KaWe MASTERMED A1 User manual

Gebrauchsanweisung
User‘s Manual
Mode d’emploi
Istruzioni per l’uso
Instrucciones de uso
Manual de operação
Руководство по применению
MASTERMED
A1/A1+, A2/A2+, A3

www.kawemed.com 8
Dear Customer, thank you for choosing our innovative aneroid
blood pressure monitor. Our products are known for their
high quality and longevity.This KaWe product meets the
requirements of EС directive 93/42/EEC (standards for medical
products) and DIN EN ISO 81060-1:2012 standard“Non-
invasive sphygmomanometers - Part 1: Requirements and test
methods for non-automated measurement type”.
Please read these instructions thoroughly and
completely before use and follow the given care
instructions.
Use:
This device and its accessories are only to be used by
physicians and trained professionals for monitoring blood
pressure.
Purpose:
This device is intended for the non-invasive measurement of
systolic and diastolic blood pressure.
Unsuited use/contraindication of
the device:
Any use other than that described here shall be deemed
improper.The manufacturer shall not be liable for any resulting
damages.The user alone shall bear all risks.
Features/preparation:
This blood pressure measuring device is an aneroid measuring
device. During measurement, there is a build-up of pressure
that constricts an artery in the upper arm. As the pressure is
released, the upper blood pressure reading (systolic blood
pressure) is calculated and after a complete blood flow
through the artery, further pressure is released and thereby
the lower blood pressure reading (diastolic blood pressure)
User‘s Manual
Aneroid blood pressure measuring device (for doctors)
is calculated.
1. Familiarize yourself fully with this product before using it.
2. Do not take your blood pressure directly after bodily
exertion or in a state of excitement.
3. Relax for approx.15 min in order to avoid measurement
inaccuracies.
4. The measuring time shall not exceed two minutes.
Between two successive measurements, a break must be
taken for a minimum of two minutes.
5. In order to ensure correct measuring results, make sure
that the proper cuff size is used. Different cuff sizes
are available for different applications. Please consult
an authorized dealer.The single-tube cuff only fits
MASTERMED A1 and A1+.The dual-tube cuff is used with
MASTERMED A2, A2+ and A3.
Basic rules for patients when
measuring blood pressure:
- sit comfortably
- do not cross your legs
- lean back or find other support for your back and arms
- the middle of the cuff should be on the upper arm at the
heart level
- during blood pressure measurement, relax and do not talk
if possible
- rest for 5 minutes before the first use
Recommended for auscultation method:
- in adults, phaseV (K5)
- in children aged 3 to 12 years, phase IV (K4)
- in pregnant women, phaseV (K5), unless noises are heard
in the cuff when pressure reduces, in such case phase IV
(K4) of Korotkoff sounds is used.
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K5 is the point at which the sounds heard with a stethoscope are
no longer audible.
K4 is the point at which the sounds heard with a stethoscope
vary from clear tapping to muffled.
Measuring blood pressure:
Attaching the arm cuff (instructions given for right-
handed users):
1. After pushing back the shirt sleeve or otherwise freeing
the upper arm of clothing, open the cuff‘sVelcro strap and
pull the cuff up over the upper left arm.The tube should
be positioned so that to point downward.The lower edge
of the cuff should stay approx. 2-3 cm above the elbow.
2. The artery pointer on the cuff (KaWe logo must be visible
on the outside) must be placed on the inside of the
upper arm near the palpating artery. If this artery cannot
be seen, it can be found by feeling the pulse with the
fingertips.
3. For the doctor’s blood pressure measuring device, a
stethoscope is required in addition.The stethoscope chest
piece (membrane side) must be inserted under the cuff
and positioned over the artery.
4. Make sure that the cuff is always at the heart level.
5. Using theVelcro closure, fasten the cuff firmly but not
tightly (leaving about 1-2 cm of space).
6. Prepare the stethoscope for use (insert the ear pieces into
your ears).
Creating pressure:
1. Close the air-release valve on the hand pump by turning
the screw to the right. Do not over-tighten the screw.
2. Inflate the cuff quickly and rhythmically with the hand
pump and use the diaphragm on the stethoscope to listen
to the pulse.
3. During this process, watch the device gauge and hold the
left arm absolutely still.
4. If a pulse can no longer be heard with the stethoscope,
raise the pressure in the cuff once again with the hand
pump by 30 mmHg.
Releasing pressure:
1. Open the air release valve slowly, so that the drop in
pressure on the gauge is approx. 2-3 mmHg/s.
Note:The speed of the pressure release affects the exactness
of measurement results.The pressure must not be released too
quickly or the point at which the pulse restarts will be missed.
If the pressure is released too slowly, the arm will be left too
long without the supply of blood because the pressure cuts
off the blood flow.
