Frequently Asked Questions

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

The transporter adapter is made for the transfer of the content of one cartridge into several INJEX – ampoules. It’s a single use product. Obviously, the adapter is used too long.

In this case, local anaesthetic agent blocks the adapter’s needle when crystallizing. A hind, that the adapter has not been changed. 

The transporter adapter is made for the transfer of the content of one cartridge into several INJEX – ampoules. It’s a single use product. Obviously, the adapter has been used too long.  

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

The injector has 2 safety - devices. One in the inner thread, deactivated by screwind in the ampoule completely. The green safety ring on the outside has to be pushed into the safe-off position.

Ampoule not seated firmly / screw the Ampoule onto the Injector

No Ampoule screwed on / Screw Ampoule on

Saftey ring not in "Saftey off" / Slide Saftey Ring to the "Safe off" Position.

Check if the Ampoule opening is blocked / Use a new Ampoule

Injector not secured / "Slide Saftey" Ring to the "safe" position

Injector or Reset Box very soiled / Clean with damp cloth

Injector in wrong position / Place the Injector into the reset Box with the open end of the injector angled downward toward the hinge of the Reset Box

Injector or reset Box very solied / clean with damp cloth

Reset Box not completly closed / Close the Reset Box

INJEX is an innovative, needle-free system for the submucous administration of medication 

The needle-free INJEX system consists of an injector, the reset box to reset and store the injector, the sterile disposable ampoules for containing and administering the medicament, as well as adapters to transport medication from a variety of different cartridges and containers to the sterile disposable ampoules. An additional cap especially developed for dental applications (SiliTop) is available as well, which allows for gentle application on firm gingiva and prevents pressure sensations during injection.  

INJEX is guaranteed for two years. INJEX is designed for multiple applications (at least 5,000 injections). 

The transporter is a dosing tool designed for transferring liquid drugs from cylinder cartridges to the INJEX system ampoule and is used in combination with the transporter adapter.
All of the commonly used cylinder cartridges may be inserted in the transporter to transfer the medicine into the ampoule. 

The adapter has to be screwed on top of the transporter carefully and "securely." The adapter may leak anaesthetic if not screwed on correctly.  

SiliTop is a cap affixed to the ampoule head before the injection developed especially for dental applications. It prevents pressure sensations that might be caused by the injector impulse when activating the trigger.  

SiliTop is a cap affixed to the ampoule head before the injection developed especially for dental applications. It prevents pressure sensations that might be caused by the injector impulse when activating the trigger.

 Adapter, ampoules, and SiliTop are sterile products for single-use only. 

If a wet shot occurs, not all of the medication has been administered as part of it remains on the skin. In the case of insulin, please measure your blood-sugar level one hour after the wet shot and correct this with a further dose of insulin accordingly.
A wet shot is caused by the INJEX not being placed firmly enough on the skin or not being applied vertically. Please ensure the next time that the INJEX is placed on the skin firmly and vertically. Press the injector firmly onto the injection site until the skin is clearly dented and the ampoule tip is completely enclosed by the skin. 

No, proper use of INJEX should not result in any recoil. Place the injector vertically on the skin while applying medium pressure and maintain this position and pressure when releasing the trigger. This should eliminate any recoil motion. In case of pressure that is too low or too high, the injector may shift when triggered resulting in an incomplete or painful injection and haematoma. 

1. INJEX has not been recharged after the previous injection.
2. The ampoule has to be screwed vertically. The ampoule has been screwed into the injector aslant and with to much pressure, thus resulting in damage of the thread and complicating the positioning of the ampoule. 

The trigger has a "pressure point." Press the trigger a few times to develop a feeling for this pressure point. Continuous pressure applied beyond the pressure point triggers the injection. Apply uniform pressure to ensure a smooth triggering action without any unexpected recoil due to the injector spring release. 

