Microlife BP3MX1 3C User Manual

BT
Accurate home blood pressure
BT
measurements with the WatchBP Home A BT.
Instruction Manual
EN
3
Federal Communications Commission (FCC) Statement changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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.
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, may 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:
This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the
specific operating instructions for satisfying RF exposure compliance.)
– Reorient or relocate the receiving antenna. – Increase the separation between the equipment and receiver. – Connect the equipment into 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.
Microlife WatchBP Home A is the world’s rst digital blood pressure measurement device that strictly follows European Society of Hypertension (ESH)
1, 2
and American Heart Association (AHA) recommendations for home blood pressure measurement. Using the
WatchBP Home A device helps you collect accurate home blood pressure measurements your doctor can trust. This WatchBP Home A
device has been clinically validated according to the ESH protocol 3.
# WatchBP Home A BT is the same WatchBP Home A with Bluetooth (BT) capability.
Indications For Use
The WatchBP Home A BT is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate. The device detects the appearance of atrial brillation during measurement and gives a warning signal with the reading once the atrial brillation is detected. The device has Bluetooth
capability. The memory data can be transferred to the Bluetooth enable phone by connecting wirelessly.
1
O’Brien E, Asmar R, Beilin L, Imai Y
measurement. European Society of Hypertension Working Group on Blood Pressure Monitoring. J Hypertens 2003;21:821-848.
2
Stergiou GS, et al. A tool for reliable self-home blood pressure monitoring designed according to the European Society of Hypertension
recommendations: The Microlife WatchBP Home monitor. Blood press Monit. 2007;12:127-131.
3
Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according
to The International Protocol. Blood Press Monit. 2007;12(3):185-188.
b
, et al. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure
BT
Table of Contents
Before using WatchBP Home A BT for the rst time
Product description .....................................................4–5
Activating the device ...................................................... 6
Selecting the correct cuff ................................................ 7
Taking measurements using WatchBP Home A BT
«DIAG.» Mode ..............................................................8–9
«USUAL» Mode .............................................................11
Eight steps for measure blood pressure properly
Blood pressure measurement procedures ............. 12–13
Special Function
Atrial Fibrillation Detection ..........................................16
About Atrial Fibrillation ................................................ 17
Atrial Fibrillation Detector ............................................ 18
Atrial brillation detection instructions ....................... 19
Information for the doctor ............................................ 19
Viewing, deleting, and transferring measurements
Viewing measurements ......................................... 20–21
Deleting measurements ......................................... 22–23
Transferring measurement ..................................... 24–27
Appendix
Batteries and power adaptor ................................. 28–29
Safety, care, accuracy test and disposal ................. 30–31
Error messages ....................................................... 32–33
Important facts ....................................................... 34–35
Technical specications................................................. 36
3
EN
4
SYS
mmHg
mmHg
/min
USUAL
DIAG.
NOCTURNAL
DIA
PUL
Bluetooth
BT
Serial Port
Cuff Socket
Mode Switch
Power Socket
Display
ON/OFF Button
Bluetooth symbol
M Button (Memory)
Battery Compartment
BT
Mode Indication
Doctor Symbol
Atrial Fibrillation Detection
Outside Measurement Time
Relax
Battery Display
Delete Memory Data
Stored Value
Morning Data
Evening Data
Date/Time
Systolic Value
Diastolic Value
Pulse Indicator
Pulse Rate
Number of Stored Data
5
EN
Before using WatchBP Home A BT for the rst time
SYS
mmHg
mmHg
/min
USUAL
DIAG.
NOCTURNAL
DIA
PUL
Bluetooth
Activating the Device
Pull out the protective strip from the battery compartment.
1) Set the year – Upon removing the protective strip or
installing new batteries, the Year number ashes in the display. Use the M Button to select the Year. Press the ON/OFF Button to conrm your selection.
6
Press M Button to make selection Press ON/OFF Button to confirm
2) Set the month – Press the M Button to set the Month.
Press the ON/OFF Button to conrm.
3) Set the day – Press the M Button to set the Day.
