gigasept® powerSET3

Ready-to-use wipes for manual reprocessing in three steps: cleaning, disinfection and rinsing.
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  • 100 % ready-to-use – no preparation or activation needed
  • comprehensive efficacy (bactericidal, yeasticidal, mycobactericidal, fungicidal, virucidal, sporicidal against C. difficile) within 5 minutes
  • flexible space-saving packaging
  • tested to the latest EN standards
  • large wipe format (20 x 20 cm)
  • high-quality nonwoven wipe fabric for optimal cleaning and wetting
  • antimicrobial cardboard coating for additional protection against cross-contamination

 

Further information

Fields of Application

The gigasept® powerSET3 is used for manual reprocessing of the following non-lumened medical devices: transvaginal and transrectal ultrasound probes, transoesophageal echocardiography (TEE/TOE) probes, non-invasive ultrasound probes and flexible endoscopes without channels (e.g. nasopharyngoscopes). The product consists of three components that are used in three successive steps and represent a complete reprocessing cycle:

1. gigasept® powerSET3 cleaning wipe for cleaning of the medical device

2. gigasept® powerSET3 disinfection wipe for high-level disinfection of the medical device

3. gigasept® powerSET3 rinsing wipe for rinsing of possible disinfectant residues on the medical device

Automated processes are generally preferred for reprocessing medical devices. If wipe decontamination is to be used and the reprocessing recommendation of the respective medical device manufacturer permits this procedure, gigasept® powerSET3 can be applied. Not suitable for reprocessing of medical devices with lumen or critical medical devices.

Product Profile

Efficient cleaning:

The powerful surfactants in gigasept® powerSET3 cleaning wipe remove organic contaminations within a very short time. With their lipophilic part, the surfactant molecules envelope water-insoluble substances (e.g. greasy soiling) and form small aggregates (micelles) detaching contamination from surfaces and enabling efficient cleaning.

Powerful disinfection:

The gigasept® powerSET3 disinfection wipe is impregnated with a solution containing 0.06% peracetic acid. Peracetic acid has an inactivating effect against a broad spectrum of bacteria, including mycobacteria and bacterial spores, as well as fungi, enveloped and non-enveloped viruses – at low concentrations. It also provides very good material compatibility and is therefore suitable for use with medical devices made from various materials. Due to the lower consumption of raw materials and the low energy balance, peracetic acid is a resource-saving antimicrobial agent. Moreover, it exhibits very good biodegradability – the active ingredient peracetic acid decomposes into acetic acid and oxygen after application.

Instructions for use

All components are part of the reprocessing cycle. For correct reprocessing of medical devices, the following three steps are necessary: cleaning, disinfection, and rinsing.

Perform the reprocessing without interruptions and only by verifiably trained staff. In the event of interruptions, individual reprocessing steps must be repeated.

Upon opening the gigasept® powerSET3 cleaning wipes and gigasept® powerSET3 disinfection wipes for the first time, pay attention to hygiene when pulling the first wipe through.

Pre-cleaning should be performed according to standard operating procedures immediately after use. If applicable, remove the protective cover and ultrasound gel from the medical device with a disposable wipe before proceeding with gigasept® powerSET3.

Thoroughly wipe medical devices until they are completely wetted and visible soiling or possible residues are removed. Pay particular attention to joints, edges and recesses.

The tubs of gigasept® powerSET3 cleaning wipes and gigasept® powerSET3 disinfection wipes should not be removed from the set. The packaging is optimised for ideal handling with tubs remaining in the packaging.

Ensure that cross-contamination caused by contact between the medical device and unclean objects or surfaces is prevented during and after reprocessing

Close the lid tightly after removing the gigasept® powerSET3 cleaning wipes or gigasept® powerSET3 disinfection wipes.

After reprocessing of the medical device, thoroughly clean and disinfect any transport containers, all hand contact surfaces (e.g. keyboard, ultrasound gel bottle, handle, etc.) and work surfaces.

Microbiological efficacy

Test methodready-to-use
Bacterial spores
sporicidal (C. difficile)EN 17126; EN 17846 dirty conditions
Bacteria, yeasts and mycobacteria
bactericidalEN 14561 dirty conditions1 min.
bactericidalEN 13727; EN 16615; VAH dirty conditions1 min.
mycobactericidalEN 14348; EN 14563 dirty conditions5 min.
mycobactericidalEN 16615 dirty conditions5 min.
yeasticidalEN 14562 dirty conditions1 min.
yeasticidalEN 13624; EN 16615; VAH dirty conditions1 min.
Fungi and spores
fungicidalEN 14562 dirty conditions5 min.
fungicidalEN 13624; EN 16615 dirty conditions5 min.
Viruses
limited spectrum virucidal activityEN 14476; EN 16615 (mod.) dirty conditions5 min.
limited spectrum virucidal activityEN 16777 dirty conditions5 min.
limited spectrum virucidal activityEN 17111 dirty conditions5 min.
limited spectrum virucidal activityin accordance with DVV/RKI guideline 5 min.
Simian virus 40 (Polyoma SV40)in accordance with DVV/RKI guideline 1 min.
Simian virus 40 (Polyoma SV40)EN 16615 (mod.) dirty conditions1 min.
virucidal activityEN 16777 dirty conditions5 min.
virucidal activityEN 14476; EN 16615 (mod.) dirty conditions5 min.
virucidal activityin accordance with DVV/RKI guideline 5 min.

Certificates / Norms

0297

Product data

Composition:

gigasept® powerSET3 cleaning wipe:

100g of solution contains: surfactants

gigasept® powerSET3 disinfection wipe:

100g of solution contains the following active substance(s): 0.06% peracetic acid. Other ingredients: hydrogen peroxide, acetic acid

gigasept® powerSET3 rinsing wipe:

100g of solution contains: deionised water

Special advice

Read label, instructions for use and product information before use.

For professional use only. Please follow the reprocessing recommendations provided by the medical device manufacturers. Any serious incidents related to the product are to be reported to the manufacturer and competent authority.

Wear protective gloves. Do not use on aluminium.

Shelf life after opening: 3 months.

Information for order

ItemDelivery formItem no.GTIN
gigasept powerSET3 1 SE5 / carton(s)700036774032651985609

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