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Topcom WRIST 3301 Handleiding

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BPM ARM 3301
USER GUIDE / HANDLEIDING / MANUEL D’UTILISATEUR
GEBRAUCHSANWEISUNG / BRUKSANVISNING / BRUGERVEJLEDNING
ANVÄNDARHANDBOK / KÄYTTÖOHJE
V 2.2
0197
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UK The features described in this manual are published with reservation to
modifications.
NL De in deze handleiding beschreven mogelijkheden worden gepubliceerd onder
voorbehoud van wijzigingen.
F Les possibilités décrites dans ce manuel sont publiées sous réserve de
modifications.
D Die in dieser Bedienungsanleitung umschriebenen Möglichkeiten, werden
vorbehaltlich Änderungen publiziert.
S Funktionerna i denna bruksanvisning publiceras med reservation för ändringar.
DK Vi forbeholder os retten til ændringer af de specifikationer, der er beskrevet i
denne brugsanvisning.
N Funksjoner beskrevet i denne manualen kan endres uten nærmere
informasjon.
SF Tässä ohjekirjassa julkaissut tiedot voivat muuttua ilman
ennakkoilmoitusta.
Authorized Representative in the European Community
Topcom Europe NV,
Grauwmeer 17
3001 Heverlee, Belgium,
Manufacturer
Health & Life Co., Ltd.
9F No.186, Jian Yi Road
Chung Ho City, Taipei, Taiwan
EC
REP
This Blood Pressure Monitor complies with the EC Directives and bears the
CE Mark "CE 0197".
This product is in compliance with the essential requirements and other
relevant provisions of the directive 93/42/EEC.
The declaration of conformity can be found on:
http://www.topcom.net/support/cedeclarations.php
The quality of the device has been verified and is in line with the provisions of
the EC council directive 93/42/EEC (EN IEC60601-1-General requirements
for safety, EN IEC 60601-1-2:2001 - Electromagnetic compatibility-
Requirements and tests) dated 14 June 1993 concerning medical devices
and the EN performance standards as follow:
• EN 1060-1 Non-invasive sphygmomanometers - General requirements
• EN 1060-3 Non-invasive sphygmomanometers - Supplementary
requirements for electromechanical blood pressure measuring systems.
• EN 1060-4 Non-invasive sphygmomanometers - Test procedures to
determine the overall system accuracy of automated non-invasive
sphygmomanometers.
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ENGLISH
TOPCOM BPM Arm 3301
1 Introduction
Congratulations with your purchase of the Topcom BPM Arm 3301. This fully automatic
blood pressure monitor is both easy to use and ideally suited for daily measurements.
The large display includes systolic, diastolic and pulse, all clearly shown at the
completion of each reading.
In addition, you can store up to 30 measurements per Memory Zone, ideal for users who
want to monitor and track their blood pressure on a regular basis. The BPM Arm 3301 is
compact and portable, making it ideal for home use and travel.
2 Safety instructions
1. This product is for household use only. It is not intended as a substitute for
consultation with your doctor.
2. For users diagnosed with common arrhythmia (atrial or ventricular premature beats
or atrial fibrillation), diabetes, poor circulation of blood, kidney problems, or for
users suffered from stroke, or for unconscious users, the device might not be
suitable for use. Consult your doctor in case of any doubt.
3. The unit should not be operated by children so to avoid hazardous situations.
4. The unit contains high-precision assemblies. Therefore, avoid extreme
temperatures, humidity, and direct sunlight. Avoid dropping or strongly shocking
the main unit, and protect it from dust.
5. Leaky batteries can damage the unit. Remove the batteries when the unit is not
used for a long time.
6. Do not press the START key when the cuff is not placed around the arm.
7. Do not disassemble the main unit or cuff.
8. If the unit is stored in a cold place, allow it to acclimate at room temperature before
use.
9. Clean the blood pressure monitor body and the cuff carefully with a slightly damp,
soft cloth. Do not press. Do not bend the pre-formed cuff inside out. Do not wash
the cuff or use chemical cleaner on it. Never use thinner, alcohol or petrol
(gasoline) as cleaner.
Please read this manual carefully before use. For specific
information on your own blood pressure, contact your
physician. Put the user guide away in a safe place for future
reference.
To avoid inaccurate results caused by electromagnetic
interference between electrical and electronic equipments,
do not use the device near a cell phone or microwave oven.
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TOPCOM BPM Arm 3301
3Helpful tips
Here are a few helpful tips to help you obtain more accurate readings:
• Do not measure your blood pressure immediately after consuming a large meal. To
obtain more accurate readings, please wait one hour before measuring.
• Do not smoke or drink alcohol before measuring your blood pressure.
