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Fukuda VaSera VS-2000 Series, Operation Manual

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Fukuda VaSera VS-2000 Series Operation Manual Download Page 170

9-20

Chapter 9 File Transfers

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Searching by Communication Type

Touch [Comm. Type]. A window for entering a 
history type is displayed.
Select the desired type.

All communication types are set as search targets by 

default.

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Searching by End Code

Touch [End Code]. A window for entering an end 
code is displayed.
Select the desired end code.

All end codes are set as search targets by default.

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Searching by IP Address

Touch [IP address]. A window for entering an IP 
address is displayed.
Enter the desired IP address.

All IP addresses are set as search targets by default.

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Searching by Port Number

Touch [Port]. A window for entering a port number is 
displayed.
Enter the desired port number.

All port numbers are set as search targets by default.

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Searching by Job ID

Touch [JOB ID]. A window for entering a job ID is 
displayed.
Enter the desired job ID.

All job ID numbers are set as search targets by default.

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Touch [Search].

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Summary of Contents for VaSera VS-2000 Series

Page 1: ...Sphygmomanometer and Sphygmograph Series Before using the product please read this manual thoroughly Store this manual where it can be always referred to Ver 03 Operation Manual ...

Page 2: ...or out of order contact Fukuda Denshi for replacement Only physician or persons instructed by physicians are allowed to use the equipment The information contained in this document is subject to change without notice due to improvement in the equipment CAUTION This manual is for the VS 2000 Series Version 03 Federal Law restricts this device to sale by or on the order of a physician CAUTION ...

Page 3: ...stand the instructions before using this device It is recommended to keep this operation manual nearby at all times when operating this device For details on this product or this manual please contact your local Fukuda Denshi service representative This is an operation manual for the following device VS 2000 A mark is used to indicate explanations of the functions of the toe blood pressure option ...

Page 4: ......

Page 5: ...damage and is used throughout the explanations in this operation manual NOTE A note is not related to product safety but provides information about the proper usage methods to prevent incorrect operation and malfunction Indicates prohibited actions Refer to the instruction Indicates a matter of Danger Warning or Caution that calls attention for safety Refer to the instruction Indicates mandatory o...

Page 6: ...damage or erase the warning labels attached to the device These warning labels contain important information for handling and operating the device properly and safely If any of these labels are damaged it may not be able to ensure safety when using the device Caution Explained in this manual Indicates the potential equalization terminal Indicates the alternating current AC power supply Indicates t...

Page 7: ... anesthetic gas or other flammable substances 5 Operation Mode Can be used continuously Preventive Maintenance Preventive maintenance should be performed to ensure that the device can be used safely at all times and prevent various problems from occurring in future This maintenance needs to be performed at least once every 12 months Inspect the mainframe and all connectors and cables for any exter...

Page 8: ... not use this product with a magnetic resonance imaging MRI device This device may be pulled towards the MRI device The local heating caused by the induced electromotive force may also cause burns to the patient or cause the performance of this product to deteriorate Use only the supplied lead cable when defibrillating Do not touch this device during defibrillation This device will return to stand...

Page 9: ...of the blood flow Connect the power cable to a hospital grade outlet Use the battery when operating in areas with no hospital grade outlet Use an outlet with a power supply sufficient for the power consumption of this device Use the battery when operating in areas with no hospital grade outlet Use an outlet with a power supply sufficient for the power consumption of this device Never disassemble o...

Page 10: ... same outlet increase in leakage current may cause danger to the patient A danger may occur if the patient is using a pacemaker or other electrical stimulator Follow the instructions in the operation manual of the pacemaker or other electrical stimulator When using this device with other devices perform equipotential grounding to prevent potential difference between the devices If potential differ...

Page 11: ...bles with wet hands This may cause electric shocks short circuiting or injury Always use your fingers to operate the touch panel or keys Using other items may cause damage such as scratching the surface of the touch panel Do not use the touch panel with film or adhesive tape attached to it It may cause malfunction or damage the touch panel Remove dirt from the surfaces by wiping with ethanol on a ...

Page 12: ...evice unsafe for the patient and operator Check the cable connection and polarity of the device and its connectors to ensure proper operation of the equipment Make sure the power system has adequate earth ground Ensure that all cables and air hoses are correctly and safely connected Pay special attention when the equipment is used in conjunction with other equipment as it may cause erroneous diagn...

Page 13: ... power when inserting removing the media An error may occur if the media is inserted or removed during operation If the media needs to be inserted or removed while the power is 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 ...

Page 14: ...sult a doctor Do not pressurize toe cuffs before wrapping them around toes Otherwise they may burst Do not wrap the toe cuffs too loosely or at an angle Otherwise they may burst Precautions for Storage Store this product in a cool area Avoid areas with direct sunlight UV rays high temperatures and high humidity Do not store this device together with volatile chemicals Precautions for Disinfection ...

Page 15: ...and communication speed vary depending on the installation location and operating environment Precautions Concerning Use With Other Devices when Using the Wireless LAN Adapter When using a wireless LAN make sure to check the operation of any medical devices nearby Stop using the wireless LAN immediately if unexpected waveform noise occurs or interference occurs in surrounding equipment Precautions...

Page 16: ...ng it 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 Pack this device in packaging specified by Fukuda Denshi when transporting This device has no handle Carry it with both hands when transporting ...

Page 17: ...r devices through the power outlet Check the source of the noise and stop the device that is causing the noise if it is possible to do so If it cannot be stopped take countermeasures to change the path of the noise such as using a filtering device Effects of Static Electricity Malfunctions may be caused by the discharge of static electricity in dry environments rooms such as in winter Measures suc...

Page 18: ...wing is the information relating to EMC Electromagnetic Compatibility When using this device verify that it is used within the environment specified below Compliance to the Electromagnetic Emissions The VS 2000 is intended for use in the electromagnetic environment specified below Emission Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The VS 2000 uses RF energy...

Page 19: ...al mode 0 5 1 2kV common mode 0 5 1kV differential mode 0 5 1 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in...

Page 20: ... 60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3Vrms 150kHz to 80MHz 3 V m 80MHz to 2 5GHz 3Vrms 3 V m PPortable and mobile RF communications equipment should be used no closer to any part of this device including cables than the recommended separation distance calculated from the equation applicable to the frequency...

Page 21: ...w this device is protected against any malfunctions that the resulting interference could produce Rated Maximum Output Power of Transmitter W Separation Distance m based on Transmitter Frequency 26 to 80MHz d 1 2 80 to 800MHz d 1 2 800MHz to 2 5GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Note 1 At 80MHz and 800MHz the separation distance for the highe...

Page 22: ...18 ...

Page 23: ...start the measurement again Inspect the cuff and air hose for damage or breakage Air is leaking due to loose air connector Reconnect the air connector correctly Message Cause Countermeasure Battery is running low Please recharge the battery During battery operation the power will automatically turn OFF when the battery capacity becomes low Connect the power cable and operate the device on AC power...

Page 24: ...mory and save the data again Check BP zero An abnormality has occurred in the pressure sensor unit Check whether there is air in the cuff Turn the power OFF and then turn it back ON Communication error has occurred An error occurred during communication with the DMS Data Management System When this message is displayed the device is not connected to the DMS Data Management System Contact your loca...

Page 25: ...patient information could not be retrieved Make sure that the correct media is used Failed to save the settings Failed to save the settings to the SD card There may be a problem with the SD card Contact your local Fukuda Denshi service representative Failed to save to SD card The device failed to save the data to the SD card SD card failure can be considered Write down the error code at the end of...

Page 26: ...the cuff is properly attached If the error is not caused by the cuff use other means to perform the measurement Message Cause Countermeasure No data selected A process was attempted without selecting a data Select a data before performing the process Message Cause Countermeasure Operation has timed out The time limit for communication with the DMS Data Management System was exceeded Check the conn...

Page 27: ... analysis range contains some calibration waves Analysis cancelled Some calibration waves are included in the specified analysis range Specify a range that does not contain calibration waves The battery voltage is too low Cannot access Media During battery operation the device could not access the media due to low battery level Connect the power cable and operate the device on AC power or charge t...

Page 28: ...not run out of battery the power supply will be switched off automatically During battery operation the power will automatically turn OFF if the operation is not performed within the specified duration Turn ON the power again Message Cause Countermeasure Valve error Cuff depressurization or deflation took too long Inspect the cuff and air hose for damage or breakage Message Cause Countermeasure ...

Page 29: ...e PCG Microphone 9 Precautions Concerning the Cuffs 10 Precautions Concerning the Toe Cuffs 10 Precautions Concerning the Limb Cushion Optional 10 Precautions Concerning the LAN 11 Storage and Cleaning 12 Transportation 12 Cleaning and Disinfecting the Device 12 Cleaning the System Devices 13 Precautions for Safe Operation under Electromagnetic Interference EMC 13 Precautions Concerning Printing o...

Page 30: ... and PCG Microphone 2 10 Installing Optional Devices 2 10 Connecting the Cuffs 4 Channel Examination 2 11 Turning the Power ON and OFF 2 12 To Turn ON the Power 2 12 To Turn OFF the Power 2 13 Acquiring the Date and Time 2 14 Basic Operations 2 15 Changing the Examination Type 2 15 Displaying the Menu 2 15 Connecting to the Network 2 16 Example of Network Configuration 2 16 Network Settings Wired ...

Page 31: ...tion 5 8 Attachment Site Guide 5 10 Waveform Length of Pulse Wave 5 11 Real Time CAVI Check 5 11 Auto Extension 5 11 CAVI Check Result Display 5 11 Examination Result Display 5 13 Changing the Measurement Content 5 18 Checking and Changing the Measurement Items and Sites 5 18 Setting Blood Pressure Measurements Manually 5 18 Setting Sensitivity Manually 5 19 Entering Blood Vessel Length 5 19 To En...

