USER GUIDE
Blood Pressure
Monitor
NS-BPMW1
Before using your new product, please read these instructions to prevent any damage.
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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications for use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Important Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . 3
Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Learning about blood pressure . . . . . . . . . . . . . . . . . . . .12
Setting up your blood pressure monitor. . . . . . . . . . . .15
Powering your blood pressure monitor. . . . . . . . .15
Attaching the cuff to the monitor . . . . . . . . . . . . . .16
Setting the date, time, and measurement units .16
Using your blood pressure monitor . . . . . . . . . . . . . . . .19
Getting accurate measurements . . . . . . . . . . . . . . .19
Attaching the cuff to your arm . . . . . . . . . . . . . . . . .19
Taking your measurements . . . . . . . . . . . . . . . . . . . .21
Recalling records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Deleting all records . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Maintaining your blood pressure monitor . . . . . . . . . .25
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Legal notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
ONE-YEAR LIMITED WARRANTY . . . . . . . . . . . . . . . . . . . .37
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Blood Pressure Monitor
Introduction
Congratulations on the purchase of your new Insignia Blood Pressure
Monitor. Your blood pressure monitor features the latest in design and
capabilities and will provide reliable and trouble-free performance.
Indications for use
This blood pressure monitor is a digital monitor intended for use in
measuring blood pressure and heartbeat rate on persons with an arm
circumference ranging from approximately 8.75” to 16.5” (22 cm to
42 cm). It is intended for adult use only.
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 atmospheric pressure, then it begins
inflating the arm cuff. Meanwhile, the unit detects pressure oscillations
generated by beat-to-beat plusatile, which is used to determine the
systolic and diastolic pressure and the pulse rate.
Important Safety Instructions
• This device is intended for adult use in homes only.
• The device is not suitable for use on neonatal patients, pregnant
women, patients with implanted, electronic devices, patients with
pre-eclampsia, premature ventricular beats, atrial fibrillation,
peripheral, arterial disease and patients undergoing intravascular
therapy or arterio-venous shunt, or people who received a
mastectomy. Please consult your doctor prior to using the unit if you
suffer from illnesses.
• The device is not suitable for measuring the blood pressure of
children. Ask your doctor before using it on older children.
CAUTION
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• The device is not intended for patient transport outside a healthcare
facility.
• The device is not intended for public use.
• 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 without asking a physician for treatment 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.
• Do not take any therapeutic measures on the basis of a self
measurement. Never alter the dose of a medicine prescribed by a
doctor. Consult your doctor if you have any question about your
blood pressure.
• When the device is used to measure patients who have common
arrhythmias (such as atrial or ventricular premature beats or atrial
fibrillation), the best result may occur with deviation. Please consult
your physician about the result.
• Don't kink the connection tube during use. The cuff pressure may
continuously increase which can prevent blood flow and result in
harmful injury to the patient.
• 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:
• Connection tubing kinking.
• 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.
• Inflating the cuff on the side of a mastectomy.
• WARNING: Do not apply the cuff over a wound. 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 simultaneously-used
monitoring ME equipment.
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Blood Pressure Monitor
• On the rare occasion of a fault causing the cuff to remain fully inflated
during measurement, open the cuff immediately. Prolonged high
pressure (cuff pressure >300 mm Hg or constant pressure >15 mm Hg
for more than three minutes) applied to the arm may lead to an
ecchymosis.
• Please check that operation of the device does not result in
prolonged impairment of the patient’s blood circulation.
• When measuring, please avoid compression or restriction of the
connection tubing.
• The device cannot be used with HF surgical equipment at the same
time.
• The accompanying documents will disclose that the
SPHYGMOMANOMETER was clinically investigated according to the
requirements of ISO 81060-2:2013.
•To verify the calibration of the AUTOMATED SPHYGMOMANOMETER,
please contact the manufacturer.
• This device is contraindicated for any female who may be or is
pregnant. Besides providing inaccurate readings, the effects of this
device on the fetus are unknown.
• Too frequent and consecutive measurements could cause
disturbances in blood circulation and injuries.
• This unit is not suitable for continuous monitoring during medical
emergencies or operations. Otherwise, the patient’s arm and fingers
will become anaesthetic, swollen, and even purple due to a lack of
blood.
• When not in use, store the device in a dry room and protect it against
extreme moisture, heat, lint, dust, and direct sunlight. Never place
any heavy objects on the storage case.
