Author : admin Date : April 19, 2016

Reference

SSKT 017

Designation

Catheter Set 1

Description

Catheter connection / disconnection set

Usage

EASY HD Catheter Set 1 is used to care catheter of patient during connection and disconnection process of hemodialysis session and to reduce the risk of infection.

Packing

All components are packed in operational order so that efficiency is ensured.  Depending on the preference 2 options are available:

  • Pouch Pack: All necessary components of disconnection set are placed inside a sub-package pouch. Contents of connections set are placed in a bigger pouch together with disconnection set sub-package pouch. Both pouches have necessary peeling opening available.
  • Blister Pack: All necessary components of connection set and disconnection set are packed inside 2 separate blister packs. These blister packs are either connected to each other with a tearable connection in order to ensure easy opening or put inside each other like pouches. Each blister pack has a peeling side marked.

In both packing methods, both connection and disconnections set packages show the information below either put inside or connected with a tearable connection on side:

  • o Product series name & product name o Set type (connection / disconnection) o Set contents with quantities o Manufacturing date o Date of expiry
  • o Lot number o Reference number
  • o Sterilization indicator o Method of sterilization o Warnings (don’t use open packages, for single use only, latex free) o Manufacturer contact & company information

Sterility

Sets are sterilized with EO sterilizer in house. Sterilization is documented and monitored through necessary forms, biological indicators, chemical indicators, dosimeters and data loggers.

Shelf Life

Product has been tested for stability. Test reports show that Catheter Set 1 (Ref: SSKT 017) has a shelf life of 3 years.

Quality Certification & Compliance

All process across SUBMED is run in compliance with EN ISO 9001 & EN ISO 13485.

Independent third party laboratories tested EASY HD series for packing sealing strength is in compliance with EN ISO 868-5, stability according to ASTM F 1980 and package leak tests according to ASTM F 1929. Thermoforming line is validated for temperature and pressure settings according to EN ISO 17025.

Sterilization process has been validated according to EN ISO 11135-1, for sterilization by Ethylene Oxide. Sterilizer is also validated by IQ and OQ tests.

Our manufacturing plant and clean room is in compliance and been tested for EN ISO 11605, EN ISO 14644-1, EN ISO 14644-2, EN ISO 14698-1 and EN ISO 14698-2 tests for bio contamination levels in order to assure relevant safety levels in all products.

EASY HD products are tested for bio-burden according to EN ISO 11737-1. To achieve highest quality EO residue is also tested according to EN ISO 10993-7.

Catheter Set 1 (Ref. No: SSKT 017) is a CE Class II product and have been certified by independent third parties from EU for compliance with standards.

Content

Connection Set Disconnection Set
Description Qty. Description Qty.
Non-woven Swab, 7,5  x 7,5 cm. 5 Non-woven Swab, 7,5  x 7,5 cm. 4
Plain Drape, 50 x 50 cm. 1 Plain Drape, 50 x 50 cm. 1
“T” Split Drape, 30 x 40 cm. 1 Nitrile Gloves, M Size 4
Nitrile Gloves, M Size 4 I.V. Dressing, 6 x 8 cm. 1
Medical plaster, 2,5 x 15 cm. 2 Catheter Pouch 1
Face Mask 1 Heparin Cap 2

 

Content Descriptions

Contents of the Catheter Set 1 (Ref. No: SSKT 017) are packed in order of use. Connection and disconnection set content are packed in separate sterile packages.

Connection Set

  • o 5 x Non-woven Swab     : 4 ply, non-woven swabs; size 7,5 x 7,5 cm.
  • o 1 x Plain Drape  : Double layered plain drape made of PE & 100% cellulose paper; size 50 x 50 cm. Folded in “Z” style.
  • o 1 x “T” Split Drape        : “T” split drape made of biflex; size 30 x 40 cm. Aseptic folded.
  • o 4 x Nitrile Glove : Surgical folded non-powdered nitrile gloves; size M.

o   2 x Medical Plaster : Non-woven medical plasters; size 2,5 x 15 cm. Easy to open with notches. Bio-compatible adhesive in order to increase patient comfort and prevent irritation. o 1 x Face Mask  : 3 ply, white face mask.

Disconnection Set

  • o 4 x Non-woven Swab     : 4 ply, non-woven swabs; size 7,5 x 7,5 cm.
  • o 1 x Plain Drape  : Double layered plain drape made of PE & 100% cellulose paper; size 50 x 50 cm. Folded in “Z” style.
  • o 4 x Nitrile Glove : Surgical folded non-powdered nitrile gloves; size M.
  • o 1 x I.V. Dressing : Made of biocompatible adhesive to prevent irritation. Size   6 x 8 cm. Used for fixing cannulas. o 1 x Catheter Pouch : Made of non-woven materials for closing catheter bag.

Design and material selection is made for increasing patient comfort.

2 x Heparin Cap : Yellow colour caps for closing catheter. Enables injections.

Technical Drawing

 SSKT17

Storage

Store the product under normal conditions for healthcare material, in a cool and dry place protected from light. The use of medical grade paper and film guarantees its sterility for the duration of its shelf life under normal transport and storage conditions.

Comments

The product must be used by specialised personnel only. Check the package’s integrity before use. Do not use if the package is open or damaged.