Kaixin BVT01 User manual

KAIXIN
BVT01
Bladder Volume Tester
User’s Manual
Xuzhou Kaixin Electronic Instrument Co., Ltd.

Bladder Volume Tester User’s Manual V1.08
Introduction
Thank you for purchasing BVT01 bladder volumetester.
Users shall carefully read through this manual and fully understand the text before operating the
equipment.
Please keep this manual after reading so that you can access at anytime when needed.
The user’s manual issue date:August 18, 2020 Version: V1.08
For the changes of appearance, this manual is subject to change without furthernotice!
Intellectual Property Information
The user’s manual and the corresponding intellectual property rights belonging to Xuzhou Kaixin
Electronic Instrument Company Ltd. (hereinafter referred to as Kaixin).
Individual or organization may not copy, modify or translate any part of this user’s manual, without
the express written permission of Kaixin.
Statement
Kaixin has the final explanation right of this user’s manual.
Kaixin was considered responsible for the safety, reliability and performance in case of meeting all
the following requirements:
1. Assembly, expansion, readjustment, improve and repair are all performed by professionals
recognized by Kaixin;
2. All replacement parts and accessories, consumables involved repairs are Kaixin company
(original) or approved by Kaixin;
3. Related electrical equipment complies with national standards and the requirements of the user’s
manual;
4. Operate the product in accordance with the user’s manual.
Warranty and repairservice
Purchased the product warranty, sees the company's service policies.
The qualified service personnel who get Kaixin written authorization can repair the instrument out of
warranty bythemselves. But this should be agreed byXuzhou Kaixin Electronic Instrument Co., Ltd. We
will provide circuit diagrams, component part lists or other information to assist service personnel to repair
those parts of our equipment that are designated byour companyas repairable by service personnel.
Manufacturer’s Information
Xuzhou Kaixin Electronic Instrument Co., Ltd.
Kaixin Mansion, C-01, Economic Development Zone, Xuzhou, Jiangsu, China.
Zip Code: 221004
Tel: [phone] 87733758
Fax: [phone] 87792848
Website: http://www.kxele.com
E-mail: [e-mail]
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Bladder Volume Tester User’s Manual V1.08
Important Statement
1. User shall be fully responsible for the maintenance and management of this product after
purchasing this product.
2. Even in the warrantyperiod, warranty does not include the following:
a) Damage or loss caused by error or rough using.
b) Damage or loss caused by force majeure (such as fires, earthquakes, floods, or lightning etc.).
c) Damage or loss caused by not meeting the conditions of use specified by the system, such as
inadequate power supply, incorrect installation or environmental conditions do not meeting
the requirements.
d) Damage or loss caused by not used the system in the initial buyregion.
e) Damage or loss caused by the system purchased not by Kaixin or its authorized dealer or
agents.
3. Medical personnel qualified with professional qualifications (defined as operator) only to use this
system.
4. Do not modify the software or hardware of the equipment without authorization of the
manufacturer.
5. In any case, Kaixin shall not be liable for the problems, damages or losses due to re-installation,
alteration or repair the system bynon-Kaixin designated personnel.
6. This product isintended to provide clinical diagnostic data for the doctor.
The doctor shall be responsible for the diagnostic process. Kaixin shall not be liable for any
problems arising out of the process.
7. Be sure to back up important data to external storage media, such as notebooks.
8. Due to operator’s error or abnormal condition causing the data stored in the internal system is lost,
Kaixin is not responsible.
9. This user’s manual contains warnings for predictable dangers. Users shall also exercise care at
any time to be aware of the dangers unforeseen in this manual. Kaixin shall not be liable for the
damages and losses arising out of neglecting to follow the operation instructions herein described.
10. This user’s manual shall be furnished with the machine so that managerial and operating
personnel can refer to it any time as necessary. Once the managerial personnel of the system
changes, it shall hand over this user’s manual.
11. Deal with the exhausted product according to the local statute.
12. The maintenance and servicing of product shall be performed by the trained engineer or by
Kaixin Electronic Instrument Company Ltd.
13. Professional engineer mentioned in the user’s manual is the person who has been trained and
authorized by Kaixin Electronic Instrument Company Ltd.
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Bladder Volume Tester User’s Manual V1.08
Safety Cautions
1. Warning Symbols and Definitions
The following warning symbols are used in this manual to indicate safety level and other important
items. Please remember these symbols and understand the meaning as you read this user’s manual. These
symbols convey specific meanings as detailed in the table below:
Symbols &Words
Connotation
Danger
Indicates an imminent danger that may result in personal death or serious
injury if not avoided.
Warning
Indicates a potential danger that mayresult in personal injury if not avoided.
Attention
Indicates a potential danger or unexpected use condition that may result in
light injury or property loss or affecting the use if not avoided.
2. Symbols
Symbols
Meaning
Symbols
Meaning
Type B applied part
Follow instructions for use
Direct current
Indicates the need for the user to
consult the instructions for use for
important cautionary information.
Polarity of direct current
power connector
Up
Standbyswitch
Keep dry
Power supply indication
Fragile
Battery charge indicator
Stacking limit by number
USB interface
Temperature limits (Storage and
transport)
Thermal printer
Humidity limitation (Storage and
transport)
Probe scanning key
Atmospheric pressure limitation
(Storage and transport)
Manufacturer
Marking for the separate collection
of electrical and electronic
equipment
Date of manufacture
IPX1
Degrees of protection for enclosure:
Protected against vertically falling
water drops
Use-by date
IPX7
Degrees of protection for enclosure:
Protected against the effects of
temporary immersion in water
Serial number
CE-Marked in accordance with the
Medical Device Directive
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Bladder Volume Tester User’s Manual V1.08
3. Labels
Label
Description
Attention:
When using the battery should pay attention to
precautions.
F-4
Symbol for the marking of electrical and electronics devices according to
Directive 2012/19/EU. The device, accessories and the packaging have to be
disposed of waste correctly at the end of the usage. Please follow Local
Ordinances or Regulations for disposal.

