Beijing M and B Electronic Instruments MB-MSA100 Part 15 Class B Computing Device Peripheral User Manual

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MSA100 Peak Flow Meter
Instruction Manual
Version: V 1.9
PLEASE READ ALL OF THE INFORMATION IN THE PACKAGE INSERT BEFORE USING THE PEAK FLOW METER.
IF YOU DO NOT UNDERSTAND THE INSTRUCTIONS, CONSULT M&B, CALL (+86) 10 61253803 (Working Time:
from Monday to Friday, 8:30 ~ 17:30), OR WRITE TO market@mbelec.com.
Beijing M&B Electronic Instruments Co., Ltd.
May 2016
MSA100 Peak Flow Meter Instruction Manual V1.9
Date
Measurements
PEF
Recommendation
Signature of the
physician
FEV1
MSA100 Peak Flow Meter Instruction Manual V1.9
About this manual
Firstly, thank you very much for using our M&B product.
To ensure correct use of MSA100 Peak Flow Meter (herein below mentioned as MSA100 or
Peak Flow Meter or the Meter), read the following points carefully and adhere to them. After
reading this manual, keep it in a safe place where it can be referred to anytime a question arises.
Model Number: MSA100
Product Name: Peak Flow Meter
Manufacturer: Beijing M&B Electronic Instruments Co., Ltd.
Address: Room 6319, Building 1, No.27, Yongwang Road, Daxing Bioengineering and Medicine
Industry Base, Zhongguancun Science Park, Daxing District, Beijing
Issued date: May 2016, Version: V1.9
Intellectual property
The intellectual property of MSA100 and its manual belong to Beijing M&B Electronic
Instruments Co., Ltd. (herein below mentioned as M&B). Copying, reproduction or translation of
all or any part of the contents of this manual without M&B’ s permission is strictly prohibited. All
rights reserved by M&B.
Statement
M&B has the final rights to interpretation for this manual.
M&B is responsible for the product’s safety, reliability and performance if below conditions
are satisfied:
 Assembly, extensions, modifications or repair are carried out by persons authorized by
M&B.
 The other related electrical equipment used together with the Meter conforms to CE
standards.
 MSA100 is used in accordance with the instructions manual.
Maintenance Service
Free service range:

Free services are offered in accordance with M&B warranty regulations.
Fee based service range:
II
MSA100 Peak Flow Meter Instruction Manual V1.9

Beyond M&B warranty regulations.

During the warranty period, warranty shall not extend to the following conditions:
1) It is damaged from improper use.
2) Battery voltage is beyond the scope of product specification.
3) Natural disasters.
4) Replaced accessories, consumables without M&B authorization.
5) Modification or repair by anyone except for Beijing M&B authorized person or company.
Contact us
Service telephone and product support:
Please contact M&B if you have any questions regarding product support.
+86‐10‐61253803 (Working Time: Monday ~ Friday，8:30 ~ 17:30);
Or contact the regional service partner or distributor.
Order consumables and repair parts
Please purchase repair parts (mouthpiece etc.) from the M&B service partner or distributor in
your country.
Other questions
Please contact us as below or visit our website：www.mbelec.com.
Headquarters
Company: Beijing M&B Electronic Instruments Co., Ltd.
Address: Room 6319, Building 1, No.27, Yongwang Road, Daxing Bioengineering and Medicine
Industry Base, Zhongguancun Science Park, Daxing District, Beijing
Information for The European Union representative:
European Union Representative Name: Shanghai International Holding Corp. GmbH (Europe).
European Union Representative Address: Eiffestrasse 80, 20537 Hamburg, Germany.
III
MSA100 Peak Flow Meter Instruction Manual V1.9
CAUTION: When the peak flow meter is used to watch lung conditions such as asthma, the user
should be under the care of a physician or other licensed health care professional. A licensed
health care professional’s advice is required to understand the meaning and importance of the
measures you get with your peak flow meter and to decide on an appropriate treatment plan.
The treatment plan given to you by your physician or other licensed health care professional will
tell you what action to take when there are changes in your peak flow number.
No matter what your peak flow measures are, if you have signs and symptoms such as chest
tightness, shortness of breath, coughing or wheezing you should follow your licensed health care
professional’s advice for contacting him or her.
Instructions for using the peak flow meter must be followed carefully in order to get correct
measure of airflow.
If you are unable to obtain a reading you should contact your physician immediately.
The peak flow meter should not be used by more than one person.
