Smart Lab easy nG User manual

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ENGLISH
User Manual
HMM Diagnostics GmbH
Friedrichstraße 89
D-69221 Dossenheim, Germany
www.hmm.info
Wrist Blood Pressure Monitor for Self-Control
Please read this manual thoroughly before
rstusingthisdevice

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Content
I. Introduction 57
Normalbloodpressureuctuation 57
Caution 59
Safety Information 62
Set Content 63
II. Your smartLAB®easy 64
Display & functions 64
Specications 66
Note 67
III. Setup & Operating procedures 69
Installing and Replacing the batteries 69
Setting Date, Time and Measuring Unit 71
Applying the cuff 75

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Body posture during measurement 76
Measuring process 77
Recall records 79
Delete records 80
Maintenance 82
IV. Miscellaneous 83
Knowledge on Blood Pressure 83
Troubleshooting 89
Complied European Standard List 92
EMC Guidance 93
Safety Notice 101
Warranty 103

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I. Introduction
Thank you for using the smartLAB®easy nG wrist-cuff blood pressure monitor.
With this device you can easily control your blood-pressure values and pulse
rate and store the measured data. Please read this manual thoroughly, before
rstusingyoursmartLAB®easy nG wrist-cuff blood pressure monitor.
Normal blood pressure uctuation
All physical activity, excitement, stress, eating, drinking, smoking and many
other activities or factors (including taking a blood pressure measurement) will
inuencebloodpressurevalue.Becauseofthis,itismostlyunusualtoobtain
identical multiple blood pressure readings.
Bloodpressureuctuatescontinually—dayandnight.Thehighestvalueusu-
ally appears in the daytime and lowest one usually at midnight. Typically, the
value begins to increase at around 3:00 AM, and reaches to highest level in the
daytime while most people are awake and active.

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Considering the above information, it is recommended that you measure your
blood pressure at approximately the same time each day.
Please always relax a minimum of 3 to 5 minutes between measurements to
allow the blood circulation in your arm to recover. It is rare that you obtain
identical blood pressure readings each time.

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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 wrist 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 treatement
based solely on this device. Please contact physician for treatement ad-
vice
• 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
• This unit is not suitable for continuous monitoring during medical emer-
gencies or operations
• If the cuff pressure exceeds 40kPa (300mmHg), the unit will automati-
callydeate.Shouldthecuffnotdeatewhenpressuresexceeds40kPa

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(300mmHg), detach the cuff from the wrist 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 the use
in the presence of ammable anesthetic mixture with air or oxygen or
nitrous oxide
• The operator shall not touch the battery and the patient simultaneously
• The user must check if the equipment functions safely and check if it is in
proper working condition before being used
• The max. temperature for the applied parts can be achieved is 42.5°C
under the enviromental temperature of 40°C
• Manufacturer will provide circuit diagrams, component part list, etc when
requested
• This unit is not suitable for continuous monitoring during medical emer-
genciesoroperations.Afterthecuffinatedlongtime,thepatient’swrist
andngerswillbeinsufcient,anaesthesia,destandingpainandecchy-
mosis

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• Please use the device under the environment which is provided in the
user manual. Otherwise, the performance and lifetime of the device will
be impacted and reduced
• During the 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
alergic reaction or contact injury
• When the device was used to measure patients who have common arrhyth-
mias such as arterial or ventricular premature beats or arterial liberation,
the test result may cause deviation. Please consult your physician about
the result
• Please use accessories and detachable parts specied/ authorised by
manufacturer. Otherwise, it may cause damage to the unit or danger to
the user/patient
• This device is contraindicated for any female subject who may be suspect-
ed of, or is pregnant. Besides provided inaccurate readings, the affects of
this device on the fetus are unknown

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Safety information
The below signs might be in the user manual, labeling or other component.
They are the required for standard and using
Caution: Consult accompanying
documents
Type BF applied part
Symbol for „COMPLIES WITH MDD
93/42/EEC REQUIREMENTS“
DISPOSAL: Do not dispose this
product unsorted municipal waste.
Collect such waste separately for
special treatment is necessary
Symbol for „MANUFACTURER“ Direct current
Symbol for „MANUFACTURE DATE“ Symbol for „Authorised Representati-
ve in the European Community“
Symbol for „SERIAL NUMBER“
EC REP

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Set Contents
1 smartLAB®easy nG Blood Pressure Monitor
1 User Manual
1 smartLAB® Blood Pressure Passport
2 „AAA“ batteries