Page 32: ... SD Card 9 2 Function Buttons Used in These Operations 9 3 Initialization 9 4 Saving Examination Data 9 5 Methods for Saving Data 9 5 Media that can be Used for This Operation 9 5 Saving 9 5 Loading Examination Data 9 8 Loading 9 8 Searching for Data 9 9 Printing Reports 9 10 Changing the Media 9 11 Printing the Data List 9 11 Clearing All Data Selections 9 11 Deleting Examination Data 9 12 Deleti...

Page 33: ...ation Settings 11 9 General ID A C 11 9 Department 11 11 Medicine Technician 11 12 File Settings 11 14 General 11 14 Printing 11 14 Communication Settings 11 15 General 11 15 DMS Settings 11 15 Printer 11 17 Settings for Blood Pressure and Pulse Wave Examinations 11 17 Pulse Wave General 11 17 File 11 17 Pulse Wave Examination 11 18 BP Examination 11 19 Print 11 20 Settings for Brachial Blood Pres...

Page 34: ...e 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 Replacing the Clock Battery 12 10 When error messages are displayed 12 11 Chapter 13Appendix 13 1 Main Specifications 13 1 Measurements 13 2 Blood Pressure and Pulse Wave Examinations 13 2 Printed Messages 13 8 Optional Accessories 13 10 Example o...

Page 35: ... brachium and ankle blood pressure on both sides or measure blood pressure in the toes Main Features CAVI Cardio Ankle Vascular Index Independent of blood pressure the Cardio Ankle Vascular Index calculates the specific stiffness of arterial walls The CAVI is also useful for time serial observation of medication effects This device measures the following 2 types of CAVI 1 R CAVI CAVI between the h...

Page 36: ...ily check patient information examination results and device statuses Capacitive Touch Panel The device has a capacitive touch panel This can be operated with a lighter touch than conventional touch panels Color Printing Examination reports can be printed in color using a printer on the network Simple Examination Mode Only for 2 channel blood pressure and pulse wave examination First time users of...

Page 37: ...amination results or a color report preview can be displayed on the screen Network In addition to the wired network the optional wireless LAN adapter can be attached to connect to the network without worrying about cables PDF File A PDF file of the examination report can be filed on the SD card or USB memory Pulse wave examination reports can also be stored in a shared folder on the network Comput...

Page 38: ... Pressure Measurement Package ASV 06 A package containing a 2 channel blood pressure and pulse wave measurement unit connection cable and toe cuffs In a simple examination mode of VS 2000 standard set the ABI cannot be measured In the standard examination mode the ABI can be measured one side at a time Optional Measuring Items BPU 100 Four Limb BP Package ASV 05U BPU 100 Toe BP unit Package ASV 06...

Page 39: ... included in the ASV 04U accessory package PCG Microphone No Accessory Model Quantity Remarks 1 Operation Manual this manual 1 No Accessory Model Quantity Remarks 1 Power Cable 3 m CS 24 1 2 NIBP Cuffs Brachium CUF 142MH 1 Ankle CUF 143MH 1 3 Air Hose 2 7 m Brachium OA 20APL2 7 BH 1 Ankle OA 20APL2 7 AH 1 1 2 3 1 PCG microphone MA 310HDS V 1 1 ...

Page 40: ...s 1 NIBP Pulse Wave Unit BPU 100 1 1 No Accessory Model Quantity Remarks 1 NIBP Cuffs Right Brachium CUF 129MRU 1 Left Brachium CUF 129MLU 1 Right Ankle CUF 138MRU 1 Left Ankle CUF 138MLU 1 2 Air Hose 2 7 m Upper limbs OA 30APL2 7 BH 1 Lower limbs OA 30APL2 7 AH 1 3 Installation Manual 1 4 NIBP Label R B L B 1 5 NIBP Label R A L A 1 No Accessory Model Quantity Remarks 1 Connection Cable 2 5m CJV 0...

Page 41: ...act while the SD card or USB memory are in operation This may damage the recorded data or break the card Do not touch the terminal parts of the SD card or USB memory with your hands or metal objects Caution about the warning labels attached to the device These warning labels contain important descriptions for handling and operating the device properly and safely Do not damage or erase the warning ...

Page 42: ...ired between the rear and side of the device and the wall 5 USB1 and 2 ports Insert a USB memory optional 6 USB3 ports Insert a USB memory optional Use this to store or read data 7 SD Card Slot Insert an SD card optional Use this to store or read data Do not remove the SD card or USB memory or turn off the device during operation of the SD card or USB memory 8 DISPLAY Connector Connects the cable ...

Page 43: ... 5 STOP Key Stops measurements 6 Touch panel A capacitive touch panel 7 LCD Monitor Displays information such as waveform information and patient information Refer to Description of the Screen P1 11 Although the LCD utilizes highly accurate picture elements occasionally there may be a few pixels which do not light or constantly light The temperature changes may also cause some irregularities in th...

Page 44: ...Function Keys Keys for performing maintenance operations These control keys are for maintenance and cannot be used during normal examinations 2 Air Connectors Connect the air hoses connected to the cuffs 3 BPU Connector Connects the cable to the main unit ...

Page 45: ... available 4 Examination Status Area Displays the status of the examination 5 Examination Button The currently selected examination is displayed Touching this button displays the Select Examination window for selecting an examination 6 Measurement Mode Button Switch the mode for obtaining waveforms Auto or Manual 7 Menu Button Touch this to display the Menu screen 8 i Button Information Button Tou...

Page 46: ...ion Normal Mode Offline Mode Normal Mode Offline Mode USB memory 1 3 Normal USB connection USB connection error ID reader connection When unused SD Card Normal SD card connection SD card connection error When unused Battery Power cable connected Remaining battery power 30 0 Remaining battery power 60 30 Remaining battery power 100 60 Battery error VaSera CAVI LAN VaSera LAN connection VaSera LAN c...

Page 47: ...External Printer Connected Error When unused BPU1 Normal connection Error When unused Item Icon Description BPU2 Normal connection Error When not connected BPU3 Normal connection Error When not connected Item Icon Description ...

Page 48: ...he Information window 3 Device Status Icons The following information is displayed to indicate the device status Icon List Alert Display Area 1 Alert Display Area 2 Previous Display 3 Device Status Icons Power Supply Battery SD Card USB1 USB2 USB3 VaSera LAN External Printer Item Icon Description Noise Noise Battery Battery 30 0 Battery 60 30 Battery 100 60 Battery Battery error USB USB1 connectio...

Page 49: ...Item Icon Description Item Icon Description Battery Remaining battery power 30 0 Remaining battery power 60 30 Remaining battery power 100 60 Battery error USB1 2 3 USB capacity level 3 USB capacity level 2 USB capacity level 1 USB connection error When unused SD SD card capacity level 3 SD card capacity level 2 SD card capacity level 1 SD card connection error When unused VaSera CAVI LAN VaSera L...

Page 50: ...rinter error External printer out of paper Paper jam in external printer Low toner in external printer External printer out of toner When unused Item Icon Description Display area Icon Description During file operations SD Card USB1 USB2 USB3 DMS Internal memory Folder Trash Message Display time CAUTION WARNING ...

Page 51: ... s bed Equipment such as X ray devices ultrasound devices radio devices stands and fluorescent lighting also causes interference Select a location where the room temperature will remain at 20 25 C Select a location with low humidity Select a location with minimal noise in the surrounding area PCG and pulse waves will not be measured correctly if there is noise or vibration from an air conditioning...

Page 52: ...35 C Make sure to remove the power cable before installing or replacing the battery Otherwise the device will be damaged and an electric shock may occur Contact Fukuda Denshi before installing or replacing the battery Incorrect handling may result in danger such as electric shock to the patient and operator Do not throw the battery into fire If the battery is placed in fire it may explode The batt...

Page 53: ...ng 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 Charging does not start if the battery is nearly full to prevent overcharging It is recommended to charge the battery at or near a normal room temperat...

Page 54: ...power The icon changes as shown above as the remaining battery power decreases When the icon indicating the remaining battery power changes to the battery needs to be charged The following message may be displayed on the screen when the battery is low Switch to AC power or charge the battery To not run out of battery the power supply will be switched off automatically Battery is running low Please...

Page 55: ...V 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 Make sure to lock all casters when using or storing the device If the casters are not locked the device may move or tip over resulting in injury to the operator or damage to the device When moving the stand ma...

Page 56: ...s of the main unit 2 Lock with the knobbed bolt 5 Insert the display unit into the fixing bracket at the top of the stand 6 Secure with the four M4 screws 7 Tilt the screen around 30 and attach the hinged cover The hinged cover can only be attached if the screen is tilted ...

Page 57: ...elease button to adjust the height of the display unit It will lock into position with a click sound Installing Without the Stand The main unit and display unit can be placed on a table etc instead of using the stand The power turns ON when the cable of the display unit is connected to the main unit The power automatically turns OFF when the cable is removed USB A B DISPLAY LAN PCG IB B Lock Relea...

Page 58: ...e is used with improper grounding danger such as electric shock may result to the patient and operator Insert the power cable all the way in Do not install the device in a location where it is difficult to plug unplug the power cable 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...

Page 59: ...ic shock may result to the patient and operator Pay special attention for use in Operating Room ICU CCU Cardiac Catheter Laboratory and Cardiovascular X ray room Equipotential Grounding 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 Pay special attention for use in Ope...

