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JH-BP01 Series User Manual_240423_142221
JH-BP01 Series User Manual_240423_142221
JH-BP01 Series
JH-BP01 A/3
User manual
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JH-BP01
Changes
This manual is identified as Part number: JH-BP01.
This manual is for the JH-BP01 series Ambulatory Blood Pressure Monitor System.
Copyright Information
All content in this manual is the proprietary information and is provided solely for purposes of
operation, maintenance or service of the JH-BP01series ABPM System. This manual and the J H - B P 0 1
series ABPM System described in it are protected under copyright law under which they may not be copied, in
whole or in part, without written consent of us. The information in this manual is furnished for guidance only,
is subject to change without notice, and should not be construed as a commitment by us. We assumes no
liability for errors or inaccuracies that may appear in this manual. We All rights reserved.
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Contents
Changes............................................................................................... 2
Copyright Information........................................................................2
1.Introduction to Ambulatory Blood Pressure Monitoring............5
2. Symbols Used in Labeling............................................................... 5
3. Foreword......................................................................................... 7
3.1 Application..............................................................................7
3.2 Scope of application.............................................................. 7
3.3 Environment.......................................................................... 7
3.4 Contraindication.................................................................... 7
3.5 Operation and management.................................................8
4. Product introduction......................................................................9
4.1 Package and part names.......................................................9
4.2 Display....................................................................................9
4.3 Switches and buttons..........................................................10
4.4 Products and Accessories....................................................10
5. Function and specification.......................................................... 11
5.1 Function................................................................................11
5.2 Performance requirement...................................................12
5.3 Operating principles............................................................ 22
6. How to use.................................................................................... 23
6.1 Flow chart.............................................................................23
7. New equipment............................................................................24
7.1 Change battery.................................................................... 24
7.2 Clock.....................................................................................24
7.3 Select measurement mode.................................................25
7.3.1Mode introduction.................................................... 25
7.3.2How to set the automatic interval mode................. 25
7.3.3How to set the automatic table mode..................... 25
7.3.4How to set the manual interval mode..................... 26
8. Use guide....................................................................................... 27
8.1 Notice...................................................................................27
8.2 How to use cuff body..........................................................27
8.3 Wear cuff and equipment...................................................28
8.3.1 The steps of wear cuff and equipment................... 28
9. Data transmission.........................................................................30
9.1How to transmit data...........................................................30
10. Maintenance...............................................................................30
10.1 Clean the cuff and equipment......................................... 30
10.2Periodic checks................................................................... 30
10.3Troubleshooting................................................................. 31
11. Error number...............................................................................31
12.Limited Warranty.........................................................................32
13.Technical assistance.....................................................................33
14.Product Disposal..........................................................................33
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1.Introduction to Ambulatory Blood Pressure Monitoring
Ambulatory blood pressure monitoring (ABPM) is an accepted clinical tool for collecting multiple blood
pressure measurements to better assist clinicians with the diagnosis and management of hypertension by
providing data related to: blood pressure variability, estimation of true blood pressure, overnight changes in
blood pressure, Blood Pressure Load, Sleep Dip, and morning surge in blood pressure.In-clinic and
home blood pressure measurements cannot provide the same depth of information that a 24-hour study
provides. Several studies have shown that ambulatory blood pressure monitoring, when compared to clinic or
home blood pressure measurement, is superior in predicting target organ damage, morbid events, or
cardiovascular risk.
The data obtained from ambulatory blood pressure monitors is accurate and useful for managing a wide
variety of hypertensive situations including:
• White-coat hypertension
• Resistant hypertension
• Masked hypertension
• Efficacy of anti-hypertensive drug therapy on a 24-hour basis
• Nocturnal hypertension
• Episodic hypertension and/or anxiety disorders
• Hypotensive symptoms
• Changes in diet and daily routine designed to reduce hypertension
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SN Serial number
Pay attention
Equipment, cuff and line are designed to prevent electric shock.
*For system products,this label may be attached to the main unit only.
The product bears CE marks indicating its conformity with the provisions of
the Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex V of this directive.
