Related Manuals for SCHWIND Carriazo-Pendular
Summary of Contents for SCHWIND Carriazo-Pendular
- Page 1 TREAT USER MANUAL (Instruction for Use) Original version Valid for Software Version 2.9 0483 SCHWIND eye-tech-solutions GmbH · Mainparkstrasse 6-10 ·63801 Kleinostheim GERMANY...
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Page 2: Dear Customer
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” “... -
Page 3: Table Of Contents
Symbols for Warnings, Precautionary Measures and Notes ........... 8 Notes on the User Manual ....................8 Scope of Documentation ..................... 9 Declaration of Manufacturer according to the European MDD 93/42/EWG for Microkeratome Carriazo-Pendular ..................9 Liability of the Manufacturer .................... 10 Warranty ..........................11 1.7.1 Limited Warranty of Parts and Items ................ - Page 4 USER MANUAL (Instruction for Use) SW 2.9 General Information 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 ................
- Page 5 USER MANUAL (Instruction for Use) SW 2.9 General Information Room and Installation Requirements ................45 Device Installation / Start-Up ................... 45 Transportation to another Location ................. 46 OPERATION ...................... 47 General Notes ........................47 Device Operation ........................ 48 6.2.1 Assembling the Microkeratome, Vacuum Test ............48 6.2.2 Connection of the Console .....................
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Page 6: List Of Figures
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 –... -
Page 7: General Information
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 –... -
Page 8: Symbols For Warnings, Precautionary Measures And Notes
This symbol provides the user with useful or additional information. 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. -
Page 9: Scope Of Documentation
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 ... -
Page 10: Liability Of The Manufacturer
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... -
Page 11: Warranty
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. -
Page 12: Exclusive Warranties
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. -
Page 13: Safety
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”... -
Page 14: Restrictions Of Use And Safety Precautions
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. -
Page 15: Training Of User's And Operating Personnel
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 Version 2.9.7 dated 2020-12-23 Page 15 of 75... -
Page 16: Protective Measures Of The Manufacturer
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. -
Page 17: Operator's Responsibility
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. -
Page 18: Device Safety
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. -
Page 19: Dangers Resulting From Device Operation
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. -
Page 20: 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. -
Page 21: Figure 2-3: Example Of Type Label Carriazo-Pendular Disposable Blades - Secondary Packaging
Safety Type Label Secondary Packaging Position: Top side of the cardboard box Figure 2-3: Example of type label Carriazo-Pendular disposable blades – secondary packaging Safety Notice Label Position: At the front side of the cardboard box Figure 2-4: Safety notice label for the secondary packaging Version 2.9.7 dated 2020-12-23... -
Page 22: Labelling Disposable Blades - Packaging Option B
Primary Packaging (Blister) Position: One piece, at the backside of each primary blade package Figure 2-5: Example of type label of Carriazo-Pendular disposable blades – primary packaging The primary packaging includes a quantity of one sterile disposable blade. Secondary Packaging (pouch) -
Page 23: Figure 2-7: Example Of Tertiary Packaging (Folding Box) (Front And Side View)
The tertiary packaging does include the following information at the front side: Figure 2-8: Example of type label Carriazo-Pendular disposable blades – equal to secondary packaging The environmental storage conditions as well as manufacturer address are part of the type label (Figure 2-6 and Figure 2-8). -
Page 24: Type Label Of The Disposable Tubings
It includes a quantity of one folding box from corrugated cardboard and serves as mechanical protection during delivery/transport. Figure 2-9: Example of Quarternary transport box for Carriazo-Pendular disposable blades Additionally, the transport box has an identification label of Pendular Disposable Blades sticked to the cardboard that shows equal information as on secondary and tertiary packaging (Figure 2-6 and Figure 2-8). -
Page 25: Figure 2-10: Example Of Type Label Of Carriazo-Pendular Disposable Tubings - Primary Packaging
USER MANUAL (Instruction for Use) SW 2.9 Safety Position: One piece, at the rear side of each primary tubing package. Figure 2-10: Example of type label of Carriazo-Pendular disposable tubings – primary packaging Version 2.9.7 dated 2020-12-23 Page 25 of 75... -
Page 26: Figure 2-11: Example Of Type Label Of Carriazo-Pendular Disposable Tubings - Secondary Packaging
The secondary packaging serves as mechanical protection for the product and represents the smallest sales unit. Each secondary package is identified with one label. Position: Front side of the cardboard. Figure 2-11: Example of type label of Carriazo-Pendular disposable tubings – secondary packaging Version 2.9.7 dated 2020-12-23 Page 26 of 75... -
Page 27: Explanation Of Graphic Symbols Used In The Labels
The following symbols are used in the labels placed to the equipment, accessories or components: Sign Explanation Where placed SCHWIND-Logo CE sign. Confirms the observance the Regulation for 0483 Medical Devices MDD 93/42/EEC. Application part type B (applied) Consult operating instructions, electronic instructions for use. - Page 28 USER MANUAL (Instruction for Use) SW 2.9 Safety Sign Explanation Sterilization by radiation The component/unit may only be used until: Date [year, four-digit] [month in two digits ] YYYY-MM Lot name The lot name of the manufacturer must be added to this symbol.
