CRYO IQ DERM CIQ-D-L User manual

-89°C / -128°F
0537
USER’S GUIDE
English
The innovative way of cryosurgery
®
DERM, PRO

2
Table of contents
Chapter Page
1. Introduction and Warnings 3
2. Legal 3
3. Used Symbols 3
4. Products 4
5. Pictures of products 5-6
6. How to work with CryoIQ®7-8
7. Liquid Cryo 8
8. Medical Considerations 9
9. Suggested Freezing Times 10
10. Simple Treatment for Success 11
Document version: UGENG2016A7.INDD
All mentioned products are manufactured in
the European Community by:
The most recent version of this user manual and other language versions
can be downloaded from the manufacturer’s website www.cryoiq.com
CryoIQ
Apelrödsvägen 1
439 32 Onsala
Sweden
Phone: [phone]
E-mail: [email protected]
Website: www.cryoiq.com

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3. Used symbols
Manufacturer
Warnings
Upper temperature limit 50°C / 122°F
Part number
Serial number
Protect from direct sun exposure
Notied body no. 0537
0537
1. Introduction and Warnings
Only medical professionals or skilled specialists are allowed to use the units.
Patients must be informed about eventual risks prior to start the treatment.
With this device you will operate directly on the patient. Therefore
it is mandatory to carefully go through the user guide and to follow
the instructions in detail. If there are any doubts please consult your
dealer or contact the manufacturer in Sweden.
2. Legal
CryoIQ®devices are intended for the controlled destruction of unwanted tis-
sue by application of extreme cold using liquided N2O (-89°C/-128°F) or CO2
(-78°C / -108,4°F).
CryoIQ®is the registered trademark of Skafte Medlab.
Other registered trademark are a property of respective owners.
Notied Body Number: 0537
Please note the liability waiver at the back of this user guide.

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This user guide is applicable for the following products and accessories:
Devices CryoIQ Ref
CryoIQ DERM - Liquid CIQ-D-L
CryoIQ DERM - Contact 1 CIQ-D-C1
CryoIQ DERM - Contact 3 CIQ-D-C3
CryoIQ DERM - Contact 5 CIQ-D-C5
CryoIQ PRO - Liquid CIQ-P-L
CryoIQ PRO - Contact 1 CIQ-P-C1
CryoIQ PRO - Contact 3 CIQ-P-C3
CryoIQ PRO - Contact 5 CIQ-P-C5
CryoIQ PRO - Contact 7 CIQ-P-C7
Cartridges with valve*
Cartridge 16 gram N2O CIQ-G-VN16
Cartridge 25 gram N2O CIQ-G-VN25
Cartridge 16 gram CO2CIQ-G-VC16
Cartridge 16 gram N2O, box of 4 pcs CIQ-G-VN16x4
Cartridge 25 gram N2O, box of 4 pcs CIQ-G-VN25x4
Applicators for use with PRO
Dermatology tip, L=22 mm, spray freeze Ø1-6 mm CIQ-PA-D1
Dermatology tip, L=22 mm, spray freeze Ø7-18 mm CIQ-PA-D2
Dermatology tip, L=22 mm, spray freeze Ø9-22 mm CIQ-PA-D3
Contact freezing tip Ø1 mm ”gold-plated” CIQ-PA-C3
Contact freezing tip Ø3 mm ”gold-plated” CIQ-PA-C3
Contact freezing tip Ø5 mm ”gold-plated” CIQ-PA-C5
Contact freezing tip Ø7 mm ”gold-plated” CIQ-PA-C7
Long tip, L=130 mm, spray freeze Ø7-18 mm CIQ-PA-L13
Angled tip, 45°, L=80 mm, spray freeze Ø7-18 mm CIQ-PA-A45
Accesories for use with PRO
LED light, for 16 gram gas cartridge. CIQ-A-LED
4. Products
* Please note the gas cartridges (CA-K-V16 & CA-K-V25) from Cryoalfa®
will not work with CryoIQ devices even if the products look similair.