Page 60: ...rs and PCG Microphone 1 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 PCG Microphone ...

Page 61: ... Connecting the Toe Cuffs 1 Insert the connector of the toe cuff into the air connector on the BPU 100 and rotate the connector to secure it 1 The position of the right toe cuff is indicated in black and the position of the left toe cuff is indicated in green 2 Secure the connectors properly to prevent air from leaking The toe cuffs are interchangeable Toe Cuff Sizes and Colors When the device is ...

Page 62: ... on the screen after the power is turned ON followed by the home display A crackling sound is heard after the power is turned ON This is the operation sound of the valve It occurs during the preparation operations of the device and is not a malfunction The device may take longer to start up after the power is turned ON when the temperature in the room or other area where the device is being used i...

Page 63: ...ble from the main unit When the power is turned OFF the device will enter into standby mode and the AC power indicator will light faintly If the device will not be used for a long time remove the power cable from the main unit for safety purposes If the device does not turn OFF after pressing and holding the POWER key on the display unit keep pressing the POWER key After pressing and holding for a...

Page 64: ...date and time can be obtained from the NTP server the date and time can be set automatically by touching Acquire Time Date from NTP Server It is possible to automatically obtain the date and time from the NTP server each time the device is turned ON by placing a check mark for Acquire Automatically on Power On 5 Set the time difference between UTC Touch the box for UTC Enter the time difference be...

Page 65: ...ouch 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 1 Touch the Menu button on the touch panel 2 Touch the desired item Touch To exam or press HOME on the display unit The screen returns to the examination display ...

Page 66: ...s possible when installing the device 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 The devices connected to the network such as the e...

Page 67: ...d to the device computer and printer Contact Fukuda Denshi for more information on configuring the wireless LAN settings Configuring the Settings 1 Touch the Menu button 2 Touch Setting Enable communication Configure network settings on the device Set the examination equipment name Set the IP address Set the gateway information Register the host Host name Enter the IP address Enter the port number...

Page 68: ...he DMS Settings tab 8 Enter the subnet mask and default gateway in Gateway Refer to Example Setting For Example of Network Configuration P2 16 P2 19 for details on the settings 6 Register the host 1 Touch the Host Info tab 2 Enter the host name IP address and port number in Host Info X Host refers to information about the computer to connect Set the host name IP address and port number Up to 6 hos...

Page 69: ... Example host device information settings If installing multiple host programs on the same PC set a different port number for each program A pulse wave host is a host for recording and reading examination data for pulse wave examinations A patient information host is the master ID communication host if VS PC is selected as the location from which to load patient information Select Communication DM...

Page 70: ...in alphanumeric characters and the following symbols equals sign at sign double quotation mark slash hyphen _ underscore comma period number sign question mark curly brackets square brackets parentheses Refer to Configuring Sharing Settings on the Computer separate manual for details on configuring the sharing settings Item Description IP Address 192 168 0 6 Port No 9100 Item Description IP Addres...

Page 71: ...ted at once The time required depends on the usage environment When Using a Network Printer 1 Install the network printer Refer to Connecting to the Network P2 16 2 Check the IP address of the network printer Refer to the operation manual of the printer 3 In the Settings select Communication Printer Network Printer and set the IP address of the network printer in the IP address field 4 Select Comm...

Page 72: ...ct SD card USB memory or Shared Folder for Save Media Examination When examination results are displayed for pulse wave examinations and brachial blood pressure examinations a PDF file containing the report is written to the storage media according to the report output settings PDF files can only be written to the shared folder for pulse wave examinations and brachial blood pressure examinations I...

Page 73: ...he size range applies to the circumference measured at the center part of the cuff The cuff size and applicable size range are listed below Make sure that the air hose are not bent and that no object has been placed on them Make sure that the cuffs and air hoses exhibit no cracks or other damage No Model Usage Size Applicable Circumference Range 1 CUF 142S Brachium S 17 22cm 6 7 8 7 2 CUF 142M Bra...

Page 74: ...e Bending the knees of the patient will facilitate the cuff application 2 Wrap the cuff around the ankle securely but not too tightly Make sure there is no gap between the cuff and the ankle Attaching the Limb Cuffs 4 Channel Examination There are right brachial left brachial right ankle and left ankle cuffs Attach to the correct site according to the edge color of the cuff The edge colors of the ...

Page 75: ... cuff and the brachium No Model Usage Size Applicable Circumference Range 1 CUF 129SRU Right brachium S 17 22cm 6 7 8 7 2 CUF 129SLU Left brachium S 3 CUF 138SRU Right ankle S 17 22cm 6 7 8 7 4 CUF 138SLU Left ankle S 5 CUF 129MRU Right brachium M 22 30cm 8 7 11 8 6 CUF 129MLU Left brachium M 7 CUF 138MRU Right ankle M 20 30cm 7 9 11 8 8 CUF 138MLU Left ankle M 9 CUF 129LRU Right brachium L 30 39c...

Page 76: ...cushion below the elbow or heel to obtain a stable pulse wave The limb cushion can be used in horizontal or vertical direction Use it in a suitable direction so that the cuff will not touch the bed The limb cushion is an optional accessory If the limb cushion is too high or if it causes pain to the patient use a towel instead of the limb cushion Fold the towel 2 or 3 times place it under the heel ...

Page 77: ...the PCG microphone to the second intercostal sternum 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 CAUTION Second Intercostal Sternum The dual side adhesive tape cannot be reused Take measurements in a quiet room with no ...

Page 78: ...f around the toe in this condition When wrapped the air is exhausted from the air bag to provide an adequate wrapping Finally check that there is no gap between the cuff and the toe Set Toe Cuff Attachment Guide to No in the BP Exam Setting if not using the toe cuff attachment guide The toe cuffs and toe cuff covers are optional and need to be purchased separately Be careful not to wrap the toe cu...

Page 79: ...sic Information P4 3 Master ID Load information from the DMS Loading Information from the DMS Master ID P4 8 Patient file selection Use patient information registered to an SD card Using Patient Information Registered to an SD Card Patient File Selection P4 9 Load past information Use patient information from examination data saved to the media including internal memory Using Patient Information f...

Page 80: ...rmation Code 2 4 digits 16 single byte characters Up to 20 items can be registered Symp Subjective symptoms Code 2 4 digits 16 single byte characters Up to 20 items can be registered Comment Comment Code 2 4 digits 100 single byte characters Alphanumeric characters and symbols can be entered Up to 20 items can be registered BP Systolic diastolic blood pressure 3 digits each Unit mmHg kPa Body posi...

Page 81: ... s birth date 1 Touch the number buttons to enter the patient s year of birth Clear All entered numbers are cleared BS The number to the left of the cursor is cleared Years Mths Weeks Days Switches the age unit when entering the age Age Age input window will be displayed D O B Date of birth input window will be displayed x Closes the Date of birth window 2 Press the number buttons to enter the mon...

Page 82: ...rsor to the left Moves the cursor to the right Space Makes a space x Closes the Name window 2 Touch The entered name is reflected in the Patient Information window If Clear All IDs is not set to Yes Test pattern remains in the Name field if a test pattern is measured immediately beforehand In this case enter the correct name or clear the name 7 Enter the height 1 Touch the number buttons to enter ...

Page 83: ...ching the applicable medicine and then touching Change The medicines with codes 1 to 10 cannot be changed 11Enter the symptoms 1 Touch the applicable symptom Clear All entered numbers are cleared x Closes the window 2 Touch The selected symptoms are reflected in the Patient Information window 3 The code and symptom name can be changed by touching the applicable symptom and then touching Change The...

Page 84: ...lect Dept 1 window 2 Touch The selected department classification is reflected in the Patient Information window Entering the Department Code Directly Department codes can be directly entered by the following process 1 Touch Input Code 2 Touch the number buttons to enter the code Clear All entered numbers are cleared BS The number to the left of the cursor is cleared 1 1 is added to the current co...

Page 85: ... window 18Enter the doctor and technician 1 Touch the applicable code Clear All entered numbers are cleared x Closes the window 2 Touch The selected content is reflected in the Patient Information window 3 The code and doctor technician name can be changed by touching the applicable doctor technician name and then touching Change 19Check the entered information and touch The display will return to...

Page 86: ...s to enter the ID number x Closes the Input ID window 2 Touch The entered ID is reflected in the Patient Information window The entered ID number is turned into a button and the patient information is loaded from the DMS and displayed in the Patient Information window The message No patient information was found for the entered ID number is displayed if there is no patient information correspondin...

Page 87: ...nshi Registering the Patient Information Enter the patient information perform the examination and then save the patient information to the SD card 1 Insert a formatted SD card in the SD card slot 2 Enter the patient information and perform the examination When the examination is completed the patient information used in the examination is automatically registered to the SD card The message There ...

Page 88: ...light the corresponding row in black Touch To exam to display the selected information on the patient information display area Only the following patient information is registered examination date ID number name date of birth gender height weight and Dept 1 4 Enter other patient information separately as needed Searching the Patient Information Using Search Condition The patient information can be...

Page 89: ... touch Yes 2 Touch the patient information to be deleted The selected patient information is highlighted 1 Select the patient to be deleted and touch Delete A confirmation window will be displayed 2 Touch Execute The specified patient information is deleted from the SD card More than one patient information can be selected for deletion 3 Touch Back to return to the patient information list ...

Page 90: ...be different depending on the examination date This function is the same as the Load from CF Card function of the previous models such as the VS 1500 series The data will be searched in the media selected under File General Read from This Media 1 Touch the patient information display area 2 Enter the ID number 1 Touch the number buttons to enter the ID number 2 Touch The entered ID is reflected in...