- Page 29 USER MANUAL (Instruction for Use) SW 2.9 Safety Further labelling of the equipment Sign Explanation Where placed Logo of SCHWIND eye-tech-solutions Console Warning label Bottom plate of the console Before opening disconnect mains Back side of the Mains supply label 115V...
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Page 30: Introduction
Carriazo-Pendular Microkeratome with its blades and its accessory disposable tubings. As far as Carriazo-Pendular is used in combination with an excimer laser during intrastromal surgery of type LASIK, the side-effects relevant to LASIK must also be considered . -
Page 31: Contraindications For Lasik
Contraindications for LASIK Regarding the contraindications - please refer to information contained in the provided “Treatment Guideline Carriazo-Pendular” chapter 3.3 (included on the Product Documentation DVD). Version 2.9.7 dated 2020-12-23 Page 31 of 75... -
Page 32: Device / System Description
(Instruction for Use) SW 2.9 Device / System Description DEVICE / SYSTEM DESCRIPTION System Overview The Carriazo-Pendular microkeratome is a medical device for creating a corneal lamella. The main components of the Carriazo- Pendular microkeratome are: Hand piece consisting of: ... -
Page 33: Product Features And Components
The cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a higly prdictable flap thickness and very smooth cutting edges. -
Page 34: Disposable Blades
The sterile disposable blades are delivered in a sterile packaging with blade case to protect them from damage. The sterile (primary) packing may be opened prior to treatment only. For additional information the packaging and labelling of Carriazo-Pendular Disposable Blades refer to chapters 2.10.2 and 2.10.3. -
Page 35: Suction Ring
/ severe surgical consequences or may damage the Carriazo- Pendular head. IMPORTANT NOTE SCHWIND cannot be held liable for damages resulting from the use of disposable blades more than once and/ or the use of blades from other manufacturing sources. -
Page 36: Drive Motor
Made of surgical stainless steel and glass. Especially designed for the requirements of the Carriazo-Pendular. The tonometer delivered with the SCHWIND Carriazo- Pendular consists of a conical shaft of glas, a silicone retaining ring and a slip ring handle. There is an Carriazo-Pendular tonometer engraved ring reticle on the endpoint of the shaft indicating a predetermined intraocular pressure of 65 mmHg. - Page 37 (Instruction for Use) SW 2.9 Device / System Description Automatic test of Carriazo-Pendular drive motor prior to the cutting procedure (treatment). Continuous monitoring of motor motion and automatic failure detection. Continuous vacuum monitoring during treatment. Acoustic warning indication of vacuum irregularities.
