Artex Facebow , Leipzig glabella Support and Universal Joint Instruction Manual

TABLE OF CONTENTS

– Translation of the original Instruction Manual – user manualen

EN

Legend to figure 1:

Table of Contents

Facebow

Explanation of Symbols... 13

1 Set screws (218606) 2 Support mounting slot 3 Rest for axis plane indicator

General Safety Instructions... 14 Suitable Personnel... 14

4 Axis plane indicator optional (218610) 5 Support bracket right/left (pair) (218603) 6 Removable porus buttons (pair) (218607)

Warranty/Exclusion of Liability... 14 Product Specifications... 15

7 Porus button hole/transfer 8 Acoustics hole 9 Porus button thread 10 Removable axis pins (pair) (218608) 11 Axis pin thread 12 Support bracket screw (218616) 13 Thread for telescopic legs and axis plane indicator Leipzig glabella support 14 Fixing screw for nasion (218692) 15 Set screw for nasion (218693) 16 Nasion bar (218613) 17 Nasion adapter (217695) 18 Nasion support (218695) Universal joint 19 Adapter to bow (218632) 20 Adapter screw (217696) 21 Fork mounting (217633) 22 Collar screw (217634) 23 Toggle nut, complete (218696) 24 Toggle screw (218697) 25 Tray handle, cranked (217928)

12

Fitting the facebow to a dentate jaw... 15 Processing... 18 Accessories/single components... 19

EXPLANATION OF SYMBOLS

Explanation of Symbols

Other symbols on the product

Warning indications

Symbol

Warning indications in the text are

MD

Meaning

EN

Medical device

marked with a colour-backed triangle and boxed. In case of hazards through electricity, the exclamation mark in the warning triangle is substituted by a lightning bolt.

UDI REF LOT

Signal words at the beginning of a warning indi-

Unique Device Identifier Catalog number Batch code Manufacturer

cation specify the type and severity of the conCountry of manufacture

sequences, if the measures to avert the hazard are not adhered to. _ NOTE means that property damage can occur. _ CAUTION means that light to fairly serious personal injury can occur. _ WARNING means that serious personal injury can occur. _ DANGER means that serious personal injury can occur.

Use by YYYY-MM-DD or YYYY-MM

Rx only

Symbol that may be used in place of statement “CAUTION”. US Federal law restricts this device to sale by or on the order of a dentist. Maximum number of reprocessing cycles - Follow reprocessing instruc-

Important information

tions

Important information that do not lead to hazards for humans or property damage are marked with the icon aside and are also boxed. Other symbols in the Manual Symbol

Meaning

▷

Item of an operation description

_

Item of a list ▪

Subitem of an operation description or a list

[3]

Numbers in square brackets refer to position numbers in graphics/figures

13

GENERAL SAFETY INSTRUCTIONS

EN

General Safety Instructions

Warranty/Exclusion of Liability

When using the product, always observe the fol-

Application-technical recommendations,

lowing safety instructions:

whether given orally, in writing or in the course of practical training, are guidelines. Our prod-

CAUTION:

ucts are subject to continuous further develop-

A defective product can lead to malfunctions!

ment and are tested according to the state of

On detection of damage or a functional defect

the art and to legal requirements. We reserve

of the product:

the right to make any resulting changes in han-

▷ Label the product as defective.

dling and composition.

▷ Prevent further use until the product has

The respectively valid instruction-manual ver-

been repaired.

sion can be found under www.amanngirrbach.com/instruction-manuals.

NOTE: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Suitable Personnel NOTE: The product may only be used by trained specialised personnel.

14

This version replaces all previous versions.

PRODUCT SPECIFICATIONS

Product Specifications Intended use Supporting aid for determining the skull-axis-oriented position of the patient's upper jaw. This information is used for the subsequent skull axis-oriented mounting of the upper-jaw model

NOTE:

EN

Some components must be prepared using specifi- cally selected procedures before first use and also before every further use. ▷ Please note the processing of the Artex facebow.

in the articulator.

