safety, installation and commissioning
file: n:\article\cos14310m5-v1_08hpc-en\20150130_cos14310m5-v1.08hpc-en_instructions_for_use_h-p-cosmos_treadmill.doc
© 2015 h/p/cosmos sports & medical gmbh author: fh [email protected] created 30.01.2015 printed 30.01.2015 page: 111 of 216
Class „A“ network or data network:
The general hospital network is an example for class A. Such a network or data network carries general applications
including administrative or demographic patient data. The norm accepts a longer time falling out longer down times because
hospitals normally avail of alternatives.
The system administrator, appointed by the operator, is responsible for such systems.
Such clearly defined, closed categorization / classification do not exist in practice. The following example shows that a
mixture of the three classifications will normally be found:
A radiology network of class B sends images and diagnostic findings from the radiology network via the general hospital
network of class A to a PACS server (Picture and Communication System). The radiological images are accessible to all
users can be opened in the operating room, intensive care unit and so on. Some manufacturers of intensive care observation
systems which, according to the norm, belong to class C, offer the possibility to show x-ray images on the bed side monitor
in intensive care. Routinely a mixture of all three network classes occurs. It is important that the 3
rd
edition of DIN EN 60601-
1 handles the increasing networking of medical technical devices with networks and server-based databases, and shows a
possible solution to cover the complexity and potential risks of tele-medical techniques in form of the required system
administrator or risk management according to DIN EN 14971.
Telemedicine is not yet described explicitly in DIN EN 60601-1 3
rd
edition, but the chapter on network and data network
includes an approach to handling this development.
The standard requires that when using a network or data network with the aim of exchanging data between PEMS and
PEMS or other IT devices (such as servers and databases),the manufacturer as well as the operator must have the
necessary knowledge to build such networks, to serve and control, including all related processes and functions.
The standard requires, for example, manufacturers or suppliers of PEMS and / or networks and data networks to choose the
configuration of their products so that they meet internationally known network standards such as Ethernet, Fast Ethernet,
Gigabit Ethernet, FDDI, and others. Furthermore, the available bandwidth according to the intended use or purpose in
accordance with § 3 para 10 MPG use must be appropriate. Optimal application performance must be achievable.
The third edition of DIN EN 60601-1 requires that a hospital as an operator, represented by a system integrator, and the
PEMS manufacturer discuss any major technical parameters to ensure a reliable installation of a PEMS operating in a
network or data network. This procedure is required to avoid unacceptable risks where possible.
Table H.4 of the standard gives an example of a collection of parameters that are needed to describe a network or a data
network. This list should be considered r only a draft of a comprehensive documentation to follow.
Summary:
The operation of programmable electrical medical systems (PEMS) requires the observance of and compliance with the
Medical Devices Act and safety standards, as described in the technical rules (standards) to ensure quality and safe patient
care. In particular, the third edition of DIN EN 60601-1 is directed much more at the operator of telemedicine connections
than the second edition. In order to operate a safe and high quality tele-medicine as tele-neurology network, the safety
standards should be met.
