KaVo INTRA 3630 N User manual

Instructions for use
INTRA Chirurgie shank 3630 N - REF
0.534.5670

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

Table of contents
1 User instructions ............................................................................................................................................... 4
1.1 Warranty terms and conditions ................................................................................................................. 6
2 Safety ............................................................................................................................................................... 8
2.1 Description of safety instructions .............................................................................................................. 8
2.2 Purpose – Proper use ............................................................................................................................. 10
2.3 Safety instructions .................................................................................................................................. 12
3 Product description ......................................................................................................................................... 15
3.1 Technical Specification ........................................................................................................................... 16
3.2 Transportation and storage conditions ................................................................................................... 18
4 First use .......................................................................................................................................................... 20
4.1 Cooling medium supply .......................................................................................................................... 20
Table of contents 1

5 Operation ........................................................................................................................................................ 22
5.1 Attach the medical device ...................................................................................................................... 22
5.2 Remove the medical device ................................................................................................................... 25
5.3 Inserting the INTRA head ....................................................................................................................... 25
5.4 Removing the INTRA head .................................................................................................................... 27
6 Preparation methods according to ISO 17664 ............................................................................................... 28
6.1 Preparations at the site of use ................................................................................................................ 28
6.2 Disassembling the medical device ......................................................................................................... 29
6.3 Assembling the medical device ............................................................................................................. 30
6.4 Cleaning ................................................................................................................................................. 30
6.4.1 Cleaning: Manual cleaning - external ......................................................................................... 30
6.4.2 Cleaning: Automated external cleaning ...................................................................................... 31
6.4.3 Cleaning: Manual cleaning - internal .......................................................................................... 32
6.4.4 Cleaning: Automated internal cleaning ....................................................................................... 34
Table of contents 2

6.5 Disinfection ............................................................................................................................................. 35
6.5.1 Disinfection: Manual disinfection - external ................................................................................ 36
6.5.2 Disinfection: Manual disinfection - internal ................................................................................. 37
6.5.3 Disinfection: Machine disinfection - external and internal .......................................................... 38
6.6 Drying ..................................................................................................................................................... 39
6.7 Care products and systems - Servicing .................................................................................................. 40
6.7.1 Care products and systems - Servicing: Care with KaVo spray ................................................. 41
6.7.2 Care products and systems - Servicing: Care with the KaVo SPRAYrotor ................................ 42
6.7.3 Care products and systems - Servicing: Care with KaVo QUATTROcare ................................. 43
6.8 Packaging ............................................................................................................................................... 44
6.9 Sterilisation ............................................................................................................................................. 45
6.10 Storage ................................................................................................................................................... 47
7 Tools ............................................................................................................................................................... 49
Table of contents 3

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 Safety/Warning chapter
Important information for users and technicians
User instructions 4

Action request
CE mark (Communauté Européenne). A product bearing this mark
meets the requirements of the applicable EC directive.
Sterilisable in steam up to 135°C (275°F)
Thermodisinfectable
Target group
This document is intended for dentists and their assistants. The section on
starting up is also intended for service technicians.
User instructions 5

1.1 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 free
replacement or repair. 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 have
arisen or may arise from to 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 ac‐
User instructions 6

cordance with KaVo's instructions for use or other manufacturer's instruc‐
tions.
No liability is assumed when defects or their consequences are derived
from manipulations or changes to the product by the customer or a third
party.
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, type and serial number must be clearly
visible on this document.
User instructions 7

2 Safety
2.1 Description of safety instructions
Warning symbol
Structure
DANGER
The introduction describes the type and source of the danger.
This section illustrates the potential consequences of non-observance.
▶The optional step covers necessary measures for avoiding hazards.
Safety 8

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
or moderate physical harm.
WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
Safety 9

DANGER
DANGER
indicates the maximum hazard level. indicates a hazardous situation that
can directly cause death or serious injury.
2.2 Purpose – Proper use
This medical device is
▪ intended for dental treatment only. All other types of use or alterations
to the product are not permitted and can be hazardous. The medical
product is designed to be used with the corresponding heads in the
following applications: surgery e.g. placing an implant, bone augmen‐
tation, sinus lift, dental extraction, implantology and maxillo-facial sur‐
gery.
▪ A medical device according to relevant national statutory regulations.
Safety 10

According to these regulations, this medical device may only be used for
the described application by a knowledgeable user. The following must be
observed:
▪ 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,
▪ protect him or herself, the patient and third parties from danger, and
▪ avoid contamination from the product..
Safety 11

2.3 Safety instructions
WARNING
Hazard to the care provider and patient
Damage, irregular noise during operation, excessive vibration, unusual
build-up of heat.
▶Stop work and seek service support.
Safety 12

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
location, according to instructions, before long periods of nonuse.
CAUTION
Risk of burn injury if the instrument is hot.
Burn injuries in the mouth may be caused if the instrument overheats.
▶Never touch soft tissue with the instrument!
Safety 13

The following individuals are authorized to repair and service KaVo prod‐
ucts:
▪ Technicians at KaVo branches throughout the world
▪ Technicians specially trained by KaVo
To ensure proper function, the medical device must be set up according to
the methods described in the KaVo instructions for use, and the care prod‐
ucts and methods described therein must be used. KaVo recommends
specifying a service interval at the dental office for a licensed shop to clean,
service and check the functioning of the medical device. This service in‐
terval should take into account the frequency of use.
Service may only be provided by repair shops that have undergone training
by KaVo and that use original KaVo replacement parts.
Safety 14

3 Product description
INTRA surgical shank 3630 N (Mat. no. 0.534.5670)
Product description 15

3.1 Technical Specification
Drive speed max. 20,000 rpm
identification 2 green rings
Step-down ratio 30 : 1
Maximum speed 650 min-1
The INTRA surgical shank can be disassembled.
See also: 6.2 Disassembling the medical device, Page 29
Product description 16

The following INTRA heads can be inserted:
▪INTRA head 67 CN (Mat. no. 0.540.8440)
▪INTRA head 68 CN (Mat. no. 0.540.2030)
▪INTRA head 67 H (Mat. no. 0.540.8420)
▪INTRA head 67 I (Mat. no. 0.540.8150)
▪INTRA head 67 IC (Mat. no. 0.540.8430)
▪INTRA head 67 R (Mat. no. 0.540.8320)
▪INTRA Kopf 67 RC (Mat. no. 0.540.8330)
▪INTRA head 67 RIC (Mat. no. 0.540.8340)
Product description 17

The reducing shank can be mounted on all INTRAmatic motors, and motors
with a connection in accordance with ISO 3964/DIN 13940.
3.2 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 20°C to 25°C (68°F to 77°F).
Product description 18