Delivery Scope Product Description he Artex facebow is a parallel-opening bow made of anodised aluminium. The parallel opening of the facebow is used to insert the facebow via the porus buttons into the patient's ear canal. This

Artex Facebow (218600/218600UNI), incl.: _ universal joint _ Leipzig nasion _ porus buttons “standard”, pair _ Artex Quickbite, 10 pcs. _ tray handle

serves the supporting and holding via the patient's skull. Frontally, the facebow is supported on the skull via an adjustable rod in the nasian bar with a nasian adapter. The facebow is thus fixed to the

Declaration of conformity The product's declaration of conformity is available upon request from the manufacturer.

patient's skull by a three-point support (2 porus buttons and a nasion adapter). A bite fork is applied to the upper jaw tooth row registering mass. Bite fork and facebow are connected via a 3D joint (joint support). The 3D joint is fixated.

Fitting the facebow to a dentate jaw Preparing the facebow A

The spatial position relationship obtained by bite

Screw in all the components in advance to pre-

fork to facebow is used for mounting the

vent stressing the patient unnecessarily.

patient's upper jaw model in the articulator in

▷ Check that the support brackets [5] have been

the correct position for the patient.

screwed in firmly (porus buttons pointing inwards). The screw collar is in the key hole.

Support bracket [5] can be used on the left or right. If the axis pins are screwed in, the facebow can be placed on the main axis and fitted to the articulator axis directly.

▷ Tighten the nasion on the facebow with fixing screw [14]. ▷ Retract the nasion fully and tighten it with set screw [15]. ▷ Insert the universal joint into the front of the conical support mounting slot [2]. Press it in fully and tighten it with adapter screw [20]. Toggle screw [23] must be on the right (patient’s left).

15

FITTING THE FACEBOW TO A DENTATE JAW

▷ Allow the universal joint to hang down and tighten toggle screw [23] gently.

EN

▷ When using the facebow on the patient,

Fitting the bite fork to the patient D ▷ Place the prepared bite fork on the upper teeth.

the screws must only be loosened 1/4

▷ Gently press the warm compound (not too hot,

turn. Instead of opening the screws

then a skin would form on the surface) onto

completely, it is sufficient to loosen

the upper teeth to create slight impressions

them only slightly. This ensures that

(the teeth must not contact the metal fork).

they grip and fix the com- ponents into

The patient can then hold the bite fork bite

place immediately when tightened.

fork in position, either with his/her fingers or with cotton rolls inserted between the lower

Quickbite single-use bite fork B

molars and the bike fork.

This plastic bite fork is covered with a thermoplastic material. Before using:

If the curve of Spee is unfavourable, the

▷ Warm-up Artex Quickbite in a water bath until

bite fork may tilt.

the bite compound is plastically mouldable (maximum 45°C).

▷ In this case, it is better to hold the bite fork with a hand rather than cotton rolls.

It is used in the same way as a conventional metalike fork but does not require cleaning or disinfection. The shelf life of the Quickbite is 3 years.

Preparing the bite fork C ▷ ttach thermoplastic pellets (“Bite Tabs” (Art. No. 642150)) on self-adhesive foil to the bite fork at three locations and place bite fork for about 1 minute in approx. 40 °C warm water. ▷ The applica- tion of compound on the opposite side of the bite fork ensures that the compound does not get loose. The cranked handle of the bite fork points downwards. Although hard wax or hard silicone may be used, they are not recommended.

16

FITTING THE FACEBOW TO A DENTATE JAW

Fitting the Facebow (arbitrary) E

Registering the position of the upper jaw with the universal joint F

The patient’s mouth must always be open when the facebow is adapted, i.e. after fitting the bite fork to the upper teeth.

EN

▷ Loosen toggle nut [23] to allow the universal joint to move freely. ▷ While the patient presses the bite fork firmly on to the molar region with cotton rolls on

The Leipzig nasion incorporates a tele-

his/her lower jaw or with his/her hand, the

scope with a spring that counterbalances

dental-care provider inserts the fork mounting

the weight of the facebow when the red

[21] (with the collar screw and groove pointing

mark is covered by the outer telescope.

upwards) into the bikte fork handle and firmly

Thanks to the standardized, controllable

tightens the collar screw [22] fully.

pressure, the position of the ear adapters

The toggle nut should be positioned to the

[6]/axis pin [10] in the arbitrary hinge

right (or from the patien‘s view at left) to allow

axis region is reproducible..

the unhindered transfer into the transfer stand (figures H).

