Device ....................... 2 Safety ..........................3 Non-Explosion Proof ......................4 Using with MRI ........................4 Using with Defibrillators ...................... 4 Application to Heart ......................
Page 30 PCG Microphone ......................1-5 BPU-100 NIBP/Pulse Wave Unit (Optional) ..............1-6 ASV-05U Four-Limb Blood Pressure Package (Optional) ..........1-6 ASV-06 Toe Blood Pressure Package (Optional) ............1-6 Names of Parts and Their Functions ..................1-7 Main Unit ..........................1-7 Display Unit ........................1-9 BPU-100 NIBP/Pulse Wave Unit ...................1-10 Description of the Screen ....................1-11 How to View the Icons ....................1-12 Chapter...
Page 31 Entering the Basic Information ....................4-3 Loading Information from the DMS (Master ID) ..............4-8 Using Patient Information Registered to an SD Card (Patient File Selection) ....... 4-9 Registering the Patient Information ................. 4-9 Loading the Patient Information Using the ID Number ............ 4-9 Loading the Patient Information by Specifying the Patient ..........
Page 32 Recalculating the ABI/TBI ......................7-4 Series Examination ........................7-5 About the Series Examination ..................7-5 Setting the Examination Type ..................7-5 Measurement Procedure ....................7-5 Chapter Brachial Blood Pressure Examinations ........8-1 Measurement Preparations ....................8-2 Home Display ........................8-2 Function Buttons Used in Examinations ................8-4 Measuring Blood Pressure ....................8-5 Examination Result Display ....................8-6 How to Interpret Reports .......................8-8 Entering the BP Examination Result in the Patient Information ..........8-10...
Page 33 Chapter Recording Daily Reports ............10-1 Content of Daily Reports ..................... 10-1 Function Buttons Used in These Operations ............... 10-2 Recording a Daily Report ....................10-2 Chapter Settings of This Device ............11-1 Overview of Settings ......................11-1 Function Buttons Used in These Operations ............... 11-1 Operations Used to Configure Settings ................
Page 34 Initializing Each Setting ....................11-26 Chapter Maintenance and Inspection ...........12-1 Daily Inspection ........................12-1 Daily Inspection Procedure ....................12-1 Periodic Inspection ......................12-2 Periodic Inspection Procedure ..................12-2 Electrical Safety Inspection Methods ...................12-6 About the Consumable Parts ....................12-9 Replacement Period of Consumable Parts ..............12-9 Cleaning and Disinfection ....................12-9 Cleaning and Disinfecting the Device ................12-9 Cleaning the Accessories ....................12-9 Replacing the Built-in Battery ....................12-10...
Page 35: Chapter Preface
Chapter Preface This chapter provides basic information to be aware of before using the device, such as the merits of the device and the names of the parts. Function of This Device ● VS-2000 (Intended Use) The device measures the non-invasive blood pressure in all four limbs to simultaneously obtain measurements such as PCG and four limb pulse waves.
Page 36 Chapter 1 Preface ● ABI (Ankle-Brachial Pressure Index) The ABI is an index indicating the degree of stenosis or occlusion of the lower limb artery due to peripheral arterial disease (PAD). A value of 0.90 or less indicates the probable presence of occlusion or stenosis. ●...
Page 37 Chapter 1 Preface The device can print PVR waveforms together in a single report to make it easy to view changes to the PVR waveform over time. ● Edit Waveform Division Points The positions of the division points in the waveforms can be edited. ●...
Page 38: Product Configuration Of The Vs-2000
Chapter 1 Preface Product Configuration of the VS-2000 Below are the product configuration of the VS-2000 and the measurements that can be performed by adding the optional items. Optional Measuring Items BPU-100 BPU-100 Four-Limb Blood Toe Blood Four-Limb BP Toe BP unit CAVI Pressure Pressure...
Page 39: Accessories
Chapter 1 Preface Accessories Accessories of the VS-2000 Accessory Model Quantity Remarks Operation Manual (this manual) Accessory Package The following is a list of accessories for the VS-2000. No. 1-3 are included in the ASV-04U accessory package. Accessory Model Quantity Remarks Power Cable (3 m) CS-24...
Page 40: Nibp/Pulse Wave Unit (Optional)
Chapter 1 Preface BPU-100 NIBP/Pulse Wave Unit (Optional) An additional unit for measuring non-invasive blood pressure and pulse wave with two channels. Accessory Model Quantity Remarks NIBP/Pulse Wave Unit BPU-100 ASV-05U Four-Limb Blood Pressure Package (Optional) Accessory Model Quantity Remarks NIBP Cuffs (Right Brachium) CUF-129MRU...
Page 41: Names Of Parts And Their Functions
Chapter 1 Preface Names of Parts and Their Functions Main Unit This section explains the names and functions of the parts of the VS-2000. CAUTION • Do not bend or drop the SD card or USB memory or subject them to impact. •...
Page 42 Chapter 1 Preface ■ Control keys The following is an outline of the functions of each part. 1) AC Power Indicator (Blue) 7) SD Card Slot When the device is connected to an AC outlet, the LED is Insert an SD card (optional). Use this to store or read lit faintly.
Page 43: Display Unit
Chapter 1 Preface Display Unit ■ Front view ■ Rear view ■ Control keys 1) POWER Key Displays information such as waveform information and patient information. (Refer to "Description of the Screen" Turns the device ON and OFF. Hold down the button for (P1-11) ) 1 second or longer to turn OFF.
Page 44: Bpu-100 Nibp/Pulse Wave Unit
Chapter 1 Preface BPU-100 NIBP/Pulse Wave Unit 1) Function Keys 2) Air Connectors Keys for performing maintenance operations. Connect the air hoses connected to the cuffs. 3) BPU Connector Connects the cable to the main unit. These control keys are for maintenance and cannot be used during normal examinations.
Page 45: Description Of The Screen
Chapter 1 Preface Description of the Screen This section explains the screens for blood pressure and pulse wave examinations. This is an example of the screen shown during a 4-channel blood pressure and pulse wave examination. [Blood Pressure and Pulse Wave Examination Screen (Standard Examination Mode)] 5) Exam.
Page 46: How To View The Icons
Chapter 1 Preface How to View the Icons Home Display The icons indicating the status of external device are displayed at the bottom of the screen. The following information on devices, etc. is displayed Power VaSera External BPU1 BPU2 BPU3 Memory Card Supply/...
Page 47 Chapter 1 Preface Item Icon Description Item Icon Description External Printer Connected BPU2 Normal connection Error Error When not connected When unused BPU3 Normal connection BPU1 Normal connection Error Error When not connected When unused 1-13...
Page 48 Chapter 1 Preface Information Window The following window is displayed when the Information button is touched. 2) Previous Display 3) Device Status Icons 1) Alert Display Area 1) Alert Display Area An image indicating the type of error is displayed when the following two types of errors occur. •Device errors •Examination errors 2) Previous Display...
Page 49 Chapter 1 Preface Item Icon Description Item Icon Description VaSera (CAVI) VaSera LAN connection error External Printer Paper jam in external printer VaSera wireless LAN connection Low toner in external printer error External Printer External printer error External printer out of toner External printer out of paper ●...
Page 50 Chapter 1 Preface Icons displayed in other windows Item Icon Description External Printer External printer connection Display area Icon Description During file SD Card operations External printer error USB1 External printer out of paper USB2 Paper jam in external printer USB3 Low toner in external printer External printer out of toner...
Page 51: Chapter Installation
Chapter Installation Install the device in preparation to conduct measurements. Cautions when Selecting the Installation Location Take the following precautions when selecting the installation location. • Radio interference occurs if there are strong radiated radio waves nearby (leakage currents, static induction and electromagnetic induction enter by the path shown in the figure).
