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SCHWIND Carriazo-Pendular, User Manual

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SCHWIND Carriazo-Pendular User Manual Download Page 16

 

USER MANUAL 

(Instruction for Use)

 

SW 2.9

 

Safety 

 

 

Version 2.9.7 dated 2020-12-23

 

Page 16 of 75 

_ 

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. 

 

Summary of Contents for Carriazo-Pendular

Page 1: ...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 _ ...

Page 2: ...or 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 a...

Page 3: ...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 2 SAFETY 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 ...

Page 4: ...4 DEVICE 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 Di...

Page 5: ... 6 5 Assembly of the New Disposable Blade 55 7 TREATMENT 56 8 CLEANING 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 Disinfecti...

Page 6: ... 20 Figure 2 3 Example of type label Carriazo Pendular disposable blades secondary packaging21 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 fro...

Page 7: ...ial 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 Kl...

Page 8: ... also the following related documents listed below o Treatment Guideline Carriazo Pendular o Reprocessing Instruction for Resterilisable SCHWIND Products o User Manual Monitoring Software o Assembly 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 ...

Page 9: ...e 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 pr...

Page 10: ...essories 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 suita...

Page 11: ... 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 eith...

Page 12: ...ies 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 lac...

Page 13: ...nology 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 us...

Page 14: ...ons 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 chap...

Page 15: ...onvenience 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 su...

Page 16: ...e 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 Perso...

Page 17: ...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 ...

Page 18: ...stem 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 sho...

Page 19: ...ed 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 Infor...

Page 20: ...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 disposab...

Page 21: ...75 _ 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 ...

Page 22: ...y packaging The primary packaging includes a quantity of one sterile disposable blade Secondary Packaging pouch Position Top side of the aluminium PE peel with ten primary blade packages included Figure 2 6 Example of type label of Carriazo Pendular disposable blades secondary packaging The secondary packaging includes a quantity of ten sterile disposable blades and one desiccant bag Tertiary Pack...

Page 23: ...rtiary 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 Furthermore a sticker with a safety notice is attached to the tertiary packaging ...

Page 24: ...iazo 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 2 10 4 Type Label of the Disposable Tubings Primary Packaging Label singular packed tubings Each primary tubing package is identified with one label The primary...

Page 25: ...or Use SW 2 9 Safety Version 2 9 7 dated 2020 12 23 Page 25 of 75 _ 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 ...

Page 26: ...ging accommodates 10 primary packaged products 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 ...

Page 27: ...n part type B applied Consult operating instructions electronic instructions for use Read operating instructions Consider accompanying documents Manufacturer in accordance with Medical Device Directive 93 42 EEC yyyy Year of manufacture Serial number Article number Datamatrixcode International article number This product is labelled with this symbol in accordance with European Directive 2002 96 EC...

Page 28: ...e symbol Single use only Storage conditions Do not use in case of damaged packaging Product does not contain any pyrogenic particles FREE OF NATURAL RUBBER LATEX does not contain natural rubber latex Do not use in case of damaged packaging PRODUCT CONTAINS DEHP This product contains the plasticiser DEHP As means of precautions the application of medical products containing DEHP should be restricte...

Page 29: ... Explanation Where placed Logo of SCHWIND eye tech solutions Console Warning label Before opening disconnect mains Bottom plate of the console Mains supply label 115V Back side of the console Mains supply label 230V Back side of the console Maintenance intervals for the next TSC Two pieces On the console front label and foot switch ...

Page 30: ...excimer laser during intrastromal surgery of type LASIK the side effects relevant to LASIK must also be considered1 Regarding possible side effects arising from the treatment planning with diagnostic devices and or laser treatment please also refer to the documentation of the appropriate diagnostic devices and or the excimer laser Application of Carriazo Pendular Microkeratome with its blades and ...

Page 31: ...ction treating Retinal detachment detachment of the vitreous gel IMPORTANT NOTE Even when everything goes perfectly there are effects that might cause some dissatisfaction Side effects and complications are not limited to this list Please inform yourself about additional side effects and complications from relevant technical literature and medical associations 3 3 Contraindications for LASIK Regar...

Page 32: ... and 4 4 Hand piece Console control unit 4 2 Principle of Cutting Carriazo Pendular is based on the principle of convex applanation of the cornea protecting the center during the cut Drop and Go advantageous quick coupling of suction ring and cutting head in front of the patient s eye facilitates surgery on patients with deep set eyes The cut can be initiated immediately after the bilateral coupli...

