Keeler

Instructions for use

Home Back Next 1

Contents

1. Safety Considerations 6. Cryo-Tip Probes

2. Introduction 7. Cleaning & Sterilization
About this Manual Cleaning
About Cryomatic Steam Sterilization
Product Description Cleaning the Console
3. Controls, Indicators & Connections 8. Servicing and Preventative Maintenance
4. Installation & Commissioning Scheduled Maintenance
Preparing the Cryomatic for use User Maintenance
5. Operation 9. Spare Parts and Accessories
Initialisation 10. Troubleshooting Guide
Cryo-Tip Probe Connection 11. Warranty
Freeze Cycle 12. Disposal
Cryo-Tip Probe Disconnection 13. Technical Data
Mute Option
Fault Conditions Annex I – EMC Statement & Guidelines
End of Use Contact Information

Click on the headings above to go directly to that section.

Use the buttons on the right to navigate the document.
Clicking ‘home’ from any page brings you back to this contents page.
Home Back Next 2
1. Safety Considerations
Before you connect system to the mains For your own safety and the safety of the • Keep this operator manual safe for future
socket, carefully read and understand all the equipment, always take the following reference.
installation instructions in Section 3. precautions:
• Inspect the Cryo Tip for damage before
• Keep the console away from sources of every use. If there is any sign of damage
The system has been designed to comply with
liquids and do not spray with water. return to the manufacturer for servicing
the following regulatory standards for Safety
prior to use. Do not try to straighten a bent
and Electromagnetic Compatibility: • Switch off the electrical supply and
Cryo Tip.
disconnect from the mains electrical supply
• IEC60601-1, UL60601-1
before cleaning and inspection. • Do not try to re-shape a Cryo Tip.
& CAN/CSA-C22.2 No 601.1
• Do not use hypercarbonate or phenolic
• IEC60601-1-2:2001
based cleaning solutions or disinfectants
containing cationic surfactants (e.g. Dettox)
Although compliant with applicable EMC
to clean the console. SAFETY WARNINGS
standards, this equipment may still be
susceptible to excessive emissions and/or may • Ensure that the system is clean and dry prior Electrical equipment may be hazardous
interfere with other more sensitive material. to storage. if misused. The equipment covers
This system should be installed and used • Observe the usual safety precautions, should only be removed by authorised
following the EMC environment guidelines associated with the use of medical gases, at technical personnel.
contained in Annex I of this manual. all times. Copies of these guidelines will be Do not use the system in the presence
available from the gas supplier. of flammable gases such as anaesthetic
This system should only be used in conjunction agents.
• Ensure the correct disposition of gas
with the relevant accessories and mains
exhausted from the system so as to minimise
leads as supplied by the manufacturer or
the exposure to Nitrous Oxide or Carbon
distributor. Failure to do this may affect the
Dioxide. This is the responsibility of the user.
EMC performance of the system i.e. increased
emissions or reduced immunity. Relevant • Ensure that the system is inspected by
accessories are listed in the Spare Parts & properly trained personnel once per annum
Accessories section. for performance and safety checks.

Home Back Next 3

2. Introduction
About this Manual Product Description Cryo-Tip Probes
This handbook forms the Instructions for The system comprises a control console and The Cryo-Tip probe is connected to the
Use for the Keeler Cryomatic, a clinical interchangeable Cryo-Tip probes which are Cryomatic console via a simple quick release
instrument for cryogenic ophthalmic surgery. connected to the console for use. The Cryo- coupling. The system will not operate until
It contains complete, step-by-step instructions Tip probe is re-usable and can be sterilized by this connection is correctly made. Each Cryo-
for the Cryomatic and is intended for use autoclaving or other approved methods. The Tip probe is a complete assembly and no
by trained medical personnel. This manual system requires mains electricity and Nitrous attempt should be made to dismantle or
does not contain clinical instructions or any Oxide or Carbon Dioxide gas to function, this separate the coupling from the probe.
recommendations for medical applications. is the responsibility of the user.
When the footswitch is pressed, high pressure
The use of the Cryomatic in any surgical
cryogen gas is circulated through the Cryo-
procedure must always be at the discretion of
Console Tip probe, rapid gas expansion in the probe
a licensed medical practitioner.
tip causes freezing according to the Joule-
The Cryomatic console is a self contained
Thompson principle. The freezing zone of
system. The console provides the connection
About Cryomatic the Cryo-Tip probe is limited so that the ice-
points for the Cryo-Tip probe, footswitch,
ball propagates only at the tip. When the
The Keeler Cryomatic System and probes mains electricity, gas supply and scavenging
footswitch is released, an active de-frost is
are for use in ophthalmic surgery such system. Freeze cycles are controlled by the
caused by the equalisation of pressure on
as cryopexy for retinal detachment, cyclo user operating the footswitch. When the
either side of the Joule-Thompson nozzle.
destructive procedures in refractory glaucoma, footswitch is depressed the Cryo-Tip probe
The gas condenses releasing its latent heat
extraction of fragments within the vitreous freezes and when the footswitch is released
causing a rapid de-frost.
cavity, cataract extraction, cryo destruction of the Cryo-Tip probe defrosts. Routine functions,
lash follicles for trichiasis and treatment of like purging the Cryo-Tip probe are performed The Cryo-Tip probe assembly is re-usable and
retinopathy of prematurity (ROP). automatically when the Cryo-Tip probe is as such is fully autoclaveable according to the
connected to the system. procedures outlined in this manual.
Once the Cryo-Tip probe has been correctly
positioned the freeze control is activated and
an ice ball is formed around the tip of the
Cryo-Tip probe and the adjacent area.

