Medel CONTROL Manual De Instrucciones página 37

Measurement Max. permissible standard deviation
inaccuracy according to clinical testing:
Systolic 8 mmHg /
Diastolic 8 mmHg
Memory 4 x 30 memory spaces
Dimensions L 112 mm x W 110 mm x H 58 mm
Weight Approximately 219 g (without batteries
and cuff)
Cuff size 22 to 42 cm
Permissible opera- +10°C to +40°C, 15 to 85% relative
ting conditions humidity (non-condensing)
Permissible sto- -20°C to +55°C, 10-90% relative humi-
rage conditions dity, 800-1050 hPa ambient pressure
Power supply 4 x 1.5 V
Battery life For approx. 300 measurements, depen-
ding on levels of blood pressure and
pump pressure
Accessories Instructions for use, 4 x 1.5V AA batte-
ries, storage bag
Classification Internal supply, IPX0, no AP or APG,
continuous operation, application part
type BF
Technical information is subject to change without notifica-
tion to allow for updates.
100029_95142MEDELcontrol_userMANUAL_REV.02_22.03.2017.indd 37
AA batteries
37
• This device complies with European Standard EN60601-
1-2 and is subject to particular precautions with regard
to electromagnetic compatibility. Please note that porta-
ble and mobile HF communication systems may interfere
with this unit. More details can be requested from the sta-
ted Customer Services address or found at the end of the
instructions for use.
• The device complies with the EU Medical Devices
Directive 93/42/EEC, the German Medical Devices Act
(Medizinproduktgesetz) and the standards EN1060-1
(Non-invasive sphygmomanometers – Part 1: General
requirements), EN1060-3 (Non-invasive sphygmoma-
nometers – Part 3: Supplementary requirements for elec-
tro-mechanical blood pressure measuring systems) and
IEC80601-2-30 (Medical electrical equipment – Part 2
– 30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphyg-
momanometers).
• The accuracy of this blood pressure monitor has been
carefully checked and developed with regard to a long
useful life. If using the device for commercial medical pur-
poses, it must be regularly tested for accuracy by appro-
priate means. Precise instructions for checking accuracy
may be requested from the service address.
24/05/2017 14:47:20