Cryoterapi Manual

MedGyn Cryotherapy System
Model MGC-200
Product Manual
English
Release V2
© Copyright 2010 MedGyn Products. All Rights Reserved

Product Information
Product model: MedGyn Cryotherapy System MGC-200
Standard
This product is made under the ISO13485 quality systems certified by

MEDCERT. The product has passed the CE and FDA certification.
Manufacturer
MedGyn Products Inc.

100 W. Industrial Rd, Addison, IL 60101 USA

t: 630.627.4105
toll-free: 800.451.9667
f: 630.627.0127
e: info@medgyn.com
w: medgyn.com
Edition
Second Edition: June 2012

All Rights Reserved

2
Model MGC-200
Table of Contents
PAGE
Introduction............................................................................................ 4
Package Content ............................................................................ 4
Device Description .......................................................................... 4
System Assembly.............................................................................5
Cryotherapy System.............................................................................. 5
Cryo Features.................................................................................. 5
Gas Types and Temperatures...........................................................5
Instructions for Use............................................................................... 7

Preparing Cryotherapy System for Use...........................................7
Caution............................................................................................ 8
Operation................................................................................................ 9
Trigger Off Position.......................................................................... 9
Trigger Freeze Position.................................................................... 10
Trigger Defrost Position................................................................... 10
Warnings..........................................................................................10
Cleaning, Disinfecting and Sterilization Procedures........................11
Gas Tank Information.............................................................................16
Accessories.............................................................................................17
Trouble-Shooting....................................................................................18
Warranty..................................................................................................20
Cryo Hotline............................................................................................20

3
INTRODUCTION
MedGyn Cryotherapy System, Model MGC-200 is for Ob/Gyn, Dermatology and

General Surgery.
You now have a Cryotherapy System embodying state-of-the-art cryogenic en-

gineering. Designed for use by Ob/Gyns, Dermatologists and General Surgeons,
MedGyn Model MGC-200 combines ease of operation, economy of gas and the
highest safety with unique features to provide the finest system possible. These
features are included at the suggestion of medical practitioners and permit
simple, trouble-free operation with the utmost in comfort for doctor and patient.
Simply turn on gas tank and unit is ready for use. Tips may be changed during
the procedure as required. Precision-engineered and built in the USA, this Cryo-
therapy System is the most reliable and convenient system available.
Package Content:
1 MedGyn Cryotherapy System with Tubing, Cylinder Yoke & Pressure Gauge
Any Optional Cryotherapy Tips
3 Replacement Cryotherapy system “O” rings
1 Manual
1 Warranty Registration
Device Description:
MedGyn’s Cryotherapy System is a pneumatic probe 7.25 inches in length at

one end of a 64-inch-long pneumatic tube (inside a plastic sheath) with a gas
cylinder yoke and pressure gauge assembly at the other. The cylinder yoke as-
sembly is adapted for either a 6-pound tank or for a 20-pound tank. The yoke
differs for Nitrous Oxide (N2O) gas tank or Carbon Dioxide (CO2) gas tank. Unless
specified in the order, the Cryotherapy System is supplied with N2O and with
20-pound tank US standard fitting

4
Model MGC-200
System Assembly:
The cylinder yoke assembly must be connected to an appropriate-sized, suffi-

ciently-full N2O or CO2 gas tank. An optional Cryotherapy tip, appropriate for the
procedure, must be connected to the tip of Cryotherapy System. This completes
the System Assembly.
Cryotherapy System
Cryo Tip Valve Body
Pressure Gauge
Gas Connection/Fitting
Exhaust Vent
Probe Shaft Main Valve

Cylinder Yoke
Trigger
Supply Tube CO2 or

CO2 orNN2O
O
2
Non-siphon gas tank
Features
MedGyn’s Cryotherapy System is designed to provide the most reliable, saf-

est and the highest-performing unit available. Below is some useful information
about your Cryotherapy System.
Gas - Type & Temperature
MedGyn’s Cryotherapy Sysyem is designed for use with N2O or with CO2. N2O
produces a lower temperature, and thus destroys tissue faster. (A faster rate of
freeze is considered more effective).