Bladder Volume Tester User’s Manual V1.08
Contents
Chapter One Overview……………………………………………………………………………1
Chapter Two Technical Specifications……………………………………………………………2
Chapter Three System Outline……………………………………………………………………3
3.1 Structure composition of the instrument……………………………………………………3
3.2 Components name……………………………………………………………………………3
3.3 Parts of the probe………………………………………………………………………..3
3.4 Function keys description…………………………………………………………………..3
Chapter Four System Configuration……………………………………………………………5
Chapter Five Operation Condition………………………………………………………………5
Chapter Six System Installation and Check…………………………………….……………6
6.1 System placement……………………………………………………………………………7
6.2 Probe bracket installation……………………………………………………………………7
6.3 Connecting and disconnecting the probe……………………………………………………7
6.4 Connecting the foot switch…………………………………………………………………8
6.5 Install/Remove the battery…………………………………………………………………8
6.6 Connection to power…………………………………………………………………………8
6.7 Use the touch screen………………………………………………………………………9
6.8 Ultrasonic probe check before and after operation…………………………………………9
6.9 Main unit check before and after operation………………………………………………9
6.10 Reset………………………………………………………………………………………10
Chapter Seven Work Main Interface…………………………………………………………11
7.1 Work main interface………………………………………………………………………11
7.2 Title information region…………………………………………………………………11
7.3 Image and data region…………………………………………………………………11
7.4 Menu region…………………………………………………………………………………12
Chapter Eight System Preset…………………………………………………………………13
8.1 Basic settings………………………………………………………………………………13
Chapter Nine Functional Operation…………………………………………………………..15
9.1 Startup and Shutdown……………………………………………………………………15
9.2 Input patient information………………………………………………………………15
9.3 Save data…………………………………………………………………………………15
9.4 Read data…………………………………………………………………………………16
9.5 Thermal print……………………………………………………………………………17
Chapter Ten Bladder volume measurement……………………………………………………18
10.1 Scanning and positioning bladder………………………………………………………18
10.2 Operation processes………………………………………………………………………19
10.3 Manual contour……………………………………………………………………………20
Chapter Eleven Principle of Acoustic Power…………………………………………………21
Chapter Twelve System Maintenance…………………………………………………………22
12.1 Inspection and verification by users………………………………………………………22
12.1.1 Probe general inspection…………………………………………………………………22
12.1.2 Power-on verification……………………………………………………………………22
12.2 Maintenance by users……………………………………………………………………22

Bladder Volume Tester User’s Manual V1.08
12.2.1 System cleaning and disinfection…………………………………………………………22
12.2.2 Clean the probe socket……………………………………………………………………24
12.2.3 Clean the touch screen……………………………………………………………………24
12.2.4 Clean the foot switch……………………………………………………………………24
12.2.5 Clean the shell and probe bracket………………………………………………………24
12.2.6 Clean the thermal printer…………………………………………………………………24
12.3 Replacement of accessories and consumables……………………………………………24
12.3.1 Replace the thermal paper………………………………………………………………24
12.3.2 Replace the battery………………………………………………………………………25
12.3.3 Replace the probe, foot switch, power adapter and power supply cord, fuse…………25
12.4 Use and maintenance for the rechargeable battery………………………………………26
12.5 Troubleshooting…………………………………………………………………………27
12.6 Periodic Safety Checks…………………………………………………………………27
12.7 Essential Performance Checks……………………………………………………………28
Chapter Thirteen Storage and Transportation………………………………………………29
Chapter Fourteen Standard Compliance………………………………………………………29
Chapter Fifteen Safety Classification…………………………………………………………30
Chapter Sixteen Guidance and Manufacturer’s Declaration………………………………31
Appendix A System Block Diagram……………………………………………………………34
Appendix B Acoustic Output Data Disclosure…………………………………………………35

