Mizuho 5348 User manual

MES-CK08-068-21EN Prepared: 2020-05-14 (Ver.2)
Shoulder Positioner
Operator’s Manual
Table of Contents
1.Introduction .......................................... 2
2.Component .......................................... 3
3.Instructions for use .............................. 4
4.Maintenance / Inspection .................... 5
5.Specifications ...................................... 6
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.

2
1. Introduction
1-1. Intended purpose
This product is used with Ultra shoulder positioner® patient care kit with rehab sling for supporting
the patient's head and back when shoulder operations are being performed. Swap the head plate
and the back plate of the applicable Mizuho operating tables with this product to use it.
1-2. Intended user
This product is to be used by health care professionals, including but not limited to surgeons,
nurses and biomedical technicians.
1-3. Warning/Caution
To ensure safe operation and proper functionality, please read the following instructions
thoroughly before use and follow them carefully. Failure to follow these instructions could lead to
serious injury of the patient or the user or damage to this product.
If these indications are ignored and the product is incorrectly used, death and/or
serious injury may result.
• Do not use this product for any purposes other than the intended use. This
product is designed for shoulder operations and cannot be used for other
purposes.
• When using this product, 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.
• Ensure all fixing handles are tight. Loose condition can cause the product to
come off or move, which may result in a patient injury.
If these indications are ignored and the product is incorrectly used, injury and/or
damage to property may result.
• Do not use this product with other company’s operating table. This product is only
validated for use with Mizuho operating tables. Do not use this product beyond
the allowable load. Doing so may damage this product. (See the section
“Specifications” for the allowable load.) Before attaching this product to the
operating table, check that the tabletop is in the midpoint by using the sliding
function.
• Do not use the sliding function after this product is attached to the operating
table.
• Check that this product has been completely inserted to the operating table body.
• 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. Otherwise the product could break.
• For hygiene, be sure to use sterilized drapes on the areas on this product where
the patient comes into contact with it.
1-4. Symbol mark for labeling
MD : Medical Device

3
2. Component
Option: Ultra shoulder positioner® patient care kit with
rehab sling (3/case)
Component Material
(13) Forehead strap Plastic
(14) Head pad Urethane foam
(15) Jaw strap Plastic
(16) Back pad Urethane foam
(17) Arm fixing strap Plastic
Note: Ultra shoulder positioner® patient care kit with rehab sling
(3/case) is the product of Mizuho OSI.
Main body: Shoulder Positioner
Component Material
(1) Head rest Thermosetting resin
laminated board
(2) Flexion positioning
lever Plastic
(3) Head rest sliding
adjustment knob Plastic
(4) Right shoulder panel Thermosetting resin
laminated board
(5) Left shoulder panel Thermosetting resin
laminated board
(6) Upper rotation lock Plastic
(7) Plunger Plastic
(8) Lower rotation lock Plastic
(9) Back panel Thermosetting resin
laminated board
(10) Mounting handle Aluminum alloy
(11) Adapter Aluminum alloy
(12) Drape support rod Stainless steel
(1)
(2)
(3)
(4)
(6)
(7)
(8)
(9)
(5)
(12)
(11)
(10)
(13)
(16)
(14)
(15)
(17)

4
3. Instructions for use
The following describes how to attach, detach and operate this product.
1. Check that the tabletop is in the horizontal position by using the operating table's automatic
re-leveling function.
2. Check that the tabletop is in the center position by using the sliding function of the operating
table.
3. Remove the head plate and the back plate from the operating table.
4. Attach the Adapter part of the Shoulder Positioner to the back plate attaching pin on the
operating table.
5. Attach the disposable patient care kit to the Shoulder Positioner.
6. Transfer and set the patient to the Shoulder Positioner.
7. Operate the back plate up function of the operating table to adjust the angle of the Back panel.
8. Use the Flexion positioning lever and Headrest sliding adjustment knob of the Head rest to
adjust the head position.
9. After use, put the position and angle of the Head rest back to in place, detach the Adapter
part of the Shoulder Positioner from the back plate attaching pin on the operating table, and
then attach the head plate and the back plate to the operating table.
Note: Ultra shoulder positioner® patient care kit with rehab sling is disposable. Do not reuse this
product.
Adapter
Back plate attaching pin
Head rest

5
4. Maintenance/Inspection
4-1. Inspection before and after Use
• Check that this product is not damaged or broken before and after each use.
4-2. Cleaning and Disinfection
• After using this product, make sure to follow the steps below to clean up and disinfect this
product.
a) Detach this product from the operating table.
b) Detach all the Ultra shoulder positioner® patient care kit with rehab sling (3/case) from this
product.
c) Use a lint-free cloth soaked with proper volume of disinfectant to wipe off the upper, side,
and back side of the surface of the product.
d) Wipe this product dry with a clean cloth within 15 minutes after disinfecting.
• Make sure to use Mizuho authorized disinfectants listed below.
Disinfectants
a) Sodium hypochlorite 0.1% (halogen containing compound)
b) Hypo Alcohol (iodine decolorant color removing agent)
c) Chlorhexidine (chlorhexidine gluconate 0.5%)
d) Benzalkonium chloride (invert soap 10%)
e) Povidone iodine
f) Ethanol 80%
g) Oxydol (hydrogen peroxide)
h) Saline
i) Isopropyl alcohol (IPA)
4-3. Repair and Maintenance
• When this product is broken, clearly label the device as “Broken”, “Do not use”, “Need repair”,
etc., and contact your local dealer or Mizuho.
• Only Mizuho or its certified agents can provide repair and maintenance services of this product.
Services by other agents could cause adverse events and/or deterioration of the performance
and functions.
4-4. 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.
4-5. Disposal
This device must be disposed of in accordance with local regulations. Please contact your local
distributor for proper disposal.
4-6. 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.

6
5. Specifications
Code No. Product description Weight
(kg) Component
08-068-22 Shoulder Positioner without Pad 9 (1) to (12)
5348 Ultra shoulder positioner® patient care kit
with rehab sling (3/case) - (13) to (17)
Note: Ultra shoulder positioner® patient care kit with rehab sling (3/case) is the product of Mizuho OSI.
Head rest
Specifications
Slide range Max. 200 mm
Lift range Max. 115 mm
Side adjustment
angle Max. 30°on each right and left
Allowable load 120kg: Amount of weights of the patient and devices used together.
Operating
environment
Temperature 10 to 40 °C
Relative humidity 30 to 75 %
Atmospheric pressure 700 to 1060 hPa
Transportation
and storage
environment
Temperature -10 to 50 °C
Relative humidity 10 to 85 %
Atmospheric pressure 700 to 1060 hPa
Service life 7 years (Subject to the specified maintenance and inspection and is
stored properly.)
Unit: mm
Shoulder positioner Ultra shoulder positioner® patient care kit with rehab sling (3/case)

7