5
• MedGyn’s cryotherapy tip reaches about – 89°C with N2O and – 65°C with
CO2 (boiling points).
• Tissue necrosis occurs at approximately – 20°C.
• Tissue temperature at edge of ice ball formed by Cryo tip is 0°C.
Temperature graduates from edge of ice ball to proper operating temperature at the
tip. Limit of tissue destruction occurs approximately 1 to 2mm inside periphery of
visible ice ball.
Duration
The longer cryotherapy tip and tissue contact, the deeper penetration of tissue
freeze and the larger the ice ball.
The colder the temperature, the faster the freeze and the deeper the penetration.
Ice ball should cover all diseased tissue plus 1-2mm. If additional depth is required,
allow tissue to thaw; then re-freeze. To speed procedure, Model MGC-200 has a
prolonged defrost mode to gently thaw frozen tissue. The second freeze procedure
will freeze tissue faster and deeper. Depth may be judged to be 2/3 of lateral visible
ice ball.
Indications for Use
MedGyn Cryotherapy System is indicated for use in office-based cryo treatment, in

gynecology, and dermatology. It is suitable for application in a wide range of disease
indications (viral, pre-malignant and malignant).
Contraindications
Use of Cryotherapy System is contraindicated in these cases:
• Patients with any infective condition in surrounding tissue

• Patients with inflammatory disease in surrounding tissue
• Pregnant patients

6
Model MGC-200
Instructions for Use
1. Attach selected tip onto probe staft (finger-tighten).
Attach cryotherapy
tip by turning cryo-
therapy tip clockwise
onto probe shaft
2. Connect pressure gauge to gas tank.
Connect gas connector/

fitting to gas tank fitting
and hand-tighten
3. Open gas tank valve (SLOWLY open gas tank and verify correct gas pressure).

7
Slowly open main valve on

gas tank and verify pressure
on pressure gauge
CAUTION
It is important to observe pressure gauge supplied with cryotherapy sys-

tem, particularly with a new tank of gas. If pressure indicator enters red
area, even slightly, device should NOT be used. Turn off valve, remove
yoke-valve assembly from tank and vent tank for 30 seconds in a well-ven-
tilated room, or preferably outdoors. Following this procedure, reconnect
tank and make certain pressure indicator is in Green operating area. If, af-
ter venting for 30 seconds, tank indicator is still in Red area, tank should be
returned to supplier and not be used. Continued use may damage device
and/or rupture hoses. Hoses are not covered by warranty. Ruptured hoses
may harm attendants.
The probe is now ready for use.

After use, turn off gas tank.

8
Model MGC-200
Operation
NOTE: An essential element in Cryotherapy is moisture. Ensure that tissue is moist-
ened with saline, jelly or similar agents.
• Place cryotherapy tip on moistened tissue and gently squeeze trigger until first
“click” position. This is “Freeze” mode. There is no need to maintain finger
pressure on trigger.
• To defrost, squeeze trigger fully against handle and hold. In 10-15 seconds
tip will appear frost-free and detach easily from tissue. Do not attempt
to withdraw tip prior to defrost as tissue will tear.
• When practicing the freeze-thaw-freeze method, the time needed to thaw

frozen tissue may be lessened by holding cryotherapy tip against tissue while
squeezing trigger fully against handle. This provides a prolonged defrost and
gently thaws the frozen tissue.
Trigger Positions: Single Trigger has 3 Positions

1. OFF POSITION
To ensure trigger
is in off position,
squeeze trigger
to handle and
release.

9
2. FREEZE POSITION (Latched for Convenience)
Squeeze trigger slightly

until it clicks in place to start
freeze mode.
3. DEFROST POSITION (Choice of short or prolonged)
Prolonged defrost will thaw tissue in seconds for fast refreezing

procedure used in decisive necrosis.
Squeeze trigger to
handle and hold to defrost.
Typical defrost takes 10-15
seconds.
WARNING
• The cryotherapy unit shaft and cryotherapy tip must be cleaned

and adequately disinfected prior to use to eliminate risk of infec-
tion or cross-infection.
• If pressure indicator enters red area, even slightly, cryotherapy unit

should NOT be operated as this may damage device and/or rup-
ture hoses.
• Ruptured hoses may harm attendants.