Page 33: ...ter than in the periphery This technology provides a higly prdictable flap thickness and very smooth cutting edges Made of surgical stainless steel Cutting head without external gears Driven by two separate powerful electric motors Ingenious pendulum drive system Different thicknesses of cutting head Choice of 360 hinge position Automated cutting Simple connection between cutting head and suction ...

Page 34: ...Manual Advantages of the 90 m cutting head Thin flap LASIK combines advantages of Standard LASIK and LASEK PRK Highly predictable flap thickness Preserving a greater quantity of stromal tissue which allows a safer correction of higher myopia levels Ideal for patients with thin corneas CAUTION Pay more attention using the 90 m and 110 m cutting heads It requires more skill and experience of the sur...

Page 35: ...Annex I Section 13 6 h Do not use blades when the sterile packing is damaged or already open Used blades should be put back into the box to prevent any injuries Do not use disposable blades from other suppliers Only disposable blades supplied by SCHWIND can be used with the device The use of other disposable blades can result in malfunctions Use of disposable blades which are not original SCHWIND ...

Page 36: ... There is an engraved ring reticle on the endpoint of the shaft indicating a predetermined intraocular pressure of 65 mmHg For details regarding the application of tonometer refer to the Treatment Guideline 4 3 7 Console Control Unit The console as control unit is a microprocessor controlled unit with multiple functions for monitoring and documentation as well as an interactive display It indicate...

Page 37: ...g up Selects previous item of the menu or increases the value which is currently alternating in the display down Selects next item of the menu or decreases the value which is currently alternating in the display edit store Allows editing the currently displayed parameter to change the value by the use of up down buttons After the changes have been done the alternating parameter will be stored eith...

Page 38: ...d to 110 120V indication 115V or 230V refer to chapter 9 3 Changing Fuses 4 3 8 Foot Pedal 1 Forward Pedal Forward motion of cutting head with blade oscillation Motion stops when the pedal is released 2 Reverse Pedal Reverse motion of the cutting head without oscillation of the blade Motion stops when the pedal is released 3 VAC Pedal Press and release the pedal once to activate the vacuum press a...

Page 39: ... range provided by Carriazo Pendular tubings may withstand evacuation up to 675 mmHg 900 mbar at sea level The connectors are such that they can be connected with a SCHWIND suction ring on the one side and with the Carriazo Pendular console on the other side The tubings are intended to establish and maintain a partial vaccum within the suction chamber of the SCHWIND suction ring in order to fix it...

Page 40: ...ex I Section 13 6 h Do not use tubing when the sterile packing is damaged or already open Do not use the tubing as a suction device to remove water from the patient s eye The fluid absorber is an important safety device which will not work properly when filled with fluids Do not use disposable tubing from other suppliers Only disposable tubing supplied by SCHWIND can be used with the device The us...

Page 41: ... could result in complications with the cut CAUTION Use only lid speculums which are recommended and provided by SCHWIND eye tech solutions Use of lid speculums which are not original provided from SCHWIND eye tech solutions may result in severe surgical complications SCHWIND cannot be held liable for damages resulting from the use of a lid speculum from other manufacturing sources 4 5 Approved Sy...

Page 42: ...rvice personnel of SCHWIND eye tech solutions will perform the initial installation start up of the Carriazo Pendular as well as instruction in operating the system Unauthorized starting of initial installation start up or use of the device invalidates the warranty CAUTION Allow the whole system to adapt to the operating environment temperature humidity etc before you start your treatments CAUTION...

Page 43: ...rt no 202160x 01 EN 202160x 02 DE refer to chapter 1 4 Scope of Documentation Content of the box with instruments o Motor motor cable cutting head pendulum axis tonometer suction rings lid speculum forceps and sterilizable motor cover 5 3 2 Packing of the Shipping Units The packing boxes and materials have been especially designed for best protection of the contents The devices have been packed pr...

Page 44: ...e 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 A service technician of SCHWIND eye tech solutions will carry out checking and inspection of the device and its components for damage and completeness according to delivery list If the device or its parts have to be ...

Page 45: ... to the technical data listed in chapter 10 Technical Data CAUTION When installing the medical system take care of allowing sufficient space between the system and other medical devices which may be situated in the same treatment room Electrostatic processes can damage electronic assemblies 5 5 Device Installation Start Up Unpacking connection of the system components to the Carriazo Pendular init...

