Power Supply, Disposal Instructions; Batteries, Mains Adapter; Disposal; Safety Information Concerning The Device - Hartmann Tensoval duo control Instructions For Use Manual

English
GB
Reference to standards: DIN EN IEC 60601-1; DIN EN IEC 60601-1-2
PAUL HARTMANN AG
89522 Heidenheim, Germany

14. Power supply, disposal instructions

14.1 Batteries, mains adapter

The four high-quality batteries included in the
■ ■
delivery guarantee at least 1400 measure-
ments. Use only high-quality batteries (see
specification in Chapter 13 "Technical data").
If you use less efficient batteries, we can no
longer guarantee 1400 measurements.
Never mix old and new batteries or batteries
■ ■
from different manufacturers.
Remove exhausted batteries immediately.
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If you do not intend to use the device for a
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longer period of time, you should remove the
batteries to prevent possible leakage.
If you use the device with the mains adapter,
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position the device in such a way that you can
disconnect the power supply at any time.

14.2 Disposal

In the interests of environmental protection,
■ ■
exhausted batteries may not be disposed of
in household waste. Please note the appli-
cable waste disposal regulations or use public
collecting bins.
This product is subject to European
■ ■
Directive 2012/19/EU on used electrical
and electronic equipment and is marked
accordingly. Never dispose of electronic equip-
ment together with your household waste.
Please obtain infor mation concerning the
local regulations on the proper disposal of
electrical and electronic products. Proper
disposal protects the environment and human
health.
15. Safety information concerning the
device
This blood pressure monitor is not waterproof!
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This blood pressure monitor consists of high-
■ ■
quality electronic precision components.
Protect the device from hard knocks or
vibrations and do not drop it to the floor.
Do not excessively bend or fold cuff and air
■ ■
tube.
Never open the device. The device must not
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be altered, dismantled or repaired by the user.
Repairs may only be carried out by authorised
professionals.
Never inflate the cuff when it is not properly
■ ■
applied to the upper arm.
Use the device only with the approved upper
■ ■
arm cuff. Otherwise the device can be
damaged externally or internally.
The cuff tube may only be removed from the
■ ■
device by pulling on the red connector. Never
pull on the tube itself!
Do not expose the device to extreme
■ ■
temperatures or to humidity, dust or direct
sunlight, as this may lead to malfunction.
Keep the packaging, batteries and device
■ ■
out of reach of children.
Please note the storage and operating
■ ■
conditions defined in Chapter 13 "Technical
data". Storage or use outside the specified
temperature and humidity ranges can have
an impact on the measuring accuracy and
functioning of the device.
Portable and mobile high-frequency and
communication devices, such as telephone and
mobile phone, can impair the functional
capability of electronic medical devices and
should therefore be kept at a distance of 3 m
from the blood pressure monitor. In compliance
with European Standard DIN EN IEC 60601-1-2
further information can be supplied by
HARTMANN on request.

16. Legal requirements and guidelines

Tensoval duo control complies with the European
regulations on which the provisions of the
93/42/EEC Medical Device Directive are based
and bears the CE mark.
The device complies, among others, with the
requirements of the European Standard EN 1060:
Non-invasive sphygmomanometers – Part 1:
104
General requirements and Part 3: Supplementary
requirements for electro-mechanical blood
pressure measuring systems, as well as with the
standard EN 80601-2-30.
The clinical testing of measuring accuracy was
performed according to the European Standard
EN 1060-4 as well as to EN 81060-2.
The requirements of the ANSI/AAMI test protocol
SP10-1992 are also fulfilled.
Over and beyond the legal requirements, the
device has been clinically validated in accordance
with the ESH-IP2 protocol of the European Society
of Hypertension (ESH), the protocol of British
Hypertension Society (BHS) and the protocol of
the Deutsche Hochdruckliga (DHL).
17. Instructions for measurement function
check
Each Tensoval duo control device has been
thoroughly tested by HARTMANN for measuring
accuracy and has been developed for a long
useable service life. We recommend a measure-
ment function check at intervals of 2 years in the
case of professionally used devices, for exam-
ple in pharmacies, medical practices or hospitals.
You should also note the national regulations
determined by the legislator. Measurement func-
tion checks can only be carried out either by
competent authorities or authorized maintenance
providers against compensation.

18. Instructions for the calibration mode

A device function check can be carried out on
people or using a suitable simulator. Measure-
ment function check involves testing for leak
tightness of the pressure system and possible
deviations of the pressure reading. Remove at
least one battery to switch to calibration mode.
Press down the START/STOP button and insert
the battery again. Release the button after a
few seconds and, after a few moments, two
zeros will appear one above each other on the
display. Instructions on the measurement function
check will be supplied on request to competent
authorities or authorised maintenance providers
by HARTMANN.
English
19. Contact information for customer
queries
AE – PAUL HARTMANN
Middle East FZE
P.O. Box 54525
Dubai
United Arab Emirates
AU – PAUL HARTMANN Pty. Ltd.
Level 6, 5 Ryder Boulevard
Rhodes, NSW 2138 Australia
CN – PAUL HARTMANN (Shanghai)
Trade Co., Ltd.
Shanghai 200233, P.R.China
GB – PAUL HARTMANN Ltd.
Heywood/Lancashire OL10 2TT
HK – PAUL HARTMANN
Asia-Pacific Ltd.
Hong Kong
ZA – HARTMANN South Africa
2194 Johannesburg
You will find more information on Tensoval duo
control and other Tensoval products at
www.tensoval.com
Date of revision of the text: 2015-02
105
GB