Operating instructions for INJEX30 in dentistry
Contents
1. Operating instructions tor INJEX30 in dentistry INJEX30 is approved for infiltration anaesthesia into all teeth of permanent and deciduous dentition EX X t z Soft Shot How it works The INJEX30 system for Dental application is a stainless steel device for delivery of anaesthetic from sterile disposable 0 3ml ampoules and sterile disposable silicone cushioning caps though a micro nozzle in the ampoule into the gum at a consistent pressure by means of an integrated spring 0 3ml of anaesthetic injected with INJEX is sufficient for superficial fillings to all teeth of deciduous and permanent dentition under normal circumstances Top up anaesthetic as required for other procedures The anaesthetic is transferred from standard containers into the ampoules using a range of adapters The sensation that the patient should feel will vary from none to a flick of the fingernail instant then gone immediately The injection site Best practice for maximum patient comfort The Injector is placed in the same position and angle as the traditional needle into the buccogingival sulcus A at the point of the sulcus that is as close as possible to the attached gingival ensuring that the Injector is held with medium pressure and at 90 degrees to the point of injection nb not at 90 degrees to the teeth WARNING The injection must be into the buccogingival area at the point of the sulcus that is as close as possible to the attache2. d gingival If the injection is too close to the buccal and lip areas there may be some bruising or bleeding Open the sterile packaging and remove one SiliTop Push the K Ampoule tip completely into the SiliTop Now withdraw the Injector fy with the SiliTop attached to the Ampoule tip out of the package RLZ Place a sterile disposable bag over the body of the Injector if required Push the green safety ring forward into the safe off position Now the second safety mechanism is deactivated and the Injector is ready for use The Injector can be used on all teeth in the same position and angle as with a traditional needle See recommendations for site selection Hold the Injector between thumb and index finger to the injection site with medium pressure Activate and continue to hold in position for two seconds to allow the anaesthetic to be fully absorbed Unscrew the Ampoule from the Injector The used Ampoules are disposable as normal domestic waste Push the green safety ring back into the safe position Store the secured and non reset Injector and its accessories in the INJEX Bag Note that storage of a reset Injector in the Reset Box will shorten the life of the product For the best patient experience fully brief the patient on what to expect For the first treatment a demonstration using water into a foam Smiley Ball is very effective especially for children A 3 2 1 countdown will avoid reflex reactions to
3. de of the Injector with a solvent free cloth The Transporter may be cleaned by rinsing it with warm water If soiled e g sticky threads due to medication residues soak the Transporter in water For maintaining function please make sure that all liquid has been removed after cleaning The INJEX30 System and its accessories should be stored between 5 C and 35 C as malfunctions could otherwise occur Store the secured and non reset Injector and its accessories in the INJEX Bag Note that storage of the reset Injector in the Reset Box can cause functional damage to the Injector and shorten the life of the product CAUTION The Injector and its accessories must not be sterilized Avoid getting water or cleaning liquid inside the Injector CAUTION Do not use the Ampoule and Adapter after the expiry date A see packaging Disclaimer amp warranty The INJEX30 System has been produced with the utmost care and has been delivered in perfect technical condition The warranty period after the date of purchase for the proper working order of the INJEX System is in accordance with current legislation Should contrary to expectations and despite careful handling of the INJEX30 System any material or production related defect occur during the warranty period we will at our own discretion replace products which prove to be defective In the event of a claim please provide the defective product together with your purchase receipt your co
4. mplete contact data and the address of the source of supply Please note that we do not assume any liability for damage caused by improper handling of the INJEX30 System and its accessories Please address your claim to Injex Australia 11 Evans Street Burwood Victoria 3125 info injex com au INJEX Injex Pharma Buchower Damm 114 12349 Berlin Germany INJEX Australia info injex com au www injex com au 03 988 88771
5. not use if packaging is damaged Fill the medication into the Ampoule without air bubbles Avoid any contact with the Ampoule tip before and after filling it with medication to avoid contamination The Adapter needle is sharp Take care to avoid injury Always hold the Injector perpendicular 90 to the injection site and press it with medium pressure onto the surface before activating the trigger During the injection always hold the Injector firmly in position with a medium pressure as injuries can otherwise occur Do not crease the skin After activation hold the Injector in place for two seconds to allow the anaesthetic to be fully absorbed If this is not done some anaesthetic may leak out Do not autoclave the Injector Protect with a sterile plastic bag if required by the procedure Clean the injector between patients using a sterile antiseptic wipe In the event of loss or malfunction of the INJEX you should always have a backup injection method available Caution Use Serial N by SN number Single use Sterilized using Catalogue Q only an Ed irradiation REF number l 4 40 Do not use if LOT Batch mm Keep away package is broken identification from moisture 8 Temperature Caution consult Name of the S limit i accompanying ual manufacturer L 4 documents Cleaning amp storage It is important that you keep your INJEX Injector clean and free from dust and medication residues Clean the outsi
6. r bubbles Unscrew the Ampoule from the Adapter and reseal with the lid Tip Slightly screw back the Transporter knob after the Ampoule is filled in order to prevent the inner piston of the Transporter from pressing against the rubber seal of the cartridge This eliminates medication leakage Preparing the Injector 1 Put the Injector into the Reset box Make sure that the green safety ring is in safe position Close the lid of the Reset Box 3 Open the lid of the Reset Box and take out the reset and secured Injector Preparing tor the injection Unscrew the filled Ampoule from the Adapter and close the lid Now screw the filled Ampoule as far as it will go into the open end of the Injector NOTE As the screw tightens the first safety mechanism will be deactivated 3 If required place a sterile disposable bag over the body of the injector Push the green safety ring forward into the safe off position Now the second safety mechanism is deactivated and the Injector is ready for use Warnings amp precautions After preparing the Injector for injection do not point the Injector at yourself or other persons especially the eyes and other sensitive body parts Accidental release may cause injuries Do not place anything other than the Ampoule into the open end of the Injector Check to see that the sterile packaging of the Ampoule and the Adapter is intact prior to opening Do
7. the sound Please consider general contraindication for local anaesthesia One should not inject with INJEX over nerval exits i e N mentalis Please follow the same general guidelines when injection in inflamed gingiva tissue is considered necessary i e antibiotic prophylaxis Filling the Ampoule from cylinder cartridges with the transporter Preparing the Transporter 1 Turn the green knob of the Transporter until the cylinder cartridge can be placed in the Transporter chamber Take the cartridge and place it in the Transporter chamber 3 To make sure the cartridge is firmly in place turn the green knob until the Transporter piston is in slight contact with the rubber seal of the cartridge 4 Take the Transporter Adapter out of its sterile packaging Screw it fully onto the Transporter During this process the needle of the Adapter must pierce the rubber seal of the cartridge To guarantee sterility amp eliminate the risk of injuries e Avoid any contact with the head of the Ampoule Avoid any contact with openings and needles of the Adapters Filling the Ampoule 1 Take an Ampoule out of its sterile packaging and pull the Ampoule plunger about halfway out 2 Open the lid of the Transporter Adapter and screw the Ampoule as far as it will go into the Adapter 3 Turn the green knob of the Transporter until the desired dose of medicine is transferred into the Ampoule without ai
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