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Summary of Contents for Keeler Cryomatic MKII
- Page 1 Keeler MKII Cryosurgical console Instructions for use Next Next...
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Page 2: Table Of Contents
5. Controls, indicators and connections ........ 11 • Electrical specifications 6. Installation and commissioning ......... 12 • Pneumatic specifications • Preparing the Cryomatic MKII for use • Transport, storage and operation 7. Operation 13. Annex I – EMC statement and guidelines ......27 •... -
Page 3: Copyright And Trademarks
As part of our policy for continued product development we reserve the right to make changes to specifications and other information contained in this document without prior notice. Cryomatic MKII is a registered trademark of Keeler Ltd 2013. Copyright © Keeler Limited 2013. Published in the UK 2013. -
Page 4: Introduction
Intended use Thank you for purchasing your Keeler Cryomatic MKII. The Keeler Cryomatic MKII System and probes are for use in We have taken the greatest care in the design, development and ophthalmic surgery such as cryopexy for retinal detachment, cyclo... -
Page 5: Product Description
Disposable and reusable Cryo probes are connected to the probes which are connected to the console for use. The re-usable Cryomatic MKII console via a simple quick release coupling. The Cryo probe can be sterilized by autoclaving or other approved system will not operate until this connection is correctly made. -
Page 6: Symbols
3. Symbols Read user instructions for warnings, cautions and High voltage additional information Trip hazard The CE mark on this product indicates it has been tested to and conforms with the provisions noted 0088 Pressurized cylinder within the 93/42/EEC Medical Device Directive Freeze hazard Consult instructions for use Non-ionizing radiation... - Page 7 3. Symbols Screen Icons Used On The Equipment Symbols used on the equipment All symbols used are in accordance with BS EN60417-2:1999 Gas cylinder status. (Graphical Symbols for use on Equipment). This symbol contains an activity bar whenever the gas supply is being checked.
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Page 8: Safety
Copies of these guidelines will be • Check your Cryomatic MKII for signs of transport / storage available from the gas supplier. damage prior to use Ensure the correct disposition of gas exhausted from the system •... - Page 9 4. Safety Caution Switch off the electrical supply and disconnect from the • Use only genuine Keeler approved parts and accessories or mains electrical supply before cleaning and inspection device safety and performance may be compromised • Do not use hypercarbonate or phenolic based cleaning •...
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Page 10: Safety Considerations
4. Safety Safety considerations Ensure the equipment is positioned in such a way that it can be disconnected from the mains easily. Before you connect system to the mains socket, carefully read and understand all the installation instructions in Section 6. For your own safety and the safety of the equipment, always take the following precautions: The system has been designed to comply with the following... -
Page 11: Controls, Indicators And Connections
Activates system: Reusable: Initiates purge cycle prior to use. Disposable: Ready for use. Mutes/un-mute audio during use. 2 Cryomatic MKII Graphical LCD used to provide Display Screen system information to the user; such as probe information, gas cylinder status and freeze time. -
Page 12: Installation And Commissioning
Connect high-pressure hose to the inlet connector (7) at the rear If any of these parts are missing, contact your distributor of the Cryomatic MKII system using the adjustable wrench that immediately. has been provided. Ensure that the coupling is tightened adequately (see page 13). - Page 13 Keeler recommends fitting a regulator, set below 83bar, procedure. The console cylinder symbol flashes to indicate empty between the cylinder and the Cryomatic MKII console to prevent when the gas supply pressure drops below 450 PSI/31 Bar (2415 overpressure due to temperature variations in the cylinder.
- Page 14 6. Installation and commissioning Electrical Supply The Cryomatic MKII system requires connection to a mains electrical supply for operation. Only a hospital grade 3-conductor electrical power supply cable must be used. For USA and Canada: Detachable power supply cord set, UL listed, type SJE, SJT or SJO, 3-conductor, not smaller than 18 AWG.