If you have any questions about your peak flow meter and its use, talk to your licensed health care
professional.
IV
MSA100 Peak Flow Meter Instruction Manual V1.9
Content
BRIEF INSTRUCTION..................................................................................................................................... ‐ 1 ‐
1.1
Function Description........................................................................................................................ ‐ 1 ‐
1.2
Intended Use .................................................................................................................................... ‐ 1 ‐
1.3
Indications for Use ........................................................................................................................... ‐ 2 ‐
1.4
Measuring Principle ......................................................................................................................... ‐ 2 ‐
1.5
Step ‐by ‐step Instructions ............................................................................................................... ‐ 2 ‐
1.6
Technical Specification..................................................................................................................... ‐ 3 ‐
1.7
Other Specification .......................................................................................................................... ‐ 3 ‐
1.8
Composition of Package .................................................................................................................. ‐ 3 ‐
1.9
Transportation and Storage Conditions .......................................................................................... ‐ 4 ‐
1.10 Operating Condition ........................................................................................................................ ‐ 4 ‐
1.11 Device Composition ......................................................................................................................... ‐ 4 ‐
SAFETY PRECAUTIONS ................................................................................................................................. ‐ 5 ‐
2.1
Safety Information ........................................................................................................................... ‐ 5 ‐
2.1.1
Terms and Symbols .............................................................................................................. ‐ 5 ‐
2.1.2
Environment......................................................................................................................... ‐ 5 ‐
2.1.3
Preparation .......................................................................................................................... ‐ 5 ‐
2.1.4
Other Notices ....................................................................................................................... ‐ 5 ‐
2.2
Transportation and Storage ............................................................................................................. ‐ 6 ‐
2.3
Interference Instruction................................................................................................................... ‐ 6 ‐
2.4
Classification .................................................................................................................................... ‐ 6 ‐
2.5
Safe Operation and Processing Conditions ..................................................................................... ‐ 6 ‐
2.6
Standards and Regulation Compliance ........................................................................................... ‐ 7 ‐
MAINTENANCE ............................................................................................................................................ ‐ 8 ‐
3.1
Battery Assemblage ......................................................................................................................... ‐ 8 ‐
3.2
Assemble Mouthpiece and Turbine into Main Unit. ...................................................................... ‐ 8 ‐
3.3
Cleaning............................................................................................................................................ ‐ 8 ‐
OPERATION ................................................................................................................................................ ‐ 10 ‐
4.1
LCD Screen Display Introduction ................................................................................................... ‐ 10 ‐
4.2
First Time Use ................................................................................................................................ ‐ 11 ‐
4.3
Time Setting ................................................................................................................................... ‐ 11 ‐
4.4
Power on/Power off ...................................................................................................................... ‐ 12 ‐
4.5
Measuring ...................................................................................................................................... ‐ 12 ‐
4.6
Important Information for Measuring and Monitoring of Peak Flow Values .............................. ‐ 14 ‐
4.7
Simple Assessment (Traffic Light Scheme) .................................................................................... ‐ 16 ‐
4.8
Records Playback ........................................................................................................................... ‐ 16 ‐
4.9
Delete records ................................................................................................................................ ‐ 17 ‐
4.10 Data Transmission .......................................................................................................................... ‐ 17 ‐
TROUBLESHOOTING .................................................................................................................................. ‐ 17 ‐
GUIDANCE AND MANUFACTURE’S DECLARATIONS ................................................................................. ‐ 19 ‐
TECHNICAL SPECIFICATION........................................................................................................................ ‐ 22 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
1 BRIEF INSTRUCTION
1.1 Function Description
MSA100 Peak Flow Meter is a hand‐held pulmonary function measuring medical device that
measures your maximum possible exhalation which is called peak expiratory flow (PEF) and forced
expiratory volume in 1 second (FEV1). The accuracy meets American Thoracic Society (ATS)
Standard 2005 Revision.
A peak flow meter is used to measure a person’s “peak expiratory flow”, which is a simple
measure of airflow that can tell you how well you are breathing. It tells you how well air is moving
through the airways in your lungs. Forced Expiratory Volume (FEV1) is a measure of the volume of
air expelled in 1 second. If you have a breathing condition such as asthma, C.O.P.D., or chronic
bronchitis, your physician (or other licensed health care professional) may recommend that you
use a peak flow meter to watch for changes in your airflow. Your physician (or licensed health care
professional) will give you a treatment plan that will tell you what actions to take when you have a
change in airflow. In addition, you should record your peak flow measures as recommended by
your physician (or other licensed health care professional). Reviewing peak flow measures can
help you and your physician (or licensed health care professional) checks closely on your asthma
or C.O.P.D. to provide the best treatment for you.