10
Model MGC-200
• Do not attempt to withdraw tip from tissue after procedure and

prior to complete defrosting, as tissue may tear.
• Do not vent gas tank in a closed environment as excessive Nitrous

Oxide or Carbon Dioxide may be harmful.
• Do not store gas tanks near radiators or in hot areas as this will
result in increased pressure in tank.
• Refill gas cylinders with medical-grade N2O or with CO2.
Cleaning, Disinfection & Sterilization

Important Information:
1. During cleaning and disinfection the Cryotherapy Tip remains attached to the
Cryo Probe Shaft to prevent water from entering the inside cavities of each.
2. Cleaning and disinfection of the Cryotherapy Probe Shaft, and cleaning, disin-
fection, and sterilization of the Tip should be done prior to first use, and should
be performed immediately after each use to prevent accumulation of dried on
debris.
3. Cleaning of the Cryotherapy Probe Shaft, Cryotherapy Tip, rest of the Cryo-
therapy Probe Unit (Regulator, Flexible Tubing, Handle, and Upper Part of Shaft)
is carried out using Enzol® enzymatic detergent and CaviWipes® & CaviCide®
4. Perform high level disinfection (Cidex® OPA Solution-0.55% ortho-phthal-

aldehyde) on the Cryotherapy Probe Shaft with Tip attached. The Cryotherapy
Tips are the only parts that may come in contact with the patient mucous mem-
branes and therefore are the only parts requiring high level disinfection followed
by autoclave sterilization. The Cryotherapy Probe Shaft should not come in con-
tact with patient-mucous membrane due to use of vaginal speculum. However,
high level disinfection of the shaft will protect the patient if there is accidental
contact by the shaft.

11
6. Automated cleaning and automated disinfection are not suitable to the Cryo-
therapy Probe System due to the risk of water entering the Cryotherapy Probe or
Cryotherapy Tips and causing damage to the unit.
7. Limitations to reprocessing: repeated processing has minimal effect on either

the Cryotherapy Probe or the Cryotherapy Tips. End of life should be deter-
mined by wear and damage due to use.
Prior to First Use:
Remove Cryotherapy Probe Unit and Cryotherapy Tips from their shipping pack-
aging
The Cryotherapy Probe Unit and Cryotherapy Tips are not supplied sterile
Follow the instructions below to prepare the Cryotherapy Probe Unit and Cryo-
therapy Tips for initial use
Reprocessing Instructions After Use:
At the Point of Use: Remove excess debris from the Cryotherapy Shaft and Tip
using a cotton cloth moistened with water. Perform the following cleaning and
disinfection method in the cleaning area:
Containment of the Unit During Transportation to Cleaning Area: Place the unit
in a tray with a lid to transport the device to the cleaning area. Discard the soiled
cotton cloth in appropriate contaminated material receptacle.
Recommended water: Fresh tap water may be used for cleaning and disinfecting
purposes and rinsing where appropriate.
Cleaning, Manual:
Equipment needed: CaviWipes, Cavicide®, clean lint-free cotton cloth, soft

scrub brush, enzymatic detergent which is mild in pH (7.8-8.8), low foaming, and
easily rinsed (Enzol® enzymatic detergent diluted as per package directions with
fresh tap water at room temperature).

12
Model MGC-200
Instructions for Cryotherapy Probe Unit (Regulator, Flexible Tubing, Han-

dle, and Upper Part of Shaft):
1. Wipe Cryo Probe Unit with detergent (Enzol® enzymatic detergent diluted 1
oz/1 gal as per package directions with fresh tap water at room temperature)
dampened lint-free cotton cloth. All parts of the probe may be wiped down, in-
cluding upper portion of Probe Shaft, handle, flexible tubing, and regulator. Care
should be taken to avoid getting water inside the unit.
2. Rinse cloth with tap water, wring out, and wipe Cryotherapy Probe again to
remove detergent. Repeat this 2 additional times or until there is no remaining
detergent residue on the Probe. Do not rinse the Cryotherapy Probe Unit with
running water as this may allow water to enter the unit.
3. Wipe Cryotherapy Probe unit with a CaviWipes® cloth. All parts of the probe
may be wiped down including the upper portion of the Probe Shaft, handle,
flexible tubing, and regulator. Multiple CaviWipes® are used. CaviCide® was
sprayed on the Probe Shaft, handle, flexible tubing, and regulator and a brush
was used to reach crevices. The nipple from the gas valve attachment was re-
moved and wiped down. The CaviWipes® process is repeated once.
Instructions for Cryotherapy Probe Shaft with Cryotherapy Tip Attached:
1. Probe Shaft with tip attached in place should be submerged up to approxi-

