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医療機器 Adept Medical AM0180のPDF 取扱説明書をオンラインで閲覧またはダウンロードできます。Adept Medical AM0180 19 ページ。 Ir system

Adept Medical AM0180 取扱説明書
EN
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Information
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Intended Purpose
STARBoard: To support a supine patient's arm,
facilitating hyperextension for radial access.
Extension Tray: To provide a transitional work
surface from the radial access site to trolley.
IR Shield: To provide scatter radiation
protection.
Intended User/Training Requirement
Intended to be used by trained medical
professionals.
Patient Target Group
Adult male or female patient requiring
diagnostic imaging and image guided therapy.
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Contraindications
Not to be used with patients over 135Kg.
Not for paediatric use.
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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.
To provide restraint for restless patient
(refer to page 6).
Not for paediatric use.
Incident Reporting Guidelines
For product complaints and incidents, please
complete form on
adeptmedical.co.nz
/repairs
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Initial Checks & Cleaning
Cleaning
Refer to Disinfection Instructions.
Product Checks
No exposed Carbon Fibre.
No break in Carbon Fibre surface.
No visible damage or sharp edges, e.g. cracks.
STARBoard
Ensure all pivoting joints can rotate with the
appropriate amount of friction and adjust if
necessary. (refer to page 5).
Correct placement (Refer to page 5).
Patient can access the handle to grip (refer to
page 6).
IR Shield
Ensure correct daggerboard placement
(refer to page 7)
Ensure the X-Ray Shield is correctly placed in
the daggerboard (refer to page 7)
Arm Support Pad
No visible damage or tearing.
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Disinfection
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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 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, breakages, or tears are present.
Any exposed carbon fibre is visible.
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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
Extension Tray: Detach the Extension Tray
from the STARBoard.
STARBoard: Remove STARBoard from
beneath the mattress.
Arm Support Pad: Remove Arm Support Pad
from STARBoard.
IR Shield: Remove from Daggerboard.
Daggerboard: Remove from beneath the
mattress.
adeptmedicaltraining.com
/productcleaning/IR-System
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.
EN
Disinfection
Refer to the Approved Cleaners List (following
page) for selection of an appropriate
disinfecting agent.
STARBoard
With a cloth dampened by an approved
disinfectant, wipe all surfaces, Armrest, Handle,
Wrist Pivot, and adjust device to wipe entire
Slider Arm.
Extension Tray
Wipe all surfaces and the bracket area with a
cloth dampened by an approved disinfectant.
IR Shield
With a cloth dampened by an approved
disinfectant, wipe all surfaces including inside
the slot on the Daggerboard.
Arm Support Pad
With a cloth dampened by an approved
disinfectant, wipe all surfaces.
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