• This device may be used only for the purpose described in these
accompanying documents. The manufacturer cannot be held liable
for damage caused by incorrect application.
• This device comprises sensitive components and must be treated
with caution. Observe the storage and operating conditions
described in these accompanying documents.
• 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.
• Warning: No servicing/maintenance while the ME equipment is in
use.
• The patient is an intended operator.
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• The patient can measure, transmit data, and change batteries under
normal circumstances and maintain the device and its accessories
according to the accompanying documents.
• To avoid measurement errors, please avoid strong electromagnetic
fields, radiated interference signals, or electrical fast transient/burst
signals.
• The blood pressure monitor and the cuff are suitable for use within
the patient environment. If you are allergic to polyester, nylon, or
plastic, please don't use this device.
• During use, the patient will be in 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 sensation or irritation reaction.
• Adapter is specified as a part of ME EQUIPMENT.
• If you experience discomfort during a measurement, such as pain in
the arm or other complaints, press the START/STOP button to release
the air immediately from the cuff. Loosen the cuff and remove it from
your arm.
• If the cuff pressure reaches 40 kPa (300 mm Hg), the unit will
automatically deflate. Should the cuff not deflate when pressure
reaches 40 kPa (300 mm Hg), detach the cuff from the arm and press
the START/STOP button to stop inflation.
• Before use, make sure that the device functions safely and is in proper
working condition. Do not use the device if it is damaged in any way.
The continuous use of a damaged unit may cause injury, improper
results, or serious danger.
• Do not wash the cuff in a washing machine or dishwasher.
• The service life of the cuff may vary by the frequency of washing, skin
condition, and storage state. The typical service life is 10,000 times.
• It is recommended that the performance should be checked every
two years and after maintenance and repair, by retesting at least the
requirements in limits of the error of the cuff pressure indication and
air leakage (testing at least at 50 mm Hg and 200 mm Hg).
• Please dispose of ACCESSORIES, detachable parts, and the ME
EQUIPMENT according to the local guidelines.
• Manufacturer will make available on request circuit diagrams,
component part lists, descriptions, calibration instructions, etc., to
assist to service personnel in parts repair.
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Blood Pressure Monitor
• The plug/adapter plug pins insulates the device from the main
supply. Do not position the device in a position where it is difficult to
disconnect from the electrical outlet to safely terminate operation of
ME equipment.
• The operator shall not touch output of batteries/adapter and the
patient simultaneously.
• Cleaning: A dusty environment may affect the performance of the
unit. Please use the soft cloth to clean the whole unit before and after
use. Don’t use any abrasive or volatile cleaners.
• The device doesn’t need to be calibrated within two years of reliable
service.
• If you have any problems with this device, such as setting up,
maintaining, or using, please contact Insignia Customer Service.
Don’t open or repair the device by yourself in the event of
malfunctions. The device must only be serviced, repaired, and
opened by individuals at authorized sales/service centers.
• Please report to Insignia Customer Service if any unexpected
operation or events occur.
• Keep the unit out of reach of infants, young children, or pets to avoid
inhalation or swallowing of small parts. It is dangerous or even fatal.
• Be careful of strangulation due to cables and hoses, particularly due
to excessive length.
• At least 30 min. required for ME equipment to warm from the
minimum storage temperature between uses until it is ready for
intended use. At least 30 min. required for ME equipment to cool
from the maximum storage temperature between uses until it is
ready for intended use.
• This equipment needs to be installed and put into service in
accordance with the information provided in the accompanying
documents.
• Wireless communications equipment such as wireless home network
devices, mobile phones, cordless telephones and their base stations,
and walkie-talkies can affect this equipment and should be kept at
least distance “d” away from the equipment. The distance “d” is
calculated by the MANUFACTURER from the 80 MHz to 5.8 GHz
column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
• Please use ACCESSORIES and detachable parts specified/authorised
by MANUFACTURER. Otherwise, it may cause damage to the unit or
danger to the user/patients.
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• There are no luer lock connectors 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.
• Please use the device under the environment which was provided in
the accompanying documents. Otherwise, the performance and
lifetime of the device will be impacted and reduced.
Contraindications
• The device should not be used by any person who may be or is
pregnant.
• The device is not suitable for use on patients with implanted
electrical devices, such as cardiac pacemakers or defibrillators.
Safety information
The signs below 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 “MANUFACTURER.”
