APPASAMY ASSOCIATES AA3 SUPER DELUXE User manual

AA3 SUPER DELUXE
CRYO
FROM YOUR RELIABLE PEOPLE
APPASAMY ASSOCIATES
User Manual
DOC.ID: RD-7.3-13 CRYO REV-01
Jan-2012

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TABLE OF CONTENTS
# CHAPTER PAGE NUMBER
1. PRODUCT DESCRIPTION……………………………………………………………….. 3
2. QUALITY, RELIABILITY AND SAFETY………………………………………………. 3
3. GENERAL WARNINGS………………………………………………………………….… 4
4. PREFACE………………………………………………………………………………………. 4
5. TERMS IN THIS MANUAL………………………………………………………………. 4
6. PRECAUTIONS………………………………………………………………………………. 5
7. CAUTION FOR USE………………………………………………………………………… 5
8. CONTRAINDICATION ……………………………………………………………………. 6
9. IMPORTANT SAFETY & MAINTENCANCE INSTRUCTIONS……………….. 5
10. CLEANING AND DISINFECTION INFORMATION……………………………… 4
11. ENVIRONMENTAL CONSIDERATION……………………………………………. 5
12. PRODUCT SPECIAL FEATURES……………………………………………………….. 7
13. TECHNICAL DATA……………….………………………………………………………… 7
14. PARTS DESCRIPTION…………………………………………………………………….. 8
15. FOOTSWITCH DESCRIPTION…………………………………………………………. 8
16. CRYOPROBE CARE AND MAINTENANCE……………………………………….. 12
17. UNPACKING……………………………………………………………………………….. ..12
18. INSTALLATION INSTRUCTIONS…………………………………………………….. 13
19. STERILIZATION INSTRUCTIONS…………………………………………………..… 13
20. FAULT DIAGNOSIS………………………………………………………………………… 11
21. WARRANTY………………………………………………………………………………….. 17
22. CUSTOMER SUPPORT……………………………………………………………….…… 18

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PRODUCT DESCRIPTION
CRYO “AA3 SUPER DELUXE” unit is Non-Electric, Foot operated, quick freeze and defrost, works
with low cost Nitrous oxide or Carbon-dioxide as refrigents.
CRYO is very useful for Cataract, Retinal, Glaucoma, Intravitreous and other cryo surgeries. The
performance of the Instrument is comparable with any cryo available internationally.
QUALITY, RELIABILITY AND SAFETY
The equipment has been designed with an emphasis on quality, reliability and safety, but
APPASAMY ASSOCIATES can only accept responsibility for these aspects, provide the following
conditions are met
Electrical installation of the room or building in which the equipment is to be used must
comply with regulations specified by the country in which the equipment to be used.
The equipment used in accordance with the instructions for use mentioned in the
operating manual provide by APPASAMY ASSOCIATES.
All modifications and repairs to the equipment are carried out by authorized APPASAMY
ASSOCIATES personnel or their agents.
The equipment must comply with regulation specified in warning and cautions
GENERAL WARNING
Warnings are intended to alert you to importance of following the correct operating procedures
where risk of injury to the patient or system user exits.
Use the device for intended clinical purposes.
Before each use, Ensure that the AA3 SUPER DELUXE is not damaged and is working
properly.
No modification of this equipment is allowed.
Only trained personal service / handle the equipment.

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PREFACE
This manualcontains operating information for the CRYO “SUPERDELUXE AA3”. The manual
consists of thefollowing chapters:
The Getting started chapter, Product Description of our console.
Technical data.
Product special features.
Installation chapter covers the entire installation instruction of the CRYO “AA3 SUPER
DELUXE”
Fault Diagnosis
We hope that this manual meets your needs. The Research & Development department at
APPASAMY ASSOCIATES would appreciate any comments you can share with us.
Kindly feel free to send your feedbacks, suggestions andclarifications to our e-mail:
APPASAMY ASSOCIATES
20, SBI Officer’s Colony, 1st street,
Arumbakam, Chennai-600 106,
Tamil nadu, INDIA.
Tel: [phone]. – Fax: [phone].
E-MAIL: [e-mail] Web site: www.appasamy.com

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TERMS IN THIS MANUAL
These terms may appear in this manual:
WARNING: Warning statements identify condition or practices that could result in
injury or loss of life.
CAUTION: Caution statements identify conditions or practices that could result in
damage to thisproduct or other property.
DISPOSE OF PROPERLY
NOTE
SYMBOLS ON THE PRODUCT LABELING
Number following this symbol indicates the serial number of the Equipment
Character following the symbol indicates the Model number of the Equipment
Consult User’s Manual
Caution, refer to accompanying documents
Manufactured By
Temperature Limitations
Keep away from Sunlight