Manufacture date
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3. Foreword
3.1 Application
This manual is applicable to JH-BP01 Series , hereafter this text will be abbreviated as BP01. This product use for
under the guidance of doctor operation of 24 hours
ambulatory blood measurement of adults, With the function of setting different time intervals, automatic
measurement of the patient's blood pressure and pulse and
stored.
3.2 Scope of application
This device is suitable for adults (including pregnant or pre-eclamptic)
3.3 Environment
This equipment is used in the hospital by professional measurement settings, and guide patients to wear, not
in the home healthcare environment.
3.4 Contraindication
The ambulatory blood pressure monitoring device designed for monitoring blood pressure in the majority of
the adults. Generally, the product has no
contraindications.
Considerations:
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When measuring blood pressure on the upper arm which wearing adult cuff, please straighten out your
arm and keep still. Please lie low when sleeping, otherwise the results will be affected because of the
arm and heart are not at the same level.
During the measurement, please wear loose, comfortable clothes, don't swimming or bathing.
Avoid operating heavy equipment or power tools, vibration may cause the product working abnormal.
Please mid don't disconnect the hose and BP01 when you take off your clothes
Do not drive or ride a car, do not take off the cuff,don’t take out the battery
from BP01 during measurement. Please keeping the product dry.
Do not measure blood pressure in following situations:
1) The acute cardiovascular disease attack, such as acute myocardial infarction and unstable angina
pectoris
2) Serious hematological system disorders, serious skin diseases, acute
infectious disease and arm blood vessel disease.
3) Serious arrhythmia, such as atrial fibrillation etc.
3.5 Operation and management
Time and measurement mode can be set according to user needs
After connecting PC and BP0 1 , you can set the time and mode by software
There are three automatic measurement modes, such as automatic interval, manual interval and
automatic table.
When you disconnect the power supply, the data in the device will not be lost.
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4. Product introduction
4.1 Package and part names
When you first open the package, please make sure that the following parts:
4.2 Display
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1 USB port √ √
hardware
2 bluetooth module √
Accessories
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pressure.
Memory
This device can store 500 sets of data. A set of data includes diastolic blood pressure (SYS), systolic blood
pressure (DIA), pulse rate, and measurement time.
5.2 Performance requirement
Measurement
method Oscillometric method
Mini pump
Pressure
Display range 0-299mmHg
Systolic blood pressure 60-280 mmHg
Measure range Diastolic blood pressure 40-160 mmHg
Pulse 30-200bpm
Pressure ±3mmHg
Accuracy
Pulse ±2%
Minimum display Pressure 1mmHg
unit Pulse 1bpm
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Protection
Common
of harmful
liquid
Operating environment: +10°C~+40°C, <85%RH
Storage environment: -20°C~+55°C, <95%RH
Environment: Atmospheric pressure range:700hPa~1060hPa
*no condensation
Outline Size 70(W)*97(D)*26(H)mm
dimension Weight 105g (Without batteries)
EN Medical electrical equipment — Part 1: General
60601-1 :2006/A1:2013 requirements for basic safety and essential
performance
EN 1060-3 Non-invasive
:1997+A2:2009
sphygmomanometers — Part 3 : Supplementary
requirements for electro-mechanical blood
pressure measuring systems
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standard: Electromagnetic compatibility —
Requirements and tests
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Store
Pay attention to moisture, shock, dust, corrosion prevention! Don’t store in high temperature or high
humidity place! Don’t expose to the sun!
Before use
Check the normal working state, make sure the cuff and air hose connected correctly.
The JH-BP01 Series fulfils the requirements of EMC standards; nevertheless, the device should not be
exposed to strong electromagnetic fields and ESD environment, as outside the limits they may cause
malfunction.
Not to be used with high frequency surgical equipment.
Using
If the patient feels pain in his arm, or the product cannot be measured correctly, please stop using!
This product may not be used in the mixture of flammable gas and air or the mixture of flammable gas
and oxygen or Nitrous Oxide.
If the product or the internal parts are wet, please turn off the power supply and contact with the Custom
Service Department.
Please relax as much as possible and not talk during the measurement procedure.
After use
The JH-BP01 series monitor cannot be sterilized. DO NOT immerse the monitor in any fluid, or attempt to
clean with any liquid detergents, cleaning agents,or solvents, or solvents. You may use a soft, damp cloth
to remove dirt and dust from the monitor. If the unit does become immersed in water, do not use,
contact ou service department.