Symbol for “SERIAL NUMBER.”
Symbol for “DIRECT CURRENT.”
Caution: These notes must be observed to prevent any
damage to the device.
Symbol for “MANUFACTURE
DATE.”
Symbol for “TYPE BF APPLIED PARTS.”
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Blood Pressure Monitor
Symbol for “ENVIRONMENT PROTECTION - Electrical
waste 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 “RECYCLE.”
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Features
• Blood Pressure Monitor
•Cuff
• AAA batteries (4)
•User Guide
Front
Back
LCD display
Start/Stop button
Set button
Memory button
Swith user button
DC power jack
Air connector plug
Air hose
Cuff
Battery compartment
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Blood Pressure Monitor
Display
#ITEM DESCRIPTION
1
Memory
Shows that the monitor is in the memory mode and
which group of memory it is.
2
User A
Recording measurements for User A.
3
User B
Recording measurements for User B.
4
Average
value
The average value of the latest three records.
5
Low
battery
Batteries are low and need to be replaced.
6
Heartbeat
Blood pressure monitor is detecting a heartbeat
during measurement.
Irregular
heartbeat
Blood pressure monitor is detecting an irregular
heartbeat during measurement.
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Learning about blood pressure
What are 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.
This is called systolic pressure.
When the ventricles relax, the blood
pressure reaches its minimum value in the
cycle. This is called diastolic pressure.
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Inflation/
Deflation
The cuff is inflating or
deflating.
8
Current
time
Shows the date (year, month, day) and time of
measurements.
9
Blood
pressure level
Indicates the blood pressure level.
10
Systolic
blood pressure
Shows your heart’s systolic pressure.
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kPa
Blood pressure is displayed in kilopascals (kPa).
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mmHg
Blood pressure is displayed in millimeters of
mercury (mmHg).
13
Diastolic
blood pressure
Shows your heart’s diasoltic pressure.
14
Pulse
display
Shows your pulse in beats per minute.
#ITEM DESCRIPTION
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Blood Pressure Monitor
What is the standard blood pressure classification?
The chart on the right is the standard blood pressure classification
published by American Heart Association (AHA):
Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies
while the device is measuring systolic pressure and diastolic pressure.
During each measurement, the blood pressure monitor will keep a
record of all the pulse intervals and calculate the average value of them.
If either of the following occur, the
irregular heartbeat symbol will
appear on the display with the measurement result:
• You have two or more pulse intervals and the difference between
each interval and the average is more than the average value of ±25%
BLOOD PRESSURE
CATEGORY
SYSTOLIC
MMHG
(UPPER #)
DIASTOLIC
MMHG
(LOWER #)
Normal Less than 120 and Less than 80
Elevated 120–129 and Less than 80
High blood pressure
(hypertension) stage 1
130–139 or 80–89
High blood pressure
(hypertension) stage 2
140 or higher or 90 or higher
Hypertensive crisis
(consult your doctor
immediately)
Higher than 180 and/
or
Higher than 120
This chart reflects blood pressure categories defined by American Heart
Association.
CAUTION: Consult a physician if your measuring result falls outside
the range. Only a physician can tell whether your blood pressure
value has reached a dangerous point.
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• You have four or more pulse intervals and the difference between
each interval and the average is more than the average value of ±15%
Why does my blood pressure fluctuate throughout the day?
• Your blood pressure varies multiple times everyday. It is also affected
by the way you tie your cuff and your measurement position, so take
the measurement under the same conditions.
• Your blood pressure may vary more if you take a medication.
• Wait at least three minutes between measurements.
Why do I get a different blood pressure at home compared to the
hospital?
Blood pressure varies throughout the day due to weather, emotions,
exercise, and other factors. Also, there is a “white coat” effect, meaning
blood pressure usually increases in clinical settings.
When you measure your blood pressure at home:
• Make sure that the cuff is attached correctly.
• Make sure that cuff is not too tight or too loose.
• Make sure that the cuff is attached to your upper arm.
• If you feel anxious, take two to three deep breaths before beginning.
Relax for four to five minutes until you calm down.
Is the result the same if measuring on the right arm?
While it is okay to measure with either arm, we suggest you measure
the same arm every time.
