NuvoMed TBP-6/0923 User manual

TBP-6/0923
Blood Pressure Monitor
Instruct i on Manual
Please read all instructions carefully and retain for future use

Know your Device 3
IndicaƟon for Use
Warning
BaƩery Warning 4
About Blood Pressure 5
PreparaƟon 6
Setup your Device 7
Seƫng of User, Year, Date and Time 8
Before Measurement
Measurement
9
Using Memory 10
Care and Maintenance 11
TroubleshooƟng
EMC DeclaraƟon 12
FCC Compliance 14
SpecificaƟons 15
Warranty InformaƟon 16

Know your Device
Indications for Use
This arm blood pressure monitor is intended to be used to measure blood pressure and
pulse rate from the upper arm by using the oscillometric method, at home.
This device is intended for use on adults only and is not for use on groups such as
neonatal babies, children, pregnant women, or pre-eclamptic patients.
Important Safety Information and Precautions
MEDICAL DISCLAIMER: This device and manual are not meant to be a substitute for
advice provided by doctors or other medical professionals.
Contact your physician for interpretation of measurements, or if you have or suspect
you have a medical issue.
WARNING
•Contact your physician if you suspect you have a medical issue.
•Not for use by children, pregnant women, or pre-eclamptic patients.
•If you suffer from arrhythmia, diabetes, blood circulation problems, or apoplexy, only
use this device under a physician’s care.
•Prolonged over-inflation of the monitor will result in harmful injury to the patient.
•Do not use this device over a wound, as this can cause further injury.
•Too frequent measurements can cause injury due to blood flow interference.
•This device possible cause improper result due to external interference, such as
acceleration during transport or transport in general.
•Do not attempt to modify this device in any way.
•Store this device in a cool, dry place. Do not subject this device to extreme
temperatures, humidity, or sunlight. This device might not meet performance
specifications if stored or used outside the ranges specified in the “Specifications”
section. Keep away from rain.

Warning
(continued)
•Do not immerse this device in water or clean with cleaning products, alcohol, or
solvents. Carefully follow cleaning instructions provided.
•Remove batteries if this device will not be used for three or more months.
•Ensure that the device is used in the environment specified in the EMC
declaration in this IM, otherwise, may result in improper operation.
•Use of this device adjacent to or stacked with other device should be avoided
because it could result in improper operation.
•This electrical medical equipment requires specific precautions regarding
electromagnetic compatibility. It must be installed and used according to the
electromagnetic information.
•Do not use this device where flammable gases or liquids are present.
•Never drop the device.
Technical description is contained in the instruction manual.
Battery Warning
•Do not mix alkaline, stand (carbon-zinc) and rechargeable batteries
(nickel hydride).
•Do not mix old and new batteries.
•Non-rechargeable batteries are not to be recharged.
•Rechargeable batteries are to be removed from the unit being charged
(if removable).
•Rechargeable batteries are only to be charged under adult supervision
(if removable).
•Exhausted batteries are to be removed.
•The supply terminals are not to be short-circuited.
•Only batteries of the same or equivalent type as recommended are to be used.
•Batteries are to be inserted with the correct polarity (see diagram).

*Consult A Physician
When systolic and diastolic pressure fall into different categories, the higher pressure
determines color code.
Blood pressure measurements determined with this device are equivalent to those obtained
by at trained observer using the cuff/stethoscope auscultatory method, within the limits
prescribed for manual, electronic, or automated sphygmomanometers by the American
Naonal Standards Instute and the Associaon for the Advancement of Medical
Instrumentaon.
An irregular heartbeat (IHB) rhythm is defined as a rhythm that is more than25% slower or
25% faster from the average rhythm detected while the device is measuring the systolic blood
pressure and the diastolic blood pressure. When the device detects an irregular rhythm two
or more mes during the measurement, the Irregular Heartbeat Symbol will be displayed with
the measurement values.
BLOOD PRESSURE INDICATOR CHART
(Based on 2017 ACC/AHA guidelines)
Systolic mmHg (Upper Number)
Stage 2 Hypertension *
Below 80
140 &
above
130-139
120-129
Below 120
Stage 1 Hypertension *
Elevated BP *
Normal BP
80-89 90 & above
Diastolic mmHg (Bottom Number)
Red
Red
Yellow
Green