Instead of a needle, the INJEX system utilises an ampoule with special scaling and a micro orifice of only 0.18 mm in diameter that is applied directly to the skin. Medication is administered through this opening to the underlying subcutaneous fatty tissue in a fraction of a second. 

Maybe the Injector is charged. When you took the Injector out of the Reset Box he will be charged and secured.

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

The INJEX system has many advantages such as the following:
 

• Without needle
• Virtually painless
• Reduces psychological inhibitions and fears
• Minimizes injection-induced stress
• Targeted anaesthetizing of specific areas possible
• Easy dosing of anaesthetic
• Economic since only small doses of anaesthetic are required
• Less time between injection and effect due to shorter dispersion times of the anaesthetic compared with conventional syringe, thus saving time
• Anaesthetic effect below limit dose for local anaesthesia - also with children
• Fewer risks of side effects or negative interactions with other medications due to lower doses
• Elimination of injury to patient and physician caused by needle
•  Safe and easy use

INJEX is guaranteed for two years. INJEX is designed for multiple applications (at least 5,000 injections). 

Yes, costs for INJEX are being reimbursed by health insurance. In Germany the medical service of central associations (MDS) has positive evaluated the INJEX System after prior testing its functional efficiency, therapeutical benefit and quality. Thereupon central associations of health insurance funds declared requirements for the registration of INJEX as auxiliary aid as fulfilled in compliance with §139, para. 2 SGB V (German Social Code). On April 30, 2002 the Federal Association IKK (Guild Health Insurance Fund) registered the INJEX System accordingly and assigned the relevant position number (position no. 03.99.10.0001).

Yes, costs for INJEX are being reimbursed by health insurance. In Germany the medical service of central associations (MDS) has positive evaluated the INJEX System after prior testing its functional efficiency, therapeutical benefit and quality. Thereupon central associations of health insurance funds declared requirements for the registration of INJEX as auxiliary aid as fulfilled in compliance with §139, para. 2 SGB V (German Social Code). On April 30, 2002 the Federal Association IKK (Guild Health Insurance Fund) registered the INJEX System accordingly and assigned the relevant position number (position no. 03.99.10.0001).

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

Is the word „edema“the correct characterisation? A swelling can be seen in very few cases, when the injection site is producing an allergic reaction on the preservatives of the local anaesthetic agent. 

The Adapter is a disposeble product intended to be used only once. Sterility is not guaranteed for multiple use, so never use the same Adapter for more than one medication contained. No refurbishment allowed. 

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

The injector has 2 safety - devices. One in the inner thread, deactivated by screwind in the ampoule completely. The green safety ring on the outside has to be pushed into the safe-off position.

INJEX is an innovative, needle-free system for the submucous administration of medication 

The needle-free INJEX system consists of an injector, the reset box to reset and store the injector, the sterile disposable ampoules for containing and administering the medicament, as well as adapters to transport medication from a variety of different cartridges and containers to the sterile disposable ampoules. An additional cap especially developed for dental applications (SiliTop) is available as well, which allows for gentle application on firm gingiva and prevents pressure sensations during injection.  

The INJEX system has many advantages such as the following:
 

• Without needle
• Virtually painless
• Reduces psychological inhibitions and fears
• Minimizes injection-induced stress
• Targeted anaesthetizing of specific areas possible
• Easy dosing of anaesthetic
• Economic since only small doses of anaesthetic are required
• Less time between injection and effect due to shorter dispersion times of the anaesthetic compared with conventional syringe, thus saving time
• Anaesthetic effect below limit dose for local anaesthesia - also with children
• Fewer risks of side effects or negative interactions with other medications due to lower doses
• Elimination of injury to patient and physician caused by needle
•  Safe and easy use

Yes, INJEX has been CE certified on 1 September 1999 according to the German medical product law 

The patient should be sitting upright in a relaxed position. The time between positioning and releasing the injector should be kept as brief as possible with children and especially restless patients . 