CAUTION: The appearance of the
irregular heartbeat symbol
indicates that a pulse irregularity consistent with an irregular
heartbeat was detected during measurement. Usually this is NOT a
cause for concern. However, if the symbol appears often, seek
medical advice. This monitor does not replace a cardiac
examination but serves to detect pulse irregularities at an early
stage.
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Blood Pressure Monitor
Setting up your blood pressure monitor
Powering your blood pressure monitor
Your blood pressure monitor can be powered with either batteries
(included) or the AC adapter (not included).
Installing the batteries
Replace the batteries whenever the low battery indicator ( ) is
shown or if the display is dim or doesn’t light up.
1 Squeeze the tab to open the battery cover.
2 Insert four AAA batteries. Make sure that the + and – symbols in the
compartment match the batteries.
3 Close the battery cover.
CAUTION: For the best results and to protect your monitor, use the
the correct batteries or a power adapter (not included).
CAUTION:
• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Remove batteries if the device is not likely to be used for a long
period of time.
• Remove the old batteries from the device following your local
recycling guidelines.
• Do not dispose of the batteries in fire. Batteries may explode or
leak.
• Worn batteries are harmful to the environment. Do not dispose
with daily garbage.
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Connecting an AC adapter (not included)
1 Make sure that your adapter meets the following requirements:
• Input: AC 100–240 V, 50/60 Hz, 0.2 A max
Output: 6 V, 1 A
2 Connect the AC adapter from the monitor’s DC power jack to a
power outlet.
Attaching the cuff to the monitor
Connect the cuff’s air hose to the air connector plug on the side of the
monitor.
Setting the date, time, and measurement units
Set the clock before using your blood pressure monitor so that a time
stamp can be assigned to each record in its memory.
1 When the monitor is off, press SET. The time is shown.
2 Press and hold SET again to change the year.
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Blood Pressure Monitor
3 Press MEM repeatedly to change the year, then press SET to save
your selection. Each press increases the year by one, cycling from
2018–2058.
4 When you get the right year, press SET to save the year. The display
shows the date (month/day) settings.
5 Press MEM repeatedly to change the month, then press SET to save
your selection. Each press increases the month by one, cycling from
1–12 (January–December).
6 Press MEM repeatedly to change the day, then press SET to save
your selection. Each press increases the day by one, cycling from 1–
31.
7 Press MEM repeatedly to change the time format, then press SET to
save your selection. Each press switches between 12h and 24h.
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8 Press MEM repeatedly to change the hour, then press SET to save
your selection. Each press increases the hour by one, cycling from
1–12 (if you selected 12h) or 0–23 (if you selected 24h).
9 Press MEM repeatedly to change the minutes, then press SET to
save your selection. Each press increases the minutes by one, cycling
from 00–59.
10 Press MEM repeatedly to change the blood pressure unit, then press
SET to save your selection. Each press switches between mmHg and
kPa.
The display shows “donE,” all the date and time settings you made,
then turns off.
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Blood Pressure Monitor
Using your blood pressure monitor
Getting accurate measurements
Follow these tips for the most accurate readings (especially for people
with hypertension):
• Rest for five minutes before the first measurement. Relax as much as
possible and do not move and talk during the measurement.
• Keep the cuff at the same level as the right atrium of the heart.
• Sit comfortably with your feet flat on the ground. Do not cross your
legs.
• Keep your back against the backrest of the chair.
• Wait at least three 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, on the same arm, or as directed by a physician.
Measurements may be inaccurate if they are taken:
• Within one hour after eating or drinking.
• Immediately after tea, coffee, or smoking.
• Within 20 minutes after taking a bath.
• While talking or moving your fingers.
• In a very cold environment.
• When you need to discharge urine.
Attaching the cuff to your arm
1 Remove all jewelry (such as watches and bracelets) from your left
arm.
2 Roll or push up your sleeve to expose the skin. Make sure that your
sleeve is not too tight.
3 Hold your arm out with your palm facing up and attach the cuff to
your upper arm. Make sure that the cuff is snug but not too tight.
You should be able to insert one finger between the cuff and your
arm.
Note: If your doctor has diagnosed you with poor circulation in
your left arm, use your right arm.
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4 Position the tube off-center toward the inner side of your arm
(in-line with the little finger).
OR
Position the artery mark ( ) over the main artery on the inside of
your arm.
5 Sit upright in a chair and rest your arm on a table so the cuff is at the
same level as your heart. Turn your palm upward. Take five or six
deep breaths before starting measurements.