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PRECAUTIONS
Use only standard Non-Siphoned cylinder in Vertical Position.
Before clamping the yoke of the gas tube let off some gas, so that nay particles in the
value will be flushed off.
Use the extra dry nitrous oxide or carbon-di-oxide, Low dew point gases effect the
proper functioning of the system.
Cylinder must be kept at room temperature for atleast six hours before use
In case the unit does not function properly, refer to the section “FAULT DIAGNOSIS”.
If the fault persists, inform to the manufacturers.
Periodically check all gaskets and ‘O’ rings. I n case of doubt change the gaskets if even
the slightest gas leakage
CAUTION FOR USE
Cautions are intended to alert you to importance of following the correct operating
procedures where risk of injury to the patient or system.
CONTRAINDICATIONS
There are no specific contraindications for the use of this device

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IMPORTANT SAFETY & MAINTENANCE INSTRUCTIONS
Maintenance by Medicalstaff, Bio-medical Engineer,Clinical Engineer or Qualified Technician
Only
Use this Equipment according to the User’s manual
Handle the Equipment carefully.
Cover the Equipment when not in use.
When using the instrument after a prolonged period of inactivity, confirm normal and
safe operation beforehand
Refer servicing to qualified service personnel under the following condition
If the product isn’t able to use after done all the Fault diagnosis in this
manual.
CLEANING AND DISINFECTION INFORMATION
Use Dry cloth to clean Dust Particles in the equipment.
Do not wipe the parts with hazardous solvent. To prevent the plastic parts from
discoloring or deteriorating, do not use benzine, thinner, either or gasoline.
Wipe External cover with a dry cloth at regular interval.
ENVIRONMENTAL CONSIDERATIONS
Environmental Conditions for Use
Operating Temperature: 21°C ~ 25°C
Storage, Usage Period and Transportation
Protect the unit against heat when in storage and transportation temperature should be
10°C ~ 45°C
Do not expose to temperature above 50°C / 122°F

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PRODUCT SPECIAL FEATURES
Completely Non-electric
Portable
Works with Carbon-dioxide gas (CO₂) or Nitrous oxide gas (N₂O).
Foot switch controlled
Quick freezing
Instant defrosting by reversible flow of gas system-cleans the probes for every cycle
automatically
Lightweight probe tips have high conductivity silver
Useful for Cataract, Retinal Detachment, Glaucoma and Intravitreal Surgery
Two years unconditional Warranty
TECHNICAL DATA
CRYOPROBES TECHNICAL DETAILS
PROBE Tip size (mm) Tip Temperature
Cataract Straight/ Curved 1.4 -40°C
Retinal Straight/ Curved 2.5 -80°C
Glaucoma Straight 3.5 -80°C
Intravitreal Straight 1.0 -20°C
Dimension: Length-310mm, Width-220mm and Height-100mm
Net Weight: 3.8 Kg’s (Console with Footswitch)
Gross Weight: 5.5 Kg’s

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PARTS DESCRIPTION
Front panel
Back panel
1 2 3
4 5

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1. Cryoprobe lead connector
2. ON/OFF Indicator
3. Pressure Gauge
4. Footswitch Connector
5. Gas Connector
FOOTSWITCH DESCRIPTION
AA3 SUPER DELUXE Foot switch on fully Press Position
Foot switch on Release/ Ideal Position
PRESS DOWNWARD

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CRYOPROBE CARE AND MAINTENANACE
Your Cryoprobe is a delicate device which must be handled carefully. Proper care and handling
will extend the service life of your Cryoprobe. It has been dropped causing scratches or bend.
Sterilize Cryoprobe to prevent patient-to-patient infection. (See more details on chapter-19)
Warranty of your Cryoprobe is based on normal usage.
UN PACKING
Unpack the Equipment and save all packing materials. They are specially designed to protect
the Equipment and will make repacking easy if you ever need to ship your
AA3 SUPER DELUXE
After unpacking verifies the Packing list we indicate below.
2 1 3 4 5