Home Back Next 4

3. Controls, Indicators & Connections
1 Mute Key Allows the audible sounder to be
disabled by the operator.

2 Cryomatic Display Screen Graphical LCD used to provide system

information to the user; such as probe
information, gas 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 connection for mains input lead.

6 On/Off Switch On/off mains rocker switch.

7 Gas Inlet Connection point for cylinder hose.

8 Exhaust For connection of vent hose

(see Section 4).

Home Back Next 5

4. Installation & Commissioning
Preparing the Cryomatic system for use Connecting the Footswitch
The Cryomatic system consists of the following: Connect the footswitch to the appropriate connection point on the
rear of the console noting the alignment of the orientation key (see
• Cryomatic console.
page 5).
• Cryo-Tip probe(s).
• Footswitch. The footswitch can be disconnected for storage and to facilitate
• Mains cord. cleaning. Disconnection is achieved by pulling the collar of the
• High-pressure gas hose. footswitch connector.
• Exhaust hose.
• Adjustable wrench.
Installing the High Pressure Gas Hose
• Instructions for use.
• 2 spare mains fuses. Connect high-pressure hose to the inlet connector at the rear of the
Cryomatic system using the spanner that has been provided. Ensure
If any of these parts are missing, contact your distributor immediately.
that the coupling is tightened adequately (see page 5).

Installing Exhaust Hose Connecting/Changing Gas Cylinders

Connect the exhaust hose provided from the gas exhaust connection
Gas cylinders must be stored upright, and for a minimum of eight
of the console to a scavenging system or suitably ventilated area (see
hours at ambient room temperature prior to use.
page 5).
Ensure that the gas cylinder is secured properly before use. Use the
It is the responsibility of the user to ensure the safe disposition of
following procedure for connecting or changing gas cylinders:
exhaust gases.

Home Back Next 6

4. Installation & Commissioning
Connection of Cylinder before this point. After this the system will continue to function in the
usual way, however freeze performance will be reduced.
1 Secure cryogen cylinder correctly in the
upright position. Information regarding the correct storage and handling of gas
cylinders should be obtained from the gas supplier.
2 Connect the high pressure hose to the cylinder using
the relevant adaptor.
Electrical Supply
3 Open cylinder valve (using the spanner provided).
The Cryomatic system requires connection to a mains electrical supply
4 Any noise of escaping gas indicates that the cylinder for operation.
has not been connected correctly – turn off the gas
1 Connect the system to a suitable mains supply using
valve and check connections.
the mains cord that has been supplied.

Removal/Disconnection of Cylinders 2 Switch on power via the rocker switch at the side of
the system.
1 Ensure that cylinder valve is closed.
3 The cylinder symbol is activated while the Cryomatic
2 Disconnect the adaptor from the cylinder. system prepares itself.

