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IFU1057 Rev B. InTrac Inflation Device - COPY Flipbook PDF

IFU1057 Rev B. InTrac Inflation Device - COPY

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InSitu Technologies Inc. InTrac™ Endoflator Balloon Inflation Device 1.0

DEVICE NAME

InSitu Technologies Inc. InTrac™ Endoflator 2.0 DEVICE DESCRIPTION The InSitu Technologies Inc. InTrac™ Endoflator Balloon Inflation Device is a disposable balloon inflation device mainly used in PTCA procedures to inflate and deflate the balloon so that the vessel can be inflated and the stent can be indwelled. This product is composed several part such as pressure gauge, high pressure line, cylinder, piston, handle and cylinder cap. The pressure gauge is with fingers and two ways of pressure reading, one is ATM/bar and another is psi; at the front-end of the high pressure line is rotating male luer; there is graduation on the cylinder which is easy for the doctor to observe content of contrast solution. InSitu Technologies Inc. InTrac™ Endoflator disposable balloon inflation has various specifications according to the clinical need. 3.0 HOW SUPPLIED STERILE, FOR SINGLE USE ONLY. The InTrac™ Endoflator is sterilized using ethylene oxide (EtO). DO NOT RESTERILZE. Do not use if the package has been opened or damaged. Contents: Package contains: 1 Balloon Inflation Device 1 500psi 3 Way Stop Cock 1 30cm Extension Line Storage:  It should be stored in a dry and ventilated place, with no active gases under 5-45°c.  Use by the “Use By” date noted on the package.  The package of the product is made of Tyvek-plastic bag; then the sterilized and packed in paper cartons for transportation;  The products must be used before expiry date SEE LABEL.  The product should be stored in a dark/dry place. Specifications (Sizes): Dial Pressure Capacity 21001-25 30ATM

h

Dial Liquid Capacity 20mL

Extension Line Length 30cm

4.0 INDICATION FOR USE Patients needing balloon inflation in PTCA procedures.

IFU1057 Rev. A 01/09/2013

5.0 Contraindication None 6.0 PRECAUTIONS None 7.0 WARNING  This product is ETO sterilized. The package should be checked before using. If unsealing as leakage and breakage is found, the pressure line must not be used  Must be used before expiration date  This product can only be used with matching products which must be able to bear pressure indicated in the label  This product can only be used once; DO NOT REUSE  Choose and Use proper specification. 8.0 PREPARATION FOR USE  This product must be used by professional doctors who must be familiar with instruction for use of this product;  Check before using to see if the package is integrated and whether the product is without damage。 9.0 DIRECTIONS FOR USE 1. Squeeze the trigger and slide the red lock into the slot in plunger. 2. Simply aspirate up to 20ml of contrast solution by pulling back on the handle and then inspect the tubing and stopcock to insure that there is no air in the system. 3. Squeeze handle and slide the red lock out of slot, attaching the balloon inflation device to the balloon 4. Prepare and test the balloon catheter according to the catheter manufacturer’s directions for use. 5. Create a fluid-fluid connection between the balloon and the balloon inflation device extension tube and connect the luer connector securely. 6. Squeeze the trigger and pull back on the handle to apply a vacuum to the balloon. 7. Using of balloon inflation device, inspect if finger of pressure gauge is in the resting position; otherwise, it shall not e used. Rotate he handle clockwise until the desired inflation pressure is reached; then the lock mechanism maintains the pressure and observe if the balloon is inflated; if so, squeeze the trigger and pull the handle back to the resting position; finally, take the balloon inflation device off.

M Manufactured For:

InSitu Technologies Inc. 593 Phalen Boulevard St. Paul, MN 55130 USA Tel 651 389 1017 By: Sunny Medical Device

P

C0029

Aad Stove AS Medical Trading Vander Heimstraat 56 2582SB The Hague Netherlands

www.insitu-tech.com FDA Registered Facility ISO 13485 Certified For International Distribution THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE INSITUSEAL. PRODUCT(S) DESCRIBED IN THIS PUBLICATION UNDER NO CIRCUMSTANCES SHALL BE LIABLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY TO BIND INSITU TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH HEREIN. Descriptions or specifications in InSitu Technologies printed matter, including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties.

IFU1057 Rev. A 01/09/2013