Microlife 3MX1-1 Instruction Manual

EN
3
Accurate home blood pressure measurements with the WatchBP Home.
Instruction Manual
1, 2
and American Heart Association (AHA) recommendations for home blood pressure measurement. Using the WatchBP Home device helps you collect accurate home blood pressure measurement your doctor can trust. This WatchBP Home device has been clinically validated according to the ESH protocol 3.
1
O’Brien E, Asmar R, Beilin L, Imai Y, et al. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure
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.
EN
Before using WatchBP Home for the first time
Product description .....................................................3–4
Activating the device ...................................................... 5
Selecting the correct cuff ................................................ 6
Taking measurements using WatchBP Home
«DIAG.» Mode ..............................................................7–9
«USUAL» Mode ............................................................. 10
Eight steps for taking proper blood pressure measurements
Blood pressure measurement procedures ............. 11–14
Viewing, deleting, and transferring measurements
Viewing measurements ......................................... 15–16
Deleting measurements ......................................... 17–18
Transferring measurements ................................... 19–20
Appendix
Batteries and power adaptor ................................. 21–22
Safety, care, accuracy test and disposal ................. 23–24
Error messages ....................................................... 25–26
Important facts ....................................................... 27–28
Technical specifications ................................................ 29
Table of Contents
3
SYS
mmHg
DIA
mmHg
Pulse
/min
Cuff Socket
USB Port
Mode Switch
Power Socket
ON/OFF Button
Display
M Button (Memory)
Battery Compartment
4
EN
Mode Indication
Doctor Symbol
Relax
Outside Measurement Time
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
3) Set the day – Press the M Button to set the Day.
Press the ON/OFF Button to confirm.
2) Set the month – Use the M Button to set the Month.
Press the ON/OFF Button to confirm.
Press ON/OFF Button to confirm Press M Button to make selection
1) Set the year – Upon removing the protective strip or
installing new batteries, the Year number flashes in the display. Use the M Button to select the Year. Press the ON/OFF Button to confirm your selection.
Activating the Device
Pull out the protective strip from the battery compartment.
Before using WatchBP Home for the first time
SYS
mmHg
DIA
mmHg
Pulse
/min
EN6
Selecting the correct cuff
The WatchBP Home device is available with different
cuff sizes. If you believe the cuff size provided with your
device is incorrect, please consult your doctor.
*
please use only Microlife cuffs!
5) If you want to change the date and time, briefly take out and put back one battery from the battery compartment. The Year number will flash. Complete the process as described above.
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.
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
«DIAG.» Mode
The «DIAG.» mode should be selected when blood pressure is to be measured in accordance with measurement guidelines of the European Society of Hypertension (ESH), and as requested by your doctor.
Prior to each measurement, use the Mode Switch on the side of the device to select the proper measurement mode. The two options include: «DIAG.» (Diagnostic) or «USUAL» (Usual) mode.
DIAG. USUAL
Taking measurements using WatchBP Home
DIAG. USUAL
EN8
Two sets of measurements per day
ESH guidelines recommend to take two measurements in the morning between 06:00 - 09:00 and two measurements in the evening between 18:00 - 21:00.
Always take measurements before taking your medication, unless otherwise directed by your doctor.
No measurements on non-work days
In «DIAG.» mode, blood pressure measurements are taking 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!
30
JAN
7
working days
X1
06:00 – 09:00
X1
18:00 – 21:00
9
Evaluation
After measurements have been carried out for a total of 7 working days, bring the device to your doctor for evaluation of your home blood pressure.
Extended measurement period
WatchBP Home has an extended measurement period and allows morning measurements between 04:00 - 12:00 and evening measurements between 18:00 - 24:00.
Outside these times, measurements cannot be taken and the symbol on the left will be displayed on the screen.
When measurements have been carried out for the full 7 days, the doctor symbol will flash on the screen.
Taking measurements using WatchBP Home (cont.)
EN10
«USUAL» Mode
The «USUAL» mode should be selected when blood pressure is to be measured independent of recommended guidelines. In «USUAL» mode, single measurements can be taken at any time, and results are automatically stored for later evaluation by your doctor.
250 measurements safely stored
The WatchBP Home device can store up to 250 single measurements in «USUAL» mode.
*
When memory is full, each new measurement will
automatically overwrite the earliest measurement.
250
Measurements
Anytime
11
Eight steps for taking proper blood pressure
1 Hour Before
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.
