Adept Medical AM0700 Руководство по эксплуатации - Страница 7

Просмотреть онлайн или скачать pdf Руководство по эксплуатации для Медицинское оборудование Adept Medical AM0700. Adept Medical AM0700 20 страниц. Prone support

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Information

Intended Purpose

To provide a support surface for patient's arm and

head in prone position.

Intended User/Training Requirement

Intended to be used by trained medical

professionals.

Patient Target Group

Adult male or female patient undergoing

procedures in prone position.

Contraindications

●

Not to be used with patients over 135Kg.

●

Not for paediatric use.

●

Not intended for CT Bore diameter less

than 78cm.

●

Not to be used on patients with extreme

Kyphosis.

●

Head Assembly not to be used with

intubated patient

Warnings and Cautions

●

Ensure IFU is read prior to use.

●

Ensure Preparatory Cleaning is conducted.

●

Ensure Preparatory Product Check is

conducted.

●

Do not use with patients over 135Kg.

●

Ensure patient has adequate mobility for

shoulder flexion.

●

Not for paediatric use.

●

Ensure patients fingers, if over edge, do

not impact with Xray camera C-arm.

●

Ensure hair is managed in hair net for

patients with long hair.

●

If comfortable position cannot be achieved

or patient is restless, the head assembly

can be removed and replaced with a pillow.

●

Warning, a non-cooperative patient may

dislodge device as it is not fixed to Image

table.

●

Use of the Product is intended only for

contact with intact skin.

●

For patients suspected of requiring an

emergency transition to the supine

position during a procedure, do not use

Head Assembly

Incident Reporting Guidelines

For product complaints and incidents, please

complete form on:

adeptmedical.co.nz

/repairs

adeptmedical.com |

Initial Checks & Cleaning

Cleaning

Refer to Disinfection Instructions.

Product Checks

●

No break in Carbon Fibre surface.

●

No visible damage or sharp edges, e.g. cracks

●

Adjustable Assembly: Ensure the assembly

is not free to move up and down when lever

is in the lock position.

●

Adjustable Assembly: Ensure the assembly

can move up and down when pushed when

lever in the unlocked position.

●

Adjustable Assembly: Ensure the assembly

is not free to tilt when the screw is locked.

Adjustable Assembly: Ensure the assembly

●

is free to tilt when the screw is unlocked.

●

Ensure Face Pad pin is inserted securely into

locating holes.

●

Ensure the Adjustable Assembly is fully

inserted on the Face Support (refer to page

5).

●

Ensure the Adjustable Assembly is fully

inserted on the Base Board (refer to page 6).

Disinfection

Warnings

●

Insufficient cleaning may compromise

disinfection process and lead to transmission

of pathogens.

●

Do not use any disinfectant products or

abrasive/corrosive agents which are not on

the approved cleaners list.

●

Always read manufacturer's instructions

and consult the manufacturers MSDS for

cleaning and disinfectant products.

●

Do not use any cleaning procedure which

exceeds 65°C/149°F.

●

Some disinfectants may cause slight

discolouration to the soft blue or white

material used on some components within

the product range. This will not affect the

strength and the product will remain fit for

purpose.

Limitations on Processing

Discontinue use if:

●

any cracks or breakages are present.

●

any exposed carbon is visible.

| adeptmedicaltraining.com

Disinfection Instructions

Initial treatment at the point of use

It is important to clean the product once it

is removed from the packaging and after

each procedure. Ensure all areas including

joints, clips, sockets, brackets and levers are

thoroughly cleaned after use to remove all

contaminant build-up that may be present

following a procedure.

Preparation before cleaning

Remove Prone Support from beneath the

mattress.

Remove Adjustable Assembly.

Remove Face Pad.

Ensure the Adjustable Assembly is fully

extended.

adeptmedicaltraining.com

/productcleaning/Prone-Support

Cleaning: Manual

●

If any visible residue is present, rinse

under water but avoid submerging the

device.

●

A soft bristle brush can be used.

●

Ensure the device is completely dried

prior to disinfection.

Disinfection

Refer to the Approved Cleaners List (following

page) for selection of an appropriate

disinfecting agent.

Face Pad

With a cloth dampened by an approved

disinfectant, wipe all surface.

Adjustable Assembly

With a cloth dampened by an approved

disinfectant, wipe all surface, especially the

blue lever and screw.

Carbon Fiber Base Board

With a cloth dampened by an approved

disinfectant, wipe the entire surface, including

crevices in which contaminants may build up.

Drying

All components should be dried thoroughly

before use.

Maintenance, Inspection and Testing

For all components ensure:

●

No exposed Carbon Fibre is visible.

●

No visible damage or sharp edges, e.g.

cracks.

Face Pad

●

Ensure there is no damage, e.g. tear or pin

detachment.

Adjustable Assembly

●

Ensure the assembly is free to move up

and down when lever is in unlocked and

does not move up and down when lever

is locked.

Adjustable Assembly

●

Ensure the assembly is not free to tilt

when the screw is locked and is free to tilt

when the screw is unlocked.

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 in which the temperature

will not exceed 65°C/149°F.

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.