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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

RF emissions
CISPR 11

Group 1

The Cryomatic System uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions
CISPR 11

Class B

The Cryomatic System is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations /
flicker emissions
IEC 61000-3-3

Complies

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Содержание Cryomatic MKII

Страница 1: ...Next Next Cryosurgical console Instructions for use Keeler MKII ...

Страница 2: ...s End of use 18 Page 8 Cryo probes 19 9 Cleaning and sterilization 20 Cleaning Steam sterilization 21 Cleaning the console 22 10 Servicing and preventative maintenance 23 Scheduled maintenance User maintenance 11 Troubleshooting guide 24 12 Specifications and electrical ratings 26 Electrical specifications Pneumatic specifications Transport storage and operation 13 Annex I EMC statement and guidel...

Страница 3: ...t 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 ...

Страница 4: ...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 Intended use The Keeler Cryomatic MKII System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment cyclo des...

Страница 5: ... performed automatically when the Cryo probe is connected to the system Cryo Probes Disposable and reusable Cryo probes are connected to the Cryomatic MKII console via a simple quick release coupling The system will not operate until this connection is correctly made Each Cryo probe is a complete assembly and no attempt should be made to dismantle or separate the coupling from the probe When the f...

Страница 6: ...ation The CE mark on this product indicates it has been tested to and conforms with the provisions noted within the 93 42 EEC Medical Device Directive Consult instructions for use Manufacturer s name and address This symbol on the product or on its packaging and instructions indicates that it was put on the market place after August 2005 and that this product shall not be treated as Household Wast...

Страница 7: ...hecked It is solid when reporting cylinder pressure Ready Symbol Displayed whenever the freeze function can be activated via the footswitch Wait Symbol Animated icon that is displayed for the duration of the purge cycle Freezing symbol Displayed with the probe symbol while in freezing mode Run Defrosting symbol Displayed with the probe symbol while in defrosting mode Audible sounder enabled during...

Страница 8: ...periodically inspect for signs of damage Do not use in the presence of flammable gases liquids or in an oxygen rich environment This product should not be immersed in fluids Do not fit mains power adapter into a damaged mains outlet socket Route power cords safely to eliminate risk of tripping or damage to equipment US Federal law restricts this device to sale by or order of a physician or practit...

Страница 9: ...s bottle change Follow guidance on cleaning routine maintenance to prevent personal injury damage to equipment Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection Do not use hypercarbonate or phenolic based cleaning solutions or disinfectants containing cationic surfactants e g Dettox to clean the console Failure to carry out recommended ...

Страница 10: ... accessories and mains leads as supplied by the manufacturer or distributor Failure to do this may affect the EMC performance of the system i e increased emissions or reduced immunity Relevant accessories are listed in the Spare Parts and Accessories section Ensure the equipment is positioned in such a way that it can be disconnected from the mains easily For your own safety and the safety of the ...

Страница 11: ... Display Screen system information to the user such as probe information gas cylinder status and freeze time 3 Footswitch Connection Connection point for footswitch plug 4 Cryo Probe Interface Connection point for probe 5 Electrical Input IEC connection for mains input lead 6 On Off Switch On off mains rocker switch 7 High Pressure Gas Inlet Connection point for cylinder hose 8 Exhaust For connect...

Страница 12: ...s Connecting the Footswitch Connect the footswitch to the appropriate connection point on the rear of the console noting the alignment of the orientation key see page 11 The footswitch can be disconnected for storage and to facilitate cleaning Disconnection is achieved by pulling the collar of the footswitch connector Installing the High Pressure Gas Hose Connect high pressure hose to the inlet co...

Страница 13: ...oval Disconnection of Cylinders 1 Ensure that cylinder valve is closed 2 Disconnect the adaptor from the cylinder 3 Replace cylinder with a fresh one The cylinders must be medical grade vapour withdrawal types to ensure that liquid cryogen is not delivered to the system Cryogen gas cylinders used must meet national regulations and be in accordance with ISO R 32 and NFPA 99 USA Ensure there is enou...

Страница 14: ...et UL listed type SJE SJT or SJO 3 conductor not smaller than 18 AWG Plug cable and ground lead connection of the socket have to be in perfect condition At this stage the probe should NOT be connected 1 Connect the system to a suitable mains supply using the mains cord that has been supplied 2 Switch on power via the rocker switch at the side of the system 3 The cylinder symbol is activated while ...

Страница 15: ...ipment is switched on using the mains inlet rocker switch 2 An activity bar within the Cylinder Symbol indicates that the gas supply is being checked If a warning is displayed refer to troubleshooting in Section 11 3 When the initialisation checks are complete verify that there is adequate cryogen gas supply this is indicated by the Cylinder Symbol on the front panel display The Cylinder Symbol wi...

Страница 16: ...robe is properly connected the relevant Probe Symbol is displayed together with the Run option 3 To proceed the Run button must be pushed 4 If a reusable probe has been connected the system automatically initiates a purging cycle of 90 seconds During the purge cycle an animated Wait Symbol is displayed alongside the Probe Symbol Three short beeps signal that the purge cycle is complete 5 The equip...

