User`s Manual Built-In

Good Vibrations
User’s Manual Built-In
PIEZO ULTRASONIC SCALER
Important!
Read this manual carefully before using the product.
How to read this manual
This manual contains instructions for several models of scalers. Each chapter
starts with a section with general instructions for all models, which is followed
by sections with additional information concerning each model. First read the general section and then proceed to the section that applies to your model of scaler.
If there are any questions regarding the contents of this manual, please contact
Amdent AB.
Trademarks
Amdent is a trademark owned by Amdent AB.
Manufacturer
Amdent AB
Box 230
SE-149 23 Nynäshamn, Sweden
Telephone: +46 8 520 131 20
Fax: +46 520 8 185 74
E-mail: [email protected]
Internet: www.amdent.com
2
Copyright
Copyright 2005 Amdent AB. All rights
reserved. The contents of this manual
may be changed without notice. No part
of this manual may be reproduced in
any form or by any means without permission in writing from Amdent AB.
Printed in Sweden, March 2010
Contents
Safety . .......................................................................................................... 4
1
Unpacking ............................................................................................ 6
1.1 General content of delivery ................................................................... 6
2
2.1
2.2
2.3
Equipment description .......................................................................
General description ...............................................................................
Handpiece Ergo UltraLED additional description...................................
Symbols . ...............................................................................................
7
7
7
8
3
Operating instructions ........................................................................ 10
3.1 General . ................................................................................................ 10
4
Cleaning and maintenance ................................................................. 15
4.1 General cleaning procedure .................................................................. 15
4.2 Autoclave temperatures . ....................................................................... 16
4.3 Maintenance .......................................................................................... 16
5
Troubleshooting .................................................................................. 18
6
Technical data . .................................................................................... 19
7
Warranty and Declaration of conformity ........................................... 20
7.1 Warranty ................................................................................................ 20
7.2 Declaration of conformity . ..................................................................... 21
3
Safety
Intended use
This scaler is designed for dental purposes. It is designed for removal of tartar or calculus on teeth and other dental work where the ultrasonic vibration
is beneficial. Do not use it for applications where it is not intended. If you are
unsure about your application, please contact your local dealer or place of
purchase.
General requirements
Installation and service of the product is only to be performed by authorized
service personnel.
The product must be connected to electricity supply and water supply meeting
the requirements specified in the Technical data section on page 19.
Contraindications
Do not use the scaler on patients with cardiac pacemakers. The scaler may
disturb the function of the pacemaker.
General precautions
• The product is not suitable for use in the presence of flammable gases.
• Systemic antibiotics must be used appropriately and with the advice of a
medical doctor.
• Only use the product in combination with Amdent scaler tips.
• If the handpiece tubing is damaged or worn-out, it must immediately be
replaced to avoid exposing the user or the patient to electric hazard.
4
Safety notices in this manual
Warning indicates a potentially dangerous
situation. Non-observance may lead to death
or injury.
WARNING
WARNING
WARNING
Caution
Caution indicates a potentially harmful
situation. Non-observance may damage
the equipment.
Caution
Caution
Note
Note
Note indicates a situation where special notice
should be observed.
Note
5
11 Unpacking
Unpacking
1.1
1.1
General
General content
content of
of delivery
delivery
1.
1. Handpiece
Handpiece incl.
incl. tubing
tubing
Note
Note
2.
2. Electronic
Electronic unit
unit (installed
(installed inside
inside the
the unit)
unit)
3.
3.
ErgoGrips
ErgoGrips (type
(type and
and quantity
quantitydepending on
what
was
ordered)
depending on what was ordered)
4.
4.
Tip
Tip wrenches
wrenches (type
(type and
and quantity
quantity
depending
on
what
was
depending on what wasordered)
ordered)
This
This chapter
chapter describes
describes the
the
components
components of
of the
the delivery
delivery
and
can
be
used
as
a
checkand can be used as a checklist
list when
when unpacking.
unpacking. Contact
Contact
your
your place
place of
of purchase
purchase ifif
anything
is
missing.
anything is missing.
