Instructions
13 Pages
Preview
Page 1
VBM Medizintechnik GmbH
Reprocessing Instructions for reusable products
G0001 - 11/07.2015
Product Group
Classification
Respiration Tubings
Rebreathing Bags
Connectors
DE
Deutsch...Seite 3
EN
English...Page 4
CS
Česky...Strana 5
DA
Dansk...Side 6
ES
Español... Página 7
FR
Français...Page 8
IT
Italiano... Pagina 9
PT
Português...Pág. 10
RU
Русский... стр. 11
SV
Svenska...Sida 12
TR
Türkçe... Sayfa 13
Silicone Hook
Fixation Tapes
22 mm
Uncoupling Wedge
No medical device 15 mm
VBM Medizintechnik GmbH
Einsteinstrasse 1 | 72172 Sulz a.N. | Germany | Tel.: +49 74 54 / 95 96 0 Fax: +49 74 54 / 95 96 33 | e-mail: info@vbm-medical.de | www.vbm-medical.de
CONTROL
English
After disinfection and prior to each use, the products have to be checked for damages (cracks, ruptures etc.) and leaks. Damaged products must not be re-used.
Reprocessing instructions for reusable products Safety INFORMATION
PACKAGING
• Read and follow the instructions for use carefully before using the product. • Products are supplied non-sterile and must be cleaned, disinfected and sterilised prior to each use. • Manufacturer is not responsible for damages resulting from improper reprocessing. • It rests with the user to validate their procedures, devices and accessories, and to comply with the validated parameters during every reprocessing. • It is recommended to apply an automatic procedure due to a significantly higher efficiency of cleaning and disinfection. • The effectiveness has been verified by an independent and accredited test laboratory. • To achieve a more effective reprocessing rough contamination must not get dry on the product and must be removed immediately after use. • Do not bring silicone products in contact with oil and grease.
After the cleaning- and disinfection procedure the products must be packed into a pouch which is suitable for steam sterilisation.
STERILISATION
Notes regarding sterilisation • Protect the products and sterilisation pouch against mechanical damage. Sterilisation validated by the manufacturer • The products must be steam sterilised by a fractional vacuum process. • Exposure time is 5 min with a sterilisation temperature of 134 °C (273 °F).
REUSABILITY The end of the shelf life for reusable products is basically determined by wear and damage caused by its use. Considering the maximum shelf life of 5 years, reusable products can be reprocessed up to 100 times if appropriately used and under adherence of the cleaning-, disinfection- and sterilisation instructions. Every further reuse is in the responsibility of the user (see chapter “Control“).
CLEANING / DISINFECTION
Warning
Automatic Cleaning / Disinfection Notes regarding the use of washer disinfectors • Use de-ionized water. Notes regarding the use of cleaning agents and disinfectants • By the use of alkaline cleaning agents, neutralisation must be performed. • Don’t use drying agents. Procedure validated by the manufacturer 1. Place the products into the injector carriage: Product group Positioning in the injector carriage • Respiration tubing Holder for spiral coil • Rebreathing bags Injector jets • Silicone Hook Mesh tray (securing with a cover net) • Connectors • Harness • Uncoupling Wedge
By using the products on patients with suspected prion disease there might be a high risk of transmission. In such case the physician decides if the product is either disposed (see chapter “Disposal”) or reprocessed acc. to the national directives.
Storage and transport conditions Product shelf life is 5 years. • Protect from heat and store in a dry place. • Keep away from sunlight and light sources. • Store and transport in the original packaging.
SERVICE Prior to return medical products for complaint/repair they must have run through the complete reprocessing process to exclude any risk for the manufacturer’s staff. For safety reasons, the manufacturer preserves the right to refuse soiled or contaminated products.
DISPOSAL
Caution
Used or damaged products must be disposed acc. to applicable national and international legal directives. A list of compatible cleaning agents and a detailed symbol description are available at www.vbm-medical.de in the download section.
Ensure effective rinsing of all hollow spaces. 2. Start program with the following parameters: a. Rinse with de-ionized water at 20 °C (68 °F) with an exposure time of 1 min. b. Cleaning at 55 °C (131 °F) with an exposure time of 5 min using de-ionized water and the cleaner “Sekumatic® ProClean“ (Dose: 0,5 % (5 ml/l)). c. Neutralisation with “Sekumatic® FNZ“ at 20 °C (68 °F) with an exposure time of 2 min (Dose: 0,1 % (1 ml/l)). d. Rinse with de-ionized water at 20 °C (68 °F) and an exposure time of 2 min. e. Thermal disinfection at 93 °C (199 °F) for 5 min with de-ionized water. f. Drying at 100 °C (212 °F). 3. Examine the products for visible contamination. If necessary repeat the reprocessing. 4. Check the products acc. to the chapter “Control“ and prepare them for sterilisation (see chapter “Packaging“). Manual Cleaning / Disinfection Notes regarding the use of cleaning agents and disinfectants • Prepare the cleaning- and disinfection solution before each manual cycle. • Use de-ionized water. Procedure validated by the manufacturer 1. Prepare a 2 % (30 ml/l) cleaning- and disinfection solution with Sekusept® Aktiv and de-ionized water at 20 °C (68 °F). The cleaning- and disinfection solution is ready for use after 15 min. 2. Clean the products in the cleaning- and disinfection solution by using soft sponges. Areas difficult to access must be cleaned with soft brushes. Hard brushes and other materials which can damage the surface of the products must not be used. 3. Put the products into the cleaning- and disinfection solution with an exposure time of 15 min Ensure complete wetting of all hollow spaces. 4. Remove the cleaning- and disinfection solution by thoroughly rinsing with deionized water. Remaining residues can shorten the product shelf life or can lead to material damage. 5. Dry the products. Accumulation of water must be avoided. 6. Check for visible contamination. If necessary repeat the reprocessing. 7. Check the products acc. to the chapter “Control“ and prepare them for sterilisation (see chapter “Packaging“).
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