Lloydspharmacy BM52 User manual

User Manual
BM52
Speaking
Blood Pressure
Monitor

Contents
Introduction
Important information
Parts
Information on the display
Setting up your blood pressure monitor
How to use your blood pressure monitor
Using your blood pressure monitor
Selecting memory
Performing the blood pressure measurement
Evaluating your Results
Saving, displaying and deleting measurements
Error message / trouble shooting
Technical specications
Electromagnetic compatibility information
1
2-5
6
7
8-10
11
12
13
14-15
16-17
18-19
20
21-22
23-26
Thank you for purchasing the LloydsPharmacy Speaking Blood Pressure Monitor.
Please read these instructions for use carefully and keep them for later use, be sure to make them accessible
to other users.
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults arterial blood
pressure. You can use it to measure your blood pressure quickly and easily, storing the results and displaying the
progression of readings together with the average reading.
• This symbol is displayed for anyone suffering from cardiac arrhythmia.
• The values determined are classified and graphically evaluated.
Introduction
1

Important information
Caution
Note
Note on important information
Follow instructions for use
This symbol indicates that the Blood Pressure
Monitor is a type BF device. The cuff is type BF
applied part.
Direct current
Disposal in accordance with EC Directive
WEEE (Waste Electrical and Electronic
Equipment).
Batch code
Date of manufacture
The name and address of the manufacturer
Storage
RH ≤85%
-20°C
50°C
Permissible transport and storage
temperature. Permissible transport and
storage humidity.
Operating
RH ≤85%
+10°C
+40°C
Permissible operating temperature and humidity
Keep dry
SN Serial number
0483
The CE labelling certifies that the product com-
plies with the essential requirements of Directive
93/42/EEC on medical products.
Model number
SN
SN
SN
Signs and symbols
The following symbols are used in these instructions
Advice on use
• In order to ensure comparable values, always measure your blood pressure at the same time of day.
• Before every measurement, relax for about five minutes.
• If you want to perform several measurements on the same person, wait five minutes between each measurement.
• Do not take a measurement within 30 minutes after eating, drinking, smoking or exercising.
• Repeat the measurement if you are unsure of the measured value.
• The measurements taken by you are for your information only – they are not a substitute for a medical examination.
Discuss the measurements with your doctor, and never base any medical decisions on them (e.g. medicines and
their administration).
• Do not use the blood pressure monitor on newborns or patients with pre-eclampsia. We recommend consulting a doctor
before using the blood pressure monitor during pregnancy.
• T his device is not intended for use by people (including children) with restricted physical sensory or mental
skills or lack of experience and/or lack of knowledge, unless they are supervised by a person who has re-
sponsibility for their safety or they receive instructions from this person on how to use the device. Supervise
children around the device to ensure they do not play with it.
•
Cardiovascular diseases may lead to incorrect measurements or have a detrimental effect on measurement accuracy.
The same also applies to very low blood pressure, diabetes, circulatory disorders and arrhythmias as well as chills
or shaking.
• The blood pressure monitor must not be used in connection with a high-frequency surgical unit.
• Only use the device on people who have the specified upper arm measurement for the device.
• Please note that when inflating, the functions of the limb in question may be impaired.
• During the blood pressure measurement, blood circulation must not be stopped for an unnecessarily long time. If the
device malfunctions, remove the cuff from the arm.
• Avoid any mechanical restriction, compression or bending of the cuff tube.
Important information
23

• Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may
cause injury.
• Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g.
intravascular access or therapy, or an arteriovenous (AV) shunt.
• Do not use the cuff on people who have undergone a mastectomy.
• Do not place the cuff over wounds as this may cause further injury.
• You can either use the blood pressure monitor with batteries or with a mains charger. Please note that data transfer
and data storage is only possible when your blood pressure monitor is supplied with power. As soon as the batteries are
empty or the mains disconnected from the power supply, the blood pressure monitor loses the date and time.
• To conserve the batteries, the monitor switches off automatically if no buttons are pressed for 3 minutes.
• The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for
damage resulting from improper or careless use.
Storage and Care
• The blood pressure monitor is made up of precision electronic components. Accuracy of readings and the instrument’s
service life depend on careful handling.
– You should protect the device from impact, moisture, dirt, major temperature fluctuations and direct exposure to the
sun’s rays. – Never drop the device. – Do not use near strong electromagnetic fields, i.e. keep it away from any
radiosystems and mobile phones. – Only ever use the cuffs provided with the monitor or original replacement cuffs
Important information
otherwise erroneous results will be recorded.
• If the instrument is not to be used for any length of time, we recommend removing the batteries.
Notes on handling batteries
•
I f your skin or eyes come into contact with battery fluid, flush out the affected areas with water and seek medical assistance.
•
C hoking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.
•
O bserve the plus (+) and minus (-) polarity signs.
•
I f a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
•
Protect the batteries from excessive heat.
•
Risk of explosion! Never throw batteries into a fire.
•
Do not charge or short-circuit batteries.
•
If the device is not to be used for a long period, take the batteries out of the battery compartment.
•
Use identical or equivalent battery types only .
•
Always replace all batteries at the same time.
•
Do not use rechargeable batteries.
•
Do not disassemble, split or crush the batteries.
General disposal
•
For environmental reasons, do not dispose of the device in the household waste at the end of its
useful life. Dispose of the unit at a suitable local collection or recycling point. Dispose of the device
in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any
questions, please contact the local authorities responsible for waste disposal.
Battery disposal
•
The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or
electronics retailers. You are legally required to dispose of the batteries.
•
The codes below are printed on batteries containing harmful substances:
•
PB = Battery contains lead,
•
Cd = Battery contains cadmium,
•
Hg = Battery contains mercury.
Important information
45

Parts
Cuff
Cuff tube
Cuff connector
Display
Function buttons
Start/Stop button
Scale for classifying the
measurements
Connection for cuff connector
(left-hand side)
Information on the Display
Inflate , release air
Systolic pressure
Diastolic pressure
Pulse value
Memory display: average value (AVG)
morning (AM), evening (PM)
Cardiac arrhythmia symbol
Time and date
Battery replacement symbol
Multi-user memory
Classification of measurements
Memory space number
67
Memory button

Insert the batteries
• Open the battery compartment lid.
• Insert four 1.5V AA (alkaline type LR6) batteries. Make sure that the batteries are
inserted with the correct polarity, according to the label. Do not use rechargeable
batteries. The message “The device is ready for use. You may start measuring.” is
displayed.
• Close the battery compartment lid again carefully.
• With inserted batteries, the unit permanently displays the time and date.
If the the low battery indicator and appear, no further measurements can be performed. The
device will announce: “Battery weak.” Please replace all batteries. Once the batteries have been removed
from the unit, the date, time and language must be set again.
4 x AA (LR6) 1,5 V
Setting up your Blood Pressure Monitor Setting up your Blood Pressure Monitor
Set date, time and language
This menu allows you to set the following functions, one after another.
Date Time Language Volume
It is essential to set the date and time. Otherwise, you will not be able to save your measured
values correctly with a date and time and access them again later.
The time is displayed in 24-hour format.
In addition, the device has 1 language setting.
If you press and hold the function buttons , you can set the values more quickly.
89

Setting up your Blood Pressure Monitor
Voice output
Date/Time
• Insert the batteries or press and hold the Memory button for 5 seconds.
The year flashes on the display.
The device is ready for use.
You may start measuring.
• Set the year with the function buttons and confirm with the Memory button .
• Set the month, day, hour and minutes and confirm each setting with the Memory button
.
Language
The language will flash on the display .
• You can select the following languages with the function buttons :
= English
= Language off
English
Confirm your selection with the Memory button .
= Language off means that there is no voice output and therefore no acoustic
playback.
Volume
Volume level Vo1 flashes on the display.
• You can set the volume of the selected language using the function buttons :
Vo3 = loud
Vo2 = medium
Vo1 = quiet
Confirm your selection with the Memory button .
How to use your Blood Pressure Monitor
If the measurement is performed on the right upper arm, the line should be located on the inside of your elbow.
Ensure that your arm is not pressing on the line.
Fit the cuff on your arm.
Blood circulation in the arm
should not be restricted by tight
clothing or other objects.
The cuff should be placed on the upper
arm so that the lower edge is about 2 to 3
cm from the bend of the elbow and above
the artery. The tube should be in line with
the centre of the palm.
Tighten the free end of the cuff,
but make sure that it is not too
tight around the arm and close
to the hook-and-loop fastener.
The cuff should be fastened
so that two fingers fit under
the cuff.
• Please ensure the unit is at room temperature before measuring.
Insert the cuff line into the
connection for the cuff connector.
Positioning the cuff
1.
3.
2.
4.
10 11