The patient should be informed about the release noise of the injector to prevent defensive arm movement or startle reflexes 

Haematoma at the injection site are still possible even when using a needle-free system.
They might occur with patients taking anticoagulants to treat cardiovascular disease (e.g., Marcumar) or thrombocytic aggregation inhibitors (e.g., ASS100 = time-released aspirin), or patients occasionally taking aspirin for pain relief.
Small bruises can also be due to too little or too much pressure when positioning the injector on the gingiva. 

Swelling is observed in a few cases, which might also be caused by the local anaesthetic itself (preservatives).  

Bleeding usually does not occur. As with needle injections, INJEX might cause some damage to the uppermost capillaries. In rare cases, this might cause a pin-sized drop of blood to emerge at the injection site. This is especially the case if the patient has been taking medication to treat cardiovascular disease (e.g., Marcumar, ASS100 = time-released aspirin) or normal aspirin for pain relief. 

The recommended basic dosage is 0.3 ml per injection. A second injection to prolong the effect can be administered at any time. The local anaesthetic dose is still lower than with a conventional syringe in spite of the second injection. 

Less than 0.3 ml for the initial injection is not sufficient and the degree of anaesthesia is too low, just as with conventional infiltration anaesthesia.  

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds 

Injecting with INJEX provides a therapeutic window larger than with conventional infiltration anaesthesia due to the better distribution within the tissue. 

It is recommended to use a probe to check the anaesthesia depth before commencing treatment. An additional injection may be administered if necessary. 

Each ampoule of the INJEX system may be filled with max 0.3 ml of anaesthetic. A dose of 0.3 ml is recommended for dental applications.  

The transporter adapter is a sterile disposable product and can be used only with one cylinder cartridge to prevent contamination as well as diminishing functionality. Dispose of the adapter when the medication cartridge is empty. The local anaesthetic may crystallize within the adapter if the same adapter is used with additional medication cartridges. This can impair the transfer to the INJEX ampoule. 

No. The pressure and speed are calculated in such a way that the medication only enters into the subcutaneous adipose tissue. Accidental administration of the medication into the muscle is virtually impossible.
In contrast to insulin injections in diabetic children that frequently and unintentionally are performed intramuscular when using a needle syringe (30,5 % of performed injections). (literature review: POLAK et al., 1996)  

A modified injection angle results in an enlarged medication injection point. This may lead to increased bleeding and risk of haematoma. 

The pressure and speed are calculated in such a way that the medicine only enters into the subcutaneous adipose tissue. The depth of penetration is depending on the applied volume, it reaches from 4 to 9 mm.
Accidental intramuscular administration of the medication is virtually impossible.
 

The adapters are for the transfer of liquid drugs from conventional medicine containers into the ampoule of the INJEX system.
Up to now, conventional medicine containers are designed for injection by needle (cannula), e.g. pen cartridges, piercing of injection vials or snap-off ampoules. As the INJEX has no needle, INJEX Pharma´s medical technology division has developed special adapters to transfer the drug from medicine containers into the ampoules. 

The basic equipment you need is the INJEX injector and the reset box.
In addition, you will need the appropriate ampoules and adapters for the medication concerned. If you use U-40 insulin, you will need the U-40 ampoules, or for U-100 insulin the U-100 ampoules. For all other medications, the 0.3 ml ampoules must be used.
The choice of the adapter depends on the vessel containing the medication. The following rule can be applied in this regard:
 

• If you use pen cartridges without a pen (e.g. first use of insulin), you should use the transporter with transporter adapter.
• If you use a (insulin) pen, you should use the pen adapter.
• If you use injection vials (e.g. U-40 or Heparin), you should use vial adapter 14.
•  If you use snap-off ampoules (e.g. Heparin, local anaesthetics, homeopathics), you should use the Luer adapter.