Press the ON/OFF Button to conrm.
BT
4) Set the time – Once you have set the Hour and
Minutes and pressed the ON/OFF Button, the date and time are set, and the current time is displayed.
5) If you want to change the date and time, take out one battery from the battery compartment briey and put it back. The Year number will ash. Complete the process as described above.
Selecting the correct cuff
The WatchBP Home A BT device is available with different cuff sizes. If the cuff provided with the device is an unsuitable size , please consult your doctor.
please use only Microlife cuffs!
*
M (Medium size)
22 - 32 cm (8.7 - 12.6 inches)
M is the correct size for most people.
L (Large size)
32 - 42 cm (12.6 - 16.5 inches)
7
EN
USUAL
Taking measurements using WatchBP Home A BT
Prior to each measurement, use the Mode Switch on the right side of the device to select the proper measurement mode. The two options include:
«DIAG.» (Diagnostic) or «USUAL» (Usual) mode.
DIAG.
8
USUAL
«DIAG.» Mode
The «DIAG.» mode should be selected as requested by your doctor when blood pressure is measured in accordance with the measurement guidelines of the European Society of Hypertension (ESH).
DIAG.
BT
No measurements on non-work days
In «DIAG.» mode, blood pressure measurements are taken on 7 consecutive working days (or normal week days). No readings should be taken on «non-working» days (or particularly relaxing days) in this mode!
Two sets of measurements per day
ESH guidelines recommend one double measurement taken in the morning between 06:00 - 09:00 and one in the evening between 18:00 - 21:00. Always perform
measurements before taking your medication, unless otherwise directed by your doctor.
Jan
JAN
30
7
working days
X1
06:00 - 09:00
X1
18:00 - 21:00
ESH Guidelines
9
EN
Taking measurements using WatchBP Home A BT (cont.)
Extended measurement period
WatchBP Home A BT has an extended measurement period and allows morning measurements between 04:00 - 12:00 and evening measurements between 18:00 - 24:00.
X1
04:00 - 12:00
X1
18:00 - 24:00
Extended Time
Outside these times, measurements cannot be taken and the symbol on the right will be displayed on the screen.
10
Evaluation
After measurements have been carried out for a total of 7 working days, take the device to your doctor for evaluation of your home blood pressure data.
When measurements have been carried out for the full 7 days, the doctor symbol will ash on the screen.
BT
USUAL
«USUAL» Mode
The «USUAL» mode is selected for regular blood pressure measurement with Ab detection. In «USUAL» mode, three consecutive measurements are taken automatically at 15 second intervals. The results are averaged and displayed. The averaged readings are automatically stored for later evaluation by your doctor.
Anytime
1 2
15 sec.
USUAL
3
15 sec.
250 measurements safely stored
The WatchBP Home A BT device can store up to 250 averaged measurement readings in «USUAL» mode.
250
Measurements
When memory is full, each new reading will automatically
*
overwrite the earliest measurement.
To review the last three individual measurements, press
*
and hold the M button until a “1” is displayed on the screen. The values of the last three individual measurements are displayed sequentially.
11
EN
Eight steps for measure blood pressure properly
Step 1
Avoid taking measurements directly after eating, drinking or smoking. Allow at least one hour between these activities and measurement of your blood pressure.
1 Hour Before
12
Step 2
Prepare a chair and table for the measurement. The chair should have a vertical back-rest and the table should allow your upper arm to rest at the same height as your heart.
BT
Step 3
Remove all clothing covering or constricting the arm to be measured. Apply the cuff. Make sure the lower edge of the cuff is exactly 2–3cm from the inner fold of your arm. The tube connecting the cuff to the device should be placed on the inside of the arm. (Additional visual instruction can be found on the cuff)
Step 4
Sit down and relax for at least ve minutes prior to the measurement.
13
EN
SYS
mmHg
mmHg
/min
USUAL
DIAG.
NOCTURNAL
DIA
PUL
Bluetooth
Eight steps for measure blood pressure properly (cont.)
