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.

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1.7 Warranty
IMPORTANT NOTE
The period of warranty is 12 months starting from the date of delivery
Refer also to General Warranty Regulations of SCHWIND eye-tech-solutions GmbH.
1.7.1 Limited Warranty of Parts and Items
SCHWIND grants warranty exclusively for the following main components:
Electronic console
Foot switch
Electrical motor
Suction ring
Lid speculum
Tonometer
Carriazo-Pendular head
Any defective parts exchanged during the period of warranty belong to SCHWIND.
Disposable and non-reusable items such as blades, vacuum tubings are not covered by the
warranty.
1.7.2 Limitation of Warranty and Liability - General
SCHWIND eye-tech-solutions warrants that the above mentioned parts are free from defects in
materials and workmanship.
SCHWIND eye-tech-solutions grants no other warranty, either express or implied, concerning the
above mentioned parts and their documentation. Any implied warranties of merchantability and
fitness for the particular purpose are disclaimed.
SCHWIND eye-tech-solutions’ liability in case of delivery of a defective product arising from or in
connection with this warranty shall be limited at SCHWIND eye-tech-solution sole discretion, to
either repair or replace the defective product.
SCHWIND eye-tech-solutions shall not be liable for incidental, consequential, indirect, or special
damages of any kind, loss of information or data, or other financial loss arising from or in
connection with the sale or use of the product, whether based in contract, tort (including
negligence) or any other theory.
1.7.3 Exclusion of Warranty and Liability
This warranty excludes damage caused by:
Misuse, neglect, improper installation or testing.
An unsuitable and/or unsafe transportation box. Only the original transportation box supplied
by SCHWIND eye-tech-solutions is suitable for shipping.
Connection of the unit to an unsuitable power source.

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Unauthorized attempt to repair, to service or modify the product, or if the service is performed
by persons who are not authorized by SCHWIND. The same applies should it be determined
to have contributed to the malfunction of the equipment. This could result in being invoiced
at current price list rates.
Use of parts, accessories and/or components other than those provided by SCHWIND.
Use of the product by persons who are not trained by SCHWIND or instructors who are not
authorized by SCHWIND.
Hardware or software neither supplied nor authorized by SCHWIND.
Use of instructions which have been provided by means of telephone or facsimile, unless it
has been shown that SCHWIND acted with intent or negligence to cause damage.
Recommendations provided in this manual for pre- and post-operative LASIK procedures are
based on the experience of LASIK surgeons. SCHWIND will not be liable for damage which
may result from following these recommendations.
1.7.4 Exclusive Warranties
The foregoing warranties and remedies are exclusive and in lieu of all other warranties,
express or implied, including warranties of merchantability, fitness for a particular purpose,
correspondence with description, and non-infringement, all of which are expressly
disclaimed.
The above mentioned exclusion of liability is void if the cause of damage is based on intent
or gross negligence. Furthermore, it does not apply to damage due to lack of a warranted
quality and claims under product liability.
This warranty is constructed according to German Law. German Courts will be solely
competent.
1.8 License Agreement
The license agreements realized between the licencee and SCHWIND eye-tech-solutions GmbH
are binding.
1.9 Copyright
Copyright © 2002-2021 SCHWIND eye-tech-solutions GmbH, Kleinostheim.
All rights reserved.
Pages or parts of this document may not be reproduced or passed to third parties in any form,
i.e. either electronically, mechanically or by any other means without prior written authorization
by SCHWIND eye-tech-solutions.
1.10 Trademarks
All names of other companies and their products mentioned in this manual could be trademarks
or registered trademarks.
Quoting of product names is for information only and does not represent any trade mark misuse.
SCHWIND eye-tech-solutions is not liable for the performance or the use of these products.

