BRASSELER USA EZX Instructions Download Page 4

4. Do not contact the a

achment and its moving part during use. They can injure the user.

5.    

Do not a

ach, insert or remove components during opera

on of the handpiece. Place 

the mode lever on Safe po

si�o

n before inse

r�ng

 or removing the product.

6.    

Do not contact the cut surface when blade is a

ached to the handpiece. Sharp surface 

can cause injury.

7.    

A

er use, properly dispose the blade used together according to the regula

�on

 and 

procedure of the hospital.

8.    

Do not re-sterilize and reuse disposable blade. Re-steriliza

�on

 standard for disposable 

products has not been established, and reusing such products can reduce performance, 

safety and sterility of the product.

c. Precau

�on

s

1. This product must be used according to the intended purpose.

2.    

Be careful in handling the device. When the device is dropped on the 

oor or damaged, 

immediately return it to the place of purchase for service.

3.    

The product must be used with equipment and accessories tested and approved 

according to the medical device standards of the manufacturer. The product may not 

func

on properly with other products or violate the medical device standards.

4.    

When the product, its components and other products used together are not used, stored 

and managed as described in Instruc

on for use, or repaired and altered by a person not 

authorized by the manufacturer, they are excluded from free warranty service.

5. Do not arbitrarily alter the product since none of its parts can be repaired by the user.

6.    

Chec

k

 whether all components are accurately and safety a

ached and perform f

unc�o

test before use.

minutes. Use a syringe or pipe

e to 

ush lumens and channels. Actuate joints, handles 

and other movable device features in order to rinse thoroughly under running water.

6) 

   

If visible contamina

on has been remained, repeat steps 1–5. If visible contamina

on 

has been removed, 

nal rinse for (2) minutes. 

7) Final rinse with de-ionized or pu

rifi

ed water for a minimum of (2) minutes.

8) Dry device using a clean, so

 lint-free cloth or clean compressed air. 

3. Steriliza

on

Warning and precau

�o

n

1)   Using a disinfectant to wipe the exterior does not help steriliza

�on and is not 

recommended.

2) Always separate components from the product before steriliza

on.

3)   Recommended minimum drying 

me must be permi

ed whenever a

achment are 

sterilized. Failure to do so may reduce performance of the product and induce early failure.

Steriliza

�on 

method

Steam steriliza

�on

 is a safe and e

ec

ve method, and there are no res

tric�ons

 in sterilizing 

the product.

<Method of steam steriliza

on>

1) Sterilize according to the recommended method described in the table below.

E. Prec

au�ons

 for Use

a. Restric

�on

s

There are no 

kn

own restric

ons.

b. Warning

1. Protec

ve glasses are recommended when using the product.

2.   The medical sta

 is responsible to have thorough understanding on the method of 

using the product and accessories connected to it prior to using the product.

3.   Since the a

achment is provided as unsterilized, it must be cleaned and sterilized 

before use.

Summary of Contents for EZX

Page 1: ......

Page 2: ...c on for Use of the product to understand the method of use and precau ons 2 Iden fy the status of Steriliza on 3 Removeanyscrewsandclearawayanyso ssuetoensurenointerferencewiththeblade b Size the Liner and the Blade I N S T R U C T I O N S 1 Linersizingtoolandbladesizingtool 1 Removetheexistedacetabularliner 2 MeasuretheinnerdiameterofthecupbyusingtheLinersizingtoolincludedinthetray 3 Selectthe1s...

Page 3: ...ice thoroughly using cool to lukewarm running water for a minimum of 2 3 Selectthe1st Linerofthesamesizeastheinnerdiameterofthecup 4 Placethe1st Linerinthecup 5 MeasuretheouterdiameterofthecupbyusingtheBladesizingtoolincludedinthetray 6 SelecttheBladewhichis2 3mmlarger thantheouterdiameterofthecup c RemovalofcupwithT handle 1 AssembletheSha andtheBladebyinser ngtheconnectorsoftheBladeintotheslot 2...

Page 4: ...Do not arbitrarily alter the product since none of its parts can be repaired by the user 6 Check whether all components are accurately and safety a ached and perform func on test before use minutes Use a syringe or pipe e to flush lumens and channels Actuate joints handles and other movable device features in order to rinse thoroughly under running water 6 If visible contamina on has been remained ...

Page 5: ...scribed in User Manual a er use 11 Since the product can be damaged components must be a ached as designated 12 Donotletbladetocontactothersurgicalinstruments Bladeandinstrumentscanbedamaged F Contraindica on It is not indicated for long term use or implanta on G Complica ons Complica ons related to Brasseler EZX are very rare but when they occur they can be serious Most complica ons are related t...

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