Mizuho Standard Armboard User manual

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MES-CK08-117-16EN-0
PREPARED: (2022-08-19) (Version 5)
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 if its upper surface is lower than
the surface of the operating table.
Symbol mark for labeling
MD :Medical Device
Specifications
Accessory：Pad for armboard
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.
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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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
①Make sure that the clamping lever is fixed to the side rail.
Failure to properly secure to rail may lead to damage to
Armboard or injury to patient.
②If the spring is damaged, you may hurt your hands or
fingers.
③For hygiene, be sure to use sterile drapes on the areas on
this product where the patient comes into contact with it.
④When 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.
⑤After 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.
⑥When used in the longitudinal direction of the operating
table, the standard armboard may slip and move.
Therefore, monitor the patient's condition with sufficient
care during surgery.
⑦Do not apply a load exceeding the allowable 15 kg load.
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
Note: Even within its useful life, if sudden failure,
significant wear, deterioration or damage of parts
(including the mat) occurs due to usage conditions or
frequency, the relevant parts must be replaced.
Maintenance/Inspection
1. Inspection before and after use
Check that this product is not damaged or broken before
and after use.
2. Cleaning/disinfection
Wipe off blood, chemicals, contaminants, and other stains
with water, and clean the device with gauze or other
material moistened with alcohol to disinfect.
3. In case of a malfunction
If you need to have this product repaired, consult your
local dealer or Mizuho.
Packing
1 piece per pack
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.
MIZUHO Corporation
3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
https://www.mizuho.co.jp
Emergo Europe B.V.
Prinsessegracht 20, 2514 AP, The Hague
The Netherlands