Page 46: ...ecurely fasten the system components and or accessories such as foot switch head set using packing tape to prevent damage of the components or injury of personnel Place the system carefully on a mobile cart and transport it Avoid bumps and heavy vibrations Re check the system functions after connecting all components and perform calibration or test procedure of the device as required in the respec...

Page 47: ...the console screen Consult your nearest authorized SCHWIND eye tech solutions distributor or the SCHWIND eye tech solutions Service Department in case of any questions regarding this subject CAUTION Do not use portable multiple socket outlets sharing a common grounding cable to connect several devices together with this device to mains Do not use multiple cables or any other extension cables Only ...

Page 48: ...e provide mains voltage and check the selected voltage in combination with the corresponding fuses on the rear of the console 3 Connect mains to load the internal UPS The standby is indicated by the green charge LED on the front display 4 Connect the foot pedal to the electronic console and tighten the connector 5 Connect the motor cable for the cutting head to the console 6 Connect the sterile tu...

Page 49: ...em 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 Otherwise the device switches off automatically after 90 minutes 6 2 4 Disconnection from the Electronic Circuit Complete separation from the electronic circuit is only possible by unplugging the main power cord ...

Page 50: ...Pedal can be used to test the vacuum once after switching on the console or to start the operation Low battery alert System will shut down The accumulator is empty and the Carriazo Pendular will switch off automatically Check the Accu charging fuse f4 on the rear side Check the mains cable connection to net Vacuum off Motor test mode reverse Message appears if vacuum is off and the reverse pedal i...

Page 51: ...g blade End stop reached Press reverse pedal Head has reached the final stop position you will hear an OK melody Reversing to home pos XXX mmHg Head moves backwards and will automatically stop when reaching the upright position You will hear an OK melody 6 3 2 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 ...

Page 52: ...ff when it is out of use STD 90 min MIN 10 min MAX 90 min Firmware V2 9 System information End of User menu Select with arrow keys 6 3 3 System Supervisor Error Table In case of an error the system will display the Error number Date and time and a brief error description Display 1 After a few seconds the display will start alternating showing additional information how to proceed Display 2 Error N...

Page 53: ... too high System on room temp Water in vac system Pendular drive 40 Motor current missing Check connections Change motor or cable 41 Reverse motion blocked Release blockade by removing drive from head Not displayed information Check connection drive head Check condition of axis wear out Check for foreign particles 42 Drive obstructed dirty Clean worm wheel and its bearing 43 Drive is blocked Clean...

Page 54: ... communication Repeat data transfer Handpiece detection 80 Wrong handpiece Switch the vacuum off Set the right handpiece 81 Unknown handpiece Switch the vacuum off Check the motors From SW 2 8 not applicable 6 4 Vacuum Level and Atmospheric Pressure The vacuum level provided by the console depends on the local atmospheric pressure thus on the altitude The atmospheric pressure decreases with the al...

Page 55: ...low also the instructions given below Press blade box and cutting head together with your fingers as shown by the arrows in the figure It is only possible to fixate the head by pressing below the Pendular axis During insertion of the blade into the head a direct plane parallel contact of head and blade box is mandatory If the blade stuck in spite of following the instruction please move blade back...

Page 56: ... o Automatic pendulum axis drive gear o Sterilisation tray o Plastic holder for Pendular drive Refer to the manual Reprocessing Instructions for resterilisable SCHWIND Products included on the SCHWIND Product Documentation DVD no 163160x 8 2 Cleaning and Disinfection of non sterile Parts Accessories and Components The following non sterile parts components and accessories will be cleaned and disin...

Page 57: ...frame recommended by the manufacturer Do not use solutions with visible contamination Do not use abrasives scrapers or brushes for cleaning This can lead to reduced precision of the parts and to unforeseen damage The parts and components are highly precise sensitive instruments They should be handled with special care The drive motor and the drive motor cable may not be sterilized neither with an ...

Page 58: ...ng brush and distilled water to remove residue Hold the motor assembly so that the motor is at the bottom under flowing distilled water as shown in the picture on the right At the same time clean the drive for at least 1 minute with the cleaning brush Always hold the motor assembly with the motor toward the bottom in order to avoid water intrusion The electric drive and the motor cable may not be ...

Page 59: ...mended to store the motor in an upright or vertical position This method applies only to those parts which will not come into direct contact with the patient as well as to those parts which for technical reasons the standard procedure of soaking pre cleaning followed by automatic disinfection cleaning cannot be applied CAUTION Do not use abrasives scrapers or knives for cleaning This can lead to r...