MSA100 is suitable for children through adults who are capable of following the instructions
for use. Because the Meter has an automatic memory three hundreds readings, you can take the
Meter with you the next time you visit your doctor for a review of many readings. The doctor
makes an appropriate treatment plan based on them, and helps patients to recuperate health.
MSA 100 Peak Flow Meter supports USB connection. When measurement records add up to
maximum volume, you can transfer the records to PC via USB. Then using software to help save
and track for long term.
The peak flow meter should not be used by more than one person.
1.2 Intended Use
MSA100 is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory
Volume) for patient use at home. The device is designed for pediatric to adult patients. When the
Meter is used to monitor lung conditions such as asthma or C.O.P.D., the user should be under the
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MSA100 Peak Flow Meter Instruction Manual V1.9
care of a licensed health care professional. A licensed health care professional’s advice is required
to understand the meaning and importance of measurements reported by the Meter and how to
decide on an appropriate treatment plan. This treatment plan will tell the patient what action to
take when there are changes in their peak flow measurements.
1.3 Indications for Use
This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced
Expiratory Volume in one second) for patient home use. The device is designed for pediatric to
adult patients. The device is intended for monitoring respiratory conditions such as asthma.
1.4 Measuring Principle
When air flow passes through turbine sensor, it makes the leaf of turbine rotate. Rotary
speed of the leaf is linear relationship with air flow rate. By the technology of photoelectric
conversion, turning of the leaf is converted to be pulse signal, which is processed by the main
controller after sampling. The PEF and FEV1 value are calculated by an algorithm formula and
displayed on the LCD.
1.5 Step ‐by ‐step Instructions
PLEASE READ ALL OF THE INFORMATION IN THE PACKAGE INSERT BEFORE USING THE PEAK FLOW METER.
IF YOU DO NOT UNDERSTAND THE INSTRUCTIONS, CONSULT M&B, CALL (+86) 10 61253803 (Working Time:
from Monday to Friday, 8:30 ~ 17:30), OR WRITE TO market@mbelec.com.
ASK YOUR PHXSICIAN OR OTHER LICENSED HEALTH CARE PROFESSIONAL TO WATCH YOU USE THE PEAK FlOW
METER. THIS WILL HELP ASSURE THAT YOU ARE USING IT CORRECTLY.
NO MATTER WHAT YOUR PEAK FLOW MEASURES ARE, IF YOU HAVE SIGNS AND SYMPTOMS SUCH AS CHEST
TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR WHEEZING YOU SHOULD FOLLOW YOUR LICENSED
HEALTH CARE PROFESSIONAL'S ADVICE FOR CONTACTING HIM OR HER.
IF YOU ARE UNABLE TO OBTAIN A READING YOU SHOULD CONTACT YOUR PHYSICIAN IMMEDIATELY.
a. Get the peak flow meter ready (take out of case, insert mouthpiece, position indicator;
directions will differ according to device)
b. Stand up
c. Take a deep breath in
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MSA100 Peak Flow Meter Instruction Manual V1.9
d. Place the meter in the mouth and close lips around the mouthpiece. Make sure your lips
form a tight seal around the mouthpiece. Do not put your tongue into the mouthpiece. Do
not bend your neck.
e. Blow out as hard and fast as you can.
f. Read the number next to the indicator. This is your peak flow measure. Write it down.
g. After you move the indicator back to zero, repeat the steps two more times to get two
more peak flow measures.
h. Choose the highest number of your three peak flow measures. Write the number in your
“Peak Plow Diary." Directions for the diary are written on the diary.
i.
How to store your peak flow meter (directions will differ according to device).
1.6 Technical Specification
1. Measuring method
Flow
：Turbine sensor
Volume
：Flow Integration
2. Measuring rang
Volume
：0.01L~9.99L
Flow
：50 L/min ~900L/min
3. Accuracy
Volume
：±3% or ±0.05L, whichever is greater
Flow
：±10% or ±20L/min, whichever is greater
4. Display
：Segment liquid crystal display
5. Memory
：300 measurements with data and time
1.7 Other Specification
Type B applied part.