Step 2
Prepare a chair and table for the measurement. The chair should have a vertical back-rest and the table should allow for your upper arm to rest at the same height as your heart.
EN12
Step 3
Remove all clothing covering or constricting the measurement arm. Apply the cuff. Make sure the lower edge of the cuff is 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 five minutes prior to the measurement.
13
Step 5
Sit upright and lean comfortably against the chair’s backrest. Press the start button. The device will initiate a 60-second countdown. During the measurement do not move, cross your legs, or tense your arm muscles. Breath normally and do not talk.
Step 6
One measurement cycle includes two measurements. Once the first 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 movement.
SYS
mmHg
DIA
mmHg
Pulse
/min
60 sec.
12
Eight steps for taking proper blood pressure (cont.)
EN14
Step 7
Once the two readings are complete, measurement data are automatically stored for future reference by your doctor. If an error displays after the readings, please repeat the first six steps once again.
Step 8
When seven days of measurements have been collected, the Doctor Symbol will flash on the display. Do not forget to bring your WatchBP Home device with you on your next doctor visit. (Note: the doctor symbol is only displayed for measurements in «DIAG.» Mode.)
Automatically stored
15
2) Then press the M Button.
In «DIAG.» Mode
1) When the M Button is pressed, it briefly displays the total number of measurements stored, e.g. N=20.
Viewing measurements
1) Use the Mode switch to first select the type of measurements you wish to view.
Viewing, deleting and transferring measurements
DIAG. USUAL
*
«- -» will display when the
number of measurements is less than 12.
*
«A» is displayed when
the number shown is the average of all data.
EN16
2) All individual readings can be viewed by repeatedly pressing the M Button.
In «USUAL» Mode
1) When the M Button is pressed, it briefly displays the total number of measurements stored, e.g. N=63, followed immediately by the average of all measurements stored in memory.
*
All individual readings can be viewed by repeatedly pressing
the M Button.
3) Pressing M Button once again shows the average of all evening data.
2) Pressing the M Button again displays the average of all morning data.
Individual Reading
17
*
Before deleting data, be sure to ask your doctor if the
measurement data are still required. Only delete the stored measurements when you are sure that you no longer need the data.
Deleting measurements
Data from «DIAG.» and «USUAL» can be deleted independent of each other.
Viewing, deleting and transferring measurements (cont.)
DIAG. USUAL
EN18
*
Only measurements in the selected mode will be deleted.
Measurement data in the other mode must be deleted independently.
3) Release the M Button and press it once more while the delete symbol flashes. Deletion is confirmed by the beep sound.
2) Press the M Button and hold it until the delete symbol flashes.
1) Use the Mode switch to first select the type of measurements you wish to delete.
DIAG. USUAL
Press and hold for 7 seconds...
*
Pressing the M Button to delete data will erase all measurement
data in the selected mode.
19
Transferring data to the computer
1) Start the software program and connect the device to the computer using the cable supplied.
2) A successful connection is displayed by «Connected» on the computer screen.
3) Enter name, identity number (if required), and date of birth to create a new record.
Transferring measurements
Installation of the software program
1) Put the CD in the CD-ROM drive of your computer.
Alternatively click on «
setup.exe» in the CD’s directory.
2) Follow the instructions provided in the installation window on the computer screen.
3) When installation is finished, be sure to restart the computer before you work with the program.
Viewing, deleting and transferring measurements (cont.)
*
System Requirements: 550MHz
CPU. 256MB Memory, 1024x768 pixel resolution, 256 color, CD­ROM drive, 1 free USB port, 40MB free hard disk space, Microsoft Windows 2000 / XP / Vista.
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System Requirements: 550MHz CPU. 256MB Memory, 1024x768 pixel resolution, 256 color, CD-ROM drive, 1 free USB port, 40MB free hard disk space, Microsoft Windows 2000 / XP / Vista.
Install CD
WatchBP Analyzer Home
Version 1.0.0.7
EN20
Software commands Transfer «DIAG.» mode data
Click «Download»
Corresponding value
You can remove the check mark and the corresponding value will not be used to calculate the average.
Store data
Click «Save», the file name is formed automatically from the patient’s identity number and the suffix «Dmode.xls».
View the data
Click «Patient Files»
Store the «USUAL» mode data
Click «Download Usual Mode Data», the file name is formed automatically from the patient’s identity number and the suffix «Umode.xls».
