CryoPen Cryosurgical System OPERATOR’S MANUAL cryosurgery at your fingertips® 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 -1Originated Date: 02.25.2010 Revision Date: 5.1.
(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 CONTENTS: CryoPen® Cooling System Assembly (1ea.
WARNINGS: 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.
POWER OUTAGE Step one: Turn unit off, UNPLUG FROM WALL and allow to defrost. Step two: After unit has reached room temperature, approximately 8 hours, unplug the power supply from unit and remove Pen Cores from the chilling wells. Step three: Using the 14” swab that is provided, remove all reservoir solution and water from the chilling wells. Wells should be completely dry. Step four: Remove reservoir tube from the unit, discard old solution and refill to the maximum line (3 pipettes).
DESCRIPTION: The CryoPen® system provides a means of freezing tissue without the use of cryogenic gases or liquids. The system consists of four pen cores, a refrigeration unit, re-usable tips in (4) four sizes and a temperature indicator. When used properly, the system will deliver effective temperatures for tissue ablation. The CryoPen® Cooling System: The unit is a refrigeration component that operates on AC 110-240 volts obtained from conventional convenience outlets.
Model: CT-2000 Pen Core Positioned in Chilling Well CryoPen® Cooling System Pen Core Positioned in Holding Well Reservoir Tube Re-usable CryoPen Tips-sizes 3mm, 5mm, 7mm, and 10mm Pen Core Temperature Indicator: Indicates readiness of CryoPen® Pen Cores 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 -6Originated Date: 02.25.2010 Revision Date: 5.1.
INSTRUCTIONS FOR MODEL CT-2000: WARNING: SET-UP IS SIMPLE BUT YOU WILL WANT TO CAREFULLY REVIEW THE OPERATOR’S MANUAL BEFOREHAND. 1. Read Operator’s Manual 2. Unpack contents of shipment: Unit containing (4) Pen Cores, Power Supply w/electrical cord, (1) Temperature Indicator, (1) 500ml Reservoir Bottle, 4 sizes of non-sterile tips (1 of each size), (1) Reservoir Tube (1) Reservoir Cap (1) pack of swabs and (1) CryoPen Towel. 3. Locate unit by the nearest 110-240 volt outlet.
F.) After procedure, remove pen core from tip and place in holding well for defrosting. After defrosting, proceed to clean and reprocess tip according to Step 9 below. G.) Reservoir Tube should be checked daily and filled as needed. (Fill to maximum line.) H.) Pen Cores should be rotated at the end of each day. Rotate from holding wells to chilling wells. (Each holding pen core should be wiped dry and dipped before placing it into a chilling well) I.
B-2. If tip has come into contact with intact skin perform intermediate (low or mid-level) disinfection according to manufacturer’s instructions (see Table 1) C-1. Upon removal from chemical disinfectants or sterilants, all surfaces must be wiped with CryoPen Reservoir Solution (or an alcohol pad) and allowed to air dry completely. C-2. Upon removal from autoclave, please allow tip to dry completely D. The CryoPen tip is now ready for reuse.
Expected Ablation and Transition Zones For Dermatology/General Cryosurgery a.) Expected Cryoablation zones for 5mm, 7mm, and 10mm Tip sizes (data derived from bench testing on chicken meat without skin) b.) Expected Cryoablation zone for 3mm Tip, 180 seconds of contact (data derived from bench testing on ballistic gelatin) 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.
CLEANING: The CryoPen® Cooling System: The main unit, except for the CryoPen® chilling wells, may be cleaned and disinfected as needed using isopropyl alcohol or Reservoir Solution. CryoPen® chilling wells may be cleaned periodically as dust and debris may collect in them to the point of making poor contact with the Pen Cores. To clean these chilling wells, use the provided swabs. Use a blotting and circular motion to clean out chilling wells.
QUARTERLY MAINTENANCE: The unit must be turned off before quarterly maintenance can be performed. We recommend waiting 8 hours for unit to reach room temperature. Thoroughly dry wells using the supplied swabs and wipe pen cores dry. Then, follow the initial set-up procedure located in the Operator’s Manual. Note: If the unit is not in use for more than two days (i.e. extended weekends, holidays, or vacations), it should be turned off.
FOR GENERAL INFORMATION AND TO ORDER ADDITIONAL SUPPLIES CONTACT CRYOPEN, INC.: Call: 1-877-246-3955 CryoPen, Inc. Corporate Office: 800 N. Shoreline Blvd.
WARRANTY The only warranty granted herein is an expressed, limited warranty as written, as there are no implied warranties. CryoPen, Inc. warrants, to the extent and subject to the limitations described in this warranty, the CryoPen® Cryosurgical System sold hereunder to be free from defects in material and workmanship if properly installed, serviced, and operated under normal conditions according to the CryoPen® Cryosurgical System Operators Manual. This is a limited warranty and CryoPen, Inc.
