Mizuho MES-CK08-064-23EN-0 User manual

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MES-CK08-064-23EN-0
PREPARED: (2022-07-04) (Version 2)
Instruction for Use
Trade Name: Non-adjustable Lateral Arm Support with Side Rail Clamp and Joint B
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 nerve paralysis and/or 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
This product is only validated for use with Mizuho operating tables.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description Components
08-064-23 Upper Arm Support Joint Type II with
Clamp


08-064-23-NC Upper Arm Support Joint Type II (NC) 
08-110-20 Universal Clamp for Round Bar 
2. Weight
Main body: 2.1kg
Rail clamp: 1.0kg
3. Patient’s weight: 135kg or less
4. Material
Main body
Support base: Nylon
Pad: Polyurethane
Pole: Stainless steel rod
Lever: Nylon
Rail clamp
Rail clamp: Stainless cast steel
Fixing handle: Stainless steel rod
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory for an operating table. This product 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
1-1. Attach the rail clamp on the side rail of the operating table.
1-2. Insert the pole in the rail clamp , and then tighten the fixing
handle .
1-3. Place the patient’s upper arm on the support base with the pad 
and adjust the position of the pole according to the posture of the
patient.
1-4. After the adjustment, tighten the fixing handle to fix the rail
clamp and the pole .
1-5. Adjust the position of the support base by the lever as needed.
2. Applicable operating tables
Refer to the brochure “OPERATING TABLE ACCESSORIES” of
Mizuho.
Warning/Caution
1. Warning
Ensure all fixing handles are tight. Loose condition can cause the
product to come off or move, which may result in a patient injury.
2. Important caution
2-1. 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.
Otherwise the product could break.
2-2. For hygiene, be sure to use sterilized 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.)
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.

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Maintenance/Inspection
<By the user>
1. Check before and after use
Check that this product is not damaged or broken before and after
each use.
2. Cleaning and 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
When this product is broken, clearly label the device as “Broken”,
“Do not use”, “Need repair”, etc., and contact your local dealer or
Mizuho.
<By agents>
Maintenance and inspection can only be carried out by certified
agents of 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 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