Page 52: Installing The Battery (Optional)
Leakage, overheating or explosion may occur if a battery other than the specified battery is used. Installation Installation of the battery should be performed by a Fukuda Denshi service representative. Contact your nearest service representative to install the battery. Cautions When Using the Battery Take the following precautions when using the battery.
Page 53: Charging
Remove the power cable, wait a while and then charge the battery again. If the charge lamp still lights in yellow when charging the battery again, contact Fukuda Denshi. The battery charges from a completely empty state within 2 hours and 30 minutes. The charging time varies depending on factors such as the level from which the battery is charged and the ambient temperature.
Page 54: Operating The Device On Battery Power
Chapter 2 Installation Operating the Device on Battery Power Turn on the device by pressing the [POWER] key on the display unit while the power cable is unplugged. (Refer to "Turning the Power ON and OFF" (P2-12) ) The device automatically switches to battery power if the power cable is removed or a power outage occurs while operating the device on AC power.
Page 55: Installing The Main Unit And Display Unit On A Stand
Chapter 2 Installation Installing the Main Unit and Display Unit on a Stand When using the optional stand (OTV-03), install the device as follows. WARNING • Use the specified stand (OTV-03). • Make sure to secure the device to the stand using the specified screws. If the device is not secured, it may fall off the stand, resulting in injury to the operator or damage to the device.
Page 56 Chapter 2 Installation 1) Insert the fixing bracket into the slits of the main unit. 2) Lock with the knobbed bolt. Insert the display unit into the fixing bracket at the top of the stand. Secure with the four M4 screws. Tilt the screen around 30°...
Page 57 Chapter 2 Installation Secure the hinged cover with the two screws. Connect the cable of the display unit to the DISPLAY connector on the rear side DISPLAY of the main unit. Securely tighten the screws at either end of the DISPLAY connector.
Page 58: Connecting The Cables, Hoses, Cuffs And Pcg Microphone
Chapter 2 Installation Connecting the Cables, Hoses, Cuffs and PCG Microphone WARNING • Connect the power cable to a hospital grade outlet. Grounding is only guaranteed if the device is plugged in by connecting the supplied power cable to a hospital-grade three prong grounded outlet.
Page 59: Connecting The Cuffs (2-Channel Examination)
Chapter 2 Installation To equalize the potential, connect the optional potential equalization cable to the potential equalization terminal of the device and the potential equalization terminal of another device. When connecting multiple devices, electrical potential difference may be generated between the devices. This may result in electric shock to the patient connected to these devices.
Page 60: Connecting The Pcg Microphone
The cuffs and PCG microphone can be stored in the storage case on the stand. Installing Optional Devices Installation of the BPU-100 NIBP/Pulse Wave Unit should be performed by Fukuda Denshi service representative. When installing, contact your nearest service representative 2-10...
Page 61: Connecting The Cuffs (4-Channel Examination)
Chapter 2 Installation Connecting the Cuffs (4-Channel Examination) Insert the connector of the air hose into Right Right Brachium Brachium the air connector on the device and Left Left Brachium rotate the connector to secure it. Brachium Yellow Right Ankle Connect the connector of the air hose to the Right Ankle Black...
Page 62: Turning The Power On And Off
Chapter 2 Installation Turning the Power ON and OFF To Turn ON the Power Check that the AC power indicator is lit faintly in blue. Press the [POWER] key on either the display unit or the main unit. Check that a beep sounds when the POWER key is pressed.
Page 63: To Turn Off The Power
Chapter 2 Installation To Turn OFF the Power Check that all measurement operations When turning OFF the power of the main on the device and transmissions to the unit, unplug the power cable from the computer have been completed (the main unit.
Page 64: Acquiring The Date And Time
Chapter 2 Installation Acquiring the Date and Time Check the date and time at the bottom right of the home display and set the correct date and time if they are not correct. If the date/time becomes incorrect although the correct date/time is set, the built-in battery may have reached the expiration date.
Page 65: Basic Operations
Chapter 2 Installation Basic Operations Changing the Examination Type Touch [Examination]. Touch the desired examination. Touch [V] to display the next page. Touch [x] to close the "Select Examination" window without switching the examination. Types of examination icons Blue border: Blood Pressure and Pulse Wave Green border: Series examination Displaying the Menu Touch the [Menu] button on the touch...
Page 66: Connecting To The Network
17) and change the settings. WARNING • Configure and connect to the network as specified by Fukuda Denshi. • Use an external printer and Ethernet hub specified by Fukuda Denshi. • The devices connected to the network, such as the external printer, Ethernet hub and computer, need to be installed 1.5m away from the patient (IEC 60601-1-1: 2000/EN 60601-1-1: 2001).
Page 67: Network Settings (Wired Lan)
• Consult the network administrator to confirm the IP addresses (e.g. 192.168.0.3) and port numbers that can be assigned to the device, computer and printer. • Contact Fukuda Denshi for more information on configuring the wireless LAN settings. ■Configuring the Settings Touch the [Menu] button.
Page 68 Chapter 2 Installation Touch [Communication]. Select [ON] for [Communication] in the Touch the [DMS Settings] tab. [General] tab. Enter the subnet mask and default gateway in <Gateway>. Check that [Method] is set to [Wired LAN]. Refer to "■Example Setting: For "Example of Set the IP address of the device.
Page 69 Chapter 2 Installation Set [Network Printer] to [ON] if using a Touch [Enter] after configuring the settings. network printer. Select [Equipment Control] - [Print on Normal Paper] - [Output Target] and then Enter the IP address and port number. select [Network Printer] or [PC Printer]. ■Example Setting: For "Example of Network Configuration"...
Page 70 Chapter 2 Installation Example of network printer settings Item Description IP Address 192.168.0.6 Port No. 9100 Network settings of shared folder Item Description IP Address The IP address of the Windows computer on which the shared folder was created. Shared folder settings Item Description Mounted Directory...
Page 71: Settings For External Printer Output
Chapter 2 Installation Settings for External Printer Output Network printers that can print without a computer (laser printers) can be connected as external printers. The entire process for printing via an external printer takes around 1-2 minutes per page. It may take a long time to complete a print job if a large volume of printing is requested at once.
Page 72: Settings For Saving Pdf Files
Chapter 2 Installation Settings for Saving PDF Files PDF files of examination reports can be saved on the SD card or USB memory. Pulse wave examination reports can also be stored in a shared folder on the network. Network Settings (If Using a Shared Folder) Configure the following settings.
Page 73: Pre-Examination Preparations
Chapter Pre-Examination Preparations This section explains how to attach the cuffs, sensors and to set the date and time. Attaching the Cuffs The cuffs can be attached to the brachium, ankle, or toe. Attaching the Cuffs (Standard 2-Channel Examination) • There are brachial and ankle cuffs. The edge colors of the cuffs indicate the measurement site as follows.: Brachial: Orange Ankle: Blue Attach to the correct site according to the edge color of the cuff.
Page 74: Attaching The Limb Cuffs (4-Channel Examination)
Chapter 3 Pre-Examination Preparations Attaching the Cuff to the Brachium Attach a brachial cuff (orange edge) to the right or left brachium. Wrap the cuff on the brachium with its center (where the air hose is connected) going along the center of the inside of the brachium and with the lower side of the cuff just above the elbow joint.
Page 75 Chapter 3 Pre-Examination Preparations No. Model Usage, Size Applicable Circumference Range CUF-129SRU Right brachium, S 17-22cm (6.7"-8.7") CUF-129SLU Left brachium, S CUF-138SRU Right ankle, S 17-22cm (6.7"-8.7") CUF-138SLU Left ankle, S CUF-129MRU Right brachium, M 22-30cm (8.7"-11.8") CUF-129MLU Left brachium, M CUF-138MRU Right ankle, M 20-30cm...