Step 5
Sit upright and lean comfortably against the chair’s backrest. Press the start button. The device will initiate a 60-second countdown in «DIAG.» mode or a 15-second countdown in «USUAL» mode. During the measurement do not move, cross your legs, or tense your arm muscles. Breath normally and do not talk.
14
Step 6 (in «DIAG.» mode)
One measurement cycle includes two measurements. Once the rst measurement is complete, continue to relax as you wait for the second measurement. The second measurement will start after 60-seconds. During this time avoid any movement.
1 2
60 sec.
BT
Step 7 (in «DIAG.» mode)
Once the two readings are complete, measurement data is automatically stored for future reference by your doctor. If an error displays after the readings, please repeat the rst six steps once again.
Automatically stored
Step 8 (in «DIAG.» mode)
When seven days of measurements have been collected, the Doctor Symbol will ash on the display. Do not forget to take your WatchBP Home A BT device with you on your next visit to the doctor. (Note: the doctor symbol is only displayed for measurements in «DIAG.» Mode.)
15
EN
Special Function
Atrial brillation detection
This device is designed to screen for atrial brillation during blood pressure measurements both in «USUAL» Mode and «DIAG.» Mode. If atrial brillation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode, the Ab icon displayed. If the Ab icon is displayed after a blood pressure measurement follow the instructions on page
21.
Joseph Wiesel, et al. Detection of Atrial Fibrillation Using a
*
Modified Microlife Blood Pressure Monitor. American Journal of Hypertension 2009; 22, 8, 848–852.
16
is
IAD
Atrial fibrillation, a major cause of stroke can be detected by
*
this device. However, not all risk factors for stroke, including atrial flutter, may be detected by this device.
This device may not detect atrial fibrillation in people with
*
pacemakers or defibrillators. People with pacemakers or defibrillators should therefore not use this device to detect atrial fibrillation.
BT
About Atrial Fibrillation
Atrial brillation is a common heart rhythm problem and a common cause of major strokes. It affects more than 2 million people in North America. It is more common in old age and found in 10% of people over 80 years old. About 20% of all strokes are caused by atrial brillation. The elderly, or those with high blood pressure, diabetes or heart disease are more likely to get a stroke if they have atrial brillation.
Atrial brillation is a rhythm problem that can last from a few minutes, to days or weeks and even years. Atrial brillation can lead to the formation of blood clots in the upper chambers of the heart (the atria). These clots can break off and ow to the brain causing stroke. The use of blood thinners, such as warfarin , can lower the risk of stroke in patients with atrial brillation.
A doctor can conrm the presence of atrial brillation by using an EKG. Atrial brillation can sometimes come and go. So a doctor may not see its symptoms on regularly scheduled visits.
One sign of atrial brillation is palpitations. But, many people don’t feel anything. These people can still get a stroke and should be checked for atrial brillation regularly. Diagnosing atrial brillation earlier and followed by treatment can lower the chances of getting a stroke.
17
EN
Atrial Fibrillation Detector
The WatchBP home A can screen for atrial brillation during blood pressure measurement.
Some people may have atrial brillation occasionally that lasts longer than a day. In this situation the WatchBP Home A allows frequent screening on multiple days for optimal diagnosis of atrial brillation.
Sometimes the device might falsely detect atrial brillation which can have two causes:
1) The arm has moved during blood pressure measurement. For this reason it is of essential importance that the arm is kept still during the measurement.
2) Some arrhythmia (irregular heart beat) other than atrial brillation might be present. In such a case it is still recommended to pay a visit to the doctor.
18
For people with pacemakers or debrillators it is not recommended to use the WatchBP Home A for diagnosing atrial brillation.
Measurement
If atrial brillation is detected during all readings of the triple measurements in «USUAL» Mode or all four readings of one day in «DIAG.» Mode then atrial brillation is most likely present.
Since atrial brillation sometimes lasts for only a few minutes. It is recommended to perform another measurement session one hour later. If this also shows the presence of atrial brillation then a doctor should be seen. It is recommended to take the device when visiting the doctor.