3 Replace cylinder with a fresh one. 4 The equipment is now ready for use.

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 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 PSI/24 Bar (2415 kPa) and the gas cylinder should be replaced at or

Home Back Next 7

5. Operation
These instructions cover day-to-day operation of the system. Before connecting the Cryo-Tip probe inspect it for signs of obvious
Other operations, such as maintenance and repair, should only be damage.
carried out by fully trained personnel who are employed by, or
authorized by, the supplier. 1 Connect the Cryo-Tip probe to the console by aligning
the coupling on the spigots and pushing to a positive
click. (It is impossible to connect the coupling the
Initialisation
wrong way round – correct orientation is with the
Before using the Cryomatic system, make sure it has been correctly release button uppermost). When the probe is
installed in accordance with Section 4. properly connected the relevant Probe Symbol is
displayed together with the probe serial number.
1 Ensure that the equipment is switched on using the
mains inlet rocker switch. 2 The system automatically initiates a purging cycle
of 90 seconds. During the purge cycle an animated
2 An activity bar within the Cylinder Symbol indicates
Wait Symbol is displayed alongside the Probe Symbol.
that the gas supply is being checked.
3 Three short beeps signal that the purge cycle is
3 When the initialisation checks are complete verify that
complete. The equipment is now ready for use as
there is adequate cryogen gas supply - this is indicated
indicated by the timer and the Ready Symbol.
by the Cylinder Symbol on the front panel display.

4 The equipment is now at REST. The Cryo-Tip Probe can While the probe is purging all footswitch operations are disallowed
now be connected. to ensure that the Cryo-Tip probe has completed the minimum purge
cycle.
Cryo-Tip Probe Connection
Observe sterilization protocol before using a Cryo-Tip probe.
Allow Cryo-Tip probe to cool to room temperature after a sterilization
procedure.

Home Back Next 8

5. Operation
Freeze/Defrost Cycles Cryo-Tip Probe Disconnection
Freezing of the Cryo-Tip probe is controlled manually by the operator 1 When the procedure is complete the Cryo-Tip probe
using the footswitch. can be disconnected by pressing the probe release
button on the probe coupling body.
1 Ensure that the Cryo-Tip probe is correctly
positioned. 2 When the probe has been disconnected the system

will automatically check the gas supply in readiness
2 Press the footswitch down. Freezing starts
for the next use. This will be indicated by an activity
immediately and the digital timer will increment.
bar with the Cylinder Symbol.
3 An audible warning sounds every second during the
3 When this short check is complete the system will be
freeze cycle and the Freezing Symbol is displayed.
ready for the connection of another Cryo-Tip probe.
4 In addition there is a graphical indication of probe
The system shuts off the gas supply immediately the Cryo-Tip probe is
performance.
disconnected providing a safe condition in the event of inadvertent
5 De-frosting is achieved by releasing the footswitch. operation of the release button.
The timer will stop counting and the Defrosting
It is not recommended that the Cryo-Tip probe is disconnected during
Symbol is displayed.
use as this could result in a pressure lock within the probe assembly
6 Subsequent freeze cycles can be carried out by simply which may make reconnection more difficult.
repeating steps 1-4 as soon as the Ready Symbol is
displayed.

The freezing function is often accompanied by a characteristic ‘pulsing’

sound which indicates that the Cryomatic 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 blocked probe.

Home Back Next 9

5. Operation
Mute Function End of Use

Ensure that the following procedures are carried out at the end of the
The audible indicator is normally active during freeze
current usage:
and purge cycles as indicated on the LCD screen.
1 Close the cylinder valve.
It can be disabled by simply pressing the key adjacent
to the symbol. The symbol is changed accordingly. 2 Switch off the electrical supply.

The indicator can be reactivated by simply pressing the
3 Ensure that the mains cord, footswitch and the
key again (see Section 3 [1]).
Cryo-Tip probes are stored properly to avoid
accidental damage.

Fault Conditions

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 displayed.

Contact distributor or manufacturer for assistance.

Home Back Next 10

6. Cryo-Tip Probes
The following ranges of ophthalmic Cryo-Tip Probes may be used with the Cryomatic.

Standard 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-8003 0.89mm Intra Vitreal Retinal Probe

2509-P-8004 1.5mm Curved Cataract Probe

2509-P-8006 4 x 10mm Collins Trichiasis Probe

Home Back Next 11

7. Cleaning & Sterilization
Cryo-Tip probes are reusable and should be sterilized before each use. The following reprocessing guidelines are in accordance with ISO 17664.

Warnings & Precautions

General Cryo-Tip probes are precision instruments and should be handled with care at all times. It is important that the
flexible hose does not become kinked during normal use, storage, transportation or reprocessing. If this does occur
the probe must be returned to the manufacturer for repair.
Limitations On Reprocessing Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and
damage due to use rather than reprocessing.