Print the data sheet
Click «Print»
Delete the memories
Click «Clear Memory»
Close the program
Click «Exit»
*
Stored your data before using «Clear Memory» or «Exit».
Refer to the software user manual for detailed information and instructions.
21
Replacing low batteries
When the batteries need to be replaced, the Battery Symbol will flash 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.
Battery indicator
When the batteries have ¼ power supply left, the Battery Symbol will flash each time the device is switched on.
Batteries and power adaptor
EN22
Using a power adaptor
The WatchBP Home 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 device.
2) Plug the adaptor plug into the wall socket. When the power adaptor is connected, no battery power is consumed.
SYS
mmHg
DIA
mmHg
Pulse
/min
23
Safety and protection
This device may be used only for the purpose described in this booklet. The device comprises of sensetive components and must be treated with caution. The manufacturer cannot be held liable for damage caused by incorrect application.
Protect the device from water and moisture
Protect the device from extreme heat and cold
Protect device from impact and drops
Protect the device from direct sunlight
Avoid proximity to electromagnetic fields, such as those produced by mobile phones
Never open device
Safety, care, accuracy test and disposal
Observe the storage and operating conditions described in the “Technical specifications” section of this manual.
• Ensurethatchildrendonotusethedeviceunsupervised;
some parts are small enough to be swallowed.
• Onlyactivatethepumpwhenthe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.
EN24
Do not wash the cuff!
Do not iron the cuff!
Accuracy test
We recommend the WatchBP Home device to 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.
Disposal
Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, and not as domestic waste.
Device care
Clean the device with a soft, dry cloth.
SYS
mmHg
DIA
mmHg
Pulse
/min
25
Error Description Potential cause and
remedy
«Er 1»
Signal too weak
The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement.
«Er 2 »
Error signal
During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still.
Error messages
If an error occurs during measurement, the measurement is interrupted and an error message «Er» is displayed.
Please consult your doctor,
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.
EN26
«HI»
Pulse or cuff pressure too high
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.
«LO»
Pulse too low
The pulse is too low (less than 40 beats per minute). Repeat the measurement.
«Er 3 »
No pressure in the cuff
An adequate pressure cannot be generated in the cuff. A leak may have occurred. Replace the batteries if necessary. Repeat the measurement.
«Er 5 »
Abnormal result
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.
27
There are many causes of excessively high blood
pressure readings. Your doctor will explain them in
more detail and offer treatment where appropriate.
Blood pressure is subject to wide fluctuations as the
day progresses, and can be impacted by emotions, physical exertion and other conditions .
Blood pressure is the pressure of the blood flowing in
the arteries generated by the pumping of the heart. Two data, the systolic (upper) value and the diastolic (lower) value, are always measured.
The pulse rate is the number of times the heart beats
in a minute.
Permanently high blood pressure data can damage
your health and must be treated by your doctor!
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.
Important facts about blood pressure and home measurements
EN28
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
180 110
lsolated Systolic Hypertension
140 < 90
Evaluating blood pressure data
The table at right classifies blood pressure data for adults in accordance to the guidelines of the European Society of Hypertension (ESH) in 2007. 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».
29
Operating temp.:
10 - 40 °C / 50 - 104 °F
Storage temp.
-20 - +50 °C / -4 - +122 °F
15 - 90 % relative maximum humidity
Weight:
385 g (including batteries)
Dimensions:
150 x 100 x 50 mm
Measuring procedure:
Oscillometric, corresponding to Korotkoff
Method:
Phase I systolic, Phase V diastolic
Measurement range:
30 - 280 mmHg – blood pressure
40 - 200 beats per minute – pulse
Cuff pressure display:
Range: 0 - 299 mmHg
Resolution: 1 mmHg
Static accuracy:
pressure within ± 3 mmHg
Pulse accuracy:
± 5 % of the readout value
Voltage source:
4 x 1.5 V Batteries; size AA
Mains adapter DC 6V, 600 mA (optional)
Reference to standards:
EU Directives 93/42/EEC
NIBP requirements: EN 1060-1/-3/-
4, ANSI / AAMI SP10, IEC 60601-1, IEC60601-1-2
System requirements:
550MHz CPU. 256MB Memory
1024x768 pixel resolution
256 color, CD-ROM drive
1 free USB port
40MB free hard disk space
•
Microsoft Windows 2000 / XP / Vista
Technical specifications
Microlife reserves the right to alter technical specfications without prior written notice.
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