BT
Atrial brillation detection instructions
• Use this device regularly, once per week, or once per month to screen for atrial brillation.
• If atrial brillation is detected during all readings of the triple measurements, another measurement session should be done approximately one hour later.
• If this last reading shows atrial brillation contact your doctor.
• Take this device with you when you see the doctor.
Information for the doctor
This device is designed to detect atrial brillation and false negative readings are very rare. Though it is programmed to specically detect atrial brillation, frequent premature beats, marked sinus arrhythmia or other rhythm abnormalities might cause false positive readings. If atrial brillation is detected by the device at home, we suggest another reading done in the doctor’s ofce. If the atrial brillation icon is not displayed then the previous abnormal readings may have been due to transient atrial brillation. If the atrial brillation icon is displayed then it is suggested to perform an EKG to determine the exact rhythm abnormality.
19
EN
Viewing, deleting and transffering measurements
Viewing measurements
1) Use the Mode switch to rst select the type of measurements you wish to view.
DIAG.
2) Then press the M Button.
20
USUAL
In «DIAG.» Mode
1) When the M Button is pressed, it briey displays the total number of measurements stored, e.g. N=20 and then switches to the average of all readings.
«A» is displayed when
*
the number shown is the average of all data.
«- -» will display when the
*
number of measurements is less than 12.
BT
2) Press the M Button again to display the average of all morning data. Press the M Button once again to show the average of all evening data.
3) Press the M Button repeatedly to review all the individual readings one by one.
4) The daily average is displayed after the individual readings of the day.
In «USUAL» Mode
1) When the M Button is pressed, the number of readings detected with Ab are displayed.
2) Press M Button again, the number of total readings stored, e.g. N=63, is displayed; followed immediately by the average of all measurements stored in memory.
3) All individual readings can be viewed by repeatedly pressing the M Button.
Individual Reading
21
EN
Viewing, deleting and transffering measurements (cont.)
USUAL
Deleting measurements
Data from «DIAG.» and «USUAL» can be deleted independent of each other.
DIAG.
22
USUAL
Only delete the stored measurements when you are sure
*
that you no longer need the data.
BT
1) Use the Mode switch to select the mode of measurements you want to delete.
3) Release the M Button and press it once more while the Delete symbol ashes. The deleting is conrmed by the beep sound.
DIAG.
Press the M Button and hold
2) it for 7 seconds until
USUAL
the Delete symbol flashes.
Press and hold for 7 seconds...
Only measurements in the selected mode will be deleted.
*
23
EN
Viewing, deleting and transferring measurements (cont.)
Installation of the software program
The latest WatchBP Analyzer Software is available from the Microlife website.
https://www.microlife.com/support/ softwareprofessional-products
Double click the download installer and simply follow the instructions provided in the installation window on the PC screen.
24
*
System Requirements for Software: 1GHz CPU. 512MB Memory, 4.5GB free hard disk space, Microsoft Windows 7 SP1 / 8 / 10
BT
Transferring data to the computer
1) Start the software program and connect the device to the computer using the cable supplied.
2) The date and time on the device automatically synchronize with the date and time on the PC when successfully connected with WatchBP Analyzer PC software.
3) Click <Download> button in the WatchBP Analyzer to transfer the measurement data on the device to a PC.
See instruction manual of the WatchBP Analyzer for details.
*
25
EN
Viewing, deleting and transferring measurements
Bluetooth connectivity
The measurement data in «DIAG.» and «USUAL» can be transferred to a Bluetooth enabled cell phone (android, windows, iphone). Make sure that the phone has Bluetooth turned on before transferring measurements. Before connecting with the phone, please check if Bluetooth pairing is necessary.
Press and hold the M button for around 5 seconds, the unique 6-digit device ID of the unit is displayed.
Connect the device and conrm pairing. The screen of the device will show the “bt” if successfully connected.
USUAL
DIAG.
NOCTURNAL
Bluetooth
SYS
mmHg
DIA
mmHg
PUL
/min
USUAL
DIAG.