Page 91: ... Do not connect other medical devices to the limb which a cuff is attached When the cuff is removed after the examination check the condition of the limbs When examining make sure to let the patient lie on his her back so that the cuffs are at the same level as the heart During the examination let the patient maintain a relaxed posture free from tension and instruct him her not to speak apply pres...

Page 92: ...ence from such instruments Select a location with low humidity Make sure the selected location is quiet and not exposed to engine noise noise from air conditioners vibrations from railroads passing cars or treadmills How is the condition of the patient Check if the patient is nervous If nervous his her blood pressure may be higher than normal Reassure the patient by briefly explaining the examinat...

Page 93: ...nation Mode Button Switches the mode for obtaining waveforms Auto or Manual 8 i Button Information Button Touch this to display a screen indicating the status of the device 9 Measurement Site Sensitivity Display Displays the measurement site and waveform sensitivity 10 Cuff Pressure Display Displays the current cuff pressure 11 Waveform Display Displays the PCG and the pulse waves for the brachial...

Page 94: ...nt Displays previous examination data for the same ID Measurement Content Displays the window for setting the measurement sites interval period and measurement count File List Displays the file list Result Sensitivity Blood Vessel Length Previous Measurement Measurement Content 1 2 Touch 1 2 to switch displays File List Assist Toe Cuff Normal Md Offline Md Comm Inp 2 2 Sensitivity Up Down Pressure...

Page 95: ...eze Cancels freezing and returns to the home display Measure Sets the selected area as a target for measurement cancels freezing and proceeds to the next measurement Next Proceeds to the next data if multiple items are selected from the file list in the result display Window Selection Displays the windows that can be selected in the result display Save Saves the examination data to media Print Pri...

Page 96: ...procedures for each mode Press START Print Color Report Start of Measurement End of Measurement Save Send File Waveform Acquisition Right Brachium Ankle CAVI Check If ON is set Waveform Acquisition Left Brachium Ankle Pause 10 sec CAVI Check If ON is set ABI Measurement ABI Measurement Examination Result Display Reattach the cuffs from right side to left side Right Side Measurement Right Arm Leg L...

Page 97: ...CG appears in the display Refer to Attaching the PCG Microphone P3 5 8 Check the waveform sensitivity Check whether the waveform sensitivity on the home display is appropriate or not Usually the sensitivity is set to Auto to enable automatic selection of proper sensitivity for each waveform If the sensitivity is not appropriate you can manually select the sensitivity Refer to Setting Sensitivity M...

Page 98: ...on the left brachium ankle to acquire a pulse wave The CAVI Check display appears Refer to CAVI Check Result Display P5 12 14Measure the left brachial and left ankle blood pressure 15Upon completion the examination result will be displayed Refer to Examination Result Display P5 14 If the color printer is set to automatic printing the results are automatically printed after the measurements are com...

Page 99: ...yed in the measurement content and measurement results 1 Touch Examination 2 Touch PW BP Exam The preset examination mode will be displayed when the power is turned ON 3 Enter patient information Refer to Chapter 4 Entering Patient Information P4 1 If Section or Segment is set for PW BP Exam Pulse Exam Set Distance Input Method in the Settings enter the measurement sites according to Entering Bloo...

Page 100: ...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 P5 24 To suspend the measurement press the STOP key If the cuff pulse wave is unstable reattach the cuffs or touch Up down Pressure If the current pressure is 30mmHg or 50 mmHg it will be pressurized to 50mmHg or 65 mmHg respectively The pulse wave will be a...

Page 101: ...ttings The data is automatically saved to the media set for Save Media 14Press the Back button The display will return to the home display The results can be checked before they are automatically saved or sent This mode is enabled if ON is set for PW BP Exam Pulse Wave Gen Confirm results in the Settings Touch Back in the result display to return to the home display without saving or sending In th...

Page 102: ...s common to 2 channel 4 channel and 6 channel examinations The example shown below is 2 channel examination The CAVI indicator displays the number of usable beats to measure CAVI with a reliable quality Measure until it turns green Auto Extension If Auto is set for Pulse Exam Set Wave Recording Method or ON is set for Pulse Exam Set Auto Extension pulse wave acquisition is automatically extended i...

Page 103: ...the CAVI check 4 Measured Beats Displays the number of measured beats 5 Comment Displays any comments about the measurement 6 Measured Data The measured data will be displayed The symbols displayed in the representative value column indicate the selected beats for the corresponding item 2 Channel Examination 4 or 6 Channel Examination 2 CAVI Indicator 3 Remaining Time 4 Measured Beats 5 Comment 6 ...

Page 104: ...hing the display Touch the Summary BP Wave Meas or Trend button to switch the display This function is common to 2 channel 4 channel and 6 channel examinations The example shown below is 4 channel examination Summary Displays representative examination results The patient information ID name gender age height and weight and the date time of the examination are displayed R L CAVI R L ABI R L TBI an...

Page 105: ...PCG right brachial and right ankle pulse wave measurements for the first measurement will be displayed Lower display PCG left brachial and left ankle pulse wave measurements for the second measurement will be displayed When measuring CAVI on both sides in 4 channel examination Displays PCG the right brachial left brachial right ankle and left ankle pulse wave measurements Detailed measurements are...

Page 106: ...nstead Normal measurement CAVI reference value Converted CAVI Converted CAVI reference value Reference values Refer to P5 33 Converted CAVI CAVI value converted from the VS 1000 Up to 10 items are displayed in trend graphs The Y axis range of the blood pressure is calculated based on the maximum and minimum displayed SYS DIA values Unit per segment 10mmHg 1 5kPa Up to 10 previous left and right AB...

Page 107: ...sts Back Preview of the previous report will be displayed This is not displayed if no report exists The PDF files are stored in the IMAGE folder on the card The shared folder can only be saved during blood pressure and pulse wave examinations Refer to Network settings of shared folder P2 20 for instructions on configuring shared file settings BP pulse Wave Amplitude Graph The BP pulse wave amplitu...

Page 108: ...ed A pulse wave amplitude level that is higher above the reference level indicates a more stable measurement If it is below the reference level the blood pressure cannot be measured The Y axis scale differs between the amplitude graph and the pulse wave amplitude level The shape of the pulse wave amplitude graph may be affected by R R changes caused by pacemaker arrhythmia or body movement It is r...

Page 109: ...measurement results will not be displayed If CAVI ABI or TBI is selected as a measurement item the relevant measurement sites are selected automatically TBI is displayed only for 6 channel examination Setting Blood Pressure Measurements Manually 1 Set the inflation value The inflation value can be set manually The sites that can be set are the left and right ankles and left and right toes Touch Au...

Page 110: ... input method as it will be calculated automatically from the height Entering Section Values 1 Measure the distance between the measurement sites Measure the distance using a PWV measurement scale OA 35 optional or a tape measure AF Distance The distance cm from the left side of the left second intercostal sternum point A in the diagram to the pulse position of the right femoral artery point B in ...

Page 111: ... When all values have been entered touch in the Section window Entering Segment Values 1 Measure the distance between the measurement sites Place the tape measure with the 0 point starting point at the center of the right ankle cuff point D in the diagram and measure the distances from there to the center of the right knee joint point C in the diagram the pulse position of the right femoral artery...

Page 112: ...tances to the aortic valve artery and knee joint positions 1 Touch the button for the corresponding value 2 Enter the value 3 Touch The distances between the entered positions L1 L2 and L3 are calculated automatically 4 Repeat steps 1 3 to enter all necessary values 5 When all values have been entered touch in the Segment window ...

Page 113: ...are located on the limb cushions correctly so that the patient does not become tense from the effort of keeping them in position Check that the cuffs are not too loose Note Points for Checking Waveforms PCG waveform Check that there is a primary radical wave in the second heart sound Brachial pulse wave Check that the pulse wave rises smoothly and that there is a notch on the downward slope Ankle ...

Page 114: ...o Manual is displayed at the top of the home display when the device is in the waveform capture mode 2 Perform steps 3 to 9 of Measuring CAVI ABI TBI P5 9 3 Press the START key on the display unit 4 Press the START button to acquire the waveforms is displayed when measurements can be taken 5 Touch the Freeze button after the boundaries of the waveform have been displayed The acquired waveforms wil...

Page 115: ...procedure for taking measurements The measurement procedure is the same as the standard measurement P5 6 Attach the brachial and ankle cuffs and PCG microphone Check the waveform and press the START key to start the measurement The left brachial blood pressure is measured at the same time as the pulse wave CAVI can be measured in a shorter time if ABI and TBI are not measured If ABI and TBI are al...

Page 116: ... pressure pulse amplitude graph patient body illustration trend graph age graph and comments are printed Report for Patient A report for the patient containing CAVI ABI blood pressure CAVI blood pressure weight trend graph and age graph Trend Report A report containing a trend graph of CAVI ABI TBI blood pressure weight BMI and abdominal circumference Pulse Wave Report A PCG and limb pulse wave an...

Page 117: ...olor Reports Standard Report 0 1 2 344 0 5 6 7 8 3 6 9 6 3 3 3 3 3 6 3 3 3 3 3 3 3 4 1 1 3 11 A B 6 11 A B B 6 B B 6 B 0 5 1 0 5 344 4 C D E D E 6 6 B B B A 344 4 0 5 0 5 D 344 E 6 6 B B 6 10 6 6 6 B F 1 B B F 1 B 0G1H I 0G H I H 6 J 3 3 8 4 3 K83 L 3 3 0 5 0 3 5 8 1 G 1 5 G D E 5 G 3 7 ...

