USER MANUAL (Instruction for Use) SW 2.9
Safety
Version 2.9.7 dated 2020-12-23 Page 16 of 75
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eye-tech-solutions or authorized representative will instruct and train the user according to the
User Manual of Carriazo-Pendular.
If there are different users in the clinic/hospital working with the same Carriazo-Pendular, it is
absolutely necessary to instruct every one of the users and document it accordingly. This
documentation has to be updated every time a new user of the Carriazo-Pendular is instructed.
The completion of training for the responsible Pendular operators and other persons involved in
operation, care, maintenance of the Carriazo-Pendular, must be documented in the Medical
Apparatus Book “SCHWIND MEDICAL PRODUCTS” (chapter 3 INSTRUCTIONS). The Medical
Apparatus Book is a part of the equipment documentation provided with the medical device by
SCHWIND eye-tech-solutions.
A copy of the name list in the Medical Apparatus Book has to be returned to SCHWIND or
distributor, every time a person is documented on this list.
2.5.3 Protective Measures of the Manufacturer
SCHWIND eye-tech-solutions has undertaken various measures during the manufacturing
process of the Carriazo-Pendular to offer a high degree of safety and operating comfort for both,
personnel and patient.
The most important measures are:
Technical design of the microkeratome which offers a high degree of safety and operating
comfort:
Organizational measures, such as:
Training courses for the service personnel (refer to chapter 2.5.1 Training of User’s and
Operating Personnel).
Maintenance and service (regular TSC controls) (refer to chapter 9.1 Technical Safety
Check (TSC)).
Support of the operator and user by the service department of SCHWIND eye-tech-
solutions (refer to chapter GENERAL INFORMATION – Technical Assistance).
Warranty for the microkeratome.
Providing of equipment documentation as listed in chapter 1.4 Scope of Documentation.
2.5.4 Conformity with Safety Standards
2.5.4.1 Electrical Safety, Mechanical Safety, Functional Safety
The Carriazo-Pendular has been tested for electric, mechanical and functional safety according to
the international safety standard IEC 60601-1 (general requirements for safety and performance
of medical electrical equipment), and the conformity with the above mentioned standard has
been verified.
2.5.4.2 Electromagnetic Compatibility (EMC)
The Carriazo-Pendular has been tested and found to be compliant with the European Standard
EN 60601-1-2 regarding electromagnetic compatibility.
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