07_2_Instrucciones de uso_rev10 INGLES

INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
I)
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
1of 8
INSTRUCTIONS FOR GENERAL USE
1. Handling and Storage
Reiner Dental Products should be stored in a dry place. The products do not need any other
special storage conditions.
Under no circumstances should the material be taken out of the original packaging and
manipulated without being used, as the product is perfectly packaged and thermo-sealed, and
this action can lead to the loss of properties required for decontamination and disinfection.
When withdrawing the product from its packaging, you should verify that the product is not
damaged in any way, and corresponds accordingly to the description on the label.
2. Warnings and Contraindications
The instructions given are insufficient if used as the only reference for the use of the cited
components. These elements should only be inserted by odontologists who have been fully
trained in the insertion of dental implants. The use of these products without any prior
specific knowledge can lead to component failure and may require implant removal. The
safety of our products is guaranteed only when they are used exclusively by trained
professionals.
Read the instructions carefully on the labels of the products, where you will find the basic
guidelines. Keep a record of the products used in the patient’s personal medical booklet,
stating the name of the product, the reference number, and the lot number. Please inform
Reiner Dental of any defects or complications related to any of its products.
All Reiner Dental products are solely for single use. To reuse the single-use products may lead
to a possible deterioration of the characteristics of the product, which in turn can lead to an
elevated risk in gum or tissue infection and deterioration in the patient’s health.
Contraindications:
It is contraindicated placing dental implants in patients:
-
Medically unfit for an oral surgical procedure
With inadequate bone volume unless an augmentation procedure can be considered
In whom adequate sizes, numbers or desirable position of implants are not reachable to
achieve safe support of functional or eventually parafunctional loads.
Allergic or hypersensitive to titanium alloy (grade 5).
1
INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
2of 8
Warnings:
In general, implant component’s placement and prosthetic design must accommodate
individual patient conditions.
In case of bruxism or unfavourable jaw relationships reappraisal of the treatment option may
be considered.
There is a risk of accidental inhalation and/or ingestion of the products when they are used,
therefore it is necessary to carefully hold onto the products in case of intraoral applications.
The patient should be made aware of any limitations in his treatment, and the need for
maintenance, for example, the need to seek medical assistance if any symptoms or side
effects arise. It should be recommended to the patient to conduct regular dental check-ups
for maintenance of the Reiner Dental products.
The products are not sterilized when sold, and therefore, it is recommended to clean and
sterilize the products before their use (please refer to Section 5).
3. Compatibility
Reiner Dental products should be used with compatible components. Because of this, it is
recommended to view our catalogue, available by request in paper format, or in digital format
on our website (http://www.reinerdental.com/documentos/catalogo_2014_es/index.html),
where the products are classified according to their compatibility to the corresponding
implant systems.
The products are available in different settings for height, diameter and type of connection, to
satisfy the user’s needs. Reiner Dental is not held responsible for the use of its products that
do not coincide with these settings, leaving this in the hands of the physician to reassure the
compatibility of the dimensions and the implant design with the combination of the products
to be used.
4. Cleaning and Sterilization Methods
CAUTION: The product should be cleaned and sterilized before its use.
The recommended procedure for the cleaning of the products is the following:
-
Immerse the devices in a disinfectant solution in an ultrasonic bath 15 min. at 35ºC
and follow the instructions given by the manufacturer of the cleaning solution.
2
INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
-
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
3of 8
Rinse the products with purified water and wrap the devices in sterilization packaging.
To correctly sterilize the products, use a steam sterilizer with pre-vacuum process, at a
temperature of 121⁰C for 15 minutes, with a validated cycle according to the standard EN ISO
17665-1 following the autoclave manufacturer instructions.
5. Labelling
You will find the following information on the current label models of Reiner Dental Products:
In the label model of Reiner Dental updated, you will find the following information:
-
Identification and Reference Number of the product: Description and universal
code of the product.
Lot Number: Production order, from where the product can be traced.
Quantity: Number of units of the product in the packaging.
Manufacturer and the full address of the product’s manufacturer.
CE Marked Label: Certifies the compliance of the applicable legal requisites (in
this case, with the code of the notified department).
Product not sterilized.
Product to be used only for single-use.
Store the product in a dry place.
Do not use if the packaging is damaged.
Instructions: Terms of Use on the Product, available on the website
(www.reinerdental.com).
Rx only: Caution, Federal Law restricts this device to sale by or on the order of a
physician.
Explanations of the symbols used on the labels:
Symbol and Description
Manufacturer
Single use
Standards
EN-ISO 15223-1:2012
BS-EN 980:2008
EN-ISO 15223-1:2012
BS-EN 980:2008
EN-ISO 15223-1:2012
BS-EN 980:2008
Keep dry
EN-ISO 15223-1:2012
BS-EN 980:2008
Do not use if package is damaged.
3
INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
Lot Number
Consult instructions for use
(www.reinerdental.com/)
EN-ISO 15223-1:2012
BS-EN 980:2008
EN-ISO 15223-1:2012
BS-EN 980:2008
CE Marked Label
Directiva 93/42/CEE y su
modificación 2007/47.
