KaVo SURGtorque S459 C & LUX S459 L Operating instructions

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Instructions for use
SS445599
CC
SSUURRGGttoorrqquuee
SURGtorque S459 C – 3.000.5063
SURGtorque LUX S459 L – 3.000.4808
Distributed by:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Phone: 847 550 6800
Fax: 847 550 6825
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
Table of contents
3 / 32
Table of contents
1 User instructions ............................................................................................................... 4
2 Safety................................................................................................................................. 7
2.1 Infection hazard ............................................................................................................ 7
2.2 Improper use ................................................................................................................ 7
2.3 Technical condition ........................................................................................................ 7
2.4 Accessories and combination with other equipment........................................................... 8
2.5 Qualification of personnel ............................................................................................... 8
2.6 Service and repair ......................................................................................................... 8
3 Product description ........................................................................................................... 10
3.1 Intended use................................................................................................................. 10
3.2 Technical Specifications.................................................................................................. 11
3.3 Transportation and storage conditions ............................................................................. 11
4 Startup and shut-down...................................................................................................... 12
4.1 Installing the coupling (S459 L only)................................................................................ 12
4.2 Checking the water quantity ........................................................................................... 13
4.3 Checking the pressures .................................................................................................. 13
4.4 Checking the O-rings (S459 L only) ................................................................................. 13
5 Operation........................................................................................................................... 15
5.1 Attaching medical device S459 C..................................................................................... 15
5.2 Unscrewing medical device S459 C.................................................................................. 15
5.3 Plugging medical device S459 L on .................................................................................. 16
5.4 Removing medical device S459 L .................................................................................... 16
5.5 Inserting the bur ........................................................................................................... 17
5.6 Removing the bur.......................................................................................................... 18
6 Troubleshooting ................................................................................................................ 19
6.1 Changing O-rings on the coupling.................................................................................... 19
6.2 Cleaning the spray nozzle............................................................................................... 19
7 Processing steps in accordance with ISO 17664 .............................................................. 21
7.1 Preparations at the site of use......................................................................................... 21
7.2 Manual processing ......................................................................................................... 21
7.2.1 Manual external cleaning................................................................................... 21
7.2.2 Manual internal cleaning.................................................................................... 21
7.2.3 Manual external disinfection .............................................................................. 22
7.2.4 Manual internal disinfection ............................................................................... 22
7.2.5 Manual drying .................................................................................................. 22
7.3 Automated processing.................................................................................................... 23
7.3.1 Automated internal and external cleaning and internal and external disinfection...... 23
7.4 Care products and systems - Servicing ............................................................................ 24
7.4.1 Servicing with KaVo Spray................................................................................. 24
7.4.2 Servicing with KaVo QUATTROcare PLUS ............................................................ 24
7.5 Packaging ..................................................................................................................... 25
7.6 Sterilization................................................................................................................... 25
7.7 Storage ........................................................................................................................ 26
8 Optional aids and consumables......................................................................................... 27
9 Terms and conditions of warranty .................................................................................... 28
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
1 User instructions
4 / 32
1 User instructions
Dear User,
KaVo Congratulations on purchasing this quality product. By following the in-
structions below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo is a registered trademark of KaVo Dental GmbH.
All other trademarks are property of their respective owners.
KaVo Technical Service
Please direct all questions regarding the product, service and maintenance to
the KaVo Technical Service:
Toll-free: 1-888-ASK-KAVO (888-275-5286)
Email: techservice@kavo.com
Please refer to the serial number of the product in all inquiries.
KaVo Repair Service
For repairs, please contact the KaVo Repair Service. For scheduling or if you
have any questions, please contact:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Toll-free Direct Customer Service: 1-888-ASK-KAVO (888-275-5286)
Email: techservice@kavo.com
www.kavo.com
Target group
The instructions for use are intended for medical professionals, in particular
dentists and office personnel.
The section on startup is also intended for the service staff.
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
Medical device, labeling of medical devices
Sterilization parameters
Sterilizer with Dynamic-Air-Removal (pre-vacuum) method:
3 minutes at 135 oC (275 oF)
Drying time: 16 min.
4 minutes at 132 oC (270 oF)
Drying time: 20-30 min.
Sterilizer with gravity displacement method:
10 minutes at 135 oC (275 oF)
Drying time: 30 min.
