Mizuho Lateral Cassette Holder User manual

1/2
MES-CK08-089-00EN-0
PREPARED: (2022-01-12) (Version 5) Instruction for Use
Trade Name: Lateral Cassette Holder
Contraindication/Prohibition
This product is only validated for use with Mizuho operating tables.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
The Rail clamp shown above is Clamp for Flat Bar Ver.2
Code No. Product Description Compo
nents
Weights
(kg)
08-089-03 Lateral Cassette Holder with
Clamp ①④⑤⑩

*1 1.4
08-089-03-NC Lateral Cassette Holder ①⑩
*2 1.2
08-089-05 Lateral Cassette Holder with
Clamp Ver.2 ①②③⑩

*3 1.6
08-111-00 Clamp for Flat Bar ④⑤
*4 0.2
08-111-11 Clamp for Flat Bar Ver.2 ②③
*5 0.4
08-117-02 Clamp for Flat Bar (R1) ⑤⑦
*6 0.2
08-117-10 Clamp for Flat Bar Ver.2 (R1)
③⑥
*7 0.4
08-117-12 Clamp for Flat Bar (R2) ⑤⑨
*8 0.2
08-117-13 Clamp for Flat Bar Ver.2 (R2)
③⑧
*9 0.4
Note: The number corresponds to those used in 1. Shape.
*1: *1 comes with *4.
*2: Please select *6, *7, *8 or *9 to use *2.
*3: *3 comes with *5.
*4 to *9: The size of mountable side rail is different.
2. Material
①Lateral cassette holder: Stainless steel rod
②⑥⑧ Clamp for Flat Bar Ver.2: Stainless steel
③Fixing handle: Aluminum alloy, Stainless steel rod
④⑦⑨ Clamp for Flat Bar: Stainless steel
⑤Fixing handle: Plastic molding, Stainless steel rod
⑩Fixing knob: Plastic molding, Stainless steel rod
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory to an operating table.
It is used for mounting an X-ray cassette to have an X-ray for a lateral
part of a patient.
Intended user
Thisproduct is to be used by healthcare professionals, including but not
limited to surgeons, nurses and biomedical technicians.
Instructions for use









The Rail clamp shown above is Clamp for Flat Bar Ver.2
1. Attach the Rail clamp to the Side rail of an operating table.
2. Insert theLateralcassetteholderintotheRailclampandtighten the
Fixing handle to temporarily secure the Lateral cassette holder to
the Side rail.
3. Attach the Cassette to the Lateral cassette holder and tighten the
Fixing knob to fix the Cassette storage frame.
4. Move and adjust this product to a position appropriate for the
patient’s posture.
5. After the adjustment, tighten the Fixing handle to secure the Rail
clamp and the Lateral cassette holder.
Note: The following size of cassettes can be set with the sliding
function of the Cassette storage frame.
254 mm x 305 mm
203 mm x 254 mm
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 interferewith the table top or with other
tools and appliances used in combination with this product.
Otherwise the product could break.
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.
Cassette frame
Note: Cassette is NOT included
Side rail
Fixing handle
Cassette frame
Clamp for Flat Bar
Cassette
storage
frame
(sliding
function)
Lateral cassette
holder
Fixing knob

Cassette
Cassette storage
frame
Rail clamp


2/2
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 stainswith water,
and clean the device with gauze or other material moistened with
alcohol to disinfect.
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 causedby 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