Mizuho 08-113-02-R2 User manual

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MES-CK08-113-01EN-0
PREPARED: (2021-01-25) (Version 3) Instruction for Use
Trade Name: Side Rail Adaptor for Carbon Fiber Board
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 installing the head frame, use long type only. It can be broken
since it exceeds the allowable load of the short type specified at the
Specifications, 3. Allowable load.
Contraindication/Prohibition
1. Use only on the models listed in Instructions for use, 4.
Applicable surgical table and accessory.
2. Do not exceed the allowable load specified in Specifications, 3.
Allowable load. Otherwise the product could break.
3. Short rail type may only be used for Locking Type Armboard or
Anesthesia Screen frame. When using other accessory it could fall
off and get damaged or result in a patient injury.
4. This product is only validated for use with Mizuho operating tables
and accessories
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape Unit: mm
Code No. Product Description a b
08-113-01 Side Rail Adaptor, Long for Carbon
Fiber Board
32
mm
9
mm
08-113-01-R1 Side Rail Adaptor, Long for Carbon
Fiber Board (R1)
28.6
mm
9.4
mm
08-113-01-R2 Side Rail Adaptor, Long for Carbon
Fiber Board (R2)
25
mm
10
mm
08-113-02 Side Rail Adaptor, Short for Carbon
Fiber Board
32
mm
9
mm
08-113-02-R1 Side Rail Adaptor, Short for Carbon
Fiber Board (R1)
28.6
mm
9.4
mm
Code No. Product Description a b
08-113-02-R2 Side Rail Adaptor, Short for Carbon
Fiber Board (R2)
25
mm
10
mm
Note: “a” and “b” correspond to those used in 1. Shape.
2. Weight
Long: 1.8 kg
Short: 0.9 kg
3. Allowable load
Long: 40 kg
Short: 20 kg
4. Material
Rail: Cold rolled stainless steel band
Fixing handle: Stainless steel rod, resin
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory to an operating table. It is fixed to the table top of
the operating table to attach other operating table accessories.
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. Insert this product in the table top.
2. Fix it by tightening the Fixing handle.
3. Attach the operating table accessory, etc.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Example of use: Anesthesia Screen L Type

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For details of accessory, etc. attached to this product, refer to the
instruction manual of each accessory.
4. Applicable surgical table and accessory
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 fundamental 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. Avoid excessive load or strong impact. If any heavy load or large
impact is applied to the accessory, etc., it could cause a "rebound"
against the surgical table.
2-3. 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.)
Maintenance/Inspection
<By the user>
1. Inspection 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 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
Example of use: Locking Type Armboard