U Deliver bolink™ Small Cap Gravity Feeding Set BK-2085

Indications for Use: The U Deliver Bolink™ ENFit® Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient’s enteral access device (feeding tube).Device Description: The Bolink™ small cap gravity feeding set consists of tubing (A) with a clamp (B), a small cap with cross spike (C), an ENFit® connector (D) for connecting to feeding tubes and a protective cap (E).

The Bolink™ small cap gravity feeding set is intended to connect compatible commercially available collapsible food containers with 8mm diameter connectors to feeding tubes with ENFit® proximal connectors. Not made with natural rubber latex. Not formulated with DEHP or BPA.

Warnings:

• For enteral feeding only.
• This device incorporates an ENFit® Connector and a Cross Spike which are designed to reduce the likelihood of tubing misconnections; however, the potential to misconnect this device with connectors of other healthcare applications still exists.
• Small parts are a potential choking hazard if this device is not used as intended. Use under adult supervision. Precautions:
• This device should be discarded after 24 hours and replaced with a new device.
• For single patient use only.
• Dispose with household waste. Do not recycle.

Instructions for Use

1. Confirm feeding tube position and flush following manufacturer’s instructions.
2. Close clamp (B) on Bolink™ Tubing (A).
3. Remove cap on food pouch, attach screw cap (C) to food pouch and confirm cap is secured tightly.
4. Open clamp (B) and squeeze food pouch to fill Bolink™ tubing (A).
5. When tubing is filled, close clamp (B).
6. Remove protective cover (E), use ENFit® connector to attach BolinkTM tubing to feeding tube. If the feeding tube has a funnel connector instead of an ENFit® connector use a transition connector with Christmas tree tip.
7. Open clamp (B) and squeeze container with steady, consistent pressure to deliver nutrition.
8. When finished, close clamp (B), disconnect BolinkTM tubing (A) from feeding tube and food pouch.
9. Flush Bolink™ tubing (A) with tap water by holding under a faucet and letting water flow through the tubing until the water runs clear.
10. Flush feeding tube following manufacturer’s directions.WARNING: Before connecting to a feeding tube, confirm that the Bolink™ tubing is being connected to a feeding tube only. DO NOT connect to non-feeding tube. This includes confirming that any transitional connector with a Christmas tree tip is connected to a feeding tube and not IV tubing.

Symbol Glossary:

Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified.Ref. 5.1.6 in ISO 15223-1:2016		Use-by date Indicate the date after which the medical device is not to be used.Ref. 5.1.4 in ISO 15223-1:2016
Non sterile. Indicates a medicaI device that has not been subjected to a sterilization process.Ref. 5.2.7 in ISO 15223-1:2016		Consult instructions for use Indicates the need for the user to consult the instruction for use.Ref. 5.4.3 in ISO 15223-1:2016
Keep Dry. Indicates a medical device that needs to be protected from moisture. Ref. 5.3.4 in ISO 15223-1:2016		Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened.Ref. 5.2.8 in ISO 15223-1:2016
Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Ref. 5.4.2 in ISO 15223-1:2016		Manufacturer Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.Ref. 5.1.1 in ISO 15223-1:2016
Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.Ref. 5.1.5 in ISO 15223-1:2016

For more information on Bolink™ tubing and U Deliver Medical products, visit www.UDeliverMedical.com.U Deliver Medical, LLC.7900 Excelsior Blvd, Suite 108Hopkins, MN 55343Made in ItalyBolink™ is a trademark of U Deliver Medical. ENFit® is a trademark of GEDSA, used with permission. ©2019 U Deliver Medical, LLC

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