Using your Blood Pressure Monitor
If the values between the two arms are significantly different, please consult your pharmacist or doctor to determine which arm
should be used for the measurement.
Important: The unit may only be operated with the original cuff. The cuff is suitable for an arm circumference of 22 to 36 cm.
A larger cuff for upper-arm circumferences of 35 to 44 cm can be obtained from www.lloydspharmacy.com
Correct posture
• Rest for approx. 5 minutes before each measurement.
Otherwise there may be divergences.
• You can perform the measurements either sitting or lying down.
Always make sure that the cuff is on a level with your heart.
• To carry out a blood pressure measurement, make sure you are sitting comfortably with your arms and back leaning on
something. Do not cross your legs. Place your feet flat on the ground.
• In order not to distort the result, it is important to keep still during the measurement and do not talk.
Selecting memory
Selecting memory
Voice output when voice function
is active
User memory
• Switch on the device with the Start/stop button.
When the device is switched off, the time and date are permanently
displayed.
The device is ready for use.
You may start measuring.
• Select the desired user memory by pressing the function buttons .
User memory 1
User memory 2
You have 2 memories, each with 60 memory spaces to store the measure-
ments of 2 different people separately.
12 13

Performing the blood pressure measurement
Voice output when voice function is
active
Measurement
• As described before, attach the cuff and adopt the posture in which you want to perform the
measurement.
• Switch on the device with the Start/stop button.
• Adisplay check is performed, during which all display segments light up.
• Start the device with the Start/stop button. The memory space that will be used is dis-
played.
The device is ready for use.
You may start measuring.
• The cuff is inflated to 190 mmHg. The cuff’s air pressure is slowly released. If a tendency
for high blood pressure is already recognised, the cuff is reinflated and the cuff’s pressure is
increased again. As soon as a pulse is detected, the symbol flashes.
Measuring can be cancelled at any time by pressing the Start/stop button .
• Systolic pressure, diastolic pressure and pulse measurements are displayed. Systole ... mmHg
Diastole ... mmHg
Heart rate ... beats per minute
According to the WHO guidelines your
blood pressure is
– optimal
– normal
– high to normal
– shows slight hypertension
– shows medium hypertension
– shows strong hypertension
Measurement
Whilst the message is being displayed, the volume can be adjusted with the function buttons .
• appears if the measurement could not be performed properly. Observe the chapter on error messages/
trouble-shooting in these instructions for use and repeat the measurement.
• The measurement is automatically stored.
• The device switches off automatically after 1 minute.
Wait at least 5 minutes before performing another measurement!
Performing the blood pressure measurement
14 15

