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Guidance and manufacturer’s declaration – electromagnetic immunity

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.

Immunity 
Test

IEC60601 
test level

Compliance 
level

Electromagnetic environment - guidance

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms 
150kHz - 
80MHz

3 V/m 
80MHz - 
2.5GHz

3 Vrms 

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the 
Cryomatic, including cables, than the recommended separation distance calculated from the 
equation applicable to the frequency of the transmitter.  

 
Recommended separation distance  
d = 1.2

P

d = 1.2

P  80MHz - 800MHz 

d = 2.3

P  800MHz – 2.5GHz

where P is the maximum power output of the transmitter in watts (W) according to the 
transmitter manufacturer and d is the recommended separation distance in metres (m). 

Field strengths 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 this 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 the absorption and reflection from structures, objects and people.

a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV 
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. 
If the measured field strength in the location in which the Cryomatic is used exceeds the applicable RF compliance level above, the Cryomatic should be observed to verify normal 
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Cryomatic. 
b: Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

Annex I - EMC Statement and Guidelines

Summary of Contents for Cryomatic

Page 1: ...Next Home Back 1 Keeler Instructions for use...

Page 2: ...ons End of Use 6 Cryo Tip Probes 7 Cleaning Sterilisation Cleaning Steam Sterilisation Cleaning the Console 8 Servicing and Preventative Maintenance Scheduled Maintenance User Maintenance 9 Spare Part...

Page 3: ...unity Relevant accessories are listed in the Spare Parts Accessories section For your own safety and the safety of the equipment always take the following precautions Keep the console away from source...

Page 4: ...on Dioxide gas to function this is the responsibility of the user Console The Cryomatic console is a self contained system The console provides the connection points for the Cryo Tip probe footswitch...

Page 5: ...as cylinder status and freeze timer 3 Footswitch Connection Connection point for footswitch plug 4 Cryo Tip Probe Interface Pneumatic and electrical connections for probe 5 Electrical Input IEC connec...

Page 6: ...the footswitch to the appropriate connection point on the rear of the console noting the alignment of the orientation key see page 5 The footswitch can be disconnected for storage and to facilitate c...

Page 7: ...e with ISO R 32 and ANSI NFPA 99 USA Ensure there is enough gas in the Cylinder prior to starting the procedure The console Cylinder Symbol indicates empty when the gas supply pressure drops below 350...

Page 8: ...tion protocol before using a Cryo Tip probe Allow Cryo Tip probe to cool to room temperature after a sterilization procedure Before connecting the Cryo Tip probe inspect it for signs of obvious damage...

Page 9: ...ure 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 susp...

Page 10: ...ns The Cryomatic 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 display...

Page 11: ...rd Range Part No Description 2509 P 8000 2 5mm Standard Retinal Probe 2509 P 8001 2 5mm Extended Retinal Probe Special Range 2509 P 8002 2 5mm Mid Reach Retinal Probe 2509 P 8005 3mm Glaucoma 2509 P 8...

Page 12: ...e Cryo Tip probe Instructions Point Of Use No particular requirements although excess soiling can be removed with disposable cloth paper wipe Containment Transportation Care should be taken to ensure...

Page 13: ...ed When sterilising multiple probes in one sterilization cycle ensure that the manufacturer s maximum load is not exceeded Table 1 sterilizer type temperature pressure exposure time drying time pre va...

Page 14: ...abrasive metal polish should be used b Cleaning the console surface c Inspecting the Cryo Tip probes for signs of damage before every use d Inspecting the footswitch and cord for signs of damage befor...

Page 15: ...ptor N2 O Size VF 2508 P 7016 Cylinder Adaptor CO2 Size VF 2509 P 8009 Cylinder Adaptor N2 O US CGA326 2509 P 8012 Instructions For Use 2509 P 8011 High Pressure Hose 1m 2509 P 8014 High Pressure Hose...

Page 16: ...contact supplier for repair Probe freezes but performance is poor Possible partial blockage in the probe possibly caused by excess moisture after sterilisation procedure Probe may appear to begin to...

Page 17: ...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 repr...

Page 18: ...Weight 2 5kg 6lbs Environmental Conditions Storage Operating Temperature Range 20 C to 50 C 10 C to 40 C Relative Humidity 10 to 80 30 to 70 Atmospheric Pressure 500hPa to 1060hPa 700hPa to 1060hPa Cl...

Page 19: ...symbol contains an activity bar whenever the gas supply is being checked It is solid when reporting cylinder pressure Ready Symbol Displayed whenever the freeze function can be activated via the foot...

Page 20: ...c 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...

Page 21: ...rcial or hospital environment Surge IEC 61000 4 5 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupti...

Page 22: ...ed by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with this symbol NOTE 1 At 80MHz and...

Page 23: ...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 maximum output power not listed above the recommended separation...

Page 24: ...of continued product improvement we reserve the right to alter specifications at any time without prior notice Keeler Instruments Inc 456 Parkway Broomall PA 19008 USA Toll Free 1 800 523 5620 Tel 610...

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