15 minutes at 132 oC (270 oF)
Drying time: 15-30 min.
30 minutes at 121 oC (250 oF)
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
1 User instructions
5 / 32
Drying time: 15-30 min.
Thermodisinfectable
Information on the packaging
Catalog number
Serial number
Manufacturer
Note: Please note accompanying documents
Please note the electronic instructions for use
HIBC Code
CE mark according to Medical Devices Directive EC 93/42
EAC conformity mark (Eurasian Conformity)
Transportation and storage conditions
(temperature range)
Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(humidity)
Protect from moisture
Protect from impact
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and property damage. The warning notes are designated as
shown below:
HAZARD
In cases which if not prevented directly lead to death or severe injury.
WARNING
In cases which if not prevented can lead to death or severe injury.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
1 User instructions
6 / 32
CAUTION
In cases which if not prevented can lead to minor or moderate injury.
NOTICE
In cases which if not prevented can lead to property damage.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
2 Safety | 2.1 Infection hazard
7 / 32
2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties can be infected by contaminated medical de-
vices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, process the product and acces-
sories appropriately.
4Carry out the processing as described in the instructions for use. The proce-
dure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the processing
procedure is effective.
4Process the product and accessories appropriately before disposal.
4In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
4Use gloves or a finger guard when you test, insert and remove the tool.
2.2 Improper use
Improper use of the device can lead to burns or injuries.
4Check the technical condition before each use.
Also refer to:
2.3 Technical condition,Page7
4Never press the push-button during operation of the device.
4Never use the instrument to keep the cheek, tongue or lip at a distance.
4Never touch the handpiece head or handpiece lid to soft tissue.
4Do not use the medical device as a light probe.
4Use an appropriate light probe for illumination of the oral cavity or site of
preparation.
4After treatment, place the medical device properly in the cradle without the
bur.
During the preparation of abutments, heat transmission can cause thermal
damage to the jawbone.
4During the preparation of abutments, make sure that the preparation times
are short and that there is sufficient cooling.
The use of the product, for example during dental extraction of wisdom teeth,
separation of teeth or the like, may lead to subcutaneous emphysema.
4Always hold the dental bur appropriately such that it points vertically, rather
than horizontally, into the open wound. Air does not exit in the direction of
the dental bur, but rather laterally on the head through the air slots.
2.3 Technical condition
A damaged device or components can injure patients, users and third parties.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
2 Safety | 2.4 Accessories and combination with other equipment
8 / 32
4Use the device and components only if there is no damage on the outside.
4Check to make sure that the device is working properly and is in satisfactory
condition before each use.
4Have parts with sites of breakage or surface changes checked by the Ser-
vice.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
Irregular running noise
Excessive vibration
▪ Overheating
Bur is not seated firmly in the handpiece
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
4Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
4The product should be processed and stored in a dry location, according to
instructions, if it is not to be used for an extended period of time.
2.4 Accessories and combination with other equipment
Use of un-authorized accessories on the device or un-authorized modifications
to the device can lead to injury.
4Only use accessories that have been approved for combination with the
product by the manufacturer.
4Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
The lack of control equipment for changing the speed range and the direction of
rotation can lead to injury.
4Control facility for changing the speed and the direction of rotation must be
present.
4The medical device may only be combined with a treatment center / control
unit released by KaVo.
4Comply with the Instructions for Use of the treatment center / control unit.
2.5 Qualification of personnel
Application of the product by users lacking appropriate medical training can in-
jure the patient, the user or third parties.
4Make sure that the user has read and comprehends the instructions for use.
4Make sure that the user has read and comprehends the national and re-
gional regulations.
4Only employ the device if the user has the appropriate medical training.
2.6 Service and repair
Repairs, servicing and safety checks may only be performed by trained service
personnel. The following persons are authorized to do this:
Technicians of the KaVo-branches after the appropriate product training
Technicians of the KaVo-authorized dealers after the appropriate product
training
Comply with the following items during all servicing work:
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
2 Safety | 2.6 Service and repair
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4Have the service and testing tasks carried out in accordance with the Medi-
cal Device Operation Ordinance.
4After servicing, interventions on and repairs of the device and before re-use,
have the service personnel perform safety checks on the device.
4Following expiration of the warranty, have the tool holding system checked
once a year.
