KaVo RONDOflex plus 360 User manual

Instructions for use
RONDOflex plus 360

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

Contents 1
Contents
Contents ................................................................................................................................................................. 1
User instructions ..................................................................................................................................................... 4
Purpose – Proper use ..........................................................................................................................................6
Instructions ..........................................................................................................................................................8
Warranty terms and conditions ..........................................................................................................................10
Safety ................................................................................................................................................................... 12
Description of safety instructions .......................................................................................................................12
Description of safety instructions: Warning symbol ..................................................................................... 12
Description of safety instructions: Structure ................................................................................................ 13
Description of safety instructions: Description of hazardous steps ............................................................. 14
Safety instructions .............................................................................................................................................16
Product description ............................................................................................................................................... 20
Technical data ...................................................................................................................................................21

Contents 2
Transportation and storage conditions .............................................................................................................. 23
First use ................................................................................................................................................................ 24
Checking the MULTIflex Coupling .....................................................................................................................25
Changing the RONDOflex plus .........................................................................................................................26
Changing the RONDOflex plus: Mounting .................................................................................................. 26
Changing the RONDOflex plus: Disconnection ........................................................................................... 27
Filling the powder container ..............................................................................................................................28
Changing the cannula .......................................................................................................................................30
Changing the cannula: Insertion ................................................................................................................. 30
Changing the cannula: Removal ................................................................................................................. 32
Check for malfunctions ......................................................................................................................................... 33
Setup methods according to DIN EN ISO 17664 ................................................................................................. 34
Preparation at the site of use ............................................................................................................................34
Cleaning ............................................................................................................................................................35
Cleaning: Cleaning the cannulas ................................................................................................................ 38

Contents 3
Disinfection ........................................................................................................................................................39
Drying ................................................................................................................................................................42
Care products and systems ...............................................................................................................................43
Packaging ..........................................................................................................................................................44
Sterilisation ........................................................................................................................................................45
Storage ..............................................................................................................................................................47
Accessories .......................................................................................................................................................... 48

User instructions 4
User instructions
Dear user,
KaVo hopes that you enjoy your new high-quality product. Following the
instructions below will allow you to work smoothly, economically and safely.
Symbols
See the section Safety/Warning Symbol
Important information for users and technicians
Disinfectable with heat

User instructions 5
Sterilisable up to 138°C
CE mark (Communauté Européenne). A product with this mark
meets the requirements of the relevant EC directives, i.e. the ap‐
plicable standards in Europe.
Action request
Target group
This document is intended for dentists and their assistants. The section on
starting up is also intended for service technicians.

User instructions 6
Purpose – Proper use
The RONDOflex plus is an air abrasion system that accelerates aluminium
oxide particles in an air jet to a high speed to abrade material from the
surface of teeth.
The RONDOflex plus is suitable for the following indications:
▪ Preparation for sealing fissures
▪ Opening and expanding fissures
▪ Creating micromechanical retention for adhesive restorations to the
enamel and dentin with a subsequent acid etching technique
▪ Preparing small carious defects
▪ Preparing the adhesive surfaces of brackets
▪ Cleaning and removing residual adhesive from bridges, crowns, etc.
(extraoral)
This medical device is:

User instructions 7
▪ only for dental treatment by a dental professional. The product may not
be changed or used for any other purpose since this may be hazar‐
dous.
▪ A medical device according to relevant national statutory regulations.
According to these provisions, this medical device may only be used for the
described application by a knowledgeable user. The following must be ob‐
served:
▪ 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
▪ use the equipment for the proper purpose.
▪ to protect himself, the patient and third parties from danger.
▪ to avoid contamination from the product.

