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RCS Versailles 808 040 075

SIRET : 808 040 075 00018

DECONTAMINATION AND
REPROCESSING INTRUCTIONS

INSTRUCTION-REA-014 Date Revision

Device cleaning 15/06/21 2
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 SUMMARY
1 INTRODUCTION ............................................................................................................................................ 3
1.1 Scope ................................................................................................................................................. 3
1.2 Risk assessment ................................................................................................................................ 3
2 INSTRUCTIONS ............................................................................................................................................. 5
2.1 Material needed ................................................................................................................................. 5
2.2 Hand ................................................................................................................................................... 5
2.3 Protocol .............................................................................................................................................. 6

INSTRUCTION-REA-014 Date Revision

Device cleaning 15/06/21 2
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1 INTRODUCTION

1.1 Scope

This document presents decontamination and reprocessing procedure for Tucky devices.

1.2 Risk assessment

In the context of medical device cleaning and decontamination, the following definitions are used:

Cleaning The physical removal of body materials, dust or foreign material. Cleaning will reduce the
number of microorganisms as well as the soil, therefore allowing better contact with the
surface being disinfected or sterilized and reducing the risk of soil being fixed to the
surface. Removal of soil will reduce also the risk of inactivation of a chemical disinfectant
and the multiplication of microorganisms. The removal of contamination from an item to the
extent necessary for further processing or for intended use. [ISO/TS 11139]
Disinfection The destruction or removal of microorganisms at a level that is not harmful to health and
safe to handle. This process does not necessarily include the destruction of bacterial
spores.
Sterilization The complete destruction or removal of microorganisms, including bacterial spores.
Sterility
State of being free from viable microorganisms.
Sterilization
Validated process used to render a product free from viable microorganisms.

With these definitions in mind, risk assessment to determine the level of decontamination can be
applied. This is known as the “Spaulding classification”. This system is applied to categorize a reused
medical device (RMD) according to its intended use and the subsequent level of reprocessing required
to render the medical device safe for reuse.

The following categories are used:

* critical
* semi-critical
* non-critical.

INSTRUCTION-REA-014 Date Revision

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As Tucky is intended to be used ONLY on intact skin, and not mucous membranes, its classification
according to the above table is:

Tucky risk assessment Level of processing / reprocessing

Cleaning followed by Low-level
NON-CRITICAL
disinfection

INSTRUCTION-REA-014 Date Revision

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2 INSTRUCTIONS

2.1 Material needed

For each device

• 3 wipes,
• Denatured alcohol 90°
• A low level disinfectant (ie: SurfaSafe disinfectant or equivalent)

2.2 Hand hygiene

Throughout the procedure, perform appropriate hand hygiene:

1. Wear gloves during procedure.

2. Discard dirty materials (adhesives, wipes…) in appropriate receptacles while wearing gloves.
3. Discard gloves in appropriate receptacles
4. Perform hand hygiene immediately after removal of gloves and before touching other medical
supplies intended for use on other persons.

INSTRUCTION-REA-014 Date Revision

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2.3 Protocol

1 - Remove the adhesive sticker and

the adhesive tape (if applied).

2 a - Clean dirt and glue residue with

a fresh wipe soak with alcohol 90°.

Wipe all surfaces, top, bottom, and

sides with USB strap opened*.

If residual soil is still visible, repeat

the process.

2 b – Allow to air dry for 2 minutes

3 a - Disinfect the device another

fresh wipe soak with a disinfectant (ie
Surfasafe or equivalent).

Wipe all surfaces, top, bottom, and

sides with USB strap opened*.

3 b - Let a contact time of 5 minutes

(or more depending on disinfectant
and targeted microbial activity)**

4 a – Rinse the device with another

fresh wipe soak with alcohol 90°

4 b – Allow to air dry for 2 minutes

before applying a new adhesive

INSTRUCTION-REA-014 Date Revision

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* Note 1: Be careful to avoid any liquid entering through the USB connector

** Note 2: Contact time, also known as kill time or dwell time, is the amount of time an EPA-registered
disinfecting product needs to be present on a surface in order to be effective against the
microorganisms listed on its label.

Contact times for SurfaSafe product are listed below:

INSTRUCTION-REA-014 Date Revision

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