Start/Stop Button
Battery Cover
Voice
Air Socket
Cuff
Set Button
Memory Button
USB power supply port
Systolic pressure
User number
Blood pressure
classification
IHB
Pulse rate
Heartbeat
Low battery
Diastolic pressure
Unit Indicator
Year/Date/Time
Memory Times
Average Value
Display

Figure 2
Figure 1
+
-
+
+
-
-
Set Up Your Device
Baery Installaon
1. Take offthe baery cover on
the back of this device. (Figure 1)
2. Insert 3 AA alkaline baeries
according to the + and – markings.
(Figure 2)
3. Snap the baery cover on,
ensure it clicks into place.
NOTE: When the low baery
symbol appears on screen, turn off
this device and follow the
instrucons above to replace
baeries.
CAUTION
Never leave any low baery in the baery compartment as it may leak and
cause damage to this device.

S
Setting of User
With device turned off, press and release “SET” buon to show the current user.
Press “SET” buon to toggle between User 1 and User 2.
To select user, press “START/STOP” to confirm and then the device turns off.
S
Setting of Year, Date, Time
(12-hour/24-hour System)
1. With device turned off, press and hold “SET” buon unl flashing year digits
occur.
2. Press “MEM” to increase one year, or press and hold “MEM” to increase years.
Press “SET” to confirm and then flashing month digits occur.
3. Press “MEM” to increase one month, or press and hold “MEM” to increase
months. Press “SET” to confirm and then flashing day digits occur.
4. Press “MEM” to increase one day or press and hold “MEM” to increase days.
Press “SET” to confirm and then flashing hour digits occur.
5. Press “MEM” to increase one hour or press and hold “MEM” to increase hours.
Press “SET” to confirm and then flashing minute digits occur.
6. Press “MEM” to increase one minute or press and hold “MEM” to increase
minutes. Press “SET” to confirm and then either “12” digits occur for 12-hour
system or “24” digits occur for 24-hour system.
7. Press “MEM” to toggle between “12” for 12-hour system and “24” for 24-hour
system. Press “SET” to confirm and then pressure unit digits occur.
8. Press “MEM” to toggle between “mmHg” and “kPa”. Press “SET” to confirm and
then either voice“ON”digits or“OFF”digit occur.
9.Press “MEM” to toggle between voice“ON”and “OFF”. Press “SET” to confirm and
flashing year occur again, or press “START/STOP” to confirm and then the device
turns off.
10. Seng is completed.
N
Note: Pressing “START/STOP” will confirm the setting and then the device turns off at
a
any time.

Before Taking a Measurement
For most accurate results, measurements should be taken in the same
circumstances and at the same me every day.
This device can be applied to either arm, but preferably the le. Use the same arm
for each measurement.
Any blood pressure recording can be affected by the posion and physiological
condion of the subject, as well as other factors such as background noise, stress,
talking and body movement etc.
Avoid taking measurements while under stress.
Do not eat, drink alcohol, smoke, exercise, or bathe 30 minutes before using this
device, as these acvies may change blood pressure.
For an accurate indicaon of true blood pressure, take and record several
measurements over a period of me.
If consecuve measurements are desired, allow two minutes between uses to allow
blood to flow through the arm normally.
This device is used to monitor blood pressure. However, it cannot treat or prevent
high blood pressure. If you suffer from high blood pressure, consult your doctor.
Self-diagnosis and treatment using readings may be dangerous. Follow the
instrucons of your physician or licensed healthcare provider.
Measurement
1. This device should be used on bare skin. If necessary, loosely roll up your sleeve to
expose arm.
Note: your arm cannot be ghtened by your sleeve.
2. With the hose down the inside of your arm and the boom of the cuffapprox. 1-
2cm above your elbow, wrap the cuffaround your arm. Secure the cuffwith a finger
space between the cuffand your arm by aaching hook-and-loop fastener.
3. Comfortably seated
Legs uncrossed
Feet flat on the floor
Back and arm supported
Relax as much as possible and
do not talk during the measurement.