Page 76: Using The Limb Cushion (Optional, 2-Channel/4-Channel Examination)
Chapter 3 Pre-Examination Preparations Attaching the Cuff to the Ankle Select the black-edged cuff for the right ankle and the green-edged cuff for the left ankle. Place the cuff so that the bottom is 1cm above the ankle and the label with the arrow is on the inside of the ankle. Bending the knees of the patient will facilitate the cuff application.
Page 77: Attaching The Pcg Microphone
Chapter 3 Pre-Examination Preparations CAUTION • If there is a risk of bone fracture due to osteoporosis, etc, be particularly careful when raising the patient's arm or leg to place it on the limb cushion. Special care must also be taken when attaching cuffs to these patients.
Page 78: Attaching The Toe Cuff (6-Channel Examination)
Chapter 3 Pre-Examination Preparations Attaching the Toe Cuff (6-Channel Examination) CAUTION • Be careful not to wrap the toe cuff around the toe too hard. The cuff may restrict the blood flow resulting in hemostasis. • Do not wrap the toe cuffs too loosely or at an angle. Otherwise, the cuff may burst or give inaccurate measurements.
Page 79: Entering Patient Information
Chapter Entering Patient Information Enter the name, age and gender of the patient. There are following 6 methods to enter the information. Input Method Description Reference Basic Enter items such as the ID, age, gender and height "Entering the Basic Information" (P4-3) information manually.
Page 80 Chapter 4 Entering Patient Information Display Description Setting Range Note Abdominal Abdominal Circumference 3-digit integer + 1 decimal place Unit: cm, inch Max. 300cm Circumfere Blood Blood vessel length 3-digit integer + 1 decimal place Unit: cm, inch (Displayed when the blood vessel Max.
Page 81: Entering The Basic Information
Chapter 4 Entering Patient Information Entering the Basic Information Turn ON the power. (Refer to "Turning the Power ON and OFF" (P2-12).) Touch the patient information display area. Touch the number buttons to enter the patient's year of birth. • [Clear]: All entered numbers are cleared. Enter the ID number.
Page 82 Chapter 4 Entering Patient Information Select the patient's gender. Touch "Male" or "Female". • [Clear]: The entered gender is cleared. • [x]: Closes the "Gender" window. Touch [ • The entered gender is reflected in the "Patient Touch the number buttons to enter the Information"...
Page 83 Chapter 4 Entering Patient Information Enter the abdominal circumference. Touch the applicable symptom. • [Clear]: All entered numbers are cleared. • [x]: Closes the window. Touch [ Touch the number buttons to enter the • The selected symptoms are reflected in the "Patient patient's abdominal circumference.
Page 84 Chapter 4 Entering Patient Information ■ Entering the Department Code Directly Enter the blood pressure (BP). Department codes can be directly entered by the following process: Touch [Input Code]. Touch the number buttons to enter the code. • [Clear]: All entered numbers are cleared. •...
Page 85 Chapter 4 Entering Patient Information Enter the name of the department. Touch [ • The selected content is reflected in the "Patient Information" window. The code and doctor/technician name can be changed by touching the applicable doctor/ technician name and then touching [Change].
Page 86: Loading Information From The Dms (Master Id)
Chapter 4 Entering Patient Information Loading Information from the DMS (Master Turn the ID number into a button and search for and load the patient information from the DMS. For patient information settings, select [Extended] under [General/ID-A.C.] - [Input ID], and [Master ID] under [General/ID- A.C.] - [Patient Information Reference] beforehand.
Page 87: Using Patient Information Registered To An Sd Card (Patient File Selection)
• A maximum of 5,000 patient data can be registered to the SD card, but this number may vary depending on the capacity of the SD card that is used and the content that is recorded. Use only an SD card specified by Fukuda Denshi.
Page 88: Loading The Patient Information By Specifying The Patient
Chapter 4 Entering Patient Information • The entered ID is reflected in the "Patient Information" window. The message "No patient information was found for The patient information will be searched on the entered ID number" is displayed if there is no the SD card from the entered ID, and the patient information corresponding to the specified ID searched information will be displayed in the...
Page 89: Deleting The Unnecessary Patient Information
Chapter 4 Entering Patient Information Deleting the Unnecessary Patient Information Unnecessary patient information can be deleted from the SD card. Touch [Edit]. Select the patient to be deleted, and touch [Delete]. A confirmation window will be displayed. Touch [Execute]. The specified patient information is deleted from the SD card.
Page 90 Chapter 4 Entering Patient Information Using Patient Information from Examination Data Saved to the Media (Load Past Information) The examination data saved on the media (internal memory, SD card, USB memory) can be loaded and used on the next examination. To use this function, set [General/ID-A.C.] - [Input ID] to "Extension"...
Page 91: Chapter Blood Pressure And Pulse Wave Examinations (Cavi/Abi/Tbi): Standard Mode
Chapter Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Limb blood pressure, CAVI, ABI and TBI can be measured. Take care when applying to the following patients. • Patients with swelling or who bleed easily • Patients with blood congestion that may cause a thrombus •...
Page 92: Measurement Preparations
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Measurement Preparations Check the following again before measuring. Two modes can be used for blood pressure and pulse wave examinations: Simple Examination Mode and Standard Examination Mode. This section explains Standard Examination Mode. The mode can be switched by configuring the setting in [Menu] - [Setting] - [Equipment Control] - [Examination Mode].
Page 93: Home Display
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Home Display [Pulse Wave Examination Screen (Standard Examination Mode)] 5) Examination Button 1) ID Button 7) Examination Mode Button 4) Menu Button 2) Pulse Rate 8) i Button (Information Button) 3) Examination Sequence 6) CAVI Indicator 9) Measurement Site/Sensitivity...
Page 94: Function Buttons Used In Examinations
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Function Buttons Used in Examinations Before Examination Result Sensitivity Previous Measurement Blood Vessel Length Measurement Content Touch [1/2] to switch displays Normal Md. File List Assist Toe Cuff Comm.Inp. Offline Md.
Page 95 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode [Assist Toe Cuff]: Turns ON/OFF the Assist Toe Cuff [Window Selection]: Displays the windows that can be function. This is displayed when TBI measurement is selected in the result display. available.
Page 96: Measuring Cavi/Abi (Standard 2-Channel Examination)
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Measuring CAVI/ABI (Standard 2-Channel Examination) Below is the measurement procedure for standard 2-channel examination. This section describes the procedures for each mode. Measurement Press [START]. CAVI Check Waveform Acquisition Right Side Measurement (If “ON”...
Page 97 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Touch [Examination]. Check the measurement items. Touch [PW/BP Exam.]. Select from CAVI/Pulse Wave or ABI/Limb BP. The preset examination mode will be displayed when Check the measurement sites. the power is turned ON. Check the measurement sites.
Page 98 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Change the cuff sites. Remove the cuffs reliability of the waveform. A red display indicates low reliability and a green display indicates high reliability. from the right brachium/ankle and attach If the display remains red, press the [STOP] key to stop them to the left brachium/ankle.
Page 99: Measuring Cavi/Abi/Tbi (4-Channel/6-Channel Examination)
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Measuring CAVI/ABI/TBI (4-Channel/6-Channel Examination) Below is the measurement procedure for a 4-channel or 6-channel examination. If one BPU-100 NIBP/Pulse Wave Unit is added, measurements can be performed on the left and right sides without switching the cuffs.
Page 100 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Touch [Measurement Content]. Press the [START] key on the display unit. • Inflate the cuffs to acquire a pulse wave. • If "Manual" is set as the method for acquiring a waveform, refer to "Manually Capturing and Measuring Waveforms"...
Page 101: Attachment Site Guide
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Upon completion, the examination If CAVI cannot be measured due to causes result will be displayed. (Refer to such as noise interference, the message "Examination Result Display" (P5-14) .) "Cannot measure CAVI..."...
