Mizuho 08-115-30 User manual

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MES-CK08-115-23EN-0
PREPARED: (2023-07-20) (Version 6)
Instruction for Use
Trade Name: V Attachment for Traction Device
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. For operating tables with a slide function that is instructed to use at
the center position, use only with that position.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description
08-115-23 V Attachment Pin Type
08-115-23-R1 V Attachment Pin Type (R1)
08-115-23-R2 V Attachment Pin Type (R2)
08-115-24 V Attachment Pin Type for Radiographic Table Top
08-115-24-R1 V Attachment Pin Type for Radiographic Table Top
(R1)
08-115-24-R2 V Attachment Pin Type for Radiographic Table Top
(R2)
Code No. Product Description
08-115-30 V Attachment Side Rail Type *1
08-115-30-R1 V Attachment Side Rail Type (R1) *2
08-115-30-R2 V Attachment Side Rail Type (R2) *3
08-115-31 V Attachment Side Rail Type for Radiographic
Table Top *4
08-115-31-R1 V Attachment Side Rail Type for Radiographic
Table Top (R1) *5
08-115-31-R2 V Attachment Side Rail Type for Radiographic
Table Top (R2) *6
*1, *2 and *3: The size of mountable side rail is different.
*4, *5 and *6: The size of mountable side rail is different.
2. Material
① Fixing handle: Stainless steel
② Arm fixing handle: Stainless steel
③ V Attachment: Stainless steel
Note: The numbers correspond to those used in 1. Shape.
Intended purpose
This is an accessory for the operating table.
This product is designed for attaching the Traction Device.
Intended user
This product is to be used by health care professionals, including but not
limited to surgeons, nurses and biomedical technicians.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
①
① ②
③
Weight: 7.5 kg (7.0 kg)
( ) = 08-115-24/-R1/-R2
Unit: mm
( ) = 08-115-31/-R1/-R2
Unit: mm
Weight: 6.5 kg (6.0 kg)

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Instructions for use
1. V Attachment Pin Type
1-1. Detach the leg section from the operating table.
1-2. Attach this product to the leg section insertion shafts of the
operating table.
1-3. Tighten the fixing handle to fix this product.
2. V Attachment Side Rail Type
2-1. Detach the leg section from the operating table.
2-2. Attach this product to the side rails of the operating table.
2-3. Tighten the fixing handle to fix this product.
3. Applicable operating tables
Refer to the brochure "OPERATING TABLE ACCESSORIES" of Mizuho.
Warning/Caution
1. Warning
Ensure all fixing handles are tight. 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. When attaching this product to the operating table, make sure to
fully insert this product to the leg section insertion shafts or the side
rails of the operating table. Otherwise the product may come off or
move, which may result in a patient injury.
2-3. Do not fix this product to the operating table with the Traction
Device attached. Be sure to fix this product to the operating table by
itself. If this product is not fully fixed, it may fall.
2-4. 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 distributor 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
Westervoortsedijk 60
6827 AT Arnhem, The Netherland
s
Fixing handle
V Attachment
V Attachment
Fixing handle
Side rail of the operating table