Caution
Model：MSA100
Power source：AAA 1.5V×2 alkaline batteries
1.8 Composition of Package
No.
Name
Main equipment
Unit
Quantity
Note
piece
MSA100
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MSA100 Peak Flow Meter Instruction Manual V1.9
Turbine sensor
piece
Mouthpiece
piece
Instruction manual
piece
USB cable
piece
1.9 Transportation and Storage Conditions
1. Environment temperature of ‐10 deg C ~ +55 deg C;
2. Relative humidity of
≤93%;
3. Atmospheric pressure of 500hPa~1060hPa.
1.10
Operating Condition
1. Environment temperature of +10 Deg C~+40 Deg C;
2. Relative humidity of 25%~85%;
3. Atmospheric pressure of 860hPa~1060hPa.
1.11
Device Composition
MSA100 Peak Flow Meter is divided into parts below like Figure 1‐1.
1. Main equipment.
2. AAA 1.5×2 alkaline batteries.
3. Mouthpiece and turbine sensor.
Figure 1‐1 Make‐up of MSA100 Peak Flow Meter
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MSA100 Peak Flow Meter Instruction Manual V1.9
2 SAFETY PRECAUTIONS
2.1 Safety Information
2.1.1 Terms and Symbols
As the manufacturer of medical devices, the company strives to ensure the security, reliability
and performance of the instrument. For correct use of this instrument, read the following points
carefully and adhere to them. After reading this manual, keep it in a safe place where it can be
referred to anytime a question arises.
2.1.1.1 Terms and Definition
This manual is using the term of "ATTENTION", etc. from beginning to end, which aims to
indicate the danger and specified severity degree or level. Please be familiar with its definition and
importance.
ATTENTION: Denotes potential danger or unsafe treatment which may result in slight injury
or damage to the device or other property. The note provides application hints or
other useful information. Read the note carefully to ensure safe and correct use.
2.1.1.2 Explanation of Safety Symbols
Symbols
Explanation
Denotes a note or warning content;
Denotes a prohibited operation. The operation must never be performed;
Perform the operation accurately. The instruction must be strictly adhered to.
2.1.2 Environment
ATTENTION:
Ambient temperature exceeding the range of technical specification will
affect the Meter’s accuracy, which will cause the machine damaged or machine
life reduced.
2.1.3 Preparation
ATTENTION:
Before using the device, operator must verify whether work procedures and
conditions are appropriate for the use of this instrument.
2.1.4 Other Notices
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MSA100 Peak Flow Meter Instruction Manual V1.9
ATTENTION:
In order to avoid electric shock or detector failure, do not allow any liquid to
permeate into the device. If liquid has permeated into it, please contact your
local service partner or distributor of M&B to inspect the meter.
ATTENTION:
Do not use the detector near flammable anesthetic gases, steam or liquid.
ATTENTION:
For safe operation of the device, the user must follow this instruction
manual. However, these instructions do not supersede established medical
procedures concerning respiratory system examination.
ATTENTION:
Do not replace accessories, consumables without M&B authorization.
2.2 Transportation and Storage
ATTENTION:
Put the Meter into the specified storage case during transportation.
2.3 Interference Instruction
ATTENTION:
The MSA100 has functions that it does not affect normal operation of other
devices, or is not affected by other devices.
2.4 Classification
Type of protection against electric shock
Internal power device
Degree of protection against electric shock
Type B applied part
IP22, Protected against solid foreign
objects of 12,5 mm ∅ and greater and
Degree of protection against liquid penetration
Protection
against
vertically
falling
water drops when ENCLOSURE tilted up
to 15°
ATTENTION:
The classification of the electrical shock, fire disaster, machinery and other
special risks is done according to EN60601‐1.
2.5 Safe Operation and Processing Conditions
The sterilization or disinfection method
recommend by manufacturer
Electromagnetic interference
Not applicable
Avoid the using of wireless telephones or other strong
interference equipment near the Meter
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MSA100 Peak Flow Meter Instruction Manual V1.9
Work Mode
Interval
Electric surgical interference damage
No damage
M&B Electronic Instruments Co., Ltd does not accept liability or responsibility for incorrect
use or operation of the MSA100.
ATTENTION:
If in doubt, consult your Physician or Healthcare expert
ATTENTION:
No modification of this equipment is allowed.
ATTENTION:
Do not modify this equipment without authorization of the manufacturer.
ATTENTION:
If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of the equipment.
