Use Instructions

This section describes the ML6710i. This section
is not meant to describe every operating
feature in detail. It is simply a guide to become
familiar with the essential components of the
laser device. Operating the laser device is
described in more detail in sections 3 and 4.
ML6710i is a medical electrical
(ME) device consisting of:
 ML6710i main unit accompanied by a
key switch and an interlock (suitable
for implementing remote interlock)
 Power supply and power cord
 Foot switch
 iPad for operating the graphical user interface
(GUI), not part of standard delivery. ML6710i
only operates with specific iPad models,
please see section 4.2.2 for supported models.
 Slit lamp adapter
The treatment procedure is to be performed
only by medical professionals trained and
knowledgeable about using lasers. The
process should be performed in a clinical
setting, e.g.,, hospital, physician’s office.
The output of the device is continuously operated
(continuous wave, CW, i.e., laser is operated at
constant power, not pulsed), designed for output
power range up to 400 mW. The actual operating
power depends on the device configuration,
such as the treated area and irradiance.
The laser device configuration described here is
for use with ML-SLA. The ML6710i output power
range is measured at the output of the ML-SLA.
The output power does not need to be calibrated
by the user as it is monitored internally. The
device automatically checks the ML-SLA
power based on the treatment configuration.
The GUI run on an iPad controls all the
relevant parameters related to the treatment
and functionality of the laser device. The
device is operated with sequential screens
guiding the user to perform required
tasks before the actual treatment.
ML-SLA is equipped with a safety filter
blocking the treatment light from entering the
user’s eyes when viewing through the ML-
SLA mirror. The safety filter also prevents
viewing the treatment beam in the patient’s
eye. Therefore, the laser is equipped with
a low power aiming beam for targeting the
intended laser irradiation to the target area
in the tissue. The aiming beam is concentric
with the treatment beam and is similar in size.
Once the treatment is configured and treatment
beam is targeted as intended, a foot switch is
required for enabling the actual laser emission.
2.1.1 Essential performance
The essential performance of
ML6710i is defined as follows:
 Capability of producing a specified wavelength
of light within a specified spectral range
 Capability of producing a specified
optical output irradiance from an SLA
2. The ML6710i
2.1 Description
ML6710i Instructions For Use
12 The ML6710i