User instructions 8
Instructions
Practice creating a cavity in a disposable mirror with the RONDOflex plus
to familiarize yourself with the device.
Use surgical loupes or a microscope to check the minimally invasive work.
Note
It is recommendable to use a disposable mirror during treatment.
To create cavities
▶ Focus on a point
▶ An intermittent powder jet can improve abrasion.
▶ Working distance: 1 mm
▶ Hold the powder jet perpendicular to the surface of the tooth

User instructions 9
To roughen surfaces, for example adhesive surfaces of brackets
▶ Use a brushing motion
▶ Distance: 1 mm
▶ Hold the powder jet perpendicular to the surface of the tooth
Extraoral use
You can of course also use the RONDOflex plus outside of the oral cavity.
When for example adhesive residue needs to be removed from crowns.
Remember that dust accumulates around the working field. This can impair
the function of nearby devices and instruments. You should therefore pro‐
vide suitable dust extraction. Objects that may contact the powder jet
should be protected with a cloth. Otherwise, the surface may become da‐
maged. if necessary, removed dust-sensitive objects from the affected
environment.

User instructions 10
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
guarantees zero defects in respect of material and processing for a period
of 12 months from date of invoice, subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with a repair
or free replacement. Other claims of any nature whatsoever, in particular
with respect to compensation, are excluded. In the event of default, gross
negligence or intent, this shall only apply in the absence of mandatory legal
regulations to the contrary.
KaVo cannot be held liable for defects and their consequences that are or
may be due to natural wear, improper handling, cleaning or maintenance,
non-compliance with operating or connection instructions, calcination or
corrosion, contaminated air or water supplies or chemical or electrical fac‐
tors deemed abnormal or impermissible in accordance with KaVo's instru‐
ctions for use or other manufacturer specifications. The warranty does not

User instructions 11
usually cover lamps, light conductors made of glass and glass fibres, glas‐
sware, rubber parts and the colourfastness of plastic parts.
Defects or their consequences that can be attributed to interventions on or
changes made to the product by the customer or a third party not authorised
by KaVo are excluded from the warranty.
Service 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/delivery
note. The dealer, purchase date, unit number or type and serial number
must be clearly visible on this document.

Safety 12
Description of safety instructions: Warning symbol
Warning symbol

Safety 13
Description of safety instructions: Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes the potential consequences of non-observance.
▶ The optional step contains necessary measures for avoiding hazards.

Safety 14
Description of safety instructions: Description of hazardous steps
The herein cited safety instructions with the three levels of danger will help
avert property damage and injury.
CAUTION
CAUTION
indicates a hazardous situation that can lead to property damage or minor
to moderate injury.
WARNING
WARNING
indicates a hazardous situation that can lead to serious injury or death.

Safety 15
DANGER
DANGER
indicates a maximum hazardous situation that can directly cause serious
injury or death.

Safety 16
Safety instructions
CAUTION
Premature wear and malfunction due to improper storage or longer peri‐
ods of nonuse.
Reduced product life.
▶ The medical device should be cleaned, serviced and placed in a dry
stored location according to instructions before long periods of non‐
use.
CAUTION
Injury or damage due to wear.
Irregularities in the product.
▶ Stop work and seek service support.

Safety 17
CAUTION
Hazard from aerosols.
Infection from aerosols.
▶ Never work without safety goggles, a dust mask (P 2), protective glo‐
ves, particle-impervious clothes and a hood.
▶ We recommend using a dental dam and a dust extraction system.
WARNING
Damage from soiled and moist compressed air.
Contaminated and moist compressed air can cause malfunctions and lead
to premature bearing wear.
▶ In general, ensure dry, clean uncontaminated compressed air accor‐
ding to EN ISO 7494-2.

Safety 18
CAUTION
Hazard from the jet directly contacting the gingiva and the insufflation of
blown air into open wounds.
This can cause injury, air embolisms as well as skin emphysema.
▶ Keep the jet from directly contacting the gingiva and avoid the insuf‐
flation of blown air into open wounds.
CAUTION
Cleansers and disinfectants can attack the plastic housing.
This can form hairline cracks and cause other damage which can create
a hazardous situation.
▶ The RONDOflex plus therefore has to undergo a safety check every
two years.
Note
Never use the RONDOflex plus on patients with chronic diseases of the
respiratory passages.