Pasesa AVE-2000 Pro User manual

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

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<Preface>
• Thank you for choosing the Non-invasive Vascular Screening Device AVE-2000 Pro.
• The value of blood pressure measured by the device is equivalent to that picked up by the auscultatory
method, and the error rate conforms to the requirements specied in YY 0667-2008.
• The device has passed clinical vericaon according to the requirements in YY 0670-2008, and its safety
and eecveness has been proved to conform to the related regulaons in YY 0670-2008. Please contact
the company's customer service to acquire the performance vericaon method of this device.
• Applicable scope: it is applicable for measuring blood pressure, Arterial Velocity Pulse Index (AVI),
Arterial Pressure Volume Index (API), Central Systolic Blood Pressure (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 part of this published manual may be reproduced, transmitted, transcribed, stored in a retrieval
system or translated into any language or computer language, in any form, by any means, without the
prior written permission of our company.
• Every effort has been made to ensure that the contents of this manual are accurate. If you have any
questions, please contact the customer service. If you have any question, please contact our customer
service.
• Throughout this manual, ※ indicates useful information, and images are for reference only.
Read before use

-4 -
<Terminology>
Blood Pressure
The blood pressure is the pressure of the flowing blood against the vascular wall, and it also serves as
the force to propel the blood flowing in the vessels.
• High Blood Pressure (SYS, Systolic Blood Pressure)
Systolic blood pressure refers to the maximum blood pressure appearing in an artery during systole
when the heart contracts to drive blood into the arterial system.
• Low Blood Pressure (DIA, Diastolic Blood Pressure)
Diastolic blood pressure is the minimum blood pressure appearing in an artery during diastole when
blood pressure in the artery keeps decreasing after the closure of the aortic valve.
Pulse Rate
• Pulse Rate
The frequency of arterial pulse wave detected by the cuff, which is generally comparable to heart
rate except under some special situations, such as in subjects with arrhythmia or severe occlusive
disease in artery or cardiac valve.
AVI & API
AVI & API are the new vascular index jointly researched and developed by RIKEN, AIST, and Shisei
Datum in Japan.
AVI & API are subject to the effect of age, gender, cholesterol level, blood pressure as the well as the
history of diabetes, 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 Tokyo University.
Principle: AVI shows the characteriscs of the pulse waveform when the cu pressure is higher than
maximum blood pressure, and meanwhile converts them into numerical values as the indices of the
central arterial sness. The higher the value is, the higher risk of arterial sness it represents.
The upper waveforms of below graph are those of cu pressure pulse wave, and the lower ones
are the dierenated waveforms (dierenated pulse wave). The shape of the cu oscillaon
wave varies with the increase and early arrival of reected pressure waves accompanying aging
or arterial sening, presenng an enhanced pressure augmentaon in late systole followed by a
steeper pressure decrease. AVI is an index used to quantavely assess such wave changes, which is
calculated based on the rao of the valley value (Vr) to the peak value (Vf) of the me-dierenated
cu wave (AVI=(Vr/Vf)×20).

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Vr Vr
VfVf
P1 P1 P2 P2
Differential
Pulse
Pulse
Pt
dPt
dt
Youngsters
Arteries Sffening by Aging
Oldsters
AVI = (Vr/Vf) x 20
• API (Arterial Pressure Volume Index)
API is a new vascular index that developed jointly by AIST and Shisei Datum in Japan.
Principle: The more elasc the arteries are, the more drasc the arterial volume changes when
the cu pressure decreases. The blood vessel sness is converted into numerical values using
the gradient of the curve as an index. The higher the value is, the higher risk of upper-arm arterial
sness it represents. The cu pressure-artery volume curve is rstly measured by a cu with a
decreasing working pressure, then the curve is ed with an arctan funcon (A*arctan(B*X+C)+D).
Finally, API is dened as the reciprocal of coecient 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 parameters as independent variables.
CSBP (Esmated Value) = 0.0447*age + 0.8392*PSBP + 0.1793*PDBP + 0.2718*AVI + 0.2881*API +
2.3339
• CAPP (Central Aortic Pulse 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 parameters as independent variables.
CAPP (Esmated Value) = 0.1613*age + 0.0923*PSBP + 0.8192*PPP + 0.2024*AVI + 0.2537*API -
13.1126