Page 102: Waveform Length Of Pulse Wave
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Waveform Length of Pulse Wave Select a waveform length for the pulse wave to be obtained in the CAVI examination from 5 seconds, 8 seconds or 16 seconds. A longer waveform length means that measurement takes longer, but it improves the accuracy as a larger number of pulse waves can be used for the CAVI calculation.
Page 103 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode [2-Channel Examination] 2) CAVI Indicator 3) Remaining Time 4) Measured Beats 5) Comment 6) Measured Data 1) Waveforms [4 or 6-Channel Examination] 2) CAVI Indicator 3) Remaining Time 4) Measured Beats 5) Comment 6) Measured Data 1) Waveforms...
Page 104: Examination Result Display
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● [Pause] Touch this to pause the countdown. ● [Cancel] Touch this to resume the countdown. Examination Result Display When the examination is completed, the examination result will be displayed. Flick left or right on the screen (slide your finger quickly across the screen) to switch between the examination result displays.
Page 105 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● [Wave+Meas.] The waveform and the measurement for each beat can be checked. 2-Channel Examination 4-Channel Examination • The patient information (ID, name, gender, age, height and weight) and the date/time of the examination are displayed. •...
Page 106 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode • A pulse amplitude graph is shown for the left and right brachia, left and right ankles and left and right toes. • If "ON" is set for Inflate Brachial Cuff for TBI, the SYS/DIA, UT and %MAP values and a pulse amplitude graph of the left and right brachia when measuring TBI will be also displayed.
Page 107 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● Report Preview When printing, touch "Preview" to check the preview of the report before printing. Back Next Zoom In Zoom Out Back [Zoom In]: Enlarges the display. [Zoom Out]: Reduces the display. [Next]: Preview of the next report will be displayed.
Page 108 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode amplitude graph shows the pulse wave amplitude and the blood pressure value measured by the oscillometric method. The amplitude is adjusted at recording for easy viewing. The highest level of pulse wave amplitude obtained while measuring the blood pressure will be indicated. A pulse wave amplitude level that is higher above the reference level indicates a more stable measurement.
Page 109: Changing The Measurement Content
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Changing the Measurement Content Checking and Changing the Measurement Items and Sites Touch [Measurement Content]. Touch the measurement sites. The blood pressure or pulse wave can be measured only for the highlighted sites. The default measurement sites are the sites set in The default measurement items are the items set in [PW/BP [PW/BP Exam.] - [Pulse Wave: Gen] - [Default...
Page 110: Setting Sensitivity Manually
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Setting Sensitivity Manually Touch [Sensitivity]. Touch the button displaying the sensitivity ([x4], [x1/16], etc.) to set the sensitivity to "AUTO" (automatic sensitivity). Touch [+] or [-] to change the sensitivity. Touch [Back] after configuring the •...
Page 111 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Enter the distance between the Enter the value. measurement sites. Touch [ • The L1 distance is automatically calculated and entered when the AF distance is entered. • The total L distance is calculated when all values are entered.
Page 112 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Touch [Blood Vessel Length]. Touch the button for the corresponding value. Enter the distances to the aortic valve, artery and knee joint positions. Enter the value. Touch [ The distances between the entered positions (L1, L2 and L3) are calculated automatically.
Page 113: To Ensure Accurate Measurement
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode To Ensure Accurate Measurement Pay attention to the following points to ensure accurate measurement. Note: Points for Checking Waveforms PCG waveform: Check that there is a primary radical wave in the second heart sound.
Page 114: Measuring Cavi (Manually)
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Measuring CAVI (Manually) During CAVI examinations, it is possible to obtain up to 100 seconds of waveform data and select and measure any continuous heart rate from the screen while viewing the CAVI indicator. This function is common to 2-channel, 4-channel and 6-channel examinations.
Page 115: Simple Cavi Measurement
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode After selecting the waveform, touch Check the points mentioned in "To Ensure Accurate Measurement". [Measure]. The blood pressure measurement starts after the CAVI After the CAVI check display, measurement will start. check display.
Page 116: Description Of The Reports
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Description of the Reports Types of Reports The following reports can be printed. Report Name Printed Items Standard Report A 5, 8 or 16-second PCG, limb and toe pulse waves, CAVI, ABI, TBI, blood pressure, pulse amplitude graph, patient body illustration, trend graph, age graph and comments are printed.
Page 117: Color Reports
Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode Color Reports ● Standard Report 5-27...
Page 118 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode The content to be printed can be selected by configuring the settings. 7) Waveform PCG and cuff pulse wave (for the brachia, ankles and toes) are recorded. UT and %MAP values for the ankles and toes are also recorded.
Page 119 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● Report for Patient 5-29...
Page 120 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode An ABI value of 0.90 or less is shown with a yellow background. 5) Trend Graph A trend graph of the right brachial blood pressure and weight is printed. 1) Patient information The patient information and the examination date/time are recorded.
Page 121 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● Trend Report 5-31...
Page 122 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode 1) Patient information The patient information and the examination date/time are recorded. 2) Trend Display The following trend graphs are recorded. ・ CAVI Trend ・ ABI Trend ・ TBI Trend ・...
Page 123 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● Pulse Wave Report (The above example is a pulse wave report of "5 seconds" measurement.) 1) Header Information Area 4) Footer Area The examination date, patient information and pulse Information such as hospital name is recorded.
Page 124 Chapter 5 Blood Pressure and Pulse Wave Examinations (CAVI/ABI/TBI): Standard Mode ● Beat Table Report 1) Header Information Area 3) Footer Area The examination date and time, patient information Information such as hospital name is recorded. and pulse rate are recorded. 2) Details Area The following information is recorded: Detailed values for each beat (tb, tba, CAVI,...
Page 125: Chapter Blood Pressure And Pulse Wave Examination: Simple Mode
Chapter Blood Pressure and Pulse Wave Examination: Simple Mode Take care when applying equipment to the following patients. • Patients with swelling or who bleed easily • Patients with blood congestion that may cause a thrombus • Patients with blood congestion that may cause peripheral circulation obstruction •...
Page 126: Measurement Content
Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode Measurement Content The following items can be measured in this mode. • CAVI on one side (right or left) • Brachial and ankle blood pressure on one side As Simple Examination Mode only measures one side, ABI is not measured and blood pressure is displayed for one ankle only.
Page 127 Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode Touch [Examination]. Touch [CAVI/BP]. Attach the cuffs to the brachium and ankle according to the displayed When the power is turned ON, the registered examination for startup will be displayed. instructions and then touch [Next].
Page 128 Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode Read the displayed precautions, then touch [Start]. Touch [Cancel] to perform the examination again. To proceed to the blood pressure measurement, touch [Next]. • The blood pressure is measured. • Pulse wave acquisition starts. •...
Page 129: Examination Result Display
Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode Examination Result Display When the examination is completed, the result display appears. Flick the screen (slide your finger quickly across the screen) to switch between displays. ● Result Display 1) Patient Information Display 4) Ankle BP (SYS) Displays the patient information and the examination Displays the ankle blood pressure measurements.
Page 130 Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode ● Trend Result Display 1) Patient Information Display Displays the patient information and the examination date and time. 2) Trend Graph Displays the right or left CAVI value and right brachial blood pressure (SYS/DIA) in graph format. ●...
Page 131: How To Interpret Reports
Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode How to Interpret Reports Color Reports The following report is output from color printers. ● Simple Examination Report...
Page 132 Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode 1) Patient information Records the patient information and the date/time of measurement. 2) CAVI Records the R(L)-CAVI measurement. 3) %MAP and UT for Ankle Records the %MAP and UT measurements. Displays the explanatory drawings for %MAP and UT.
Page 133 Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode Report Preview Examination reports can be checked on the display before printing. Conduct the examination. Check the report. Touch [Print] in the examination result display. [Back]: Displays a preview of the previous report. [Next]: Displays a preview of the next report.
