Zeiss INTRABEAM, Instructions For Use Manual

Page: 12 / 82

Safety measures INTRABEAM Water Phantom
Version 6.2
Page 12 G-30-1767-en
Notes for the operator
The correct use of the system is absolutely vital for safe operation. Therefore,
please thoroughly familiarize yourself with the contents of these Instructions
for Use before starting up the system. Please also observe the respective In-
structions for Use of any additional equipment.
Duties of the operator This device must be used by properly instructed and trained personnel only. It
is the responsibility of the customer or the company operating the device to
train and instruct all operating personnel.
• Only operate the device within the scope of its intended use.
• Please keep these Instructions for Use where they are easily accessible at
all times for the persons operating the system.
• Please follow the symbols and labels on the packaging and on the device,
see Page 16.
Legal regulations • Observe the legal regulations for accident prevention and occupational
health and safety applicable in the country concerned.
Precondition for
additional equipment
Additional devices that are connected to electronic medical devices must
comply with the relevant standards and guidelines. Furthermore, any config-
urations must comply with normative requirements for medical systems (see
IEC 60601-1-1:2000 or
IEC 60601-1:2005, chapter 16). Anyone connecting additional equipment to
medical electrical devices is a system configurer and as such responsible for
compliance of the system with the normative requirements for systems.
Please note that local legislation takes priority over the above-mentioned nor-
mative requirements. Please contact ZEISS Service if you have any questions.
• Only use original accessories or consumables approved by Carl Zeiss. If you
wish to use other accessories ensure that Carl Zeiss or the manufacturer
of the accessories have verified and confirmed that these accessories meet
the respective safety standards and can be used without risk.
Warranty and liability Warranty and liability depend on the applicable contractual stipulations.
The manufacturer is not liable for damages caused by unauthorized use of the
device. Furthermore, this will forfeit any rights to claim under warranty.
• Do not modify this device without the manufacturer's approval.
If the system is modified after consultation with the manufacturer, suita-
ble inspections and testing must be completed to ensure subsequent safe
use.