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1. AA3 SUPER DELUXE Console
2. Gas Connector
3. Footswitch
4. Cryoprobe (Cataract probe/ Retinal probe/ Glaucoma probe/ Intravitreal Probe)
5. Accessories (‘O’Rings-5 no’s and Metal washer-2 No’s)
And User Manual
AA3 SUPER DELUXE is marked with Model No, Serial No and Trade Mark.
INSTALLATION
The initial installation will be done by Appasamy Associates Trained Engineers only.
After installation a performances check will be carried by Appasamy Associates
Engineers.
Nobody is authorized to install the Medical Equipment except Appasamy Associates
Engineers.
INSTALLATION INSTRUCTIONS
Step-1
Unpack the Instrument and arrange all the materials from two Packing layers in the Box. Make sure
that assembling place must not be wet or dusty. After unpacking verify the packing list.
(Fig-1)

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(Fig-2)
Step-2
Clamp the cylinder connection tubing (yoke end) to the cylinder (Fig-3) and the other end to the
Union seen at the back panel gas connecter inlet (Fig-4).
(Fig-3)
(Fig-4)

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Step-3
Check the gasket in the adopter is in place and not damaged.
Step-4
Check that all the ‘O’ Rings of the Cryoprobe are in place and not damaged.
Step-5
Connect theCryoprobe BLACK lead in BLACK and WHITE lead in WHITEas indicated in the unit
(Fig-6).
(Fig-5)
(Fig-6)
Step-6
Open the cylinder value fully. Observe the pressure gauge readings. The reading should read
between 600 p.s.i. to 900 p.s.i. in nitrous oxide gas cylinder and 750 p.s.i. to 1000 p.s.i. with
cabon dioxide. (GREEN MARK IN PRESSURE GAUGE)

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(Fig-7)
Press the footswitch fully for freezing and make sure that console ON Indicator (Fig-8) and
Release the footswitch for defrosting.
(Fig-8)
After the operations is over first close the cylinder, thenpress the footswitch and release the
footswitch Vice-versa for 3 to 4 times until the pressure gauge reads zero. This is for removing
the gas inside the unit.
(Fig-9)
Wait for five minutes before disconnecting the gas connector from the cylinder.

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STERILIZATION INSTRUCTIONS
Do not Autoclave the Cryoprobe.
Satirize the Cryoprobe at room temperature with ethylene oxide, Aldilene,Amprolene for
formal vapour or similar.
If Hibitone or cidex are used always fit and tip in to the shaft before immersion. Do not
immerse the pencil for prolonged periods.
1. Never use heat to sterilize the Cryoprobe at this can seriously damage the high pressure
hoses.
2. The particular EO Cycle should be validated as per the equipment manufacturer’s
requirements.
FAULT DIAGNOSIS
No. PROBLEM CAUSE ACTION
1. Insufficient freezing
Cylinder pressure lower that
40 kg/cm. (600 p.s.i)
Cylinder in cold
Gas is not extra dry
Change the Cylinder
Change the Cylinder
Always use pure gas
2. Excessive Freezing
Liquid Nitrous oxide or
carbon-dioxide circulating
within the probe
Cylinder is not vertical
Cylinder is too full
Ensure that the cylinder is in
vertical position
As above
When the cylinder is used
open the cylinder for a few
seconds before connecting
the cryo unit
3. Leakage from the probe ‘O’ rings are defective Change the ‘O’ ring if
leakage persists inform to
the manufacturer

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4. Leakage from the cylinder
connection
Defective gasket to bounded
washer Change to bonded washer
5. Leakage from the hoses or
any others Damaged components Use could be hazardous.
contact the manufacturer
6.
Blockage, the flow of gas
through the pencil is
inaudible and tip does not
freeze
The orifice of the main
capillary tube it occluded contact the manufacturer
WARRANTY
APPASAMY ASSOCIATES Warranty for the instrument for a total period of two complete years
from the date of delivery. Our obligation under the warranty is limited to replace any part
which shall upon examination at our factory be determined to have been defective.
Use the siphon type gas cylinder completely voids the warranty of the cryo unit and Cryoprobe.
Never have unqualified staff repair the unit, by doing so the instrument can no longer be
considered under warranty as well as the instruments could be damaged beyond repair.

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DISPOSAL
Dispose of the instrument according to local
disposal and recycling laws
This symbol is applicablefor EU member countries only.
To avoid potential negative consequences for the
environment and possibly human health, this
instrument should be disposed of (i) for EU member
countries - in accordance with WEEE (Directive on Waste
Electrical and Electronic Equipment), or (ii) for all other
countries, in accordance with local disposal and
recycling laws.
CUSTOMER SUPPORT
MARKETED AND SERVICED BY:
20, SBI Officers’ Colony, First Street, Arumbakkam, Chennai - 600 106, INDIA
Tel: [phone]. – Fax: [phone].
Toll Free: 18004251945
Email: [e-mail] Website: www.appasamy.com