Page 60: ... valid and existing dealership agreement If for any reason the dealership agreement is terminated the authorization of the customer service technician is also automatically terminated Carrying out of service works as well as technical inspections and service through unauthorized persons leads to forfeiture of any claim of warranty guarantee or liability against SCHWIND eye tech solutions GmbH The ...

Page 61: ...nadequacies are found at a technical inspection which can affect the safety of patients users or third parties the device must not be used until the deficiencies have been eliminated 9 1 1 Maintenance of Batteries and Accumulators a Clock battery Type CR2430 3V No maintenance or exchange by the user Battery to be changed by trained service personnel only Is routinely yearly changed in the TSC b Ac...

Page 62: ...ing regular checks are to be carried out by the USER during the operation time of the Carriazo Pendular Visual inspection of device and accessories components Checks device parts as listed below Check the cutting head on irregularities and scratches respectively on the surface for applanation Check the automatic pendulum axis This pendulum axis can wear out during its regular work Check all drives...

Page 63: ... Disconnect the power plug on the rear side of the console Consider the selected voltage which is shown in the small red window Open the black cover next to the fuses by using a screwdriver Unplug the red fuse holder by using a screwdriver At the left and right side of the red fuse holder are the fuses which can be now replaced Pay attention to the position of the fuses After insertion of the red ...

Page 64: ...uld be cleaned and stored in a dry non corrosive atmosphere Sterilisation tray All autoclavable parts like suction ring cutting head motor cover etc Plastic holder for Carriazo Pendular drive For upright storage of the Carriazo Pendular motor no cutting head mounted CAUTION Do not store wet parts in plastic bags in the instrument etui Danger of corrosion For storage of your instruments use the ste...

Page 65: ... 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 Please consider the valid national regulations The device must be disposed off separately from other household waste Please contact your local authority or waste disposal service for the return and re...

Page 66: ...Hz or 220 240 VAC 50 60 Hz Power consumption 0 6 A 120V AC 0 3 A 230 V AC Fuses F1 F2 120V 2 x T3 15AL 250 V 240V 2 x T1 6AL 250 V Fuse F3 T 3 15 AL 250 V 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 la...

Page 67: ...Validation and routine control of sterilization by irradiation EN 11137 2 Sterilization of health care products Radiation Part 2 Establishing the sterilization dose EN 11607 1 Packaging for terminally sterilized medical devices Part 1 Requirements for materials sterile barrier systems and packaging systems EN 11607 2 Packaging for terminally sterilized medical devices Part 2 Validation requirement...

Page 68: ...ly affect medical electrical equipment Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the Carriazo Pendular including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result For Information about respective frequency range and th...

Page 69: ... 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 emission Compatibility Electromagnetic environment standards RF emission CISPR 11 Group 1 The Carriazo Pendular uses RF energy for its internal fun...

Page 70: ...4kV 8kV 15kV air Refer to NOTE 1 Floor should be according to the guidance Room Requirements If floor is covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1kV for input output lines 100kHz repetition frequency 2 kV for power supply lines Refer to NOTE 2 1kV for input output lines 100kHz repetition f...

Page 71: ...ystems 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 IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150kHz to 80MHz ...

Page 72: ...USER MANUAL Instruction for Use SW 2 9 EMC Guidance and Manufacturer s Declaration Version 2 9 7 dated 2020 12 23 Page 72 of 75 _ NOTE 6 Additional special test frequencies for Radiated RF ...

Page 73: ...ce is lost or degraded due to EM disturbances Protective Measure Control of the cutting head for oscillation of the blade Damage of the eye loss of visual acuity and cicatrisation Protective system for observation of the motor current of the blade oscillation Test function before treatment start Control of the cutting head for integrated feed of the cutting head Damage of the eye loss of visual ac...

Page 74: ...affect compliance of EMC and have to be replaced as specified Table 5 REPLACABLE CABLES AND COMPONENTS Port Description Classification Cable type Cable length used Cable length maximum AC Power in Mains cable AC power Unshielded 3 m Motor out Motor supply cable signal control Unshielded 2 5m Foot switch Cable of foot switch signal control Shielded 3 5m 1m Serial D Sub Connector Serial port for ser...

Page 75: ...y questions please do not hesitate to contact our Service Hotline The Service Hotline is free of additional charges only regular telephone charges Our customers outside of Germany should use the service hotline provided by our local distributor or authorized Service Representative first SCHWIND eye tech solutions GmbH Tel 49 0 6027 508 0 Fax 49 0 6027 508 208 E mail info eye tech net www eye tech ...

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