M
Measurement
(connued)
4. While sing upright in a chair with your feet flat on the floor, press “START/STOP".
Symbols on screen will flash and cuffwill begin to inflate. Do not move, acvate arm
muscles, or talk during measurement.
5. Measurement can be stopped at any me by pressing “START/STOP".
6. When a pulse is detected, a heart symbol will flash on screen.
7. When measurement is complete, the cuffdeflates automacally and your systolic, diastolic,
and pulse rate will display on screen.
8. Turn offthis device by pressing “START/STOP", remove from your arm by detaching hook-
and-loop fasteners. If this device is accidentally leon, it will turn itself offaer two
minutes.
NOTE: This device will remain set on the same user aer you turn it off. To change to the
other user, turn this device off, then press and release “SET” to access user seng. Either
the User 1 or User 2 icon will appear. Press “SET” to switch to the other user icon and press
“START/STOP” to confirm the user and then the device turns off.
U
Using Memory
-
-
R
Recall
This device will store up to 90 measurements each for two users. When more than 90
measurements are taken, the oldest measurement will be replaced.
1. To access Memory-Recall, press and release “MEM” while this device is off.
2. First, it will display the average of your three most recent measurements, indicated on
screen as M AVG (Measurement Average).
3. Press “MEM” again to see the most recent measurement. Press “MEM” repeatedly to
scroll towards the oldest measurement. On screen, M01 indicates the most recent
measurement, with higher M numbers indicang older measurements.
4. If you desire to delete all stored measurements, press and hold “SET” under the Memory-
recall status unl “dEL no” is displayed with “no” flashing. Press and release “SET” to
switch to “dEL YES” with “YES” flashing.
5. Press “START/STOP” with “dEL YES” to confirm clearing the memory and then blank
entry appears on screen, or press “START/STOP” with “dEL no” to go back to the
Memory-recall status without clearing the memory.
6. Press “START/STOP” to exit.

C
C
a
are and Maintenance
For regular maintenance, this device only needs to be wiped gently with a so,
dry cloth. Never immerse this device or any components in water.
Do not carry out repairs of any kind yourself. If a defect occurs, please contact
your local authorized distributor. Use only authorized parts and accessories.
T
T
r
roubleshootin
g
g
If you see any of these symbols displayed on screen, perform the corresponding
correcon:
E
Err
Error during inflaon
Correcon: Adjust cuff, ensuring it is wrapped properly, and repeat
measurement. Do not move or talk during measurement. Ensure cuffis level
with heart.
L
Lo
Low baery
Correcon: Replace baeries following instrucons in the Baery installaon
secon
If you have the following issues without an error code, perform the
corresponding correcon:
N
No Power
Low baeries or incorrect baery placement
Correcon: Ensure baeries were installed according to the + and - shown on
this device. If they were, baeries need replacement.
M
Measurement Too High / Too Low
Possible incorrect use of this device
Correcon: Adjust cuff, ensuring it is wrapped properly, and repeat
measurement.
Care and Maintenance

Guidance and Manufacturer’s DeclaraƟon - ElectromagneƟc Immunity this
device is intended for use in the electromagneƟc environment specified below.
The customer or the user of this device should ensure that it is used in such an
environment.
Immunity Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
This device uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
This device is suitable for use in all
establishments other than domestic
and those directly connected to the
public low voltage power supply
network that supplies buildings used
for domestic purposes.
Compliance Electromagnetic
Environment - Guidance

Radiated RF
IEC 61000-4-3
10V/m
80MHz to
2.7GHz
10V/m
80MHz to
2.7GHz
9V/m,
27V/m,
28V/m
385-5785
MHz
9V/m,
27V/m,
28V/m
385-5785
MHz
Portable RF communications
equipment
(including peripherals such as
antenna cables and external
antennas) should be used no
closer than 30 cm (12 inches)
to any part of this device,
including cables specified by
the manufacturer. Otherwise,
degradation of the
performance of this
equipment could result.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Immunity
Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power
frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
± 8 kV
contact
± 2 kV,
± 4 kV,
± 8 kV,
± 15 kV air
± 8 kV
contact
± 2 kV,
± 4 kV,
± 8 kV,
± 15 kV air
30 A/m 30 A/m
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%
Magnetic fields from common
appliances are not expected
to affect the device.
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance

This device complies with Part 15 of the FCC rules. Operaon is subject to the
following two condions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operaon.
Cauon: Changes or modificaons to this device not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protecon against harmful interference in a residenal installaon.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance to the Instrucons, may cause harmful interference
to radio communicaons. However, there is no guarantee that interference will not
occur in a parcular installaon. If this equipment does cause harmful interference to
radio or television recepon, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
-Reorient or relocate the receiving antenna.
- Increase the separaon between the equipment and receiver.
- Connect the equipment to an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.

