Mizuho MES-CK08-117-16EN-0 User manual

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MES-CK08-117-16EN-0
PREPARED: (2021-05-20) (Version 4)
Instruction for Use
Trade Name: Standard armboard
Warning
1.When using operating table accessories, always pay close
attention to the patient. Patients left in the same posture for
an extended period of time are at risk for developing
bedsores.
2.When using this product for a patient in the lateral recumbent
position, secure the arm on the lower side onto the Armboard.
Failure to secure the arm to the Armboard may lead to a
patient injury.
Contraindication/Prohibition
1.This product is only validated for use with Mizuho operating
tables.
2.Avoid putting a patient’s arm in any of the positions shown
below, in order to prevent nerve paralysis in the arm.
Do not allow the arm to be positioned at an angle of more
than 90 degrees with respect to the longitudinal direction
of the operating table.
Do not turn up the inside of the arm (except for patients in
the lateral recumbent position).
Do not use this product together with the shoulder
support for a patient in the Trendelenburg position (laid
flat on the back with the feet higher than the head).
(Refer to the Interactions section.)
Do not use this product if its upper surface is lower than
the surface of the operating table.
3.Care should be taken to secure the arm to the Armboard
when the table is articulated.
Failure to secure the patient’s arm may lead to patient injury.
Symbol mark for labeling
MD :Medical Device
Specifications
Accessory：Pad for armboard
Pad for armboard
Clamping lever
Board
Rotation lever
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.

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Code No. Product Description
08-117-16 Standard armboard (C2)
<Accessories>
Code No. Product Description
08-117-07 60 mm Pad for armboard (C1/C2)
08-117-08 100 mm Pad for armboard (C1/C2)
Material: Stainless steel, Aluminium alloy, Plastic
Intended purpose
This is an accessory to an operating table and is used for
supporting an upper arm of a patient.
Intended user
This product is to be used by health care professionals,
including but not limited to surgeons, nurses and biomedical
technicians.
Instructions for use
1) Attachment
While pulling the clamping lever toward you, attach the
armboard to a side rail of an operating table.
Release the clamping lever.
2) Removal
While pulling the clamping lever toward you, lift up the
edge of the board (armboard).
Remove the armboard from the side rail.
3) Rotation
After pulling the rotation lever, the armboard can be
rotated to up to 90 degrees.
Warning/Caution
1) Important caution
- When working with an operating table, take care not to
allow this product to make contact or interfere with the
table top or with other tools and appliances used in
combination with this product.
- After adjusting the rotation angle, be sure to check that the
catch at the end of the rotation lever fully engages with
the gear below the board.
2) Interaction
(Cautions on use of other tools in combination with this
product)
Product Clinical episode
Shoulder support nerve paralysis in the upper arm
When shoulder support is used, do not secure the arm in
abducted position on a standard armboard. Doing so may
result in nerve paralysis in the upper arm.
3) Defect/Adverse event
(Adverse event)
-Bedsore
-Patient’s fall
4) For hygiene, be sure to use sterile drapes on the areas on this
product where the patient comes into contact with it.
Storage/Life
1. Do not store the device in high temperatures or in areas
with high humidity where the temperature has drastic
variations.
2. Service life of this product: 7 years
(subject to the specified maintenance and inspection and
is stored properly)
Handling instructions
1. Use this product for its intended purpose only.
Incorrect use could cause damage to this product and the
operating table to which this product is attached.
2. Cleaning and disinfection
Wipe off blood, chemicals, contaminants, and other stains
with water, and clean the armboard with gauze or other
material moistened with alcohol to disinfect it.
Maintenance/Inspection
1. Check that this product is not damaged or broken before
and after use.
2. If you need to have this product repaired, consult your
local dealer or Mizuho.
Packing
1 piece per pack
Shoulder support
Shoulder su
pp
ort is not attached.

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Warranty
Mizuho Corporation will repair defective parts of this product
without charge for one year from the date of
delivery/installment except for cases of damage caused by a
third party’s repair, act of nature, improper use or
intentional damage. All other warranty terms and conditions
are subject to regulations of Mizuho Corporation.
Disposal
This device must be disposed of in accordance with local
regulations.
Please contact your local distributor for proper disposal.
Notice
Any serious incident that has occurred in relation to the
device should be reported to the manufacturer and the
competent authority in which the user and/or patient is
established.
Manufacturer
MIZUHO Corporation
3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
http://www.mizuho.co.jp
European authorized representative
Emergo Europe B.V.
Prinsessegracht 20, 2514 AP, The Hague
The Netherlands