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Pasesa AVE-2000 Pro, Instructions For Use Manual

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Pasesa AVE-2000 Pro Instructions For Use Manual Download Page 1

Non-invasive Vascular 
Screening Device

Instruction for Use

AVE-2000 Pro

To ensure the correct use of the device, please read the manual carefully.

Keep the manual near the device.

To measure accuracy, please use the device in an appropriate way.

The device can be used to measure AVI & API, CSBP & CAPP, Systolic & Diastolic blood pressure 

and the P.R. of adults.

Registration Number

20182210170

Production Certificate 

 20162890

Summary of Contents for AVE-2000 Pro

Page 1: ...device please read the manual carefully Keep the manual near the device To measure accuracy please use the device in an appropriate way The device can be used to measure AVI API CSBP CAPP Systolic Diastolic blood pressure and the P R of adults Registration Number 20182210170 Production Certificate 20162890 ...

Page 2: ...e CSBP estimated value and Central Aortic Pulse Pressure CAPP estimated value The values are only for diagnostic reference The device should be used under the direction of a physician About this Manual This manual will provide you with instructions on how to use Non invasive Vascular Screening Device AVE 2000 Pro Please read this manual carefully and keep it in a safe place for future reference No...

Page 3: ...etes smoking and exercise etc AVI may be reduced through regular exercise AVI Arterial Velocity Pulse Index AVI is a new vascular index that developed jointly by Shisei Datum in Japan and RIKEN Himeno Ryutaro with his sub generation integration simulation team and Gao muzhou with his dominant organ Scale study team are the research and development teams of RIKEN Gao muzhou is also a professor of T...

Page 4: ...easing working pressure then the curve is fitted with an arctan function A arctan B X C D Finally API is defined as the reciprocal of coefficient B API 1 B CSBP Estimated Value CAPP Estimated Value CSBP Central Systolic Blood Pressure estimated value It is cobtained by taking age radial artery systolic pressure pulse pressure arterial velocity pulse index arterial pressure volume index and other p...

Page 5: ...iscarded at will Place up Pay attention to moisture proof Fragile The maximum loading layer is 6 layers Precautions Device Precautions Warning This device is only applicable for adults and do not use it on neonates children or people who cannot express their feelings The patients with severe blood circulation disorders and blood diseases should use it under the direction of physician Pregnant pati...

Page 6: ...tricity or electric wave e g close to microwave oven Please start the device after drying it if there is moisture condensation on the device When moving the device from a low temperature environment to a high temperature environment there may be water drop condensation inside the device due to physical transformation please start the device after it cooled down to room temperature Do not use acces...

Page 7: ... with new batteries when the old ones expire In case battery liquid sticks on your clothes or contacts your skin please wipe it off with dry cloth rinse the affected area with soap and rinse with large amount of fresh water Thermal Sensitive Printer Precautions Caution Do not disassemble repair or modify the printer or its accessories Please use designated accessories and printing paper Thermal se...

Page 8: ...body and power supply you can disconnect them and tidy them as an independent product The numerical keypad is an integrated design with a keypad and USB cable 15 buttons and a LCD display screen The thermal sensitive printer in the accessories is the line thermal sensitive printer it uses thermally sensitive paper with a width of 58 mm Effective printing width of 48 mm and there is a designated RS...

Page 9: ...ot place the device in other directions especially with display interface on the desk top while changing batteries The battery status is not shown on the display when the power is sufficient more than 30 represents the power of the batteries is running out lower than 30 represents the power of the batteries has run out Please replace the batteries The battery life depends on variety of factors Ple...

Page 10: ...suring Before turning on power supply No Contents 1 Ensure there is no damage or deformity etc on the device and its accessories 2 Ensure there is no moisture condensation on the device If so please dry it thoroughly first 3 Ensure the device is placed steadily with sufficient space around 4 Ensure there are no objects in the arm cylinder 5 Please connect the device to power supply as instructed i...

Page 11: ...ted return back to the age input screen Standby screen Fig 1 2 Press the button of the device its power indicator light will be on The numerical keypad connected turns on automatically and lets out beep sound Approximately 5 seconds later the device lets out the prompt tone and enters the age input screen Please set up the date and time correctly before performing measuring Incorrect date and time...

Page 12: ... your back put your left hand through the arm cylinder and place your elbow on the elbow holder with your palm facing up as shown below 5 9V DC Fig 4 2 The cuff cover which installed on the arm cylinder of the main body if you have bought it is designed for patients Elbow holder Straighten your back 25 to 30 cm Release the arm with palm upward ...

Page 13: ... desk and chair is 25 to 30 cm Please adjust the height of the desk or the chair to keep your heart position in the same level as the heart symbol on the arm cylinder Fig 4 3 The distance between the device and the edge of the table the body and the table edge is recommended to maintain about 2 cm each The distance will be different as the height and weight of the user is different anyway please k...

Page 14: ...e your arm above your head and then clench and unclench your palm repetitively for about 15 times to relieve the symptom Pressuring up In measuring Pressuring down In case you have an emergency please press the button or the button the abort the measurement After pressing the button and the power light will turn off sooner than the LCD screen does The measuring lasts for nearly 2 minutes Please do...

Page 15: ... for 30 seconds the device will return to the age input screen Do not disconnect the power supply or press the button to force the device to terminate in the measuring or data saving process For better comparison of measurement results make measurements at the same time each day If multiple measurements are required please keep the interval over 10 minutes 5 Measurements Checking 1 Press the butto...