Page 118: ... of the patient s actual age X axis and R L CAVI value CAVI Trend Previously measured CAVI values are marked on the graph The numbers by the marks indicate the measured values BP Balance The blood pressure of each limb is indicated by the distance from the origin If the BP value of the right left brachium is not available the BP of left right brachium will be printed The same applies to the ankle ...

Page 119: ...hapter 5 Blood Pressure and Pulse Wave Examinations CAVI ABI TBI Standard Mode Report for Patient 0 1 21 3 4 4 4 5 5 5 5 6 5 7 7 7 0 4 8 3 5 9 5 5 7 7 5 8 9 3 8 9 0 7 8 9 A B A B A C D E 1 4 4 1 F 2 45 8 9 4 ...

Page 120: ...VI value is recorded A graph showing the CAVI progress in time series is printed The black line indicates the average values The red lines indicate 1 standard deviation 4 Occlusion of Artery ABI value the standard range and comments are recorded 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 ...

Page 121: ...5 31 Chapter 5 Blood Pressure and Pulse Wave Examinations CAVI ABI TBI Standard Mode Trend Report 0 1 2 1 3 4 4 5 6 7 8 5 6 79 5 06 79 1 58 6 1 7 1 4 8 8 9 8 98 8 8 1 3 1 8 3 9 7A 7 3 5 6 3 ...

Page 122: ...and the examination date time are recorded 2 Trend Display The following trend graphs are recorded CAVI Trend ABI Trend TBI Trend BP Trend Weight Trend BMI Trend Abdominal Circumference Trend The target BMI is set as 22 which is the standard value The target weight is calculated from the standard BMI of 22 and the patient s height ...

Page 123: ...ecorded R CAVI L CAVI R tb L tb R tba L tba R Tha L Tha R AI and UT and MAP for each site 4 Footer Area Information such as hospital name is recorded R CAVI and L CAVI values are marked with and designated as reference values if there is a possibility that the values may not have been correctly measured In this case check the waveforms are used in the following cases 1 When ABI is 0 90 or less 2 W...

Page 124: ...9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 1 2 31 2 1 4 5 31 4 5 1 4 5 31 4 5 1 16 4 5 3 16 4 5 16 4 5 3 16 4 5 17 3 17 17 3 17 9 9 9 9 9 9...

Page 125: ...rements will result in blood flow disorder When repeating the measurement wait until the blood flow is fully recovered 5 minutes interval is recommended Do not connect other medical devices to the limb which a cuff is attached When the cuff is removed after the examination check the condition of the limbs When examining make sure to let the patient lie on his her back so that the cuffs are at the ...

Page 126: ...es one side ABI is not measured and blood pressure is displayed for one ankle only The Simple Examination Mode is available only when English is selected as the language Measurement Procedure Below is the measurement procedure Press START Examination Result Display Start of Measurement End of Measurement Save Send File Print Color Report CAVI Check Pause 10 sec Waveform Acquisition Brachium Ankle ...

Page 127: ...e For standard use select RB Select LB if the right brachial blood pressure cannot be measured Select either the right or the left ankle 2 Touch Next Touch Cancel to return to step 3 5 Attach the cuffs to the brachium and ankle according to the displayed instructions and then touch Next Refer to Attaching the Cuffs Standard 2 Channel Examination P3 1 6 1 Attach the PCG microphone according to the ...

Page 128: ...ave acquisition 8 Touch Next When the pulse wave acquisition is completed the next display appears If the pulse wave is obtained correctly The device proceeds to the blood pressure examination after 10 seconds The following display appears if the CAVI check is not completed correctly Touch Cancel to perform the examination again To proceed to the blood pressure measurement touch Next The blood pre...

Page 129: ...screen to switch between displays Result Display 1 Patient Information Display Displays the patient information and the examination date time 2 CAVI Displays the CAVI values 3 Brachial BP SYS DIA Displays the brachial blood pressure measurements 4 Ankle BP SYS Displays the ankle blood pressure measurements 5 Dominant Wave of Ankle Pulse Wave UT MAP Displays the UT and MAP value of the dominant ank...

Page 130: ...from the file list in the result display Window Selection Displays a window for selecting a result display Save Displays the Storage Media window Select a media to save the data Print Examination results can be manually output to an external color printer etc Touch Print to display the window for printing setup Select a report and touch Print to output to the set destination Touch Preview to displ...

Page 131: ... Interpret Reports Color Reports The following report is output from color printers Simple Examination Report 0 1 2 3 4 5 24 5 66 78 9 0 4 5 2 A B 7 B 6 C 2 0 C 2 A 6 C 2 8 9 2 8 9 D 3 8 9 E 66 2 8 9 D D 24 5 3 3 3 3 3 24 5 28 D C 2 E F 6 B 6 B 8 9 8 0 9 G 2 7 2 9 7 33 9 7 H ...

Page 132: ...A circle mark indicates the CAVI value Y axis at the patient s actual age X axis The black line indicates the average values The red lines indicate 1 standard deviation 5 Trend Graph Records the trend graph of the R L CAVI and the right left brachial blood pressure 6 Blood Pressure Records the systolic diastolic and pulse wave amplitude graph for the right left brachium and right left ankle 7 Wave...

Page 133: ... before printing 1 Conduct the examination 2 Touch Print in the examination result display 3 Touch Preview 4 Check the report Back Displays a preview of the previous report Next Displays a preview of the next report Zoom In Zooms in the report display Zoom Out Zooms out the report display 5 Touch Back to return to the print display ...

Page 134: ...6 10 Chapter 6 Blood Pressure and Pulse Wave Examination Simple Mode ...

Page 135: ...n Refer to Chapter 4 Entering Patient Information P4 1 for procedures 4 After editing the patient information print and save it manually The examination result is displayed after the examination is completed It can be also displayed from the files Refer to Loading Examination Data P9 8 The examination result will be saved as new data when it is saved immediately after the examination When the exam...

Page 136: ... cursor buttons to move the line marker positions Moves the cursor a long distance to the right Moves the cursor a short distance to the right Moves the cursor a long distance to the left Moves the cursor a short distance to the left Shows the zoomed in display Touch this again to return to the normal display The zoomed in display can also be shown by touching a line marker Boundaries If there are...

Page 137: ...be configured in order to use this function Set Yes for PW BP Exam File Compare Waveforms Select the media to load the previous data under File General Read from This Media 1 Select PW BP Exam 2 Enter the ID in the Patient Information 3 If the past examination results of the same ID are saved the date time and dominant waveform of the previous examination will be displayed on the left side of the ...

Page 138: ...2 2 on the examination result display 4 Perform the recalculation To Recalculate the ABI 1 Slide the display to the BP display 2 Touch Recalculate ABI 3 Touch LB RB or BB ABI will be recalculated with the BP of the selected arm 4 Touch To Recalculate the TBI 1 Slide the display to the BP display 2 Touch Recalculate TBI 3 Touch LB RB or BB TBI will be recalculated with the systolic blood pressure S...

Page 139: ...ent Information P4 1 3 Attach the cuffs PCG microphone or sensors Refer to Chapter 3 Pre Examination Preparation P3 1 4 Check that the waveform is displayed and press the START key The set items will be printed on the report The printing will automatically stop when the examination is completed Also the data can be saved on an external media or automatically sent to a PC depending on the setting I...

Page 140: ...7 6 Chapter 7 Blood Pressure and Pulse Wave Examinations Other Functions ...

Page 141: ...reports any pain or physical abnormalities press the STOP key immediately to abort the examination Let the patient rest for 10 minutes before the examination Frequent measurements will result in blood flow disorder When repeating the measurement wait until the blood flow is fully recovered 5 minutes interval is recommended Do not connect other medical devices to the limb which a cuff is attached W...

Page 142: ...t the patient not to move or speak Are the cuffs correctly attached to the patient Is the air hose of any cuff bent and are objects placed on any of the air hoses Let the patient rest for ten minutes or more before taking measurements Home Display 1 ID Button Patient Information Display Area Tap this to display a window for entering patient information Information such as the ID name and age of th...

Page 143: ...ed 7 Menu Button Tap this to display the Menu screen 8 i Button Information Button Tap this to display a screen indicating the status of the device 9 Left Brachial BP Display Area Displays up to three blood pressure measurements for the left brachium Displayed content Current cuff pressure systolic blood pressure diastolic blood pressure pulse rate pulse amplitude graph 10 Date Time Display Area D...

Page 144: ...tches between normal mode and offline mode During normal mode data will be saved to the DMS During offline mode online operation such as master ID auto saving to DMS report output will not be performed Comm Inp Displays the comment input window Next Proceeds to the next data if multiple items are selected from the file list in the result display Save Saves the examination data to media Displayed i...

Page 145: ...m the right brachium RB the left brachium LB and both brachia BB 4 Attach a cuff to the right and or left brachium depending on the site s to be measured Refer to Attaching the Cuffs Standard 2 Channel Examination P3 1 5 Take the measurement Manual Measurement Press the START key on the display unit to measure the blood pressure The blood pressure is only measured once The blood pressure value s a...

Page 146: ...ment s and comments are shown at the top of the display Average systolic blood pressures diastolic blood pressures and pulse rates for the right and left brachia are shown at the center of the display The last three right and left systolic blood pressures diastolic blood pressures and pulse rates for this ID are shown at the bottom of the display Printing Conditions of Observation High blood press...

Page 147: ... to the set output destination Touch Preview to display the report to be printed on the screen Refer to Report Preview P8 9 The desired values for the SYS2 DIA2 SYS1 and DIA1 thresholds can be set in the Settings Set the latest values for each type of high blood pressure Refer to How to Interpret Reports P8 8 for instructions on how to interpret reports ...

