Adept Medical AM0180 Instructions For Use Manual Download

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Drying

All components should be dried thoroughly

before use.

Maintenance, Inspection and Testing

All components:

●

Ensure no visible damage or sharp edges,

e.g. cracks.

STARBoard, X-Ray Shield:

●

Ensure no exposed Carbon Fibre is visible.

STARBoard:

●

Ensure all pivoting joints can rotate with

the appropriate amount of friction and

adjust if necessary.

Extension Tray:

●

Ensure the Extension Tray is correctly

attached and secure on the STARBoard.

Packaging

It is not required to package the device following

disinfection.

Sterilisation

This device should not be subjected to

sterilisation processes.

Storage

Once disinfection is complete and all

components are dry the device should be stored

in a dry environment.

The instructions provided above have been validated

by the manufacturer of the medical device as being

capable of preparing a medical device for reuse. It

remains the responsibility of the processor to ensure

that the processing, as actually performed using

equipment, materials and personnel in the processing

facility, achieves the desired result. This requires

verification and/or validation and routine monitoring

of the process.

Used product is a biohazard, decontaminate

according to instruction provided in the

Disinfection Instructions and reach out to the

manufacturer on adeptmedical@adept.co.nz

for material specification, if required. Dispose

according to internal clinic policy taking into

consideration local regulations.

adeptmedical@adept.co.nz

Disposal

Serious Incidents

Any serious incident which occurs in relation to

the device should be reported immediately to:

●

The Competent Authority of the

applicable Member State.

●

The Manufacturer using the Serious

Incident Reporting Form found on the

Adept Medical Website.

Serious

Incidents Form

Approved Disinfectant by Brands

Approved Active Disinfectant Ingredients

Acid Based:

≤10% Malic Acid CAS 6915-15-7
≤6% Sulfamic acid CAS 5329-14-6

Alcohol Based:

≤5% 2-Butoxyethanol CAS 111-76-2
≤10% Butyldiglycol CAS 112-34-5
≤70% Isopropyl Alcohol (Propan-2-ol) CAS 67-63-0
≤10% Tridecanol CAS 69011-36-5
<10% Alcohols, C12-14, ethoxylated CAS 68439-50-9
≤70% Denatured Ethanol CAS 64-17-5

Sulphate Based:

≤0.1% PHMB CAS 27083-27-8
≤55% Potassium Peroxymonosulfate CAS 70693-62-8
≤3% Potassium Persulfate CAS 7727-21-1

Ammonium and Chloride Based:

≤5% Benzalkonium Chloride CAS 68424-85-1
≤0.28% Benzethonium Chloride CAS 121-54-0
≤10% Benzyl-C23-18-Alkyl-dimethyl Ammonium Chloride

CAS 8001-54-5
≤2% Chlorhexidine CAS 55-56-1
≤10% Didecyl Dimethyl Ammonium chloride CAS 7173-51-5
≤0.5% Quaternary Ammonium Compounds CAS

68956-79-6
<5% Benzyl-C 12-18 alkyldimethylammonium chlorides

CAS 63891-01-5

Others:

≤10% Glutaral CAS 111-30-8
≤0.63% Sodium Hypochlorite CAS 7681-52-9
≤7.5% Povidone Iodine CAS 25655-41-8
0.5% Disodium Cocoampho Dipropionate CAS68604-71-7
≤1.4% Hydrogen Peroxide CAS 7722-84-1

Liquids:

ORION Laboratories
70% Isopropyl Alcohol

Jaychem Industries
2% Chlorhexidine / 70% Alcohol

Betadine
Povidone Iodine (7.5%)

BODE Chemie GmbH
Kohrsolin FF

STERIS
Coverage Spray TB

CaviCide
Metrex Research

Dissolvable

Du Pont
Rely+On Virkon Tablets

Surface Wipes:

PDI Sani-Cloth Bleach

PDI Sani-Cloth AF3