mately ½ to 1 inch from the top of the Shaft in the enzymatic detergent solution
(Enzol® enzymatic detergent diluted 1 oz/1 gal as per package directions with
fresh tap water at room temperature) and soaked for a minimum of five minutes,
and then scrubbed with a soft brush. Care should be used to scrub well along
the seam between the shaft and tip. Repeat this cleaning procedure using fresh
diluted enzymatic detergent solution as above, rigorously scrubbing the seam
between the shaft and tip with a soft brush.
2. Rinse Cryotherapy Probe Shaft well with fresh tap water, taking care not to
get water inside the unit. Rinse the seam between the shaft and tip thoroughly
during this process.
Drying:
Dry with a clean lint-free cotton cloth.

13
Disinfection, Manual:
Equipment Needed:
Clean lint-free cotton cloths, disinfectant solution: Cidex® OPA Solution (0.55%
ortho-phthalaldehyde concentration, used full strength).
Instructions for Cryotherapy Probe Shaft with Cryotherapy Tip Attached:
1. The Cryotherapy Probe Shaft with tip attached in place can be submerged up
to approximately ½ to 1 inch from the top of the Shaft in the Cidex® OPA Solu-
tion at a minimum of 20°C (68°F) and ensuring that all air bubbles are removed
from the surface of the Cryotherapy Probe shaft and Tip. Flush the disinfectant
in the hard-to-reach areas a minimum of 5 times using a syringe. The Cryothera-
py Probe Shaft and Cryotherapy Tip are soaked for a minimum of 24 minutes.
2. The Cryotherapy Probe shaft with tip in place should be thoroughly rinsed by
submerging up to approximately ½ to 1 inch from the top in a large volume of
fresh tap water agitating for a minimum of one minute. This process should be
repeated 2 additional times using fresh batch of water each time.
Drying:
Dry all parts with a clean lint-free cotton cloth
Packaging:
Instructions for Cryotherapy Probe Unit (Regulator, Flexible Tubing, Han-

dle, Shaft):
Remove the Cryotherapy Tip from the unit. Place the clean, disinfected, dried
Cryotherapy unit (regulator, flexible tubing, handle, and shaft) in a clean plastic
bag to keep the unit clean and dust-free.
Instructions for Cryotherapy Tips:
Clean, disinfected, dried Cryotherapy Tips are to be placed singly in sterilization

pouch of the appropriate size for sterilization.

14
Model MGC-200
Sterilization:
Cryotherapy Tips:
Cryotherapy Tips (packaged individually in a pouch) are to be sterilized using the

Prevacuum autoclave using 3 preconditioning pulses. Temperature 132°C (270°F)
minimum. Cycle duration 4 minutes minimum. Drying time 30 minutes minimum.
Sterilization is only suitable for the Cryotherapy Tips. Sterilization is not suitable for
other parts of the Cryotherapy Probe System. Warning: Use of Clorox or any kind of
bleach for Cryotherapy Tip sterilization can permanently damage the tips!
Instructions for After Reprocessing:
Maintenance:
No particular requirements
Inspections and Testing:
1. Visually inspect Cryotherapy Tips for damage and wear (cuts, scratches, dents, or
chips). If damage or wear is noted, replace the Cryotherapy Tip.
2. Check that the Cryotherapy Probe or Cryotherapy Tips surfaces appear clean.
3. Make sure there is no water inside the Cryotherapy Tip as this may block the
Cryotherapy Probe with ice formation. If water gets inside the Cryotherapy Tip cav-
ity: do not use this Cryotherapy Tip, wait for the Cryotherapy Tip to dry completely.
Storage:
Store all parts in a clean dry area in a manner that minimizes contamination or dam-
age
The cleaning, disinfection and sterilization instructions provided above have been vali-
dated by MedGyn Products Inc. as being capable of preparing the device for re-use. It
remains the responsibility of the re-processor to ensure that the reprocessing as actually
performed using equipment, materials and personnel in the reprocessing facility achieve
the desired results. This normally requires validation and routine monitoring of the pro-
cess. Likewise, any deviation by the re-processor from the instructions provided should
be properly evaluated for effectiveness and potential adverse consequences.