Remove the bladder for cleaning. Dampen a soft cloth with a mild medical grade disinfectant and
wipe the bladder, let it air dry, the fabric shell of the cuff may be machine-washed in cold water with a
mild disinfectant(According to the requirement of hospital disinfection). Line dry this cuff only-machine
drying can cause damage to the fabric shell of the cuff.
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JH-BP01
The bladder needs to be inserted back into the cuff sleeve so the pneumatic hose portion of the bladder
goes through the tube opening on the cuff. Please note that the pneumatic hose connection should face
upward when using the cuff on either the right of the left arm.
Periodic maintenance
This product is a precision instrument; it is recommended to check all functions every year. It is recommended
that you check the accuracy of the JH-BP01 once every two years.Please contact with the Custom Service
Department for this work.
Environmental protection
If you stop using this product, please take out the battery.
Please put the Nickel-cadmium batteries in the battery recycling box for recycling.
All the matters to be noted in this specification are marked by sign. Please keep in mind that the relevant
consideration
This product can be used without installation.
Keep the product as far as possible away from the portable and mobile RF communication
equipment.
This product has no power cable accessories.
Please do not stack up product with other equipment.
Instrument packaging label icon:
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JH-BP01
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that patients or other staff will come into contact with have undertaken the bio-compatibility test and is
verified to be in compliance with ISO 10993-1.
For patients to wear the cuff or replacement of cuff cloth should be correct buckle cuff button, if the cuff
buckle doesn’t button well, the inflation may cause damage to the cuff.
Make sure that the cuff is wrapped around the arm. Make steel ring retained in the sliding range, Don’t flat
and does not decline,and also leave two fingers voids between arm and cuff.Don’t extrusion of the
trachea, Observe the cuff pressure carefully and make sure the pressure doesn’t exceed the limit, and the
measurement doesn’t time out
Blood pressure value
The blood pressure value of the patient can be influenced by emotion, posture, sitting posture, movement,
and the clothes on the arm.
The different of the value of this product and auscultatory method meets the specification of
IEC60601-2-30. It can be verified by mercury sphygmomanometer.
Operational environment
If the measurement is used outside of the ambient temperature specified in this product, such as the
temperature out of the range of -10℃~+40℃, relative humidity out of the range of 30%~85%,
Atmospheric pressure out of the range of700hPa~1060hPa, it will affect the accuracy of the measurement
of the product.
Pressure protection
This product has a pressure protection design and to avoid continuous inflation.
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JH-BP01
- regarding the application of the CUFF over a wound, as this can cause further injury;
- regarding the application of the CUFF and its pressurization on any limb where intravascular access or
therapy, or an arteriovenous (A-V) shunt, is present because of temporary interference to blood flow and could
result in injury to the patient;
- regarding the application of the CUFF and its pressurization on the arm on the side of a mastectomy;
- regarding the information that pressurization of the CUFF can temporarily cause loss of function of
simultaneously used monitoring ME EQUIPMENT on the same limb;
- regarding the need to check that operation of the automated sphygmomanometer does not result in prolonged
impairment of PATIENT blood circulation
Potential Adverse Reactions
Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the formation of
urticaria (allergic reaction including raised edematous patches of skin or mucous membranes and intense
itching) caused by the fabric material of the cuff.
Petechia (a minute reddish or purplish spot containing blood that appears in the skin) formation or Rumple-
Leede phenomenon (multiple petechia) on the forearm following the application of the cuff, which
may lead to Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of platelets
associated with hemorrhagic conditions) or phlebitis (inflammation of a vein) may be observed.
Warnings
The general warning sign indicates a potentially hazardous situation which could result in serious injury.
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JH-BP01
cause an explosion. This device is not suitable for use in an oxygen enriched environment.
WARNING: Do not immerse the monitor in any fluid, place fluids on top, or
attempt to clean the monitor with any liquid detergents, cleaning agents, or solvents. This may cause an
electrical hazard. Do not use the monitor if accidental wetting occurs; please return to Jinhao Medical®
(see Limited Warranty). Refer to Maintaining and Cleaning the JH-BP01 Series ABP System, for care
instructions.
