KaVo INTRA PROPHYwiz 181 P User manual

Instructions for use
INTRA Motorhandstück PROPHYwiz 181 P - REF
1.003.2278

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Table of contents
1 User instructions ................................................................................................................ 4
2 Safety.................................................................................................................................. 6
2.1 Infection hazard ............................................................................................................ 6
2.2 Technical condition......................................................................................................... 6
2.3 Accessories and combination with other equipment ........................................................... 6
2.4 Qualification of personnel................................................................................................ 7
2.5 Service and repair.......................................................................................................... 7
2.6 Property damage ........................................................................................................... 7
3 Product description ............................................................................................................ 8
3.1 Purpose – Intended use ................................................................................................. 8
3.2 Technical Specifications .................................................................................................. 8
3.3 Operating conditions ...................................................................................................... 9
3.4 Transportation and storage conditions.............................................................................. 9
4 Start up and shut down ......................................................................................................10
4.1 Check the pressure ........................................................................................................ 10
5 Operation............................................................................................................................ 11
5.1 Connecting the motor handpiece to the supply hose.......................................................... 11
5.2 Attach the prophylaxis head............................................................................................ 11
5.3 Removing the prophylaxis head....................................................................................... 12
6 Reprocessing steps in accordance with ISO 17664 ...........................................................13
6.1 Preparation at the site of use .......................................................................................... 13
6.2 Manual Reprocessing...................................................................................................... 13
6.2.1 Manual cleaning - external................................................................................... 13
6.2.2 Manual internal cleaning...................................................................................... 13
6.2.3 Manual external disinfection................................................................................. 13
6.2.4 Manual internal disinfection.................................................................................. 14
6.2.5 Manual drying .................................................................................................... 14
6.3 Automated reprocessing................................................................................................. 14
6.4 Care products and systems - Servicing............................................................................. 14
6.4.1 Servicing with KaVo Spray................................................................................... 15
6.4.2 Servicing with KaVo QUATTROcare PLUS .............................................................. 15
6.4.3 Servicing with KaVo SPRAYrotor........................................................................... 16
6.4.4 Servicing with KaVo QUATTROcare ....................................................................... 17
6.5 Packaging ..................................................................................................................... 17
6.6 Sterilisation................................................................................................................... 18
6.7 Storage ........................................................................................................................ 18
7 Auxiliary equipment ...........................................................................................................19
8 Warranty terms and conditions..........................................................................................20
Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
Table of contents
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Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
1 User instructions
4 / 22
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the in-
structions below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo Technical Service
If you have any questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
KaVo Repair Service
For repairs, please contact your local dealer or the KaVo
Repair Service directly:
[phone]
[e-mail]
Target group
This document is intended for dentists and their assistants. The startup section
is also intended for service technicians.
General marks and symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Action request
CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directive.
Can be steam sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4
oF)
Information on the packaging
Material number
Serial number
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42
Please note the electronic instructions for use

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
1 User instructions
Note: observe accompanying documents
EAC conformity mark (Eurasian Conformity)
GOST R certification
Transportation and storage conditions
(Temperature range)
Transportation and storage conditions
(Air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture
Protect from impact
HIBC Code
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and material damage. The warning notes are designated as
shown below:
DANGER
In cases which – if not prevented – directly lead to death or severe in-
jury.
WARNING
In cases which – if not prevented – could lead to death or severe in-
jury.
CAUTION
In cases which – if not prevented – could lead to minor or moderate
injury.
NOTICE
In cases which – if not prevented – could lead to material damage.
5 / 22

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
2 Safety | 2.1 Infection hazard
6 / 22
2 Safety
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 could be infected by contaminated medical
devices.
▶Take suitable personal protective measures.
▶Follow the instructions for use of the components.
▶Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
▶Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
▶Reprocess the product and accessories appropriately before disposal.
2.2 Technical condition
A damaged device or components could injure patients, users and third parties.
▶Only operate devices or components if they are undamaged on the outside.
▶Check that the device is working properly and is in satisfactory condition
before each use.
▶Have parts with sites of breakage or surface changes checked by the Ser-
vice.
▶If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
▪ Imbalance
▪ Insufficient retention force
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
▶Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
▶The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it will not be used for a longer period.
2.3 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device
could lead to injury.

