SCHWIND Carriazo-Pendular User manual

SCHWIND eye-tech-solutions GmbH · Mainparkstrasse 6-10 ·63801 Kleinostheim GERMANY
USER MANUAL (Instruction for Use) TREAT
Original version
Valid for Software Version 2.9
0483
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Dear Customer
Thank you very much for purchasing this medical product and for the confidence you have in our
company. You have chosen a high-tech product, which was manufactured and tested to meet
highest standards.
Construction and production fully complies with regulations and requirements which apply to
medical products.
Compliance with all effective standards and laws is displayed by the CE symbol,
which is displayed on the type label.
The CE Symbol stands for conformity with current laws and consequently for safety and
effectiveness.
Constant research and development may cause changes in design and scope of supply.
Therefore, in individual cases, the figures in this manual might deviate from the delivered
product.
If you have any questions or desire further information about your equipment, please do not
hesitate to contact us via phone, fax or e-mail. Our team of specialists will be glad to help you.
Our address, phone and fax numbers, as well as the e-mail address can be found at the beginning
of this manual in chapter Technical Assistance / Application Support.
Sincerely,
SCHWIND eye-tech-solutions GmbH
IMPORTANT NOTE
Until February 2017, the Carriazo-Pendular (and likewise all other products
mentioned herein) has been placed on the market under the company name
“SCHWIND eye-tech-solutions GmbH & Co.KG” (with identical address).

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Table of Contents
Dear Customer ................................................................................................................................. 2
Table of Contents............................................................................................................................. 3
List of Figures ................................................................................................................................... 6
1GENERAL INFORMATION .................................................................................7
1.1 System Identification Data.................................................................................................. 7
1.2 Symbols for Warnings, Precautionary Measures and Notes........................................... 8
1.3 Notes on the User Manual .................................................................................................. 8
1.4 Scope of Documentation..................................................................................................... 9
1.5 Declaration of Manufacturer according to the European MDD 93/42/EWG for
Microkeratome Carriazo-Pendular ..................................................................................... 9
1.6 Liability of the Manufacturer ............................................................................................ 10
1.7 Warranty ............................................................................................................................. 11
1.7.1 Limited Warranty of Parts and Items.............................................................................11
1.7.2 Limitation of Warranty and Liability - General .............................................................11
1.7.3 Exclusion of Warranty and Liability............................................................................... 11
1.7.4 Exclusive Warranties....................................................................................................... 12
1.8 License Agreement ............................................................................................................ 12
1.9 Copyright ............................................................................................................................ 12
1.10 Trademarks ......................................................................................................................... 12
2SAFETY.............................................................................................................13
2.1 General Notes..................................................................................................................... 13
2.2 Regulations for Medical Devices ...................................................................................... 13
2.3 Restrictions of Use and Safety Precautions .................................................................... 14
2.4 Data and Virus Protection ................................................................................................. 14
2.5 Manufacturer’s Responsibility .......................................................................................... 14
2.5.1 Training of User’s and Operating Personnel ................................................................ 15
2.5.2 Instruction and Training ................................................................................................. 15
2.5.3 Protective Measures of the Manufacturer .................................................................... 16
2.5.4 Conformity with Safety Standards ................................................................................ 16
2.5.4.1 Electrical Safety, Mechanical Safety, Functional Safety .................................16
2.5.4.2 Electromagnetic Compatibility (EMC)............................................................... 16
2.6 Operator’s Responsibility.................................................................................................. 17
2.6.1 Patient and Personal Safety ........................................................................................... 17
2.6.2 Device Safety ................................................................................................................... 18
2.6.3 Electrical Safety ............................................................................................................... 18
2.7 Dangers Resulting from Device Operation...................................................................... 19
2.8 Protection from Unauthorized Use .................................................................................. 19

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2.9 In Case of Emergency ........................................................................................................ 19
2.10 Labelling.............................................................................................................................. 20
2.10.1 Labelling Pendular Device .............................................................................................. 20
2.10.2 Labelling Disposable Blades - Packaging Option A ..................................................... 20
2.10.3 Labelling Disposable Blades – Packaging Option B..................................................... 22
2.10.4 Type Label of the Disposable Tubings .......................................................................... 24
2.11 Explanation of Graphic Symbols used in the Labels...................................................... 27
3INTRODUCTION...............................................................................................30
3.1 Intended Use ...................................................................................................................... 30
3.2 Side-Effects ......................................................................................................................... 30
3.3 Contraindications for LASIK.............................................................................................. 31
4DEVICE / SYSTEM DESCRIPTION ..................................................................32
4.1 System Overview ............................................................................................................... 32
4.2 Principle of Cutting ............................................................................................................ 32
4.3 Product Features and Components ................................................................................. 33
4.3.1 Cutting Head .................................................................................................................... 33
4.3.2 Disposable Blades ........................................................................................................... 34
4.3.3 Suction Ring .................................................................................................................... 35
4.3.4 Drive Motor ...................................................................................................................... 36
4.3.5 Pendulum Axis ................................................................................................................ 36
4.3.6 Tonometer ....................................................................................................................... 36
4.3.7 Console – Control Unit....................................................................................................36
4.3.8 Foot Pedal ........................................................................................................................ 38
4.3.9 Monitoring Software....................................................................................................... 39
4.3.10 List of Applied Parts ........................................................................................................39
4.4 Intended Accessory............................................................................................................ 39
4.4.1 Disposable Tubing .......................................................................................................... 39
4.4.2 Lid Speculum................................................................................................................... 40
4.5 Approved System Combinations ..................................................................................... 41
5INSTALLATION ................................................................................................42
5.1 General Notes..................................................................................................................... 42
5.2 System Requirements ....................................................................................................... 43
5.3 Shipping .............................................................................................................................. 43
5.3.1 Scope of Delivery ............................................................................................................ 43
5.3.2 Packing of the Shipping Units........................................................................................ 43
5.3.3 Unpacking and Checking the Delivery .......................................................................... 44
5.3.4 Transportation Damages ................................................................................................ 45