Note: To locate the main artery, press two fingers approximately
.8 in. (2 cm) above the bend of your elbow on the inside of your left
arm. Identify where the pulse can be felt the strongest. This is your
main artery.
.8–1.2 in. (2–3 cm)
Positioning in-line
with little finger
Positioning with
the artery mark
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Blood Pressure Monitor
Taking your measurements
WARNING:
• This monitor is not suitable for measuring children.
• If you need to stop the cuff from inflating, press START/STOP to
immediately release the air. Loosen the cuff and remove it from
your arm.
• Read all ”Important Safety Instructions
” on page 3 before using
this monitor.
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1 When the monitor is off, press the START/STOP to turn on the
monitor. The monitor takes your measurements and saves the data
for the selected user.
2 Press the START/STOP to turn off the monitor, or it will turn off
within one minute.
Note: You can select user A or B by pressing the
user button
during measurement or when in the memory mode.
Monitor turns on Adjusting the zero point
Inflating and measuring
Displays and saves
measurement
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Blood Pressure Monitor
Recalling records
1 When the monitor is off, press MEM. The monitor cycles through the
last three records. If there are less than three records, it will show the
latest record instead.
2 If needed, press the user button to switch between User A or
User B’s records.
3 Press the MEM to move forward or SET to move backward through
the records. Press and hold MEM to look over ten records quickly.
Note: 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 (for example, 2 becomes 3, and so on), and
the last record (250) is dropped from the list.
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Deleting all records
If you did not get the correct measurement, you can delete all records
for the selected user. You cannot delete a single record.
1 When the monitor is off, press MEM to enter memory recall mode.
2 Press and hold SET for three seconds. “dEL ALL” and the user ID flash
on the display.
3 Press SET to confirm that you want to delete all records. “dEL donE”
and the user ID are shown, then the monitor turns off.
Note: If you don’t want to delete the records, press START/STOP,
then press SET.
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Blood Pressure Monitor
4 When all records are deleted, the screen shows “- - -.” Press MEM to
return to the correct screen.
Maintaining your blood pressure monitor
In order to get the best performance:
• Store in a dry place and avoid the sunshine.
• Avoid intense shaking and collisions.
• Use a wet or dry cloth to remove dirt on the monitor.
• Avoid contact with water. Clean with a a dry cloth.
• Avoid dusty and unstable temperature environments.
• Do not attempt to clean the reusable cuff with water. Never immerse
the cuff in water.
• Do not fold the cuff’s tubing.
• Take the batteries out if the monitor won’t be used for a long period
of time.
Troubleshooting
PROBLEM POSSIBLE SOLUTIONS
The display will not light
up.
• The batteries may be low. Replace with new
batteries.
• Make sure that the batteries are inserted
correctly.
• Make sure that the AC adapter is securely
connected to the blood pressure monitor
and a working power outlet.
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Error messages
The display says “out.” • Your results are out of measurement range.
Take a moment to relax. Refasten the cuff
and measure again. If the problem persists,
contact your physician.
ERROR CODE POSSIBLE PROBLEM/SOLUTION
“E 01” is shown. The cuff is too tight or too loose. Refasten the
cuff and measure again.
“E 02” is shown. The monitor detected motion, talking, or the
pulse is too poor while measuring. Relax for
moment, then measure again.
“E 03” is shown. The monitor doesn’t detect the pulse signal.
Loosen or remove clothing on your arm, then
measure again.
“E 04” is shown. The measurement failed. Relax for a moment
and then measure again.
“EExx” is shown.
(“xx” is a number, such
as 01, 02, etc. If this type
of message is displayed,
all are calibration
errors.)
A calibration error occured. Retake the
measurement. If the problem persists, contact
customer service.
Display is dim or shows
.
Batteries are low. Replace the batteries.