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
2 Safety | 2.4 Qualification of personnel
▶Only use accessories that have been approved for combination with the
product by the manufacturer.
▶Only use accessories that are equipped with standardised interfaces.
▶Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
2.4 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure the patients, the users or third parties.
▶Make sure that the user has read and understood the instructions for use.
▶Only employ the device if the user has the appropriate medical training.
▶Observe national and regional regulations.
2.5 Service and repair
Repairs and servicing may only be performed by trained service personnel. The
following persons are authorised to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate product
training
Observe all the following items during servicing work:
▶Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
▶KaVo recommends specifying in-house service intervals where the medical
device is brought to a professional shop for cleaning, servicing and a func-
tion check. Define the service interval depending on the frequency of use.
2.6 Property damage
Contaminated and moist compressed air can cause malfunctions and premature
wear.
▶Ensure that the compressed air is dry, clean and uncontaminated according
to DIN EN ISO 7494-2.
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Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
3 Product description | 3.1 Purpose – Intended use
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3 Product description
INTRA Motor handpiece PROPHYwiz 181 P (Mat. no. 1.003.2278)
3.1 Purpose – Intended use
Indications for use:
The motor handpiece is:
▪ an air motor intended to operate/drive a dental prophylaxis head
▪ designed only for dental treatment by a dental professional. The product
may not be changed or used for any other purpose since this may be haz-
ardous
▪ a medical device according to relevant national statutory regulations
Proper use:
According to these provisions, this medical device may only be used for the de-
scribed application by a properly trained user. You need to comply with the fol-
lowing:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
According to these regulations, the user is required to:
▪ to only use equipment that is operating correctly
▪ adhere to the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
3.2 Technical Specifications
Drive pressure 1.8 to 2.5 bar (26 to 36 psi)
Motor speed 17,000 to 21,000 rpm
Step-down ratio 7.4 : 1
Operating speed 2,300 to 2,800 min-1
Air consumption up to 65 Nl/min
Idle torque max. 8 Ncm
Clockwise rotation.
All prophylaxis heads with a Doriot connection can be attached. The clamping
system is designed for drive shafts in accordance with EN ISO 1797 part 1 and
part 2 for shaft diameters from 2.3 to 2.35 mm.

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
3 Product description | 3.3 Operating conditions
The INTRA motor handpiece can be attached to all hoses with Borden 4-hole
standard connection.
Air requirements
Air quality in accordance with DIN
EN ISO 7494-2
dry, oil-free, dirt-free, non-contam-
inated
Air filter, supplied by customer < 20 µm
3.3 Operating conditions
Temperature: +5 oC to +40 oC (41 oF to 104 oF)
Maximal rel. humidity: < 80 %
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
3.4 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶Prior to startup, strongly refrigerated products must be allowed to warm up
to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
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
9 / 22

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
4 Start up and shut down | 4.1 Check the pressure
10 / 22
4 Start up and shut down
WARNING
Hazard from non-sterile products.
Infection hazard for dentist and patient.
▶Prior to initial startup and after each use, reprocess the product and
accessories.
See also:
26 Reprocessing steps in accordance with ISO 17664, Page 13
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Reprocess and sterilise the product and accessories before disposal.
See also:
26 Reprocessing steps in accordance with ISO 17664, Page 13
NOTICE
Damage to the handpiece caused by spray air and spray water.
Damage to the handpiece.
▶Before startup, unselect spray air and spray water on the supply unit.
4.1 Check the pressure
NOTICE
Contaminated or moist compressed air at the compressed air connec-
tion
Premature wear
▶Ensure that the cooling air is dry, clean and uncontaminated in accordance
with EN ISO 7494-2.
▶Insert the test manometer (Mat. no. 0.411.8731) between hose and mo-
tor and check the following pressures:
ð- Drive pressure: 1.8 to 2.5 bar (26 to 36 psi)
ð- Return air: max. 0.7 bar (10 psi)