Page 16: ...asurements Printing 1 Please first ensure proper thermal sensitive papers are put in the thermal sensitive printer and the printer is correctly connected to the device and power supply COM COM Fig 6 1 Please refer to the instructions for use provided with the thermal sensitive printer for the methods of thermal sensitive printer installation and for operation by other people Date and time Data Num...

Page 17: ...re for adults Tab 5 1 Definition and Classification of Blood Pressure Level for Adults Type SYS mmHg DIA mmHg Hypotension 100 60 Ideal blood pressure 120 80 Normal blood pressure 130 85 High normal blood pressure 130 to 139 85 to 89 Borderline hypertension 140 to 149 90 to 94 Grade 1 hypertension Mild 140 to 159 90 to 99 Grade 2 hypertension Moderate 160 to 179 100 to 109 Grade 3 hypertension Seve...

Page 18: ...Year Age Year AVI Fig 7 1 Correlations between AVI API and Age AVI and API both increase with age For a subject with a higher measurement of AVI or API her his risk of cardiovascular disease may be higher 60 55 50 45 40 35 30 25 20 15 10 5 0 10 20 30 40 50 60 70 80 90 100 Age Year Age Year AVI API The dotted line indicates the standard deviation range value of the average 2X 60 55 50 45 40 35 30 2...

Page 19: ... 1mmHg 0 133kPa CAPP Estimated Value range is 1 to 180 mmHg 0 1 to 24 kPa and its display resolution is 1mmHg 0 133kPa CSBP estimated value and CAPP estimated value are the items in the initial stage of clinical research And these estimated values cannot be used as a basis for clinical diagnosis they are just a reference for doctors ...

Page 20: ...wer light turns off and then close the elbow holder Press the button on the thermal sensitive printer to turn off the printer Fig 9 1 2 Turn off the switch of the power supply socket remove all accessories from the device and the power supply socket such as the AC adapter numerical keypad thermal sensitive printer and mains charger etc Charger for the printer Thermal sensitive printer RS232 connec...

Page 21: ...ck Protection II Grade of Electric Shock Protection B Measuring Method Oscillographic determination method Pressuring Up Intelligent automatic pressuring method of force pump Pressure Releasing Electromagnetic valve controller automatic pressure releasing method Air Releasing Electromagnetic valve controller quick air releasing method Pressure Detection Diffuse type semiconductor pressure sensor D...

Page 22: ... 260 mm Weigh of Main Body Approx 2 6 kg W O batteries Composition Main body AC Adapter Thermal sensitive printer Numerical keypad Accessories AC Adapter AA Alkaline battery 4 Thermal sensitive printer Numerical keypad User manual Warranty card Fuse Type F0603CP2500V032T 2 5A Standard of Performance Requirements YY 0670 2008 Safety Standard GB 9706 1 2007 EMC Standard YY 0505 2012 Biological Asses...

Page 23: ...in please contact your local service representative Measurement can not be completed even if it exceeds 3 minutes from the start of the measurement Pressure is unstable at the beginning of the measurement Pressure rise is not completed Cuff pressure suddenly dropped during pressurization Cuff pressure suddenly increased during pressurization The cuff pressure can not be reduced during the measurem...

Page 24: ...played when winding operation is abnormal It is displayed when there is a function error It is displayed when there is an abnormality in emergency exhaust function after measurement is completed Press the emergency release button to reduce the pressure See Handling of Emergency Situations in page 34 in the user manual for details It is displayed when there is an abnormality in the USB cable keypad...

Page 25: ...ries correctly See Battery Insertion in page 12 of the user manual for details The measured values are abnormally low or high Incorrect use of the arm cylinder Use the arm cylinder correctly Talking or arm motion in the measuring Perform the measuring under static state Talking or arm motion in the measuring Take another measuring after taking off the clothes that compressed the arm See Measuremen...

Page 26: ...omponents will reset and the emergency release button will spring up to return to the reset state Pressing State Reset State Fig 4 2 If the emergency release button is unable to return to reset state after pressing the button please contact your local supplier 5 Safety Management Cleaning Maintenance and Safekeeping In order to ensure the safety and effectiveness of the device conform to the requi...

Page 27: ... cleanser solution Clean the smudges on the cuff with a soft cloth with ethanol for disinfection Concentration of 75 Dip the cloth in the ethanol first and then take it out and squeeze the remaining ethanol out If the cuff is accidentally contaminated with blood please contact our customer service to replace the new cuff to minimize the possibility of risking of infectious diseases Suggestions on ...

Page 28: ...at Buttons Button pressing is normal LCD Screen Display of measuring screen is normal Measuring All connectors are correctly connected Pressure Cuff pressuring up and air release are normal Date Time Setup of date and time are normal Calibration Do not attempt to calibrate the device by yourself Calibration should be performed only by authorized service only If you need this service please contact...

Page 29: ...rt component replacement Cuff or extended air soft tube etc caused by regular torn 3 6 The date of purchase commodity type or manufacturing code on the warranty card is altered torn up or unrecognizable 3 7 Damage caused by majeure of natural disaster 3 8 Damage caused by external factors such as abnormal voltage etc 4 No compensation will be made for the release deletion or alteration of audio vi...

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