Tests with different types of needle-free systems have shown hat the medication chooses the path of least resistance, thus going around blood vessels and nerve fibres to penetrate the subcutaneous adipose tissue.
Changes in the skin described as lipodystrophy in diabetics in the case of prolonged administration of insulin are quite improbable. Individual publications even report receding of existent thickening in the subcutaneous adipose tissue resp. fat atrophy.
 

Medications licensed for subcutaneous use can be administered with the needle-free INJEX.
The main applications for the INJEX system at present are diabetes (subcutaneous administration of insulin), the prevention of thrombosis (by means of Heparin) and local anaesthesia (e.g. prior to venous catheterisation, prior to minor surgical procedures or for dental infiltration anaesthesia). Other applications for INJEX are the treatment of dupuytren´s disease or homeosiniatry. Please note the technical reports for these mentioned applications.

When applied correctly the injection with INJEX is virtually painless. The sensation can be described as a short slight pressure on the skin surface. As pain is felt individually one cannot state a general and obliging assertion. As fluid is pressed under the skin the patient will sense the injection with INJEX more or less, depending on the volume and the individual sensibility. Patients generally assesse the sting from a needle as more unpleasant than the injection with INJEX.
(literature review: DENNE et al., 1992, TEINTZ et al., 1991, RESMAN et al., 1985)
The micro orifice of the ampoule has a diameter of 0.18 mm. Currently, the thinnest needle has a comparatively thick diameter of 0.25 mm. 

No. In order to guarantee sterility and function, the ampoules are intended to be used once only. 

If a wet shot occurs, not all of the medication has been administered as part of it remains on the skin. In the case of insulin, please measure your blood-sugar level one hour after the wet shot and correct this with a further dose of insulin accordingly.
A wet shot is caused by the INJEX not being placed firmly enough on the skin or not being applied vertically. Please ensure the next time that the INJEX is placed on the skin firmly and vertically. Press the injector firmly onto the injection site until the skin is clearly dented and the ampoule tip is completely enclosed by the skin. 

Besides experiences with INJEX in the field of diabetes mellitus, further experiences in the field of thrombosis prophylaxis with Heparin have been obtained also (literature review: HOLLINGSWORTH et al., 2000, BAER et al., 1996, HARENBERG et al., 1982) and local anaesthesia (ZSIGMOND et al., 1999, FLORENTINE et al., 1997, QUERALT et al., 1995, COOKE et al., 1980).
Furthermore experience reports in the fields of Dupuytren treatment and homeosiniatry are available.
The following reports regarding these questions:
 

• Abstract Heparin; Pharmacokinetics of Low-Molecular-Weight Heparin following Needle-free and Conventional Subcutaneous Injections; Prof. Dr. Gerhard Anton Müller, University Clinic Göttingen
• Technical report Dupuytren; INJEX and Dupuytren Treatment; Dr. med. Klaus Beller, Kenzingen; July 2001
• Technical report Homeosiniatry; Using INJEX in Homeosiniatry; Dr. med. Klaus Beller, Kenzingen; July 2001
•  Technical report local anaesthesia; A preliminary study using the INJEX with local anaesthesia; Yale W., March 1999

Instead of a needle, the INJEX system utilises an ampoule with special scaling and a micro orifice of only 0.18 mm in diameter that is applied directly to the skin. Medication is administered through this opening to the underlying subcutaneous fatty tissue in a fraction of a second. 

Skin irritations are most unlikely, since only miniscule liquid droplets penetrate into the tissue during the injection. 

A minimum of 0.05 ml and a maximum of 0.30 ml of a liquid drug can be administered using the INJEX (for insulin, see the set of questions under the heading of Questions on the use of insulin"). 

No, the utilized materials are not suitable for autoclave treatment. Adapter, ampoules, and SiliTop are sterile products for single-use only. The injector, the reset box, and the transporter are designed for multiple-use and need not be sterilized since they are not in direct contact with the patient.  

