Mizuho Knee Rests User manual

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MES-CK08-072-01EN-0
PREPARED: (2022-10-18) (Version 6) Instruction for Use
Trade Name: Knee Rests
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
1. This product is only validated for use with Mizuho operating tables.
2. The Knee Rest is designed to support the patient’s knees and legs
as shown in Fig. 1-1, Fig.2-1, Fig.3-1 and Fig.4-1 of Instructions
for use. Any other positioning may damage the knee rest, clamp
or table, and may injure the patient.
3. Donot ride orsit on the edge of the board (shown in Fig.1-2,Fig.
2-2, Fig.3-2 and Fig. 4-2 of Instructions for use). Doing so may
cause damage to the product and injury to patient or staff.
4. Do not exceed the allowable load specified in Specifications, 3.
Allowable load. Otherwise the product could break.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description Components
08-072-01 Knee Rests ①②③④
08-072-02 Radiographic Tops for Knee Rests ①②③④⑦⑧
08-072-03 70mm Pads for Knee Rests ④
08-110-01 Clamp for Round Bar*3 ⑤⑥
08-117-09 Clamp for Round Bar (R1) *4 ⑤⑥
08-117-11 Clamp for Round Bar (R2) *5 ⑤⑥
*1: The number corresponds to those used in 1. Shape.
*2: 1 set (1 each for right and left)
*3,*4 and *5: The size of mountable side rail is different.
2. Weight (per piece)
Main body 2.5kg/4.4kg (08-072-02)
Pad 0.5kg
Clamp (including R1, R2) 0.9kg
3. Allowable load
Unit: 20kg (per board)
Maximum patient weight: 135kg
4. Material
①Insertion rod：Stainless steel
②Frame：Stainless steel
③Board：Thermosetting resin
④Pad：Urethane
⑤Clamp (including R1･R2)：Stainless steel
⑥Fixing handle (including R1･R2)：Stainless steel
⑦Cassette collar：Carbon tool steel
⑧Cassette board：Thermosetting resin
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory for an operating table. This product is an operating
tableattachmentused forsupportingpatientsin prone kneeling position*
and extending leg plate's length. This is horizontally attached onto a leg
plate that is lowered 90° to support the patient’s knee.Or, this is
horizontally attached onto the tip of the leg plate to support the patient’s
leg.
*Note: Refer to Instructions for use, Fig.1-1 and Fig.3-1.
Intended user
Thisproduct is to be used byhealth care professionals, including but not
limited to surgeons, nurses and biomedical technicians.
Instructions for use
1. To support patient's knee.
Fig.1-1
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Unit:mm

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Fig.1-2
1-1. Articulate the leg plate of the operating table down 90°.
1-2. Attach the clampto the side rail of the leg plate.
1-3. Insert the insertion rodto the clamp, and rotate the fixing
handleto secure the insertion rod.
1-4. Attach the padto the board.
2. To support patient's leg
Fig.2-1
Fig.2-2
2-1. Check the leg plate of the operating table is in the horizontal
position.
2-2. Attach the clampto the side rail of the leg plate.
2-3. Insert the insertion rodto the clamp, and rotate the fixing
handleto secure the insertion rod.
2-4. Attach the padto the board.
3. To support patient's knee. (Radiographic Tops)
Fig.3-1
Fig.3-2
3-1. Articulate the leg plate of the operating table down 90°.
3-2. Attach the clampto the side rail of the leg plate.
3-3. Insert the insertion rodto the clamp, and rotate the fixing
handleto secure the insertion rod.
3-4. Attach the cassette board to the board .
3-5. Attach the padto the cassette board.
4. To support patient's leg (Radiographic Tops)
Fig.4-1

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Fig.4-2
4-1. Check the leg plate of operating table is in the horizontal position.
4-2. Attach the clampto the side rail of the leg plate.
4-3. Insert the insertion rodto the clamp, and rotate the fixing
handleto secure the insertion rod.
4-4. Attach the cassette board to the board.
4-5. Attach the padto the cassette board.
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.
2-2. Use a pair of Knee rests (right and left) to support the patient.
2-3. When using this product to support patient's leg (Fig.2-1 and
Fig.4-1), read instructions for use of operating table carefully and
pay close attention to the patient and devices. Patient could fall
down by the condition or position of the devices.
2-4. For hygiene, be sure to use sterilized drapes on the areas on this
product where the patient comes into contact with it.
3. Interaction
3-1. Combination contraindicated
Do not use the Knee Rests (08-072-01) which are incompatible
with cassettes with the cassette board attached to the operating
table. When the board is flexed upwards, the board will bump into
the cassette board, and it may get damaged.
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 asthe 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 dealer or Mizuho.
<By agents>
Maintenance and inspection can only be carried out by certified agents of
Mizuho.
Packing
1 set per pack
Warranty
MIZUHO Corporation will repair defective parts of this product without
charge for one year from the date of delivery/installment except forcases
of damage caused by a third party’s repair, act ofnature, improperuse 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