Cryo-Tip Probes are tolerant of alkaline cleaning agents when followed by acidic neutralization and/or thorough rinsing.

Gamma irradiation or dry air sterilization methods involving temperatures in excess of 139°C should not be used
since they may damage the Cryo-Tip probe.

Instructions
Point Of Use No particular requirements although excess soiling can be removed with disposable cloth/paper wipe.
Containment & Care should be taken to ensure that the flexible hose of the Cryo-Tip probe is not coiled too tightly or kinked
Transportation during reprocessing.

Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary con-
tamination risk. It is recommended that instruments are reprocessed as soon as is reasonably practical following use.
Preparation For Cleaning No particular requirements. Disassembly not required.
Cleaning: Automated Use equipment meeting relevant standards1 and which uses the following typical automated sequence:
• Pre-Rinse/Wash
• Detergent wash; hot water using (detergent specified by the washer/disinfector manufacturer)
• Thermal rinse; hot purified water (80-93°C/176-200°F); 1 minute
• Hot Air Dry
1 HTM2030 and BS EN ISO 15883 or equivalent
Cleaning: Manual Not recommended – use an automated system if possible.
If manual cleaning is carried out care should be taken not to use abrasive materials on the Cryo-Tip probe stem.

Home Back Next 12

7. Cleaning & Sterilisation
Instructions continued
Drying No particular requirements.
Maintenance Check for obvious signs of damage – return for manufacturer if any damage is noted.
Inspection & Function Testing Visually inspect for damage and wear. Check probe tips for signs of bending, distortion or other damage.
Connect Cryo-Tip Probe to ‘Cryomatic’ console to check correct and smooth function of probe quick release coupling.
Packaging No particular requirements.
Sterilisation Disinfection is only acceptable as a precursor to full sterilisation for reusable surgical instruments. See Table 1 for
recommended sterilization parameters using equipment meeting relevant standards. Sterilizer manufacturer
recommendations should always be followed. 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
gravity 121-124°C - 30 minutes -
(250-255°F)
It is the responsibility of the user to validate any sterilisation process that deviates from these recommendations.

Storage Sterile, packaged Cryo-Tip probes should be stored in a designated, area that is well ventilated and provides protection
from dust, moisture and temperature/humidity extremes. Cryo-Tip probes should be coiled loosely during storage.

Cleaning the Console

The Cryomatic console can be cleaned using a disposable cloth soaked
in mild detergent and warm water. Do not use abrasive compounds
or pads. The user should avoid getting electrical parts wet during the
cleaning process.

Warning: Switch off the electrical supply to the console and disconnect
the power cord from the mains supply before cleaning and inspection.

Home Back Next 13

8. Servicing and Preventative Maintenance
Scheduled Maintenance
The Cryomatic system should be inspected annually by Keeler trained
personnel. This service will include performance checks, cleaning or
replacement of inlet filters and safety checks on pneumatic couplings.

User Maintenance
There are no user serviceable parts in the Cryomatic system and
operator maintenance is restricted to the following:

a) Cleaning the Cryo-Tip probe tip. Non-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 before
every use.
e) Inspecting the mains cord for signs of damage before every use.
f) Inspecting the high pressure hose and exhaust hose for signs of
damage before every use.

All repairs should be carried out only by Keeler trained personnel or

their representatives.

Potentially dangerous voltages are present inside the equipment

– under no circumstances should the covers be removed.

Home Back Next 14

9. Spare Parts & Accessories
The following parts are available from the distributor:

Part Number Description

2508-P-7018 Cylinder Adaptor
N2O Size VF

2508-P-7016 Cylinder Adaptor

CO2 Size VF

2509-P-8009 Cylinder Adaptor

N2O (US - CGA326)

2509-P-8012 Instructions For Use

2509-P-8011 High Pressure Hose (1m)
2509-P-8014 High Pressure Hose (2m)
2509-P-8013 Footswitch Assembly
2509-P-8010 Exhaust hose
2509-P-8015 Probe Sterilising Box

Home Back Next 15

10. Troubleshooting Guide
The following table provides a troubleshooting guide for the Cryomatic system in the event of minor problems. If the problem is not cleared then the
supplier must be contacted for further assistance.