Evaluating results
Cardiac arrhythmia:
This unit can identify potential disruption of the heart rhythm when measuring and if necessary, indicates this after the
measurement with the symbol . If the voice function is activated, the device will announce: “A possible cardiac arrhythmia was
found.” This can be an indicator for arrhythmia. Arrhythmia is an illness in which the heart rhythm is abnormal because of flaws in
the bioelectrical system that regulates the heartbeat. The symptoms (skipped or premature heart beats, pulse being slow or too
fast) can be caused by factors such as heart disease, age, physical make-up, excess stimulants, stress or lack of sleep. Arrhythmia
can only be determined through an examination by your doctor. If the symbol is shown on the display after the measurement
has been taken, it should be repeated. Please ensure that you rest for 5 minutes beforehand and do not speak or move during the
measurement. If the symbol appears frequently, please consult your doctor. Self-diagnosis and treatment based on the
measurements can be dangerous. Always follow your GP’s instructions.
Evaluating results
16 17
WHO (World Health Organisation) Definitions and Classification of Blood Pressure Levels.
* If systolic and diastolic BP fall into different categories, the higher value should be taken for classification e.g, if your BP is
141/83 you should read the advice in the Hypertension category (not the normal category). Your BP should be re-assessed
professionally at least once every 5 years unless you have high BP in which case it should be re-assessed at least once a year -
speak to your LloydsPharmacy pharmacist or healthcare professional.
BLOOD PRESSURE
CLASSIFICATION
SYSTOLIC
MMHG
DIASTOLIC
MMHG
WHO
INDICATOR ADVICE ON RESULTS
Optimal ≤120 ≤80 GREEN
Practice a healthy lifestyle. Consult your
doctor only if suering symptoms of low BP
(e.g fainting).
Normal 120-129 80-84 GREEN Practice a healthy lifestyle
High
Normal 130-139 85-89 GREEN Practice a healthy lifestyle
Mild
Hypertension 140-159 90-99 YELLOW
Practice a healthy lifestyle.
Re-measure BP monthly over the next 3 weeks.
If high levels (≥140/90) persist (e.g. 2 high
readings on 2 separate occasions) consult your
LloydsPharmacy pharmacist or doctor.
Moderate
Hypertension 160-179 100-109 ORANGE
Practice a healthy lifestyle.
Re-measure BP monthly over the next 4 weeks.
If high levels (≥140/90) persist (e.g. 2 high
readings on 2 separate occasions) consult your
LloydsPharmacy pharmacist or doctor.
Severe
Hypertension ≥180 ≥110 RED We would recommend that you see your doctor urgently.
Savere Hypertension
Moderate Hypertension
Mild Hypertension
High-normal
Normal
Optimal
180
160
140
130
120
80 85 90 1001 10

Saving, displaying and deleting measurements
Whilst the message is being displayed, the volume can be adjusted with the function buttons .
Voice output when voice function
is active
User memory
The results of every successful measurement are stored together with
the date and time. If there are more than 60 measurements, the oldest
measurements are lost.
• Switch on the device with the Start/stop button. The device is ready for use.
You may start measuring.
• Select the desired user memory ( or ) by pressing the function
buttons .
User memory 1
User memory 2
Average values
• Press the Memory button . The average value of all saved measured
values in this user memory is displayed first .
• If you press the Memory button again, the average value of the
morning measurements for the last 7 days will be displayed (morning: 5
a.m. – 9 a.m., display ).
• If you press the Memory button again, the average value of the
evening measurements for the last 7 days will be displayed (evening: 6
p.m. – 8 p.m., display ).
Average count:
Systole ... mmHg
Diastole ... mmHg
Heart rate ... beats per minute
According to the WHO guidelines
your blood pressure is ...
Saving, displaying and deleting measurements
Individual measured values
• If you continue to press the Memory button , the most recent individ-
ual measured values are displayed in turn with the date and time.
Memory space ...
Systole ... mmHg
Diastole ... mmHg
Heart rate ... beats per minute
According to the WHO guidelines
your blood pressure is ...
Delete measured values
• The measured values in the corresponding user memory can be deleted
by switching on the device, selecting the desired user memory and
pressing the function buttons and simultaneously for 5 seconds. All the counts in the memory
have been erased.
• The device will go directly into standby mode (clock mode).
18 19

Error message/trouble shooting
In the event of errors, the error message _ appears on the display.
Error messages can occur when
1. it was not possible to record the pulse ( ),
2. you move or speak during the measurement ( ),
3. the cuff is fastened too tightly or loosely ( ),
4. errors occur during the measurement ( ),
5. the pump pressure is higher than 300 mmHg ( ),
6. the batteries are almost empty ( ).
In such cases, repeat the measurement. Ensure that you do not move or speak.
If necessary, reinsert or replace the batteries.
Cleaning and storing the unit
• Clean your blood pressure monitor carefully using a slightly damp cloth only.
• Do not use any cleaning agents or solvents.
• Under no circumstances should you hold the unit under water, as this can cause liquid to enter and damage the unit.
• If you store the unit, no heavy objects should be placed on top of it. Remove the batteries. The cuff line should not be
bent sharply.
Technical specifications
Model no. BM 52
Measurement method Oscillometric, non-invasive blood pressure measurement on the upper arm
Measurement range Cuff pressure 0– 300 mmHg, systolic 50-250 mmHg,
diastolic 30-200 mmHg, Pulse 30 –180 beats/minute
Display accuracy Systolic ± 3 mmHg, diastolic ± 3 mmHg, pulse ± 5% of the value shown
Measurement inaccuracy Max. permissible standard deviation according to clinical testing:
systolic 8 mmHg /diastolic 8 mmHg
Memory 2 x 60 memory spaces
Dimensions L 145 mm x W 96 x H 60 mm
Weight Approx. 264 g (without batteries)
Cuff size 22 to 36 cm
Permissible operating conditions +10 °C to +40 °C, ≤ 85 % relative air humidity (non-condensing)
Permissible storage conditions -20 °C to +50 °C, ≤ 85 % relative air humidity, 800 –1050 hPa ambient pressure
Power supply 4 x 1,5V AA batteries
Battery life For approx. 250 measurements, depending on the blood pressure level and/
or pump pressure
Accessories Instruction for use, 4 x 1.5V AA batteries, storage pouch
Classification Internal supply, IPX0, no AP or APG, continuous operation, type BF
applied part
20 21

