Instructions for Use
1 Safety and Certifications
2660021169042 Rev. A 2018-03
1.3 Safety
2660021169042 Rev. A 2018-03
11 / 246
NOTE
Report Serious Accidents
u
If a serious incident has occurred in relation to this medical
device, to the user, or to another person, then the user (or
responsible person) must report the serious incident to the
medical device manufacturer or the distributor. In the European
Union, the user (or responsible person) must also report the
serious incident to the Competent Authority in the state where
the user is established.
1.3.1 Product Safety
WARNING!
An ungrounded Device
could lead to electric shock.
u
Do not remove or disable the ground pin.
u
Only an authorized ZEISS service representative may service the
instrument.
u
Only an authorized ZEISS representative may install the
instrument.
WARNING!
Installation of devices and systems by persons not autho-
rized by ZEISS
can lead to the injury of patients and operators, as well as to
property damage. Installation requires special knowledge and skills.
u
Have the installation performed only by persons authorized by
ZEISS.
WARNING!
Non-compliance with system requirements laid out in
standard IEC 60601–1
could result in compromised patient safety.
u
The person or the responsible organization connecting
additional devices or reconfiguring the system must evaluate
the complete system to ensure compliance to the applicable
IEC 60601–1 requirements.
WARNING!
Use of accessories, transducers, and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
u
Use only the accessories, transducers, and cables specified or
provided by ZEISS.
Содержание PLEX Elite 9000
Страница 1: ...PLEX Elite 9000 Version 1 7 Instructions for Use...
Страница 54: ...Empty page for your notes...
Страница 106: ...Empty page for your notes...
Страница 174: ...Empty page for your notes...
Страница 182: ...Empty page for your notes...
Страница 210: ...Empty page for your notes...
Страница 218: ...Empty page for your notes...
Страница 224: ...Empty page for your notes...
Страница 226: ...Empty page for your notes...
Страница 228: ...Empty page for your notes...
Страница 230: ...Empty page for your notes...
Страница 233: ...Instructions for Use Index 2660021169042 Rev A 2018 03 2660021169042 Rev A 2018 03 233 246 Index...
Страница 245: ...Empty page for your notes...