Page 134 Chapter 6 Blood Pressure and Pulse Wave Examination: Simple Mode 6-10...
Page 135: Correcting The Patient Information
Chapter Blood Pressure and Pulse Wave Examinations: Other Functions Correcting the Patient Information In the examination result display, patient information can be corrected. Conduct the examination. Correct the patient information. After the examination, examination result will be displayed. Touch the patient information display area.
Page 136: Correcting The Boundaries For Cavi Measurement
Chapter 7 Blood Pressure and Pulse Wave Examinations: Other Functions Correcting the Boundaries for CAVI Measurement The boundaries for calculating CAVI can be manually corrected. The boundaries that can be edited in each examination are as follows. • CAVI: Second heart sound, right brachial rise, left brachial rise, right brachial notch, left brachial notch, right ankle rise, left ankle rise Display the waveforms on the Touch the following cursor buttons to move...
Page 137: Using The Compare Waveforms Function
Chapter 7 Blood Pressure and Pulse Wave Examinations: Other Functions Using the Compare Waveforms Function If the past examination results of the same ID are saved, the previous results of dominant waveform, ABI, TBI, CAVI, tb, tba values can be loaded and displayed. This function is not available for 2-channel mode examination.
Page 138: Recalculating The Abi/Tbi
Chapter 7 Blood Pressure and Pulse Wave Examinations: Other Functions Recalculating the ABI/TBI To eliminate influences such as subclavian stenosis, ABI/TBI can be recalculated by changing the measurement site on the brachium. ■ To Recalculate the TBI Select [PW/BP Exam.]. Slide the display to the BP display.
Page 139: Series Examination
Chapter 7 Blood Pressure and Pulse Wave Examinations: Other Functions Series Examination Maximum of three types of examinations can be performed continuously on the same patient. About the Series Examination A series examination allows to perform maximum of 3 examinations continuously, which can be selected from PW/ BP or other newly registered examination.
Page 140 Chapter 7 Blood Pressure and Pulse Wave Examinations: Other Functions...
Page 141: Chapter Brachial Blood Pressure Examinations
Chapter Brachial Blood Pressure Examinations Brachial blood pressure examinations measure the blood pressure in the right, left or both brachia. The measurement count can be selected from 1, 2, or 3 (default: 1), interval time can be selected from 1 to 5 minutes, and simultaneous measurement on both brachia, multiple measurements, average calculation is possible.
Page 142: Measurement Preparations
Chapter 8 Brachial Blood Pressure Examinations Measurement Preparations Check the following again before measuring. Is the place of examination appropriate? • Check for noise generating electrical devices such as x-ray equipment or ultrasonic instruments nearby. If any, turn them OFF or change the place of examination to avoid adverse influence from such instruments. •...
Page 143 Chapter 8 Brachial Blood Pressure Examinations Displayed content: Current cuff pressure, systolic blood pressure, diastolic blood pressure, pulse rate, pulse amplitude graph 4) Function Button Buttons for controlling the main unit are available. 5) Examination Status Displays the status of the examination. 6) Examination Button Tapping this button displays the "Select Examination"...
Page 144: Function Buttons Used In Examinations
Chapter 8 Brachial Blood Pressure Examinations Function Buttons Used in Examinations Before Examinations Result Measurement Content Touch [1/2] to switch displays Normal Md. File List Comm. Inp. Offline Md. During Examination Results Display Next Save Print Back [Measurement Content]: Set the measurement site, [Print]: Prints an examination report.
Page 145: Measuring Blood Pressure
Chapter 8 Brachial Blood Pressure Examinations Measuring Blood Pressure The following is an outline of measurement operations. Interval Interval 1 to 5 min. 1 to 5 min. Measurement Measurement Measurement Press [START]. Print Report Touch Examination BP Measurement Save File [Use] Button.
Page 146: Examination Result Display
Chapter 8 Brachial Blood Pressure Examinations when the first measurement is completed. The second • The results of the last three blood pressure and third measurements start automatically when the measurements are displayed. specified time has elapsed after the start time of the •...
Page 147 Chapter 8 Brachial Blood Pressure Examinations Refer to "How to Interpret Reports" (P8-8) for instructions on how to interpret reports. ● [Print] Examination results can be manually output to an external color printer, etc. Touch [Print] to print to the set output destination. Touch [Preview] to display the report to be printed on the screen.
Page 148: How To Interpret Reports
Chapter 8 Brachial Blood Pressure Examinations How to Interpret Reports ● Brachial BP Report When a comment area is printed When a blood pressure and pulse wave graph is printed Patient information The patient information and the measurement date and time are printed.
Page 149 Chapter 8 Brachial Blood Pressure Examinations Blood Pressure Trend Graph Blood Pressure and Pulse Wave Graph A trend graph of the systolic and diastolic blood A graph of the blood pressure and pulse amplitude at pressure for the left and right brachia is recorded. the time of the blood pressure measurement is printed.
Page 150: Entering The Bp Examination Result In The Patient Information
Chapter 8 Brachial Blood Pressure Examinations Entering the BP Examination Result in the Patient Information On the patient information setting window for each examination, selecting [BP mon] for entering BP value will proceed to the brachial blood pressure examination. This examination result can be automatically entered in the patient information. Touch [Use].
Page 151: Chapter File Transfers
• Use only SD cards and USB memory devices specified by Fukuda Denshi If an external media that is not specified by Fukuda Denshi is used, examination data may not be saved correctly and it may not be possible to load recorded data.
Page 152: Files And Folders
Chapter 9 File Transfers Files and Folders It is difficult to organize and manage data if a large number of data items (files) are recorded. Folders are therefore used to organize files in a functional way by keeping multiple files together. Folder1 is the first folder to be created.
Page 153: Function Buttons Used In These Operations
Chapter 9 File Transfers Function Buttons Used in These Operations File List Display Display Report Back Search Media Delete Copy Select All Clear All List Trash Box Trash Box List Display Recover Search Media Back Select All Clear All Folder Management Display Back List Change Name...
Page 154: Initialization
• Formatting these will clear all data recorded on the media. Check that there is no necessary data on the media before formatting. (Refer to "Loading Examination Data" (P9-8).) • Use only SD cards and USB memory devices specified by Fukuda Denshi. • USB memory devices can only be initialized via USB Connector 3.
Page 155: Saving Examination Data
Chapter 9 File Transfers Touch the button corresponding to the Check that the correct media and type and purpose of the media to be purpose has been selected and touch formatted. [Execute]. The media is formatted. Saving Examination Data Examination data recorded on the device can be saved to media or sent to another device for storage. Methods for Saving Data The following methods can be used to save data to the SD card, USB memory(*) or DMS.
Page 156 Chapter 9 File Transfers Auto Save Examination data is automatically saved to a specified media after each examination is finished. Configure the following items in the Settings. • Set [File] - [General] - [Auto Save] to "Yes". • Specify the desired media in [File] - [General] - [Save Media]. If [Auto Save] is set to "Each Exam.
Page 157 Chapter 9 File Transfers Press [Menu] on the touch panel. Touch [Int. memory]. Touch [File/Communication]. Touch [ Touch the data to be saved. The data is highlighted. Touch [File list]. Touch [1/3] - [Copy]. Touch [Media]. Touch [ The selected data is copied. Specify the internal memory as the location of the data to be copied (Copy From).
Page 158: Loading Examination Data
Chapter 9 File Transfers Loading Examination Data The examination data can be read from the media to review on this device. Loading Insert the media containing the desired data into this device. Touch [Menu] on the touch panel. Specify the location of the data to be loaded.
Page 159: Searching For Data
Chapter 9 File Transfers • The selected data is played and the Exam. Results examination results of the next data item. display appears. Examination results can be displayed and printed from this display. An analysis guide and commentary are not printed if •...