WARNING: Too frequent measurements can cause injury to the patient due to
blood flow interference.
WARNING: The cuff should not be applied over a wound as this can cause further injury.
WARNING: The cuff should not be placed on the arm on the side of a mastectomy. In the case of a
double mastectomy use the side of the least dominant arm.
WARNING: Pressurization of the cuff can temporarily cause loss of function of simultaneously used
monitoring equipment on the same limb.
WARNING: Do not use if device is dropped and/or is damaged. Have a
qualified service representative check the monitor before using again.
WARNING: Do not attach the cuff to a limb being used for IV infusions or any other intravascular access,
therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially
causing harm to the patient.
WARNING: Use only with the cuffs supplied by Jinhao Medical. Different cuffs have not been validated with
JH-BP01 Series and measurements with non-validated components may not be accurate.
WARNING: The JH-BP01 Series may be interfered with by other equipment even ifthe other equipment
complies with CISPR Emission Requirements
Warning : Performance can be affected by extremes of temperature, humidity and altitude
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JH-BP01
Cautions
The caution symbol indicates a potentially hazardous situation which may result in minor or moderate injury. It
may also be used to alert against unsafe practices.
CAUTION: Do not connect the device to equipment that does not meet
EN60601- 1. When the device is attached to a patient, the device’s communication port must only be connected
to equipment that meets EN60601- 1 standard
CAUTION: Do not use the monitor if it has failed its diagnostic self test, or if it
displays a greater than zero pressure with no cuff attached. The values displayed by such a monitor may be
inaccurate.
CAUTION: If cuff fails to deflate within two and a half minutes, instruct patient
on manual removal of cuff.
CAUTION: Check that operation of the monitor does not result in prolonged impairment of the circulation
of the patient.
CAUTION: Remove batteries when device is not in use for long periods of time to prevent possible battery
leakage and product damage.
CAUTION: A compressed or kinked connection hose may cause continuous
cuff pressure resulting in blood flow interference and potentially harmful injury to the patient.
CAUTION: Using an incorrect cuff size could result in erroneous and
misleading blood pressure measurement results.
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6. How to use
6.1 Flow chart
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7. New equipment
7.1 Change battery
Note!
Do not mix old and new batteries together!
Please use alkaline batteries
the steps for replace the battery:
7.2 Clock
This note uses the following examples, Set the data and clock to December 12, 2020 PM 10:24
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8. Use guide
8.1 Notice
Please tell following to the patient before use.
In the process of measuring blood pressure, please keep the correct position and relax, quiet, no
shaking arms, etc.
Try to avoid the noise and do not move in the process of measurement. the longest time of
measurement process is about 90 s.
If the device is to be re-measured for some reason, you must stay relaxed and do not move.
If the patient feels pain in his arm, please stop using immediately.
To cancel or to stop the measurement
The patients who want to stop or cancel the measurement can press the "M" key or turn off the main
power switch.
Manual measurement
If you want take a blood measurement immediately, press the "S" key. Wear the cuff and
equipment note
Equipment do not fall or vibration
The equipment and the cuff is not waterproof, please prevent rain, sweat or water soaked equipment
and cuff
Do not place any objects on the device
Before moving, please ensure tight, to prevent the equipment or the cuff slipped
When patient got sleep, please put the hose on the body to prevent extrusion hose.
change battery
If the device display “ low battery” or , please replace the battery.
8.2 How to use cuff body
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JH-BP01
Note!
If you do not wear the cuff in the correct position, the equipment may measure the blood pressure
incorrectly, and get error result.
The cuff for the left arm, circumference is 20-35cm. If you need another size of cuff, please measure the
circumference of arm first and choose the right one.
if the patient got skin diseases, please don’t use the equipment for infectiousness concern.
do not use other cuffs, a different cuff might result in measurement error.
the distance between the elbow and cuff is about 2 fingers wide.
Step 4 Wrapped the cuff around the arm. Make steel ring retained in the sliding
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JH-BP01
range, remain flat and does not be fall,but also make two fingers wide between the elbow and cuff. (if the steel
ring is out of the sliding range, that means cuff size is not correct).
