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
- 3 -
Originated Date: 02.25.2010
Revision Date: 5.1.2012
OM-CT2-01-R6
WARNING: If re-usable tip gets stuck on skin, remove the Pen Core from tip by gently rotating counter clockwise to
unlock it and allow to thaw.
WARNING: Never leave the chilling wells open. Doing so will render your unit inoperable. Always replace a cold pen
core with a warm pen core that has been wiped dry and dipped in the CryoPen Reservoir Solution.
WARNING: Do not use the electrical charging unit near or in water. Doing so may cause electrical shock resulting in
serious injury or death to the user.
WARNING: Do not use an extension cord. Use of extension cords may present potential fire hazards.
WARNING: Explosion hazard! Do not use in presence of flammable anesthetics. Unit contains 1oz. of an ethanol
based proprietary solution.
WARNING: Ethanol is poisonous! May be fatal if swallowed and harmful if inhaled or absorbed through skin.
Please refer to Material Safety Data Sheet regarding the ethanol based reservoir solution.
WARNING: The CryoPen
®
Pen Cores are extremely cold. Accidental contact with core may result in frostbite.
Touch only the blue plastic handle when core is at cryogenic temperatures.
WARNING: Clean CryoPen
®
Pen Cores by wiping down with soap and water or with standard solutions such as
CryoPen’s Reservoir Solution or isopropyl alcohol. Clean only when they have reached room temperature. Do not
submerge the Pen Cores in water or any cleaning solution. Doing so will render them inoperable.
WARNING: Do not use the CryoPen
®
Pen Core without a sterile or disinfected tip. Use of unprocessed tip will expose
your patients to non-sterile conditions and may cause cross patient contamination. Pen Core at cryogenic
temperatures could also become stuck on patient’s skin thereby causing injury to the patient.
CAUTION: This device should be used with caution on patients with diabetes, peripheral vascular disease or
cold intolerance problems.
CAUTION: Use of CryoPen
®
on lesions with hair, may cause patient to lose hair.
CAUTION: Use of CryoPen
®
on lesions in areas where pigment is critical to patient, patient should be made
aware that change in pigment may result.
CAUTION: Federal Law restricts this device to sale, distribution and use by or on the order of a physician.
CAUTION: Reservoir solution contains alcohol (ethanol) Avoid skin contact with the reservoir solution on
persons taking the medication ANTABUSE®.
CAUTION: Handle the copper pen cores with great care. Dropped pen cores will be damaged and may
become trapped in the pen tips.
CAUTION: Cold pen cores should be placed in a tip or defrost wells immediately to avoid damage.
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