4Have the medical device evaluated by a professional shop with regard to its
cleaning, servicing and functional needs according to an in-house service in-
terval. Define the service interval depending on the frequency of use.
If you use any NON- KaVo original spare parts during the repair, parts such as
covers may become undone and injure the patient, user or others. This may re-
sult in aspiration, swallowing of parts and possibly even a risk of suffocation.
4Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
NOTE
If a repair is done with NON- KaVo original spare parts, this may constitute a
product modification and thus lead to the loss of CE conformity. In the event
of damage, the responsibility is with the service company or the operator.
The introduction into the market of a modified product, where there is reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate conformity check.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
3 Product description | 3.1 Intended use
10 / 32
3 Product description
SS445599
CC
SSUURRGGttoorrqquuee
SURGtorque S459 C (Mat. No. 3.000.5063)
SURGtorque S459 L (Mat. No. 3.000.4808)
The SURGtorque S459 C andS459 L are dental handpieces according to 21 CFR
§ 872.4200 (dental handpieces and accessories).
The SURGtorque S459 C and S459 L are air-driven dental handpieces, designed
for use by a trained professional in the field of general dentistry only. The de-
vices are air-powered handpieces that are reusable and ergonomically shaped,
and are provided with a fiber optic light system. The dental handpieces can be
sterilized in a steam sterilizer (autoclave). The SURGtorque handpieces S459 C
and S459 L are connected to the treatment unit through an inside hose and the
coupling as the means for the supply of the requisite drive air and coolant me-
dia for conservative dental treatment; light and water are also supplied to the
treatment field by this means.
3.1 Intended use
Indications for use:
The SURGtorque S459 C and S459 L are intended for the removal of carious
material, reduction of hard tooth structure, cavity and crown preparations, re-
moval of fillings, processing and finishing of tooth preparations and restora-
tions, and for polishing teeth. They may be used by trained professionals in
general dental medicine exclusively.
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.
Proper Use:
According to these regulations, this product may only be used for the described
application by a properly trained user. You need to comply with the following:
the applicable health and safety regulations
the applicable accident prevention regulations
these Instructions for use
In accordance with these regulations, the user is required to:
only use equipment that is operating properly
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
3 Product description | 3.2 Technical Specifications
11 / 32
adhere to the specified intended use
protect himself or herself, the patient and third parties from danger
avoid contamination from the product
3.2 Technical Specifications
S459 C S459 L
Drive pressure 2.1 to 3.0 bar (30 to 44
psi)
2.1 to 3.5 bar (30 to 51
psi)
Recommended drive
pressure
2.8bar (41psi) 2.8bar (41psi)
Return air pressure < 0.5 bar (7 psi) < 0.5 bar (7 psi)
Cooling water pressure 0.8 to 1.0 bar (12 to 15
psi)
0.8 to 1.0 bar (12 to 15
psi)
Air consumption 45 to 55 Nl/min 45 to 55 Nl/min
Idle speed 380,000 to 420,000 rpm 350,000 to 400,000 rpm
Recommended contact
pressure
2 to 3 N 2 to 3 N
Connector Midwest 4-hole connec-
tors
MULTIflex couplings
Insert Burs and diamonds in accordance with ISO 1797
type 3
NOTE
The air consumption and idle speed values were determined at a drive pres-
sure of 2.8 bar (41 psi).
3.3 Transportation and storage conditions
4Do not store in a refrigerated environment.
Temperature: -20 °C to +70 °C (-4 °F to +158 °F)
Relative humidity: 5% RH to 95% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
4 Startup and shut-down | 4.1 Installing the coupling (S459 L only)
12 / 32
4 Startup and shut-down
WARNING
Hazard from contaminated products.
Infection hazard for dentist and patient.
4Prior to initial startup and after each use, process the product and acces-
sories.
WARNING
Dispose of the product in the appropriate manner.
Infection hazard.
4Process the product and accessories before disposal.
Also refer to:
7 Processing steps in accordance with ISO 17664,Page21
NOTICE
Damage from soiled and moist cooling air/compressed air.
Contaminated and moist cooling air can cause malfunctions.
4Make sure that the supply of cooling air is dry, clean and uncontaminated
according to ISO 7494-2 .
4.1 Installing the coupling (S459 L only)
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the coupling dur-
ing treatment.
