TyTek medical TPAK 10 Chest Decompression Needles Instruction Manual
- June 12, 2024
- TyTek medical
Table of Contents
Tension Pneumothorax Access Kit
For Single Use Only
14 ga x 3.25 in. NSN: 6515-01-541-0635 REF TM-303
10 ga x 3.25 in. NSN: 6515-01-673-1701 REF TM-310
(+1) 513-247-2002
STERILE R
1639
TyTek Medical Inc.
8904 Beckett Rd, West Chester, OH 45069, US
www.tytekmedical.com
Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands
Instructions For Trained Medical Personnel
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The TPAK/TPAK10 is a sterile device intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax.
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Select the location for the needle/catheter to enter by identifying:
– The second intercostal space on the anterior chest at the mid-clavicular line on the same side of the body as the injury
– The fourth intercostal space on the anterior axillary line on the same side of the body as the injury -
Use antimicrobial solution to cleanse the needle-insertion site.
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Inspect that the safety seal is intact. If not intact, do not use the kit. With a firm grip on the TPAK/TPAK10, twist the red hex cap to break the seal, and remove cap.
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Remove the TPAK/TPAK10 needle/catheter from its case.
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Insert the needle/catheter assembly into the patient’s skin in the selected location, just above the superior edge of the rib, avoiding the inferior rib edge. Direct the needle/ catheter into the intercostal space at a 90° angle to the chest wall.
– If using mid-clavicular line, ensure that the needle entry into the chest is not medial to the nipple line and is not directed towards the heart.
– If using anterior axillary line, ensure that the needle entry point is not inferior to the nipple -
Once the needle/catheter is properly in the pleural space, you will hear a sudden escape of air as the tension pneumothorax is decompresses – hold needle in place for 5-10 seconds.
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Remove the needle but leave the catheter in place. Secure it in a manner directed by your training.
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Monitor the patient carefully for any tension pneumothorax recurrences or respiratory distress.
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Note: Any serious incident that occurs in relation to the device shall be reported to the manufacturer and competent authority in which the user/patient is established.
Body Substance Isolation Alert
Always use appropriate body substance isolation procedures and personal protective equipment in order to prevent contact with contaminated fluids.
Caution
TPAK/TPAK10 — Tension Pneumothorax Access Kit should only be used by personnel who have received proper training on procedures for relieving a tension pneumothorax. Improper use of TPAK/TPAK10 could cause injury. Use TPAK/TPAK10 as directed by your EMS authority or by a physician.
Potential hazards of needle decompression include cardiac tamponade, life- threatening bleeding due to pulmonary artery, aorta or intercostal vessel injury, non-therapeutic insertion and potential nerve injury at insertion site. Hazards can be avoided by adhering to approved protocols, training and site placement. Failure to adhere may result in patient decompensation, injury and/or death.
Disposal
TPAK/TPAK10 is for single-use only. It is not re-usable under any circumstances. It may be used once, and then must be properly disposed. Dispose of TPAK/TPAK10 in a way that assures body substance isolation of potentially infectious substances and prevents sharps injury.
Storage
Keep TPAK/TPAK10 – Tension Penumothorax Access Kit dry. Stored in temperatures between 10° F and 140°F.
Limited Warranty
The products and components contained in this package are medical devices intended solely for use by appropriately trained healthcare professionals. TyTek Medical Inc. warrants that the products and components are free from defects in material and workmanship and fit soley for use as medical devices for the specific purpose described in the manual by trained healthcare professionals for a period of 12 months from the date of shipment by TyTek Medical Inc. Any use of the products or components beyond the specific use described in this manual or by a person not trained or legally authorized to use the products or components voids this limited warranty. EXCEPT AS SET FORTH HEREIN, TYTEK MEDICAL INC. MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE PRODUCTS OR COMPONENTS AND SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
This item sold and to be used strictly per terms and conditions at www.tytekmedical.com.
Rev 08112022a
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>