Mizuho 08-096-02 User manual

MES-CK08-096-02EN Ver.2 2023-07-20
Kidney Bridge
Operator’s Manual
Table of Contents
1.Introduction .......................................... 2
2.Component .......................................... 4
3.Instructions for use .............................. 5
4.Maintenance/Inspection ...................... 6
5.Specifications ...................................... 7
This product is designed for medical operations. Using this product for any other purpose
other than this intended use may cause serious injury.
The operator and the person in charge of the maintenance of this product must read this
operator's manual thoroughly and understand the contents before operating, inspecting,
adjusting and maintaining it.
Keep this manual for reference in a place where is readily accessible.

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1. Introduction
1-1. Intended purpose
This is an accessory for the operating table. This product is used to set prone position or other
operating position for kidney and gallbladder surgery. This accessory is used for supporting
obese patients.
1-2. Intended user
This product is to be used by health care professionals, including but not limited to surgeons,
nurses and biomedical technicians.
1-3. Warning/Caution
This manual contains information for safely and effectively using this product.
Before operating this product, read this manual thoroughly to understand how to operate and
inspect the product. Failure to follow these instructions could lead to serious injury.
If these indications are ignored and the product is incorrectly used, serious injury or
death may result.
• 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.
• Ensure all fixing handles are tight. Loose condition can cause the product to
come off or move, which may result in a patient injury.
If these indications are ignored and the product is incorrectly used, injury and/or
damage to property may result.
• This product is only validated for use with Mizuho operating tables.
• 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.
• For hygiene, be sure to use sterilized drapes on the areas on this product where
the patient comes into contact with it.
1-4. Symbol mark for labeling
MD : Medical Device

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2. Component
The components of this product are as follow.
Component Material
① Handle Stainless steel
② Interlocking shaft Stainless steel
③ Gear box Stainless steel
④ Kidney bridge Polyurethane
⑤ Support pole Stainless steel
⑥ Rail clamp Stainless steel

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3. Instructions for use
The following describes how to attach, detach and operate this product.
1. Attach the kidney bridge④ to the support poles⑤ adjusting the width. (532 mm or 582 mm).
2. Attach the gear boxes③ to the side rails of the operating table.
3. Turn two rail clamps⑥ to fix the gear boxes③ to the side rails.
4. Insert the support poles⑤ to the gear boxes③.
5. Adjust the height of the kidney bridge④ by turning the handle①.
6. After use, pull out the support poles⑤ from the gear boxes③ by turning the handle①.
Loosen the rail clamps⑥ and detach the gear boxes③ from the side rails. Detach the support
poles⑤ from the kidney bridge④.
[Operating principle]
When turning the handle①, the gear integrated with the handle① inside the gear box③ turns the
gear that meshes. This gear meshes with the rack that is integrated with the kidney bridge④, and
when the handle① is turned, the rack moves and the kidney bridge④moves up and down.
* Maximum elevation height: 270 mm

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4. Maintenance/Inspection
4-1. Check before and after Use
• Check that this product is not damaged or broken before and after each use.
4-2. Cleaning and Disinfection
• After using this product, make sure to follow the steps below to clean up and disinfect this product.
a) Detach this product from the operating table.
b) Use a lint-free cloth soaked with proper volume of disinfectant to wipe off the upper, side, and
back side of the surface of the product.
c) Wipe off this product with a clean dry cloth within 15 minutes after disinfecting it.
• Make sure to use Mizuho authorized disinfectants. The disinfectants are as shown below.
Disinfectants
a) Sodium hypochlorite 0.1% (halogen containing compound)
b) Hypo Alcohol (iodine decolorant color removing agent)
c) Chlorhexidine (chlorhexidine gluconate 0.5%)
d) Benzalkonium chloride (invert soap 10%)
e) Povidone iodine
f) Ethanol 80%
g) Hydrogen peroxide
h) Isopropyl alcohol (IPA)
4-3. Repair and Maintenance
• When this product is broken, clearly label the device as “Broken”, “Do not use”, “Need repair”, etc.,
and contact your local dealer or Mizuho.
• Only Mizuho or its certified agents can provide repair and maintenance services of this product.
Services by other agents could cause adverse events and/or deterioration of the performance and
functions.
4-4. 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.
4-5. Disposal
This device must be disposed of in accordance with local regulations. Please contact your local
distributor for proper disposal.
4-6. 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.

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5. Specifications
Code No. Product Description Weight
(kg) Component
Dimension of
attachable side rail
Thickness x Hei
g
ht
(
mm
)
08-096-02 Kidney Bridge with Pad 9.0 ①〜⑥ 9×32
Operating
environment
Temperature 10 to 40 °C ( 50 to 104 °F)
Humidit
y
30 to 75 %
A
tmospheric pressure 700 to 1060 hPa
Transportation
and storage
environment
Temperature -10 to 50 °C (14 to 122 °F)
Humidit
y
10 to 85 %
A
tmospheric pressure 700 to 1060 hPa
Service life 7 years (Subject to the specified maintenance and inspection and
is stored properly.)
Unit: mm
532
582

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