TS PAA15 2110 EN V07 FIN

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PAA 15 Technical sheet Product description Belimed Protect TM PAA 15 Dilution/Operational Temperature/Exposure Time For AERs: 10 ml/l, 35 °C, 5 min CE Mark Conforms to the requirements of European Directive 93/42/EEC Color Clear/colorless pH of ready-to-use solution pH 2.7 (1% dilution) Storage conditions 5–25 °C Shelf life 24 months Disposal instructions See Safety Data Sheet For the reprocessing of endoscopes Belimed Protect TM PAA 15 is a powerful peracetic acid-based, high-level disinfectant concentrate suitable for use in automated endoscope reprocessing (AER) and manual endoscope reprocessing, as well as for surgical instruments and temperature-sensitive reusable medical devices. · Bactericidal, mycobactericidal, fungicidal, virucidal, and sporicidal · Disinfection efficacy was tested according to EN 14885 · Single component – does not require activator compounds · Contains anti-corrosion additives · Effective even at temperatures down to 35 °C within 5 minutes of exposure · Contains no aldehydes and formaldehyde Dilute Belimed Protect TM PAA 15 at 1% with RO or sterile water only and use at 35 °C. Then thoroughly rinse with water. Efficacy Microbiocidal performance of Belimed Protect TM PAA 15 Microbiocidal efficacy at 25 °C Concentration Application Time Sporicidal – EN ISO 17126, EN ISO 13704, EN ISO 14347 1.0% 5 min Bactericidal – EN ISO 13727, EN ISO 14561 1.0% 5 min Mycobactericidal – EN ISO 14348, EN ISO 14563 1.0% 5 min Fungicidal – EN ISO 13624, EN ISO 14562 1.0% 5 min Virucidal – EN ISO 14476 1.0% 5 min For Flexible Endoscope Reprocessing Wear appropriate Personal Protective Equipment (PPE) and follow the reprocessing recommendations of the endoscope manufacturer. 1. Pre-clean in the examination room immediately after the examination. 2. Thoroughly manually clean in the reprocessing room, followed by a thorough rinse with water. 3. Machine reprocess in an Automated Endoscope Reprocessor (AER). Recommended for use in all Belimed AERs: For automated cleaning: Belimed Protect TM Neutral Enzyme Cleaner Belimed Protect TM Mild Alkaline Enzyme Cleaner For automated chemical disinfection: Belimed Protect TM Glutaraldehyde Disinfectant Belimed Protect TM PAA15 Allow to dry completely, then proceed with low-temperature sterilization (if available and required). 4. Store according to the specifications of your health care facility (e.g., storage/drying cabinet). Order Details: 5 l

Transcript of TS PAA15 2110 EN V07 FIN

Page 1: TS PAA15 2110 EN V07 FIN

PAA 15

Technical sheet

Product description Belimed ProtectTM PAA 15

Dilution/Operational Temperature/Exposure Time For AERs: 10 ml/l, 35 °C, 5 min

CE Mark Conforms to the requirements of European Directive 93/42/EEC

Color Clear/colorless

pH of ready-to-use solution pH 2.7 (1% dilution)

Storage conditions 5–25 °C

Shelf life 24 months

Disposal instructions See Safety Data Sheet

For the reprocessing of endoscopes

Belimed ProtectTM PAA 15 is a powerful peracetic acid-based, high-level disinfectant concentrate suitable for use in automated endoscope reprocessing (AER) and manual endoscope reprocessing, as well as for surgical instruments and temperature-sensitive reusable medical devices.

· Bactericidal, mycobactericidal, fungicidal, virucidal, and sporicidal· Disinfection efficacy was tested according to EN 14885· Single component – does not require activator compounds· Contains anti-corrosion additives· Effective even at temperatures down to 35 °C within 5 minutes of exposure· Contains no aldehydes and formaldehyde

Dilute Belimed ProtectTM PAA 15 at 1% with RO or sterile water only and use at 35 °C. Then thoroughly rinse with water.

Effi cacy

Microbiocidal performance of Belimed ProtectTM PAA 15

Microbiocidal effi cacy at 25 °C Concentration Application Time

Sporicidal – EN ISO 17126, EN ISO 13704, EN ISO 14347 1.0% 5 min

Bactericidal – EN ISO 13727, EN ISO 14561 1.0% 5 min

Mycobactericidal – EN ISO 14348, EN ISO 14563 1.0% 5 min

Fungicidal – EN ISO 13624, EN ISO 14562 1.0% 5 min

Virucidal – EN ISO 14476 1.0% 5 min

For Flexible Endoscope Reprocessing

Wear appropriate Personal Protective Equipment (PPE) and follow the reprocessing recommendations of the endoscope manufacturer.