Страница 17: ...s the Ready Symbol is displayed The freezing function is often accompanied by a characteristic pulsing sound which indicates that the Cryomatic MKII is regulating the gas to the optimum pressure for the probe The pulsing may vary or cease completely depending on the pressure of gas in the cylinder If the probe performance drops below 100 permanently check the cylinder gas pressure or suspect a blo...

Страница 18: ... 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 Refer to section 11 for troubleshooting Contact distributor or manufacturer for assistance Caution In the event of power interruption during use the device valves fail safely closed End of Use Ensure that the following procedures are carried out at the e...

Страница 19: ... of 10 Single Use Retinal Probes Standard Probe Range 2509 P 8020 2 5mm Standard Retinal Probe 2509 P 8021 2 5mm Extended Retinal Probe Special Probe Range Part No Description 2509 P 8022 2 5mm Mid Reach Retinal Probe 2509 P 8023 Intra Vitreal Retinal Probe 2509 P 8024 1 5mm Curved Cataract Probe 2509 P 8025 3mm Glaucoma 2509 P 8026 4 x 10mm Collins Trichiasis Probe ...

Страница 20: ...must be sterilized Sterilization by steam autoclave has been validated Point Of Use No particular requirements although excess soiling can be removed with disposable cloth paper wipe Containment and Transportation Care should be taken to ensure that the flexible hose of the Cryo Tip probe is not coiled too tightly or kinked during reprocessing Used instruments must be transported to the central su...

Страница 21: ...e instruments with cold water for cooling Be careful when unloading the autoclave the contents may be hot Make sure that the sterile package of the instruments is not damaged If the package has been perforated if the sealing has been opened if the packaging is wet or if the packaging is damaged in any other way repackage and then re sterilise the instruments Disinfection is only acceptable as a pr...

Страница 22: ... environmental conditions such as high atmospheric pressure high or low temperatures high or low humidity direct ventilation direct sunlight dust salty or sulphurous air Do not store the equipment where there is a risk of flammable gases The storage life of sterilised instruments depends on the type of packaging and the storage conditions Refer to national and local laws and guidelines Cleaning th...

Страница 23: ...e replaced before sterilisation and use Only Keeler specified parts should be used See spares Section 14 d Inspecting the footswitch and cord for signs of damage before each use e Inspecting the mains cord for signs of damage before each use f Inspecting the high pressure hose and exhaust hose for signs of damage before each use All repairs should be carried out only by Keeler trained personnel or...

Страница 24: ... Probe may appear to begin to freeze but then blocks or performs poorly Check front panel for associated fault code Ensure that correct sterilization procedures are followed including a drying cycle in sterilizer or drying oven Disconnect and reconnect probe to force another purging cycle If this fails then probe should be allowed to dry completely before use Probe freezes initially but then perfo...

Страница 25: ...age Re purge the probe Use an alternative probe Contact distributor or manufacturer for assistance F 05 V1 Error Solenoid valve error Contact distributor or manufacturer for assistance F 06 V2 Error Solenoid valve error Contact distributor or manufacturer for assistance F 07 V3 Error Solenoid valve error Contact distributor or manufacturer for assistance F 008 Over Pressure Cylinder pressure too h...

Страница 26: ...ange 40 C to 70 C 10 C to 55 C 10 C to 40 C Relative humidity 30 to 95 30 to 95 30 to 95 Atmospheric pressure 500hPa to 1060hPa 700hPa to 1060hPa 800hPa to 1060hPa Dimensions Width 350mm 14 Depth 200mm 8 Height 190mm 7 5 Weight 4 5kg 10lbs Classification and Safety Standards Complies with EN60601 1 UL60601 1 CAN CSA C22 2 No 601 1 Equipment Classification Class 1 type BF Applied Part Mode of opera...

Страница 27: ... emissions CISPR 11 Group 1 The Cryomatic System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Cryomatic System is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power s...

Страница 28: ...00 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in U...

Страница 29: ...gths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp...

Страница 30: ...ter m 150 kHz to 80MHz d 1 2 p 80MHz to 800MHz d 1 2 p 800MHz to 2 5GHz d 2 3 p 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rati...

Страница 31: ...rench 2509 P 6000 Mains cord Japan 2509 P 8010 Exhaust hose 2509 P 8013 Footswitch assembly 2509 P 8014 High pressure gas hose 2m Part Number Description 2508 P 7015 Pin index yoke E Size Carbon Dioxide 2508 P 7016 Cylinder Adaptor CO2 Size VF 2508 P 7017 Pin index yoke E Size Nitrous Oxide 2508 P 7018 Cylinder Adaptor N2O Size VF 2509 P 8009 Cylinder Adaptor N2O US CGA326 2509 P 8011 High pressur...

Страница 32: ...urpose are expressly disclaimed The obligations of the manufacturer as set forth in this warranty are expressly conditional upon the following i No alterations or repairs of any malfunction of the system shall be made to the system except by the manufacturer or his authorized representative without the prior written approval of the manufacturer or his authorized representative and in no case will ...

Страница 33: ...Wai St Chao Yang District Beijing 10020 China Tel 86 10 51261868 Fax 86 10 58790155 Disposal of old electrical and electrical equipment Applicable in the European Union and other European Countries with separate Collection Systems This symbol on the Product or on its Packaging and instructions indicates it was put on the market place after August 2005 and this product shall not be treated as House...

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