5.
quantityon
depending
5. Tips
Tips (type
(type and
depending
what wason what
was ordered)
ordered)
For
For aa description
description of
of the
the feafeatures
tures of
of the
the equipment,
equipment, read
read
the
Equipment
description
the Equipment description
section
on
page
7.
section on page 7.
3
This
This chapte
chapte
of
of the
the delive
delive
checklist
checklist wh
wh
place
of
place of pur
pur
2
2
4
1
66
55
Note
Note
For
For aa descri
descr
equipment,
equipment,
description
description
2 Equipment description
2.1
General description
The Amdent Built-in is a piezo ultrasonic scaler that is supposed to be
mounted on a dental unit. The ultrasonic power can be regulated to provide
a wide range of settings.
The Built-in is equipped with one of the handpieces; Ergo Basic, Ergo Ultra or
Ergo UltraLED. The tips can easily be changed during the treatment and can
also be cleaned and autoclaved together with the individual ErgoGrips in the
same procedure.
2.2
Handpiece Ergo UltraLED additional description
The light will illuminate when the foot control is depressed, or when the handpiece is lifted from the unit arm (option).
7
Ultrasonic scaler
Class I
Model US30em Type 5603711
No 324009
115VAC/50-60Hz
T 315 mAL 250V
H2O 0.2-1.0 MPa, 30-145
10W, 24-28 kHz
Ultrasonic scaler
Class I
Conforms to
Model US30em Type UL
5603711
2601-1, Sec.ed No 324009
Cert.to CAN/CSA C22.2 T 315 mAL 250V
115VAC/50-60Hz
NO 601.1-M90
H O 0.2-1.0 MPa,Amdent
30-145 AB
10W,9800163
24-28 kHz
2
Nynäshamn Sweden
Conforms to
UL 2601-1, Sec.ed
2.3
Cert.to CAN/CSA C22.2
NO 601.1-M90
Symbols
9800163
Example of type plate. The type plate is placed on the bottom side of the scaler unit.
Example of type plate. The type plate is placed on the bottom side of the scaler unit.
Amdent AB
Nynäshamn Sweden
Attention! Consult accompanying documents!
Attention! Consult accompanying documents!
RECOGNIZED COMPONENT
Medical electrical equipment classified by ETL with respect to electric shock, fire, mechanical, and other speciMedical
electrical
equipment
classified
by ETL
withedition
refied
hazards
in accordance
with
UL 2601-1,
second
Medical
electrical
equipment
classified
by ETL
with
spect
to
electric
shock,
fire,
mechanical,
and
other
speciand
theto
Canadian
Standard mechanical
CAN/CSA-C22.2
No 601.1respect
electric
shock, fire,with
andsecond
other
fied hazards
in accordance
UL 2601-1,
edition
UL60601-1,
first edition
M90
specified
hazards
in
accordance
with
UL60601-1
and601.1and the Canadian Standard CAN/CSA-C22.2 No
the
M90Canadian Standard CAN/CSA-C22.2 No 601.1-M90
Compliance label indicating compliance with the Medical
Device Directive 93/42/EEC
Compliance label indicating compliance with the Medical
Device Directive 93/42/EEC
0413 is the ID-number of the Notified Body: SEMKO
0413 is the ID-number of the Notified Body: SEMKO
Withstands autoclave temperature 135°C (275°F).
Withstands autoclave temperature 135°C (275°F).
Withstands autoclave temperature 121°C (248°F)
Withstands autoclave temperature 121°C (248°F)
Type B equipment according to the degree of protection
against electrical shock
Type B equipment according to the degree of protection
against electrical shock
Fuse
Fuse
Input
Input
8
Output
Output
Withstands autoclave temperature 135°C (275°F).
Withstands autoclave temperature 121°C (248°F)
Withstands autoclave temperature 121°C (248°F)
Type B equipment according to the degree of protection
against electrical shock
of of
protection
Type B equipment
equipmentaccording
accordingtotothe
thedegree
degree
protection
against
electricalshock
shock
Fuse electrical
Fuse
Input
Input
Output
Output
Water flow adjustment
Please do not throw the equipment into the domestic refuse.
