Mizuho MES-CK08-075-20EN-0 User manual

1/3
MES-CK08-075-20EN-0
PREPARED: (2023-07-26) (Version 6) Instruction for Use
Trade Name: Head Extension
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
This product is only validated for use with Mizuho operatin
g
tables.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description Compon
ent
s
Wei
g
ht
08-075-23 Radiographic Top for Head
Extension *1 ⑦⑧⑨
1.3 ㎏
08-075-23-UE Radiographic Top for Head
Extension (UE) *2 ⑦⑧⑨
1.3 ㎏
08-075-28 Head Extension for 5701 *3 ①②③④
⑤⑨
7.0 ㎏
08-075-28-R1 Head Extension (R1) *4 ①②③④
⑤⑨
7.0 ㎏
08-075-28-R2 Head Extension (R2) *5 ①②③④
⑤⑨
7.0 ㎏
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
08-075-23/23-UE/18-042-00/01 (mm)
08-075-90/-R1/-R2 (mm)
(mm)
⑩
08-075-28/-R1/-R2
08-083-02/22/42/18-042-00/01

2/3
08-075-90 Head Extension II *6 ①③④⑤⑨ 4.2 ㎏
08-075-90-R1 Head Extension II (R1) *7 ①③④⑤⑨ 4.2 ㎏
08-075-90-R2 Head Extension II (R2) *8 ①③④⑤⑨ 4.2 ㎏
18-042-00 Mizuho Original Pad for Head
Section Type A *9 ⑥
0.6 ㎏
18-042-01 SUSANO Pad for Head Section
Type A *9 ⑥
0.5 ㎏
08-083-02 R ad i o gr ap h i c Ta b l e To p s F i xe d Ty p e
for Head Extension (240 mm) ⑦⑧⑨
1.5 ㎏
08-083-22
Digital Radiographic Table Tops
Fixed Type for Head Extension
(240 mm)
⑦⑧⑨ 1.5 ㎏
08-083-42
Phenolic Board for Radiographic
and Digital Radiographic Table
Tops Fixed Type for Head
Extension (240 mm)
⑩
1.3 ㎏
*1: Height: 37 mm
*2: Height: 46 mm
*3, *4 and *5: The size of mountable side rail is different.
*6, *7 and *8: The size of mountable side rail is different.
*9: Accessory (non-medical device)
2. Material
① Headrest board: Thermosetting resin
② Fixing handle: Carbon steel, nylon
③ Head section fixing handle: Carbon steel, nylon
④ Side rail: Stainless steel
⑤ Insertion shaft: Stainless steel
⑥ Pad: Polyurethane
⑦ Radiographic top: Thermosetting resin
⑧ Support pole: Stainless steel, polycarbonate
⑨ Velcro tape: Nylon
⑩ Table board: Thermosetting resin
Note: The number corresponds to those used in 1. Shape.
Intended purpose
This is an accessory for the operating table. This product is to be
attached to the back section of an operating table to extend the tabletop
length.
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
1. Attachment of the Head Extension (before use)
1-1. Loosen the fixing handles ① of the operating table back section
and detach the head section.
1-2. Insert the insertion shafts ③ of the Head Extension into the
reception holes ② on the operating table back section.
1-3. Make sure that the Head Extension is fully inserted into the
operating table back section.
1-4. Tighten the fixing handles ①of the operating table back section
to fix the Head Extension.
2. Attachment of the head section (before use)
If necessary, attach the head section detached from the operating
table to the Head Extension.
2-1. Loosen the fixing handles ④of the Head Extension.
2-2. Insert the insertion shafts ⑥of the head section into the
reception holes ⑤of the Head Extension.
2-3. Make sure that the head section is fully inserted into the Head
Extension.
2-4. Tighten the fixing handles ④of the Head Extension to fix the
head section.
3. Detachment of the head section (after use)
If the head section is attached to the Head Extension, detach the head
section first.
3-1. Loosen the fixing handles ④of the Head Extension.
3-2. Pull the head plate toward you to detach it from the Head
Extension.
4. Detachment of the Head Extension (after use)
4-1. Loosen the fixing handles ① of the operating table back section.
4-2. Pull the Head Extension toward you to detach it from the operating
table back section.
5. 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. Make sure that this product or other accessories are fully inserted.
Incomplete insertion may cause the products to come off or move,
which may result in a patient injury.
2-2. When performing the head down or the back plate bending down
operation with the Head Extension and the head plate attached, be
aware that they might come into contact with the floor.
2-3. 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.
2-4. 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 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.

3/3
<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