Page 148: ...e graphs are recorded 5 Blood Pressure Group Graph A graph showing the blood pressure value group is printed with the left and right brachial blood pressure plotted on the graph The graph is divided into three areas blood pressure groups These are determined by blood pressure thresholds specified in the Settings Green area Normal BP Yellow area Normal High Red area Hypertension Grade 1 2 3 The blo...

Page 149: ...de at the time of the blood pressure measurement is printed Graphs for up to three measurements can be printed 8 Comment A field for entering comments Set whether to print 7 or 8 in the Settings Report Preview Examination reports can be checked in the display before printing to an external printer 1 Conduct the examination 2 Touch Print in the examination result display 3 Touch Preview 4 Check the...

Page 150: ... examination result can be automatically entered in the patient information 1 Touch Use The selected examination result is entered for BP in the Patient Information Convenient Functions Graphic simulation of mercurial sphygmomanometer During blood pressure measurement a graphic representation of a mercurial sphygmomanometer is shown in the display Pulse amplitude graph display A pulse amplitude gr...

Page 151: ...da 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 Make sure to format the media before using it for the first time Do not bend the media drop it or subject it to impact Do not remove the media or turn off the power during operation Also do not subject this device to impact or vi...

Page 152: ...r1 until Folder1 becomes full Data is then saved to Folder2 The maximum number of folders depends on the capacity of the media A folder is created when the SD card or USB memory is formatted The folder to save the data can be changed Refer to Changing the Folder to Save the Data P9 17 Inserting the SD Card Insert the optional card in the SD card slot of this device Make sure to insert the SD card ...

Page 153: ...eys can be used to display the second page if there is one List Prints the data list Trash Box Switches to the Trash Box List Display Delete Deletes the selected data Select All Selects all data in the file list Clear All Clears all data selections Recover Recovers the deleted data Change Name Changes the name of the folder Folder to Save Sets the folder to save the data Display Report Search Medi...

Page 154: ...ia 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 1 Insert the storage media into this device 2 Touch Menu on the touch panel 3 Touch File Communication 4 Touch Media Mgmt 5 Touch Format Media Format Examinat...

Page 155: ...es the function buttons to save the examination data during the next examination Refer to Saving Manually Simple Operation P9 6 Manually save examination data during the next examination File Utility Operation The user uses the file utility to save the examination data during the next examination Refer to Saving Manually File Utility Operation P9 6 Media that can be Used for This Operation The fol...

Page 156: ...utton to confirm it Saving Manually Simple Operation Manually save examination data to a specified media after each examination is finished 1 Conduct the examination 2 Insert the storage media into this device If the media is not formatted format it first Refer to Initialization P9 4 3 Touch Save after the examination is finished The Storage Media window is displayed 4 Touch the media to save the ...

Page 157: ...list 6 Touch Media 7 Specify the internal memory as the location of the data to be copied Copy From 1 Touch Int memory 2 Touch 8 Touch the data to be saved The data is highlighted 9 Touch 1 3 Copy 10Touch The selected data is copied To change the media to copy the data touch Change and specify a media ...

Page 158: ...ch Menu on the touch panel 3 Touch File Communication 4 Touch File list 5 Touch Media 6 Specify the location of the data to be loaded 1 Touch the location of the data to be loaded 2 Touch 7 Touch the data to be loaded When the data is highlighted touch Display The Search function needs to be used to display the examination data when loading examination data from the DMS Refer to Searching for Data...

Page 159: ...ia if any of the following information is known ID number name of the patient examination date and or folder number 1 Follow steps 1 6 in Loading P9 8 2 Touch Search A window for entering search conditions is displayed 3 Touch the item to be used as a search condition and enter the condition Parts of the display indicating the search conditions that can be entered differ depending on the media bei...

Page 160: ...art date onward are search targets Searching by Folder Number Touch Folder A window for entering a folder number is displayed Enter the number of the desired folder All folder numbers are set as search targets by default A start number and end number can be entered If no start number is entered all data items below the end number are search targets If no end number is entered all data items above ...

Page 161: ...h Media The Storage media window is displayed Specify the media and folder to load the data and touch Printing the Data List 1 Touch 1 3 2 3 LIST The data list is printed Clearing All Data Selections 1 Touch 1 3 Cl All All of the data selections are cleared ...

Page 162: ...onger displayed in the list The data is still stored on the media Data stored on the DMS cannot be deleted 1 Follow steps 1 6 in Loading P9 8 2 Touch the data to be deleted The data is highlighted 3 Touch 1 3 Delete 4 Touch Execute The data is deleted from the list To restore the deleted data follow the steps in Restoring Deleted Data P9 13 ...

Page 163: ...x Data in the Trash Box can be restored 1 Touch 1 3 2 3 Trash Box 2 Select the data to be restored 1 Touch the data to be restored Alternatively touch Search to search for data and then select data from the results 2 Touch Recover 3 Touch Yes The data is restored Data cannot be deleted from the Trash Box ...

Page 164: ...orrecting the Patient Information P7 1 Editing Boundaries Refer to Correcting the Boundaries for CAVI Measurement P7 2 Recalculating ABI TBI Refer to Recalculating the ABI TBI P7 4 Copying Examination Data Examination data can be copied between different media SD card USB memory DMS or Int memory can be selected as the media of copy source A different media from the copy source SD card USB memory ...

Page 165: ...ed from media to the DMS the PC icon is displayed in the Storage media field Naming Folders Folders on SD cards and USB memory devices can be named to organize the saved data clearly Naming 1 Insert the SD card or USB memory into this device 2 Touch Menu on the touch panel 3 Touch File Communication 4 Touch Media Mgmt 5 Touch Folder Management ...

Page 166: ...the department 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 2 Touch The name of the folder is registered If x is touched the entered folder name is not registered Printing the Folder List 1 Touch LIST The folder list is printed ...

Page 167: ...r to Saving Manually File Utility Operation P9 6 Use a USB memory to transfer and store files Use an SD card for ordinary operations Changing the Folder 1 Insert the SD card or USB memory 2 Touch the Menu button on the touch panel 3 Touch File Communication 4 Touch Media Mgmt 5 Touch Folder Management 6 Select the folder to save the data 1 Touch the media to save the data 2 Touch the folder to sav...

Page 168: ...vice and the DMS and or media The latest 500 communication data items are recorded Printing the Communication History 1 Insert the SD card or USB memory to be named into this device 2 Touch Menu on the touch panel 3 Touch File Communication 4 Touch Media Mgmt 5 Touch Communication History 6 Touch LIST ...

Page 169: ...nd number are search targets If no end number is entered all data items above the start number are search targets Searching by ID Number Touch ID A window for entering an ID number is displayed Enter the desired ID number All ID numbers are set as search targets by default Wild cards can be specified with a Searching by Examination Date Touch Date A window for entering an examination date range is...

Page 170: ...argets by default Searching by IP Address Touch IP address A window for entering an IP address is displayed Enter the desired IP address All IP addresses are set as search targets by default Searching by Port Number Touch Port A window for entering a port number is displayed Enter the desired port number All port numbers are set as search targets by default Searching by Job ID Touch JOB ID A windo...

Page 171: ...9 21 Chapter 9 File Transfers Erasing the Communication History Touch Erase The communication history is erased Reports File List ...

Page 172: ...9 22 Chapter 9 File Transfers Communication History ...

Page 173: ... report list in the order in which the examinations were conducted Examination date and time Examination information Patient information ID number name age gender Up to 500 daily reports can be saved When another daily report is saved after this the oldest daily report is deleted If more than the maximum number of daily reports are saved in one day a message saying Daily report data is full is dis...

Page 174: ...lay the second page if there is one Recording a Daily Report 1 Touch the Menu button on the touch panel 2 Touch Daily Report 3 Touch the desired recording method The content recorded by each recording method is as follows Today Prints a daily report for the current day Date Prints a daily report for the data specified by the user All Prints all daily reports recorded in the device If Today is Touc...

Page 175: ...date 3 Touch If All is Touched All registered daily reports are printed 4 Touch Print Daily reports for the selected period are printed 5 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: ...10 4 Chapter 10 Recording Daily Reports ...

Page 177: ...ion Set whether to enter items as patient information P11 9 File Configure settings such as the methods for saving and loading examination data P11 14 Communication Configure settings for communication methods with other devices P11 15 External device Configure settings for connections with external devices P11 17 PW BP Exam Configure settings concerning examination methods and recorded content fo...

Page 178: ...re Settings The settings are configured by selecting setting values entering text entering numbers and using sliders Performing Operations in the Settings Display 1 Select the setup item to be configured by touching it 2 Touch the desired setting value to change the setting of the item Repeat these steps to configure other setup items Selecting Setting Values Below are instructions on selecting on...

Page 179: ...ight 1 Use the numeric keys to enter the numbers 1 Enter the desired number using the number keys 2 Touch Touch BS to clear one digit of the entered number Touch Clear to clear the whole of the entered number Touch x to discard the entered number and close the input window Entering Text Below are instructions on how to enter the hospital name doctor name technician name department medicine symptom...

Page 180: ...anum Switches to alphanumeric characters Symbol Switches to symbols BS The character to the left of the cursor is cleared Clr All All entered characters are cleared Moves the cursor to the left Moves the cursor to the right Space Enters the space x Closes the Input ID window 2 Touch The entered name is reflected in the Patient Information window ...

Page 181: ...h Setting 3 Touch the desired examination 4 Change the settings Refer to the items below for information on the settings and setting values for each item 5 Touch To exam after configuring the settings 6 To enable the new settings touch Yes Touching No will discard the changes and return to the examination display Pressing Cancel will return to the settings display This completes the changing of th...