Water flow
Please
useadjustment
the return and collection systems available in your
On/off
country for the disposal of this product.
On/off
Ultrasonic power adjustment
Ultrasonic power adjustment
Endodontic mode
Endodontic mode
Scaling mode
Scaling mode
Protective ground
Protective ground
17
17
9
Caution
3 Operating instructions
3.1 General
Mode of operation
With cooling fluid, the scaler can be operated
continuously. Recommended flow: 20 ml/min.
Without cooling fluid, the scaler may only be
operated for shorter periods and the maximum
operating time is 2 minutes followed by a cooling
down period of 8 minutes. Operating without cooling fluid is recommended only for special clinical
treatments, for example, crown removal and thixotropic cementing when cooling of the treated surface is not necessary. When performing root canal
treatments, the canal must be filled with fluid.
Before treatment
1. To rinse the water line, hold the handpiece over the bowl.
Depress the foot switch and allow the water to flow for 30 seconds.
2. Gently slide the ErgoGrip on
to the handpiece.
10
Note
These instructions are
valid for the Ergo Basic,
Ergo Ultra and Ergo
UltraLED
handpiece.
WARNING
Caution
Without cooling fluid, the
maximum operating time
is 2 minutes followed by
a cooling down period
of 8 minutes. Operating
the scaler Note
for more than
2 minutes may cause
overheating and damage
to the handpiece.
3.
Carefully align the tip and screw
it clockwise into the handpiece.
WARNING
A tip that is bent, altered,
scratched or worn more
than 2 mm will lose performance and must be
exchanged. Prolonged
use mayCaution
cause tip
breakage and injury to
the patient.
4.
Use the tip wrench to firmly tighten
the tip to the handpiece.
Do not use nickel-titanium files, since they
easily break
at high
Note
frequencies.
The operator should be
aware of that ultrasonic
instruments with small
diameters are subject to
breakage at any time.
If not used correctly or
with too much power
or force the instrument
WILL break.
11
Scaling
1. Set the ultrasonic power to minimum position.
2. Keep the handpiece over the bowl and depress the
foot control to activate the scaler. Adjust the
waterflow.
3. Adjust the ultrasonic power according to the
working mode marked on each tip (see below).
4. Keep the patient’s lips, cheeks, and tongue out of
the way of the tip and perform treatment accord
ing to the following instructions.
Recommended working mode
Code
100 %
70 %
12
Max power
40 %
WARNING
New tips are not sterile
upon delivery. Sterilize
before use according to
the clinic’s routines.
WARNING
Caution
Keep the patient’s lips,
cheeks, and tongue out
of the way of the activated tip, since contact
may cause burns.
Caution
Note
Note
At low power settings
there will be no spray.
How to use the scaler
The side of the tip-end shall be appl
the tooth so that the movement of th
is parallel to the surface of the tooth
first 2 mm of the tip are the most effi
Place the tip on the tooth surface be
How to use the scaler
activating
The side of the tip-end shall be applied
to the foot switch.
the tooth so that the movement of the tip
Normal
is parallel to the surface of the tooth.
Thescaling rarely requires more th
The side of the tip-end shall be applied
to the tooth so that theefficient!
movement
of calculus migh
hard to remove
first 2 mm of the tip are the mostHowever,
the tip is parallel to the surface of the
tooth.
The
first
2
mm
of
the
tip
are
the
setting.
Place the tip on the tooth surface before
activating
the footbefore
switch. activating the foot
most efficient! Place the tip on the tooth
surface
switch.
Normal scaling rarely requires
remove calculus might require
Ensure that contact between
Normal scaling rarely requires more
power
level.
thethan
tip 50%
and the
tooth
surface
hard to
remove level.
calculus is
might
require
a
higher
power
moreHowever,
than 50%
power
However,
hard
maintained duringto
scaling.
setting.
a higher
power setting.