2.6 Standards and Regulation Compliance
EN 60601‐1‐2006: Medical Electrical Equipment‐General Requirements for Safety;
IEC60601‐1‐2‐2004: Medical Electrical Equipment‐Safety Requirements‐EMC;
ATS Standardizations of spirometry 2005 Revision.
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MSA100 Peak Flow Meter Instruction Manual V1.9
3 MAINTENANCE
3.1 Battery Assemblage
Show as figuire3‐1, slide the cover down, insert two AAA batteries in the shell following
symbol inside, and close the cover.
Figure3‐1 MSA1000 battery assemble
ATTENTION:
If do not use Meter for long time, please take out batteries from battery case
to avoid battery leakage.
ATTENTION:
Please select batteries with regular factory instead of fake and shoddy
batteries.
3.2 Assemble Mouthpiece and Turbine into Main Unit.
Insert mouthpiece to turbine sensor, then the assemblage of mouthpiece and turbine screw
clockwise into main unit. See the procedure at figure 3‐2.
Figure 3‐2 Assemble mouth piece and turbine
3.3 Cleaning
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MSA100 Peak Flow Meter Instruction Manual V1.9
ATTENTION:
Please clean mouthpiece when first time use, prevent from dust because of
transport or storage.
The Meter should be cleaned within 30 minutes after each use. Separate mouthpiece and
turbine from main body. Disconnect mouthpiece and turbine. Immerse the mouthpiece and
turbine in a prepared soap solution. Clean thoroughly by swirling. Thoroughly rinse the
mouthpiece with water (distilled water is recommended). Allow the device to air dry.
Figure3‐3 Disassemble turbine and mouthpiece
ATTENTION:
Don’t use high pressure water or running water to rinse turbine, which
maybe lead to damage turbine, and make accuracy deteriorative.
Don’t use boiling water to rinse turbine.
When dried, assemble mouthpiece and turbine, and insert it into main unit.
Use clean and damp cloth clean main body of MSA100, but never put main body into water.
Show as figure3‐4.
Figure3‐4 cleaning to main unit
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MSA100 Peak Flow Meter Instruction Manual V1.9
4 OPERATION
4.1 LCD Screen Display Introduction
Figure4‐1 LCD demonstration
Figure4‐1 shows all segment of LCD displaying, and the characters and symbols meaning is
described below.
: Four rows digit display, indicating individually date, time, measurement value, and record
number.
Day
: Indicate now or historical measurement record day.
Month : Indicate now or historical measurement record month.
: Indicate now or historical measurement record time.
: Indicate now or historical measurement record year.
AM
: Indicate now or historical measurement record time is before 12:00.
PM
: Indicate now or historical measurement record time is after 12:00.
PEF
: Indicate now or historical measurement PEF value.
FEV1
: Indicate now or historical measurement FEV1 value.
: Symbol of insufficient battery volume
L/min
: Unit of PEF value.
: Unit of FEV1 value.
MR
: Records number or ID.
: Indicator to traffic colour outside surface of main unit, the position of arrow means the
degree of PEF normal or declined.
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MSA100 Peak Flow Meter Instruction Manual V1.9
: Indicate USB cable has connected，and the records can be read.
4.2 First Time Use
Firstly assemble mouthpiece and turbine according section 3.2.
Secondly insert batteries according to section 3.1. Power on MSA100, the main unit enters
time setting state.
4.3 Time Setting
After new batteries have been inserted, the LCD display is shown as figure4‐2. While the year
“2012” is blinking, it indicates the year waiting for setting. System default setting is year: 2012,
month: 1, day: 1, time 12:00 am o’clock. Assume target year is 2013, setting methods are below.
Figure4‐2 Initial display after power on
Press left key or right key to change year. If press left key once, the year displaying decrease 1.
If press right key once, the year displaying increase 1. Set 2013, you should press right key once.
Then press power/confirm key once turn to next setting, shown as figure4‐3. Please note: if you
hold down the key more than 2 seconds, it speeds up.
ATTENTION:
If date and time is not set, you can’t use to measure. If date and time is not
set correctly, your records date maybe wrong later, which will make historical
record time incorrect.
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MSA100 Peak Flow Meter Instruction Manual V1.9
Figure4‐3 year setting
Now the year characters are not blinking, meaning the year has set over. Following the month
“1” begins blinking, you should set month. The setting way like month, day, hour and minute, is
the same as that of year. When all date and time is set over, the device enters into measure status.
4.4 Power on/Power off
With the meter off, press power/confirm key once; the meter will power on.