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5. Models
Cap
Cartridge N2O 16 or 25 gram
Cartridge CO216 gram
Lever
Glass tip
Serial nr
Body
Contact tip
CryoIQ PRO
CryoIQ DERM
Liquid
Freezing
Contact
Freezing
Contact
Freezing
Liquid
Freezing
CIQ-D-L CIQ-D-C1
CIQ-P-C1
CIQ-P-L
CIQ-D-C3
CIQ-P-C3
CIQ-D-C5
CIQ-P-C5 CIQ-P-C7

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5.1 Options for Model PRO
Glass p, length 22 mm
D1= Treatment area Ø1-6 mm
D2= Treatment area Ø7-18 mm
D3= Treatment area Ø9-22 mm
Tips for Liquid ”Spray” Freezing
Glass p, length 130 mm
Treatment area Ø7-18 mm
Long p for Liquid ”Spray” Freezing
Glass p, length 80 mm
Treatment area Ø7-18 mm
Angled p 45° for Liquid ”Spray” Freezing
Contact surface Ø1, 3, 5, 7 mm
Tips for Contact Freezing
Available for all models using
16 gram cartridge (does not
t Pro)
LED Light
Cartridge designed to work with the
CryoIQ® |DERM, PRO
Cartridge 16 /25 gram with valve
Packed in box with 1 cartridge
Packed in box with 4 cartridges
D1 D2 D3
C1 C3 C5
L13 A45
C7

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6.1 Installation of cartridge N2O: Unscrew the cap of the cartridge and remove
the small white plastic stopper. Then screw (clockwise) the cartridge into
the threads of the CryoIQ® body, continue to turn until you feel a light stop
position (resistance). DO NOT USE FORCE!
The cartridge has a built-in lter and valve and can be screwed or unscre-
wed without any gas loss. The cartridge is empty when no white stream
of nitrous oxide is being expelled anymore through the applicator when
pressing the lever. There is only air coming out at that point. Replace the
empty cartridge with a new one in the next treatment.
6.2 Operation Liquid ”Spray” Freezing:Remove the cap from the glass tip
and bring the device in an angle towards the lesion. By pressing the lever
the ow of Nitrous oxide starts. You have to stay in the rst 4mm distance
of the skin as Otherwise only air will be expelled onto the skin instead of
liquid nitrous oxide and there will be no freezing effect. Always, move the
applicator around in small circles or in a diagonal line from the border of
the lesion towards the center or from the center to the border. For smaller
lesions (1-2 mm) a tipping movement can be practiced toward the lesion.
Movement is needed to avoid ice crystals building up on top of the lesion.
The closer the tip is on the lesion, the larger of a surface will be treated
and more freezing power is brought onto the lesion.
6.3 Operation ”contact freezing”:By pressing the lever with the nger the
contact tip starts to cool down. After approx 20 sec the tip has reached
-50°C / -58°F and you are ready to start the treatment.
6.4 Application range: All typical skin indications occurring in a medical practice,
such as treatments of all types of warts, hemangioma, papilloma, keratosis,
condyloma, lentigo and more.
6.5 Treatment time: Treatment time depends on the depth at which the user
deems necessary. Please refer to the treatment guidelines (included) for
more details.
6.6 Cleaning: The glass tip can be cleaned and disinfected with a disinfectant
or alcohol. If the device comes into contact with blood, mucous, or any
other infected area it is mandatory to steam sterilize.
Unscrew the gas cartridge from the body and sterilize the body and glass
tip. Use a steam sterilizer at 134°C / 273°F, according to EN norms13060
and 285. All other sterilization methods are excluded. NEVER STERILIZE
A CARTRIDGE!
A hot air sterilization may damage the glass tip and must be
avoided under all circumstances.
6. How to work with your CryoIQ®