4Before each use, pull on the medical device to make sure that it is securely
locked onto the coupling.
4Screw the MULTIflex coupling onto the turbine hose and tighten it with the
wrench (Mat. No. 0.411.1563).
4Rotate the spray ring on the MULTIflex coupling (465 series) in order to reg-
ulate the water supply.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
4 Startup and shut-down | 4.2 Checking the water quantity
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4.2 Checking the water quantity
CAUTION
Overheating of the tooth due to insufficient amount of cooling water.
Insufficient spray water can cause the medical device to overheat and damage
the pulp and tooth.
4Adjust the water amount for the spray cooling to a minimum of 50 ml/min
(3.1 inch3).
4Check the spray water channels and if necessary clean the spray nozzles
with the nozzle needle (Mat. No. 0.410.0921).
4.3 Checking the pressures
NOTICE
Damage from soiled and moist cooling air/compressed air.
Contaminated and moist cooling air can cause malfunctions.
4Make sure that the supply of cooling air is dry, clean and uncontaminated
according to ISO 7494-2 .
4Insert the pressure gauge (Mat. No. 0.411.8731) between the coupling
and the medical device and check the following pressures:
Drive pressure
Recommended drive pressure
Return air pressure
Cooling water pressure
Spray air pressure (Spray air pressure of the treatment unit is not available
on the SURGtorque)
Also refer to:
3.2 Technical Specifications,Page11
4.4 Checking the O-rings (S459 L only)
NOTICE
Missing or damaged O-rings.
Malfunctions and premature failure.
4Make sure that all O-rings are present on the coupling and are undamaged.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
4 Startup and shut-down | 4.4 Checking the O-rings (S459 L only)
14 / 32
Number of O-rings: 5
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
5 Operation | 5.1 Attaching medical device S459 C
15 / 32
5 Operation
NOTE
At the beginning of each workday, the water-conducting systems should be
rinsed for at least 2 minutes (without transmission handpieces being at-
tached) and if there is a risk of contamination from reflux or back suction, the
system may also need to be rinsed for 20 to 30 seconds after each patient.
WARNING
Dental extraction of wisdom teeth, separation of teeth or the like.
The use of the product, for example during dental extraction of wisdom teeth,
separation of teeth or the like, may lead to subcutaneous emphysema.
4Always hold the dental bur appropriately such that it points vertically, rather
than horizontally, into the open wound. Air does not exit in the direction of
the dental bur, but rather laterally on the head through the air slots.
WARNING
Rotating bur.
Cuts, infection and burn injury.
4Never push the press-button while the bur is rotating.
4Do not touch the bur while it is rotating.
4Never touch the handpiece head or handpiece lid to soft tissue.
4Remove the bur from the handpiece after treatment to avoid injury and in-
fection during storage.
CAUTION
Heat transmission during the preparation of abutments.
Thermal damage to the jawbone.
4During the preparation of abutments, make sure that the preparation times
are short and that there is sufficient cooling.
5.1 Attaching medical device S459 C
4Connect the coupling part of the medical device to the hose proceeding in
clockwise direction.
4Pull on it to make sure that the medical device is securely attached to the
hose.
NOTE
The water quantity can be regulated through the coupling or the treatment
centre.
5.2 Unscrewing medical device S459 C
4Disconnect the coupling parts of the medical device from the hose proceed-
ing in counterclockwise direction.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
5 Operation | 5.3 Plugging medical device S459 L on
16 / 32
5.3 Plugging medical device S459 L on
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the coupling dur-
ing treatment.
4Before each use, pull on the medical device to make sure that it is securely
locked onto the coupling.
NOTICE
Inexact coupling.
Reduces the service life of the lamp.
4Avoid inexact coupling.
4Check the secure fit of the (LUX) handpieces on the coupling by pulling on
them.
4Lightly spray O-rings on the motor coupling with KaVo Spray.
4Accurately attach the medical device to the MULTIflex and push is to the
rear until the coupling audibly locks in the medical device.
4Pull on the medical device to make sure that it is securely affixed to the cou-
pling.
NOTE
The water quantity can be regulated through the coupling or the treatment
centre.
