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SCHWIND Carriazo-Pendular - 1 General Information; System Identification Data

SCHWIND Carriazo-Pendular
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USER MANUAL (Instruction for Use) SW 2.9
General Information
Version 2.9.7 dated 2020-12-23 Page 7 of 75
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1 GENERAL INFORMATION
1.1 System Identification Data
Product name
Carriazo-Pendular
Device type Ophthalmic Microkeratome
Intended use Shaving the cornea prior to lamellar (partial thickness)
transplant or to create a flap in the cornea
Software firmware Version 2.9
Product classification IIa according to annex IX of 93/42/EEC
CE labelling
0483
Serial number Refer to identification label of the device.
Approved device
combination:
Only products specified by SCHWIND eye-tech-
solutions acc. to Declaration of Conformity EEC 12 for
system combination:
Tubings for Carriazo-Pendular
Lid Speculum
System requirements: Refer to the User Manual “Carriazo-Pendular
Monitoring Software”.
Manufacturer:
SCHWIND eye-tech-solutions GmbH
Mainparkstrasse 6-10
63801 Kleinostheim, GERMANY
Tel: + 49-(0)-6027-508 – 0
Fax: + 49-(0)-6027-508 – 208
Email: info@eye-tech.net
http:\\www.eye-tech.net
Distributor:
SCHWIND eye-tech-solutions GmbH or
authorized local SCHWIND representative
Current status of User Manual: Version 2.9.7 dated 2020-12-23

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