Haag-Streit IM 900, Instructions For Use Manual, Page: 17 / 23

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DEUTSCH ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA DEUTSCH ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220551‑04070 – 2021 – 08
10.2 Legal regulations
• This device was developed and designed taking the EN 60601-1 and EN
60601-1-2 standards into account.
• The EN 60601-1 standard must be observed when using different medical and/
or non-medical electrical devices in combination.
• Compliance of the device with the Medical Device Regulation 2017/745 is
confirmed by the CE-designation.
• You can request a copy of the declaration of conformity for this device from
Haag-Streit at any time.
• Statutory accident regulations are to be observed.
WARNING!
The device may only be operated in an environment in which standard
values pursuant to standard EN 60601-1 are observed.
10.3 Classification
Standard EN 60601-1 Protection class I
Operating mode Continuous operation
CE Medical Device Regulation
2017/745
Class I
FDA Class II
10.4 Disposal
Electrical and electronic devices must be disposed of separately from
household waste! This device was made available for sale after the
13th August 2005. For correct disposal, please contact your Haag-
Streit representative. This will guarantee that no hazardous
substances enter the environment and that valuable raw materials are
recycled.
10.5 Observed standards
EN 60601-1
EN 60601-1-2
10.6 Information and manufacturer's declaration concerning
electromagnetic compatibility (EMC)
10.6.1 General
This device fulfills the requirements on electromagnetic compatibility according to
IEC 60601-1-2:2014 (4th Edition). The device is built so that the generation and
emission of electromagnetic interference is limited to the extent that other devices
are not disturbed in their use in accordance with the regulations and so that the
device itself is suitably immune to electromagnetic interference.
WARNING!
Avoid damages due to high electrostatic discharges (ESD). Electrostatic
discharges with voltages exceeding 6 kV to some parts of the slit lamp
like joystick or metallic parts on the instrument base may influence the
device.
• The communication between imaging module and PC could be
interrupted, which would require a restart of the EyeSuite software.
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC
instructions contained in this accompanying document.
• Use of accessories, transducers and cables other than those
specified or provided by Haag-Streit could result in increased
electromagnetic emissions or decreased electromagnetic immunity
of this device and result in improper operation.
• Third-party devices may only be connected in compliance with the
IEC 60601-1 standard.