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Page 15: Operation
The equipment is now at REST. The Cryo Probe can now be connected. Before using the Cryomatic MKII system, make sure it has been correctly installed in accordance with Section 6. The collar will move in a clockwise direction indicating that the probe is correctly locked. -
Page 16: Cryo Probe Connection
7. Operation Cryo Probe Connection To proceed, the Run button must be pushed. If a reusable probe has been connected, the system Observe sterilization protocol before using a Cryo probe (see automatically initiates a purging cycle of 90 seconds. section 9). Allow Cryo probe to cool to room temperature after During the purge cycle an animated Wait Symbol is a sterilization. -
Page 17: Freeze/Defrost Cycles
The freezing function is often accompanied by a characteristic is disconnected. It is not recommended that the Cryo probe is ‘pulsing’ sound which indicates that the Cryomatic MKII is disconnected during use. regulating the gas to the optimum pressure for the probe. -
Page 18: Mute Function
(see Section 5 [1]). Fault Conditions The Cryomatic MKII system has the ability to detect a range of system faults. In the unlikely event of a fault condition arising, the fault symbol icon will flash and a short error message will be displayed. -
Page 19: Cryo Probes
8. Cryo probes The following ranges of ophthalmic Cryo Probes may be used with the Cryomatic MKII. Disposable Probe Special Probe Range Part No. Description Part No. Description 2509-P-8022 2.5mm Mid Reach Retinal Probe 2508-P-7022 Box of 10 Single Use... -
Page 20: Cleaning And Sterilization
9. Cleaning and sterilization Device All reusable Cryo Probes supplied by Keeler Ltd. As part of the Keeler Cryomatic MKII ophthalmic cryosurgery system. Warnings and Precautions General Cryo Probes are precision instruments and should be handled with care at all times. It is import that the flexible hose does not become kinked during normal use, storage, transportation or reprocessing. -
Page 21: Steam Sterilization
Visually inspect for damage and wear. Check probe tips for signs of bending, distortion or other damage. Connect Cryo Probe to Function Testing ‘Cryomatic MKII’ console to check correct and smooth function of probe quick release coupling. Packaging Paper autoclave bag meeting ISO 11607 requirements with chemical indicators meeting ISO 11140-1, or follow guidance provided in ANSI/AAMI ST79 - Refer to the product-specific instruction manual for compatibility with steam sterilisation. -
Page 22: Cleaning The Console
Warning: Switch off the electrical supply to the console and disconnect The Cryomatic MKII console can be cleaned using a disposable the power cord from the mains supply before cleaning and cloth soaked in mild detergent and warm water. Do not use inspection. -
Page 23: Servicing And Preventative Maintenance
Inspecting the high pressure hose and exhaust hose for signs User Maintenance - Console of damage before each use. There are no user serviceable parts in the Cryomatic MKII console, operator maintenance is restricted to cleaning the All repairs should be carried out only by Keeler trained console surface. -
Page 24: Troubleshooting Guide
11. Troubleshooting guide The following table provides a troubleshooting guide for the Cryomatic MKII system in the event of minor problems. If the problem is not cleared then the supplier must be contacted for further assistance. In the unlikely event that the probe fails to defrost, immediately switch off the console and apply saline solution to the probe. - Page 25 11. Troubleshooting guide The following table provides a troubleshooting guide for the Cryomatic MKII system error messages. Error message Possible cause Corrective action F-01 Gas Check Fault Faulty valves and/or pressure sensors. Contact distributor or manufacturer for assistance. F-02 P2 Error Pressure sensor error.
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Page 26: Specifications And Electrical Ratings
12. Specifications and electrical ratings Cryo System Transport, storage and operating conditions Gas Specification Medical grade Nitrous Oxide (N O) or Transport Storage Operation Medical grade Carbon dioxide (CO ) in Temperature range -40°C to -10°C +10°C Non-syphonic cylinders +70°C to +55°C to +40°C Operating range... -
Page 27: Annex I - Emc Statement And Guidelines
13. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic emissions The Cryomatic is intended for use in the electromagnetic environment specified below. The customer or user of the Cryomatic should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance... - Page 28 13. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic immunity The Cryomatic is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level...
- Page 29 13. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic immunity The Cryomatic is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level...
- Page 30 13. Annex I – EMC statement and guidelines Recommended separation distances between portable and mobile RF communications equipment and the Cryomatic The Cryomatic is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cryomatic can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cryomatic as recommended below, according to the maximum output power of the communications equipment.
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Page 31: Spare Parts And Accessories
14. Spare parts and accessories The following accessories are supplied with the device: The following additional accessories are available from the distributor: Part Number Description Part Number Description EP59-11410 Instructions For Use MIS094 Spare mains fuse (x2) 2508-P-7015 Pin index yoke (E Size - Carbon Dioxide) MIS100 Mains cord (UK) 2508-P-7016... -
Page 32: Warranty
15. Warranty The obligations of the manufacturer as set forth in this warranty The Cryomatic MKII and its components are covered by warranty that they meet their performance standards and are free from are expressly conditional upon the following:- any defects in materials or workmanship. Within 24 months from... -
Page 33: Contact And Disposal Information
WEEE entering landfills we encourage at product end of USA Sales Office life that this Equipment is recycled and reused. Keeler China Keeler Instruments Inc 1012B If you need more information on the collection, reuse and 3222 Phoenixville Pike...
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