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
5 Operation | 5.1 Connecting the motor handpiece to the supply hose
5 Operation
5.1 Connecting the motor handpiece to the supply hose
▶Attach plug-in fitting ① to the motor connection and screw tight in clock-
wise direction using the sleeve ②.
Note
Details on the hose coupling can be obtained from the manufacturer.
5.2 Attach the prophylaxis head
Note
All prophylaxis heads with a Doriot connection can be attached.
The clamping system is designed for drive shafts in accordance with EN ISO
1797 part 1 and part 2 for shaft diameters from 2.3 to 2.35 mm.
CAUTION
Use of impermissible prophylaxis heads.
Injury to the patient or damage to the medical device.
▶Comply with the manufacturer instructions and use the prophylaxis heads
properly.
▶Only use prophylaxis heads that do not deviate from the specified data.
CAUTION
Damaged prophylaxis head.
Injuries.
▶Check the prophylaxis head for damage before each use.
▶See the manufacturer's instructions for use.
NOTICE
Rotating prophylaxis head.
Damage to the chucking system.
▶Never attach or remove the prophylaxis head while the device is rotating.
▶See the manufacturer's instructions for use.
▶Attach the prophylaxis head to the handpiece proceeding in axial direction
until it hits the stop.
▶Before the start of treatment, check if the seat is secure by pulling on the
head.
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Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
5 Operation | 5.3 Removing the prophylaxis head
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5.3 Removing the prophylaxis head
CAUTION
Hazard due to incorrectly stored instrument.
Injury and infection from clamped prophylaxis head.
▶After each treatment, place the instrument properly in the cradle without
the prophylaxis head.
▶Remove the prophylaxis head axially from the handpiece.

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
6 Reprocessing steps in accordance with ISO 17664 | 6.1 Preparation at the site of use
6 Reprocessing steps in accordance with ISO 17664
6.1 Preparation at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
▶Take suitable personal protective measures.
▶Reprocess the medical device as soon as possible after treatment.
▶The medical device must be dry when transported to reprocessing.
▶To minimise the risk of infection during reprocessing, always wear protect-
ive gloves.
▶Remove the prophylaxis head from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not place in solutions or similar substance.
6.2 Manual Reprocessing
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶For manual cleaning only.
6.2.1 Manual cleaning - external
Accessories required:
▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Brush, e.g. medium-hard toothbrush
▶Brush off under running tap water.
6.2.2 Manual internal cleaning
Not applicable.
6.2.3 Manual external disinfection
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungi-
cidal and virucidal.
▶If the disinfectants used do not meet these requirements, the process must
be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.
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Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
6 Reprocessing steps in accordance with ISO 17664 | 6.3 Automated reprocessing
14 / 22
NOTICE
Malfunctioning from using a disinfectant bath or chloride-containing
disinfectants.
Defects in the device.
▶Disinfect manually only!
KaVo recommends the following products based on compatibility of the materi-
als. The microbiological efficacy must be ensured by the disinfectant manufac-
turer and proven by an expert opinion.
Approved disinfectants:
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▪ FD 322 made by Dürr
▪ CaviCide made by Metrex
Consumables required:
▪ Cloths for wiping the medical device.
▶Spray the disinfectant on a cloth, then wipe down the medical device and
allow the disinfectant to act according to the instructions of the
disinfectant manufacturer.
▶Follow the instructions for use of the disinfectant.
6.2.4 Manual internal disinfection
Not applicable.
6.2.5 Manual drying
▶If there is any residual moisture after cleaning and disinfecting, soak up the
residual moisture with a soft cotton cloth and then wipe dry.
▶Immediately after drying, lubricate the KaVo medical device with care
agents from the KaVo care system.
See also:
26.4 Care products and systems - Servicing, Page 14
6.3 Automated reprocessing
Not applicable.
6.4 Care products and systems - Servicing
CAUTION
Improper service and care.
Risk of injury.
▶Service regularly with suitable agents.