Patient in lying position. This counteracts the

▷ Tighten toggle nut [23] fully by centralizing

weight of the facebow and lever effect of the

the toggle and exerting uniform pressure on

front section. Only loosen the set screws [1] - do not attempt to un- screw them fully. This also applies to the clinched collar screw [22] on the fork mounting, which might jam. ▷ Loosen the set screws [1] and insert the porus buttons [6] into the patient’s auditory canals,

both ends to prevent it from tipping. ▷ Once the position has been registered, loosen nasi on set screw [15] immediately. Retract nasion [16] and fix it in place with set screw [15], holding the facebow to prevent it tipping. ▷ Loosen set screws [1] and open the facebow. ▷ Remove the facebow and registration downwards.

allo wing the patient to assist. ▷ Tighten set screws [1], loosen nasion set screw [15] (1/4 turn), and gently press the nasion [16] onto the glabella. ▪ The middle and index fingers are used to grasp behind the nasion support while the thumb exerts gentle, continual pressure on it. ▪ The other thumb is used to stretch the forehead skin to allow the nasion adapter [17] to adapt to the bridge of the nose. ▷ When the red mark is covered by the outer telescope, tighten the set screw [15] with your free hand.

17

PROCESSING

Adaption of the facebow to a toothless

EN

▷ Insert the universal joint with upper registration into the transfer stand.

jaw G ▷ Select one of the following procedures: ▪ Use a custom tray with tray handle [25]. ▪ Proceed as described for the “toothed jaw”, but adapt the fork to the customized tray furnished with 2 - 3 notches (see Centrofix instructions).

Securing for transport (transfer) H

▷ Tighten adapter screw [20]. ▷ Raise the table [c] to just beneath the bite fork and tighten the Allen screw [b]. Remove the joint and bite fork from the transfer stand. ▷ Mix a small amount of articulating plaster (Artifix 711211) to a creamy consistency and place it onto the table. ▷ Reinsert the universal joint with the registration, i.e. place the bite fork above the soft plas-

PREFERRED METHOD: Securing the situation

ter mush, and tighten the adapter screw [20]

of the upper jaw in plaster for safe transporta-

so that the bite fork rests on the soft plaster.

tion. Once the plaster has set: This method is also recommended if the models are to be articulated in the dental practice. In any case, the position of the upper jaw should be secured in plaster directly at the dental practice. The plas-

▷ Loosen adapter screw [20], toggle nut [23] and collar screw [22] to separate the joint and bite fork. [a] = socket for Allen wrench). ▷ Remove the transfer table from the transfer stand for articulation.

ter provides for a solid base. Transfer stand and transfer table are both stable

Processing

and cannot be distorted. The plaster index can be kept for control purposes and to position the upper jaw at any time without the patient being present. Few things can be carried out incorrectly and, generally speaking, nothing can be manipulated falsely. Thus, articulating has considerably been simplifed. The method shown here with the magnetic Splitex® Plate Set is also applicable for articulator systems with screw-mounted model plates where the transfer table is screwed to the lower part of the articulator. ▷ Loosen adapter screw [20] and remove the universal joint from the facebow.

18

NOTE: All components with semi-critical contact to the patient must be cleaned, disinfected and sterilised before each use (see Artex facebow preparation instructions). This also applies in particular for first use after delivery, as these components are delivered non-sterile. The usual surface disinfection procedures can be used for all other components (without contact to the patient).

ACCESSORIES/SINGLE COMPONENTS

Accessories/single components EN

Art.-No. 217650

Artex Quickbite (20898), 10 pcs.

217611

Bite fork partial two-pack

217611UNI

Bite fork partial UNI two-pack

217661

Bite fork total two-pack

217928

Tray handle, 5 pcs.

218607

Porus Buttons “Standard”, pair

218609

Porus Buttons long, pair

218610

Axis-plane pointer w. screw

218620

Joint Support

218680

Leipzig nasion

218690

Nasion vertically adjustable

217695

Nasion adapter

Tab. 1

19

E

E

17

E

E

F

15

F 23

23

21 22 F

15

16

F

H

20 22 a

c 23 2

b 23

F

F

G

H

H

H

20