Bladder Volume Tester User’s Manual V1.08
- 1 -
Chapter One Overview
1.1 Introduction
BVT01 bladder volume tester is composed of main unit, probe, power adapter, etc., which is used to
non-invasively measure bladder volume with ultrasound principle. It is used to assess urinary retention and
urinary incontinence, and given the timing of implement an objective clinical catheterization to reduce the
catheterizing frequency and reduce the risk of urinary tract infections. But also by measuring the amount
of residual urine volume after voiding, evaluate the therapeutic effect of certain drugs and treatment for
urinary system diseases.
BVT01 bladder volume tester uses 2.5MHz ultrasound to mechanical sector scanning, identify the
reflected wave of the front and rear wall of the bladder to obtain the cross-sectional area of the bladder;
again through 15°intervals to automatically transform the scanning plane, based on the areas of 12
reference plane to calculate the bladder volume with ellipsoid integration.
To improve the accuracy of the operation and measurement, the screen displays the B-mode image of
section bladder and the projection of bladder; it is convenient for doctors to check the location and
determine the measurement results.
The expected service life of BVT01 bladder volume tester is 6 years.
BVT01 measurement accuracy must meet the following indicators: Urine volume display resolution
is 1mL. When urine volume is within 20mL～99mL, the measurement error is ±15mL; urine volume is
within 100mL～999mL, the measurement error is ±15%.
In a typical commercial or hospital environment, the use of instrument depends on the following
essential performance:
1. Electromagnetic disturbance does not make the instrument generate artifacts or distortion in an
image or error of a displayed numerical value and not alter the diagnosis.
2. Electromagnetic disturbance does not make the instrument generate the display of incorrect
numerical values associated with the diagnosis to be performed.
3. Electromagnetic disturbance does not make the instrument generate the production of unintended
or excessive ultrasound output.
4. Electromagnetic disturbance does not make the instrument generate the production of unintended
or excessive transducer assembly surface temperature.
1.2 Intended Use
BVT01 bladder volume tester projects ultrasound energy through the lower abdomen of the patient to
obtain images of the bladder which is used to calculate bladder volume noninvasively. The BVT01 bladder
volume tester is intended to be used onlyby qualified medical professionals.
Contraindications: The equipment is not suitable for fetal use or pregnant patients, patients with
ascites, patients with open or damaged skin, wounds in the suprapubic region.
Warning:This equipment cannot be used at home.
Attention: For patients with hypertrophy of the prostate, space occupying disease or
scars, there is a risk of producing a result exceeding the given accuracy range.
Warning:This equipment cannot be used to treat.

Bladder Volume Tester User’s Manual V1.08
- 2 -
Chapter Two Technical Specifications
2.1 Technical data
1. Monitor: 5.7” LED
2.Adapter rating: 100-240V~, 1.2-0.6A, 50-60Hz
3. Output of adapter: DC12.8V 3.0A
4. Main device rating: DC12.8V 3.0A
5. Main Unit Size: approx. 205 * 168 * 165 (mm, L * W * H)
6.Weight of main unit: approx. 1.7kg (excluding accessories)
2.2 Primary functions
1. System preset function: hospital name, date, date format and time.
2. Displaybasic information: hospital name, patient information (name, ID, age), date and time.
3. Patient information input function.
4. Screen saver time can be set.
5. Select the patient type.
6. Measurement information store function.
7. Urine volume measurement function.
8. Manually marking function.
9. USB disk can be encrypted to protect patient privacy.
10. Support language selection.
11. Thermal printing for ultrasound images and measurement results.
12. Displaybattery status indicator and lowbattery reminder function.
2.3 Technical index
1
Probe frequency, MHz
2.5
2
Urine volume display resolution, mL
1mL
3
Urine volume measurement range, mL
20mL～999mL
4
Urine volume measurement accuracy, mL
20mL～99mL
measurement error: ±15mL
100mL～999 mL
measurement error: ±15%

Bladder Volume Tester User’s Manual V1.08
- 3 -
Chapter Three System Outline
3.1 Structure composition of the instrument
BVT01 bladder volume tester is composed of main unit, probe, power adapter, etc.
3.2 Components name
Fig. BVT01 sketch map
3.3 Parts of the probe
Fig. Parts name of 2.5MHz probe
Name
Function
(1) Probe connector
To connect the probe to ultrasonic diagnostic system.
(2) Cable
To connect the probe to the probe connector.
(3) Scanning key
Press this keyto start urine volume measurement.
(4)Acoustic lens
Usemechanical methodsso thatthesoundbeamtransmittedbythe
transducercan sectorscanningforacertainangle.
3.4 Function keys description
SN.
Key symbol
Key name
Key function
1
System preset
Touch the key to enter system setting interface;
2
New patient
·Access to the new patient module;
·Input the information and data for a new
patient;
3
Scanning
In the power-on state, touch the keyto start
two-dimensional scan, touch this keyagain to
start the three-dimensional scan.