Instructions for use INTRA LUX KL 701 - 1.001.8776

Transcription

Instructions for use
INTRA LUX KL 701 - 1.001.8776
Distributed by:
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone +49 7351 56-0
Fax +49 7351 56-1488
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com
Contents
3 / 62
Table of contents
1 User instructions....................................................................................................................................... 6
2 Safety........................................................................................................................................................ 8
2.1 Description of safety instructions....................................................................................................... 8
2.1.1 Warning symbol.................................................................................................................... 8
2.1.2 Structure............................................................................................................................... 8
2.1.3 Description of danger levels................................................................................................. 9
2.2 Safety instructions........................................................................................................................... 11
3 Product description................................................................................................................................. 19
3.1 Purpose – Intended use .................................................................................................................. 19
3.2 Technical Specifications.................................................................................................................. 22
3.2.1 Operation with high-pressure lamp..................................................................................... 25
3.3 Transportation and storage conditions............................................................................................ 26
3.4 Operating conditions........................................................................................................................ 27
4 Start up and shut down........................................................................................................................... 28
Contents
4 / 62
5 Operation................................................................................................................................................ 29
5.1 Connecting the drive motor to the supply hose............................................................................... 29
5.2 Regulating the spray water.............................................................................................................. 31
5.3 Attaching attachment instruments to the drive motor...................................................................... 32
5.4 Removing the attachment instrument from the drive motor............................................................. 35
6 Troubleshooting...................................................................................................................................... 36
6.1 Check for malfunctions at initial startup........................................................................................... 36
6.2 Troubleshooting............................................................................................................................... 39
6.2.1 Replacing the high-pressure lamp...................................................................................... 39
6.2.2 Replacing the O-rings......................................................................................................... 41
7 Reprocessing steps in accordance with ISO 17664............................................................................... 43
7.1 Preparation at the site of use........................................................................................................... 43
7.2 Cleaning.......................................................................................................................................... 44
7.2.1 Manual cleaning - external.................................................................................................. 44
7.2.2 Automated external cleaning.............................................................................................. 46
7.2.3 Manual cleaning - internal................................................................................................... 47
Contents
5 / 62
7.2.4 Automated internal cleaning...............................................................................................
7.3 Disinfection......................................................................................................................................
7.3.1 Manual disinfection - external.............................................................................................
