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Guarantee, Reference to standards – Welch Allyn OSZ 3 Easy - User Manual User Manual

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Directions For Use

13

a periodic inspection of the static pressure display every 2 years.
Your dealer will provide more extensive information about this.

8. Guarantee

The blood-pressure monitor is guaranteed for 2 years from date
of purchase. This guarantee includes the instrument and the cuff.
The guarantee does not apply to damage caused by improper
handling, accidents, not following the operating instructions, or
alterations made to the instrument by third parties.
The guarantee is only valid upon presentation of the guarantee
card filled out by the dealer.

9. Reference to standards

The stipulations of the EU-Guidelines 93/42/EWG for Medical
Products Class IIa have been fulfilled.

Device standard:

Device corresponds to the requirements of the European
standard for non-invasive blood- pressure monitor
EN1060-1 / 12:95
EN 1060-3 / 09:97

Electromagnetic
compatibility:

Device fulfils the stipulations of the European standard
EN 60601-1-2

Clinical testing:

The clinical performance test was carried out in Germany
according to the DIN 58130/1997 procedure N6 (sequential)
ANSI/AAMI SPI O. NIBP - requirements