Problem Possible Cause Corrective Action

Front panel blank – equipment Mains fuse(s) blown. Disconnect equipment from mains supply and replace with
appears dead. fuses of the correct rating.
Probe coupling will not connect Probe is still too hot after a sterilisation procedure (this may Allow probe to cool to room temperature before trying to
correctly. cause possible expansion of some coupling components). connect it.
Probe is connected but automatic Possible damage to electrical contacts of console or probe. Inspect contacts and clean carefully if necessary. If fault does
purging does not start. Dirty or oxidised probe contacts. not clear then contact supplier for repair.
Probe does not freeze at all. Insufficient gas supply or gas cylinder valves not opened Replace empty* gas cylinders with full ones. Ensure that all
properly – cylinder symbols on front panel will be shown as gas valves are opened correctly (see Section 3).
empty.
Footswitch may have become disconnected. Reconnect footswitch to console. If fault does not clear,
contact supplier for repair.
Probe freezes but performance is Possible partial blockage in the probe (possibly caused by Ensure correct sterilisation procedures are followed, including
poor. excess moisture after sterilisation procedure). Probe may a drying cycle (in sterilizer or drying oven). Disconnect and
appear to begin to freeze but then block or perform poorly. reconnect probe to force another purging cycle. If this fails,
then probe should be left to dry completely before use.
Exhaust hose is blocked or occluded. Check the exhaust hose for blockages or occlusions and
replace if necessary.
Probe freezes correctly initially but Blocked probe. Release footswitch. Allow console to back-flush the probe
then performance is reduced or probe before attempting another freeze.
does not freeze. Gas supply has run out. Replace empty* gas cylinder. Ensure that the gas valve is
opened correctly. If fault does not clear, contact supplier for
repair.
Probe freezes correctly but Cryomatic Cylinder pressure has dropped due to usage, but Gas cylinder pressure has reduced (indicated on front panel
delivery system is not pulsing. performance is still above the acceptable level. display).
Auto Defrost takes longer than usual. Possible leaking internal hose connectors. Return the console and probe for repair.
Possible fault in console.

*gas cylinders are deemed to be empty when the internal pressure is less than 350 PSI/25 Bar (2415 kPa)

Home Back Next 16

11. Warranty
The Cryomatic and its components are covered by warranty that they (i) No alterations or repairs of any malfunction of the system shall
meet their performance standards and are free from any defects in be made to the system except by the manufacturer or his authorized
materials or workmanship. Within 12 months from delivery by Keeler, representative, without the prior written approval of the manufacturer
the manufacturer shall at no charge to the customer, upon written or his authorized representative (and in no case will the manufacturer
notice from the customer, repair or replace any components which are assume responsibility for repairs or alterations made by those other
defective in material or workmanship. than the manufacturer or his authorized representative).

The customer agrees that it shall have no remedy in the event of any And
breach of the foregoing warranty other than as provided above. This
(ii) The customer shall give notice to the manufacturer or their
warranty is exclusive and in lieu of all other warranties, expressed or
authorized representative of any malfunction of the system and shall
implied, and all implied warranties of merchantability or fitness for a
not use the system in any surgical operation after they are aware of
particular purpose are expressly disclaimed.
any malfunction.
The obligations of the manufacturer as set forth in this warranty are
(iii) The customer complies with manufacturer’s recommended
expressly conditional upon the following:-
Preventative Maintenance (see Section 8) and can provide proof of
such action.

12. Disposal
Ensure that this equipment is disposed of in accordance
with local regulations.
Please contact the supplier if in doubt.

Home Back Next 17

13. Technical Data
Cryogenic System Environmental Conditions
Gas Specification Medical Grade Nitrous Oxide (N2O) or Storage Operating
Medical Grade Carbon Dioxide (CO2) in Temperature Range -20°C to +50°C +10°C to +40°C
non-syphon cylinders. Relative Humidity 10% to 80% 30% to 70%
Operating Pressure Range 3100–5860 kPa (450–850 PSI/31-58 Bar) Atmospheric Pressure 500hPa to 1060hPa 700hPa to 1060hPa
Maximum Pressure 8275 kPa (1200 PSI/83 Bar)

Electrical Ratings
Input Voltage Range 100-240Vac (50/60Hz)
Power Rating 100VA
Fuses 2 x T2AH 250V

Dimensions
Width 305mm (12”)
Depth 200mm (8”)
Height 190mm (7.5”)
Weight 2.5kg (6lbs)

Classification & 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 operation Continuous
Protection against ingress Console IPx0
Footswitch IP68

Home Back Next 18

13. Technical Data
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 Symbols for use on Equipment).
gas supply is being checked. It is solid when reporting
cylinder pressure. BF (Applied Part) Fuse rating
Ready Symbol.
Displayed whenever the freeze function can be activated
via the footswitch.

