Vive DMD1001 User manual

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 classication?
Why does my blood pressure uctuate throughout the day?
Why do I have different readings when I take my blood pressure
at the doctor’s ofce 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
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.
Features
• 2.36”x 3.6” Digital LCD display
• Maximum 500; f250 records
per each user
• 3rd technology: Measuring
during ination (Most up to date
technology in the world)
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.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
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”
Symbol for “CAUTION”
These notes must be
observed to prevent any
damage to the device.
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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 deate. Should the
cuff not deate when pressure
exceeds 40 kPa (300 mmHg),
detach the cuff from the arm
and press the START/STOP button
to stop ination.
• 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
ammable 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 eld
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 specied/
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 ngers 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 10993-
5:2009 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 brillation, 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 ow and inuence 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 arterio-
venous (A-V) shunt, is present;
Inating 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 inate the cuff on the
samelimbwhichothermonitoring
ME EQUIPMENT is applied around
simultaneously, because this
could cause temporary loss of
function of those simultaneously-
used 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 ow 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 uid 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
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SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse per minute Beats per minute, BPM
Deflatin UFF air is exhausting of deflating
Memory The displayed measurement values
is from the memory.
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low battery Batteries are low and need to be replaced
Irregular heartbeat Detection
Grade The grade of the blood pressure
kPa
mmHg
Current Time Year/Month/Day, Hour/Minute
Pulse/ Min
User A Start measurement for User A
User B Start measurement for User B
Heartbeat detection during the
measurement
Heartbeat
The average value The average value of the latest three
records
Irregular heartbeat
C
g

The Choice of Power Supply
1. Battery powered mode:
6VDC 4×AAA batteries
2. AC adaptor powered mode:
6V 1A
(Please use the recommended
AC adaptor model).
(Not Included)
*Please unplug the adaptor
when not in use.
BEFORE YOU START
Component List of Pressure
Measuring System
1. Cuff
2. Air pipe
3. PCBA
4. Pump
5. Valve
What’s Included
1. Blood Pressure Monitor
(DMD1001)
Monitor Components 2. Arm Cuff (Type BF applied
part) 8 3/4”- 16 1/2”
3. 4x AAA batteries
4. User manual
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BATTERY COMPARTMENT
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
MEM BUTTON
START•STOP BUTTON
SET BUTTON
USER SWITCH
DC POWER SOCKET
AC adaptor

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.
MEASUREMENT PRINCIPLE
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 inating 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%.
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
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.
Installing and Replacing the
Batteries
• Open the battery cover.
• Install the batteries by matching
the correct polarity, as shown.
• Replace the cover.
Replace the batteries when:
(See Below)
• The shows
• The display dims
• The display does not light up
• Remove the old batteries from
the device and follow your local
recycling guidelines.
• Do not dispose of batteries in
re. Batteries may explode or
leak.
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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)
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.
2. Press the “M” button to change
the [YEAR]. Each press will increase
the numeral by one in a cycling
manner.
3. When you get the right year,
press “S” button to set down and
turn to next step.
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.
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7. Repeat step 2 and 3 to set the
[MEASUREMENT UNIT].
8. After the unit is set, the LCD will
display “done” rst, then display
all the settings you have done
and then it will turn off.
MEASUREMENT
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 nger.
3. The cuff should be snug but not
too tight. You should be able to
insert one nger between the cuff
and your arm.
4. Sit comfortably with your test
arm resting on a at surface
5. Patients with Hypertension: The
middle of the cuff should be at the
leveloftherightatriumoftheheart;
Before starting measurement,
please sit comfortably with legs
2~3cm
11
mmHg is
U.S. Standard
Measurement
6. Repeat step 2 and 3 to set the
[HOUR] and [MINUTE].

uncrossed, feet at on the oor,
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.
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
nish the whole measurement.
And save the measurement data
for the desired user. (See image
above.)
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LCD display
Adjust the zero.
Inating and measuring.

Display and save the results.
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.)
Notes: It will display the latest
record rst when the records are
less than three groups.
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.
The date and time of the record
will be shown alternately.
.
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The corresponding
date is January 2nd.
The corresponding
time is P.M. 10:08.
The current No. is No 2.

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
ash display “dEL ALL” will show.
CAUTION
The most recent record (1) is shown
rst. Each new measurement is
assigned to the rst (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 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.
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2. Press the “S” button to conrm
deleting and the LCD will display
“dEL dOnE”, and then turn off.
3. If you don’t want to delete the
records, press “START/STOP” button
to escape.
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
ngers.
6. When you need to urinate.
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Maintenance
In order to get the best
performance, please follow the
instructions below.
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.
ABOUT BLOOD PRESSURE
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.
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
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This chart reects blood pressure
categories dened by American Heart
Association.
Blood
Pressure
Category
Normal
Prehyper-
tension
High Blood
Pressure
(Hyper-
tension)
Stage 1
High Blood
Pressure
(Hyper-
tension)
Stage 2
Hyperten-
sive Crisis
(Emergen-
cy care
needed)
Systolic
mmHg
(upper#)
less than
120
120-139
140-159
160 or
higher
Higher
than 180
and
or
or
or
or
Diastolic
mmHg
(lower#)
less than
80
80-89
90-99
100 or
higher
Higher
than 110
What is the standard blood
pressure classification?
The chart below is the standard
blood pressure classication
published by American Heart
Association (AHA).
AHA Home Guideline for Upper
Limit of Normal BP
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SYS 135mm Hg
DIA 85mm Hg

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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.
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.
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.
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 measu-
rements using the same method
to ensure accuracy.
2.Thevariationsinthepressurecan
be greater or smaller, depending
on the actual medicine taken.
3. Waiting at least 3 minutes for
another measurement.
Why do I have different readings
when I take my blood pressure at
the doctor’s office and my
home?
Blood pressure can uctuate
over a period of 24 hours based
on: weather, emotions, exercise,
stress, etc.
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.
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PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display will not
light up.
Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Display is dim or
show Batteries are low.
Refasten the cuff and then
measure again.
E 3 shows The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
E10 or E11
shows
E20 shows
The measurement
process does not detect
the pulse signal.
Loosen the clothing on the
arm and then measure
again
EExx,shows on
the display.
A calibration error
occurred (XX can be
some numeric
characters,such as 01,
02 and so on .
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.
E21 shows The treatment of the
measurement failed.
Relax for a moment and
then measure again.
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Readjust the cuff ,not too
loose or too tight and then
measure again.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
Relax for a
moment and then
measure again.
E 1 shows
E 2 shows
The cuff is not secure.
The cuff is very tight.

SPECIFICATIONS
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About 22cm~42cm
Type BF applied part
Temperature:-20 -60
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
Temperature:5to 40
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Power supply
Battery powered mode:
AC adaptor powered mode:
(Please only use the recommended AC
adaptor model).(Not Included)
Display mode
Measurement mode Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Weight Approx.366g(Excluding the dry cells)
External dimensions
Attachment
Mode of operation Continuous operation
Degree of protection
Protection against
ingress of water IP21
Accuracy
Normal working condition
Storage & transportation
condition
Software Version V01
Rated cuff pressure:
0kPa - 40kPa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
6V 1A
WARNING: No modication of this equipment is allowed.
Pressure:
5 -40 within±0.4kPa(3mmHg)
pulse value:±5%
ºC ºC
ºC ºC
ºC ºC

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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 certicate)
Risk management
Labeling
User manual
General Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements and Clinical
Investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1; 2012 Medical electrical
equipment - Part 1: General requirements for basic
safety and essential performance
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
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
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
COMPILED STANDARDS LIST