PROBLEM POSSIBLE SOLUTIONS
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Blood Pressure Monitor
Specifications
Dimensions
(H × W × D)
Blood pressure monitor: 2.3 × 5.1 × 5.5 in. (5.9 × 13 ×
14 cm)
Weight .6 lbs (260 g)
Power supply Batteries: 6VDC 4×AAA batteries
AC adapter:
Input: AC 100–240 V, 50/60 Hz, 0.2 A Max
Output: 6 V, 1 A
Display mode Digital LCD
Measurement
mode
Oscillographic testing mode
Measurement
range
Rated cuff pressure: 0 mmHg ~ 299 mmHg (0 kPa ~
39.9 kPa)
Measurement pressure:
SYS: 60 mmHg ~ 230 mmHg (8.0 kPa ~ 30.7 kPa)
DIA: 40 mmHg ~ 130 mmHg (5.3 kPa ~ 17.3 kPa)
Pulse value: (40–199) beats/minute
Accuracy Pressure: 41° ~ 104°F (5° ~ 40° C) within ±4 kPa
(3 mmHg)
Pulse value: ±5%
Operating
conditions
Temperature range: 41° ~ 104° F (5° ~ 40° C)
Relative humidity range: 15% to 90%
(non-condensing, but not requiring a water vapor
partial pressure greater than 50 hPa)
Atmospheric pressure range: 700 hPa to 1060 hPa
Storage &
transportation
temperature
Temperature: -20° ~ 60° C
Relative humidity range: . ≤93% (non-condensing, at a
water vapor pressure up to 50 hPa)
Circumference
of the upper
arm
8.6–16.5 in. (22–42 cm)
NS-BPMW1
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Legal notices
Compliance standards list
Mode of
operation
Continuous operation
Degree of
protection
Type BF applied part
Protection
against ingress
of water
IP21
(The device is protected against solid foreign objects of
.5 in. (12.5 mm) and greater and is protected against
vertically falling water drops.)
Device
classifications
Battery mode: Internally-powered ME equipment
AC adapter: Class II ME equipment
Software
version
A01
Risk
management
• EN ISO 14971:2012 / ISO 14971:2007 Medical
devices - Application of risk management to
medical devices
Labeling • EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical
devices. Symbols to be used with medical device
labels, labeling and information to be supplied. Part
1 : General requirements
User manual • EN 1041:2008+A1:2013 Information supplied by the
manufacturer of medical devices
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Blood Pressure Monitor
General
requirements
for safety
• EN 60601-1:2006+A1:2013/ IEC
60601-1:2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic
safety and essential performance
• EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical
electrical equipment - Part 1-11: General
requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
Electomagnetic
compatibility
• EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical
electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
Performance
requirements
• EN ISO 81060-1:2012 Non-invasive
sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement
type
• EN 1060-3:1997+A2:2009 Non-invasive
sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure
measuring systems
• IEC 80601-2-30:2018 Medical electrical equipment-
Part 2-30: Particular requirements for the basic
safety and essential performance of automated
non-invasive sphygmomanometers
Clinical
investigation
• EN 1060-4:2004 Non-invasive sphygmomanometers
- Part 4: Test procedures to determine the overall
system accuracy of automated non-invasive
sphygmomanometers
• ISO 81060-2:2013 Non-invasive
sphygmomanometers - Part 2: Clinical validation of
automated measurement type
NS-BPMW1
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EMC guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare
environments.
• Warning: Don’t use near active HF surgical equipment and the RF
shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbances is high.
• Warning: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.
• Warning: Use of accessories, transducers, and cables other than
those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
Usability • EN 60601-1-6:2010+A1:2015/IEC
60601-1-6:2010+A1:2013 Medical electrical
equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral
standard: Usability
• IEC 62366-1:2015 Medical devices - Part 1:
Application of usability engineering to medical
devices
Software
life-cycle
processes
• EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015
Medical device software - Software life-cycle
processes
Bio-
compatibility
• ISO 10993-1:2009 Biological evaluation of medical
devices- Part 1: Evaluation and testing within a risk
management process
• ISO 10993-5:2009 Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical
devices - Part 10: Tests for irritation and skin
sensitization
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Blood Pressure Monitor
• Warning: Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 12 in. (30 cm) to any part of the equipment
NS-BPMW1, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could
result.
Technical de scription
1 All necessary instructions for maintaining BASIC SAFETY and
ESSENTIAL PERFORMANCE with regard to electromagnetic
disturbances for the excepted service life.
2 Guidance and manufacturer’s declaration – electromagnetic
emissions and immunity.