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5.4 Room and Installation Requirements .............................................................................. 45
5.5 Device Installation / Start-Up ........................................................................................... 45
5.6 Transportation to another Location................................................................................. 46
6OPERATION......................................................................................................47
6.1 General Notes..................................................................................................................... 47
6.2 Device Operation................................................................................................................ 48
6.2.1 Assembling the Microkeratome, Vacuum Test ............................................................ 48
6.2.2 Connection of the Console ............................................................................................. 48
6.2.3 Switch ON/OFF the Console ........................................................................................... 48
6.2.4 Disconnection from the Electronic Circuit .................................................................... 49
6.3 Software Operation ........................................................................................................... 50
6.3.1 Standard System Messages........................................................................................... 50
6.3.2 User Menu ....................................................................................................................... 51
6.3.3 System Supervisor & Error Table .................................................................................. 52
6.4 Vacuum Level and Atmospheric Pressure....................................................................... 54
6.5 Assembly of the New Disposable Blade.......................................................................... 55
7TREATMENT ....................................................................................................56
8CLEANING AND REPROCESSING ..................................................................56
8.1 Cleaning and Reprocessing of Resterilisable Parts, Accessories and Components ... 56
8.2 Cleaning and Disinfection of non-sterile Parts, Accessories and Components........... 56
8.2.1 Safety Notes and Warnings ........................................................................................... 56
8.2.2 Manual Cleaning and Disinfection of the Console and Foot Switch .......................... 58
8.2.3 Manual Cleaning and Disinfection of the Motor and Motor Cable............................. 58
9MAINTENANCE, FUNCTION CONTROL AND STORAGE..............................60
9.1 Technical Safety Check (TSC) ........................................................................................... 61
9.1.1 Maintenance of Batteries and Accumulators ............................................................... 61
9.1.2 Test Protocol of Technical Safety Check .......................................................................62
9.1.3 Maintenance Intervals .................................................................................................... 62
9.2 Regular Technical Inspections .......................................................................................... 62
9.3 Changing Fuses .................................................................................................................. 63
9.4 List of Parts ......................................................................................................................... 64
9.5 Storage................................................................................................................................ 64
9.6 Lifetime ............................................................................................................................... 65
9.7 Disposal............................................................................................................................... 65
10 TECHNICAL DATA ...........................................................................................66
10.1 Electronic Console ............................................................................................................. 66

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10.2 Suction Rings ..................................................................................................................... 66
10.3 Cutting Head....................................................................................................................... 66
11 REFERENCE TO STANDARDS ........................................................................67
12 EMC GUIDANCE AND MANUFACTURER’S DECLARATION ........................68
12.1 Electromagnetic Interference ........................................................................................... 68
12.2 Essential Performance ....................................................................................................... 73
12.3 List of Replacable Cables and Components .................................................................... 74
13 MANUFACTURER ............................................................................................75
13.1 Technical Assistance / Application Support ................................................................... 75
List of Figures
Figure 2-1: Position of Carriazo-Pendular type label example - rear side of the console ............. 20
Figure 2-2: Example of type label Carriazo-Pendular disposable blades – primary packaging ... 20
Figure 2-3: Example of type label Carriazo-Pendular disposable blades – secondary packaging 21
Figure 2-4: Safety notice label for the secondary packaging........................................................... 21
Figure 2-5: Example of type label of Carriazo-Pendular disposable blades – primary packaging22
Figure 2-6: Example of type label of Carriazo-Pendular disposable blades – secondary packaging
............................................................................................................................................................... 22
Figure 2-7: Example of tertiary packaging (folding box) (front and side view) ............................. 23
Figure 2-8: Example of type label Carriazo-Pendular disposable blades – equal to secondary
packaging ............................................................................................................................................. 23
Figure 2-9: Example of Quarternary transport box for Carriazo-Pendular disposable blades ..... 24
Figure 2-10: Example of type label of Carriazo-Pendular disposable tubings – primary packaging
............................................................................................................................................................... 25
Figure 2-11: Example of type label of Carriazo-Pendular disposable tubings – secondary
packaging ............................................................................................................................................. 26

