Mizuho MES-CK08-078-20EN-0 User manual

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MES-CK08-078-20EN-0
PREPARED: (2023-07-21) (Version 5) Instruction for Use
Trade Name: Leg Plate
Warning
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.
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
08-078-20 Leg Plate *1
08-078-20-R1 Leg Plate (R1) *2
08-078-20-R2 Leg Plate (R2) *3
*1, *2 and *3: The size of mountable side rail is different.
2. Material
①Handle: Stainless steel
② Gear case: Stainless steel
③Motion axis: Stainless steel
④Clamp: Stainless steel
⑤Leg plate: Polyurethane
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory for the operating table. This product is used to set
the surgical positions for the lateral recumbent position.
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. Attach this product to the side rail of the operating table.
2. Use the handle to adjust the Leg plate up or down.
Maximum elevation height of the Leg plate: 270 mm
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 tabletop 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.)
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 materials soaked in
disinfectants. In addition, use the same disinfectants as the
authorized disinfectants on Mizuho's operating table described in the
operating table operator's manual.
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 distributor or
Mizuho.
<By agents>
Maintenance and inspection can only be carried out certified agents
of Mizuho.
Packing
1 piece per pack
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
④
Side rail
Unit: mm
⑤

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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.
MIZUHO Corporation
3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
https://www.mizuho.co.jp
EMERGO EUROPE
Westervoortsedijk 60
6827 AT Arnhem, The Netherland
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