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CryoIQ®Liquid Cryo provides a highly concentrated freezing for a successful
treatment. Our cryosurgical devices are equipped with a specic liquid gas dosing
applicator. The operator is able to control the release of sufcient liquid N2O to
treat lesions without wasting gas. With a temperature of -89°C / -128°F the liquid
gas is evaporating on the lesion. A freeze thaw freeze method is recommended
to achieve maximum results.
This process causes the cells of the tissue to be destroyed due to the cell
membrane rupturing as a consequence of ice crystal formation within the cell.
Please note: According to clinical studies, the freezing method Liquid “spray”
Freezing with N2O is as efcient as liquid nitrogen (N2) in most cryodermato-
logic indications.
7. Liquid Cryo
6.7 Storage: After use, place the device back in the storage case. Once closed,
make sure the lever is not being pressed down by the lid of the storage box.
Otherwise, the gas will leak out unintentionally.
Protect the gas cartridge from heat and direct sun exposure.
Never expose the gas cartridge to a temperature above
+50°C / 122°F.
Store the device at room temperature 21°C / 70°F. Make sure that the tip is
always protected by the cap.
6.8 Disposal: The disposal of a cartridge must be conducted in accordance with
local requirements. An empty gas cartridge may be disposed of as scrap
metal.
6.9 Safety instructions and risk: Only use the device as described in the user
guide for the purpose specied therein. Do not try to modify the device.
Any manipulations of the device will result in an exclusion of warranty and
liability.
Cartridges are under extreme pressure. Follow all suggested
safety instructions.
Never use a damaged device. The manufacturer should check
any device that has been dropped before it is used again.
Do not apply pressure when connecting the components. Place the cartridge
straight in the threads of the unit’s body when replacing the cartridge.
6.10 Warranty: The warranty is strictly limited to the exchange of defective parts.
Dropped devices or broken tips are not under warranty. Other claims for
damages such as loss of working hours, incorrect treatment and their con-
sequences, non-executed after treatment and their consequences as well as
the non- observance of the safety instructions are excluded from all warranty
and liability.

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Relative contraindications
• Insecurity when making a diagnosis of the skin lesion (biopsy by skin
carcinoma).
• Depigmentation as a side effect on dark skin can be cosmetically disturb-
ing. On light skin depigmentation this can hardly be seen and the skin
tends to recover after exposure to the sun.
• Potential risk for hyperpigmentation when a newly treated area is ex-
posed to a lot of sun.
• Freezing too long, especially peripherally on ngers, toes, wrist or the
area behind the ear can theoretically give tissue damage.
• It is recommended that a treatment of multiple lesions on a toe or nger
is done on one side at a time.
• Lesions which in principal could be cryosurgical treated but also are
infected should initially be medically treated for the infection.
• In case of freezing nerves, a short period of pain is possible. Nerves or
vessels can usually be protected by lifting, folding or moving the skin with
the lesion.
• Treatment of areas on the head can cause brief headaches.
• Please consult literature for more relative contraindications.
Absolute contraindications
Cryosurgery is contraindicated in patients with cryoglobulinemia, diabetics,
cancer, HIV, circulation problems, Raynaud’s, collagen diseases, hemophilia,
patients undergoing immunosuppressive treatments, patients being medicat-
ed with anticoagulant medicine, and children under 4 years. Consult literature
for more absolute contraindications.
Not getting expected result?
A. No result – The treatment time was probably not long enough, the glass tip
wasn’t within the 1-4 mm range from the skin or a freeze-thaw-freeze cycle
wasn’t performed. Ice crystals will affect the result when they are build-up
onto the lesion into an pyramid form as the cryogen will be expelled only to
the sides..
B. A blister, sometimes lled with blood, may develop after the treatment. Do
not puncture the blister; instead cover it with a band aid.In rare, extreme
cases this might lead to a scar formation or hyperpigmentation.
8. Medical considerations
Follow-up treatment suggestions
• Keep the treated area clean.