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II. Your smartLAB®easy
Display & functions
Norm.
Hype.
G3
G2
G1
Opt.
Time/Date
Memory
Pul/min
SYMBOL DESCRIPTION EXPLANATION
Systolic
blood pressure
High pressure result
Diastolic
blood pressure
Low pressure result
BPM Pulse/minute; heartbeats/minute
Memory For instructions, refer to Page
Movement error
symbol
Shocking will result in inaccurate values
Low battery Batteries are low and need to be
replaced 79
kPa Measurement unit of the blood pressure
(1kPa=7.5mmHg)
mmHg Measurement unit for blood pressure

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MEMORY
LCD Display
GRADE
TIME
MEM BUTTON
SYSTOLIC
SET BUTTON
DIASTOLIC
START/STOP BUTTON
PULSE RATE
SYMBOL DESCRIPTION EXPLANATION
Deating CUFFairisexhaustingordeating
Current time Year/Month/Day, Hour/Minute
Grade The grade of the blood pressure
Arrhyhmia Irregular heartbeat
Heartbeat Heartbeat detection during the measu-
erement

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CUFF
(Type BF applied part)
BATTERY
COMPARTEMENT
Specications
1. Device: smartLAB®easy nG
2. Size: 68 mm x 75 mm x 31 mm
3. Weight: 120g (without batteries)
4. Measuring mode: Oscillographic testing mode
5. Display Mode: Digital LCD V.A46x33.5mm
6.DeviceClassication:InternallyPoweredME
Equipment
7. Memory volume: 60 values
8. Batteries: 2xAAA Alkaline Batteries
9. Measurement range: Rated cuff pressure: O kpa
- 40 kpa (0mmHg - 300mmHg). Measurement pres-
sure: 4kPa-34kPa (40mmHg - 230mmHg)
10. Measuring accuracy: ± 3 mmHg
11. Heart / Pulse range: 40-199 times/min
12. Pulse accuracy: within ± 5%
13. Environmental temperature for usage:
5°C-40°C
14. Environmental humidity: <80%
15. Storage temperature: -20°C~60°C
16. Environmental storage humidity: 10%-93%
17. Environmental pressure: atmosphere
pressure (50-106kPa)

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Note:
1. Stay quite, calm and rest for 5 minutes before blood pressure measure-
ment.
2. The cuff should be placed at the same level as your heart.
3. During measurement, neither speak nor move your body and arm.
4. Please measure on same wrist for each measurement.
5. For a meaningful comparison, try to measure under similar conditions. For
example, take dialy measurements at approximately the same time, on the
same wrist, or as directed by physician
6. Please always relax minimum 3 to 5 minutes between measurements to
allow the blood circulation in your arm to recover.
7. Remove the batteries if the monitor will not be used for a month or more
to avoid damage of battery leakage.
8. This blood pressure monitor is designed for adults and should never be
used on infants or young children. Consult your physician or other health
care professionals before use on older children.
9. Blood pressure measurements determined by this monitor are equivalent

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to those obtained by a trained observer using the cuff/stethoscope aus-
cultation method, within the limits prescribed by the American National
Standard, Electronic or automated sphygmomano-meters.
10. Please avoid strong magnetism interference, such as mobile telephone,
microwave oven, etc.
11. Patients with arrhytmia are not supposed to use this device.
12. Up to half an hour before every measurement you should not smoke, eat
or do intensive physical exercise.
13. Please stay seated during measurement.
14. Please wear your smartLAB®easy nG on the left wrist.

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III. Setup & Operating procedures
Installing and Replacing the batteries
• Slide off the battery cover
• Install the batteries by matching the correct polarity, as shown below.
Always use the correct battery type (2x AAA alkaline batteries)
• Replace the cover
Replace the batteries when:
- The shows
- The display dims
- The display does not light up

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Remove batteries if the device is not likely to be used for some
time
 Donotdisposethebatteriesinre.Batteriesmayexplodeorleak.
The monitor, the batteries and the cuff, must be disposed
according to local regulations at the end of their usage.

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Setting Date, time and measurement unit
It is important to set the clock before using your wrist blood pressure monitor,
so that a time stamp can be assigned to each record that is stored in the me-
mory. You need to reset the device after a battery exchange.
1.When the monitor is OFF, press
the SET button to enter the
clock mode, then press and hold the
“SET” button for 3 seconds to
enter year setting
2.Press the “MEM” to
change the [YEAR]

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3.When you get the right year,
press“SET”toconrmandturn
to next step
4.Repeat the 2 and 3 to set the
[MONTH] and [DAY]