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MES-CK08-086-07EN-0
PREPARED: (2020-07-28) (Version 4)
Instruction for Use
Trade Name: Arm Shield
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 allowable listed in Specifications, 4 Allowable load.
Otherwise the product could break.
Symbol mark for labeling
MD :
Medical Device
Specifications
1.
Shape
Code No.
Product Description
L
(mm)
H
(mm)
08-069-18
Pad for Arm Shield
400
180
08-069-45
Pad for Arm Shield (150mm)
400
150
08-086-07 Arm
Shield
400 160
08-086-27
Arm Shield with Pad (130mm)
400
130
08-086-28
Arm Shield with Pad (160mm)
400
160
08-086-29
Arm Shield with Pad (190mm)
400
190
2.
Weight (excluding pad)
1.0 kg/unit (08-086-07)
0.9 kg/unit (08-086-27)
1.0 kg/unit (08-086-28)
1.1 kg/unit (08-086-29)
3.
Material
Main body: Polycarbonate
Pad: Urethane
4.
Allowable load
Unit: 13kg
Maximum patient weight: 450kg
Intended purpose
This is an accessory to an operating table to prevent the patient’s arms
from falling.
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
The product is inserted underneath the mattress on an operating
table.
Warning / Caution
Important caution
1.
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.
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.
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.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Main Unit
Mattress
Pad
Unit: mm