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2SAFETY
2.1 General Notes
The instructions given in this chapter are to be considered for proper and safe operation of the
Carriazo-Pendular.
The medical device was designed and manufactured in compliance with applicable legal
standards and further technical specifications. It is a state-of-the-art product and offers a high
level of safety.
This level of safety can only be maintained in practical use of the system when all required
measures are taken. It is the obligation of every system user to plan and supervise the
performance of these measures.
You will find relevant information in chapter 2.5 Manufacturer’s Responsibility and in chapter 2.6
Operator’s Responsibility.
IMPORTANT NOTE
Observe all safety regulations, notes and precautions in this User Manual to
ensure that the device is operated only in accordance with generally accepted
rules of technology and the relevant regulations for medical devices (refer to
chapter 2.2 Regulations for Medical Devices).
Observe any other instructions and requirements provided by the user
documentation of the different medical devices to ensure compatibility and safe
operation of the combination between devices.
For safety recommendations regarding electromagnetic compatibility (EMC) and
restrictions on the use of radio frequency (RF) equipment such as cellular phones,
refer to chapter 12 EMC Guidance and Manufacturer’s Declaration.
This is meant for the safety of the patients, for your own safety and for the
protection of the product from damage.
2.2 Regulations for Medical Devices
IMPORTANT NOTE
For safe use of the SCHWIND Carriazo-Pendular the operator must consider the
applicable, normative regulations and directives.
The most important regulations are:
1. Standard IEC 60601-1 Medical electrical equipment – Part 1: “General requirements for basic
safety and essential performance”
(Regulation valid worldwide)
2. Council Directives concerning Medical Devices MDD 93/42/EEC, as amended
(Regulation valid for EEC countries; please consider the valid national regulations)

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3. Medical Product Operator Regulation – MPBetreibV
(Regulation valid only for Germany; please consider the valid national regulations)
4. European Directive 2012/19/EEC (Waste Electrical and Electronic Equipment – WEEE)
(Regulation valid for EEC countries; please consider the valid national regulations)
2.3 Restrictions of Use and Safety Precautions
Please strictly follow the notes listed below:
IMPORTANT NOTE
Device use by trained personnel only!
Only authorized and suitably trained personnel should use the microkeratome
Carriazo-Pendular. The received training is annotated and must be signed in the
Medical Apparatus Book.
The Carriazo-Pendular may only be used according to the application conditions
specified by the manufacturer.
Service by trained and authorized personnel only!
Only suitably trained and from SCHWIND eye-tech-solutions authorized
personnel may perform initial installation, modifications, and service of the
Carriazo-Pendular.
Do not open the microkeratome housing! The housing may only be opened by
authorized service personnel
Consider also the Patient and Personal Safety Notes in chapter 2.6.1 Patient and Personal Safety,
the installation notes in chapter 5 Installation, notes regarding operation the device in chapter 6
Operation and notes for maintenance in chapter 9 Maintenance, Function Control and Storage.
2.4 Data and Virus Protection
The notes regarding data and virus protection are contained in the User Manual of the Pendular
Monitoring Software.
2.5 Manufacturer’s Responsibility
Manufacturer is only responsible for proper operation, reliability and security of the device when:
Service personnel authorized by SCHWIND eye-tech-solutions exclusively carry out transport,
installation, initial operation, changes, service and maintenance.
The power connection in the room in which the medical device is operated complies with the
legal regulations and technical specifications of SCHWIND eye-tech-solutions concerning the
installation.

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The device and equipment are operated in accordance with the specifications in this user
manual and the accompanying documents.
2.5.1 Training of User’s and Operating Personnel
As with any technological highly-developed medical device, the operation of the Carriazo-
Pendular requires special training and abilities of the user personnel.
IMPORTANT NOTE
The SCHWIND Carriazo-Pendular shall only be operated by specially trained
physicians or surgeons who have mastered the functions of the device and who
possess the necessary skills to use it in accordance with the instructions in this
User Manual.
Likewise, the medical product shall only be used by a doctor specializing in
ophthalmology with specific training in the preparation, calibration, and
maintenance of the device and accessories, as well as special training in the use
of the same in accordance with its intended use. At your convenience, during the
first sessions ask for the collaboration of suitably trained personnel from
SCHWIND eye-tech-solutions.
IMPORTANT NOTE
Each surgeon has ultimate responsibility for the treatment as well as
postoperative measures and follow-ups.
Hands-on training should be passed before you start to work with the Carriazo-
Pendular system. Please notice that a general knowledge about refractive surgery
is presumed.
WARNING
Risk of injury!
Insufficient training of the user can give rise to human errors when using the
device with the consequent risk of injury to the patient.
Demand or agree regular training upgrades, whenever you feel that you or your
team need further support.
The training can be accomplished by the manufacturer SCHWIND eye-tech-solutions or through
a SCHWIND eye-tech-solutions authorized representative.
SCHWIND eye-tech-solutions or authorized representative will instruct and train the user
personnel in accordance with this User Manual.
2.5.2 Instruction and Training
The instruction and training of the Carriazo-Pendular is performed by suitably trained personnel
from SCHWIND eye-tech-solutions or your authorized local SCHWIND representative. SCHWIND