1. Pre-clean in the examination room immediately after the examination.

2. Thoroughly manually clean in the reprocessing room, followed by a thorough rinse with water.

3. Machine reprocess in an Automated Endoscope Reprocessor (AER). Recommended for use in all Belimed AERs: For automated cleaning: Belimed ProtectTM Neutral Enzyme Cleaner Belimed ProtectTM Mild Alkaline Enzyme Cleaner For automated chemical disinfection: Belimed ProtectTM Glutaraldehyde Disinfectant Belimed ProtectTM PAA15

Allow to dry completely, then proceed with low-temperature sterilization (if available and required).

4. Store according to the specifi cations of your health care facility (e.g., storage/drying cabinet).

Order Details: 5 l

Page 2: TS PAA15 2110 EN V07 FIN

Product properties overview

This table is for guidance only. Intended use Microbicidal spectrum pH value*

Inst

rum

ent c

lean

ing

Inst

rum

ent d

isinf

ectio

n

Inst

rum

ent m

aint

enan

ce/c

are

Bedp

an m

achi

ne c

lean

ing

For g

lass

war

e

For t

herm

olab

ile in

stru

men

ts

For fl

exib

le e

ndos

cope

s

Bact

eria

(all

vege

tativ

e ba

cter

ia in

cl. m

ulti-

resis

tant

bac

teria

, e.g

. MRS

A, V

RE, E

SBL)

Levu

rocid

al (y

east

s)

Fung

icida

l (fu

ngi)

Myc

obac

teric

idal

(e

.g. t

uber

culo

sis b

acte

ria)

Viru

cidal

for e

nvel

oped

viru

ses

(incl.

HBV

, HCV

, HIV

)

Fully

viru

cidal

(env

elop

ed a

nd n

on-

enve

lope

d vir

uses

, e.g

. pap

illom

aviru

s,pa

rvov

irus)

Mild

alk

alin

e

Neut

ral

Acid

ic

Belimed ProtectTM Pre Treat Spray • • •

Belimed ProtectTM Neutral Enzyme Cleaner • • • •

Belimed ProtectTM Mild Alkaline Enzyme Cleaner • • • •

Belimed ProtectTM Mild Alkaline Cleaner • • • • •

Belimed ProtectTM Rinse and Dry Aid • •

Belimed ProtectTM Scale and Rust Remover • •

Belimed ProtectTM Neutralizer • •

Belimed ProtectTM Lubricant WD • •

Belimed ProtectTM Glutaraldehyde Disinfectant • • • • • • • • • •

Belimed ProtectTM PAA 15 • • • • • • • • • •

Belimed ProtectTM Cleaner and Disinfectant • • • • •

Belimed ProtectTM Bedpan Cleaner • •

*Ready-to-use solution

Instructions for use

Please follow the manufacturer’s recommendations for the reprocessing of medical devices according to EN ISO 17664. For more details regarding instrument reprocessing, visit www.a-k-i.org.

Safety information For safety and handling, please refer to the Product Safety Data Sheet.

Associated products and services

The Belimed ProtectTM range of chemistries has been developed and validated with Belimed Washer Disinfectors to meet the cleaning efficacy requirements of medical devices according to consistent and repeatable standards outlined in EN ISO 15883. For further support regarding optimization of your cleaning process and/or troubleshooting, please contact your local Belimed representative.

Symbols and color coding system of Belimed ProtectTM

Symbols – recommended use

Safe for use with flexible endoscopes

For manual reprocessing

Color coding system – product category

For cleaning

For disinfecting

For neutralization

For rinsing and drying

For maintenance and care

For automated reprocessing in WDs/AERs

2110

EN

Sub

ject

to m

odifi

catio

ns

Amity InternationalLibra Hause West Street Worsbrough Dale Barnsley South Yorkshire S70 5PG UK +44 126 770787 www.aihc.co.uk

Amity Healthcare (EU) LtdSuite 6, Block 5.1 Woodford Court Woodford Business Park Dublin 9 Ireland

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