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
6 Reprocessing steps in accordance with ISO 17664 | 6.4 Care products and systems - Servicing
CAUTION
Incorrect servicing of prophylaxis heads.
Infection.
▶Comply with the manufacturer's instructions concerning the reprocessing of
prophylaxis heads.
Note
KaVo guarantees the proper function of KaVo products only if the care
products listed as accessories are used, since these were tested for proper
use on our products.
6.4.1 Servicing with KaVo Spray
KaVo recommends servicing the product as part of the reprocessing after each
use, i.e. after each cleaning, disinfection, and before each sterilisation.
▶Take the head off.
▶Unscrew the motor handpiece from the hose.
▶Cover the medical device with the KaVo Cleanpac bag.
▶Use an appropriate cannula and apply spray into the smaller of the two
large tubes.
▶Press the spray key for 1 to 2 seconds.
Note
Additional servicing is required if the working speed decreases due to con-
tamination or particles being present in the air supply system.
Chuck care
KaVo recommends servicing the chucking system once weekly.
▶Remove the head and spray into the opening using the tip of the spray
nipple.
▶Press the spray key for 1 to 2 seconds.
6.4.2 Servicing with KaVo QUATTROcare PLUS
Cleaning and servicing device with expansion pressure for internal cleaning of
inorganic residues and optimum care.
(no validated cleaning of the interior according to German Robert Koch Institute
(RKI) requirements)
KaVo recommends servicing the product as part of the reprocessing after each
use, i.e. after each cleaning, disinfection, and before each sterilisation.
▶Take the head off.
▶Unscrew the motor handpiece from the hose.
▶Service the product in the QUATTROcare PLUS.
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Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
6 Reprocessing steps in accordance with ISO 17664 | 6.4 Care products and systems - Servicing
16 / 22
See also:
2Instructions for use KaVo QUATTROcare PLUS
Servicing the clamping chuck
KaVo recommends servicing the chuck system once a week using the chuck
servicing program integrated in the device.
Note
Handpieces must be taken off the service couplings before the chuck service
can be started and performed.
▶Take the head off.
▶Close the front door and press the chuck service button for at least three
seconds until the spray canister control LED flashes three times consecut-
ively.
ðThe device is in chuck service mode.
▶Remove the service coupling of the chuck from the side hatch of the QUAT-
TROcare PLUS and attach it to coupling service point four, on the far right.
A MULTIflex adaptor must be mounted there.
▶Press the handpiece together with the guide bush of the chuck to be ser-
viced against the tip of the service coupling.
▶Press the button marked with the chuck service symbol.
Note
Close the chuck service mode.
Option 1: Place the dental handpieces in the QUATTROcare PLUS 2124 A,
close the front door and start theservice procedure.
Option 2: After three minutes with no service procedure running, the device
automatically switches back to normal service mode.
6.4.3 Servicing with KaVo SPRAYrotor
Note
KaVo SPRAYrotor is no longer included in the current delivery pro-
gramme.
Follow-up product:
▶QUATTROcare PLUS 2124 A
KaVo recommends servicing the product as part of the reprocessing after each
use, i.e. after each cleaning, disinfection, and before each sterilisation.
▶Take the head off.
▶Unscrew the motor handpiece from the hose.
▶Place matching care insert on the appropriate coupling on the KaVo
SPRAYrotor and cover the product with the Cleanpac bag.
▶Apply spray into the smaller of the two tubes for one second.
See also:
2Instructions for use KaVo SPRAYrotor