NOCTURNAL
Bluetooth
SYS
mmHg
DIA
mmHg
PUL
/min
Bluetooth
26
BT
When you press the start button to take the measurement, the Bluetooth also turns on and displays the 6-digit device ID awaiting the connection.
The screen will show “FL” if the connection fails.
If the Bluetooth connection keeps failing, please reset
*
the Bluetooth Bonding by pressing and holding the Start/ Stop button of the device for 7 seconds and start the connection again.
USUAL
DIAG.
NOCTURNAL
Bluetooth
USUAL
DIAG.
SYS
mmHg
DIA
mmHg
PUL
/min
NOCTURNAL
Bluetooth
SYS
mmHg
DIA
mmHg
PUL
/min
27
EN
Batteries and power adaptor
Battery indicator
When the batteries have ¼ power supply left, the Battery Symbol will ash each time the device is switched on.
28
Replacing low batteries
When the batteries need to be replaced, the Battery Symbol will ash each time the device is switched on.
1) Open the battery compartment at the back of the device.
2) Replace the batteries – ensure correct polarity as shown by the symbols in the compartment.
Use 4 new, long-life 1.5V, size AA batteries.
*
Do not use batteries beyond their date of expiry.
*
Remove batteries, if the device will not be used for a
*
prolonged period.
BT
Using a power adaptor
The WatchBP Home A BT device can also be operated using a Microlife power adaptor (DC 6V, 600mA).
Only use Microlife branded power adaptors.
*
1) Plug the adaptor cable into the Power Plug in the WatchBP Home A BT device.
2) Plug the adaptor plug into the wall socket. When the power adaptor is connected, no battery power is consumed.
External power adaptor shall be fulfilled in compliance with the
*
requirements of IEC 60601-1:2005
.
29
EN
Safety, care, accuracy test and disposal
“Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use.”
Safety and protection
This device may be used only for the purpose described in this booklet. The device comprises of sensitive components and must be treated with caution. The manufacturer cannot be held liable for damage caused by incorrect application.
Caution: Federal law restrics this device to sale by or on the order of a physician.
• Strangulation due to cables and hoses, particularly due to excessive length. Inhalation or swallowing of small parts,if some parts are small enough to be swallowed.
• Only activate the pump when cuff is installed.
• Do not use the device if you think it is damaged or if anything appears unusual.
• Read the further safety instructions in the individual sections of the instruction manual.
• Do not connect the device to a computer until prompted to do so by the computer software.
30
Observe the storage and operating conditions described in the “Technical specications” section of this manual.
Keep dry
Protect the device from water and moisture
Protect the device from direct sunlight
Protect the device from extreme heat and cold
Do not use this device close to strong
electromagnetic elds such as mobile telephones
or radio installations.maintain a minimum distance of 3.3m from such devices when using this unit.
Never open device
Protect device from impact and drops
IP20: Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against water, please do not drop water on device for
avoid performance inuence.
BT
Device care
Clean the device with a soft, dry cloth.
Accuracy test
We recommend the WatchBP Home A BT device be tested for accuracy every 2 years or after mechanical impact (e.g. being dropped). Please contact Microlife to arrange for an accuracy test.
Cuff care
DO NOT wash the cuff. DO NOT iron the cuff cover.
Do not wash the cuff!
Do not iron the cuff!
31
EN
Error messages
If an error occurs during measurement, the measurement is interrupted and an error message «Er» is displayed.
Please consult microlife, if
this or any other problem occurs repeatedly.
If you think the results are
unusual, please read through the information in this instruction manual carefully.
32
Error Description Potential cause and
remedy
«Er 1» Signal too
weak
«Er 2» Error signal During the measurement,
The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.
error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.
BT
«Er 3» No pressure
in the cuff
«Er 5» Abnormal
result
An adequate pressure cannot be generated in the cuff. A leak may have occurred. Replace the batteries if necessary. Repeat the measurement.
The measuring signals are inaccurate and no result can therefore be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement.
«HI» Pulse or cuff
pressure too high
«LO» Pulse too
low
The pressure in the cuff is too high (over 300 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement.