Step 5 Use a clamp to fix the hose on the patient’s clothes.
Step 6 Assembling belt and carrying bag
Step 7 Adjust the position of the belt, when the patients wear the cuff on the left (right) arm, place the carrying
bag on patients’ right side (left side).
Step 8 Connect the air hose to the metal interface.
Step 9 Put the equipment into the carrying bag.
Note!
During the measuring time, don't disturb the cuff or air hose。
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JH-BP01
9. Data transmission
9.1How to transmit data
1) Install Data analysis software on the computer
2) Connect the USB data line to the computer
3)Connect the USB data line to the USB interface
which on the right side of the JH-BP01 Series device
4)confirm the equipment and computer connection
5)Complete data transmission
Note!
Computer connected to the device shall comply with the relevant requirements of IEC 60950-1 or IEC 60601-1,
otherwise, the risk of electrical shock may occur.
10. Maintenance
10.1 Clean the cuff and equipment
Please remove the battery cover and turn off the power. Please take out the battery before cleaning the
equipment.
The equipment is not waterproof, so the liquid is not allowed to splash or immerse the box during the
cleaning process.
After each use, please clean equipment shell with a soft, damp cloth with cleaning agents.
Do not use preservatives, alcohol and other to clean equipment, hose or cuff.
If the cuff body is dirty, replacement of cuff body is recommended.
Clean and disinfect according to the requirements of medical institutions before each use
10.2Periodic checks
The blood pressure equipment is a precision instrument.Please check all functions
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JH-BP01
every year. If you have any questions about periodic check, please contact with the Custom Service Department.
10.3Troubleshooting
Note!
Equipment contains a lot of small electrical components and air units, please do not open the shell to
avoid damage to the equipment.
If you are not sure the problem, please contact with the Custom Service Department.
Custom Service Department supports authorized dealers and users for technical information and
components.
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12 INFLATE ERROR Press any key to exit and press “S” to
measure again
13 LOW BATTERY Please replace the batteries
14 unknow error Wait, the device will measure again after 3
min
12.Limited Warranty
Jinhao Medical provides to the original purchaser the following limited warranty
from the date of original invoice.
Serialized blood pressure monitor 24 months
Jinhao ABPM Cuffs 6 months
Accessories (i.e. patient hoses, interface cables, 90 days
etc.)
Jinhao Medical. warrants each instrument to be free from defects in material and workmanship. Liability
under this warranty covers servicing of the instruments when returned from the customer’s facility prepaid to
the prospective factory depending on location. Jinhao Medical will repair any component(s) or part(s) that it finds
to be defective during the period of this limited warranty. Should a defect become apparent, the original
purchaser should notify Jinhao Medical of the suspected defect.
The instrument will be repaired in the shortest possible time and returned prepaid by the same
shipping method as received by the factory.
This limited warranty is void if the instrument has been damaged by accident, misuse, negligence, or
serviced by any person not authorized by Jinhao Medical.
This limited warranty contains the entire obligation of Jinhao Medical and no other warranties expressed,
implied, or statutory are given. No representative or employee of Jinhao Medical is authorized to assume
any further liability or grant any further warranties except as set herein.
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13.Technical assistance
For any questions, please reference the Help section within the software, this user manual, or our website. If
these do not fully address your problem, please contact our service department.
Prolinx GmbH
EC REP Brehmstr.56,40239 D ü sseldorf
Germany
Tel:0049 2131 4051968-0
Fax:0049 2131 4051968-9
14.Product Disposal
Device
Do not dispose of this product as unsorted municipal waste.
Prepare this product for reuse or separate collection as
specified by Directive 2002/96/EC of the European
Parliament and the Council of the European Union on Waste
Electronic and Electrical Equipment (WEEE).
If this product is contaminated, this directive does not apply. Please dispose of materials according to local
regulations for medical waste.
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Battery Disposal
The J H - B P 0 1 Series device contains battery that contains materials which may be hazardous to human
health. Do NOT dispose of battery in domestic waste! Instead, please dispose of in an environmentally
responsible way.
Cuff
Do not return used cuffs. Used blood pressure cuffs may be contaminated medical waste and should be dealt
within accordance to your local regulations for medical waste.
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