Mizuho 08-068-31 User manual

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MES-CK08-068-30EN-0
PREPARED:(2022-10-18) (Version 3)
Instruction for Use
Trade Name: Back Section Board Attachment for Pediatric
Warning
1. 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.
2. Avoid sudden impacts or excessive vibrations to the device.
Otherwise, the device may unintendedly rebound and vibrate that
may harm the patient.
Contraindication/Prohibition
1. Do not exceed the allowable load specified in Specifications, 3
Allowable load. Otherwise, the product could break.
2. This product is only validated for use with Mizuho operating tables.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape Unit: mm
*Pad thickness: 08-068-32/08-083-63 70mm
Code No. Product Description
08-068-31 Back Section
s
Board Attachment for Pediatric *1
08-068-31-R1 Back Sections Board Attachment for Pediatric (R1)
*2
08-068-31-R2 Back Sections Board Attachment for Pediatric (R2)
*3
08-068-32 Pad for Back Sections Board Attachment for Pediatric
08-068-33 Radiolucent Top for
B
ack Sections Board Attachment
for Pediatric
08-083-06 Radiographic Table Tops Fixed Type for Back Section
Board Attachment for Pediatric
08-083-45 Phenolic Board for Radiographic Table Tops Fixed
Type for Back Section Board Attachment for Pediatric
08-083-63 Mizuho Original Pad for Bac
k
Section Board
Attachment for Pediatric
*1,*2 and *3: The size of mountable side rail is different.
2. Weight
Main unit: 20 kg (Phenolic Board: 5.0kg)/Radiolucent Top: 5.0 kg/
Pad: 1.8kg
3. Allowable load
50 kg
4. Material
① Board: Thermosetting resin
② Side rail: Stainless steel
③ Lever: Carbon steel
④ Frame: Aluminum alloy
⑤ Radiolucent Top: Thermosetting resin
⑥Pad: Urethane foam
⑦ Pad: Soft urethane foam
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory for an operating table. It is used for supporting a
pediatric patient.
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
Pad is attached to the Back Section Board Attachment for Pediatric.
1. Attachment
1-1. Remove the head plate and the back plate of the operating table.
1-2. Check that the pins of the back plate are in a horizontal position,
and insert the Back Section Board Attachment for Pediatric.
1-3. Pull the Back Section Board Attachment for Pediatric toward you to
check whether it is fully inserted.
1-4. Attach the Radiolucent tops as needed.
1-5. Attach the dedicated pad.
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. When working with an operating table, take care not to allow this
product interfere with other accessories or the table top.
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.)
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.

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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 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