7.3.2 Manual disinfection - internal..............................................................................................
7.3.3 Automated disinfection - external and internal....................................................................
7.4 Drying .............................................................................................................................................
7.5 Care products and systems - Servicing...........................................................................................
7.6 Packaging........................................................................................................................................
7.7 Sterilisation......................................................................................................................................
7.8 Storage............................................................................................................................................
8 Auxiliary equipment.................................................................................................................................
9 Warranty terms and conditions...............................................................................................................
49
49
50
51
52
52
53
54
55
56
57
58
1 User instructions
6 / 62
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the
instructions below you will be able to work smoothly, economically and
safely.
© Copyright by KaVo Dental GmbH
Symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
1 User instructions
7 / 62
Action request
CE mark (European Community). A product bearing this mark
meets the requirements of the applicable EC directive.
Non-sterilisable
Target group
This document is intended for dentists and their assistants. The section on
starting up is also intended for service technicians.
2 Safety
8 / 62
2 Safety
2.1 Description of safety instructions
2.1.1 Warning symbol
Warning symbol
2.1.2 Structure
DANGER
The introduction describes the type and source of the haz‐
ard.
This section describes potential consequences of non-compliance.
2 Safety
9 / 62
▶ The optional step includes necessary measures for hazard prevention.
2.1.3 Description of danger levels
The safety instructions listed here, together with the three levels of danger
will help avert property damage and injury.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild
to moderate injuries.
2 Safety
10 / 62
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause
death or fatal injury.
2 Safety
11 / 62
2.2 Safety instructions
WARNING
Hazard from incorrectly reconditioned products.
An infection hazard exists from contaminated products.
▶ Take suitable personal protective measures.
2 Safety
12 / 62
WARNING
Hazard to the care provider and patient.
Irregular running noise, significant vibration, overheating, imbalance or in‐
sufficient grip.
▶ Stop working and contact service support.
WARNING
Risks from electromagnetic fields.
The functions of implanted systems (such as pacemakers) can be influ‐
enced by electromagnetic fields.
▶ Ask patients before treatment and counsel them about the risks.
2 Safety
13 / 62
WARNING
Electrical power.
Electrical shock from incorrectly connecting a non-KaVo system to the
medical device.
▶ When installing and operating the medical device on treatment equip‐
ment and furnishings from other manufacturers, observe the provisions
of "Protection from electrical shock," "Leakage current," and "Not
grounding the applied part" in accordance with DIN EN IEC 60601-1.
▶ Make sure that the medical device is combined only with a treatment
unit that has been released by KaVo.
2 Safety
14 / 62
WARNING
Hazard from direct exposure to radiation.
Blinding.
▶ Do not look directly into the lamp.
2 Safety
15 / 62
CAUTION
Risks due to lack of control equipment.
Hazards can arise if control equipment is not available for changing the
speed and the direction of rotation.
▶ The dental treatment unit connected must have control equipment for
changing the speed and direction of rotation.
▶ A note is to be included in the documents accompanying the dental
treatment unit, referring to responsibilities arising from safety, reliability
and performance.
▶ The medical device may only be combined with a treatment centre re‐
leased by KaVo.
2 Safety
16 / 62
CAUTION
Damage from soiled and moist cooling air.
Contaminated and moist cooling air can cause malfunctions and lead to
premature bearing wear.
▶ Make sure that the supply of cooling air is dry, clean, and uncontami‐
nated in accordance with DIN EN ISO 7494-2.
CAUTION
Damage due to contaminated water.
Ensure that the water quality generally complies with DIN EN ISO 7494-2.
Permissible pH value 7.2 to 7.8.
2 Safety
17 / 62
CAUTION
Premature wear and malfunctioning from improper storage
during long periods of nonuse.
Reduced product life.