With the meter on, press power/confirm key until the buzzer begin beep, then release the
key, the meter will power off. Before the meter switches off, the highest vales of the current
measurement session and its related memory position “MR XXX” is displayed.
After power on, the system can keep active status within one minute, then it will power off
automatically. If press any key or measure once more, the system will prolong 1 minute to power
off.
4.5 Measuring
When the system power on, the last result is shown, and then the device indicates “READY”
for a measurement by two short beeps. Inhale completely and hold your breath for moment.
Cover the mouthpiece tightly with your lips. Blow into turbine as hard and as fast as you can.
Show as figure4‐4. A long beep confirms that the result is recorded. PEF is displayed for about 3
seconds followed by FEV1 and then the monitor is ready for a new measurement which is
indicated by two short beeps. Show as figure4‐5.
It is recommended to perform three or more measurements sequentially. The device shall
memory the best value as the test result.
After each measurement, at first the actual reading is shown in the display and then it
switches automatically to the highest reading of your current measurement session.
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MSA100 Peak Flow Meter Instruction Manual V1.9
Store the Meter in a clean and dust free place.
ATTENTION:
Ask your physician (or other licensed health care professional’s) to watch you
use this peak flow meter before you rely on any measurements. Read all
information in this instruction booklet before using.
Contact M&B at 800‐810‐0520, +86 010 61253747、+86 010 61253716‐8020、+86
010 61253716‐8001/8002 8AM‐5PM Monday – Friday with questions; or contact
with M&B service partner or distributor.
ATTENTION:
If you have signs and symptoms such as chest tightness, shortness of breath,
coughing or wheezing follow your physician’s (or other licensed health care
professional’s) advice for contacting them no matter what readings you obtain.
If you do not get a reading contacts your physician immediately.
ATTENTION:
Do not measure PEF and FEV1 under strong sunlight.
Figure4‐4 Peak expire measuring method
Figure4‐5 PEF and FEV1 measurement value display
Please note: MSA100 saves the highest PEF reading from switching the device on until
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MSA100 Peak Flow Meter Instruction Manual V1.9
switching the device off.
4.6 Important Information for Measuring and Monitoring of Peak Flow
Values
It is important to regularly monitor your peak flow values. Doctors generally recommend
taking one measurement in the morning and one in the evening, every day normally before
inhaling your prescribed drugs. Carry out additional measurement whenever you feel unwell or
perceive shortness of breath.
Please note that asthma attacks are indicated in advance by low peak flow values before you
feel it! Please contact your doctor in cases such as these. Also do so if you have signs and
symptoms such as chest tightness, shortness of breath coughing or wheezing.
Self‐measurement means control, not diagnosis or treatment. In any event, please be sure to
discuss your measured values with your doctor. Your doctor will also explain which values are
normal for you.
You should never alter the dosages of any medication without talking to your doctor.
Please note that the device stores up to 300 measured values with date and time. When the
memory is full, shown as figure4‐5, erase all records yourself, or visit your doctor in time, let
he/she to analyze your data.
Please confirm that date and time settings are always actual.
Do not measure PEF and FEV1 under outdoor strong sunlight.
The performance of the Meter can be affected by extremes of temperature and humidity.
Please refer to “technical specifications” for details.