Table 1
GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC EMISSIONS
EMISSIONS TEST COMPLIANCE
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class [ B ]
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Comply
NS-BPMW1
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Table 2
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
IMMUNITY TEST
IEC 60601-1-2
TEST LEVEL
COMPLIANCE LEVEL
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15
kV air
±8 kV contact
±2 kV, ±4kV, ±8 kV,
±15 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV signal
input/output
100 kHz repetition
frequency
±2 kV for power supply
lines
±1 kV signal
input/output
100 kHz repetition
frequency
Surge
IEC61000-4-5
±0.5 kV, ±1 kV
differential mode
±0.5 kV, ±1 kV, ±2 kV
common mode
±0.5 kV, ±1 kV
differential mode
±0.5 kV, ±1 kV, ±2 kV
common mode
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0% U
T
; 0,5 cycle. At 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°.0%
U
T
;
1 cycle and 70% U
T
;
25/30 cycles;
Single phase: at 0°.0%
UT; 250/300 cycle
0 % U
T
; 0,5 cycle. At 0°,
45°, 90°, 135°, 180°,
225°, 270° and 315°.0 %
U
T
;
1 cycle and 70% UT;
25/30 cycles;
Single phase: at 0°.0 %
U
T
; 250/300 cycle
Power frequency
magnetic field
IEC 61000-4-8
30 A/m
50 Hz/60 Hz
30 A/m
50 Hz/60 Hz
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Blood Pressure Monitor
Conduced RF
IEC61000-4-6
3 V
0.15 MHz – 80 MHz
6 V in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
80% AM at 1 kHz
3 V
0.15 MHz – 80 MHz
6 V in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
80% AM at 1 kHz
Radiated RF
IEC61000-4-3
10 V/m
80 MHz – 2.7 GHz
80% AM at 1 kHz
10 V/m
80 MHz – 2.7 GHz
80% AM at 1 kHz
Note: U
T
is the a.c. mains voltage prior to application of the test level.
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
IMMUNITY TEST
IEC 60601-1-2
TEST LEVEL
COMPLIANCE LEVEL
NS-BPMW1
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Table 3
GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC IMMUNITY
Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment).
TEST
FRE-
QUENCY
(MHZ)
BAND
(MHZ)
SERVICE MODULATION
MODU-
LATION
(W)
DIS-
TAN CE
(M)
IMMU-
NITY
TEST
LEVEL
(V/M)
385 380–
390
TETRA 400 Pulse
modulation b)
18Hz
1.8 0.3 27
450 430–
470
GMRS 460,
FRS 460
FM c) ± 5kHz
deviation
1kHz sine
20.328
710 704–
787
LTE Band 13,
17
Pulse
modulation b)
217Hz
0.2 0.3 9
745
780
810 800–
960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
20.328
870
930
1720 1700–
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE
Band 1, 3,
4,25; UMTS
Pulse
modulation b)
217Hz
20.328
1845
1970
35
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Blood Pressure Monitor
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.
2450 2400–
2570
Bluetooth,
WLAN, 802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217Hz
20.328
5240 5100–
5800
WLAN 802.11
a/n
Pulse
modulation
217Hz
0.2 0.3 9
5500
5785
GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC IMMUNITY
Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communications equipment).
TEST
FRE-
QUENCY
(MHZ)
BAND
(MHZ)
SERVICE MODULATION
MODU-
LATION
(W)
DIS-
TAN CE
(M)
IMMU-
NITY
TEST
LEVEL
(V/M)
NS-BPMW1
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FCC Caution
Changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate
this 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 protection against
harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, maybe cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television
reception, 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 separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different form that
to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
37
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Blood Pressure Monitor
ONE-YEAR LIMITED WARRANTY
Definitions:
The Distributor* of Insignia branded products warrants to you, the original
purchaser of this new Insignia-branded product (“Product”), that the Product
shall be free of defects in the original manufacturer of the material or
workmanship for a period of one (1) year from the date of your purchase of the
Product (“Warranty Period”).
For this warranty to apply, your Product must be purchased in the United States
or Canada from a Best Buy branded retail store or online at www.bestbuy.com
or www.bestbuy.ca and is packaged with this warranty statement.
How long does the coverage last?
The Warranty Period lasts for 1 year (365 days) from the date you purchased the
Product. Your purchase date is printed on the receipt you received with the
Product.
What does this warranty cover?
During the Warranty Period, if the original manufacture of the material or
workmanship of the Product is determined to be defective by an authorized
Insignia repair center or store personnel, Insignia will (at its sole option): (1)
repair the Product with new or rebuilt parts; or (2) replace the Product at no
charge with new or rebuilt comparable products or parts. Products and parts
replaced under this warranty become the property of Insignia and are not
returned to you. If service of Products or parts are required after the Warranty
Period expires, you must pay all labor and parts charges. This warranty lasts as
long as you own your Insignia Product during the Warranty Period. Warranty
coverage terminates if you sell or otherwise transfer the Product.