▶ The medical device should be cleaned, serviced and stored in a dry lo‐
cation, according to instructions, before long periods of nonuse.
Note
This medical device in conjunction with the dental treatment unit meets
the requirements of DIN EN IEC 60601-1.
2 Safety
18 / 62
The following individuals are authorized to repair and service KaVo prod‐
ucts:
▪ Technicians at KaVo branches throughout the world
▪ Technicians specially trained by KaVo
The present product is subject to the EC Directive on used electrical and
electronic devices and must be disposed within Europe at a special facili‐
ty. Further information can be obtained from KaVo or a dental distributor.
3 Product description
19 / 62
INTRA LUX KL 701 (Mat. no. 1.001.8776)
3.1 Purpose – Intended use
Indications for use:
The motor is:
20 / 62
▪ an electrical low-voltage motor for dental purposes according to DIN
EN ISO 11457 and DIN ISO 80601-2-60 and classified as a type B ap‐
plied part
▪ intended to drive / operate a dental handpiece / contra-angle hand‐
piece equipped with a handpiece connection according to ISO 3964
▪ not approved for use in areas at risk of explosion
▪ intended only for dental treatment by a dental professional; the prod‐
uct must not be modified or used for any other purpose since this may
be hazardous
▪ a medical device according to relevant national statutory regulations
21 / 62
Proper use:
According to these regulations, this medical device may only be used for
the described application by a knowledgeable user. You need to comply
with the following:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
According to these regulations, the user is required to:
▪ only use equipment that is operating correctly,
▪ adhere to the specified intended use
▪ protect him or herself, the patient and third parties from danger, and
22 / 62
▪ avoid contamination from the product.
3.2 Technical Specifications
Motor electronics
KL2 (Mat. no. 0.696.0161), KL3
(Mat. no. 1.004.4317), KL4 (Mat. no.
1.006.1037), and ET-PLUS (Mat. no.
1.001.8321)
Motor voltage rating
22 V AC
Motor speed rating
40,000 rpm
Motor torque rating
2.7 Ncm
Information about the connected loads on the device side should be ob‐
tained from the manufacturer.
23 / 62
Mode
Intermittent operation 2 min. on, 5
min. off
Air exit of the motor coupling
7.5 ± 1.5 NL/min
Amount of cooling air
20 ± 2 NL/min
Cooling air
2.5 - 4.5 bar (36 - 65 psi)
Spray air
1.0 - 2.5 bar (15 - 36 psi)
Spray water
0.8 - 2.0 bar (12 - 29 psi)
Air requirements
Air quality in accordance with DIN
EN ISO 7494-2
dry, oil-free, dirt-free, non-contami‐
nated
Air filter, supplied by customer
< 20 µm
24 / 62
Water requirements
Water quality in accordance with
DIN EN ISO 7494-2
Tap water
pH
7.2 - 7.8
Water filter, supplied by customer
< 80 µm
All dental handpieces and contra-angle handpieces can be connected to a
DIN EN ISO 3964 compliant handpiece connection.
Note
Please comply with the Instructions for Use of the product to which the IN‐
TRA LUX motor is to be attached. Check the suitability of the product for
operation with the INTRA LUX motor.
25 / 62
Note
Designed for operation on KaVo units:
▶ ESTETICA E80 / ESTETICA E70 / ESTETICA E50 / ESTETICA E30 /
Status 1080 / Globus 1078 / Primus 1058 / ELECTROtorque Plus
3.2.1 Operation with high-pressure lamp
Operating voltage of the high-pres‐
sure lamp
max. 3.2 V DC
High-pressure lamp power
max. 2.5 Watt
26 / 62
3.3 Transportation and storage conditions
CAUTION
It is hazardous to start up the medical device after it has
been stored strongly refrigerated.
This can cause the medical device to malfunction.
▶ Prior to start-up, very cold products must be heated to a temperature
of 20oC to 25oC (68oF to 77oF).
Temperature: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% RH to 95% RH absence of condensation
27 / 62
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture
3.4 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)
4 Start up and shut down
28 / 62
4 Start up and shut down
WARNING
Hazard from contaminated products.
Infection hazard for care provider and patient.
▶ Prior to initial commissioning and after each use, reprocess the prod‐
uct and accessories.
WARNING
Disposal of the product in the appropriate manner.
Prior to disposal, the product and accessories must be appropriately pre‐
pared or sterilised.
5 Operation
29 / 62
5 Operation
Note
At the beginning of each workday, the water-conducting systems should
be rinsed for at least 2 min. without the instrument being attached; if there
is a risk of contamination from reflux or back suction, the system must be
rinsed for 20-30 seconds.
5.1 Connecting the drive motor to the supply hose
▶ Slightly spray the O-rings on the supply hose with KAVO Spray.
5 Operation
30 / 62
▶ Connect the motor to the supply hose and twist.
ð The correct attachment position is attained automatically.
▶ Screw tight the hose-side union nut in the direction of the arrow.
Note