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

Is the word „edema“the correct characterisation? A swelling can be seen in very few cases, when the injection site is producing an allergic reaction on the preservatives of the local anaesthetic agent. 

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

The patient should be sitting upright in a relaxed position. The time between positioning and releasing the injector should be kept as brief as possible with children and especially restless patients . 

The patient should be informed about the release noise of the injector to prevent defensive arm movement or startle reflexes 

Haematoma at the injection site are still possible even when using a needle-free system.
They might occur with patients taking anticoagulants to treat cardiovascular disease (e.g., Marcumar) or thrombocytic aggregation inhibitors (e.g., ASS100 = time-released aspirin), or patients occasionally taking aspirin for pain relief.
Small bruises can also be due to too little or too much pressure when positioning the injector on the gingiva. 

Swelling is observed in a few cases, which might also be caused by the local anaesthetic itself (preservatives).  

Bleeding usually does not occur. As with needle injections, INJEX might cause some damage to the uppermost capillaries. In rare cases, this might cause a pin-sized drop of blood to emerge at the injection site. This is especially the case if the patient has been taking medication to treat cardiovascular disease (e.g., Marcumar, ASS100 = time-released aspirin) or normal aspirin for pain relief. 

The recommended basic dosage is 0.3 ml per injection. A second injection to prolong the effect can be administered at any time. The local anaesthetic dose is still lower than with a conventional syringe in spite of the second injection. 

Less than 0.3 ml for the initial injection is not sufficient and the degree of anaesthesia is too low, just as with conventional infiltration anaesthesia.  

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds 

Injecting with INJEX provides a therapeutic window larger than with conventional infiltration anaesthesia due to the better distribution within the tissue. 

It is recommended to use a probe to check the anaesthesia depth before commencing treatment. An additional injection may be administered if necessary. 

Each ampoule of the INJEX system may be filled with max 0.3 ml of anaesthetic. A dose of 0.3 ml is recommended for dental applications.  

The transporter adapter is a sterile disposable product and can be used only with one cylinder cartridge to prevent contamination as well as diminishing functionality. Dispose of the adapter when the medication cartridge is empty. The local anaesthetic may crystallize within the adapter if the same adapter is used with additional medication cartridges. This can impair the transfer to the INJEX ampoule. 

Insulins with differing period of effect can be mixed and administered with one ampoule. Please ask your doctor or pharmacist, if the mixture is recommended by the manufacturer. 

In Germany, all commercially available U-40 und U-100 insulin can be used. 

When using a U-40 insulin, a minimum of 2 and a maximum of 12 units can be administered in dosage stages of half units.
When using a U-100 insulin, a minimum of 5 and a maximum of 30 units can be administered in dosage stages of one unit. 

Yes, the pen cartridges and even the pens can still be used. INJEX has developed special adapters for this purpose which can be used to transfer the insulin directly from the pen or pen cartridges in to the needle-free INJEX. 

If a wet shot occurs, not all of the medication has been administered as part of it remains on the skin. In the case of insulin, please measure your blood-sugar level one hour after the wet shot and correct this with a further dose of insulin accordingly.
A wet shot is caused by the INJEX not being placed firmly enough on the skin or not being applied vertically. Please ensure the next time that the INJEX is placed on the skin firmly and vertically. Press the injector firmly onto the injection site until the skin is clearly dented and the ampoule tip is completely enclosed by the skin. 

Yes, the injections site should be changed in the same way as with the conventional syringe. 

In contrast to the conventional subcutaneous injection method, you must not form any folds of the skin, rather the INJEX must be placed on the skin vertically and firmly  until a visible indentation of the skin appears and the ampoule tip is completely enclosed by the skin. If the INJEX is not held on the skin firmly enough, a so-called wet shot can occur. You cannot harm yourself in this way (though a small bruise can form in exceptional cases). However, in the case of a wet shot, the desired dose is not fully administered. Part of the medication remains on the surface of the skin, hence the moisture.  