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The symbols appearing in the manual are used to facilitate your correct and safe use of this device, and
prevent the injury caused to you or others.
<Symbol Descripon>
Warning
The sign shows that careless use may lead to injury or damage to the user.
Cauon
The sign shows that careless use may lead to inability for measuring or incorrect
measurements.
Insulation degree of equipment (Class II equipment).
Electric shock protection degree of equipments (B type).
Separated disposal symbol for waste electric and electronic equipments (Please
follow local laws and regulations).
Do not disassemble or modify the device by yourself.
Caution! Refer to appendix documents.
/
Pollution control sign of electronic information products
This product can be used in an environmentally friendly manner for 10 or 5
years. It is recyclable and should not be discarded at will.
Place up
Pay attention to moisture-proof
Fragile
The maximum loading layer is 6 layers.
<Precauons>
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 patients or postoperative patients should use it under guidance of physician.
Please follow the direction of physician. The result is not to be used for self-
diagnosis or self-treatment. Users should seek advice of healthcare professional
in case of any doubts about the measurement results.
In the case of arrhythmia such as atrial extrasystole, ventricular extrasystole and
atrial fibrillation, the measurement maybe inaccurate.
Device cannot be used in environment that does not allow wireless communication.
The patients with wound, inflammation, edema or hemorrhage tendency on the
arms are not recommended to use the device.
Safety Precautions

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Warning
Do not use it in case of receiving blood transfusion or intravenous drip.
Do not use it when arteriovenous fistula is equipped for hemodialysis.
Do not use it when there is possibility of thrombus formation due to blood flow
obstruction or stagnation.
Do not use it when there is possibility of peripheral circulation disorders due to
blood flow obstruction or stagnation.
Do not change the power supply or other parts by yourself. Maintenance
should be done by local service representative authorized by the manufacturer.
Otherwise, it may lead to inaccurate measurement.
Disassembly
Prohibited
Do not disassemble or modify the device.
This device is a precision instrument, please take it gently in the handling and
transportaon process. Never crash or drop it.
Do not leave liquids beside the device. Please wipe it off in time with soft cloth
if there is spill of liquid on the device.
Do not perform blood pressure measuring if there is arm-cuff break.
Do not perform blood pressure measuring when the arm-cuff is placed upside down.
Please use this device in the temperature range of 5°C to 40°C, with relative
humidity not more than 80% but no direct sunlight.
This device conforms to EMC specification. Do not place it in an environment
with high-intensity magnetism, static electricity 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 accessory parts or components other than what specified by the company.
Do not connect any other removable porous sockets or extension cable to this system.
Components not specified in the accessories supplied with this device should
not be connected to it.
Please make the connection according to the instructions of each part in this
manual. Do not mix the jacks together.
Cauon
Do not use the device on person with frequent occurrence of arrhythmia.
Do not use the device on a moving transport vehicle (e.g., car or plane).
Do not measure when your arm is not in the arm arm cylinder.
Do not use cell phone beside the device in measuring process.
Do not use the device in thundering weather.
※ If stored or used outside the range of temperature and humidity specified by the manufacturer,
the system may not be able to achieve the claimed performance specifications.
※ There may be a risk when the airbag is over inflated.
※ Using other unauthorized attachments may cause safety hazards. Please follow the instructions in
the manual for the connection of the external jacks. No random connection is allowed.

-8 -
AC adapter Precautions
Warning
Do not disassemble, repair or modify the AC adapter.
Please connect the AC adapter to AC 100-240V power supply.
Do not use damaged power cable or plug.
Avoid any damaging, processing, heating, bending with force, pulling, twisting
or pressing, etc. or lay heavy objects on the AC adapter and power cable.
Please only use designated AC adapter for this device.
When disconnecting the device from power supply, pull off the power plug with
hand on it and do not pull the power cable.
Battery Precautions
Warning
Please use batteries of designated type and specification. Do not mix new and
old batteries or use different types of batteries. In battery replacement, please
replace 4 batteries at the same time.
Please dispose old batteries according to related regulations for environment
protection of your residential area.
In case battery liquid splashes into your eyes, please rinse your eyes with large
amount of fresh water for at least 15 minutes and resort to medical assistance.
Please check always the correct placement of batteries. Do not mix up batteries
anode (+) and cathode (-).
Please take out batteries in case device will not be in use for more than 3
months. Please replace 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
Cauon
Do not disassemble, repair or modify the printer or its accessories.
Please use designated accessories and printing paper (Thermal sensitive paper of 384
spots with width of 58 mm, and effective printing width of 48 mm) for the printer.
Please connect the mains charger to AC 100-240 V power supply.
Avoid any damaging, processing, heating, bending with force, pulling, twisting or
pressing, etc. or lay heavy objects on the RS232 connecting cable and power cable.
Do not use damaged power cable or plug or RS232 connecting cable.
When disconnecting the device from power supply, pull off the power plug with
hand on it and do not pull the power cable.
The note of measurements acquired from the printer can be kept for a month
under normal conditions, but the storage time may be decreasing with change of
storage conditions, such as intense lighting or high temperature.
Numerical keypad Precautions
Cauon
Do not disassemble, repair or modify the keypad.
Please only use designated numerical keypad for this device.
Avoid any damaging, processing, heating, bending with force, pulling, twisting or
pressing, etc. or lay heavy objects on the USB cable.

