Sanitas SBM 21 Instructions For Use Manual page 20

Permissible operating +5 °C to +40 °C, < 85 % relative air hu-
conditions midity (non-condensing)
Permissible storage - 10 °C to + 55 °C, < 95 % relative air hu-
conditions midity, 800 –1060 hPa ambient pressure
Power supply
4 x 1,5 V
Battery life For approx. 180 measurements, de-
pending on the blood pressure level
and/or pump pressure
Accessories Instruction for use, 4 x 1.5 V AA alkaline
batteries., storage pouch
Classification Internal supply, continuous operation,
type BF applied part, IP22, no AP or
APG
Technical information is subject to change without notification
to allow for updates.
• This unit is in line with European Standard EN 60601-1-2 and
is subject to particular precautions with regard to electro-
magnetic compatibility (EMC). Please note that portable and
mobile HF communication systems may interfere with this
unit. More details can be requested from the stated Custo-
mer Service address or found at the end of the instructions
for use.
• This device is in line with the EU Medical Devices Directive
93/42/EC, the „Medizinproduktegesetz" (German Medical
Devices Act) and the standards EN 1060-1 (non-invasive
sphygmomanometers, Part 1: General requirements),
EN 1060-3 (non-invasive sphygmomanometers, Part 3:
Supplementary requirements for electro-mechanical blood
AA alkaline batteries.
20
pressure measuring systems) and IEC 80601-2-30 (Medical
electrical equipment – Part 2 – 30: Particular requirements
for the safety and essential performance of automated non-
invasive blood pressure monitors).
• The accuracy of this blood pressure monitor has been ca-
refully 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 appropriate means.
Precise instructions for checking accuracy may be requested
from the service address.