No. The pressure and speed are calculated in such a way that the medication only enters into the subcutaneous adipose tissue. Accidental administration of the medication into the muscle is virtually impossible.
In contrast to insulin injections in diabetic children that frequently and unintentionally are performed intramuscular when using a needle syringe (30,5 % of performed injections). (literature review: POLAK et al., 1996)  

Yes, publications from the past two decades and our own clinical results show a comparable resorption of insulin between the injection with INJEX or with a pen.
(literature review: BREMSETH et al., 2001, MALONE et al., 1986, HALLE et al., 1986, PEHLING et al., 1984)
Clinical findings and laboratory tests demonstrate unchanged molecular structures and normal potencies of the insulin formulations.
 

A modified injection angle results in an enlarged medication injection point. This may lead to increased bleeding and risk of haematoma. 

The pressure and speed are calculated in such a way that the medicine only enters into the subcutaneous adipose tissue. The depth of penetration is depending on the applied volume, it reaches from 4 to 9 mm.
Accidental intramuscular administration of the medication is virtually impossible.
 

The basic equipment you need is the INJEX injector and the reset box.
In addition, you will need the appropriate ampoules and adapters for the medication concerned. If you use U-40 insulin, you will need the U-40 ampoules, or for U-100 insulin the U-100 ampoules. For all other medications, the 0.3 ml ampoules must be used.
The choice of the adapter depends on the vessel containing the medication. The following rule can be applied in this regard:
 

• If you use pen cartridges without a pen (e.g. first use of insulin), you should use the transporter with transporter adapter.
• If you use a (insulin) pen, you should use the pen adapter.
• If you use injection vials (e.g. U-40 or Heparin), you should use vial adapter 14.
•  If you use snap-off ampoules (e.g. Heparin, local anaesthetics, homeopathics), you should use the Luer adapter.

Children (over 7 years) can use INJEX for injection after prior consultation of a doctor. 

Tests with different types of needle-free systems have shown hat the medication chooses the path of least resistance, thus going around blood vessels and nerve fibres to penetrate the subcutaneous adipose tissue.
Changes in the skin described as lipodystrophy in diabetics in the case of prolonged administration of insulin are quite improbable. Individual publications even report receding of existent thickening in the subcutaneous adipose tissue resp. fat atrophy.
 

Medications licensed for subcutaneous use can be administered with the needle-free INJEX.
The main applications for the INJEX system at present are diabetes (subcutaneous administration of insulin), the prevention of thrombosis (by means of Heparin) and local anaesthesia (e.g. prior to venous catheterisation, prior to minor surgical procedures or for dental infiltration anaesthesia). Other applications for INJEX are the treatment of dupuytren´s disease or homeosiniatry. Please note the technical reports for these mentioned applications.

When applied correctly the injection with INJEX is virtually painless. The sensation can be described as a short slight pressure on the skin surface. As pain is felt individually one cannot state a general and obliging assertion. As fluid is pressed under the skin the patient will sense the injection with INJEX more or less, depending on the volume and the individual sensibility. Patients generally assesse the sting from a needle as more unpleasant than the injection with INJEX.
(literature review: DENNE et al., 1992, TEINTZ et al., 1991, RESMAN et al., 1985)
The micro orifice of the ampoule has a diameter of 0.18 mm. Currently, the thinnest needle has a comparatively thick diameter of 0.25 mm. 

No. In order to guarantee sterility and function, the ampoules are intended to be used once only. 

No, the utilized materials are not suitable for autoclave treatment. Adapter, ampoules, and SiliTop are sterile products for single-use only. The injector, the reset box, and the transporter are designed for multiple-use and need not be sterilized since they are not in direct contact with the patient.  

Basically it is not necessary to adjust insulin doses for the use of INJEX in comparison with needle injections. Pharmacokinetics are almost identical. Regarding injection-food-periods adjustment is not required either.
Yet a primary requirement is the extensive briefing of the patient for the administration of INJEX by a physician or diabetes consultant, similar to the briefing for the use of disposable syringes or pens. 