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Page 38: Foot Pedal
USER MANUAL (Instruction for Use) SW 2.9 Device / System Description (1) Serial Connector: (2) Foot pedal socket: Safe screwed connection to foot pedals (3) Secondary fuse F3 (4) Accu charging fuse F4 (5) Primary fuses F1, F2 and Power Supply Socket with indicator of the selected input voltage. -
Page 39: Monitoring Software
The tubings are intended to establish and maintain a partial vaccum within the suction chamber of the SCHWIND suction ring in order to fix its position on the eyeball and in order to remove tear liquid and wash or moisten liquids commonly used in refractive surgery from the eye and guide them into the vaccum chamber of the tubing. -
Page 40: Lid Speculum
Use of disposable tubings which are not original SCHWIND disposable tubings may result in major or severe surgical consequences, may damage the Carriazo- Pendular. SCHWIND cannot be held liable for damages resulting from the use of disposable tubings more than once and/ or the use of tubings from other manufacturing sources. -
Page 41: Approved System Combinations
We cannot guarantee compatibility of other lid speculums due to the possibility of collision between the lid speculum and the Carriazo-Pendular cutting head or and/or the motor during tilting movement while cutting. Extreme cases could result in complications with the cut. -
Page 42: Installation
SW 2.9 Installation INSTALLATION General Notes This chapter describes the delivery, unpacking and installation of the Carriazo-Pendular microkeratome. IMPORTANT NOTE Please contact your authorized local SCHWIND representative or the Service Department of SCHWIND eye-tech-solutions to organize the installation of the software and/or device. -
Page 43: System Requirements
The devices have been packed properly and in perfect condition at the factory after conclusion of all examinations. The several components of the Carriazo-Pendular are packed separately and can be shipped by air, by forwarding agency or as direct delivery. -
Page 44: Unpacking And Checking The Delivery
5.3.3 Unpacking and Checking the Delivery Upon delivery of the device, inform SCHWIND eye-tech-solutions in Kleinostheim or your responsible representative in order to organize the installation by our service technicians/engineers. After delivery of the device units, check immediately for outside damages to the boxes and its completeness. -
Page 45: Transportation Damages
In case of outer damage, transporting agent has to be informed, to check damage and record it on the delivery note. In any case of damage call SCHWIND eye-tech-solutions or responsible representative immediately to prepare a report with cost estimation for the insurance. ... -
Page 46: Transportation To Another Location
USER MANUAL (Instruction for Use) SW 2.9 Installation Unauthorized starting of initial installation/start-up or use of the device invalidates the warranty. Do not install any devices other than those defined in the prescribed system combination (refer to chapter 4.5). Transportation to another Location If you intend to transport the microkeratome to a new location, observe the following points: ... -
Page 47: Operation
Use the system only in a room with a compatible electrical supply. Correct operation of the medical device is necessary to ensure safe service life. The handling and operation of the Carriazo-Pendular and control features in any other way as described in this User Manual may cause dangerous exposure! Version 2.9.7 dated 2020-12-23... -
Page 48: Device Operation
USER MANUAL (Instruction for Use) SW 2.9 Operation Observe further notes in chapter 2.3 Restrictions of Use and Safety Precautions and installation notes in chapter 5 Installation. Device Operation 6.2.1 Assembling the Microkeratome, Vacuum Test The assembling of the microkeratome, connection the disposable tubing, the vacuum test - are described in the manual “Treatment Guideline”. -
Page 49: Disconnection From The Electronic Circuit
USER MANUAL (Instruction for Use) SW 2.9 Operation IMPORTANT NOTE To switch off the console to zero potential, unplug the system from the power supply. IMPORTANT NOTE If the device is intended to be switched off over a longer period, use the main switch to shut off the device completely. -
Page 50: Software Operation
VAC-Pedal can be used to test the vacuum, once after switching on the console, or to start the operation: “microkeratome” “Low battery alert!” The accumulator is empty and the Carriazo-Pendular will switch off automatically. “System will shut down!” Check the Accu charging fuse (f4) on the rear side. -
Page 51: User Menu
The User Menu can be activated by pressing the ‘menu’ button. In the User Menu it is possible to display and modify user parameters of the Carriazo-Pendular. The values can be modified by pressing the ‘edit/store’ button and then pressing either the ‘up’ or ‘down’ button. The modified value will be stored by pressing the ‘edit/store’... -
Page 52: System Supervisor & Error Table
USER MANUAL (Instruction for Use) SW 2.9 Operation The operation can only be started when the vacuum is lower than “Max vacuum OP start” the Max OP start vacuum. As long the vacuum is higher the XXX mmHg system will produce a beep sound. STD: 620 mmHg MAX: 675 mmHg The operation can only be started when the vacuum is higher... - Page 53 USER MANUAL (Instruction for Use) SW 2.9 Operation Error No. Display 1 Display 2 Internal voltages “Change battery!” “Send system to service”. “Clock battery!” “Changed during next service (TSC)”. “Missing Voltage +5V/A” “Send system to service”. “Missing Voltage +15V” “Send system to service”. “Missing Voltage -15V”...
