
Manufactured in the U.S.A by IDM Tech, LLC for CryoPen, Inc.
Distributed by CryoPen, Inc
CryoPen
®
is a Registered Trademark of CryoPen, Inc. All Contents Copyright © All Rights Reserved
- 2 -
Originated Date: 02.25.2010
Revision Date: 5.1.2012
OM-CT2-01-R6
(Minimally invasive cryosurgical unit and accessories for physician use only)
Caution: “Federal law restricts this device to sale by or on the order of a Physician”.
Model number: CT-2000
Manufactured in the U.S.A. by IDM Tech, LLC for CryoPen, Inc.
Distributed by: CryoPen, Inc.
Corporate Office: 800 N. Shoreline Blvd. • Suite 900S • Corpus Christi TX 78401
p: 1.888.246.3928 efax: 1.281.754.4359 www.cryopen.com
CryoPen
®
Cooling System Assembly (1ea.)
Non-Sterile re-usable CryoPen
®
tip (1ea.) 3mm
Non-Sterile re-usable CryoPen
®
tip (1ea.) 5mm
Non-Sterile re-usable CryoPen
®
tip (1ea.) 7mm
Non-Sterile re-usable CryoPen
®
tip (1ea.) 10mm
Temperature Indicator (1ea.)
Reservoir Solution 500ml (1ea.)
Reservoir Tube- Plastic (23ml)
Reservoir Tube Cap (1ea.)
Cleaning Swabs –Single end 14”(6)
Transfer Pipette- ½ dozen
CryoPen® Operators Packet
Indications For Use:
Intended use: Cryosurgical unit used for ablative type surgical technique
Indications for use: Multiple organ systems, wide range of disease, viral, premalignant and malignant
tissue.
Contraindications:
The CryoPen
®
is contraindicated in patients with recurrent basal cell cancers; lesions on the lower extremities (i.e. feet,
ankles, lower legs) when circulation is in question, especially in patients with diabetes; lesions in the nasolabial fold or
preauricular area (basal cells often are more extensive in this area); lesions in the immediate periorbital area; port-wine
stains, lesions in areas in which hair loss or pigmentary changes are critical to the patient. Cryosurgery is not recommended
for Melanomas.
WARNING: Do NOT use the CryoPen
®
when the above listed conditions are present. The use of cryosurgical
procedures in the treatment of the above listed conditions may cause serious injury to the patient.
Kommentare zu diesen Handbüchern