Details on the hose connection can be obtained from the manufacturer.
5 Operation
31 / 62
5.2 Regulating the spray water
CAUTION
Hazard from insufficient amount of spray water.
Damage to the cog due to overheating.
▶ Make sure that the motor speed is appropriate for the preparation on
hand.
▶ Use the requisite minimal amount of spray water.
5 Operation
32 / 62
▶ Rotate the regulating sleeve of the motor hose to adjust the water
portion of the spray in a continuous manner.
ð When the regulating sleeve is locked into place, the passage is
opened as much as is possible.
5.3 Attaching attachment instruments to the drive motor
All handpieces and contra-angle handpieces can be mounted with the IN‐
TRAmatic connection DIN EN ISO 3964.
5 Operation
33 / 62
CAUTION
Attaching and removing instruments during rotation.
Can cause damage.
▶ Do not attach or remove the instruments during rotation.
▶ Only use reliable handpieces.
5 Operation
34 / 62
CAUTION
Make sure that the handpiece is firmly seated on the motor.
The handpiece detaching inadvertently from the motor during treatment is
a hazard to the patient and user.
▶ Pull on the instrument before each use to check that it is engaged and
locked in place.
▶ Place the KaVo handpiece on the motor, lightly press it against the
motor while turning it slightly in the direction of the arrow until the
latch can be heard to lock into place.
5 Operation
35 / 62
5.4 Removing the attachment instrument from the drive
motor
▶ Pull the instrument off the motor in axial direction.
6 Troubleshooting
36 / 62
6 Troubleshooting
6.1 Check for malfunctions at initial startup
CAUTION
Danger due to hot bulb.
Burning hazard.
▶ Do not touch the bulb after it has been used. Let the lamp cool off.
6 Troubleshooting
37 / 62
CAUTION
Missing or damaged O-rings.
Malfunctions and premature failure.
▶ Make sure that all O-rings are on the coupling and undamaged.
Note
Stop working if the O-ring is missing or damaged.
The motor becomes too hot while idling:
▶ Check the amount of cooling air.
The motor runs too hot under load:
6 Troubleshooting
38 / 62
▶ Also check the handpiece.
When the speed drops or is uneven:
▶ Check the hose connection.
Motor coupling O-ring is missing:
▶ Replace O-rings.
6 Troubleshooting
39 / 62
6.2 Troubleshooting
6.2.1 Replacing the high-pressure lamp
CAUTION
Danger due to hot bulb.
Burning hazard.
▶ Do not touch the bulb after it has been used. Let the lamp cool off.
▶ Unscrew the sleeve in counterclockwise direction.
6 Troubleshooting
40 / 62
▶ Push the lamp out of the recess with your fingernail and remove it.
▶ Inset a new lamp into the recess such that the contact surfaces align
with those of the recess.
▶ Push the lamp into the mount.
▶ Place the sleeve on the motor and screw it tight.
6 Troubleshooting
41 / 62
6.2.2 Replacing the O-rings
CAUTION
Vaseline, oils or other greases.
This can cause malfunctions.
▶ Do not use Vaseline, oils or other greases on this medical device.
Note
The O-rings on the motor attachment may only be lubricated with a cotton
ball which has been wetted with KAVO Spray.
▶ Press the O-rings between your fingers to form a loop.
6 Troubleshooting
42 / 62
▶ Slide the O-rings forwards and remove them.
▶ Insert new O-rings into the grooves and spray them with KaVo spray.
7 Reprocessing steps in accordance with ISO 17664
43 / 62
7.1 Preparation at the site of use
WARNING
Hazard from incorrectly reconditioned products.
An infection hazard exists from contaminated products.
▶ Take suitable personal protective measures.
▶ Remove all residual cement, composite or blood immediately.
▶ Recondition the medical device as soon as possible after treatment.
▶ The medical device must be dry when transported for reconditioning.
44 / 62
▶ Do not place it in a solution or similar.
7.2 Cleaning
CAUTION
Malfunctions from cleaning in the ultrasonic unit.
Defects in the product.
▶ Only clean manually!
7.2.1 Manual cleaning - external
Accessories required:
▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Soft lint-free clean cotton cloth
45 / 62
▶ Screw off the sleeve turning counterclockwise and pull off from the
front of the motor.
▶ Wipe the motor body and handpiece coupling with a dry cloth and re‐
move any residual oil.
46 / 62
▶ Wipe the inside and outside of the motor sleeve with a water-soaked
cotton cloth and then dry it with a soft cotton cloth.
▶ To maintain uninterrupted operation, it is recommended to clean the
grooves for the O-rings semi-annually. For this purpose, take all 3 Orings off the coupling peg and remove all adhering particles and lime
scale from the grooves using a wet, lint-free cotton cloth.
7.2.2 Automated external cleaning
Not applicable.
7.2.3 Manual cleaning - internal
Not applicable.
47 / 62
48 / 62
Note
The dental motor is an integral part of the water-conducting
system of the treatment centre. Germs and bio-films may
be formed in the lines. This is associated with an infection
risk.
This results in requirements for the workflow at the practice:
▶ All withdrawal sites of the water-conducting systems must be rinsed for
2 minutes at the start of the workday (without any transfer handpieces
attached).
▶ After each treatment of a patient, the cooling water withdrawal sites
should be rinsed with air and/or water for at least 20 seconds.
▶ The permanent/intensive germ reduction of the water-conducting sys‐
tems is managed through the unit. Please note the compatibility of the
materials with the disinfectants used.
49 / 62
7.2.4 Automated internal cleaning
Not applicable.
7.3 Disinfection
CAUTION
Malfunctioning from using a disinfectant bath or chlorinecontaining disinfectant.
Defects in the product.
▶ Disinfect manually only!
50 / 62
7.3.1 Manual disinfection - external
KaVo recommends the following products based on compatibility of the
materials. The microbiological efficacy must be ensured by the disinfec‐
tant manufacturer.
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▪ FD 322 made by Dürr Dental
▪ CaviCide made by Metrex
Consumables required:
▪ Cloths for wiping off the medical device.
51 / 62
▶ Spray the disinfectant on a cloth, then thoroughly wipe down the
medical device and leave the disinfectant to soak in according to the
instructions from the disinfectant manufacturer.
▶ Follow the instructions for use of the disinfectant.
Note
Do not place the motor in disinfectant baths!
7.3.2 Manual disinfection - internal
Not applicable.
The interior of this product is not designed for manual disinfection.
52 / 62
7.3.3 Automated disinfection - external and internal
Not applicable.
7.4 Drying
Note
Store motors in a dry place. Exposure to moisture may cause corrosion
and other damage to the product.
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.
53 / 62
▶ Carefully apply low doses of compressed air to the inside and outside
of the disassembled sleeve until no droplets of water are visible any
longer.
Automatic Drying
Not applicable.
7.5 Care products and systems - Servicing
The bearing sites of the INTRA LUX motors are provided with a high-quali‐
ty, lifelong lubrication.
54 / 62
Note
Excess fluids exiting the contra-angle handpiece (oil, cleanser or disinfec‐
tant) can penetrate the motor and cause a malfunction. Please only care
for all instruments according the care instructions accompanying the in‐
struments.
Note
Remove the motor sleeve once a week, and wipe off the inside and out‐
side of the motor sleeve with a wet cloth. Wipe off the outside of the open
motor with a dry cloth.
7.6 Packaging
Not applicable.
55 / 62
Note
Only the removable motor sleeve can be sterilised in an autoclave at up to
135 oC.
7.7 Sterilisation
Not applicable.
56 / 62
Note
Only the removable motor sleeve can be sterilised in an autoclave at up to
135 oC.
7.8 Storage
Prepared products must be stored, protected from germs (as far as possi‐
ble) and dust, in a dry, dark, cool room.
8 Auxiliary equipment
57 / 62
8 Auxiliary equipment
Available from dental suppliers.
Material summary
Mat. no.
High-pressure lamp
0.553.3881
O-ring
0.200.6120
Airflow measuring tube
0.411.4441
9 Warranty terms and conditions
58 / 62
The following warranty conditions apply to this KaVo medical device:
KaVo provides the end customer with a warranty of proper function and
guarantees zero defects in respect of material and processing for a period
of 36 months from the date of the invoice, subject to the following condi‐
tions:
In case of justified complaints, KaVo will honour its warranty with a free re‐
placement or repair. Other claims of any kind 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 reg‐
ulations to the contrary.
KaVo shall not be liable for defects and their consequences that have aris‐
en or may arise from natural wear, improper handling, cleaning, mainte‐
nance or servicing, non-compliance with operating, maintenance or con‐
nection instructions, calcination or corrosion, contaminated air or water
59 / 62
supplies or chemical or electrical factors deemed abnormal or impermissi‐
ble in accordance with KaVo's instructions for use or other manufacturer's
instructions. The warranty granted does not usually extend to lamps, opti‐
cal fibres 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 ma‐
nipulations of 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.
60 / 62
1.002.2982 · kb · 20141105 - 06 · en

Instructions for use INTRA LUX KL 701 - 1.001.8776

Transcription

Similar documents

- KaVo. Dental Excellence.

T-REX Manual - RC Helitechnics

COMMERCIAL BOOTHS

Q Series Brochure - International.indd

Installation of Robo-Focus Motor

N3 Quick Start Guide - TECO-Westinghouse Motors (Canada) Inc.

C-System

The perfect fit for your daily challenges.

Honda 300ex National Race Machine

Power Lead screw for 7x12 lathes

Automatic Bases

Superiority is at hand - all day, every day.

ShoreStation Installation Guide * DANGER

Work Steps for the Reprocessing of KaVo Handpieces, Turbines and

Instructions for use DURAtec Prophy 2953