Reference number
EN-ISO 15223-1:2012
BS-EN 980:2008
EN-ISO 15223-1:2012
BS-EN 980:2008
Non- sterile
QTY
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
4of 8
Preparedbymanufacturer
Quantity
Table1: Symbols on Labels
II)
INDICATIONS FOR USE
Reiner Dental Abutments are intended for use as accessories to endosseous dental implant, to
support a prosthetic device in a partially or completely edentulous patient. A dental abutment
is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla.
The prosthesis can be screw retained or cement retained to the abutment.
Restorative Components:
-
Healing Abutments are intended for use to shape and maintain the soft tissue opening
during healing.
Provisional or temporary abutments are intended for use to support a prosthesis in the
mandible or maxilla for up to 180 days during endosseous and gingival healing, and are
for non occlusal loading of provisional restorations. The prosthesis will be mechanically
retained to the abutment system.
Healing caps, temporary abutments and impression abutments are used for a limited
time
-
-
Definitive titanium abutments are intended to be placed into dental implants to
provide support for prosthetic cement-retained reconstructions, such as crowns and
bridges.
Screw components are intended for use as accessories to endosseous dental implants
for retention of screw retained abutments to the dental implant.
Definitive abutments and screw components are intended for a definitive use.
4
INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
III)
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
5of 8
INSTRUCTIONS FOR SPECIFIC USE OF CLASS IIb PRODUCTS
1. Abutments
The abutments are used to restore a dental implant, acting like the base for the prosthesis.
They are available in different shapes and sizes to respond to different needs:
a.
Cobalt-chrome cast-to abutments
The base guarantees maximum precision as it is made from cobalt-chrome with a machined
base, and a castable plastic body (outstanding medical material of the highest quality) allowing
simple and flexible processing.
For casts over Cr-Co bases, it is only recommended to use Cr-Co. If another metal is used that
is not Cr-Co, cracks may appear due to the different coefficients of the bases. For the preheating of the casts, in particular the Cr-Co one, the temperature should be 950⁰C.
b.
Titanium Abutments
There are two types of titanium abutments available:
i.
Straight Abutments: The base permits it to contour and adapt to the prosthesis. They
are made from Grade 5 Titanium to ensure maximum compatibility and durability.
ii.
Angular Abutments: In general, they are angled at 15ºand 25º, which can be adapted
to the majority of clinical cases. They are also made from Type 5 Titanium, which
increases the holding power of the cemented prosthesis. Its straight base allows for a
reduction in the vestibular surface, adapting itself to each clinical case.
It is important to verify the compatibility of the implant model to be used. You should avoid
causing any damage around the area where the implant is connected, so care must be taken if
carving or machining in this area. A radiography is recommended in the height of the junction
of the union with the perpendicular axis of said union,once the implant is fixed, for
verification.
c.
Interfaces
The titanium interface is a transepithelial base which serves to support the prosthesis. It is
made from medical Grade 5 Titanium, a material recommended for its biocompatibility,
mechanical strength and hardness. As such, its use provides greater security and adjustment to
the most delicate part of the prosthesis with the implant setting.
It can be used together with its own castable cap or to reinforce a zirconium structure in high
stress areas, thus prolonging the useful life of the prosthesis. Its design and size ensure a
5
INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
6of 8
stable connection. Its function is to improve the fit of the prosthesis to the implant, and to the
base of the clamping screw on the interface, and not on the zirconium structure or cast metal
structure.
It can also be used for performing scans, either contactor digital. For this use, a flat face is
available which provides us with a clear positioning mechanism.
d.
Multiunit Converters
Titanium attachments that convert internal connections into a tapered external connection. It
allows the lifting of the emergence profile and transforms the internal connections to the
external connections to meet the requirements of special clinical cases. It is also made from
medical Grade 5 Titanium. It is available in several heights and angulations (in general, from 1
to 5mm high, and in straight and angular types 17 and 30 degrees).
2. Screws
The screws are made from Grade 5 Titanium, recommended for its biocompatibility, its
mechanical strength and hardness. It serves to attach the abutment or prosthesis to the
implant (clinical case screw) or to the laboratory analogue (laboratory case screw).
Recommendations for its specific use include:
-
Use for screwing (or unscrewing) the right tool (refer to the list of models by
screw head). If in doubt, contact Reiner Dental.
-
The screws are for single-use only. It is not recommended to use the screws again
after their removal, not even in the laboratory, due to the possible deterioration
of their behaviour. It is vitally important to not use clinical case screws that have
been previously used in a dental laboratory.
-
The recommended torque for definitive prostheses are described on the product
labels. Please follow the following standards in case these are missing:
MetricScrewThread (mm)
M 1.4
M 1.6
M 1.8
M2
M 2.5
Recommended Torque
(N-cm)
≈ 15
≈ 25
≈ 25
≈ 30
≈ 35
6
INSTRUCTIONS FOR USE OF DENTAL
ATTACHMENTS
CODE:
IFU
REVISION:
7
DATE: 2015-01
PAGE.
7of 8
3. Healing Caps
The healing cap is placed on the implant, to protect it against masticatory stress during the
osseointegration phase. It is made from Grade 5 Titanium and available in several heights for
each implant system. Its height is defined by the distance that assures its correct functioning
and avoids the transmission of tension from masticating.
If in doubt, please contact us.
Reiner Medical SL
Pol Ind Itziar, parcela H3,
20820 Deba (Guipuzcoa) – Spain
Telephone 943 606 286 /
email: info@reinermicrotek.com / www.reinerdental.com
0434
7