* Table4‐1 Normal PEF values for Males (Caucasian‐American)
Age
(Years)
10
15
20
25
30
35
40
45
50
120
171
185
246
347
354
357
357
352
344
332
130
208
222
283
384
392
395
394
390
382
369
140
249
262
324
425
432
435
435
430
422
410
Height (cm)
150 160 170
292 339 388
306 352 402
367 414 463
468 515 564
475 522 571
479 525 575
478 525 574
474 520 570
465 512 561
453 500 549
‐ 14 ‐
180
441
454
516
616
624
627
626
622
614
601
190
496
510
571
672
679
682
682
677
669
657
200
554
568
629
730
738
741
740
736
727
715
MSA100 Peak Flow Meter Instruction Manual V1.9
55
60
65
70
75
80
85
90
316
296
272
244
212
176
137
93
353
333
309
281
249
214
174
131
394
373
349
322
290
254
215
171
437
417
393
365
333
298
258
215
483
463
439
411
380
344
304
261
533
513
489
461
429
393
354
310
585
565
541
513
482
446
406
363
641
621
597
569
537
501
462
418
699
679
655
627
595
560
520
477
* Table4‐2 Normal PEF value for Females (Caucasian‐American)
Age
(Years)
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
120
170
207
262
275
282
286
286
284
278
270
258
243
225
204
180
153
123
90
130
198
235
290
303
310
313
314
312
306
298
286
271
253
232
208
181
151
118
140
228
265
320
333
340
344
344
342
336
328
316
301
283
263
238
211
181
148
Height(cm)
150 160 170
261 295 332
297 332 369
353 387 424
365 400 437
372 407 444
376 411 448
377 411 448
374 409 446
369 403 440
360 395 432
349 383 420
334 368 405
316 351 387
295 330 366
271 305 342
244 278 315
213 248 285
180 215 252
180
371
408
463
476
483
487
487
485
479
471
459
444
427
406
381
354
324
291
190
413
449
505
517
524
528
529
526
521
512
501
486
468
447
423
396
365
332
200
456
493
548
561
568
572
572
570
564
556
544
529
511
490
466
439
409
376
*Spirometric Reference Values from a Sample of the General U.S. Population, John L. Hankinson, John R. Odencrantz, and Kathleen
B. Fedan, et. al., Division of Respiratory Disease Studies, National Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention, Morgantown, West Virginia, 1999. The Third National Health And Nutrition Examination Survey (NHANES
III).
Figure4‐5 Memory is full
‐ 15 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
4.7 Simple Assessment (Traffic Light Scheme)
Using green, yellow and red traffic light to express the degree of your illness is a straight way.
Green indicates illness is under control, don’t require higher medication dosage. Yellow indicates
you must caution, if your measured values frequently be located in this area, increase your
medication dosage as discussed with your physician. Red indicates it is dangerous. Act as discussed
with your physician or seek emergency medical treatment.
Simple assessment settings need to consult with your doctors (or other licensed health care
professional’s). The general setting method is below.
(1) Measure your personal best value using MSA100, which is the highest value you achieve
under optimum conditions (free of symptoms, feeling well). Or choose NHANES III or other
effective prediction to calculate a normal value, it is to be as a best value.
(2) Press and hold Power Key for a long time, while install the battery. Do not loosen Power
Key, until you can see predicted value of PEF blinked. It is traffic light scheme basic value or
prediction value.
(3) Then use Right Key or Left Key to increase or decrease value, enter your best value or
“normal PEF value” shown as Table4,
(4) Press Power Key once again, then display “
”, setting successes.
(5) The green area lower limit usually reaches up to 80% of the predicted value, the yellow
area lower limit usually reaches up to 50% of the predicted value, the percent is not allowed to
edit, and it is default in the Meter.
4.8 Records Playback
When the system enters into measuring status, press key left or right, you can watch
historical records. If you keep pressing the button you can move quickly through the records. At
the same time record number will refresh with increasing or decreasing number. The records
contain measured date, time, PEF value, FEV1 value and position in memory. Press power/confirm
key once or wait the current record display over, the system will enters into measuring state.
‐ 16 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
Figure4‐6 Records playback
4.9 Delete records
In measuring status press left and right key for five seconds long, and all records will be
deleted. The hint after deleted is shown as figure 4‐7.
Figure4‐7 All records has deleted
4.10
Data Transmission
MSA100 can transmit measured records to PC via USB. All records could be playback and
statistically analyzed. When MSA100 is connected with PC, MSA100 displays “
ATTENTION:
This function is optional, you may ask distributor for detail.
5 TROUBLESHOOTING
Message
Cause
Remedy
The PEF result is higher than 900L/min, or
FEV1 result is higher than 9.99L
‐ 17 ‐
this is a very good result
”.
MSA100 Peak Flow Meter Instruction Manual V1.9
NO display
screen
Measuring
error
on
Means records address exceeds limit, or
record date and time is error, or software
is failure
Restart system
Records do not exist
no records
Memory is full
It is better to delete records,
or new record is not stored
battery insufficient
It is better to change new
batteries
Battery is low, or battery pole is reversed.
Change new batteries, and
note pole direction
value
Inspect whether the leaf of
turbine is run freely. And the
leaf is dirty. Or consult
whether the value is normal
with your doctor
Other question please contact with M&B service partner or distributor.
‐ 18 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
6 GUIDANCE AND MANUFACTURE’S DECLARATIONS
Electromagnetic Emissions
The MSA100 peak flow meter is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should ensure that it is used in such an environment.