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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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Further information on electromagnetic compatibility (EMC)
Despite adherence to all applicable EMC requirements, malfunctioning cannot be ruled out
entirely. This equipment has been tested and found to comply with the limits of EN 60601-1-2 for
medical devices. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates, uses and radiates radio
frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
Relocate the receiving device.
Separate the equipment by increasing the distance.
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected. Consult the manufacturer or field service engineer for assistance.
2.6 Operator’s Responsibility
In order to ensure the safety of patients and user’s personnel as well as the proper function of
the device, the operator / user must undertake certain measures as listed in the following
chapters.
2.6.1 Patient and Personal Safety
The purpose of safety precautions and preventive measures is to reduce the possibility of injuries
to the patient and to avoid other risks.
WARNING
Risk of injury!
Only a suitable trained and from SCHWIND eye-tech-solutions authorized
personnel should operate, maintain and repair the medical device.
Take care not to injure the patient when positioning the medical device.
Make sure that the patient remains calm and relaxed during the treatment.
Do not swallow, open, recharge or expose to water, fire or high temperature: may
explode, leak or cause damage.
Any complication or difficulty in using the device that could generate
misunderstanding or ambiguities need to be taken into account to avoid risks to
the patient.
After activation and during operation of the medical system pay attention to error
messages and warnings displayed on the computer screen.

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Do not continue the treatment / measurement, if there is any indication for incorrect
processing data or malfunction of the system in order to avoid possible injuries to
the patient!
Keep the batteries away from children!
CAUTION
While handling the accessories, components or other materials which come into
direct contact with the patient, precautionary measures must be met in order to
prevent disease transmission.
2.6.2 Device Safety
Follow the accident prevention regulations and regulations concerning installation,
operation and usage of medical products.
Use the system only for its intended purpose (refer to 3.1 Intended Use).
Provide proper and secure conditions for the product.
Maintain all documentation in good condition and store them with the Carriazo-Pendular
system.
Make sure that none of the labels on the system are removed or made illegible.
Request the inspection of the system at regular intervals (TSC).
2.6.3 Electrical Safety
WARNING
Risk of electric shock!
To avoid the risk of electric shock, the Carriazo-Pendular must only be connected
to supply mains with protective earth.
To ensure the safety of personnel and the device, the following arrangements must be
kept by the operator.
Inspect the electrical equipment for proper fitting and connection, damage to cables, lines
and housing at regular intervals.
Disconnect the power supply immediately in case of fire.
Extinguish fire only with CO2 or powder extinguisher.

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2.7 Dangers Resulting from Device Operation
IMPORTANT NOTE
There are no dangerous affects to the operator or to the patient resulting from
operation of the device in accordance with its intended use.
To ensure safe operation of the medical device please operate the device according to the
instructions given in this manual and in the manual “Treatment Guideline”.
2.8 Protection from Unauthorized Use
It is recommended to switch off the microkeratome completely when the device is intended to be
not in use for a longer period (refer to chapter 6.2 Device Operation).
2.9 In Case of Emergency
If a danger for the user, user’s personnel and the patient during the medical device operation
should arise despite the protective measures of the manufacturer, the following steps have to be
taken:
Switch off the medical device.
Bring the patient and the service personnel in a safe environment.
Inform the service department of SCHWIND eye-tech-solutions or the local contact person
(refer to Service Hotline).
In case of a work accident resulting in injury of a patient or the service personnel, after
carrying out any medical care, an accident notice is to be submitted to the responsible
supervisory authority. A copy of this message is to be sent to SCHWIND eye-tech-solutions
GmbH.

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2.10 Labelling
2.10.1 Labelling Pendular Device
Type Label
Figure 2-1: Position of Carriazo-Pendular type label example - rear side of the console
IMPORTANT NOTE
The availability of disposable blade packaging (option A or option B) as specified
in the following chapters 2.10.2 and 2.10.3 varies with supply and regulatory
status.
2.10.2 Labelling Disposable Blades - Packaging Option A
Type Label Primary Packaging
Position: One piece, at the backside of each
primary blade package
Figure 2-2: Example of type label Carriazo-Pendular disposable blades – primary packaging