• You should not be physically tired or exhausted while taking a measurement.
• It is important that you relax during measurement. Try to take 15-minutes rest
before a reading.
• Do not take measurements if you are under stress or under tension.
• Take your blood pressure at normal body temperature. If you are feeling cold or
hot, wait a while before taking a measurement.
• If the monitor is stored at very low temperature (near freezing), have it placed at a
warm location for at least one hour before using it.
• Wait about 5 minutes before taking the next pressure measurement.
4 Disposal of the device
At the end of the product lifecycle, you should not throw this product into
the normal household garbage but bring the product to a collection point
for the recycling of electrical and electronic equipments. The symbol on
the product, user guide and/or box indicate this.
Some of the product materials can be re-used if you bring them to a
recycling point. By re-using some parts or raw materials from used products you make
an important contribution to the protection of the environment. Please contact your local
authorities in case you need more information on the collection points in your area.
5 Blood pressure
5.1 What is Blood Pressure?
Blood pressure is the pressure exerted on the artery tube while blood flows through the
arteries. The pressure measured when the heart contracts and sends blood out of the
heart is systolic (highest). The pressure measured when
the heart dilates with blood flowing back into the heart is called diastolic (lowest) blood
pressure.
5.2 Why Measure Your Blood Pressure?
Among the various health problems afflicting modern people, problems associated with
high blood pressure are by far the most common. High blood pressure's dangerously
strong correlation with cardiovascular diseases
and high morbidity has made measuring blood pressures a necessity of identifying those
at risk.
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ENGLISH
TOPCOM BPM Arm 3301
5.3 Blood Pressure Standard
The World Health Organization (WHO) and National High Blood Pressure Education
Program has developed a Blood pressure standard, according to which areas of low and
high-risk blood pressure are identified. This standard however, is a general guideline as
individual's blood pressure varies among different people and different groups...etc.
It is important that you consult with your physician regularly. Your physician will tell you
your normal blood pressure range as well as the point at which you will be considered at
risk.
5.4 Blood Pressure Fluctuation
Blood pressure fluctuates all the time!
You should not be worried if you encountered two or three measurements at high levels.
Blood pressure changes over the month and even throughout the day depending on
circumstances (state of mind, temperature, ...)
Ex. Fluctuation within the day for a Male, 35 years old.
Systolic >= 160
Diastolic >= 100
Stage 2 Hypertension
Systolic
140 - 159
Diastolic
90 - 94
Stage 1 Hypertension
Systolic < 120
Diastolic < 80
Normal
Systolic (mmHg) ->
140
90
100
160
Diastolic (mmHg)
!
120
Prehypertension
Systolic 120 - 139
Diastolic 80 - 89
80
18u 24u12u6u
50
100
150
200
mmHg
Systolic
Diastolic
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TOPCOM BPM Arm 3301
6 Battery installation
• Open the battery compartment by pulling the cover away on the bottom of the unit.
• Insert 4 AA non - rechargeable batteries. Follow the polarity as indicated in the
battery compartment.
7 Buttons
1. LCD display
2. SET button
3. MEMORY button
4. MODE button
5. START / STOP button
6. Cuff
7. Air Jack
8. Air Plug
2
3
4
5
6
8
7
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ENGLISH
TOPCOM BPM Arm 3301
8 Display
9 Applying the cuff
1. Systolic pressure
2. Diastolic pressure
3. Pulse rate
4. Pulse symbol
5. Memory number
6. Error indication
7. Battery Low indicator
8. Blood pressure unit
9. Date
10. Time
1. Remove all watches, jewelry, etc. prior
to attaching the arm monitor. Clothing
sleeves should be rolled up.
2. Press your brachial artery by two
fingers approximately 2,5 cm above
the elbow on the inside of your left arm
to determine where your strongest
pulse is.
3. Slide the end of arm cuff furthest from
the tube through the metal ring to a
loop. The smooth cloth should be on
the inside of the cuff. The Velcro will
be on the outside of the cuff.
4. Put the left arm through the cuff loop.
The bottom of the cuff should be
approx. 1,5 cm above the elbow. The
cuff should lie over the brachialartery
on the inside of the arm.
5. Pull the cuff so that the top and bottom
edges are tightened around your arm.
mmHg
P
ERROR
9
10
1
2
3
4
6
7
8
5
1.5cm
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TOPCOM BPM Arm 3301
10 Measurement
10.1 Important
1. This monitor automatically switches off 1 minute after the last key operation.
2. To interrupt the measurement, simply press any key. The cuff will deflate
immediately after a key is pressed.
