Use Instructions

2.2 Approved beam delivery systems
The ML6710i is designed for PDT treatments
of the retina and to be used together with a slit
lamp. For delivering the laser light into the treated
eye, only compatible slit lamp adapters are
allowed to be used together with the device. The
Instructions For Use describe use with, Modulight
Slit Lamp Adapter, part number ML-SLA.
The following radio field/electromagnetic
disturbances may affect the essential
performance of ML6710i:
 Communication loss between main
unit and GUI may occur in case of a
strong disturbance at 2.4 GHz
 Major mains supply voltage dips and
interruptions may cause the main
unit to shut down or reboot
PROHIBITED
MANDATORY
2.3 General classifications
Table 1. General ML6710i classification.
Description Classification Applied standard
Medical device Class III 21CFR860.3
Protection against electric shock Class II IEC 60601-1
Protection against harmful ingress of water or particulate
matter
Laser unit: IP 2X
Foot switch: IP X6
IEC 60529
Laser safety Treatment beam: Class 3B
1
Aiming beam: Class 2
IEC 60825-1
Electromagnetic emissions Class A, Group 1 CISPR 11
Applied part (SLA) Type B IEC 60601-1
1
Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in
Laser Notice No. 56, dated May 8, 2019.
Use of a Slit Lamp Adapter other than verified for compatibility is strictly forbidden
to avoid incorrect beam characteristics, wrong dose and other hazards.
Use only a Slit Lamp Adapter (SLA) compatible with the laser device.
Revision 9
13The ML6710i