Emissions test
Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Electromagnetic environment – guidance
The MSA100 peak flow meter detector 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.
The MSA100 peak flow meter detector is suitable for use in all
establishments, other than domestic establishments and
power supply is internal.
Electromagnetic Immunity
The MSA100 peak flow meter detector is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should ensure that it is used in such an environment.
Electromagnetic
environment–guidance
Immunity test
IEC 60601 test level
Compliance level
Electrostatic
discharge (ESD)
±2 kV contact
±4 kV contact
±6 kV contact
±8 kV contact
±2 kV air
±4kV air
±8 kV air
±15 kV air
±2 kV contact
±4 kV contact
±6 kV contact
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
10 A/m
10A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3V/m
80 MHz to 2.5 GHz
3 V/m
IEC 61000‐4‐2
Power frequency
(50/60 Hz)
magnetic field
IEC 61000‐4‐8
Radiated RF IEC
61000‐4‐3
d  2.3  P
800 MHz
to 2,5 GHz
where P is the maximum
output power rating of the
transmitter in watts (W) and
d is the recommended
separation distance in
meters (m)b.
‐ 19 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
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:
a Field strengths from fixed 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 fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which MSA100 peak flow meter detector is used exceeds the applicable RF
compliance level above, MSA100 peak flow meter detector should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating MSA100 peak flow meter detector.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
EMC Declaration
With many electronic devices such as microwave, TV, wireless router, PC’s, and mobiles, medical
devices in use may be susceptible to electromagnetic interference from these devices. This may
result in incorrect operation of the medical device and create a potentially unsafe situation.
Medical devices should be kept distance 1m from those electronic devices.
In order to regulate the requirements for EMC with the aim to prevent unsafe product situations,
the EN60601‐1‐2 standard has been implemented.
This standard defines the levels of immunity to electromagnetic interferences as well as maximum
levels of electromagnetic emissions for medical devices.
Medical devices manufactured by M&B conform to this EN60601‐1‐2 standard for both immunity
and emissions.
The medical devices should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use is unavoidable, the medical device should be seen to operate normally as it should
in this situation.
FCC Declaration
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
‐ 20 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
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:
– 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.
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.
‐ 21 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
7 TECHNICAL SPECIFICATION
MSA100 Peak Flow Meter is a hand hold pulmonary function measuring medical device that
measures your maximum possible exhalation which is called peak expiratory flow (PEF) and forced
expiratory volume in 1 second (FEV1). The parameters are displayed on the LCD screen. MSA100
also can record measurements up to 300 pieces, and supports USB connection. When
measurement records add up to maximum or other patient would use, you can transfer the
records to PC via USB, then a software help to save and track for long time.
General
Sensor type
Turbine
Measurement parameters
FEV1/PEF
Memory size
300
BTPS
PEF and FEV1 results displayed at BTPS conditions
Accuracy
Meet ATS 2005 Revision accuracy requirement
Volume range
0.01L~9.99L
Air flow range
50 L/min ~900L/min
Volume accuracy
±0.050L or ±3%
Air flow accuracy
±10% or ±20L/min
Resolution
Volume resolution
0.01L
Air flow resolution
1L/min
Resistance to flow
Back pressure @ 660L/min
< 0.11 KPa/sec
Back pressure @ 900L/min
< 0.15 KPa/sec
Repeatability
PEF
±5% or ±10L/min
FEV1
±3% or ±0.05L
Display screen
Size
1.8 inches
Type
LCD
Control
Standard
power/confirm key, left/right key
Environment specification
Power source
AAA1.5×2 batteries
Design
Interval, ordinary device
Battery work time
Maximum one year
Connection
Where fitted, USB for PC connection. Require a USB ‘A’ to ‘USB’ mini ‘B’
Operation
Temperature
Humidity
10oC～40oC
25%~85%
‐ 22 ‐
MSA100 Peak Flow Meter Instruction Manual V1.9
Atmosphere
860hPa～1060hPa
Storage
Temperature
Humidity
Atmosphere
‐10oC～55oC
15%~93%
500hPa～1060hPa
Zoning
Green/Yellow threshold
80% of reference
Green/Yellow threshold
50% of reference
Physical specification
Height
12.6 centimeter
Wide
5.4 centimeter
Thickness
2.8 centimeter
Weight
120g（contain batteries
and mouthpiece）
Maintenance warranty
Standard
One year
Option
Provide other options.
The detail please contact with M&B and distributors.
‐ 23 ‐

---

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