Keeler MKII

1 Keeler mkii . Cryosurgical console Instructions for use Next Contents Page Page 1. Copyright and 3 8. Cryo 19 2. Introduction 9. Cleaning and 20. About this 4 Cleaning About Cryomatic mkii Steam 21. Product 5 Cleaning the 22. 3. 6 10. Servicing and preventative 23. 4. Safety Scheduled maintenance Device classification User maintenance Warnings and 8 11. Troubleshooting 24. Safety 10 12. Specifications and electrical 26. 5. Controls, indicators and 11 Electrical specifications 6. Installation and 12 Pneumatic specifications Preparing the Cryomatic mkii for use Transport, storage and operation 7. Operation 13. Annex I EMC statement and 27. 15 14. Spare parts and 31. Cryo probe 16 15. 32. Freeze/Defrost cycles 16. Contact and disposal 33. Cryo probe 17. Mute Function Fault conditions End of 18. Click on the headings above to go directly to that section. Use the buttons on the right to navigate the document.

2 Clicking Home' from any page brings you back to this contents page. Back Next 2. 1. Copyright and trademarks The information contained within this manual must not be reproduced in whole or in part without the manufacturer's prior written approval. 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. Home Back Next 3. 2. Introduction Thank you for purchasing your Keeler Cryomatic mkii . Intended use 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 manufacture of this product to ensure that you get many years of destructive procedures in refractory glaucoma, extraction of trouble free service.

3 However, it is important that you read the fragments within the vitreous cavity, cataract extraction, cryo descriptions, installation and operating instructions carefully prior destruction of lash follicles for trichiasis and treatment of to installing or using your new Cryomatic mkii . retinopathy of prematurity (ROP). About this Manual Once the Cryo probe has been correctly positioned the freeze This handbook forms the Instructions for Use for the Keeler control is activated and an ice ball is formed around the tip of the Cryomatic mkii , a clinical instrument for cryogenic ophthalmic Cryo probe and the adjacent area. surgery. It contains complete, step-by-step instructions for the Cryomatic mkii and is intended for use by trained medical personnel. This manual does not contain clinical instructions or any recommendations for medical applications. The use of the Cryomatic mkii in any surgical procedure must always be at the discretion of a licensed medical practitioner.

4 Please read and follow these instructions carefully. Home Back Next 4. 2. Introduction Product Description Cryo Probes The system comprises a control console and interchangeable Cryo 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. methods. The system requires mains electricity and Nitrous Oxide Each Cryo probe is a complete assembly and no attempt should be or Carbon Dioxide gas to function, this is the responsibility of made to dismantle or separate the coupling from the probe. the user. When the footswitch is pressed, high pressure cryogen gas is Console circulated through the Cryo probe, rapid gas expansion in the The Cryomatic mkii console is a self contained system.

5 The probe tip causes freezing according to the Joule-Thompson console provides the connection point for the Cryo probe, principle. The freezing zone of the Cryo probe is limited so that footswitch, mains electricity, gas supply and scavenging system. the iceball propagates at the tip. When the footswitch is released, Freeze cycles are controlled by the user operating the footswitch. an active de-frost is caused by the equalisation of pressure on When the footswitch is depressed the Cryo probe freezes and either side of the Joule-Thompson nozzle. The gas condenses when the footswitch is released the Cryo probe defrosts. releasing its latent heat causing a rapid de-frost. Routine functions, like purging the Cryo probe are performed automatically when the Cryo probe is connected to the system. The Cryo probe assembly is re-usable and as such is fully autoclaveable according to the procedures outlined in this manual.

6 Home Back Next 5. 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 0088 tested to and conforms with the provisions noted Pressurized cylinder within the 93/42/EEC Medical Device Directive Freeze hazard Consult instructions for use Non-ionizing radiation Manufacturer's name and address This way up This symbol on the product or on its packaging and instructions indicates that it was put on the Keep dry market place after August 2005 and that this product shall not be treated as Household Waste Fragile Type BF protections against shock Material suitable for recycling Mandatory action sign Audio active Home Back Next 6. 3. Symbols Screen Icons Used On The Equipment Symbols used on the equipment Gas cylinder status. All symbols used are in accordance with BS EN60417-2:1999 (Graphical This symbol contains an activity bar whenever the gas Symbols for use on Equipment).

7 Supply is being checked. It is solid when reporting cylinder pressure. Ready Symbol. Displayed whenever the freeze function can be activated BF (Applied Part) Fuse rating via the footswitch. Wait Symbol. Animated icon that is displayed for the duration of the Attention, consult Footswitch purge cycle. accompanying connection documents Freezing symbol. Displayed with the probe symbol while in freezing mode. Dangerous voltages present Exhaust Run. inside the connection equipment Defrosting symbol. Displayed with the probe symbol while in defrosting mode. Gas inlet AC voltage input Audible sounder enabled during freezing mode. connection Audible sounder disabled during freezing mode. Fault Condition. Remove Probe. This symbol will flash to inform the user that the probe needs to be removed. Reusable probe. Disposable probe. Home Back Next 7. 4. Safety Device classification This product should not be immersed in fluids CE Regulation 93/42 EEC: IIb Do not fit mains power adapter into a damaged mains FDA: II outlet socket Carefully read this Instruction Section before using your Keeler Route power cords safely to eliminate risk of tripping or product.

8 For your own safety and that of your customers damage to equipment observe all cautionary information provided in this section. The US Federal law restricts this device to sale by or order of a following information is intended to highlight potential safety physician or practitioner hazards that can be associated with misuse, or damage. High pressure gases are present inside unit. Maximum Warnings and cautions operating pressure 58 Bar / 650 PSI, maximum cylinder pressure 83 Bar / 1200 PSI. Warning WARNING: To avoid the risk of electric shock, this equipment Observe the usual safety precautions associated with the use of must only be connected to a supply mains with protective earth medical gases, at all times. 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 Do not use if the product is visibly damaged, and periodically so as to minimise the exposure to Nitrous Oxide or Carbon inspect for signs of damage Dioxide.

9 This is the responsibility of the user. Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment Home Back Next 8. 4. Safety Caution Care should be taken not to trap fingers in pinch points Use only genuine Keeler approved parts and accessories or during gas bottle change device safety and performance may be compromised Follow guidance on cleaning / routine maintenance to prevent The product has been designed to function safely when at an personal injury / damage to equipment ambient temperature between +10 C and +35 C. Switch off the electrical supply and disconnect from the Keep out of the reach of children mains electrical supply before cleaning and inspection To prevent condensation from forming, allow instrument to Do not use hypercarbonate or phenolic based cleaning come to room temperature before use solutions or disinfectants containing cationic surfactants ( Dettox) to clean the console For indoor use only (protect from moisture).

10 Failure to carry out recommended routine maintenance as per Keep the console away from sources of liquids and do not these Instructions for Use may reduce the operational lifetime spray with water of the product This product is suitable for use with only Nitrous Oxide or There are no user serviceable parts inside. Contact authorised Carbon Dioxide medical gases service representative for further information Only non-syphonic gas cylinders should be used with At product end of life dispose of in accordance with local this device environmental guidelines (WEEE). No modification of this equipment is allowed Home Back Next 9. 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, The system has been designed to comply with the following always take the following precautions: regulatory standards for Safety and Electromagnetic Compatibility: Ensure that the system is inspected by properly trained IEC60601-1, UL60601-1 & No personnel once per annum for performance and safety checks IEC60601-1-2.