Page 160: Printing Reports
Chapter 9 File Transfers ■ Searching by Patient Name Touch [Name]. A window for entering a patient • All examination dates are set as search targets by name is displayed. default. Enter the patient name for the desired data. • An examination start date and end date can be entered.
Page 161: Changing The Media
Chapter 9 File Transfers Changing the Media Touch [Media]. Specify the media and folder to load the data and touch [ The "Storage media" window is displayed. Printing the Data List Touch [1/3] - [2/3] - [LIST]. The data list is printed. Clearing All Data Selections Touch [1/3] - [Cl.
Page 162: Deleting Examination Data
Chapter 9 File Transfers Deleting Examination Data Deleting Data from the List Deleting data from the list simply means that it is no longer displayed in the list. The data is still stored on the media. Data stored on the DMS cannot be deleted. Follow steps 1-6 in "Loading"...
Page 163: Restoring Deleted Data
Chapter 9 File Transfers Restoring Deleted Data Data deleted from the list is moved to the [Trash Box]. Data in the Trash Box can be restored. Touch [1/3] - [2/3] - [Trash Box]. Touch the data to be restored, Alternatively, touch [Search] to search for data and then select data from the results.
Page 164: Correcting Examination Data
Chapter 9 File Transfers Correcting Examination Data The height, age and boundaries in examination data files can be edited to correct the CAVI values. Follow steps 1-7 in "Loading" (P9-8). • Touch [Back] in the Exam. Results display to return to the Touch [Save] and then touch the "File list"...
Page 165: Naming Folders
Chapter 9 File Transfers Check the media to copy the data and When data is copied from media to the touch [ DMS, the PC icon is displayed in the "Storage media" field. To change the media to copy the data, press [Change]. Naming Folders Folders on SD cards and USB memory devices can be named to organize the saved data clearly.
Page 166: Printing The Folder List
Chapter 9 File Transfers Select the folder for which to change the Enter the name of the department. name. This is entered in the same way as the name in Patient Information. (Refer to "Chapter 4 Entering Patient Information" (P4-1)) Only alphanumeric characters can be used for folder names.
Page 167: Changing The Folder To Save The Data
Chapter 9 File Transfers Changing the Folder to Save the Data When saving data to an SD card or USB memory(*), the folder to save the data can be changed. The folder can also be changed at the timing of saving the data. (Refer to "Saving Manually (File Utility Operation)" (P9-6).) *Use a USB memory to transfer and store files.
Page 168: Communication History
Chapter 9 File Transfers Communication History Print the history of communication between the device and the DMS and/or media. The latest 500 communication data items are recorded. Printing the Communication History Insert the SD card or USB memory to be Touch [Communication History].
Page 169: Selecting Communication History Data
Chapter 9 File Transfers Selecting Communication History Data Communication history items can be selected for printing by specifying conditions. Touch [Search]. start number is entered, all data items below the end number are search targets. If no end number is entered, all data items above the start number are search targets.
Page 170 Chapter 9 File Transfers ■ Searching by Communication Type ■ Searching by Port Number Touch [Comm. Type]. A window for entering a Touch [Port]. A window for entering a port number is history type is displayed. displayed. Select the desired type. Enter the desired port number.
Page 171: Erasing The Communication History
Chapter 9 File Transfers Erasing the Communication History Touch [Erase]. The communication history is erased. Reports ●File List 9-21...
Page 172 Chapter 9 File Transfers ●Communication History 9-22...
Page 173: Chapter Recording Daily Reports
Chapter Recording Daily Reports This chapter explains how to record daily reports of examinations. Content of Daily Reports It is possible to confirm the execution status of examinations that have been conducted by printing the recorded information in daily reports. The following information is printed in the daily report list in the order in which the examinations were conducted.
Page 174: Function Buttons Used In These Operations
Chapter 10 Recording Daily Reports Function Buttons Used in These Operations "Specify Daily Report" Display Save Print Back To exam [Print]: Prints the daily report. [Save]: Saves the daily report data to the SD card in CSV format. [To exam]: Proceeds to the examination. [Back]: Returns to the menu display.
Page 175 Chapter 10 Recording Daily Reports Specify a date. Touch [ ■ If [All] is Touched All registered daily reports are printed. Touch [Print]. • Daily reports for the selected period are printed. Touch [Save]. The daily report data is saved to the SD card in CSV format. Daily reports can only be saved to an SD card.
Page 176 Chapter 10 Recording Daily Reports 10-4...
Page 177: Settings Of This Device
Chapter Settings of This Device Detailed settings relating to the operations of this device can be configured to suit your purpose. This chapter explains how to configure the settings. Overview of Settings Settings relating to the operations of this device and each examination method can be configured as necessary. Item Description Reference...
Page 178: Operations Used To Configure Settings
Chapter 11 Settings of This Device [Initialize Settings]: Initializes the settings. [Save Code.]: Saves the code to the SD card. [Save settings]: Saves the settings to the SD card. [Read Code.]: Loads the code from the SD card. [Load settings]: Loads settings from the SD card. [Back]: Returns to the menu display.
Page 179: Specifying Settings By Using Sliders
Chapter 11 Settings of This Device Specifying Settings by Using Sliders This method is used to specify colors from a color palette or the volume and tone of the buzzers. Move the slider. Touch [ ] or [ ] to move the slider. Touch [ Entering Numbers Below are instructions on how to enter numbers.
Page 180 Chapter 11 Settings of This Device Touch the characters to be entered. • [A→a] [a→A]: Switches between capital and lower case English letters. • [Alphanum.]: Switches to alphanumeric characters. • [Symbol]: Switches to symbols. • [BS]: The character to the left of the cursor is cleared. •...
Page 181: Setting The Examination Method
Chapter 11 Settings of This Device Setting the Examination Method Contact Fukuda Denshi for more information on connecting and configuring the settings of ID readers. Touch [Menu] on the touch panel. Change the settings. Refer to the items below for information on the settings and setting values for each item.
Page 182: Equipment Control Settings
Chapter 11 Settings of This Device Equipment Control Settings The text in [ ] indicates the factory default setting. General/Power Setup Item Description Setting Range Examination mode Specifies the examination mode. [Standard Examination Mode], (Displayed only during 2-channel examination.) Simple Examination Mode The Simple Examination Mode is available only when English is selected as the language.
Page 183: Buzzer Control
Chapter 11 Settings of This Device Buzzer Control Buzzer Control 1, 2, 3 Setup Item Description Setting Range <Buzzer> Volume Setting All: Set all volumes at once. [All], Individual Individual: Set each volume individually. <Buzzer> Set All Set all volumes. 0, 1, 2, [3], 4, 5 Volumes 0: Sound will be silenced.
Page 184: Print
Chapter 11 Settings of This Device Print General Setup Item Description Setting Range Paper Size for Normal Specify the paper size for printing on normal paper. B5 can only be used when [A4], B5, LETTER Paper printing blood pressure and waveform reports. Output Target Specify the output target type.
Page 185: Patient Information Settings
Chapter 11 Settings of This Device Patient Information Settings General/ID-A.C. Configure general settings relating to input of patient information. General Setup Item Description Setting Range Input ID Extension (2 Levels): Specified items other than ID, gender and age are [Extension (2 Levels)] displayed in 2 levels.
Page 186 Chapter 11 Settings of This Device ID Number Setup Item Description Setting Range Enter Specifies whether to enter, display and print ID numbers. [ON], OFF Number of digits Specifies the number of digits to be used in ID numbers. [20], 3-20 ID Auto Increment Automatically generates ID numbers by adding 1 after using automatic ON, [OFF]...
Page 187: Department
Chapter 11 Settings of This Device Height, Weight, BMI, Abdominal Circumference Setup Item Description Setting Range <Height> Enter Specifies whether to enter, display and print the patient's height. [ON], OFF <Height> Backup* ON: Data is backed up. The content before the power was turned off is called ON, [OFF], Daily the next time the power is turned on.