Determining the systolic pressure:
1. While releasing the pressure, listen continuously for the
sound of the pulse in the artery with the stethoscope.
When the first pulse is heard, read the upper blood
pressure value (systolic pressure) and remember this value.
2. As the pressure is released even further, the pulses
will become quieter until they disappear completely.
Remember the last pressure value by which a pulse was
heard.This is the lower blood pressure value (diastolic
pressure).
Completing the measurement procedure:
1. Open the air release valve completely to let the air escape
completely from the cuff.
2. Remove the cuff from the arm and store the entire
instrument in its storage case.
Cleaning:
Gauge: To clean the device, use only a soft, dry cloth.
Reusable cuff: If necessary, wipe the cuff with a damp cloth.
Disinfection:
Gauge: For disinfection of the device by wiping (minimum
exposure time of at least 5 minutes) it is recommended to use
the disinfectant Mikrozid sensitive liquid (manufactured by
Schülke & Mayr).
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Reusable cuff: Wipe the cuff with a damp cloth and clean
with soap or disinfectant.The cuffs have been tested to
withstand the following recommended disinfectants: Buraton
liquid, Cidex®, Ethanol 70%, Isopropyl-acohol 70%, Mikrozid®
and Sporicidin®. After disinfection, the cuff cover should be
rinsed with water and left to air dry.
Single patient cuffs: The single patient cuff is to be used on
one and the same patient for the duration of their treatment.
The cuffs can be personalized. Do not clean or disinfect the
single patient cuffs! Dispose of the cuff properly after use!
Warnings:
1. When the cuff is not connected to the gauge, always use
a tube stopper to prevent accidental penetration of liquid.
The penetration of liquid into the tube may cause damage
to the gauge.
2. Periodically inspect and replace damaged or deteriorated
cuffs.
3. Use only the appropriate size cuffs.The arterial pointer
must be in the marked area, otherwise the measurement
readings may be incorrect.
4. Single-patient cuffs are not intended for use on more than
one patient.
5. Do not immerse the device in liquid to clean it.
6. Do not sterilize the device!
7. The blood pressure measuring device must be handled
carefully and must not be exposed to pressure, sharp
objects or any other mechanical stress.
8. The pointer on the gauge must point within the tolerance
range of the zero position when there is no pressure in the
cuff.
9. Always let all of the pressure out of the cuff before storing
the instrument.
10. Protect the surface of the stethoscope diaphragm from
damage.
11. Never inflate to more than 300 mmHg.
12. When replacing or repairing parts, please ensure that only
original KaWe replacement parts are used.
13. Make sure that the tube system is airtight.
14. It is recommended that the device be handed over to the
manufacturer or an authorized service center at least every
2 years for proper metrological control according to the
Medical Devices Operator Ordinance.
No changes to the device are allowed!
Technical specifications:
Measurement range: 0-300 mmHg
Measurement accuracy: ± 3 mmHg
Storage/operating conditions:
Gauge:
Storage conditions: - 30 °C to +70 °C
Operating conditions: + 10 °C to +40 °C
Relative humidity: 15% - 85%
Cuff:
Storage conditions: - 20 °C to +55 °C
Relative humidity: 15% - 90%
Operating conditions: + 10 °C to +40 °C
Sea level: from -70 m to +1700 m
Warranty:
If used properly and in accordance with the instructions
for use, the warranty period is two years from the date
of purchase. If used properly and in accordance with the
instructions for use, the product life is at least 10 years. If you
have any questions or need repairs, please contact your dealer.
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Accessories:
Accessories A1 / A1+:
Reusable single-tube cuff
04.85104.211 - infant
04.85104.221 - children
04.85104.231 - adult
04.85104.241 - large adult
Single patient single-tube cuff
04.85140.221 - children
04.85140.231 - adult
04.85140.241 - large adult
Accessories A2 / A2+:
Reusable dual-tube cuff
04.85204.211 - infant
04.85204.221 - children
04.85204.231 - adult
04.85204.241 - large adult
Accessories A3:
Reusable dual-tube cuff
04.86600.221 - children
04.86600.231 - adult
04.86600.241 - large adult
Arm circumference:
Infant: 13.8 - 21.5 cm
Children: 20.5 - 28.5 cm
Adult: 27.5 - 36.5 cm
Large adult: 36 - 46 cm
Contact:
Address or telephone number of your dealer.
Further information: www.kawemed.com
Disposal:
The product is to be disposed of in accordance with the local
requirements.
Symbol key:
REF Product reference number
LOT Lot code
SN Batch No
Date of manufacture
Please follow the instructions for use
Manufacturer
Compliance with relevant guidelines
Caution!
Latex free
Relative humidity
Temperature range limits
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