106
GB
11 Technical Data
1505093, Edition 2012-05, Version 5
Optional brakes
Friction brakes on the extension arm
Brakes
Friction brakes on the NRH and LCH spring arms
Noise level
Sound energy................................................> 60db(A) (EN ISO 3744) are not exceeded
Operation
Manual forces......................................................................................................... < 550N
Medical Device Directive
Classification ..................................................................................................................... I
Protection class / type
ACROBAT 2000: Protection class in accordance with EN 60601-1.................................. I
ACROBAT LCH: Protection class in accordance with EN 60601-1 .................................. I
IP classification in accordance with IEC 60529 ......................................................... IP 20
Applicable standards
•
Medical Devices Act (Medizinproduktegesetz - MPG);
•
MDD 93/42/EEC, 2007 – Medical Device Directive;
•
EN 60601-1: 2006 - Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance.
Approvals of the standard equipment
Recognised UL component.
Approved adaptations
The following Ondal products are approved as adaptations to the pendant system:
•
Ondal spring arms in accordance with
“Chapter 11” on page 105
•
Ondal adaptations in accordance with
“Chapter 12” on page 107
•
The components are adapted to each other and safe to operate. Any other type of
installation, and in particular the use of components from third-party manufacturers, is
strictly prohibited because these components can be potential sources of danger.
•
The combination of any other Ondal product with the pendant system must be
approved by Ondal Medical Systems GmbH. If applicable, the conformity evaluation
must be renewed.
Read the operating instructions
for combined medical products.
•
The pendant system can be equipped with adaptations and end devices of third-party
manufacturers. To prevent dangerous overload, which can damage or lead to a col
-
lapse of the pendant system, the maximum loading capacities specified in
“Chapter
11, Technical Data, on page 105”
must be adhered to.
•
The party placing the appliance into operation is responsible for the validation of the
overall system. A conformity evaluation procedure shall be executed if required and a
declaration in accordance with Article 12 of 93/42/EEC (Medical Device Directive,
MDD) shall be provided.
•
Read the Operating Instructions provided by the third-party manufacturer and in par
-
ticular the relevant pages with information on the operation of the end device.
CE marking
Ondal Medical Systems GmbH • Wellastraße 6 • D-36088 Hünfeld • Germany