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Page 54: Vacuum Level And Atmospheric Pressure
USER MANUAL (Instruction for Use) SW 2.9 Operation Error No. Display 1 Display 2 “Vacuum loss detected!” “Create proper vacuum to continue procedure!” “Vacuum loss detected!” “Create proper vacuum to cont reverse motion”. “Vacuum loss! STOP!” “Remove head carefully and slowly from the eye!” “Vacuum loss! STOP!”... -
Page 55: Assembly Of The New Disposable Blade
USER MANUAL (Instruction for Use) SW 2.9 Operation Assembly of the New Disposable Blade The assembly of the new disposable blade is described in the Pendular User Information No. 01- 07 “Assesmlby Instructions for new Disposable Blade”. Follow also the instructions given below: ... -
Page 56: Treatment
(Instruction for Use) SW 2.9 Treatment TREATMENT Please take the information regarding treatment with the Carriazo-Pendular from the applicable document “Treatment Guideline” included on the SCHWIND Product Documentation DVD no. 163160x. CLEANING AND REPROCESSING Cleaning and Reprocessing of Resterilisable Parts, Accessories and... - Page 57 The user/operator is responsible for the disinfection, cleaning and sterility of the system and must ensure that only proper cleaning and disinfection solutions and utilities are employed, and that only product-specific pre-processing instructions and parameters are used as recommended by SCHWIND. Furthermore, national laws, regulations and recommendations, as well as cleaning instructions of the respective hospital, should be regarded.
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Page 58: Manual Cleaning And Disinfection Of The Console And Foot Switch
USER MANUAL (Instruction for Use) SW 2.9 Cleaning and Reprocessing 8.2.2 Manual Cleaning and Disinfection of the Console and Foot Switch The console and the footswitch do not come in contact with the patient. If necessary, wipe all surfaces of the console and the foot switch with a lint-free cloth dampened with disinfection solution. - Page 59 USER MANUAL (Instruction for Use) SW 2.9 Cleaning and Reprocessing For disinfection, wipe all sides of the electric motor/drive and the cable with a lint-free cloth dampened with disinfection solution. Before treatment, check the motor for oscillation and movement! Refer to manual Treatment Guideline.