3. During the measurement, do not talk or move your arm or hand muscles.
4. After each measurement, the result will be automatically stored. The BPM ARM
3301 has 3 memory zones with each 30 location. Select the desired Memory Zone
before measurement (see §11)
10.2 Procedure
6. When the cuff is positioned properly,
press the Velcro firmly against the pile
side of the cuff. The metal ring will not
touch your skin.
7. Relax your entire body,especially the
area between your elbow and fingers.
Place your elbow on a table so that the
cuff is at the same level as your heart.
Avoid leaning back while the
measurementis being taken.
1. Press the SET button
repeatedly to select the desired
memory zone.
2. Press the START/STOP button
to start measurement. The cuff
will inflate to the level that is
right for you.
3. When the right level is reached,
the cuff will deflate.
mmHg
mmHg
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ENGLISH
TOPCOM BPM Arm 3301
11 Memory
4. When the measurement is
completed, systolic, diastolic
and pulse will be shown
simultaneously on the LCD
screen.
When a mistake was detected dur-
ing measurement the Error mark
appears on the display
The BPM 3301 has 3 Memory zones. Each can store
up to 30 measurements including the date and time.
The result will be stored automatically in the selected
Memory Zone after the measurement.
Select the desired Memory Zone before measurement,
by pressing the SET button repeatedly.
To recall measurement results:
• Press the SET button repeatedly to select the
desired memory zone.
• Press the MEMORY button to see the last
measurement result.
• Press the MEMORY button repeatedly for prior
values stored.
• To stop reading the data, press the START/STOP
button to switch back to normal time.
To erase all data from one memory zone:
• Press the SET button repeatedly to select the
desired memory zone.
• Press the MODE and SET button simultaneously
to erase all data from the selected memory zone.
mmHg
ERROR
mmHg
When the batteries are installed, the data in the memories
will not be lost even when the Blood Pressure Monitor is
switched off.
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TOPCOM BPM Arm 3301
12 Time adjustment
13 Technical specifications
*Specifications are subject to change without notice.
To adjust the date an time:
• Press the SET button to activate the display. The memory
zone will be displayed.
• Press the MODE button, the month will blink on the
display.
• Press the SET button succesively to change the month.
• Press the MODE button to confirm the month. The day
will blink on the display.
• Change the day, hours and minutes as described above,
using the SET button to change and the MODE button to
confirm every setting.
• After setting the minutes, the device is ready to use.
Model
Power source
Measurement zone
Accuracy
Pressure sensor
Inflation
Deflation
Memory capacity
Auto-shut-off
Operation environment
Storage environment
Weight
Cuff Arm circumference
Limited patient
Classification
BPM Arm 3301
6V DC: 4 x AA - Alkaline batteries
Pressure: 0~300 mmHg
Pulse: 40~199 beats/minute
Pressure: ±3 mmHg
Pulse: within ±5% of reading
Semi-conductor
Automatic - Pump driven
Automatic Pressure release valve
3 Memory zones for each 30 memories
1 minute after last key operation
+10°C~+40°C
<85% RH max.
-20°C~+70°C
<85% RH max.
265g (with batteries)
23~33 cm / 9~13 in
Over 18 years old
• Internally powered equipment
• Classification of type BF
•IPX0
• Not suitable for use in presence of flammable
anaesthetic mixture with air or with oxygen or
nitrous oxide
• Continuous operation with short-time loading
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ENGLISH
TOPCOM BPM Arm 3301
The CE symbol indicates that the unit complies with the essential
requirements of the directive 93/42/EEC.
14 Topcom Warranty
14.1 Warranty period
The Topcom units have a 24-month warranty period. The warranty period starts on the
day the new unit is purchased. Consumables or defects causing a negligible effect on
operation or value of the equipment are not covered.
The warranty has to be proven by presentation of the original purchase receipt, on which
the date of purchase and the unit-model are indicated.
14.2 Warranty handling
A faulty unit needs to be returned to a Topcom service centre including a valid purchase
note. If the unit develops a fault during the warranty period, Topcom or its officially
appointed service centre will repair any defects caused by material or manufacturing
faults free of charge.
Topcom will at its discretion fulfill its warranty obligations by either repairing or
exchanging the faulty units or parts of the faulty units. In case of replacement, colour and
model can be different from the original purchased unit.
The initial purchase date shall determine the start of the warranty period. The warranty
period is not extended if the unit is exchanged or repaired by Topcom or its appointed
service centres.
14.3 Warranty exclusions
Damage or defects caused by incorrect treatment or operation and damage resulting
from use of non-original parts or accessories not recommended by Topcom are not
covered by the warranty.
The warranty does not cover damage caused by outside factors, such as lightning, water
and fire, nor any damage caused during transportation.
No warranty can be claimed if the serial number on the units has been changed, removed
or rendered illegible.
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