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Preparation before Use
1 Packaging and Accessories
Open the box to check the product composition before use. If anything is missing or appears to be
damaged, please contact your local supplier.
Main body
Non-invasive Vascular Screening Device AVE-2000 Pro (Non-detachable)
Accessories
AC Adapter AA Alkaline battery × 4 Numerical keypad Thermal sensitive printer
※Accessories can not be disassembled by yourself. After connecting main 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 RS232 connecting cable and mains charger its box. Please refer to the instructions for
its usage.
Dedicated RS232 connecon cable for thermal printerDedicated power supply charger for thermal printer
Instruction for Use Warranty card

-12 -
3 Power Supply
The device supports two methods of power supply, alkaline batteries and connection to power supply
with AC adapter.
3-1 Baery Inseron
1. Locate the back of the device with battery cover in front of you and take off the battery cover (Fig.
①, ②).
2. Install the batteries along the direction of anode (+) and cathode (-) marked in the battery
chamber of the device.
3. Close battery cover (Fig. ③, ④).
Fig. 3.1.1
※Even when the AC adapter is used, it is recommended to also put in AA alkaline battery to
avoid sudden power loss and affecting the measuring in the process.
※Do not 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. Please monitor the condition of the battery.
3-2 Connecon of AC Adapter
1. Fit the plug of AC adapter in the AC adapter port on the main body of the device (Fig. ①).
2. Fit the power plug of AC adapter in the socket of power supply (Fig. ②).
5.9V DC
1
2
Fig. 3.2.1
※Only use the power supply delivered with the device. For replacement please contact your
local service representative.

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<Pre-usage>
User preparation
No. Content
1The device is designed and validated for measurements on arm diameter of 19 to 32 cm. Arm
diameter higher or lower than the range may lead to incorrect measurements.
2Individuals should not eat, drink, smoke, exercise or take a bath/shower in 30 min before measuring.
3Measurement should be done with emptied bladder.
4
Individuals should take off thick clothes, such as coat and sweater, etc. Thin clothes like
shirts not disturbing the measurement. Expose the left upper arm for measurement. Do not
compress the arm when rolling up the sleeve.
5Individuals should rest statically for more than 10 min, and perform the measuring in a quiet
and appropriate (Temperature 5 to 40˚C, relative humidity not more than 80%) environment.
6Please maintain both the body and mood in a peaceful state when performing the measuring.
Check List
Please check the following before performing the measuring.
Before
turning
on power
supply
No. Contents
1Ensure there is no damage or deformity, etc. on the device and its accessories.
2Ensure there is no moisture condensation on the device. If so, please dry it
thoroughly first.
3Ensure the device is placed steadily with sucient space around.
4Ensure there are no objects in the arm cylinder.
5Please connect the device to power supply as instructed in this manual, with the
designated AC adapter or AA baeries.
6Ensure the device is correctly connected to the numerical keypad and printer.
After
turning
on power
supply
1Conrm there is no abnormal sound from the device.
2Ensure there is no smoke or unusual odor coming out from the device.
3Ensure there is no excessive heat in the device.
4Ensure the display of LCD screen on the device and numerical keypad is normal.
5Ensure the buttons on the device, numerical keypad and printer are normal.
6Ensure the emergency release button is in the pop-up status. For details see
"handling of emergency situations in page 34.
7Ensure there is normal compression and air release in the cuff when pressing the
button.
Usage

- 15 -
1 How to Set Up Date and Time
At power-off state, press the button and button simultaneously to enter the date and
time setup screen. While the indicator of the Year and Time is flashing, press the /
buttons to adjust「Year」first, and then press the button to save the setting.
Fig. 1.1
Please sequentially set the「Month」/「Date」/「Hour」/「Minute」in the same way. After the
settings are completed, 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
record may lead to deranged record of measurements and thus affect the correctness of the data of
mean values of various items outputted from the device.
「Year」
「Month」
「Day」
「Hour」
「Minute」

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4 Measurement
1. Open the Elbow holder as shown below.
Fig. 4.1
2. Put the device on the center-left position near your body.
3. Relax, straighten 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

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※When measuring, please follow the instructions below:
• Relax your body and sit upright as much as possible. If you are nervous, take a deep breath.
• Keep your heart position in the same level as the heart symbol on the arm cylinder.
Generally, the heart is in the thoracic cavity between the 2 lungs, approximately between the
2nd rib and the 5th rib of left chest bones from the body surface.
• The recommended height difference between the 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 keep your back straight.
Fig. 4.4
• Do not speak, laugh, move or shake the body.
Fig. 4.5
※ Incorrect posture when performing measuring (e.g., bowing, sitting on sofa or low desk with legs
crossed, bending down, etc.) may lead to incorrect measurements.

