MERZ DENTAL 907354 CreaPRINT Instruction Manual

: June 3, 2024
: MERZ DENTAL

MERZ DENTAL 907354 CreaPRINT

Instructions for use, please read carefully!

Intended purpose

Liquid acrylate mixture for the additive production of steam-sterilisable drilling templates in dentistry using tub-based photopolymerisation at 385 nm.
Classification according to MDR (EU) 2017/745
Class I medical device for temporary contact with intact and / or injured mucous membranes.

Patient target groups

All genders and age groups
Intended users
Dental professionals
Indication
Total or partial tooth loss
Contraindication
Hypersensitivity to one of the components Composition
Diurethane dimethacrylate, Mix of isomers (UDMA)
Ethylene dimethacrylate
1,4-Butanediol dimethacrylate
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO)
2-[[(butylamino)carbonyl]oxy]ethyl acrylate
Propoxylated glycerol triacrylate
Mequinol
Colourants

Symbols

Article number
Batch
Use by
Colour
Wavelength
Protect from the sun
Observe Instructions for use (IfU)
Safety notes in the IfU
Reference that the product is a medical device
Manufacturer

Physical data

Property	Value	Test method

Acrylate mixture
Viscosity| 650 ± 100 mPa·s| ISO 3219
End product
Flexural strength| > 80 MPa| ISO 10477
Modulus of elasticity| 3150 ± 130 MPa| ISO 10477*

*based on

CAD design

Dimension the material thickness so that the wall thickness after completion is at least 1 mm for reasons of strength and a maximum of 7 mm for reasons of complete postcuring.

CAM processing

Use the correct printer / material combination. Released parameter sets are available for download at www.merz-dental.de
The material is designed for layer thicknesses / slices of 50 µm and 100 µm.
To avoid dimensional errors in the z-axis, it is recommended to use support structures to place the design on a base plate with a perforated pattern, e. g. a hexagonal grid.
A design aligned parallel to the construction platform has a lower printing time than a vertically aligned one, due to the lower number of layers, but this also requires significantly more support structures, which must be manually removed and cleaned in post-processing. It is recommended to angle the designs between 30° and 90°.
The use of predetermined breaking points / tapering of the supports towards the component is recommended, as this reduces the risk of damaging the surface when removing the supports.
When positioning the supports, make sure that overhangs are supported and, wherever possible, fitting surfaces are not pinned to minimise reworking.

Additive fabrication on a 3D-printer

Use the parameter set corresponding to the material.
For printing, use the same layer thickness as in CAM planning, otherwise inaccuracies in fit and / or misprints may occur.
Ensure clean work. Contamination, especially at the optical window to the projector and at the material tub (vat), can cause errors on the printed part or misprints.
When filling the material tub, make sure that the material is exposed to ambient light as briefly as possible and that the filling level markings are observed.
The further procedure, as well as the operation of the printer, are described in the associated manual.
After printing, the design should remain suspended in the printer for 10 minutes to allow excess print material to drip off the surface. This saves material and prolongs the service life of the cleaning fluid.

Post-processing

Post-processing should be performed immediately after completion of printing to minimise the risk of contamination and unwanted polymerisation of material still present on the surface.

Process step

| Time required [min]
---|---

1

| Allow the design still in the printer after the printing process has been completed to drip off.|

10

2| Remove construction platform, remove design and carefully cut off supports.|

5

3

| Clean the design in a closed container with propan-2-ol; isopropanol cleaning fluid (≥ 99%) for 5 minutes in an ultrasonic bath.

Note: Do not heat the design in the cleaning solution and do not leave it in the solution for a long period.

|

5

4

| Use a pair of tweezers to remove the printed part from the cleaning fluid, blow it off with compressed air if necessary, and let it dry.

Recommendation: Dry the design in an oven at 40 °C.

Note: Residues of the alcoholic cleaning fluid on the surface lead to a softer and sometimes scratch-sensitive surface after post-curing.

|

30

5

| Post-curing of the design in the Otoflash G171 light curing device with 2 x 2700 flashes – turn the design between the two cycles. Recommendation: Use the nitrogen (protective gas) function, as this minimises oxygen inhibition and thus leads to improved surface and material properties.

Observe the manufacturer’s specifications for the device.

|

8

6

| Manual post-processing, e.g. cleaning of the supports and polishing with commercially available rotating instruments for plastic processing.

