Mizuho 08-007-21 User manual

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MES-CK08-007-21EN-0
PREPARED: (2022-10-18) (Version 4)
Instruction for Use
Trade Name: Back Section Board Short
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, 2.Applicable
operating tables.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description Compo
nents Weight
08-007-21 Back Section Board
Short *2
①②③
④⑤ 6.0kg
08-007-21-R1 Back Section Board
Short (R1) *3
①②④
⑤⑩ 6.0kg
08-007-21-R2 Back Section Board
Short (R2) *4
①②④
⑤⑪ 6.0kg
08-083-43
Phenolic Board for
Radiographic and Digital
Radiographic Table Tops
Fixed Type for Back
Section Board Short
① 1.4kg
08-083-23
Digital Radiographic
Table Tops Fixed Type
for Back Section Board
Short
②⑥⑧ 1.4kg
08-083-03
Radiographic Table Tops
Fixed Type for Back
Section Board Short
②⑥⑦ 1.4kg
08-083-64 Mizuho Original Pad
(252mm) ②⑨ 0.5kg
*1: The number corresponds to those used in 1. Shape.
*2,*3 and *4: The size of mountable side rail is different.
2. Weight
Refer to the table shown above.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Unit: mm
Unit: mm
Unit: mm
Unit: mm

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3. Material
①Board: Thermosetting resin
②Velcro tape: Nylon
③Side rail: Stainless steel
④Frame: Aluminum alloy
⑤Locking levers: Stainless steel
⑥Cassette board: Thermosetting resin
⑦Cassette collar: Stainless steel
⑧Radiographic top leg: Polycarbonate
⑨Pad: Urethane foam
⑩ Side rail (R1) : Stainless steel
⑪ Side rail (R2) : Stainless steel
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory for an operating table. This product is intended to be
attached to the table for supporting a patient’s back. It can be used for
X-ray imaging.
Intended user
This product is to be used by health care professionals, including but
notlimited to surgeons, nurses and biomedical technicians.
Instructions for use
1. Attachment
1-1. Move the back plate of the operating table to horizontal, and
detach the head plate and the back plate.
Note: State whereby the head plate and the back plate are
detached.
1-2. Check that the pins of the operating table back plate are in a
horizontal position, and insert the Back Section Board Short.
Note: State whereby the Back Section Board Short is attached.
1-3. Pull the Back Section Board Short toward you, and check that it
is fully attached to the operating table.
Note: The photo shows the Back Section Board Short.
2．Applicable operating tables
Refer to the brochure "OPERATING TABLE ACCESSORIES" of
Mizuho.
Warning/Caution
1. Warning
Ensure the attaching parts are secured. Loose condition can cause the
product to come off or move, which may result in a patient injury.
2. Important caution
2-1. Be sure to check that Back Section Board Short is fully inserted into
the pins of the operating table.
2-2. 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.
2-3. 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 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 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