AMHH2600A Respiratory Humidifier EC Declaration of Conformity and Warranty Statement Dec 2012

EC Declaration of Conformity according to the Medical Devices Directive 93/42/EEC (as amended 2007/47/EC)

Medical Device Respiratory Humidifier AMHH2600A is herewith confirmed to comply with the requirements set out in the Council Directive on the harmonisation of the Laws of the Member States concerning Medical Device Directive 93/42/EEC (as amended by 2007/47/EC) with compliance to conformity assessment Annex II (excluding section 4) as product classification Class IIa certified by Det Norske Veritas (Notified Body number 0434). The following harmonised standards are applied, in respect of product manufacturing control and product performance and safety in use: • Medical Device Directive 93/42/EEC (as amended) • EN 1041:2008, EN 980:2008, EN ISO14971:2009, EN ISO8185:2009, EN 60601-1:1990 ; EN 60601-1-2:2007, EN 60601-1-4:1996 The undersigned hereby declares that the medical device specified above conforms to the Essential Requirements listed in Annex II (excluding section 4) of Medical Device Directive 93/42/EEC. European Authorized Representative: Wellkang Tech Consulting Suite B, 29 Harley Street London W1G 9QR, UK The following person is responsible for the compliance of this Declaration: Great Group Medical Co., Ltd. No.81, Sec 1, Kuo Kuang Road, Dali City, Taichung 41262 Taiwan, R.O.C KEVIN HUNG ___________________

______________________

(Name/Position)

(Legal Signature)

2012/12/03

__________________ (Date)

Warranty Statement Great Group Medical Co., Ltd (GGM) warrants that a previously unused device, when used in accordance with the instructions for use (IFU), shall be free from defects in workmanship and manufacturing materials and will perform in accordance with GGM’s published product specifications for a period of 2 (two) years from the date of purchase from GGM or from an approved stockist.

Accessories, such as temperature probes and heater wire cables are warranted for a period of 1 (one)

year from the date of purchase from GGM or from an approved stockist.

Exclusions This warranty excludes: • Accidental damage • Misuse or abuse • Unauthorised Modification • Failure to adhere to IFU

• Use in unsuitable physical or operating environments • Failure to use original or approved spare parts

• Other defects not related to manufacturing materials or workmanship