Page 182: ... language Standard Examination Mode Simple Examination Mode Terminal Number Specifies the terminal number of the device This is useful when creating system configurations 0 255 Auto power off Turns the power off automatically if no operations are performed for the prescribed period of time when using the battery OFF 5 minutes 10 minutes Power Frequency Specifies the frequency of the AC power suppl...

Page 183: ...d will be silenced 1 5 The volume will increase with the value respectively 0 1 2 3 4 5 Key sound Volume Set the volume of the tone that sounds when a key is pressed 0 Sound will be silenced 1 5 The volume will increase with the value respectively 0 1 2 3 4 5 Process End Tone Volume Set the volume of the tone that sounds when a process such as auto record is finished 0 Sound will be silenced 1 5 T...

Page 184: ...ion Setting Range Auto Save PDF Automatically saves data as a PDF after taking a measurement ON OFF XML Output Saves the PDF as XML file ON OFF Save Media Specifies the media to save PDF Multiple items can be selected Caution If a shared folder is selected only reports from PW BP examinations and brachial blood pressure examinations are saved SD Card USB1 2 3 Shared Folder Setup Item Description S...

Page 185: ...ID number Age Gender Name Department Code 1 4 Height Weight Inquiry Medicine Info Subjective Symptoms Comment BP Doctor Technician Auto Window Others Specifies the input window to be opened when patient information is entered by means other than an ID card or bar code ID number Age Gender Name Department Code 1 4 Height Weight Inquiry Medicine Info Subjective Symptoms Comment BP Doctor Technician ...

Page 186: ... of each day ON OFF Daily ID number zero padding ON Uses zero padding adds zeros OFF Does not use zero padding does not add zeros Zero padding adds zeros to numbers below the set number of digits If 12 is set as the number of digits for ID numbers and 123 is entered as the ID in the Patient Information window this becomes 000000000123 if zero padding is set to ON ON OFF Setup Item Description Sett...

Page 187: ...to display and print the patient s BMI BMI Weight kg Height m x Height m ON OFF A C Enter Specifies whether to enter display and print the patient s abdominal circumference ON OFF Setup Item Description Setting Range Department Code 1 4 Enter Specifies whether to enter display and print the department code ON Department Code 1 and 2 OFF Department Code 3 and 4 Input Length Setting Specifies the in...

Page 188: ... is backed up The content from before the power was turned off is called the next time the power is turned on OFF Data is not backed up Content is erased when the power is turned off Daily Recorded data is erased at the end of each day ON OFF Daily Subjective symptoms Enter Specifies whether to enter display and print subjective symptoms ON OFF Input Length Setting Specifies the input length of su...

Page 189: ...s turned off is called the next time the power is turned on OFF Data is not backed up Content is erased when the power is turned off Daily Recorded data is erased at the end of each day ON OFF Daily Technician Enter Specifies whether to enter display and print technician names ON OFF Input Length Setting Specifies the input length of technician codes 2 12 4 Regist Code Register a technician name 1...

Page 190: ...ach examination mode ON OFF Each Exam Mode ID Confirm Displays a confirmation window when ID is not entered ON OFF Check Storage Checks whether the previous examination result data has been saved before starting the examination A message is displayed if the data has not been saved Specifies the media to be checked SD Card USB1 2 3 DMS Display List Select the display format of the file list Date Or...

Page 191: ...0 seconds 180 seconds 30 seconds Setup Item Description Setting Range DMS Settings Recording Playback Host Specifies the recording and playback host to connect 1 2 3 4 5 6 PW BP Host Specifies the host to send PW BP examination results 1 2 3 4 5 6 Patient Info Host Specifies the master ID communication host 1 2 3 4 5 6 Shared Folder Specifies the shared folder host 1 2 3 4 5 6 Gateway Sub Network ...

Page 192: ...Specifies the authentication method WEP64Bit WEP128Bit WPA WPA2 Network key Specifies the network key Up to 64 single byte alphanumeric characters and symbols Item Description Setting Range Mounted Directory Specifies the name of the shared folder set on the Windows computer If a hierarchical file structure is used the path can be set using Up to 32 single byte alphanumeric characters and symbols ...

Page 193: ...2 Buzzer Control 3 Confirm results Specifies whether to confirm the result display before performing actions such as saving after taking measurements ON OFF Default Measurement Site Set the default measurement site The site set here is set as the measurement site when the power is turned on or when switching to a new patient Multiple items can be selected RB LB RA LA RT LT Default Measurements Set...

Page 194: ...e from the center of the ankle cuff are entered in segments This is enabled if CAVI is selected as the measurement item Height Section Segment Wave Recording Method Select whether to manually check the measured waveform that is recorded during CAVI examinations or perform the process automatically Auto The measured waveform is automatically recorded as soon as it can be measured Manual The measure...

Page 195: ...r limbs at once Simultaneous Inflation Inflates the cuffs of all four limbs at once Right to Left Inflation The blood pressure on the left side is measured after the blood pressure measurements on the right side are completed This is enabled if ABI is selected as the measurement item Simultaneous Inflation Right to Left Inflation Calc auto Pressure Increment Set whether to automatically calculate ...

Page 196: ... the right graph of the Standard Report Age Graph BP Balance CAVI Trend ABI Trend TBI Trend Brachial BP Trend Weight Trend BMI Trend Abdominal Circumference Trend BPB Arrow Specifies whether to output a BPB arrow in the Standard A Color Report ON OFF Setup Item Description Setting Range Automatic Print Copies 1 Simple Examination Report Specifies the number of color copies of the Simple Examinatio...

Page 197: ...ding waveforms OFF 1 minute 2 minutes 3 minutes 4 minutes 5 minutes Default Measurement Count Set the default measurement count 1 time 2 times 3 times Hypertension Threshold SYS1 The SYS threshold between the green and yellow areas of the blood pressure value group graph 135 30 280 Hypertension Threshold SYS2 The SYS threshold between the yellow and red areas of the blood pressure value group grap...

Page 198: ...ducted in a series Up to 16 examinations can be registered including the initially registered examination Changing the Examination Order 1 Touch Menu on the touch panel 2 Touch Setting 3 Touch Register Examination 4 Change the examination order 1 Touch the Change Exam Pos tab 2 Touch the examination to change the order 3 Touch the direction keys to change the position Up to eight examinations can ...

Page 199: ...s registered as the examination to be displayed on startup Adding a New Examination New examinations can be set Newly registered examinations can be selected in the Select Examination window in the same way as other examinations 1 Perform steps 1 3 in Changing the Examination Order P11 22 2 Touch the Create a new exam tab 3 Touch the New name input area or touch Enter 1 Enter the name of the new e...

Page 200: ... Change Exam Pos tab 1 Touch the examination to be deleted 2 Touch Delete 3 Touch Yes The selected examination is removed from the Examination List Copying an Examination 1 Perform steps 1 3 in Changing the Examination Order P11 22 2 Touch the Copy tab Touch the ExamName input area or touch 1 Enter the name 2 Touch 3 Touch the examination to be copied 4 Touch The copy of the examination is registe...

Page 201: ...conducted in a series examination 1 Perform steps 1 3 in Changing the Examination Order P11 22 2 Touch the Series Examination tab 3 Touch the SerExamName input area Enter the name of the series examination 1 Enter the name 2 Touch 4 Specify the examinations to be conducted in a series 1 Touch the examination to be conducted first 2 Touch Examination 2 3 Touch the examination to be conducted second...

Page 202: ...ard 1 Insert the SD card into the device 2 Touch Menu on the touch panel 3 Touch Setting 4 Touch 1 2 5 Touch Save Code The codes registered for Dept 1 4 Med Symp Dr Nm1 2 and Tech along with the names and facility name are saved to a file called TABLE INI in the ETC folder on the SD card The codes saved to the SD card can be loaded later using Read Code This is useful in situations such as when th...

Page 203: ...ts arising from failure to perform maintenance and inspections Never disassemble or modify the device It may result in fire hazard or electric shock Do not perform the Maintenance menu procedure which is not described in this manual It may result in malfunction Item Inspection Item Procedure Criteria Main Unit 1 Enclosure Verify that there are no scratches cracks deformation or rust No scratch cra...

Page 204: ...up screen at power ON The screen should be displayed at power ON Display Check the screen No abnormality or flickering should be found Check for errors on the screen No errors should be displayed on the screen Icon display At power on Check the status of the icons The device connection status should be displayed correctly Keys and Buttons Press and check the keys and buttons Operation should be sm...

Page 205: ... screen No abnormality or flickering should be found Check for errors on the screen No errors should be displayed on the screen Icon display At power on Check the status of the icons The device connection status should be displayed correctly Keys and Buttons Press and check the keys and buttons Operation should be smooth 0mmHg check Check the pressure value displayed at power ON Should be within 1...

Page 206: ...est see the VS 2000 Service Manual Should be 320 10mmHg Inflation time Should be 20 sec or less Air leakage Should be 4mmHg min or less Quick exhaust Should be 10 sec or less 100 open Should be within 100 to 250mmHg sec 75 open Should be within 20 to 190mmHg sec Time Limit Should be 130 10 sec Should be 8 1 sec at high speed PCG PCG filter characteristics PWV Input sine wave signals to the PCG con...

Page 207: ...n Item Criteria Power Supply Check that the power can be turned ON and OFF when operating the device on AC and battery power Should be able to turn the power ON and OFF when operating the device on AC and battery power Power Supply Cable Perform continuity test using a tester and check that continuity occurs Should maintain continuity ...

