Guarantee/Service - Sanitas SBM 22 Instructions For Use Manual

Power 4 x 1.5 V
supply
Battery life For approx. 300 measurements, depend-
ing on levels of blood pressure and pump
pressure
Expected At least 20.000 measurements
service life
Classifica- Internal supply, IP21, no AP or APG, continu-
tion ous operation, application part type BF
The serial number is located on the device or in the battery
compartment.
Technical specifications are subject to change without notifi-
cation to allow for updates.
• This device conforms with the European stand-
ard EN 60601-1-2 (in accordance with CISPR-11,
IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2,
IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5,
IEC 61000-4-6, IEC 61000-4-7, IEC 61000-4-8,
IEC 61000-4-11) and is subject to particular precautions
with regard to electromagnetic compatibility. Please note
that portable and mobile HF communication systems
may interfere with this unit.
• The device complies with Regulation (EU) 2017/745 of
the European Parliament and of the Council for medical
devices as well as the respective national regulations and
the standard IEC 80601-2-30 (Medical electrical equip-
ment Part 2-30 – Particular requirements for basic safety
AA batteries
and essential performance of automated non-invasive
sphygmomanometers).
• 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
purposes, it must be regularly tested for accuracy by ap-
propriate means. Precise instructions for checking accu-
racy may be requested from the service address.

12. GUARANTEE/SERVICE

Further information on the guarantee and guarantee condi-
tions can be found in the guarantee leaflet supplied.
Notification of incidents
For users/patients in the European Union and identical
regulation systems (EU Medical Device Regulation (MDR)
2017/745), the following applies: If during or through use of
the product a major incident occurs, notify the manufacturer
and/or their representative of this as well as the respective
national authority of the member state in which the user/pa-
tient is located.
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