Page 188: Medicine - Technician
Chapter 11 Settings of This Device Medicine - Technician Configure settings relating to input of the medicine, subjective symptoms, comments, blood pressure measurements, body position, respiration rate, inquiry, doctor and technician. Medicine Info-Comment Setup Item Description Setting Range <Medicine Info> Medicine Info1 Input Info Specifies whether to enter medicine information.
Page 189 Chapter 11 Settings of This Device Doctor Name-Technician Name Setup Item Description Setting Range <Dr. Nm1-2> Enter Specifies whether to enter, display and print doctor names. ON, [OFF] Input Length Setting Specifies the input length of doctor codes. 2-12 [4] Regist Code Register a doctor name.
Page 190: File Settings
Chapter 11 Settings of This Device File Settings General Configure settings relating to saving and loading data and communication with other devices. Setup Item Description Setting Range Save Media Specifies the media to save the data. [SD Card], Multiple items can be specified. USB1, 2, 3, DMS Read from This Media Specifies the media to load the data.
Page 191: Communication Settings
Chapter 11 Settings of This Device Communication Settings General Setup Item Description Setting Range Communication Specifies whether to communicate with other devices. ON, [OFF] Communication method Specifies whether to use wired LAN or wireless LAN. [Wired LAN], Wireless LAN Retry Count on Comm. Specifies the number of retries when a timeout occurs during communication.
Page 192 Chapter 11 Settings of This Device Host Information Setup Item Description Setting Range Host Info1-6 Specifies the host name. [DMS (Host Info 1 Only)] Host name No default settings for Host Info Host Info1-6 Specifies the IP address of the host. [0.0.0.0] IP Address Host Info1-6...
Page 193: Printer
Chapter 11 Settings of This Device Printer Setup Item Description Setting Range <Network Printer> Network Printer Specifies whether a printer is connected via the wired LAN or wireless LAN. ON, [OFF] IP Address If "Network Printer" is set to "ON", specify the IP address of the printer. [0.0.0.0] Port No.
Page 194: Pulse Wave Examination
Chapter 11 Settings of This Device Pulse Wave Examination Setup Item Description Setting Range PCG Characteristic Specifies the PCG characteristic. [L], PWV L: Displays the standard PCG waveform. PWV: Uses a special waveform for detecting the second heart sound. "L" should usually be used as the PCG characteristic. Use "PWV" to check the position of the PWV boundaries.
Page 195: Bp Examination
Chapter 11 Settings of This Device BP Examination Setup Item Description Setting Range BP Re-Inflation Select whether to use the re-inflation function when measuring blood pressure. [ON], OFF Meas Pause Right to Left Set the pause to occur between measuring the right side and measuring the left side. [5 seconds] 5-120 seconds This is enabled if "ABI"...
Page 196: Print
Chapter 11 Settings of This Device Print Print 1 Setup Item Description Setting Range Printing Item Setting Set whether to print each item in color when conducting each blood pressure [ID], [Name], [Age], [Height], and pulse wave examination. [Weight], [A.C.], [Med.], [Symp.], [Dept.
Page 197: Settings For Brachial Blood Pressure Examinations
Chapter 11 Settings of This Device Settings for Brachial Blood Pressure Examinations Brachial BP: General Setup Item Description Setting Range Anonymous Specifies whether to make patient information anonymous. ON, [OFF] Buzzer Specifies the buzzer setting. [Buzzer Control 1], Buzzer Control 2 Buzzer Control 3 File Setup Item...
Page 198: Registering Examinations
Chapter 11 Settings of This Device Registering Examinations Touch [Examination] to display the "Select Examination" window. It is possible to change the display order and positions of the examinations in this window. It is also possible to register new examinations based on existing examinations and register a series examination in which multiple examinations are conducted in a series.
Page 199: Selecting The Examination On Startup
Chapter 11 Settings of This Device Selecting the Examination on Startup The examination to be displayed on startup can be selected. Perform steps 1-3 in "Changing the Select the examination to be displayed on startup. Examination Order" (P11-22). The icon of the selected examination is displayed in Touch the [Exam.
Page 200: Deleting An Examination
Chapter 11 Settings of This Device Deleting an Examination Examinations that are no longer needed can be removed from the "Select Examination" window. Perform steps 1-3 in "Changing the Touch the examination to be deleted. Examination Order" (P11-22). Touch [Delete]. Touch [Yes].
Page 201: Registering A Series Examination
Chapter 11 Settings of This Device Registering a Series Examination It is possible to register a series examination on this device to conduct up to three types of examinations in a series. Series examinations need to be registered in advance in order to perform them. Registered series examinations can be selected in the "Select Examination"...
Page 202: Saving And Initializing The Settings
Chapter 11 Settings of This Device Saving and Initializing the Settings The current settings can be saved to the SD card or printed as a report. The settings can also be initialized. Saving Settings to an SD Card Insert the SD card into the device. •...
Page 203: Maintenance And Inspection
This chapter describes the maintenance and inspection procedures for this device. Make sure to perform daily inspections and periodic inspections to maintain functionality, performance and reliability. Fukuda Denshi shall not be liable for accidents arising from failure to perform maintenance and inspections. WARNING •...
Page 204: Periodic Inspection
Chapter 12 Maintenance and Inspection Item Inspection Item Procedure Criteria Cables Power supply cable Verify that there is no scratch or damage. No scratch or damage should be found. LAN cable Verify the connection status of the cables. Should be connected properly. BPU cable * Cuffs, air hoses, PCG microphone, etc.
Page 205 Chapter 12 Maintenance and Inspection ● Accessories, Cables Item Inspection Item Procedure Criteria Accessories Sensors (*) Verify that there is no scratch or damage. No scratch or damage should be found. Verify the connection status of the cables Should be connected properly. and hoses.
Page 206 Chapter 12 Maintenance and Inspection ● Performance Item Inspection Item Procedure Criteria Four-Limb Zero point Read the pressure value at the atmospheric Should be within 0±1mmHg. Blood pressure when no connection is made to the Pressure air connectors. Pressure accuracy Perform this inspection in Maintenance - Should be within ±3 mmHg.
Page 207 Chapter 12 Maintenance and Inspection ● Others Item Inspection Item Criteria Power Supply Check that the power can be turned ON and Should be able to turn the power ON and OFF when OFF when operating the device on AC and operating the device on AC and battery power.
Page 208: Electrical Safety Inspection Methods
It is recommended to use specialized safety testing and measurement equipment to simplify the testing and ensure accuracy. For details on safety testing and measurement equipment, contact your local Fukuda Denshi service representative. ● Inspection Items The following types of electrical safety inspections should be conducted.
Page 209 Chapter 12 Maintenance and Inspection 1. Safety specifications of this device Classification by protection type: Class I equipment Classification of applied part by degree of protection: Type CF applied part 2. Earth leakage current inspection 1) Measurement wiring diagram Outlet Outlet Safety Evaluation Medical Electrical...
Page 210 Chapter 12 Maintenance and Inspection 2) Allowable values Normal condition Single fault condition Direct Current 0.01mA 0.05mA Alternating Current 0.01mA 0.05mA 5. Patient leakage current (external voltage) inspection 1) Measurement wiring diagram Outlet Outlet Safety Evaluation Medical Electrical Test Device Equipment (Leakage Current) Patient Applied Part...
Page 211: About The Consumable Parts
If the fan stops moving, the internal temperature of the device increases and the power will automatically turn OFF. If the power repeatedly turns OFF automatically during AC power operation, the cooling fan may be damaged or the vents may be clogged. Contact your local Fukuda Denshi service representative. Cleaning and Disinfection Cleaning and Disinfecting the Device ■...