How to obtain warranty service?
If you purchased the Product at a Best Buy retail store location or from a Best
Buy online website (www.bestbuy.com or www.bestbuy.ca), please take your
original receipt and the Product to any Best Buy store. Make sure that you place
the Product in its original packaging or packaging that provides the same
amount of protection as the original packaging.
To obtain warranty service, in the United States and Canada call
1-877-467-4289. Call agents may diagnose and correct the issue over the
phone.
Where is the warranty valid?
This warranty is valid only in the United States and Canada at Best Buy branded
retail stores or websites to the original purchaser of the product in the county
where the original purchase was made.
NS-BPMW1
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38
What does the warranty not cover?
This warranty does not cover:
• Customer instruction/education
• Installation
• Set up adjustments
• Cosmetic damage
• Damage due to weather, lightning, and other acts of God, such as power
surges
•Accidental damage
•Misuse
• Abuse
• Negligence
• Commercial purposes/use, including but not limited to use in a place of
business or in communal areas of a multiple dwelling condominium or
apartment complex, or otherwise used in a place of other than a private
home.
• Modification of any part of the Product, including the antenna
• Display panel damaged by static (non-moving) images applied for lengthy
periods (burn-in).
• Damage due to incorrect operation or maintenance
• Connection to an incorrect voltage or power supply
• Attempted repair by any person not authorized by Insignia to service the
Product
• Products sold “as is” or “with all faults”
• Consumables, including but not limited to batteries (i.e. AA, AAA, C etc.)
• Products where the factory applied serial number has been altered or
removed
• Loss or Theft of this product or any part of the product
• Display panels containing up to three (3) pixel failures (dots that are dark
or incorrectly illuminated) grouped in an area smaller than one tenth
(1/10) of the display size or up to five (5) pixel failures throughout the
display. (Pixel based displays may contain a limited number of pixels that
may not function normally.)
• Failures or Damage caused by any contact including but not limited to
liquids, gels or pastes.
REPAIR REPLACEMENT AS PROVIDED UNDER THIS WARRANTY IS YOUR
EXCLUSIVE REMEDY FOR BREACH OF WARRANTY. INSIGNIA SHALL NOT BE
LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR THE BREACH
OF ANY EXPRESS OR IMPLIED WARRANTY ON THIS PRODUCT, INCLUDING, BUT
NOT LIMITED TO, LOST DATA, LOSS OF USE OF YOUR PRODUCT, LOST BUSINESS
OR LOST PROFITS. INSIGNIA PRODUCTS MAKES NO OTHER EXPRESS
WARRANTIES WITH RESPECT TO THE PRODUCT, ALL EXPRESS AND IMPLIED
WARRANTIES FOR THE PRODUCT, INCLUDING BUT NOT LIMITED TO ANY
IMPLIED WARRANTIES OF AND CONDITIONS OF MERCHANTABILITY AND
39
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Blood Pressure Monitor
FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE
WARRANTY PERIOD SET FORTH ABOVE AND NO WARRANTIES, WHETHER
EXPRESS OR IMPLIED, WILL APPLY AFTER THE WARRANTY PERIOD. SOME
STATES, PROVINCES AND JURISDICTIONS DO NOT ALLOW LIMITATIONS ON
HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY
NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND
YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE OR
PROVINCE TO PROVINCE.
Contact Insignia:
1-877-467-4289
www.insigniaproducts.com
INSIGNIA is a trademark of Best Buy and its affiliated companies.
*Distributed by Best Buy Purchasing, LLC
7601 Penn Ave South, Richfield, MN 55423 U.S.A.
©2020 Best Buy. All rights reserved.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No. 105, Dongli Road, Torch Development District,
Ahongshan, 528437, Guangdong, China
www.insigniaproducts.com
1-877-467-4289 (U.S. and Canada) or 01-800-926-3000 (Mexico)
INSIGNIA is a trademark of Best Buy and its affiliated companies.
Distributed by Best Buy Purchasing, LLC
7601 Penn Ave South, Richfield, MN 55423 U.S.A.
©2020 Best Buy. All rights reserved.
V1 ENGLISH
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