Note: To prevent inaccurate fitting after polymerisation, avoid excessive heat development during finishing and polishing.

|

Design- dependent

Manual cleaning

Thoroughly rinse the construction under running water.
Pay particular attention here to drill holes and inspection holes and clean with a suitable brush, especially if there is visible adhesion.

Disinfection

The post-cured designs can be disinfected with both alcoholic and non- alcoholic disinfectants.

Sterilisation with heat / steam

(Validated method in accordance with ISO 14937 and ISO 17665-1)

Rinse off soiling under running water; take special care given the presence of drill holes.
Select a package that is suitable for the product and sterilisation procedure.
The package must be large enough that the seal is not under tension.
Transparent sterile packages with welded or bonded seams:
- Sealed seams must be at least 8 mm wide
- Allow a distance at least 10 mm between the sealing seam and the insertion

Parameters for steam sterilisation

Fractionated pre-vacuum (Type B)
Sterilisation temperature: 134°C
Hold time: at least 3 min (full cycle)
Drying time: at least 10 min
A sterilisation indicator should be on every sterilisation package or preferably in every package.
The labelling of the sterilisation package should include the following:
- Content
- Sterilisation and “Use by” date
- Responsible person (acc. to Quality Management)

Storage of the liquid

Store dry and at room temperature (15 °C to 25 °C).
Avoid direct sunlight.
Keep containers closed and seal carefully after use.
Do not return residual amounts from the material tub to the original container.
Long-term storage of the liquid in the material tub can reduce its service life.
For short-term storage, such as when changing materials, it is advisable to store the materialfilled tub in the original packaging, as this protects against dirt and light at the same time.

Disposal

The fully polymerized components are disposed of as residual waste.
Disposal of nonpolymerized product residues according to legal regulations. Do not allow entry into the sewage system or waterways.

Notes

Do not use the material after the expiration date.
Record the LOT number with every process that requires identification of the material.
When selecting the parameter set, make sure it matches the version number of the liquid on the batch label.
Due to the reactivity of the liquid, it is recommended to clean wetted parts, such as forceps and the construction platform, immediately after use, as the polymerised material is difficult to remove.
If the cleaning fluid becomes noticeably cloudy, the cleaning capacity is spent and it should be replaced with fresh fluid. If there are still damp, sticky patches on the designs after the drying process, this is also an indication of a saturated cleaning fluid and the design should be cleaned again with fresh cleaning fluid.
•
When changing material / cleaning the material tub, use soft cloths and the silicone wiper to avoid damaging the surface of the material tub.
If other printers are used, make sure that the appropriate printer data sets are available in the CAM and that material parameters for the printers are available.
All serious incidents occurring with users and / or patients in connection with this product must be reported to Merz Dental, as well as to the German Federal Institute for Drugs and Medical Devices (BfArM), or the respective competent authority of the member state in which the user and / or patient is resident.

Warnings

Processing frameworks may generate dust which can lead to mechanical irritation of the eyes and airways. Therefore, always ensure that the extraction system at the workplace is working properly for individual post-processing and that you are using personal protective equipment.
Avoid direct skin contact with the unpolymerised mixture.
It is recommended to wear nitrile gloves when handling the liquid.
The biocompatibility can only be assured with correct post-curing.

Danger instruction

H317 May cause an allergic skin reaction.
H335 May cause respiratory irritation.
H412 Harmful to aquatic life with long lasting effects.

Safety instruction

P261 Avoid breathing dust / fume / gas / mist / vapours / spray.
P280 Wear protective gloves / protective clothing / eye protection / face protection. P302 + P352 IF ON SKIN: Wash with plenty of water.
P333 + P313 If skin irritation or rash occurs: Get medical advice / attention. P362 + P364 Take off contaminated clothing and wash it before reuse.

For detailed information please see the applicable Material Safety Data Sheet, available upon request or as download from www.merz-dental.de.

The product properties are based on compliance with and observation of these instructions for use
Printed copies of these instructions for use can be requested free of charge using the contact details provided.
The users themselves are responsible for the use of the product. Merz Dental assumes no liability and / or guarantee for the use of components that are not part of the system and / or for components that have not been tested and for incorrect results, as the manufacturer has no influence on processing. Any claims for dama-ges that may still arise relate exclusively to the value of our products.
Date of information 2022-05

Merz Dental GmbH
Kieferweg 1 24321 Lütjenburg, Germany Tel + 49 (0) 4381 / 403-0 Fax + 49 (0) 4381 / 403-403 www.merz-dental.de