5.4 Removing medical device S459 L
4Firmly grasp the coupling and pull the medical device off while twisting
slightly.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
5 Operation | 5.5 Inserting the bur
17 / 32
5.5 Inserting the bur
NOTE
Only use carbide burs or diamonds that comply with ISO 1797 type 3, are
made of steel or hard metal and meet the following criteria:
- Shaft diameter: 1.59 to 1.60 mm (0.0626 to 0.0629in)
- Overall length: 25 mm (0.9842in)
- Shaft clamping length: min. 11 mm (0.433 in)
- Blade diameter: max. 2 mm (0.0787 in)
WARNING
Use of unauthorized burs.
Injury to the patient or damage to the medical device.
4Comply with the instructions for use and the intended use of the bur.
4Only use burs that do not deviate from the specified data.
CAUTION
Do not use damaged burs.
Risk of injury from swallowing a bur that falls out.
4Do not use damaged burs.
4Do not use burs that have been hit.
4Do not use burs with adherent soiling.
4Do not use visibly imbalanced burs.
CAUTION
Bur with damaged, worn or deformed shafts.
Risk of injury, bur may fall out during treatment.
4Never use burs with damaged, worn or deformed shafts.
CAUTION
Defective chuck system.
Risk of injury, bur may fall out during treatment.
4Pull on the bur to check if the chuck system is functioning properly and that
the bur is firmly clamped.
CAUTION
Contaminated, sharp-edged bur.
Infections or cuts.
4Use gloves or a finger guard when you test, insert and remove the bur.
NOTICE
Bur with damaged, worn or deformed shafts.
Property damage to the chuck system, bur is difficult or impossible to remove
from the chuck system.
4Never use burs with damaged, worn or deformed shafts.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
5 Operation | 5.6 Removing the bur
18 / 32
NOTICE
Bur shaft slips inside the chuck due to excessive speed of the bur or
abrupt engagement of the bur.
Property damage to bur shaft and chuck system, reduction of the service life of
bur and chuck system.
4Do not operate the bur at a higher speed than recommended by the manu-
facturer.
4Firmly press the push-button with your thumb and, simultaneously, always
insert the bur until it hits the stop.
4Make sure that the bur is seated securely by pulling on it.
5.6 Removing the bur
WARNING
Rotating bur.
Cuts, infection and burn injury.
4Never push the press-button while the bur is rotating.
4Do not touch the bur while it is rotating.
4Never touch the handpiece head or handpiece lid to soft tissue.
4Remove the bur from the handpiece after treatment to avoid injury and in-
fection during storage.
NOTICE
Damage to the chuck system.
Material damage.
4Never push the press-button while the bur is rotating.
4After the bur has stopped rotating, firmly press the push-button down with
your thumb and simultaneously remove the bur.
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
6 Troubleshooting | 6.1 Changing O-rings on the coupling
19 / 32
6 Troubleshooting
WARNING
Use of NON- KaVo original spare parts in repairs.
Parts such as covers can become undone and cause injury. Aspiration, swallow-
ing of parts, danger of suffocation.
4Only use spare parts that comply with specifications for repair, KaVo spare
parts comply with specifications.
NOTE
If a repair is done with NON- KaVo original spare parts, this may constitute a
product modification and thus lead to the loss of CE conformity. In the event
of damage, the responsibility is with the service company or the operator.
The introduction into the market of a modified product, where there is reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate conformity check.
6.1 Changing O-rings on the coupling
NOTICE
Improper care of the O-rings.
Malfunction or complete failure.
4Do not use Vaseline or other grease or oil.
NOTE
The O-rings on the coupling may only be lubricated with a cotton ball wetted
with KaVo Spray.
4Press the O-ring between your fingers to form a loop.
4Push the O-ring to the front, and remove it.
4Insert new O-rings into the grooves and spray them with KaVo Spray.
6.2 Cleaning the spray nozzle
WARNING
Hazard from contaminated products.
Infection hazard for dentist and patient.
4Prior to initial startup and after each use, process the product and acces-
sories.
CAUTION
Overheating of the tooth due to insufficient amount of cooling water.
Insufficient spray water can cause the medical device to overheat and damage
the pulp and tooth.
4Check the spray water channels and if necessary clean the spray nozzles
with the nozzle needle (Mat. No. 0.410.0921).
Instructions for use SURGtorque S459 C 3.000.5063, SURGtorque LUX S459 L 3.000.4808
6 Troubleshooting | 6.2 Cleaning the spray nozzle
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