3
PM-1157-01-07/2013
The manufacturer produces the ear thermometer Omron Gentle Temp 521 with the
applicable accessories included, necessary for the application of its intended purpose.
1. Main unit
2. Instruction manual
3. Test battery
4. Probe cap
5. 21 Probe covers
6. Connection Ring
7. Warranty card
The complete set of the medical device is specified in the Instruction Manual in the
Technical Data section
The above mentioned medical device belongs to a IIa (MDD Annex IX Rule 10)
potential risk class.
Applicable Directives: Medical Device Directive (MDD) 93/42/EEC
Standards: EN980:2008
EN1041:2008
EN60601-1:2006
EN60601-1-2:2007
EN60601-1-6:2007
EN
ISO14971:2012
EN
ISO
10993-1:2009
EN
ISO
10993-5:2009
EN
ISO
10993-10:2010
EN62304:2006
EN62366:2008
EN12470-5:2003