15
Gas Tank Information
Tank Instructions:
1. Use only a non-siphon tank. See diagrams below.
2. Do not store gas tanks near radiators or in hot areas, as this will result in in-
creased pressure inside tank. The Cryotherapy system is designed to automati-
cally and safely bleed tank to operating pressure, so this leads to faster deple-
tion of gas.
3. Refill gas cylinders with medical-grade gas only,

either N2O or CO2. Look in your local telephone
directory for a local gas supplier under the heading
GAS MEDICAL & INDUSTRIAL. Medical supply com-
panies can usually recommend a gas source
4. Store gas tanks upright.
A non-siphon tank has a short delivery tube

that draws gas ONLY from the inside of tank.
The delivery tube is not submerged in
liquid-phase gas. It is extremely important
that liquid does not get into
delivery tube.
A siphon tank has a long delivery tube

that draws liquid from inside tank. The deliv-
ery tube is submerged in liquid-phase gas.
This tank is easily confused with a non-siphon
tank. Make sure your gas supplier knows that
you need a non-siphon tank.

16
Model MGC-200
Never place tank horizontally. Liquid

will get into delivery tube
and damage probe.
Accessories
See enclosed flyer for available tips for Model MGC-200
The following tips all fit the Model MGC-200 Cryotherapy Unit. The first two
digits refer to diameter of tip, the second pair of digits refers to depth of tip that
freezes. Both are expressed in mm. Uses for various tips are indicated, but tips
are not limited to these suggestion.
Cryotherapy Tips
Identifier Catalog Number Alternate Number Description and Purpose

019002/0219 MGC-0219 Micro tip, 2mm diameter
for OB/GYN — small to
medium size Condylomata,
polyps, and eradicating
granulation tissue (scar tis-
sue) in the cuff of a hyster-
ectomy patient which tends
to bleed at the junction of
the granulation and normal
tissue
019002/0507 MGC-0507 Skin lesion tip, 5mm diam-
eter, 45� angle
019002/0811 MGC-0811 Skin lesion tip, 8mm diam-
eter, 45� angle
019002/0800 MGC-0800 Endocervical, round tubular
tip

17
Identifier Catalog Number Alternate Number Description and Purpose

019002/1910 MGC-1910 OB/GYN small size for exo/
endocervical and a com-
bination freeze with 10mm
penetration into the os.
019002/2507 MGC-2507 Exo/Endo-cervical, Large
019002/1900 MGC-1900 OB/GYN 19mm flat tip for
exocervix of a normal sized
cervix. If the cervix is large
and lesion extends beyond
size of an ice ball that would
be produced with a single
freeze, then physician can
elect to make two freezes;
one on the anterior lip and
one overlapping on the pos-
terior lip of the cervix. With
a flat tip, this is possible;
with a cone, it is difficult.
This tip is also used for
treating extensive areas of
Condylomata
019002/1905 MGC-1905 OB/GYN convex (19mm x
5mm) for exocervical use
019002/2500 MGC-2500 Exocervical 25mm flat tip
Trouble-Shooting
TWO main situations may arise with the Cryotherapy Unit:
Lack of freezing, or Lack of defrost.
Lack of Freezing may be due to
• low pressure in tank, or

• 2-step trigger is fully depressed to defrost position, or
• unit is clogged with gas particles or water or liquid from tank, obstructs flow of
gas.
Lack of Defrost may be due to cryotherapy system valves sticking in the open
position due to an obstruction or water-vapor freeze. If so, depress trigger fully to
defrost, shut off gas valve and irrigate tissue area to defrost.

18
Model MGC-200
The following remedies are suggested if these conditions occur:
Condition Remedy
1) Low pressure causing Open gas valve fully. If needle goes to and stays in
lack of freezing and yellow zone, replace gas cylinder.
gauge needle in red zone
2) Gauge needle goes to Vent gas cylinder as explained on Page 8

red zone CAUTION
3) Gas leak is heard or seen If leak is at tank yoke, tighten yoke.

If at base of tip, change “O” ring. (3 “O” rings
are supplied with unit.)
If in flexible, sheathed tube or in cryo
probe handle, contact manufacturer.