- 21 -
4. Press the button, and the cuff will pressure up automatically, and the icon of cuff pressure
will light up. When the device picks up the pulse, the icon will flicker.
Fig. 4.6
※During the measurement, certain degree of numbness in the arm can normally occur. If you feel
severe discomfort in your arm due to compression, please press the button to stop the
measuring. If there is poor blood circulation in finger tips due to arm compression, please raise
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 not move your body or your arms during the
process.
5. When the measuring comes to an end, the device will release a prompt tone. Pull your arm out from
the arm cylinder aer the pressure release from the cu ends, and it is the end of this measuring.

-22 -
6. Check the measurements: this measurements will be shown on the LCD screen.
Fig. 4.7
※ If you have not input the age or the age is not in the valid range, the device is unable to provide
CSBP or CAPP values. If the AVI or API picked up exceeded related range, the values will be not
shown either.
7. If there is no operation after the measurements have been shown 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 button and button simultaneously longer than 3 seconds on standby
screen to enter data check screen, and then press the / button to switch between
measurements.
Fig. 5.1

- 23 -
2. After specific measurement number is selected, the measurement number, date and time, age will
loop display.
Fig. 5.2
3. The device will return to standby screen if there is no operation for 30 seconds.
6 Measurements Prinng
1. Please rst ensure proper thermal sensive papers are put in the thermal sensive 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 Number」
「Age」

- 25 -
7 Measurements Analyzing
Systolic and Diastolic Blood Pressure
Blood pressure is subject to the influence of cardiac function, vascular tone, blood volume, nerves,
body fluid, age, gender, season, climate and profession, etc.
Exercise, emotional stress and constipation may lead to an increase in blood pressure, whereas,
longtime rest and deep sleep may lower blood pressure.
The increase of environment temperature, such as lukewarm bath, etc. may make diastolic pressure
decrease, and the decrease of temperature, such as cold bath in winter, etc. may make systolic
pressure increase.
The following tables are the reference value or range of blood pressure 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 (Severe) ≥180 ≥110
Isolated systolic hypertension ≥140 <90
Critical systolic hypertension 140 to 149 <90
Tab. 5.2 Reference of Mean Normal Blood Pressure of Chinese People
Age Male Female
SYS (mmHg) DIA (mmHg) SYS (mmHg) DIA (mmHg)
16 to 20 115 73 110 70
21 to 25 115 73 110 71
26 to 30 115 75 112 73
31 to 35 117 76 114 74
36 to 40 120 80 116 77
41 to 45 124 81 122 78
46 to 50 128 82 128 79
51 to 55 134 84 134 80
56 to 60 137 84 139 82
61 to 65 148 86 145 83

-26 -
Pulse Rate
Pulse rate is subject to the effect of many factors, such as age and gender.
Exercise and emotional stress can elevate pulse rate, while rest and sleep can drop the pulse rate
down.
Normal range of pulse rate for healthy adults under normal resting conditions: 60 to 100 beats/ minutes.
AVI & API
AVI & API are subject to the effect of age, gender, cholesterol level, blood pressure as the well as the
history of diabetes, smoking and exercise, etc. AVI may be reduced through regular exercise.
The usefulness of AVI and API have been proved by a number of clinical studies:
100 20 30 40 50 60 70 80
0
10
20
30
40
50
R=0.46
API
R=0.59
Age — AVI Age — API
100 20 30 40 50 60 70 80
0
10
20
30
40
50
Age/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 doed line indicates the standard deviaon range value of the average ± 2X.
60
55
50
45
40
35
30
25
20
15
10
5
0
10 20 30 40 50 60 70 80 90 100
The solid line indicates the average value of normal healthy adults.
Vascular Indexes of AVI and API Values for Ordinary Healthy People of Different Age Stages
Fig. 7.2 Age-specific normal ranges of AVI and API
※Whenever the result of AVI/API measurement exceeds the reference (normal) range, the screen
display of AVI/API will flash.
References:
秋山義隆・久野裕輝・早川尚雅・重藤誠・桝澤政広・岡部正・松田昌文（2010.7)『2型糖尿病患者のオ
シロメトリック血圧測定による血管指標とFMD、IMTとの比較―オシロメトリック血圧測定血管指標の
意義―』[M]、Prog.Med.

- 27 -
CSBP (Estimated Value) & CAPP (Estimated Value)
CSBP (Estimated Value) rang is 19 to 300 mmHg (2.5 to 40 kPa), and its display resolution is 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.

-28 -
8 Measuring Record Deleting
At power-off status, press the button and button simultaneously to enter the setup
screen, and then press the button and button simultaneously longer than 3 seconds
to delete all measurements.
Fig. 8.1
9 Power O
1. Press the button to turn off the device, the power 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 sensive printer RS232 connecng line for the printer AC Adapter Main body Numeric keypad
AA Alkaline baery × 4
Fig. 9.2