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

Is the word „edema“the correct characterisation? A swelling can be seen in very few cases, when the injection site is producing an allergic reaction on the preservatives of the local anaesthetic agent. 

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

All local anaesthetics usually employed by dentists can be used with the needle-fee INJEX system for dental applications. However, general pharmaceutical considerations for local anaesthesia should be taken into account when using INJEX.  

The patient should be sitting upright in a relaxed position. The time between positioning and releasing the injector should be kept as brief as possible with children and especially restless patients . 

The patient should be informed about the release noise of the injector to prevent defensive arm movement or startle reflexes 

Haematoma at the injection site are still possible even when using a needle-free system.
They might occur with patients taking anticoagulants to treat cardiovascular disease (e.g., Marcumar) or thrombocytic aggregation inhibitors (e.g., ASS100 = time-released aspirin), or patients occasionally taking aspirin for pain relief.
Small bruises can also be due to too little or too much pressure when positioning the injector on the gingiva. 

Swelling is observed in a few cases, which might also be caused by the local anaesthetic itself (preservatives).  

Bleeding usually does not occur. As with needle injections, INJEX might cause some damage to the uppermost capillaries. In rare cases, this might cause a pin-sized drop of blood to emerge at the injection site. This is especially the case if the patient has been taking medication to treat cardiovascular disease (e.g., Marcumar, ASS100 = time-released aspirin) or normal aspirin for pain relief. 

The recommended basic dosage is 0.3 ml per injection. A second injection to prolong the effect can be administered at any time. The local anaesthetic dose is still lower than with a conventional syringe in spite of the second injection. 

Less than 0.3 ml for the initial injection is not sufficient and the degree of anaesthesia is too low, just as with conventional infiltration anaesthesia.  

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds 

Injecting with INJEX provides a therapeutic window larger than with conventional infiltration anaesthesia due to the better distribution within the tissue. 

It is recommended to use a probe to check the anaesthesia depth before commencing treatment. An additional injection may be administered if necessary. 

Each ampoule of the INJEX system may be filled with max 0.3 ml of anaesthetic. A dose of 0.3 ml is recommended for dental applications.  

The transporter adapter is a sterile disposable product and can be used only with one cylinder cartridge to prevent contamination as well as diminishing functionality. Dispose of the adapter when the medication cartridge is empty. The local anaesthetic may crystallize within the adapter if the same adapter is used with additional medication cartridges. This can impair the transfer to the INJEX ampoule. 

Yes, various adapters are designed for different containers and are used to transfer local anaesthetic directly from the container to the ampoule of the INJEX system. 

No. The pressure and speed are calculated in such a way that the medication only enters into the subcutaneous adipose tissue. Accidental administration of the medication into the muscle is virtually impossible.
In contrast to insulin injections in diabetic children that frequently and unintentionally are performed intramuscular when using a needle syringe (30,5 % of performed injections). (literature review: POLAK et al., 1996)  

A modified injection angle results in an enlarged medication injection point. This may lead to increased bleeding and risk of haematoma. 

The pressure and speed are calculated in such a way that the medicine only enters into the subcutaneous adipose tissue. The depth of penetration is depending on the applied volume, it reaches from 4 to 9 mm.
Accidental intramuscular administration of the medication is virtually impossible.
 

The basic equipment you need is the INJEX injector and the reset box.
In addition, you will need the appropriate ampoules and adapters for the medication concerned. If you use U-40 insulin, you will need the U-40 ampoules, or for U-100 insulin the U-100 ampoules. For all other medications, the 0.3 ml ampoules must be used.
The choice of the adapter depends on the vessel containing the medication. The following rule can be applied in this regard:
 

• If you use pen cartridges without a pen (e.g. first use of insulin), you should use the transporter with transporter adapter.
• If you use a (insulin) pen, you should use the pen adapter.
• If you use injection vials (e.g. U-40 or Heparin), you should use vial adapter 14.
•  If you use snap-off ampoules (e.g. Heparin, local anaesthetics, homeopathics), you should use the Luer adapter.