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1GENERAL 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: [email protected]
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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1.2 Symbols for Warnings, Precautionary Measures and Notes
The following conventions are used in this manual:
WARNING
This symbol advises the user of serious danger for the patient and the user.
CAUTION
The symbol informs the user that particular care is required for safe and efficient
operation of the system.
IMPORTANT NOTE
This symbol provides the user with useful or additional information.
1.3 Notes on the User Manual
The purpose of the user manual is to familiarize the operator(s) of the Carriazo-Pendular with the
design, operating principle, transport, installation, set-up, safe operation, safety notes and the
care and maintenance of the medical device.
Consider also the following related documents listed below:
oTreatment Guideline Carriazo-Pendular
oReprocessing Instruction for Resterilisable SCHWIND Products
oUser Manual Monitoring Software
oAssembly Instructions for new Disposable Blades (UI_PENDULAR_01-07)
The manuals are included on the SCHWIND Product Documentation CD/DVD.
Keep the User Manual and all related documents close to the medical device. Allow any user
access to this User Manual at all times, store it readily available.
If you have any questions regarding any matters, contact an authorized local SCHWIND
representative or SCHWIND eye-tech-solutions directly for advice.
IMPORTANT NOTE
Read this User Manual carefully and consider all instructions and safety warning
notes before starting operation of the SCHWIND Carriazo-Pendular. Follow all
safety instructions.
CAUTION
This User Manual does not contain all information which is necessary for the
safe and effective application according to its intended use.

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IMPORTANT NOTE
The present manual contains the ORIGINAL INSTRUCTIONS, which are legally
binding. Translations of these must bear the words “Translation of the Original
Instructions”.
1.4 Scope of Documentation
The Scope of Documentation includes the includes the Accompanying Documentation
“SCHWIND MEDICAL PRODUCTS”, art.no. 202160x-01 (EN), 202160x-02 (DE), consisting of: 
Medical Apparatus Book “SCHWIND MEDICAL PRODUCTS”
CD-ROM/DVD “SCHWIND Product Documentation” art.no. 163160x containing the
appropriate Carriazo-Pendular documents as listed in chapter 1.3 Notes on the User
Manual.
1.5 Declaration of Manufacturer according to the European MDD 93/42/EWG
for Microkeratome Carriazo-Pendular
The Carriazo-Pendular microkeratome has been developed according to the applicable
requirements of the European Medical Device Directive 93/42/EEC, as amended (and hence also
according to its German equivalent Medical Device Law MPG 1). The manufacturer SCHWIND
eye-tech-solutions GmbH has been authorized by the notified body “mdc” (listed at the European
Commission with number 0483) to produce and inspect medical devices for ophthalmologic
purposes and to market and service them.
Conformity of the device with the Directive and MPG is ensured only under the following
preconditions:
Delivery is accomplished by SCHWIND eye-tech-solutions or a distributor authorized by
SCHWIND eye-tech-solutions.
All service and maintenance work is performed only by personnel who are authorized by
SCHWIND eye-tech-solutions.
Accessories, consumables and disposables are only authorized and approved by SCHWIND
or an authorized independent testing authority confirm a completely safe operation and
interaction
1) MPG – Medizin-Produkte-Gesetz is the German Medical Device Regulation
IMPORTANT NOTE
The Declarations of Conformity for Carriazo-Pendular microkeratome and as
System Combination with tubings and lid speculum can be found on the Product
Documentation DVD in the SCHWIND Accompanying Documentation folder
“SCHWIND MEDICAL PRODUCTS”.

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1.6 Liability of the Manufacturer
SCHWIND eye-tech-solutions does not assume any liability for:
Injuries to persons, unless caused by gross negligence of the manufacturer.
Damages of properties.
Damages / destruction of equipment or software.
Data loss.
Financial, legal, commercial and productivity-related disadvantages for the company
and the personal user.
due for the following courses of action:
Lack of reading this manual completely and carefully before starting operations with
the microkeratome.
Using the medical software on computers not officially approved by SCHWIND eye-
tech-solutions.
Lack of understanding the instructions provided in the user documentation, and the
explanations provided by SCHWIND’s application specialists (otherwise contact
SCHWIND’s application specialists for further details).
Lack of observation of any other instructions and safety requirements provided by the
user information of compatible devices and accessories for ensuring compatibility and
safe operation of the combination between devices.
Use of any compatible device or accessory without having received adequate
inspections and calibrations for proper use and measurement.
Insufficient training of the user, which can give rise to human errors when using the
device with the consequent risk of injury to the patient.
Use of the equipment by not suitably trained personnel.
Use of this device for purposes different than its intended use or for its use outside the
environment of an ophthalmic surgery.
Any attempt to alter, modify or manipulate the product in a way not stipulated in the
User Manual of SCHWIND eye-tech-solutions.
Use of the software or any of its components in a different application.
Manipulation, alterations or damages to the software by technicians not authorized by
SCHWIND eye-tech-solutions or other third parties.
Non-observance of the operating notes, warning symbols and safety instructions in
this manual.
Operational error of user.
Computer virus.
Excessive force.
Power failure, voltage fluctuations, electromagnetic interference.
Inappropriate storage of the data medium (e.a. humidity or temperature influences)
Erroneous deletion of data by the user.
Negligence by the user.