3 | Legal Information
Haag-Streit AG
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1500 4000089 02010_web
3 Legal Information
The part of the surgical microscope system described in these instructions for use supplements the
intended use of the surgical microscope system.
3.1 Intended Use
The C.MOR HD and C.MOR HD³ are part of a surgical microscope system and are HD video cam-
eras intended for video documentation.
Monitors, which are connected to C.MOR HD or C.MOR HD³, are exclusively intended to display
information that is directly related to the operation. Before use in diagnostic applications, the user
must subjectively check key parameters such as color accuracy, gray-level scaling, image size and
height to width ratio.
C.MOR HD and C.MOR HD³ can be connected to the surgical microscope system via camera at-
tachments.
3.2 Important Notes
Obligatory Reporting of Serious Incidents
Any serious incident occurring in relation to the product must be reported to Haag-Streit and the
competent authority of the member state in which the user and/or the patient is established.
First Installation and Commissioning
The first installation and commissioning of the medical device must be done in accordance with the
instructions in the service manual for the medical device. The first installation and commissioning of
the medical device must be performed by the authorized local representative or by Haag-Streit dir-
ectly.
An installation report, stating the full and error free functionality of the medical device, must be
signed by both parties after the medical device has been installed and is commissioned.
Liability for Function and Damage
If the device is modified, repaired or serviced improperly, the warranty of Haag-Streit is void. Only
personnel authorized by Haag-Streit may modify, repair or service the device.
Liability for Precaution
The user shall always take precaution appropriate to the application to be able to end the surgical
procedure without the surgical microscope system.
Accessories
External accessories from 3rd party manufacturers must only be connected to the system after au-
thorization by Haag-Streit. The interfaces and the combination of systems have to be validated.