The pulse is too low (less than 40 beats per minute). Repeat the measurement.
33
EN
Important facts about blood pressure and home measurements
diastolic (lower) value, are always measured.
The pulse rate is the number of times the heart beats
in a minute.
Permanent high blood pressure can damage your
health and therefore must be treated!
Always discuss your home blood pressure
measurement data with your doctor and tell him/her if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings.
There are many causes of excessively high blood
Blood pressure is the pressure of the blood owing in
the arteries generated by the pumping of the heart. Two data readings, the systolic (upper) value and the
34
pressure. Your doctor will explain them in more detail and offer treatment when appropriate.
Blood pressure is subject to wide uctuations as the
day progresses, and can be impacted by emotions, physical exertion and other conditions .
BT
Evaluating blood pressure data
The table on the right classies blood pressure data for adults in accordance to the guidelines of the European Society of Hypertension (ESH). (Data in mmHg)
The higher value is the one that determines the evaluation. Example: a readout value between 150/85
or 120/98 mmHg indicates «Grade 1 Hypertension».
Category Systolic Diastolic
Optimal < 120 < 80
Normal 120 - 129 80 - 84
High normal 130 - 139 85 - 89
Grade 1 Hypertension 140 - 159 90 - 99
Grade 2 Hypertension 160 - 179 100 - 109
Grade 3 Hypertension
lsolated Systolic
180 110
140 < 90
Hypertension
35
EN
Technical specications
Operating condition:
Storage condition. Weight: • 385 g (including batteries) Dimensions: • 150 x 100 x 50 mm Measuring
procedure: Method: • Phase I systolic, Phase V diastolic Measurement
range:
Cuff pressure display:
Voltage source: • 4 x 1.5 V Batteries; size AA
36
• 10 to 40 °C (50 to 104 °F)
• 15 - 90 % relative maximum humidity, Air pressure 700 to 1040 hPa.
• -20 to 50 °C (-4 to 131 °F)
• 15 - 90 % relative maximum humidity
• Oscillometric, corresponding to Korotkoff
• SYS: 60 to 255 mmHg
• DIA :40 to 200 mmHg
•Pulse:40 to 199 per minute
• Range: 0 - 299 mmHg
• Resolution: 1 mmHg
• Static accuracy: pressure within ± 3 mmHg
• Pulse accuracy: ± 5 % of the readout value
• Mains adapter DC 6V, 600 mA (optional)
Battery life: Approximately 250 measurements Reference to
standards:
Electromagnetic compatibility: Expected service life: Cuff service life: • Approximately
Microlife reserves the right to alter technical specications without prior written notice.
• Device corresponds to the requirements of the standard for noninvasive blood pressure monitor.
EN 1060-1; EN 1060-3 ; IEC 60601-1 IEC 60601-1-2; IEC 60601-1-11, ESH protocol
• Device fullls the stipulations of the standard IEC 60601-1-2.
5 years or 10,000 measurements
and cuff are not included.
2 years
Type BF applied part
(batteries
BT
Guarantee card
This device is covered by a ve-year guarantee from the date of purchase. This guarantee is valid only on presentation of the guarantee card completed by the owner conrming date of purchase or purchase receipt. Batteries, cuff and wearing parts are not covered by this guarantee.
Model: WatchBP Home A BT
ERP Model Number: BP3MX1-3C
Date:
Name:
Address:
Date:
Telephone:
Email:
Manufacturer’s Declaration of the Product
(Altogether 4 pages)
Guidance and manufacturer´s declaration – electromagnetic emission –
for all EQUIPMENT AND SYSTEMS
Row
1 Guidance and manufacturer´s declaration – electromagnetic emission
The model BP3MX1-3C(WatchBP Home A BT) is intended for us environment specified below. The customer or the user of the model BP3MX1-3C(WatchBP Home
2
A BT) should assure that it is used in such an environment.
