Mizuho MES-CK08-070-16EN-0 User manual

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MES-CK08-070-16EN-0
PREPARED: (2023-07-21) (Version 6)
Instruction for Use
Trade Name: Pediatric Knee Crutches
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 weight capacity specified in Specifications, 4.
Allowable load. Otherwise the product could break.
Symbol mark for labeling
MD : Medical Device
Specifications
1. Shape
Code No. Product Description a b
08-070-16 Pediatric Knee Crutches with Clamps,
Large *1 150 100
08-070-16-NC Pediatric Knee Crutches, Large (NC) *2 150 100
08-070-17 Pediatric Knee Crutches with Clamps,
Middle *1 120 80
08-070-17-NC Pediatric Knee Crutches, Middle (NC) *2 120 80
08-070-18 Pediatric Knee Crutches with Clamps,
Small *1 85 50
08-070-18-NC Pediatric Knee Crutches, Small (NC) *2 85 50
Code No. Product Description
08-110-01 Clamp for Round Bar *3
08-117-09 Clamp for Round Bar (R1) *4
08-117-11 Clamp for Round Bar (R2) *5
*1: *3 is included.
*2: Select *4 or *5 to use *2.
*3, *4 and *5: The size of mountable side rail is different.
2. Weight
08-070-16 : 2.9 kg
08-070-16-NC : 2.0 kg
08-070-17 : 2.7 kg
08-070-17-NC : 1.8 kg
08-070-18 : 2.5 kg
08-070-18-NC : 1.6 kg
08-110-01, 08-117-09, 08-117-11: 0.9 kg
3. Material
① Thigh receiver: Stainless steel, Polyurethane
② Fixing band: Nylon
③ Support pole: Stainless steel
④ Thigh receiver fixing handle: Stainless steel
⑤ Thigh receiver adjustment handle: Stainless steel
⑥ Rail clamp: Stainless steel
⑦ Fixing handle: Stainless steel
Note: The numbers correspond to those in 1. Shape.
4. Allowable load
Unit: 17 kg
Maximum patient weight: 95 kg
Intended purpose
This is an accessory for the operating table.
This product is mainly for supporting the legs in lithotomy position for
pediatric patients.
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. Attach the Knee Crutches symmetrically.
1-1. Attach the rail clamp①to the side rail of the operating table.
1-2. Insert the support pole③into the rail①, and then tighten the
fixing handle②.
1-3. Adjust the position of the support pole③and the thigh receiver
⑤according to the posture of the patient.
1-4. After the adjustment, turn the fixing handle②to fix the rail
clamp①and the support pole③.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Unit: mm Example of use

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2. Move the patient in a way that the pubic bone comes at the place
where the Knee Crutches is attached, and place the patient on the
Knee Crutches.
2-1. Adjust the position of the thigh receiver⑤by loosening the thigh
receiver adjustment handle④and the thigh receiver fixing
handle⑥.
2-2. After the adjustment, tighten the thigh receiver adjustment
handle④and the thigh receiver fixing handle⑥to fix the thigh
receiver⑤.
2-3. Fix the thigh of the patient with the fixing band⑦.
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 cautions
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. Set this product in symmetrical positions.
2-3. 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 pair per package
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
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