Attention, consult Footswitch

Wait Symbol. accompanying connection
Animated icon that is displayed for the duration of the documents
purge cycle.

Dangerous Exhaust
Freezing symbol.
voltages present connection
Displayed with the probe symbol while in freezing mode.
inside the
equipment

Probe performance meter. AC voltage input Gas inlet

Displayed with the probe symbol while in freezing mode. connection

Defrosting symbol.
Displayed with the probe symbol while in defrosting
mode.

Audible sounder enabled during freezing mode.

Audible sounder disabled during freezing mode.

Fault Condition

Home Back Next 19

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
Harmonic emissions Class A establishments and those directly connected to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for domestic purposes.
Voltage Fluctuations/ Complies
flicker emissions
IEC 61000-3-3

Home Back Next 20

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 of the Cryomatic should assure that it
is used in such an environment.
Immunity Test IEC60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD) +6kV contact Floors should be wood, concrete or ceramic tile. If floors are
IEC 61000-4-2 +8kV air covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast transient/burst +2kV for power supply lines Mains power quality should be that of a typical commercial
IEC 61000-4-4 +1kV for input/output lines or hospital environment.
Surge +1kV differential mode Mains power quality should be that of a typical commercial
IEC 61000-4-5 +2kV common mode or hospital environment.
Voltage dips, short <5% UT (>95% dip in UT) Mains power quality should be that of a typical commercial
interruptions and voltage for 0,5 cycle or hospital environment. If the user of the Cryomatic requires
variations on power supply 40% UT (60% dip in UT) continued operation during power mains interruptions, it
input lines IEC 61000-4-11 for 5 cycles is recommended that the Cryomatic be powered from an
70% UT (30% dip in UT) uninterruptible power supply or battery.
for 25 cycles
<5% UT (>95% dip in UT)
for 5 sec
Power frequency (50/60 Hz) 3 A/m Power frequency magnetic fields should be at levels
magnetic field characteristic of a typical location in a typical commercial or
IEC 61000-4-8 hospital environment.

Home Back Next 21

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 of the Cryomatic should assure that it
is used in such an environment.
Immunity IEC60601 Compliance Electromagnetic environment - guidance
Test test level level
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

Conducted RF 3 Vrms 3 Vrms
d = 1.2√P
IEC 61000-4-6 150kHz -
d = 1.2√P 80MHz - 800MHz
80MHz 3 V/m
d = 2.3√P 800MHz – 2.5GHz
Radiated RF
where P is the maximum power output of the transmitter in watts (W) according to the
IEC 61000-4-3 3 V/m
transmitter manufacturer and d is the recommended separation distance in metres (m).
80MHz -
2.5GHz Field strengths from fixed RF transmitters, as determined 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 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.

Home Back Next 22

Annex I - EMC Statement and Guidelines
Recommended separation distances between portable and mobile RF equipment and the Cryomatic
The Cryomatic is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or 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 power output of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power m
of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
W d = 1.2√P d = 1.2√P 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 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 rating of the transmitter in watts (W)
according to the transmitter manufacturer.
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.
The Cryomatic should not be used adjacent to or stacked with any other equipment. If this configuration is required then normal operation of the
Cryomatic should be verified in this setting.

Home Back Next 23

Contact Information
Keeler Limited Keeler Scotland Keeler Instruments Inc.
Clewer Hill Road 25 Deerdykes View 456 Parkway
Windsor Westfield Estate Broomall
Berkshire SL4 4AA Cumbernauld PA 19008, USA
Freephone: 0800 521251 G68 9HN Toll Free: 1 800 523 5620
Tel: +44 (0)1753 857177 Freephone: 0800 521251 Tel: 610 353 4350
Fax: +44 (0)1753 827145 Tel +44 (0) 1236 721214 Fax: 610 353 7814
Fax + 44 (0) 1236 721231

As part of our policy of continued product improvement we reserve the

right to alter specifications at any time without prior notice.

2509 – P – 8012 Issue D Home Back Next 24