Mizuho 08-077-70 User manual

MES-CK08-077-50EN-0
PREPARED: (2020-12-28) (Version 1)
Instruction for Use
Trade Name: Leg-side Reversal Adapter
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Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
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. Do not exceed the Maximum patient weight specified in
[Specifications], Item 4. Doing so could cause the product to
break.
3. Do not apply an unbalanced load to the tip of the board. The
product may fall or be damaged.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
1-1．Leg-side Reversal Adapter A
Unit: mm
1-2．Leg-side Reversal Adapter B, B(R1) & B(R2)
Unit: mm
1-3．Leg-side Reversal Adapter C, C(R1) & C(R2)
Unit: mm
1-4．Digital Radiographic Table Top for Leg-side Reversal Adapter
Mizuho Original Pad for Leg-side Reversal Adapter
Unit: mm
Code No. Product Description No.
08-077-70 Leg-side Reversal Adapter A 
08-077-60 Leg-side Reversal Adapter B 
08-077-60-R1 Leg-side Reversal Adapter B (R1) ⑪
08-077-60-R2 Leg-side Reversal Adapter B (R2) ⑫
08-077-50 Leg-side Reversal Adapter C 
08-077-50-R1 Leg-side Reversal Adapter C (R1) ⑪
08-077-50-R2 Leg-side Reversal Adapter C (R2) ⑫
18-097-00 Digital Radiographic Table Top for
Leg-side Reversal Adapter 
18-042-90 Mizuho Original Pad for Leg-side
Reversal Adapter 
Note: The numbers match the ones that are used in Fig. 1-4.
2. Weight
08-077-70: 4.0 kg
08-077-60/R1/R2: 5.8 kg
08-077-50/R1/R2: 6.0 kg
18-097-00: 0.5 kg
18-042-90: 0.2 kg
Fi
g
. 1
Fi
g
. 2
Fi
g
. 3
Fi
g
. 4

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3. Material
Board: Thermosetting resin laminated board
Insertion shaft A: Stainless steel rod
Insertion shaft B: Stainless steel rod
Velcro fastening: Nylon
Unlock button: Polyacetal
⑪⑫ Bracket: Stainless steel rod
Fixing handle: Stainless steel rod
Cassette board: Thermosetting resin laminated board
Radiographic top leg: Polycarbonate
Pad: Urethane foam
Note: The numbers match the ones that are used in 1. Shape, Fig. 1-4.
4. Maximum patient weight
135 kg
Intended purpose
This is an accessory which is supplied with the operating table. The
adapter makes it possible to attach the back plate side mounting
accessories onto the leg plate sides by attaching them onto the
waist plate with the leg plates detached.
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. 08-077-70/-60/-60-R1/-60-R2
Insertion shaft Radiographic top
Pad Unlock button
1-1. Insert the Leg-side Reversal Adapter insertion shaft into
the leg plate insertion hole of the operating table.
1-2. Pull on the Leg-side Reversal Adapter to make sure it is
firmly inserted.
1-3. Attach the pad .
1-4. If radiography is required, attach the radiographic top 
between the Leg-side Reversal Adapter and pad .
1-5. When detaching the Leg-side Reversal Adapter, then pull
the Leg-side Reversal Adapter straight out while pressing
the unlock button ④.
2. 08-077-50/-50-R1/-50-R2
Pad Bracket
Radiographic top Fixing handle
2-1. Insert the bracket of the Leg-side Reversal Adapter into
the side rails of the seat board on the operating table.
2-2. Make sure that the Leg-side Reversal Adapter is completely
inserted, and then tighten the fixing handle to fix it.
2-3. Attach the pad .
2-4. If radiography is required, attach the radiographic top 
between the Leg-side Reversal Adapter and pad .
2-5. When detaching the Leg-side Reversal Adapter, then loosen
the fixing handle ⑥, and pull the Leg-side Reversal Adapter
straight out.
3. Applicable operating tables
Mizuho operating tables
Warning / Caution
1. Important caution
1-1. For hygiene, be sure to use sterilized drapes on the areas on
this product where the patient comes into contact with it.
1-2. Ensure that all of the fastener components are tied up. Failure
to do so may result in a patient injury.
1-3. 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. Interaction
[Precautions when using with other items]
If the operating table’s slide is slid the maximum amount with this
product and accessories attached to it, then the operating table’s
operations might be slowed down.
Storage / Life
1. Do not store the device in areas where there are high
temperatures or high humidities, nor in places where there are
drastic temperature or humidity fluctuations.
2. Service life of this product: 7 years
(When it is maintained and inspected as specified, and when it
is properly stored.)
Fig. 5
Leg-side Reversal Adapter A
Fig. 6
Leg-side Reversal Adapter A
Fig. 7
Fig. 8

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Maintenance / Inspection
<By the user>
1. Inspection before and after use
Check that this product is not damaged or broken before and
after 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
If you need to have this product repaired, clearly label the device
as "Broken", “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.
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