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9. Suggested freezing times
Acne 4 - 6
Actinic Keratosis 4 - 8
Basiloma 8 - 9
Cavernous Angioma 4 - 6
Condyloma 5 - 12
Granuloma Anulare 5 - 6
Keloids 4 - 6
Lentigo 2 - 5
Literature freeze
Type of lesion Time range in seconds
The medical literature has many reports of various cryogenic freezing
technics. The thickness, location and hydration of the target tissue can affect
outcomes. Medical professionals should be familiar with cryosurgical techni-
ques when using CryoIQ®.
Although not exhaustive, the table below contains suggested freezing times
as reported in the literature. These are wide ranges and provide only a guide-
line for consideration.
Molluscum Contagiosum 3 - 10
Seborrheic Keratosis 5 - 10
Skin Tags 5 - 10
Verruca Juvenile 3 - 4
Verruca Plana 5 - 15
Verruca Plantaris 10 - 20
Verruca Vulgaris 10 - 20
References for cryosurgery in general
1. Dockery G, Treating A Child With Multiple, Mildly Pruritic Papules, Podiatry Today,
20:4, 2007.
2. Strumia R, La Crioterapia in Dermatologia, Published by Business Enterprise SRL,
2006.
3. Dawber R, Colver G, Jackson A, Cutaneous Cryosurgery - Principles and Clinical
Practice, Martin Dunitz Publisher, 3:d Edition, 2005.
4. Andrews M, CryoSurgery for Common Skin Conditions, American Family Physician,
69:10, 2365-2372, 2004.
5. Bassukas ID, Hundeiker M, ”Liquid freezing®“ A new approach for the cryosurgical
treatment of supercial skin lesions
6. Rubinsky B, CryoSurgery, Annual Review Biomedical Engineering, 02:157-187, 2000.
7. Gage A, What Temperature is Lethal for Cells? J Dermatol Surg Oncol, 5-6, 1979.

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10. Simple treatment for success
1. Draw a circle around the lesion to be treated. Measure the size of
the lesion to be able to see the treatment result by the next visit,
document the ndings in a patient journal.
2. When treating warts debride the wart to pinpoint bleeding. If the
wart is bleeding we recommend you to use hemostatic solution to
stop the bleeding (this point only valid for warts on the foot).
3. Place the patient in such a way that you easily can treat the lesion.
The lesion to be treated should point towards the ceiling.
4. Place your device within the 1-4 mm range from the target lesion.
Activate your device by pressing the lever on the side. The angle
against the treatment area should be 65-90° to get the best result.
Spraying from a further distance has absolutely no effect.
5. For every 3 seconds of freeze, the CryoIQ is penetrating 1 mm in
depth of the skin. The freezing times will vary depending on the
particular lesion being treated.
6. Freezing starts immediately. From this moment on the patient could
feel a stinging sensation or sometimes a slight pain if there are
many nerve endings turned downwards in the treated area. Even a
small part of healthy skin may be treated during this process. 7. If
the treatment has been done on the sole of the foot we recommend
to cover the area with a band aid the area in order to relieve the
treated area.
7. If treatment has been done on the footpad we recommend a plaster
on the area to relieve the treated area.
8. A follow up visit should be scheduled within 2-3 weeks.
Sometimes 2 to 3 treatments are necessary before the wart / lesion
is removed. By each treatment occasion the prescribed procedure
should be taken.

Liability waiver
Improper use, including excess freezing levels beyond those, which are
recommended or for an excessive duration, may result in bodily injury to
clients/patients or to operator. CryoIQ AB and their afliates, respective
directors, ofcers, shareholders, employees, agents and contractors are
not liable or responsible, regardless of whether such liability or responsibi-
lity is based on breach of contract, tort, strict liability, breach of warranties,
failure of essential purpose, fundamental breach or otherwise, for any
death or injury, whether physical or mental, or for any incidental, conse-
quential, indirect, special or punitive damages, arising out of the CryoIQ
products, its design, specications, possession and use, and treatment
procedures, and whether or not any such death, injury, loss, damage(s)
result from the negligence, default or error in judgment by CryoIQ AB,
their afliates, respective directors, ofcers, shareholders, employees,
agents and contractors, and even if advised of the possibility of such
damages. You agree to indemnify CryoIQ AB, their afliates, respective
directors, ofcers, shareholders, employees, agents and contractors, from
and against any and all liability, damages, losses, costs, judgments, nes,
penalties and expenses (including legal expenses) of any kind or nature,
including, without limitation, incidental, consequential, indirect, special
or punitive damages, arising out of claims, demands, actions, causes of
action, proceeding or suits, whether in law or in equity, due to any death,
injury, loss, damage or damages as hereinbefore referred to.
© 2016 Skafte Medlab
®