Getinge 1009.25B0 - Basic Requirements; Use in Accordance with the Intended Purpose; Applicable Standards; Intended Use

1
Introduction
Basic requirements
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1009.25B0
IFU 1009.25 EN 01
1.4 Basic requirements
1.4.1 Use in accordance with the intended purpose
This product is a medical device.
The product may only be operated by persons who have been instructed in the use of the product
by an authorised person.
The product is designed solely for the purpose of human medicine.
The patient may only be placed and positioned under medical supervision.
Rooms used for medical purposes in which the product is operated must comply with HD
60364-7-710 or equivalent national regulations.
The EMC characteristics of this product allow its use in industrial and hospital environments
(CISPR 11, Class A). This product may not provide adequate protection against radio services
when used in a residential environment (which typically requires Class B according to CISPR 11).
If necessary, the user must take corrective measures such as conversion or reorientation of the
product.
The test levels use conform to those used for professional medical equipment.
Operation
The operator must ensure that the product is fully functional and in good working order prior to
use.
Accessories
Accessories or combinations of accessories may only be used as and when indicated in these in-
structions for use.
Other accessories, combinations of accessories or consumables may only be used if they are de-
signed specifically for the use in question and will not adversely affect either performance fea-
tures or safety requirements.
1.4.2 Applicable standards
The product meets the basic safety and performance requirements in accordance with the local
applicable legal specifications for medical devices.
1.4.3 Intended use
The universal remote control (1009.25BX) is intended for operation of operating tables from
Getinge.
The design of the operating key pad indicates the individual adjustment functions of the operating
table. In addition, the control device is equipped with a touchscreen for controlling secondary
functions. Adjustment functions of the operating table can be controlled directly only via operating
buttons.
An operating table can either be operated wirelessly or via an infrared or Bluetooth interface us-
ing the control device or as a corded control unit in conjunction with a cable.
The product may only be operated by medically trained staff within the OR environment.
Any use other than described above is deemed not to be in accordance with the intended use.