Australian ARTG Registration Citadel Plus Bed Number 250116 July 2015

Australian Register of Therapeutic Goods Certificate Issued to

Huntleigh Healthcare Pty Ltd for approval to supply

Huntleigh Healthcare Pty Ltd - Citadel Plus Bariatric Bed Frame Systems - Bariatric bed ARTG Identifier

250116

ARTG Start date

23/07/2015

Product Category

Medical Device Included Class Im

GMDN

35563

GMDN Term

Bariatric bed

Intended Purpose

A mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Manufacturer Details

Address

Certificate number(s)

ArjoHuntleigh AB

Hans Michelsensgatan 10 , Malmo, 21120 Sweden

DV-2014-MC-10996-1

ARTG Standard Conditions The above Medical Device Included Class Im has been entered on the Register subject to the following conditions: · The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41FN of the Therapeutic Goods Act 1989. · The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the Register are as set out in the following paragraphs. · For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be identified. · Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device, the distribution records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for a minimum period of 5 years. · The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation 5.8. · It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Product Review, Therapeutic Goods Administration following inclusion of the device in the ARTG (as specified in 5.8 of the regulations). Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided on 1 October for a further 2 years. The annual report must include all complaints and adverse events received by the manufacturer relating to problems with the use of the device that have been received by them over the year. For orthopaedic implant prosthesis that have been re-classified from Class IIb to Class III medical devices, annual report information must be submitted if the device meets either of the