background image

Steriliza

�on 

method

Steam sterili

z

a�on is a safe and effec�ve method, and there are 

no

 restric�ons in sterilizin

g

 

the product

.

<

Method of steam sterili

z

a�

on>

1)

 Sterili

z

e acc

o

rdi

ng

 to the recommended method described in the table bel

o

w

.

E. P

rec

au�ons

 

f

or Use

a. Restric

�on

s

There are no kn

o

wn restric�

o

ns

.

b. Warning

1.

 Pr

o

tec�ve glasses are recomme

n

ded when using the product

.

2. The medical staff is responsible t

o

 have th

o

rough u

n

dersta

n

ding 

on

 the method 

o

usi

ng

 the pr

o

duct and access

o

ries c

on

nected to it pri

o

r to using the product

.

3. Since the a�achme

n

t is pr

o

vided as unsterili

z

ed, it must be cleaned and sterili

z

ed 

bef

o

re use

.

4.

 Do not c

on

tact the a�achme

n

t and its m

o

ving part duri

ng

 use

.

 The

y

 can i

n

jure the user

.

5. D

o

 

no

t a�ach, insert 

o

r rem

o

ve compone

n

ts duri

ng

 

o

pera�

on

 

o

f the handpiece

.

 Place

the mode lever o

n

 Safe posi�on bef

o

re i

n

ser�ng or rem

o

ving the product

.

6. D

o

 

no

t c

on

tact the cut surface when blade is a�ached t

o

 the handpiece

.

 Sharp surface

can cause i

n

jur

y.

7. 

A

�er use, properl

y

 dispose the blade used t

og

ether acc

o

rding t

o

 the regula�on and 

procedure of the h

o

spital

.

  

Manual cleaning method

   

1) Rinse s

o

iled device u

n

der ru

nn

ing c

o

ld tap water f

o

r at least (2) minutes. Rem

o

ve 

g

r

o

ss 

soil usin

g

 a spon

g

e, so� li

n

t-free cloth 

o

r so�-bristled brush. 

F

or cannula�ons 

o

f the 

handpiece and a�achme

n

ts, the clea

n

i

ng

 brush should be used

.

3.

 Sterili

z

a�

on

Warning and precau

�o

n

1)

   Using a disi

n

fecta

n

t to wipe the exterior does not help sterili

z

a�on and is not recommended

.

2)

 Alwa

y

s separate compone

n

ts from the product bef

o

re sterili

z

a�

on.

3)

   Recommended minimum dr

y

in

g

 �me must be permi�ed whenever a�achme

n

t are 

sterili

z

ed

.

 

F

ailure to do so ma

y

 reduce perf

o

rmance of the pr

o

duct and induce early failure

.

2)

 Manipulate all m

o

vi

ng

 parts under ru

nn

i

ng

 tap water to l

oo

sen and rem

o

ve 

g

r

o

ss debris

.

3)

    

Spra

y

 and wipe the device using a neutral pH en

zy

ma�c solu�on for a minimum 

o

(2) minutes. 

F

oll

o

w the en

z

yma�c deter

g

e

n

t manufacturer

s direc�ons for correct 

temperature

,

 water 

q

uality (i.e

.

 p

H,

 hardness) and conce

n

tra�

on

/dilu�

on.

4)

    

C

lean the device manually under running warm water using an e

nzy

ma�c cleaner 

o

deter

g

e

n

t for a minimum of (5) minutes. Manipulate all m

o

ving parts under runnin

g

 

water

.

 Use a s

o

�-bristled brush and/

o

r s

o

� li

n

t-free cl

o

th t

o

 rem

o

ve all visible s

o

il a

n

debris. 

F

oll

o

w the en

zy

ma�c cleaner or deter

g

e

n

t manufacturer

s instruc�ons for use 

f

o

r c

o

rrect temperature

,

 water quality a

n

d conce

n

tra�on/dilu�

on.

5)

    

Rinse the device thorou

g

hly usi

ng

 c

oo

l t

o

 lukewarm ru

n

ni

ng

 water f

o

r a mi

n

imum 

o

f (2) 

minutes. Use a syrin

g

o

r pipe�e t

o

 flush lumens and channels. Actuate j

o

i

n

ts, ha

n

dles 

8)

 Dr

y

 device using a clea

n,

 s

o

� li

n

t-free cl

o

th or clean compressed air

.

 

a

n

d other m

o

vable device features in order to ri

n

se thorou

g

hly u

n

der ru

nn

ing water

.

6)

 

   

I

f visible c

on

tami

n

a�

on

 has been remained

,

 repeat steps 

1–5.

 

I

f visible c

on

tami

n

a�

on

 

has been rem

o

ved

,

 fi

n

al rinse f

o

r (2) minutes. 

7)

 Final ri

n

se with de-i

on

i

z

ed or purified water f

o

r a minimum of (2) minutes

.

Summary of Contents for EZX

Page 1: ......

Page 2: ...r use a Before use 1 Read Instruc 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 4 Operate the device and inspect each component to iden fy any defects If any damage or corrosion is found the device should not be used b Size the Liner and the Blade 1 Linersizingt...

Page 3: ...a head c RemovalofcupwithT handle 1 AssembletheSha andtheBladebyinser ngtheconnectorsoftheBladeintotheslot 2 PullbackthelockingsleeveoftheRachetT handleandconnectwiththeSha 3 Placethe poftheSha firmlytothecenteroftheLiner 4 RotateandadvancetheBladebyturningtheRachetT handleandpushingthesidehandleat the same me Keep doing it un l the Blade will create a guided pathway around the rim of thecupabout1 ...

Page 4: ...za on Warning and precau on 1 Usingadisinfectanttowipetheexteriordoesnothelpsteriliza onandisnotrecommended 2 Alwaysseparatecomponentsfromtheproductbeforesteriliza on 3 Recommended minimum drying me must be permi ed whenever a achment are sterilized Failuretodosomayreduceperformanceoftheproductandinduceearlyfailure 2 Manipulateallmovingpartsunderrunningtapwatertoloosenandremovegrossdebris 3 Spray ...

Page 5: ... 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 F Contraindica on It is not indicated for long term use or implanta on G Complica ons Complica ons related to EZX are very rare but when they occur they can be serious Most complica ons are related to surgery techniques and possible com...

Page 6: ...efer to instruction manual booklet Catalog number General Warning Manufacturer Distributor Serial Number Unique Device Identifier Keep away from sunlight Authorized representative Medical device Federal law restricts this device to sale by or on the order of a physician Keep dry c Regular inspec on must be conducted as prescribed to preserve the product in its op mal status d Do not arbitrarily ad...

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