3 Emissions test Compliance Electromagnetic environment – guidance
RF emissions
4
CISPR 11
RF emissions
5
CISPR 11
Harmonic
emissions
6
IEC 61000-3-2
Voltage fluctuations
/
flicker emissions
7
IEC 61000-3-3
Group 1
Class B
A
Complied
The Model BP3MX1-3C(WatchBP Home A BT) uses RF energy only for its emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Model BP3MX1-3C(WatchBP Home A BT) is
uitable for use in all establishments, including domestic
s establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
internal function. Therefore, its RF
e in the electromagnetic
Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity
The Model BP3MX1-3C(WatchBP Home A BT) are intended for use in the electromagnetic environment s BT) should assure that it is used in such an environment.
pecified below. The customer or the user of the Model BP3MX1-3C(WatchBP Home A
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient / burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage
variations
on power supply
input lines
IEC 61000-4-11
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the a. c. mains voltage prior to application of the test level.
IEC 60601
test level
± 6 kV contact
±8kVair
± 2 kV for power
supply lines
±1kVfor
input/output
lines
± 1 kV differential
mode
±2kVcommon
mode
<5%UT
(>95 % dip in UT )
for 0.5 cycle
40 % UT
(60%dipinUT)
for 5 cycles
70 % UT
(30%dipinUT)
for 25 cycles
<5%UT
(>95 % dip in UT )
for 5 sec
3A/m
Compliance level
± 6 kV contact
±8kVair
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 1 kV differential mode ± 2 kV common mode
<5%UT
(>95 % dip in UT )
for 0.5 cycle
40 % UT
(60 % dip in UT )
for 5 cycles
70 % UT
(30 % dip in UT )
for 25 cycles
<5%UT
(>95 % dip in UT )
for 5 sec
3A/m
Electromagnetic environment -
guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality s of a typical commercial or hospital environment. If the user of the models BP3MX1-3C(WatchBP Home A BT) product name requires continued operation during power mains interruptions, it is recommended that the models
BP3MX1-3C(WatchBP Home A
BT) be powered from an
uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
hould be that
Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The BP3MX1-3C(WatchBP Home A BT) is intended for use in the electromagnetic environment specified below. The c such an environment.
Immunity test IEC 60601 test
Conducted RF
IEC 61000-4-6
ustomer or the user of the BP3MX1-3C(WatchBP Home A BT) should assure that it is used in
level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF c
ommunications equipment should be used no closer to any part of the Models BP3MX1-3C(WatchBP Home A BT), including cables, than the recommended separation distance calculated
3Vrms
3V
from the equation applicable to the frequency of the transmitter.
150 kHz to 80
Recommended separation distance
MHz
Radiated RF
IEC 61000-4-3
3V/m
80 MHz to 2.5
GHz
3V/m
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 fixed 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:
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 affected by
absorption and reflection from structures, objects and people.
a
Field s
trengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones an d
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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model BP3MX1-3C(WatchBP Home A BT) are used exceeds the applicable RF compliance level above, the Model BP3MX1-3C(WatchBP Home A BT) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model BP3MX1-3C(WatchBP Home A BT).
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM -
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the model BP3MX1-3C(WatchBP Home A
BT)
The Model BP3MX1-3C(WatchBP Home A BT) is intended for use in an electromagnetic in which radiated RF disturbances are controlled. The customer or the user of the Model BP3MX1-3C(WatchBP Home A BT) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model BP3MX1-3C(WatchBP Home A BT) as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output of
transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23 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.
150 kHz to 80 MHz
5.3
d ]
[
P
V
1
80 MHz to 800 MHz
5.3
d ]
[
P
E
1
800 MHz to 2.5 GHz
environment
7
d ]
[
E
1
P
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 affected by
absorption and reflection from structures, objects and people.
Distributed by:
Microlife USA, Inc. 1617 Gulf To Bay Blvd., 2nd
Floor
Clearwater, FL 33755, USA Tel +1 727 442 5353 Fax +1 727 442 5377 Email: msa@microlifeusa.com www.watchbp.com
Made in China
“Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use.”
IB WatchBP Home A BT 3MX1-3C EN 4619
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