Technical Information
Technical information is subject to change without notification to allow for updates.
• This unit is in line with European Standard EN 60601-1-2 and is subject to particular precautions with regard to electromagnetic
compatibility (EMC). Please note that portable and mobile HF communication systems may interfere with this unit. More details
can be requested from the stated Customer Service address or found at the end of the instructions for use.
• This device is in line with the EU Medical Devices Directive 93/42/EC, the „Medizinproduktegesetz“ (German Medical Devices Act)
and the standards EN1060-1 (non-invasive sphygmomanometers, Part 1: General requirements), EN1060-3 (non-invasive sphyg-
momanometers, Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and IEC80601-
2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements for the safety and essential performance of automated
non-invasive blood pressure monitors).
• The accuracy of this blood pressure monitor has been carefully checked and developed with regard to a long useful life. If using
the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions
for checking accuracy may be requested from the service address.
Electromagnetic Compatibility Information
Guidance and manufacture’s declaration – electromagnetic emissions – for all EQUIPMENT and SYSTEMS
The BM52 blood pressure monitor is intended for use in the electromagnetic environment specied below. The customer of the
user of the BM52 blood pressure monitor should assure that it is used in such and environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The BM52 blood pressure monitor 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.
RF emission CISPR 11 Class B
The BM52 blood pressure monitor is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The BM52 blood pressure monitor is intended for use in the electromagnetic environment specied below. The customer or the
user of the BM52 blood pressure monitor should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If oor
are covered with synthetic material, the relative humidity
should be at least 30%.
Power frequency (50Hz) magne-
tic eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should be at levels cha-
racteristic of a typical location in a typical commercial or
hospital environment.
22 23

Electromagnetic Compatibility Information
Guidance and manufacture’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The BM52 blood pressure monitor is intended for use in the electromagnetic environment specied below. The customer or the
user of the BM52 blood pressure monitor should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
rms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
rms
3 V/m
Portable and mobile RF communications equipment should be used no closer to
any part of the BM52 blood pressure monitor, including cables, than the recom-
mended separation distance calculated from the equation applicable to the fre-
quency of the transmitter.
Recommended separation distance:
d =
d = 80 MHz to 800 MHz
d = 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic
site survey,
a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
Electromagnetic Compatibility Information
Guidance and manufacture’s declaration – electromagnetic immunity
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection
from structures, objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the mea-
sured eld strength in the location in which the BM52 blood pressure monitor is used exceeds the applicable RF compliance level
above, the BM52 blood pressure monitor should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the BM52 blood pressure monitor.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
24 25

Electromagnetic Compatibility Information
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT
or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the BM52 blood
pressure monitor
The BM52 blood pressure monitor is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the BM52 blood pressure monitor can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BM52
blood pressure monitor as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz
d =
80 MHz to 800 MHz
d =
800 MHz to 2.5 GHz
d =
0.01 0.117 0.117 0.234
0.1 0.370 0.370 0.740
11.170 1.170 2.340
10 3.700 3.700 7. 40 0
100 11.7 11.7 23.4
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reection from structures, objects and people.
Beurer GmbH, Söflinger Str. 218, 89077 Ulm, Germany
w ww.beurer-medical.de www.beurer.com
751.583-0316 V7 - 160404
26