Keep moving the tip slowly
Ensure that contact between the tip and
the
surEnsure
thattooth
contact
between
face is maintained during scaling. Keep
the surface
the tipmoving
and the tooth
maintained during
scaling.
tip slowly back and forth and let theisinstrument
do the
Keep moving the tip slowly
work. Use short and long strokes so back
thatand
theforth
whole
surand let the
face of each tooth is scaled.
instrument do the work.
Use short and long strokes
The tip is normally aimed towards the
toothpocket.
so that the whole surface of
back and forth and let the
instrument do the work.
Use short and long strokes
so that the whole surface of
each tooth is scaled.
The tip is normally aimed towards th
eachsurface
tooth is scaled.
To keep the tip working parallel to the
of each
tooth, it is important to follow the anatomy of the tooth.
The tip is normally aimed towards the toothpocket.
With the correct power setting, appropriate pressure
against the tooth (approximately 20 grams but not ex- To keep the tip working parallel
ceeding 50) and the tip operating parallel to the surface,to the surface of each tooth, it is
important to follow the anatomy
treatment will be gentle, quiet and efficient.
of the tooth.
If, during the treatment, a squeaking sound is heard
(loud and dominating), the pressure against the tooth
might be too low or the tip not parallel to the surface of
the tooth.
To keep th
to the surf
important
of the toot
With the correct power setting, appr
the tooth (approx. 20 grams but not
operating parallel to the surface, trea
and efficient.
With the correct power setting, appropriate pressure against
the tooth (approx. 20 grams butIf,
notduring
exceeding
50) and13
thea tip
the treatment,
squeaking
operating parallel to the surface, dominating),
treatment willthe
be gentle,
pressurequiet
against the
and efficient.
or the tip not parallel to the surface o
nt
After treatment
After treatment
the tip, counter-clockwise,
1.
Screw off the tip, counter-clockwise,
1. Screw off the tip, counter-clockwise,
ip- or torque
using the tip- or torque wrench.
wrench.
with the tip wrench.
he ErgoGrip
gently
at
the
top
and
2.
Squeeze the ErgoGrip gently at the top an
2. Squeeze the ErgoGrip gently at the top and
e time slide
it
off
the
handpiece.
at the same time slide it off the handpiece
at the same time slide it off the handpiece.
ueeze too hard at the ErgoGrip
Do not squeeze too hard at the ErgoGrip
Do not squeeze too hard at the ErgoGrip
n make the removal difficult.
as this can make the removal difficult.
as this can make the removal difficult.
sterilize the equipment
3.
Clean and sterilize the equipment
3. Clean
and sterilize the equipment
to the General
cleaning
according to the General cleaning
page
according
to the General cleaning
section on
15.
procedure section on page 15.
14
procedure section on page 15.
14
WARNING
4 Cleaning and maintenance
4.1 General cleaning procedure
After each treatment
1. Wipe off the handpiece and the hose with
a soft cloth. Use a 45 % isopropanol and
detergent solution.
2. Wash the ErgoGrip, the tip and the tip
wrench and autoclave according to the
clinic’s routines.
Caution
Do not sterilize any
scaler accessories using
dry heat or chemical
autoclaves. This may
damage the material.
Note
Do not immerse the
handpiece in any fluid.
Moisture may permeate
into it and damage the
ultrasonic generator.
15
each line 6.3
of the system
for 30seconds.
seconds temperatures
Autoclave
on forbottle).
30Cleaning
seconds. and maintenance
dine solution for 30 seconds.
mpty
line line
of the
withfor
a 1%
Clorhexi5.
purge each line of the system for 30 seconds
each
of system
the system
30Air
seconds
and
maintenance
linefor
of30
theCleaning
system
with
clean
water forempty
30 bottle). 121°C (248°F):
4. Flush each line of the system wi
on
seconds.
135°C
(275°F):
mpty
bottle).
3. (with
Flush an
each line of
the system with a 1%seconds.
Clorhexiemperatures
line of the system with clean dine
watersolution
for 30 for 30 seconds.