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
6 Reprocessing steps in accordance with ISO 17664 | 6.5 Packaging
6.4.4 Servicing with KaVo QUATTROcare
Note
QUATTROcare 2104 / 2104 A is no longer included in the current de-
livery programme.
Follow-up product:
▶QUATTROcare PLUS 2124 A
Cleaning and servicing device with expansion pressure for internal cleaning of
inorganic residues and optimum care.
(no validated cleaning of the interior according to German Robert Koch Institute
(RKI) requirements)
KaVo recommends servicing the product as part of the reprocessing after each
use, i.e. after each cleaning, disinfection, and before each sterilisation.
▶Take the head off.
▶Unscrew the motor handpiece from the hose.
▶Service the product in the QUATTROcare.
See also:
2Instructions for use KaVo QUATTROcare 2104 / 2104A / 2124A
Servicing the clamping chuck
KaVo recommends servicing the chucking system once weekly.
▶Remove the head and spray into the opening using the tip of the spray
nipple.
▶Press the spray key for 1 to 2 seconds.
6.5 Packaging
Note
The sterile goods package must be large enough for the handpiece so that
the packaging is not stretched.
The quality and use of the packaging of the items to be sterilised must satisfy
the applicable standards and be appropriate for the sterilisation process!
▶The medical device must be packed before sterilisation.
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Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
6 Reprocessing steps in accordance with ISO 17664 | 6.6 Sterilisation
18 / 22
6.6 Sterilisation
Sterilisation in a steam steriliser (autoclave) in
accordance with EN 13060 / ISO 17665-1
NOTICE
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶Before each sterilisation cycle, service the medical device with KaVo care
products.
NOTICE
Contact corrosion due to moisture.
Damage to product.
▶Immediately remove the product from the steam steriliser after the steril-
isation cycle.
The KaVo medical device has a maximum temperature resistance up to 138 ℃
(280.4 °F).
Sterilisation parameters:
Select a suitable procedure (depending on the available autoclave) from the fol-
lowing sterilisation processes:
Steriliser with triple pre-vacuum:
▪ at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)
Steriliser using the gravity method:
▪ at least 10 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)
▪ at least 60 minutes at 121 °C -1 °C / +4 °C (250 °F -1.6 °F / +7.4 °F)
▶Use according to the manufacturer's Instructions for Use.
6.7 Storage
Prepared products must be stored appropriately in a dry, dark, cool room such
that they are protected from germs (as far as possible) and dust.
Note
Comply with the expiry date of the sterilised items.

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
7 Auxiliary equipment
7 Auxiliary equipment
Available from dental suppliers.
Material summary Mat. no.
Seal 0.553.1872
Cleanpac 10 units 0.411.9691
Material summary Mat.No.
KaVo Spray 2112 A 0.411.9640
ROTAspray 2142 A 0.411.7520
QUATTROcare plus Spray 2140 P 1.005.4525
Spray head INTRA (KaVo Spray) 0.411.9911
19 / 22

Instructions for use INTRA Motorhandstück PROPHYwiz 181 P - REF 1.003.2278
8 Warranty terms and conditions
20 / 22
8 Warranty terms and conditions
The following warranty conditions apply to this KaVo medical device:
KaVo provides the end customer with a warranty of proper function and guar-
antees zero defects in respect of material and processing for a period of 12
months from the date of the invoice, subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with a free re-
placement or repair. Other claims of any nature whatsoever, in particular with
respect to compensation, are excluded. In the event of default, gross negli-
gence or intent, this shall only apply in the absence of mandatory legal regula-
tions to the contrary.
KaVo shall not be liable for defects and their consequences that have arisen or
may arise from natural wear, improper handling, cleaning or maintenance, non-
compliance with operating, maintenance or connection instructions, calcination
or corrosion, contaminated air or water supplies or chemical or electrical factors
deemed abnormal or impermissible in accordance with KaVo's instructions for
use or other manufacturer's instructions. The warranty granted does not usually
extend to lamps, light conductors made of glass and glass fibres, glassware,
rubber parts, and the colourfastness of plastic parts.
All liability is excluded if defects or their consequences originate from manipula-
tions or changes to the product made by the customer or a third party that is
not authorised by KaVo.
Warranty claims will only be accepted if the product is submitted along with
proof of purchase in the form of a copy of the invoice or note of delivery. The
dealer, purchase date, type, and serial number must be clearly evident from
this document.