BRASSELER USA EZX User manual

Notice: Any serious incident that has occurred in relaon to the device should be reported
to the manufacturer and the competent authority of the Member State in which the user
and/or paent is established.
A. Product Descrip�on
Brasseler EZX is an aachment of Surgical Handpiece that delivers the rotaonal force of
Surgical Handpiece. Being aached at the head of handpiece, it is connected and used
with previously reported saw.
B. Indica�on for use
EZX is intended to remove hemispherical, non-cemented acetabular cups.
C. Claims for performance
Cu bone and e, being connected with AC-powered, baery-powered, or air-
powered devices.
D. Direc�ons for use
a. Before use
1. Read Ins for Use of the product to understand the method of use and
precauons.
2. Idenfy the status of Sterilizaon.
3.Remove any screws and clear away any soue to ensure no interference with the blade.
b. Size the Liner and the Blade
I N STRUCTION S
1. Liner sizing tool and blade sizing tool
1) Remove the existed acetabular liner.
2) Measure the inner diameter of the cup by using the Liner sizing tool included in the tray.
3) Select the 1st Liner of the same size as the inner diameter of the cup.
4) Place the 1st Liner in the cup.
5) Measure the outer diameter of the cup by using the Blade sizing tool included in the tray.
6) Select the Blade which is 2~3mm larger than the outer diameter of the cup.
2. Sizing tool(XST2000M)
1) Remove the existed acetabular liner.

3) Press the jaw to the outer part of acetabular cup and adjust
another jaw to contact with the opposite part.



e. Storage aer use and maintenance
1. Storage aer use
Perform external washing and cleaning aer use, and store the product in a place not
exposed to corrosive gas. Keep clean and be careful aboutmoisture and dust.
2. Maintenance method
Appropriate regular maintenance on the product and its components is required to
maintain opmal performance.
Manual cleaning method
1) Rinse soiled device under running cold tap water for at least (2) minutes. Remove gross
soil using a sponge, solint-free cloth or so-bristled brush. For cannula of the
handpiece and aachments, the cleaning brush should be used.
2) Manipulate all moving parts under running tap water to loosen and remove gross debris.
3) Spray and wipe the device using a neutral pH enzyma  for a minimum of
(2) minutes. Follow the enzyma detergent manufacturer’s dir for correct
temperature, water quality (i.e. pH, hardness) and concentraon/don.
4) Clean the device manually under running warm water using an enzymac cleaner or
detergent for a minimum of (5) minutes. Manipulate all moving parts under running
water. Use a so-bristled brush and/or solint-free cloth to remove all visible soil and
debris. Follow the enzyma cleaner or detergent manufacturer’s ins for use
for correct temperature, water quality and concentraon/diluon.
5) Rinse the device thoroughly using cool to luewarm running water for a minimum of (2)
3. Select the 1st Liner of the same size as the inner diameter of the cup.
4. Place the 1st Liner in the cup.
5. Measure the outer diameter of the cup by using the Blade sizing tool included in the tray.
6. Select the Blade which is 2~3mm larger than the outer diameter of the cup.
c. Removal of cup with T-handle



4. Rotate and advance the Blade by turning the Rachet T-handle and pushing the side handle at

the cup about 1~2mm depth.
d. Removal of cup with Power handpiece
1. Remove the 1st Liner and place the 2nd Liner of the same size
5) Measure the outer diameter of acetabular cup by reading
O.D scale of indicator.
6) Press the jaw to the inner part of acetabular cup and adjust
vanother jaw to contact with the opposite part.


8) Measure the inner diameter of acetabular
cup by reading I.D scale of indicator.




※

then there might be a chance of the cause of Blade breakage.

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n before inse 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 and
procedure of the hospital.
8. Do not re-sterilize and reuse disposable blade. Re-steriliza standard for disposable
products has notbeenestablished, and reusing such products can reduce performance,
safety and sterility of the product.
c. Precaus
1. This productmust 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 ofpurchase 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whether all components are accurately and safety aached and perform fn
test before use.
minutes. Use a syringe or pipee to ush lumens and channels. Actuate joints, handles
and othermovable 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ed water for a minimum of (2) minutes.
8) Dry device using a clean, solint-free cloth orclean compressed air.
3. Sterilizaon
Warning and precaun
1) Using a disinfectant to wipe the exterior does not help sterilizarecommended.
2) Always separate components from the productbefore 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method
Steam steriliza is a safe and eecve method, and there are no res in sterilizing
the product.
<Method of steam sterilizaon>
1) Sterilize according to the recommended method described in the table below.
E. Precau�ons for Use
a. Restrics
There are no 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.

BM--REV 
Brasseler U.S.A.Medical, LLC
One Brasseler Boulevard, Savannah, Georgia  U.S.
IMEDICOM Co., Ltd.
#612, 172 LS-ro, Gunpo-si, Geonggi-do, Rep.,of orea 7
Tel +-31--1156
EMERGO EUROPE
Prinsessegracht 20 2514 APThe Hague The Netherlands
K. Symbols
Consult instructions for use
Catalognumber
Caution
Manufacturer
Distributor
Serial Number
Unique Device Identifier
Keep away from sunlightAuthorized representative
Medical device
Non-sterile
CE Mark
Federal law restricts this
device to saleby or on the
order of a physician
Keep dry
7. Wash and sterilize all equipment and components as described in Instrucon for use.
8. Do not disassemble the product or apply lubricant since the product is provided with
complete sealing. The product can be excluded from free warranty service.
9. Checwhether blade is bent, blunt or otherwise damaged before use. When it is
damaged,dispose it instead of trying to straighten or sharpen it.
10. Completely wash and inspect the components as described in User Manual aer use.
11. Since the product can be damaged, components must be aached as designated.
12. Do not letblade to contact othersurgical instruments. Blade and instruments can be damaged.
F. Contraindica�on
It is not indicated for long-term use or implantaon.
G. Complica�ons
Complica related to Brasseler EZX are very rare, but when they occur, they can be
serious. Most complicaons are related to surgery techniques and possible complicaons
would be, not limited to;
- Paent burn or thermal necrosis
- Paralysis by wrong operaon
- Frostbite, hematoma in target site etc. by infecon
- Injury by wrong operaon orcraced chip ofblade
H. Storage condi�ons and method
a. Perform washing and cleaning of the exterior aer use.
b. When a problem occurs in the product, appropriately indicate the problem and contact
anearby oce or service center.
c. Regular  must be conducted as prescribed to preserve the product in its
opmal status.
d. Do not arbitrarily adjust or alter the product.
e. Please return devices and aachments no longer in use to your local representave of
IMEDICOM for disposal.
I. Expira�on
Semi-permanent
J. Cau�on
Use and selling of this product are limited to medical specialists.