3.Basic
each
line of the�system
with 5.
a 1%
Clorhexieach
line 6.3
of�theErgoGrip
system
for
30Flush
seconds
Air
purge each line of the syste
Medicament
bottles
Autoclave
temperatures
emperatures
4.2
Autoclave
temperatures
4.
Flush
each
line
of
the
system
with
clean
water
forempty
30 bottle).
dine
solution
for
30
seconds.
mpty bottle). 121°C (248°F):
(with an
each line of�theErgoGrip
system forUltra
30seconds.
seconds
� Bottle connectors
4. Flush
each
line of the system
with(248°F):
clean water
formin:
30
(275°F)
for 10
min:
(248°F)
for 20
121°C
mpty bottle). 135°C
121°C (275°F):
(248°F):
ErgoGrip5.UltraLight
Air
purge each line 6.3
of the system
for
30
seconds
� Medicament
bottles
seconds.
emperatures
Autoclave temperatures
(with an empty bottle).
Tip connectors
bottles
ErgoGrip
Tips
Scaling
tip
� Bottle
5.Basic
Air purge each line of�theMedicament
system for 30
seconds
Medicament
bottles
emperatures
in:
(248°F)(with
for 20
121°C (248°F):
121°C
an min:
empty bottle). 135°C (275°F):
� Bottle connectors
ErgoGrip
Ultra
file
� Bottle
Endo
file
connectors
6.3
Autoclave
temperatures
in:
(248°F) for 20 min:
121°C (248°F):
ErgoGrip
UltraLight
Silicone
covers
� Medicament
bottles temperatures
Tip Autoclave
wrench
� ErgoGrip Basic
� Medic
6.3
135°C (275°F):
121°C (248°F):
Tip
wrench
� Bottle
Scaling
tip wrench
cassette
connectors
� Bottle
� ErgoGrip Ultra
Torque
Medicament
bottles
135°C (275°F):
121°C (248°F):
Endo
file
ErgoGrip UltraLight
� Bottle
connectors
ErgoGrip
Basic
� Medicament
bottles
ErgoGrip
Basic
� Silicone
ErgoGrip
Ultra
ErgoGripcovers
Ultra
Basic
Scalingconnectors
tip bottles
� Bottle
Medicament
� Tip
cassette
wrench
ErgoGrip
UltraLight
ErgoGrip
UltraLED
Ultra
� Bottle
Endo file
connectors
� Scaling
tipUltraLight
ErgoGrip
UltraLED Focus
� Silicone covers
� Endo
filetip
Scaling
� Tip cassette
4.3
Maintenance
� Silicone
Endo
filecovers
Handpiece
� Tip
cassette
Silicone
covers
Inspect the handpiece hose daily to insure that the equipment is in good
condition
without mechanical damage.
� Tip cassette
16
Tips
Tips
altered, scratched
scratchedororworn
worn
When a tip is bent, altered,
more than
than 22 mm
mm it
it will
will lose
more
lose performance
performance and
and
must
be
exchanged.
Check
the
tip
length
must be exchanged. Check the tip length
weekly by
tip to
to the
the template
template
weekly
by comparing
comparing the
the tip
below.
below.
PE-40
2 mm
PE-40H
2 mm
WARNING
WARNING
A tip that is bent,
A tip thatscratched
is bent, altered,
altered,
or
scratched
worn
more
worn
moreor
than
2 mm
thanlose
2 mm
will lose perwill
performance
formance
andexchanmust be
and
must be
exchanged.
Prolonged
ged.
Prolonged
Caution use may
use may
cause
tip and
cause
tipCaution
breakage
breakage
and
injury to
injury
to the
patient.
the patient.
The operator should be
The operator
be
aware
of that should
ultrasonic
aware of that
ultrasonic
instruments
with
small
Note
instruments
with
smallto
Note
diameters
are
subject
diametersat
are
subject
breakage
any
time. to
any time.
Ifbreakage
not usedatcorrectly
or
If nottoo
used
correctly
with
much
poweror
with
too much
power
or
force,
the instrument
or force,
the instrument
WILL
break.