4) Obstruction in system Contact manufacturer.
lines

Service: Only above-mentioned maintenance and
trouble-shooting should be attempted.
For service or advice on Cryotherapy unit, please contact:

100 W. Industrial Rd.
Addison, IL 60101 USA
t: 630.627.4105
toll-free: 800.451.9667
f: 630.627.0127
e: info@medgyn.com
w: medgyn.com

19
Warranty
The Cryotherapy System is warranted for 12-months from the date of ini-
tial purchase. See warranty information included with original equipment.
Fill in and mail Warranty Registration to MedGyn Products, Inc.

20
Model MGC-200

100 W. Industrial Rd.
Addison, IL 60101 USA
t: 630.627.4105
toll-free: 800.451.9667
f: 630.627.4105
e: info@medgyn.com
w: medgyn.com

21

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MedGyn Cryotherapy System

© Copyright 2010 MedGyn Products. All Rights Reserved

Product model: MedGyn Cryotherapy System MGC-200

This product is made under the ISO13485 quality systems certified by

MedGyn Products Inc.

Second Edition: June 2012

MedGyn Products Inc.

© Copyright 2010 MedGyn Products. All Rights Reserved

Instructions for Use............................................................................... 7

Gas Tank Information.............................................................................16

© Copyright 2010 MedGyn Products. All Rights Reserved

MedGyn Cryotherapy System, Model MGC-200 is for Ob/Gyn, Dermatology and

You now have a Cryotherapy System embodying state-of-the-art cryogenic en-

MedGyn’s Cryotherapy System is a pneumatic probe 7.25 inches in length at

© Copyright 2010 MedGyn Products. All Rights Reserved

The cylinder yoke assembly must be connected to an appropriate-sized, suffi-

Probe Shaft Main Valve

Supply Tube CO2 or

MedGyn’s Cryotherapy System is designed to provide the most reliable, saf-

Gas - Type & Temperature

© Copyright 2010 MedGyn Products. All Rights Reserved

Indications for Use

MedGyn Cryotherapy System is indicated for use in office-based cryo treatment, in

Use of Cryotherapy System is contraindicated in these cases:

• Patients with any infective condition in surrounding tissue

© Copyright 2010 MedGyn Products. All Rights Reserved

Instructions for Use

1. Attach selected tip onto probe staft (finger-tighten).

2. Connect pressure gauge to gas tank.

Connect gas connector/

© Copyright 2010 MedGyn Products. All Rights Reserved

Slowly open main valve on

It is important to observe pressure gauge supplied with cryotherapy sys-

The probe is now ready for use.

© Copyright 2010 MedGyn Products. All Rights Reserved

• When practicing the freeze-thaw-freeze method, the time needed to thaw

Trigger Positions: Single Trigger has 3 Positions

© Copyright 2010 MedGyn Products. All Rights Reserved

2. FREEZE POSITION (Latched for Convenience)

Squeeze trigger slightly

3. DEFROST POSITION (Choice of short or prolonged)

Prolonged defrost will thaw tissue in seconds for fast refreezing

• The cryotherapy unit shaft and cryotherapy tip must be cleaned

• If pressure indicator enters red area, even slightly, cryotherapy unit

• Ruptured hoses may harm attendants.

© Copyright 2010 MedGyn Products. All Rights Reserved

• Do not attempt to withdraw tip from tissue after procedure and

• Do not vent gas tank in a closed environment as excessive Nitrous

• Refill gas cylinders with medical-grade N2O or with CO2.

Cleaning, Disinfection & Sterilization

4. Perform high level disinfection (Cidex® OPA Solution-0.55% ortho-phthal-

© Copyright 2010 MedGyn Products. All Rights Reserved

7. Limitations to reprocessing: repeated processing has minimal effect on either

Prior to First Use:

Reprocessing Instructions After Use:

Equipment needed: CaviWipes, Cavicide®, clean lint-free cotton cloth, soft

© Copyright 2010 MedGyn Products. All Rights Reserved

Instructions for Cryotherapy Probe Unit (Regulator, Flexible Tubing, Han-

Instructions for Cryotherapy Probe Shaft with Cryotherapy Tip Attached:

1. Probe Shaft with tip attached in place should be submerged up to approxi-

Dry with a clean lint-free cotton cloth.

© Copyright 2010 MedGyn Products. All Rights Reserved

Instructions for Cryotherapy Probe Shaft with Cryotherapy Tip Attached: