The Vive Precision blood pressure monitor is a portable

The Vive Precision blood pressure monitor is a portable
The Vive Precision blood pressure monitor is a portable device that
allows you to accurately track blood pressure from the comfort of home.
Device is individually tested for superior accuracy, and has a built in
alarm function to alert you of irregular heartbeats. Features a two-user
functionality and a 500-combined measurement memory. Protected
by a two-year warranty.
TABLE OF CONTENTS
Introduction
General Description
Safety Information
LCD Display Signal
Monitor Components
Before You Start
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time and Measurement Unit
Measurement
Applying the Cuff
Start the Measurement
Data Management
Recall the Records
Delete the Records
Information For User
Tips for measurement
Maintenances
About Blood Pressure
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why do I have different readings when I take my blood pressure
at the doctor’s office and my home?
Can you take measurement from both arms?
Troubleshooting
Specifications
Authorized Component
Complied Standards List
FCC Statement
EMC Guidance
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INTRODUCTION
Symbol for “THE OPERATION
GUIDE MUST BE READ”
General Description
Thank you for selecting Vive
Precision Blood Pressure Monitor
(DMD1001). The monitor features
blood pressure measurement,
pulse measurement, and the
result storage. The design
provides you with two years of
reliable service.
Readings taken by the DMD1001
are equivalent to those obtained
by a trained observer using
the cuff and stethoscope
auscultation method.
This
manual
contains
important
safety and care information, and
provides step-by-step instructions
for using the product. Read the
manual thoroughly before using
the product.
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION-Waste
electrical products should
not be disposed of with
household waste. Please
recycle where facilities
exist. Check with your local
authority or retailer for
recycling advice”
Features
• 2.36”x 3.6” Digital LCD display
• Maximum 500; f250 records
per each user
• 3rd technology: Measuring
during inflation (Most up to date
technology in the world)
! Symbol for “CAUTION”
These notes must be
observed to prevent any
damage to the device.
Safety Information
The signs to the right might be
in the user manual, labeling or
other component. They are the
requirement of standard and
using.
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CAUTION !
• This device is intended for adult
use only.
• This device is intended for
non-invasive measuring and
monitoring of arterial blood
pressure. It is not intended for
use on extremities other than
the arm or for functions other
than obtaining a blood pressure
measurement.
• Do not confuse self-monitoring
with self-diagnosis. This unit
allows you to monitor your blood
pressure. Do not begin or end
medical treatment. Consult
your physician for treatment or
advice.
• If you are taking medication,
consult
your
physician
to
determine the most appropriate
time to measure your blood
pressure. Never change a
prescribed medication without
consulting your physician.
• If the cuff pressure exceeds
40kPa (300 mmHg), the unit will
automatically deflate. Should the
cuff not deflate when pressure
exceeds 40 kPa (300 mmHg),
detach the cuff from the arm
and press the START/STOP button
to stop inflation.
• To avoid measurement errors,
carefully read this manual
before using the product.
• The equipment is not AP/APG
equipment and not suitable
for use in the presence of a
flammable anesthetic mixture
with air of with oxygen or nitrous
oxide.
• The operator shall not touch
output of batteries and the
patient simultaneously.
• To avoid measurement errors,
please avoid the condition of
strong electromagnetic field
radiated interference signal
or electrical fast transient/
burst signal when using the AC
adaptor.
• The user must check that the
equipment functions safely and
see that it is in proper working
condition before being used.
• Please use ACCESSORIES and
detachable parts specified/
authorized by MANUFACTURE.
Otherwise, it may cause damage
to the unit or danger to the user/
patients.
•
Manufacturer
will
make
available on request circuit
diagrams, component parts list,
etc.
• This unit is not suitable for
continuous monitoring during
medical
emergencies
or
operations.
Otherwise,
the
patient’s arm and fingers will
become anesthetic, swollen and
even purple due to a lack of
blood.
• Please use the device under the
environment which was provided
in the user manual. Otherwise,
the performance
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and lifetime of the device will be
impacted and reduced.
• During using, the patient
will contact with the cuff. The
materials of the cuff have been
tested and found to comply
with requirements of ISO 109935:2009 and ISO 10993-10:2010.
It will not cause any potential
allergic reaction or contact injury.
• The device doesn’t need to be
calibrated in two years of reliable
service.
• Please dispose of ACCESSORIES,
detachable parts, and the ME
EQUIPMENT according to the
local guidelines.
• When the device was used
to measure patients who have
common arrhythmias such as
atrial or ventricular premature
beats or arterial fibrillation, the
best result may occur deviation.
Please consult your physician
about the result.
• The device is contraindicated
for any female subject who may
be suspected of, or is pregnant.
Besides provided inaccurate
readings, the effects of this
device on the fetus are unknown.
• When using this device, please
pay attention to the following
situation which may interrupt
blood flow and influence blood
circulation of the patient,
thus cause harmful injury to
the patient: Too frequent and
consecutive multiple
measurements; The application
of the cuff and its pressurization
on any arm where intravascular
access or therapy, or an arteriovenous (A-V) shunt, is present;
Inflating the cuff on the arm on
the side of a mastectomy.
• Do not apply the cuff over a
wound, otherwise it can cause
further injury.
• Do not inflate the cuff on the
same limb which other monitoring
ME EQUIPMENT is applied around
simultaneously, because this
could cause temporary loss of
function of those simultaneouslyused monitoring ME EQUIPMENT.
Using it in case to result in
prolonged impairment of the
circulation of the blood of the
PATIENT.
• Don’t kink the connection tube,
otherwise, the cuff pressure may
continuously increase which can
prevent blood flow and result in
harmful injury to the PATIENT.
• The device has been evaluated
clinically used manual cuff/
stethoscope auscultations the
reference.
Blood
pressure
measurements determined with
this device are equivalent to those
obtained by a trained observer
using
the
cuff/stethoscope
auscultatory
method,
within
the limits prescribed by the
“American National Standard,
Manual, electronic or automated
sphygmomanometers”.
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• The patient is an intended
operator. The patient can
measure
under
normal
circumstances and maintain
the device and its accessories
according to the user manual.
• The blood pressure monitor,
and the cuff are suitable for use
within the patient environment.
If you are allergic to dacron
or plastic, please don’t use this
device.
• Please keep the unit out of
reach of infants, children or pets,
since inhalation or swallowing of
small parts is dangerous or even
fatal.
• If Luer lock connectors are used
in the construction of tubing,
there is a possibility that they might
be inadvertently connected
to intravascular fluid systems,
allowing air to be pumped into a
blood vessel.
• The device is not suitable for
public use.
• The device is not intended
for PATIENT transport outside a
healthcare facility.
• This device cannot be used
with HF surgical equipment at the
same time.
• Be careful to strangulation due
to cables and hoses, particularly
due to excessive length.
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LCD Display Signal
SYMBOL
Pulse/Min
kPa
mmHg
DESCRIPTION
EXPLANATION
Systolic blood pressure
High pressure result
Diastolic blood pressure
Low pressure result
Pulse per minute
Beats per minute, BPM
Deflating
CUFF air is exhausting of deflating
Memory
The displayed measurement values
is from the memory.
kPa
Measurement Unit of the blood pressure
mmHg
Measurement Unit of the blood pressure
Low battery
Batteries are low and need to be replaced
Irregular heartbeat
Irregular heartbeat Detection
Grade
The grade of the blood pressure
Current Time
Year/Month/Day, Hour/Minute
User A
Start measurement for User A
User B
Start measurement for User B
Heartbeat detection during the
measurement
The average value of the latest three
records
Heartbeat
The average value
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Monitor Components
2. Arm Cuff (Type BF applied
part) 8 3/4”- 16 1/2”
CUFF
AIR HOSE
AIR CONNECTOR PLUG
DC POWER SOCKET
USER SWITCH
MEM BUTTON
SET BUTTON
START•STOP BUTTON
LCD DISPLAY
3. 4x AAA batteries
BATTERY COMPARTMENT
4. User manual
BEFORE YOU START
Component List of
Measuring System
1. Cuff
2. Air pipe
3. PCBA
4. Pump
5. Valve
The Choice of Power Supply
Pressure
1. Battery powered mode:
6VDC 4×AAA batteries
2. AC adaptor powered mode:
6V 1A
(Please use the recommended
AC adaptor model).
(Not Included)
What’s Included
1. Blood Pressure Monitor
(DMD1001)
*Please unplug the adaptor
when not in use.
AC adaptor
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CAUTION !
In order to get the best effect
and protect your monitor, please
use the right battery and special
power adapter which complies
with U.S. safety standard.
• Remove the old batteries from
the device and follow your local
recycling guidelines.
• Do not dispose of batteries in
fire. Batteries may explode or
leak.
MEASUREMENT PRINCIPLE
Installing and Replacing the
Batteries
• Open the battery cover.
• Install the batteries by matching
the correct polarity, as shown.
• Replace the cover.
This
product
uses
the
Oscillometric Measuring method
to detect blood pressure. Before
every measurement, the unit
establishes a “zero pressure”
equivalent to the air pressure.
Then it starts inflating the arm
cuff, meanwhile, the unit detects
pressure oscillations generated
by beat-to-beat pulsatile, which
is used to determine the systolic
and diastolic pressure, and
also pulse rate. The device also
compares the longest and
the shortest time intervals of
detected pulse waves to mean
time interval then calculates
standard deviation. The device
will display a warning signal
with the reading to indicate the
detection of irregular heartbeat
when the difference of the time
intervals is over 25%.
Replace the batteries when:
(See Below)
• The
shows
• The display dims
• The display does not light up
WARNING !
• Remove batteries if the device
is not likely to be used for some
time.
• The old batteries are harmful
to the environment, so please
DO NOT dispose with other daily
trash.
SETTING DATE, TIME AND
MEASUREMENT UNIT
It is important to set the clock
before using your blood pressure
monitor, so that a time stamp can
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be assigned to each record that
is stored in the memory. (The
setting range of the year: 2014—
2054 time format: 12H/24H)
3. When you get the right year,
press “S” button to set down and
turn to next step.
1. When the monitor is off, hold
pressing “S” button for 3 seconds
to enter the mode for year
setting. Or when the monitor
is off, press “S” button shortly, it
will display the time. Then hold
pressing “S” button to enter the
mode for year setting.
4. Repeat step 2 and 3 to set the
[MONTH] and [DAY].
5. Repeat steps 2 and 3 to set the
[TIME FORMAT] between 12 hour
time and 24 hour time.
2. Press the “M” button to change
the [YEAR]. Each press will increase
the numeral by one in a cycling
manner.
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MEASUREMENT
6. Repeat step 2 and 3 to set the
[HOUR] and [MINUTE].
Applying the Cuff
1. Attach the cuff tubing to the left
side input for proper use.
2. Apply the cuff on your upper
arm. Make sure the position of
the tube is off-center; toward the
inner side of arm in line with the
little finger.
7. Repeat step 2 and 3 to set the
[MEASUREMENT UNIT].
mmHg is
U.S. Standard
Measurement
3. The cuff should be snug but not
too tight. You should be able to
insert one finger between the cuff
and your arm.
2~3cm
8. After the unit is set, the LCD will
display “done” first, then display
all the settings you have done
and then it will turn off.
4. Sit comfortably with your test
arm resting on a flat surface
5. Patients with Hypertension: The
middle of the cuff should be at the
level of the right atrium of the heart;
Before starting measurement,
please sit comfortably with legs
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uncrossed, feet flat on the floor,
back and arm supported. Follow
these steps for accurate results:
• Resting For 5 minutes before
• Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
• For a meaningful comparison,
try to measure under similar
conditions.
For
example,
take daily measurements at
approximately the same time,
position of upper arm, or as
directed by a physician.
LCD display
Adjust the zero.
Start the Measurement
1.
Before
you
start
the
measurement, switch the User
button to select the user between
User A and User B. Switch to right
to select User A, switch to left to
select User B. When the monitor is
off,press the “START/STOP button to
turn on the monitor, and it will
finish the whole measurement.
And save the measurement data
for the desired user. (See image
above.)
Inflating and measuring.
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Display and save the results.
2. Press “M” button or “S” button
to get the record you want.
Press and hold “M” button to look
over ten groups of the historical
records quickly.
2. Press the “START/STOP” to power
off, otherwise it will turn off within 1
minute.
Tips: Combined maximum 500
records for User A and User B.
DATA MANAGEMENT
Recall the Records
1. When the monitor is off,
press the “M” button to show the
average value of the latest three
records for the selected user.
(Take User 1 for example. See
above.)
The current No. is No 2.
The corresponding
.
date is January 2nd.
Notes: It will display the latest
record first when the records are
less than three groups.
The corresponding
time is P.M. 10:08.
The date and time of the record
will be shown alternately.
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3. If you want to look over another
user’s data, switch the User button
to select the desired user. Then
you can look over its historical
records.
CAUTION !
The most recent record (1) is shown
first. Each new measurement is
assigned to the first (1) record. All
other records are pushed back
one digit (e.g., 2 becomes 3, and
so on), and the last record (500)
is dropped from the list.
3. If you don’t want to delete the
records, press “START/STOP” button
to escape.
Delete the Records
If you did not get the correct
measurement, you can delete
each user A & B results by following
the steps below.
1. Hold pressing the “S” button for
3 seconds when the monitor is
in the memory recall mode, the
flash display “dEL ALL” will show.
INFORMATION FOR USER
Tips for Measurement
It can cause inaccuracy if the
measurement is taken in the
following circumstances.
1. Within 1 hour after eating or
drinking.
2. Within 20 minutes after taking a
shower/bath.
3. In a very cold environment
4. Immediate measurement after
tea, coffee, or smoking.
5. When talking or moving your
fingers.
6. When you need to urinate.
2. Press the “S” button to confirm
deleting and the LCD will display
“dEL dOnE”, and then turn off.
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Maintenance
In order to get the best
performance, please follow the
instructions below.
What is the standard blood
pressure classification?
The chart below is the standard
blood pressure classification
published by American Heart
Association (AHA).
CAUTION !
If you have any problems with
this device, such as setting up,
maintaining or using, please
contact [email protected]
Don’t open or repair the device
by yourself.
Please report to
vivehealth.com if any unexpected
operations or events occur.
Please use a soft cloth to clean
the whole unit. Don’t use any
abrasive or volatile cleaners.
AHA Home Guideline for Upper
Limit of Normal BP
What is systolic pressure and
diastolic pressure?
When ventricles contract and
pump blood out of the heart,
the blood pressure reaches its
maximum value in the cycle,
which is called systolic pressure.
When the ventricles relax, the
blood pressure reaches its
minimum value in the cycle, which
is called diastolic pressure.
Systolic
press
135mm Hg
DIA
85mm Hg
This chart reflects blood pressure
categories defined by American Heart
Association.
ABOUT BLOOD PRESSURE
blood discharging
artery
SYS
Diastolic
blood entering
vein
Blood
Pressure
Category
Systolic
mmHg
(upper#)
Normal
less than and less than
120
80
Prehypertension
120-139
or
80-89
High Blood
Pressure
(Hypertension)
Stage 1
140-159
or
90-99
High Blood
Pressure
(Hypertension)
Stage 2
160 or
higher
or
100 or
higher
or
Higher
than 110
Hyperten- Higher
sive Crisis
than 180
(Emergency care
needed)
relax
15
Diastolic
mmHg
(lower#)
CAUTION !
Only a physician can tell your
normal BP range. Please contact
a physician if your measuring
result falls out of the range. Kindly
note that only a physician could
tell whether your blood pressure
value has reached a dangerous
point.
Why does my blood pressure
fluctuate throughout the day?
1. Individual blood pressure can
change on a daily basis. It is also
affected by the way you apply
the cuff and the measurement
position. Please take measurements using the same method
to ensure accuracy.
2. The variations in the pressure can
be greater or smaller, depending
on the actual medicine taken.
3. Waiting at least 3 minutes for
another measurement.
Irregular Heartbeat Detector
This Blood Pressure Monitor is
equipped with an intelligent
function of Irregular Heartbeat
(IHB) Detector. During each
measurement, this equipment
records the heartbeat intervals
and works out the standard
deviation. If the calculated value
is larger than or equal to 15,
this equipment will light up the
IHB symbol on the screen when
displaying the measuring result.
Why do I have different readings
when I take my blood pressure at
the doctor’s office and my
home?
Blood pressure can fluctuate
over a period of 24 hours based
on: weather, emotions, exercise,
stress, etc.
WARNING !
The appearance of the IHB icon
indicates that a pulse irregularity
consistent with an irregular
heart-beat was detected during
measurement. Usually this is NOT
a cause for concern. However,
if the symbol appears often, we
recommend you seek medical
advice. Please note that the
device does not replace a
cardiac examination, but serves
to detect pulse irregularities at an
early stage.
When you take your blood
pressure at home, make sure
to pay close attention to the
following:
• If the cuff is secured properly.
• If the cuff is too tight or too loose.
• If the cuff is secured on the
upper arm.
• If you feel anxious.
You had better take 2-3 deep
breaths. Advice: Wait at least 4-5
minutes until you calm down.
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Can you take measurement
from both arms?
You may choose to measure
both arms and then average the
two readings to get your blood
pressure result. The norm is to
measure the left arm closest to
your heart. For accuracy use the
same method each time.
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TROUBLESHOOTING
This section includes a list of error messages and frequently asked
questions for problems you may encounter with your blood pressure
monitor. If the products not operating as you think it should, check here
before arranging for servicing.
PROBLEM
No power
Low
batteries
Error
message
SYMPTOM
Display will not
light up.
CHECK THIS
REMEDY
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Insert the batteries
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
correctly
Display is dim or
show
Batteries are low.
Replace with new batteries
E 1 shows
The cuff is not secure.
Refasten the cuff and then
measure again.
E 2 shows
The cuff is very tight.
Readjust the cuff ,not too
loose or too tight and then
measure again.
E 3 shows
The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
E20 shows
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on the
arm and then measure
again
E21 shows
The treatment of the
measurement failed.
Relax for a moment and
then measure again.
E10 or E11
shows
EExx,shows on
the display.
A calibration error
occurred (XX can be
some numeric
characters,such as 01,
02 and so on .
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Relax for a
moment and then
measure again.
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance.Refer to the
warranty for contact
information and return
instructions.
SPECIFICATIONS
Battery powered mode:
Power supply
AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
adaptor model).(Not Included)
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
Weight
Oscillographic testing mode
Rated cuff pressure:
0kPa - 40kPa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
Pressure:
5ºC -40ºC within±0.4kPa(3mmHg)
pulse value:±5%
Temperature:5ºC to 40ºC
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20ºC -60ºC
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
About 22cm~42cm
Approx.366g(Excluding the dry cells)
External dimensions
Attachment
Mode of operation
Degree of protection
Continuous operation
Type BF applied part
Protection against
ingress of water
IP21
Software Version
V01
WARNING: No modification of this equipment is allowed.
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AUTHORIZED COMPONENT
Use the Vive® authorized adaptor.
(Not Included)
Adaptor
Type: UE08WCP-060100SPA
Input: 100~240V, 50~60Hz,400mA
Output: 6V 1A
(Conforms to UL certificate)
COMPILED STANDARDS LIST
Risk management
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
Labeling
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to
provide information
General Requirements for
Safety
IEC 60601-1: 2005+A1; 2012 Medical electrical
equipment - Part 1: General requirements for basic
safety and essential performance
Electromagnetic
compatibility
IEC/EN 60601-1-2:2007 Medical electrical
equipment - Part 1-2: General requirements
for basic safety and essential performance Collateral standard:Electromagnetic compatibility
- Requirements and tests
Performance
requirements and Clinical
Investigation
IEC 80601-2-30:2009 Medical electrical
equipment- Part 2-30: Particular requirements
for the basic safety and essential performance of
automated non-invasive sphygmomanometers
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated sphygmomanometers
Software life-cycle
processes
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
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FCC STATEMENT
This device complies with Part
15 of the FCC Rules. Operation
is subject to the following two
conditions: (1) this device may not
cause harmful interference, and
(2) this device must accept any
interference received, including
interference that may cause
undesired operation.
EMC GUIDANCE
1. MEDICAL ELECTRICAL EQUIPMENT
needs
special
precautions
regarding EMC and needs to
be installed and put into service
according to the EMC information
provided in the ACCOMPANYING
DOCUMENTS
2.
Wireless
communications
equipment such as wireless home
network devices, mobile phones,
cordless telephones and their
base stations, walkie-talkies can
affect this equipment and should
be kept at least a distance d=3,
3m away from the equipment.
(Note: As indicated in Table 6
of IEC 60601-1-2:2007 for ME
EQUIPMENT, a typical cell phone
with a maximum output power of
2 W yields d=3, 3m at an IMMUNITY
LEVEL of 3V/m)
© Copyright and Distributed by Vive Health
5650 Yahl Street Unit 1, Naples, FL 34109
All Rights Reserved. Made in China.
Email: [email protected]
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