To improve performance, these specificaƟons are subject to change without noƟce.
Disposal of the device, accessories and packaging shall be carried out in accordance with
naƟonal and local regulaƟons for proper handling of waste.
C
CALIBRATION AND SER
V
VICE
The accuracy of this blood pressure monitor has been carefully tested and is designed for
a long service life. It is generally recommended to have this device inspected and
calibrated every 2 years to ensure correct funcƟoning and accuracy. Please consult you
authorized distributor.
15
TBP-6/09231
cirtemollicsO2
3LCD
4Pressure: 0 to 299 mmHg
Pulse: 40 to 180 beats/minute
gHmm3nihtiW:erusserP5 ±
Pulse Rate: Within 5% of reading
±
6Automatic inflation by pump
7 Deflation Automatic rapid deflation
8 Pressure Detection Semiconductor pressure sensor
9 Memory 2 persons X 90 measurements each
10 Power Supply 3 AA alkaline batteries (not included)
11 Battery Life About 6 months when used once a day
12
13 Transport
Storage Environment
Operating
Environment
Temperature
Temperature
Humidity
Humidity
Barometric Pressure
50°F (10°C) to 104°F ( 40°C)
-4°F (-20°C) to 131°F ( 55°C)
15% to 90% (noncondensing)
0% to 95% (noncondensing)
105 kPa to 80 kPa (790 mmHg to
600 mmHg)
14 Weight of Main Unit A
pp
roximatel
y
115
g
(
not includin
g
batteries
)
15 External Dimensions 103 mm ( H) X 77.5 mm (W ) X 40.8 mm (D )
16 Measurable Circumference
of arm
22 ~36cm
17 Electric Shock Protection Internal power supply appliance type BF
18 Contents Main unit, Cuff, instruction manual
Model
Inflation
Accuracy
Measurement Range
Display
Measurement Method

16
WARRANTY DURATION:
All materials and workmanship are warranted to the original
consumer purchaser for a period of ninety (90) days from the original purchase date.
WARRANTY COVERAGE:
This product is warranted against defecve materials or workmanship.
This warranty is void if the product has been damaged by accident, in shipment, unreasonable
use, misuse, neglect, improper service, commercial use, repairs by unauthorized personnel or
other causes not arising out of defects in materials or workmanship. This warranty does not
cover the following which may be supplied with product, including but not limited to; LCD
Screens, glass parts, lenses, bulbs etc. This warranty is effecve only if the product is
purchased and operated in USA, and does not extend to any units which have been used in
violaon of wrien instrucons furnished by manufacturer or to units which have been
altered or modified or, to damaged products or parts thereof which have had the serial
number removed, altered, defaced or rendered illegible.
WARRANTY PERFORMANCE:
During the above 90 day warranty period, a product with a defect
will be either repaired or replaced with a recondioned comparable model (at manufacturer's
opon). The repaired or replacement product will be in warranty for the balance of the 90
day warranty period and an addional one-month period. No charge will be applicable for
such repair or replacement. S
SERVICE AND REPAIR:
If service is required for this product, you
should first contact Nuvomed Inc. Customer Service at [email protected] or by calling Toll-
Free Number 1 [phone], Monday to Friday 10 am to 6pm EST.-
NOTE:
Manufacturer cannot assume responsibility for loss or damage during incoming
shipment. As a precauonary measure, carefully package the product for shipment, and
insure it with the carrier. Be sure to enclose the following details with the product: your full
name, return address and dayme phone number, a note describing the problem you
experienced, a copy of your sales receipt or other proof of purchase to determine warranty
status. C.O.D. shipments cannot be accepted.
This manufacturer's product warranty extends to the original consumer purchaser of the
product. Neither the retailer nor any other company involved in the sale or promoon of this
product is a co-warrantor of this manufacturer warranty.
WARRANTY DISCLAIMERS:
This warranty is in lieu of all warranes expressed or implied and no
representave or person is authorized to assume for manufacturer any other liability in
connecon with the sale of our products. There shall be no claims for defects or failure under
any theory of tort, contractor commercial law including but not limited to, negligence, gross
negligence, strict liability, breach of warranty and breach of contract. Under no circumstances
will Manufacturer’s / Distributor’s maximum liability exceed the retail value of the product.