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Page 60: Maintenance, Function Control And Storage
All repair and service works, including regularly performed technical inspections and services, may only be performed by persons authorized by SCHWIND eye-tech- solutions GmbH Opening of the equipment is permitted only by trained maintenance staff. -
Page 61: Technical Safety Check (Tsc)
Maintenance, Function Control and Storage WARNING Device damage! Risk of injury No modification of the Carriazo-Pendular equipment is allowed. Unauthorized changes to any component of the device without the supplier’s authorization may result in device damage or operator/patient injury. Technical Safety Check (TSC) Technical safety inspections will be carried out at regular intervals by our authorized Service Representatives and documented in the Medical Device Logbook (Medical Apparatus Book). -
Page 62: Test Protocol Of Technical Safety Check
9.1.3 Maintenance Intervals The system has to be send to SCHWIND eye-tech-solutions for Technical Safety Check (TSC) every 12 month. The label on the console and a warning message in the display will remember on the renewal date. -
Page 63: Changing Fuses
USER MANUAL (Instruction for Use) SW 2.9 Maintenance, Function Control and Storage Changing Fuses There are two types of fuses for different power supply voltage: For 110 V: use T 3.15 AL fuse For 230 V use T 1.6 AL fuse To change the fuses and to select the correct voltage, the following steps have to be carried out: Disconnect power... -
Page 64: List Of Parts
Sterilisation tray Plastic holder for Carriazo-Pendular drive All autoclavable parts like suction ring, cutting For upright storage of the Carriazo-Pendular head, motor cover etc. motor (no cutting head mounted) CAUTION Do not store wet parts in plastic bags in the instrument etui! -
Page 65: Lifetime
Disposal Upon reaching the end of its lifetime, the Carriazo-Pendular is considered to be metal and electronic scrap and should be appropriately disposed off according to European Directive 2002/96/EC (Waste Electrical and Electronic Equipment – WEEE) (Regulation valid for EEC countries;... -
Page 66: Technical Data
Fuse F4 T 3.15 AL / 250 V Environmental Conditions Temperature: 15 - 35 °C (only Carriazo-Pendular, consider “Room and Installation Requirements for laser surgery”) Humidity: up to 60 % (only Carriazo-Pendular, consider “Room and Installation Requirements for laser surgery”) ... -
Page 67: Reference To Standards
USER MANUAL (Instruction for Use) SW 2.9 Reference to Standards REFERENCE TO STANDARDS Standards Content German Medical Device Law 93/42/EWG EU Medical Device Directive EN14971 Medical devices - Application of risk management to medical devices EN60 601-1 Medical electrical equipment - Part 1: General requirements for safety EN60 601-1-2 Medical electrical equipment –... -
Page 68: Emc Guidance And Manufacturer's Declaration
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC). The SCHWIND Carriazo-Pendular has been tested and found to comply with the limits defined in the IEC 60601-1-2 standard (version 2014) for devices classified as Group 1, Class A according to the CISPR 11 standard. - Page 69 Guidelines and declaration of conformity – electromagnetic emissions The Carriazo-Pendular is intended to be used in the electromagnetic environment specified below. The customer or the user of the Carriazo-Pendular should assure that it is used in such an environment. Electromagnetic...
- Page 70 ENVIRONMENT. The electromagnetic environment is specified below. The customer or the user of the Carriazo-Pendular should assure that it is used in such an environment. The Carriazo-Pendular is not intended to be used in exclusions, such as hospitals with near active HF SURGICAL EQUIPMENT and RF shielded rooms of an ME System for magnetic resonance imaging or other environments where the intensity of EM DISTURBANCES is high.
- Page 71 (Equipment and systems that are not life-supporting) The Carriazo-Pendular is intended to be used in the electromagnetic environment specified below. The customer or the user of the Carriazo-Pendular should assure that it is used in such an environment. Immunity test...
- Page 72 USER MANUAL (Instruction for Use) SW 2.9 EMC Guidance and Manufacturer’s Declaration Additional special test frequencies for Radiated RF: Version 2.9.7 dated 2020-12-23 Page 72 of 75...
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Page 73: Essential Performance
Essential Performance Basic safety and essential performance: According to the intended use the purpose of the Carriazo-Pendular is to create a corneal flap in LASIK and to shave the cornea prior to lamellar transplant. Table 4: ESSENTIAL PERFORMANCE ACCORDING TO IEC 60601-1-2 (2014) clause 5.2.1.1 b) -
Page 74: List Of Replacable Cables And Components
USER MANUAL (Instruction for Use) SW 2.9 EMC Guidance and Manufacturer’s Declaration 12.3 List of Replacable Cables and Components Cables and components according to the following table are likely to affect compliance of EMC and have to be replaced as specified. Table 5. -
Page 75: Manufacturer
MANUFACTURER 13.1 Technical Assistance / Application Support SCHWIND eye-tech-solutions offers a comprehensive warranty and service support program. Included in this program is our service package. Highly qualified representatives from our SERVICE and CUSTOMER SUPPORT departments are available to support you and to solve any operational questions.
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