WILL break.
2 mm
PE-31
2 mm
PE-32
PE-41A
2 mm
PE-41P
2 mm
PE-39
2 mm
2 mm
2 mm
2 mm
PE-37
2 mm
PE-33
2 mm
PE-41PF
PE-38
PE-41AF
PE-41PS
2 mm
17
5 Troubleshooting
The tip does not
vibrate properly.
Check that the tip is firmly tightened.
Check that the tip is not worn more than acceptable according to the
tip template in the Maintenance section on page 17.
If the problem is not resolved, try another tip, preferably unused.
The tip threads
If the tip threads are damaged, blow off the handpiece threads with
don’t fit smoothly
compressed air and try another tip, preferably unused. Throw away the
onto the handpiece. damaged tip.
If the problem still remains, contact your dealer for service instructions,
because the handpiece threads might be damaged.
Insufficient fluid
flow.
Open the water adjustment knob completely.
The handpiece is
overheated
Check that the fluid flow is sufficient (recommended: 20 ml/min).
If the fluid is still insufficient, remove the tip and inspect if fluid comes
out of the handpiece. If yes, replace the tip.
If problems cannot be resolved according to this troubleshooting guide, please contact
your dealer for further service support.
18
6 Technical data
Input voltage (different models) 24 Vac, 50-60 Hz or 24-32 Vdc ± 10 %
Output
Maximum 10 W, 24 kHz - 28 kHz, automatic tuning
Ambient temperature
Transport & storage
-40°C to 70°C
(-40°F to 158°F)
Operation
10°C to 55°C
(50°F to 131°F)
Relative humidity
Transport & storage
10% to 100%
Operation
10% to 95%
Water consumption
10 ml/min - 50 ml/min
Further technical descriptions on request. The manufacturer provides the
qualified technical staff of the dealer or distributor with necessary information for service of the equipment.
19
7 Warranty and Declaration of conformity
7.1
Warranty
The manufacturer hereby warrants that the Amdent Scaler will be free from
defects arising from faulty materials or workmanship (“Limited Warranty”).
This Limited Warranty does not cover the ultrasonic scaling tips. This Limited Warranty applies only if the Amdent scaler and/or the Amdent ultrasonic
scaling tips are installed and used by the customer according to the instruction furnished herein, is connected to a proper power supply, is not misused or
abused, and there is no evidence of tampering, mishandling, neglect, accidental or wilful damage or modifications. The customer must contact the
authorized dealer from whom the Amdent Scaler and/or ultrasonic scaling tips
were purchased to request repair or replacement under this Limited Warranty.
This Limited Warranty is void if service or repair is performed by persons not
authorized by the manufacturer. Normal wear and tear is specifically excluded from this Limited Warranty. Manufacturer disclaims any express warranty
not provided herein and any implied warranty, guarantee or representation as
to suitability for any particular purpose, performance, quality, and absence of
hidden defects, and any remedy for breach of contract, which but for this provision, might arise by implication, operation of law, custom of trade, or course of dealing, including implied warranties of merchantability and fitness for a
particular purpose, except as provided in this limited warranty. The manufacturer further disclaims any responsibility for losses, expenses, inconveniences,
special, indirect, secondary, or consequential damages arising from ownership
or use of the product.
20
7.2
Declaration of conformity
The manufacturer hereby declares that the
Piezo Ultrasonic Scaler Built-in, all models
Class I, type B according to EN 60601-1
conform to the essential requirements of the Medical Device Directive
93/42/EEC with reference to the following harmonized standards:
EN 60601-1: 1990 with A1 and A12: 1993, A2: 1995 and A13: 1996.
Classification: Medical products, Class IIa:
21
NOTES
22
NOTES
23
9770223
rev9770223 rev-E
Good Vibrations
1009
Box 230
25 Nynäshamn
SE-149 23
Sweden
131 20
20
Tel +46 8 520 131
185 74
74
Fax +46 8 520 185
E-mail [email protected]
www.amdent.com