User Manual

8 Safety During Use
Required Expertise
Required expertise The programmer is intended for use by physicians and trained medical staff. Along
with their basic medical knowledge, a detailed knowledge of cardiac electrotherapy
is also required. Only qualified medical specialists with knowledge of cardiac elec-
trotherapy can properly operate the device.
German medical device
ordinance
This ordinance only applies in the Federal Republic of Germany. However, we
recommend that customers in other countries comply with this ordinance as well.
According to section 2, § 5, operation and use:
'The user may operate a (...) listed medical product only after the manufacturer or
the authorized agent who acts on behalf of the manufacturer has performed the
following requirements:
• 1. Checked the functionality of this medical product at the location where the
device will be used.
• 2. Trained the staff appointed by the user to correctly handle, use and operate
the medical product. This training must include handling, using and operating
the product in conjunction with other medical products, implements and acces-
sories in accordance with the technical manual, as well as any applicable
safety-related information and maintenance instructions.
(...)
(3) Proof of a functional test have been performed as stated in Paragraph 1 Item 1,
and the training record of the staff appointed by the user, discussed in Paragraph 1
Item 2, are to be documented.'