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2.
SAFETY
2.1
SAFETY INFORMATION
Accessory equipment connected to the analog and digital interfaces must be certificated according
to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN
60601-1 for medical equipment).
Furthermore all configurations shall comply with the system standard EN 60601-1-2:2007.
Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard EN 60601-1-1:2001.
If in doubt, consult the technical service department or your local representative.
For EU Countries
The following mark, the name & address of the EU Representative shows compliance of the
instrument with Directive
Council Directive 93/42/EEC of 14 June 1993
as amended by
Directive 2007/47/EC
concerning medical devices.
ISO 15004
This report provides information about the hazard to the examinee’s eyed in compliance with
ISO 15004-1:2006, ISO 15004-2:2007 Ophthalmic instruments
–
Fundamental requirements
and test methods Part2
–
Light hazard protection.
This condition is satisfied even when the
instrument is operating at maximum light intensity and maximum aperture! (Maximum intensity is
the highest brightness the instrument is capable of delivering, including the highest brightness
achievable if overvoltage is provided) detailed radiation information at normal usage of this
instrument is like bellows.
Radiation output: below
117.1 μW/cm2 Limit by ISO15004: 100 mW/cm2
Number
Radiation output [μW/cm2]
1
107.0
2
117.1
3
115.5
4
115.7
5
103.6
6
103.7
7
108.8
8
109.0
9
105.6
10
105.8
average
109.1
Ellegi Medical Optics s.r.l.
Via Pisciarelli 79- 80078,
Pozzuoli(NAPLES) ITALY