Page 208: ...osure of the device to the earth 3 Patient leakage current From Patient Connection to Earth Leakage current that flows from the applied parts to the earth through the patient There are two ways to measure DC and AC 4 Patient leakage current External Voltage Leakage current that flows from the device to the earth by the power supply voltage on the patient in the type F applied parts 5 Patient auxil...

Page 209: ... values 4 Patient leakage current from patient connection to earth inspection 1 Measurement wiring diagram Patient Applied Part Cuffs PCG microphone chip etc Normal condition Single fault condition 5mA 10mA Normal condition Single fault condition 0 1mA 0 5mA Medical Electrical Equipment AC Outlet AC Outlet Safety Evaluation Test Device Leakage Current AC Outlet AC Outlet Medical Electrical Equipme...

Page 210: ...e chip etc 2 Allowable values Normal condition Single fault condition Direct Current 0 01mA 0 05mA Alternating Current 0 01mA 0 05mA Single fault condition 0 05mA Normal condition Single fault condition Direct Current 0 01mA 0 05mA Alternating Current 0 01mA 0 05mA AC Outlet AC Outlet Medical Electrical Equipment Patient Applied Part Contact Probe Safety Evaluation Test Device Leakage Current AC O...

Page 211: ... initialized is displayed Cooling fan Approximately 70 000 hours if continuously used 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 a...

Page 212: ...y charged purchase a new battery Contact your local Fukuda Denshi service representative when installing or replacing the battery Contact your local Fukuda Denshi service representative to purchase a battery Replacing the Clock Battery This device is equipped with a built in battery to power the clock If incorrect time is shown shortly after setting the correct time the service life of the clock b...

Page 213: ...n is not possible 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 Contact...

Page 214: ...12 12 Chapter 12 Maintenance and Inspection ...

Page 215: ...SB2 0 Full Speed 3 channels Safety standard ANSI AAMI ES 60601 1 2005 Type of protection against electrical shock Class I Equipment and Internally Powered Equipment Degree of protection against electrical shock NIBP Type CF applied part defibrillation proof applied part PCG input Type CF applied part defibrillation proof applied part Power Supply AC 100 to 240V 50 60 Hz 80 VA DC11 1V During batter...

Page 216: ...lationship between natural logarithm for the pressure ratio ln Px Po and the rate of change in inner diameter Dx Do Do shows a linear relationship This oblique straight line is called stiffness parameter β It is known that this parameter is independent of internal pressure and that a larger β indicates lower extensibility greater vascular stiffness Assessment of carotid arterial distensibility usi...

Page 217: ...en the two blood vessel locations The following two PWV are used to calculate CAVI Heart valve right left ankle artery PWV 5 Time measurement of pulse waves To calculate PWV we need to obtain pulse transmission time T from the heart valve to the ankle To establish T t b tba t b tb T tb tba is obtained First heart sound Includes the opening snap of the aortic valve Second heart sound Closing snap o...

Page 218: ...nkle systolic blood pressure by the brachial systolic blood pressure It is an index used to evaluate the degree of stenosis and occlusion resulting from atherosclerosis in the lower limbs It is also called ABPI ankle brachial pressure index or API ankle pressure index R ABI and L ABI are obtained through the following formulas The typical brachial blood pressure is determined according to the foll...

Page 219: ...systolic blood pressure It is effective in detecting advanced arteriosteogenesis in the ankle joints and peripheral stenosis or occlusion beyond the ankle joint It is also called TBPI toe brachial pressure index or TPI toe pressure index R TBI and L TBI are obtained from the following formulas For details on typical brachial systolic blood pressure refer to the section on ABI 5 BMI Body Mass Index...

Page 220: ... the peak of tidal wave AI is an index indicating vascular extensibility It has a positive correlation with the resistance of the aortic vessel and increases with age and arteriosclerosis R AI Measurement obtained from the right brachial pulse wave L AI Measurement obtained from the left brachial pulse wave The values are printed in the following priority order R AI L AI This shows the blood press...

Page 221: ...e 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 Arrow color Upper limbs Black Right ankle Blue Left ankle Green The arrow will only appear if ischemia is suspected Value Unit Value Unit Blood pressure mmHg kPa UT ms ABI None MAP None CAVI None AI None BMI kg m2 Systolic BP of Corresponding Site Higher...

Page 222: ...ible mild to moderate Peripheral Arterial Disease 0 41 R L ABI 0 90 Possible severe Peripheral Arterial Disease 0 00 R L ABI 0 40 Suspicion of Peripheral Arterial Disease When the pulse wave height is too small for blood pressure measurement If TASC Ⅱ ACC AHA 2011 standard is selected Noncompressible 1 41 R L ABI Normal 1 00 R L ABI 1 40 Borderline equivocal 0 91 R L ABI 0 99 Suspicion of Peripher...

Page 223: ...l stenosis occlusion When R L ABI 0 90 R L TBI 0 60 0 69 3 R L ABI is 0 90 or lower When R L ABI 0 90 Low PW Ampl 2 When the pulse wave amplitude is low RA LA UT is 180ms or higher 2 When RA LA UT 180ms RA LA MAP is 40 or higher 2 When RA LA MAP 40 RA LA Noncompressible If 2005 ACC AHA standard is selected When R L ABI 1 30 If TASC Ⅱ ACC AHA 2011 standard is selected When R L ABI 1 41 Brachial pre...

Page 224: ...for left ankle L CUF 138LLU for right ankle S CUF 138SRU for left ankle S CUF 138SLU for ankle S CUF 143SHU for ankle L CUF 143LHU 7 Air hose for upper limbs OA 30APL2 7 BU Air hose for lower limbs OA 30APL2 7 AU 8 Toe cuff M CUF 139M2 Toe cuff S CUF 139S2 9 Toe cover OA 459M 50 pieces per box 10 Limb cushion OA 461 11 Limb cushion cover OA 463 12 SD Card SD 2G 2GB 13 USB Memory TS16GJF600 16GB TS...

Page 225: ...specifications are subject to change without prior notice for quality improvement 1 2 3 4 5 12 13 15 No Accessory Model Remarks 1 Ethernet hub IEC 60950 and RoHS compliant Switching Hub 2 Color Printer Manufacturer Brother HL 3170CDW duplex color laser printer 1 2 ...

Page 226: ... standards IEC 60601 1 states that in the case of non medical devices outside the patient environment it is sufficient to ensure that the safety features comply with the applicable technical standard under IEC or the Electrical Appliance and Material Safety Act or are equivalent to such features 1 When building a medical electrical system assuming that this device is device A device B should be in...

Page 227: ...ure Display 5 3 D Daily Inspection 12 1 Danger 1 Data Management System 1 3 Date and Time 2 14 Deleting an Examination 11 24 Deleting Examination Data 9 12 Description of the Reports 5 25 Description of the Screen 1 11 Displaying the Menu 2 15 DMS 4 1 4 8 Dual Side Adhesive Tape 3 5 E Electrical scalpel 17 Electromagnetic Emissions 14 Electromagnetic Immunity 15 EMC 13 14 Entering Blood Vessel Len...

Page 228: ...ower 2 4 Replacement Period 12 9 Replacing the Clock Battery 12 10 Restoring Deleted Data 9 13 Result Display 6 5 S Safety 3 Safety Labels 2 Safety Notations 1 Saving and Initializing the Settings 11 26 Saving Examination Data 9 5 SD Card 9 2 Selecting the Examination to be Conducted on Startup 11 23 Series Examination 7 5 Setting Sensitivity 5 19 Settings for Blood Pressure and Pulse Wave Examina...

Page 229: ... a specified location Pass Fail Cables 1 Power supply cable Connector cables No scratch or damage Pass Fail Cables and hoses are connected properly Pass Fail Operation Operation 1 Power Display turns ON at power ON Pass Fail 2 Display No abnormality or flickering Pass Fail Verify that no errors are displayed on the screen Pass Fail 3 Icon display At power on Verify that the status of the connected...

Page 230: ...turns ON at power ON Pass Fail 2 Display No abnormality or flickering Pass Fail Verify that no errors are displayed on the screen Pass Fail 3 Icon display At power on Verify that the status of the connected device is displayed correctly Pass Fail 4 Keys and Buttons Smooth operation Pass Fail 5 0mmHg check Verify that the pressure value displayed at power on is within 1 mmHg Pass Fail 6 BPU 100 For...

Page 231: ...ss Fail Pass Fail Pass Fail Pass Fail 9 Time Limit 130 10sec 8 1sec at high speed Pass Fail Pass Fail Pass Fail Pass Fail BPU 100 Toes Right toe Left toe 1 Zero point Within 0 1mmHg Pass Fail Pass Fail 2 Pressure accuracy 50 mmHg Within 3mmHg Pass Fail Pass Fail 100 mmHg Within 3mmHg Pass Fail Pass Fail 150 mmHg Within 3mmHg Pass Fail Pass Fail 250 mmHg Within 3mmHg Pass Fail Pass Fail 300 mmHg Wi...

Page 232: ...A or less mA Pass Fail Single fault condition 0 05mA or less mA Pass Fail Patient leakage current from patient connection to earth AC Normal condition 0 01mA or less mA Pass Fail Single fault condition 0 05mA or less mA Pass Fail 4 Patient leakage current external voltage Single fault condition 0 05mA or less mA Pass Fail 5 Patient auxiliary current DC Normal condition 0 01mA or less mA Pass Fail ...

Page 233: ...The company and product names used in this manual are trademarks or registered trademarks of respective companies ...

Page 234: ...Printed in Japan 4L011364D 202001 3 39 4 Hongo Bunkyo ku Tokyo Japan Tel 81 3 5684 1455 Fax 81 3 3814 1222 http www fukuda com ...

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