Chapter 1 - General Info PDF
Chapter 1 - General Info PDF
Chapter 1 - General Info PDF
0 GENERAL INFORMATION
1.1 USE OF THIS MANUAL
This manual contains service instructions for the Cutera Solera Titan and Solera Opus systems. The
contents of this manual are intended solely for use by Cutera Field Service Engineers and Cutera
trained and certified customer service technicians. Cutera cannot be responsible for service or
repairs attempted by uncertified persons, and the use of this manual by such persons is prohibited.
This manual is to be used in conjunction with the Cutera Operator Manual for the Solera Titan and
Solera Opus systems. The operator manual contains important information regarding instrument
description, location of controls, specifications, and normal operating procedures.
As necessary, Cutera releases Field Modification Instructions (FMI) for the Solera Titan and Solera
Opus systems. These FMIs supplement information in this manual and, as released, become part of
the manual (Section 9).
1.2 CONVENTIONS USED IN THIS MANUAL
The schematics in this manual do not include individual numbers for the logic elements or
operational amplifiers within a single component. For example, in the following illustration, U1
contains two operational amplifiers. The top op amp would be referred to as U1‐1 (its output is pin
1) and the other would be referred to as U1‐7.
2 1
3
U1
6
7
5
U1
1.3 DELIVERY SYSTEMS
The Solera Titan and Solera Opus systems deliver pulsed light energy through a user‐detachable
handpiece. Pulsed light handpieces include, but are not limited to, OPS600, LP560, AcuTip 500,
ProWave 770, LimeLight, Titan S, Titan V, and Titan XL.
Solera Titan / Opus Service Manual GENERAL INFORMATION
P/N D0792 REV. A 1-1
1.4 SERIAL NUMBERS
The serial numbers for the Solera Titan and Solera Opus systems are in the following format, where
“X” represents a unique 4‐digit value.
• Solera Titan: TT XXXX
• Solera Opus: SO XXXX
1.5 CERTIFICATION OF COMPLIANCE
The Solera Titan and Solera Opus systems are designed and tested in accordance with Cutera’s
procedures for independent certification for a CE mark.
The CE mark is a certification label that allows Cutera to sell the Solera Titan and Solera Opus
systems throughout the European community. This label certifies that the Solera Titan and Solera
Opus systems meet all regulations set forth by various countries in Europe. It is important to ensure
that the following label is on the system chassis:
0044
1.6 SERVICE INFORMATION & FDA COMPLIANCE
In compliance with the FDA, brochures and specifications sheets must include a reproduction of a
complete warning logotype or Class IIa warning statement as required on the product
(1040.10(h)(2)(i)). Servicing information must contain the following (1040.10(h)(2)(ii)):
• Procedures for service with appropriate warnings to avoid exposure
• A schedule of maintenance to maintain the product in compliance
• A list of controls that could increase the level of accessible radiation
• Identification of removable portions of protective housings
• Procedures to avoid exposure
• Reproductions of required labels and warnings