SUGITA AVM MICROCLIP APPLYING FORCEPS Instructions for Use

Please read these instructions carefully before use. Keep this instruction leaflet for future reference when necessary.

MES-CK07-935-20EN-0 PREPARED: (2017-10-05) (Version 3) * (2014-01-28) (Version 2)

Instructions for Use Trade Name: Clip Applier (SUGITA AVM MICROCLIP APPLYING FORCEPS) Shape / Structure

Warning 1. Use with Sugita AVM Clips only. Use with any other style clip may damage the aneurysm clip. 2. When removing the proximal section of the spring handle for cleaning, handle it carefully so that its shape is not altered. If its shape is altered from the original, the clip applier may no longer

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release clips properly due to a decreased opening of jaws.

(mm)

3. When the device is used on a patient where there is a suspicion Code No.

Product Description

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1)

07-935-10

Sugita AVM Micro Clip Applier

212

2)

07-935-20

Sugita AVM Micro Clip Applier

193

of Creutzfeldt-Jakob disease (CJD), make sure to follow to the most recent and updated restrictions available in each country and/or region for its reuse. [Be cautious of the possibility of

MATERIAL:

secondary infection.] 4. Make sure to read and understand the instructions before use, and pay particular attention to the patient’s safety in order to prevent a

1) 2)

Jaws: Co-Cr alloy, Stainless steel

Other parts: Stainless steel

Intended Purpose / Potency or Effect

severe and adverse incident.

This device is exclusively designed to place Sugita AVM Microclips in surgeries.

Contraindication / Prohibition

Directions for Use

1. Do not modify or reshape the spring handle.

Make sure to wash and sterilize before each use. Refer to Maintenance /

Appropriate width of the opening for holding clip may be affected

Inspection.

by breaking and/or transforming the spring handle. This may come

1. Directions for use:

to interfere with the performance of the applier, and eventually the

jaws

clips may not easily release from the forceps.

ratchet

2. Do not use the device for anything other than its intended purpose. Use of the device outside its intended purpose may cause damage. 3. Do not use with devices by other manufacturers. Do not use with devices other than specified by Mizuho. The design and the development of unauthorized devices may differ from those of the manufacturer and it is likely they will not be suited for

handle

the procedure.

return spring

Fig-1

4. Do not use with chemical substances. Avoid exposing the device to chemicals to avoid corrosion damage.

(1) By squeezing the Applier handles, the ratchet may be locked.

5. Prohibition of secondary processing of this product

Further squeezing of the handles will release the locked ratchet.

Do not apply any secondary processing to this product, for

(Fig-1)

example, do not apply impacts or vibration markings to the surface

(2) Set a clip between the Applier jaws by placing the clip correctly in the

of this product. Doing so could break this product.

holding recesses of the jaws while the ratchet is released, then lock

6. Handle with care.

the ratchet. The clip will be held firmly between the jaws.

Do not handle the device in a rough manner that may deform or

(3) When the handles are further squeezed with the clip in the jaws, the

scratch the device. It may significantly alter the life of the device.

ratchet will be released to open the clip blade to the maximum width. At this point, gradual loosening of the handles will open the jaws and

7. Do not sterilize with the ratchets in the locked position.

release the clip while closing the clip blades.

It may damage the return spring and the device. 8. Do not use scouring powder or steel wool.

2. Caution:

Do not scrub the surface with coarse powder or steel wool when cleaning. It may result in damage to the device surface, which may

GOOD

NO GOOD

NO GOOD

NO GOOD

result in rust and corrosion. 9. Do not use alkaline / acid and/or household detergents. Ensure the use of “medical” detergent only. Do not use household

Fig-2

detergent/cleaners. The detergent should be neutral, pH 6~8. Do

(1) To set a clip in the Applier jaws, make sure that the clip is correctly

not use alkaline or acid detergent, or it may cause discoloration

placed in the recesses of the jaws.

and/or corrosion.

(2) Failure to hold the spring of the clip correctly in the recesses of the jaws may cause the clip to slip off or release. Or, the spring section of the clip may be damaged with a risk of fracture. (3) Wash the Applier and remove adhered debris after each use. Make sure NOT to leave any deposits in the Applier’s joint.

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