EXEL 1712 IV Extension Sets User Guide
- June 1, 2024
- EXEL
Table of Contents
EXEL 1712 IV Extension Sets User Guide
1 Device Description
1.1 The IV Extension Set is a non-invasive tubing that connects to active medical devices for gravity transfusions or an IV line or catheter. The device is fitted with a Luer connection that moves the liquid flow in a single direction and avoids pollution of the fluid particulates.
1.2 Gravity feed Extension Set
1.2.1 Under atmospheric pressure, the liquid medicine flows into the drip
chamber with the tubing. When the water column pressure of the drip chamber is
greater than the venous pressure, the liquid in the bottle flows into the vein
along the tubing.
1.3 Extension Set for Use with Pressure Infusion Equipment
1.3.1 One end is connected to a pressure pump, one end is passed into the
body, the rated pressure is given by the pressure pump, by the pressure
difference, the liquid enters into body from a high pressure to low pressure
by tubing.
2 Intended Use
2.1 The sterile IV Extension Set is used in various infusion operations. It
can increase filtration, flow rate regulation or dosing performance of
medications.
2.2 It is also used to increase the length of the infusion tube.
3 Indications for Use/Target Users
3.1 The sterile extension sets are used in various infusion operations. It can
increase filtration, flow rate regulation or dosing performance of
medications.
3.2 Intended users are all age groups, except newborns and preterm infants.
3.3 The product is designed for use by a qualified physician or clinician and
professional medical staff.
4 Benefits of Use
4.1 DEHP Free
4.2 Vented/Non-Vented
4.3 Includes Occlusion Clamp
5 Warnings / Precautions
5.1 Read instructions for use.
5.2 Always check the integrity of product, packaging, and expiration date
before use.
5.3 For single-patient-use only. Use once and destroy.
5.4 Re-use of device can become a carrier for communicable disease to patient
and/or user. It may lead to contamination and/or impairment of functional
capability. Contamination and/or limited functionality of the device may lead
to injury, illness.
5.5 Re-sterilization or reuse of the device can cause a change in the
mechanical properties and material used.
5.6 Adverse event may occur if device is used after expiration date as it is
the same as the sterility expiration date.
6 Contraindications
6.1 There are no recognized contraindications for the use of the IV Extension Set
7 Sterility
CAUTION: U.S Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
8 Operating Instructions
8.1 Check the package integrity and the expiration date.
8.2 Choose the extension set according to need.
8.3 Open the package and connect to the medical device with luer connector
based on clinical use.
8.4 Check the transfusion function.
8.5 After using, discard the extension set in accordance with local rules and
regulations.
9 Storage
9.1 Store at room temperature 15°C-25°C.
9.2 Do not store in high temperatures and humidity.
9.3 Keep away from direct sunlight.
9.4 Keep away from rain.
9.5 Store in a cool and dry place.
LEGAL NOTICE
© 2024 Exelint International, Co. All rights reserved. EXEL and the EXEL logo
are trademarks of EXELINT International, Co.
EXELINT International, Co. disclaims any responsibility for possible
consequences resulting from reuse, resterilization or improper use.
Graphic Symbol Legend for Medical Device Labeling
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