Mizuho Seat Extension User manual

MES-CK08-075-36EN-0
PREPARED: (2023-07-26) (Version 4)
Instruction for Use
Trade Name: Seat Extension
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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. Use only on the models listed in Instructions for use, 3.
Applicable operating tables.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description Compo
nents
08-075-36 Seat Extension (350mm) *1 ①②③④⑦
08-075-36-R1 Seat Extension (350mm) (R1) *2 ①②③④⑦
08-075-36-R2 Seat Extension (350mm) (R2) *3 ①②③④⑦
08-075-37 Pad for Seat Extension
(350mm) *4 ⑧
08-075-38 Radiographic Top for Seat
Extension(350mm) ⑤⑥⑦
08-083-01 Radiographic Table Tops Fixed
Type for Seat Extension (350mm) ⑤⑥⑦
08-083-21
Digital Radiographic Table Tops
Fixed Type for Seat Extension
(350mm)
⑥⑦⑨
08-083-41
Phenolic Board for Radiographic
and Digital Radiographic Table
Tops Fixed Type for Seat Extension
(350mm)
③⑦
08-083-61 Mizuho Original Pad for Seat
Extension (350mm) ⑧
Code No. Product Description Compo
nents
18-042-83 SUSANO pad for Seat Extension
(350mm) ⑧
Note: The number corresponds to those used in 1. Shape.
*1,*2 and *3: The size of mountable side rail is different.
*4: Pad thickness 50 mm.
Code No. Product Description Compo
nents
08-075-42 Seat Extension for 5701 *5 ①②③④⑦
08-075-42-R1 Seat Extension for 5701 (R1) *6 ①②③④⑦
08-075-42-R2 Seat Extension for 5701 (R2) *7 ①②③④⑦
08-075-43 Radiographic Top for Seat Extension
for 5701 ⑤⑥⑦
08-075-44 Pad for Seat Extension for 5701 ⑧
08-083-00 Radiographic Table Tops Fixed Type
for Seat Extension (300mm) ⑤⑥⑦
08-083-20
Digital Radiographic Table Tops
Fixed Type for Seat Extension
(300mm)
⑥⑦⑨
08-083-40
Phenolic Board for Radiographic and
Digital Radiographic Table Tops
Fixed Type for Seat Extension
(300mm)
①⑦
08-083-60 Mizuho Original Pad for Seat
Extension (300mm) ⑧
18-042-82 SUSANO Pad for Seat Extension
(300mm) ⑧
Note: The number corresponds to those used in Fig 2.
*5, *6 and *7: The size of mountable side rail is different.
Unit: mm
Fig.1
⑨
⑥
⑥
⑦
⑦
⑧
⑨

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2. Weight
Main unit: 7 kg (08-075-36/R1/R2)
10 kg (08-075-42/R1/R2)
Radiographic top: 2 kg (08-075-38/08-083-00/-01/-20/-21)
1.8 kg (08-075-43)
Phenolic board: 1.6 kg (08-083-40)
2.8 kg (08-083-41)
Pad: 1.0 kg (08-075-37/08-075-44/18-042-83)
0.6 kg (08-083-60/-61/18-042-82)
3. Material
3-1. 08-075-36/-36-R1/-36-R2/-37/-38
08-083-01/-21/-41/-61
18-042-83
①Fixing handle: Stainless steel
②Frame: Aluminum alloy
③Board: Thermosetting resin
④Side rail: Stainless steel
⑤Radiographic top leg: Carbon steel
⑥Radiographic top: Thermosetting resin
⑦Velcro tape: Nylon
⑧Pad: Polyurethane
⑨Radiographic top leg: Polycarbonate
Note: The number corresponds to those used in 1. Shape, Fig 1.
3-2. 08-075-42/-42-R1/-42-R2/-43/-44
08-083-00/-20/-40/-60
18-042-82
①Board: Thermosetting resin
②Side rail: Stainless steel
③Fixing handle: Stainless steel
④Insertion shaft: Stainless steel
⑤Radiographic top leg: Carbon steel
⑥Radiographic top: Thermosetting resin
⑦Velcro tape: Nylon
⑧Pad: Polyurethane
⑨Radiographic top leg: Polycarbonate
Note: The number corresponds to those used in 1. Shape, Fig 2.
Intended purpose
This is an accessory for the operating table. This product is
intended to be attached to the operating table seat section, with
the leg section detached. It extends the seat section length to
facilitate radiography of the kidneys in lithotomy 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. Instructions for use
(08-075-36/-36-R1/-36-R2/-37/-38/08-083-01/-21/-41/-61/
18-042-83)
1-1. Attach the Seat Extension①to the side rails of the
operating table seat section.
1-2. Fix the Seat Extension①with the fixing handle②.
1-3. Attach the pad③.
1-4. If radiography is required, attach the radiographic top④
between the Seat Extension①and the pad③.
2. Instructions for use
(08-075-42/-42-R1/-42-R2/-43/-44/08-083-00/-20/-40/-60/
18-042-82)
2-1. Detach the leg section from the operating table.
2-2. Insert the Seat Extension①into the leg section reception
holes of the operating table.
2-3. Fix the Seat Extension①with the fixing handles②at both
ends.
2-4. Attach the pad③.
2-5. If radiography is required, attach the radiographic top④
between the Seat Extension①and the pad③.
3. Applicable operating tables
Refer to the brochure "OPERATING TABLE ACCESSORIES" of
Mizuho.
Warning/Caution
1. Warning
Ensure all attaching parts are fixed. 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 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.

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<By agents>
Maintenance and inspection can only be carried out by certified 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 adverse 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 Netherlands