Page 212: Replacing The Built-In Battery
The replacement period of the battery is also indicated by a message, "Replace the backup battery. The clock will be initialized." Contact your local Fukuda Denshi service representative. CAUTION The device needs to be disassembled to replace the battery. Contact your local Fukuda Denshi service representative. 12-10...
Page 213: When Error Messages Are Displayed
Processing was aborted due to a failure occurring in the system. An error in the device settings or a failure in the built-in software may have occurred. Press and hold the POWER button for 10 seconds to turn OFF the power and then contact your local Fukuda Denshi service representative. ● If the BPU-100* Pulse Wave Unit is defective The BPU-100 Pulse Wave Unit may be defective.
Page 214 Chapter 12 Maintenance and Inspection 12-12...
Page 215: Appendix
Chapter Appendix Main Specifications Display Color LCD, 1024x768 dots (with LED backlight) Frequency characteristic L filter: 50 Hz (-6 dB/oct) PWV filter: 165 - 280Hz within -3 dB Non-Invasive Blood Maximum Measuring range 0 to 300 mmHg Pressure Measurement (BPU-100) Scale interval 1 mmHg Pressure accuracy...
Page 216: Measurements
Chapter 13 Appendix Measurements Blood Pressure and Pulse Wave Examinations [1] CAVI (Cardio-Ankle Vascular Index) A new index based on stiffness parameter β, CAVI is a pressure-independent index indicating the natural stiffness of the blood vessels. While compliant with Hasegawa PWV method, the Cardio-Ankle Vascular Index calculates the specific stiffness of arterial walls independent of blood pressure.
Page 217 Chapter 13 Appendix The actual CAVI is coordinate-transformed to correspond to aortic PWV. ⎛ ⎞ ⎛ ⎞ ⎜ ⎟ ⋅ ⎜ ⋅ ⎟ CAVI (a, b: Conversion Constant) ⎜ ⎟ − ⎝ ⎠ ⎝ ⎠ Brachial blood pressure is used as the average systolic pressure (Ps) and diastolic pressure (Pd) of the body. (4) PWV (Pulse Wave Velocity) Pulse wave traveling through the blood vessels is recorded at two blood vessel locations.
Page 218 Chapter 13 Appendix (6) Vascular length Obtain the vascular length to calculate PWV. • AF: Direct distance between the sternal border in the second intercostal space and the femoral artery pulsating site. • L1: Vascular length between the heart valve and the femoral artery pulsating site (=1.3 ×...
Page 219 Chapter 13 Appendix ■ When ABI Brachial BP Usage Method is set to "Average" • When the difference between the right and left brachial systolic blood pressures is 10 mmHg or above : Typical brachial blood pressure = the higher of the right or left brachial systolic blood pressure •...
Page 220 Chapter 13 Appendix [7] %MAP (Percent Mean Arterial Pressure) As shown in the following formula, %MAP is a quotient obtained by dividing the mean pulse pressure by the pulse pressure - assuming the cuff-induced pulse waves as blood pressure waveform - and expressed as a percentage. The mean pulse pressure is a quotient obtained by dividing the area of the pressure pulse wave by the time.
Page 221 Chapter 13 Appendix Arrow length: Corresponds to the ABI value for the lower limbs and the value of the following equation for the upper limbs. Systolic BP of Corresponding Site Higher Systolic BP of Left/Right Brachial An arrow is drawn as far as the inner line when the ABI of the lower limbs or the value from the above equation for the upper limbs is 0.90, and as far as the outermost line when the value is 0.50.
Page 222: Printed Messages
Chapter 13 Appendix Printed Messages Print Location Message Printout Conditions ■ If 2005 ACC/AHA standard is selected Degree of arterial occlusion (ABI) • 1.30 ≦ R/L-ABI Noncompressible. Test result (interpretation)(*1) • 1.00 ≦ R/L-ABI ≦ 1.29 Normal. • 0.91 ≦ R/L-ABI ≦ 0.99 Borderline (equivocal).
Page 223 Chapter 13 Appendix Print Location Message Printout Conditions Interpretation (*1) RA/LA: This examination is in normal range. ■ If 2005 ACC/AHA standard is selected • 0.91 ≦ R/L-ABI ≦ 1.29 and R/L-CAVI ＜ 9.0 ■ If TASC Ⅱ (ACC/AHA 2011) standard is •...
Page 224: Optional Accessories
Chapter 13 Appendix Optional Accessories Accessory Model Remarks Equipotential lead CE-11 Built-in battery BTE-001 Lithium-ion Battery Stand OTV-03 Cuff cover (for upper limb) OA-1129M Cuff cover (for lower limb) OA-1130M NIBP cuffs (for right brachium, S) CUF-129SRU (for left brachium, S) CUF-129SLU (for brachium, S) CUF-142SHU...
Page 225 Chapter 13 Appendix 4, 5 Peripheral Devices Accessory Model Remarks Ethernet hub IEC 60950 and RoHS compliant Switching Hub Color Printer Manufacturer: Brother HL-3170CDW duplex color laser printer Please note that specifications are subject to change without prior notice for quality improvement. 13-11...
Page 226: Example Of Combinations Of Medical Devices And Non-Medical Devices
Chapter 13 Appendix Example of Combinations of Medical Devices and Non-Medical Devices Below is an overview of situations that may be created when combinations of different devices described in IEC 60601-1: "General Requirements for Medical Electrical Systems" are used in different medical environments. Systems used in patient environment must contain safety features equivalent to medical devices that comply with IEC 60601-1.
Page 227: Index
Chapter 13 Appendix Index Symbols Description of the Reports ......... 5-25 Description of the Screen ........1-11 %MAP ............... 13-6 Displaying the Menu .......... 2-15 DMS ............. 4-1, 4-8 ABI ......5-1, 13-4, 13-5, 13-6, 13-7, 13-8 Dual-Side Adhesive Tape ........3-5 AC Power Supply Connector ......
Page 228 Chapter 13 Appendix Measuring Blood Pressure ........8-5 Stiffness Parameter ........... 13-2 Messages and Countermeasures ...... -19 Storing the Battery ..........2-2 Methods for Saving Data ........9-5 Symbols on the Device ......... -2 Names of Parts and Their Functions ....1-7 tb ...............
Page 229: Inspection List
Clock Verify that the present date/time is displayed Pass / Fail in the Clock Setting window and is correct. Overall judgment Pass / Fail Model Name VaSera VS-2000 Series Model Serial number Location Date of Purchase Date of Inspection Checked by Approval ●...
Page 230 Chapter 13 Appendix Periodic Inspection List Conduct inspections according to the Periodic Inspection Procedure. Management No. Item Inspection Item Procedure and Criteria Judgment Remarks (Repair Needed) Visual Main Unit Enclosure No scratch, crack, deformation and rust Pass / Fail Inspection Labels and panels No peeling or staining Pass / Fail...
Page 231 Chapter 13 Appendix Item Inspection Item Procedure and Judgment Remarks (Repair Criteria Needed) Perfor- Blood mance pressure Zero point Within 0±1mmHg Pass/Fail Pass/Fail Pass/Fail Pass/Fail Pressure Within ±3mmHg Pass/Fail Pass/Fail Pass/Fail Pass/Fail accuracy mmHg Within ±3mmHg Pass/Fail Pass/Fail Pass/Fail Pass/Fail mmHg Within ±3mmHg Pass/Fail...
Page 232 (AC) Single fault 0.05mA or less Pass/Fail condition Cleaning Cleaning Should be clean. Pass/Fail Final judgment Pass/Fail Model Name VaSera VS-2000 Series Model Serial number Location Date of Purchase Date of Checked Approval Inspection ● Copy this sheet for use.
Page 233 The company and product names used in this manual are trademarks or registered trademarks of respective companies.
Page 234 3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan Tel: +81-3-5684-1455 Fax: +81-3-3814-1222 http://www.fukuda.com Printed in Japan 4L011364D 202001...

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