Tests with different types of needle-free systems have shown hat the medication chooses the path of least resistance, thus going around blood vessels and nerve fibres to penetrate the subcutaneous adipose tissue.
Changes in the skin described as lipodystrophy in diabetics in the case of prolonged administration of insulin are quite improbable. Individual publications even report receding of existent thickening in the subcutaneous adipose tissue resp. fat atrophy.
 

A minimum of 0.05 ml and a maximum of 0.30 ml of a liquid drug can be administered using the INJEX  

Medications licensed for subcutaneous use can be administered with the needle-free INJEX.
The main applications for the INJEX system at present are diabetes (subcutaneous administration of insulin), the prevention of thrombosis (by means of Heparin) and local anaesthesia (e.g. prior to venous catheterisation, prior to minor surgical procedures or for dental infiltration anaesthesia). Other applications for INJEX are the treatment of dupuytren´s disease or homeosiniatry. Please note the technical reports for these mentioned applications.

When applied correctly the injection with INJEX is virtually painless. The sensation can be described as a short slight pressure on the skin surface. As pain is felt individually one cannot state a general and obliging assertion. As fluid is pressed under the skin the patient will sense the injection with INJEX more or less, depending on the volume and the individual sensibility. Patients generally assesse the sting from a needle as more unpleasant than the injection with INJEX.
(literature review: DENNE et al., 1992, TEINTZ et al., 1991, RESMAN et al., 1985)
The micro orifice of the ampoule has a diameter of 0.18 mm. Currently, the thinnest needle has a comparatively thick diameter of 0.25 mm. 

No. In order to guarantee sterility and function, the ampoules are intended to be used once only. 

No, the utilized materials are not suitable for autoclave treatment. Adapter, ampoules, and SiliTop are sterile products for single-use only. The injector, the reset box, and the transporter are designed for multiple-use and need not be sterilized since they are not in direct contact with the patient.  

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

Is the word „edema“the correct characterisation? A swelling can be seen in very few cases, when the injection site is producing an allergic reaction on the preservatives of the local anaesthetic agent. 

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

Infiltration anaesthesia using INJEX is possible on ALL teeth, except wisdom teeth.  Use the injector in the same area you would a traditional needle but at an angle of 90˚.

Injection should be performed into the firm gingiva.
Injecting into the free gingiva may result in intraligamentous injection and damage to the tooth support apparatus due to the applied pressure.
Injecting into the periodontal membrane fold of the mucosa allows rapid penetration of the local anaesthetic into the infra-orbitale foramen. This should be prevented as well. 

The patient should be sitting upright in a relaxed position. The time between positioning and releasing the injector should be kept as brief as possible with children and especially restless patients . 

The patient should be informed about the release noise of the injector to prevent defensive arm movement or startle reflexes 

The prepared injector is positioned above the tooth to be anaesthetized at an angle of 90"‑ while applying medium pressure. It is the same method as with a traditional needle. Once the patient has been informed about the release noise the trigger mechanism should be pressed as quickly as possible. The injector should be left firmly in place of the injection site for 2 seconds after injecting the anaesthetic.

The number of required ampoules should be filled and fitted with the SiliTop prior to use. Resetting the injector with the reset box takes only seconds. Administration is even quicker if several injectors are utilized 

Studies with different needle-free systems have shown that medication chooses the path of least resistance and thus no blood vessels or nerve fibres are injured. The mucous membrane is not damaged if the injector is positioned vertically while applying medium pressure. 

Haematoma at the injection site are still possible even when using a needle-free system.
They might occur with patients taking anticoagulants to treat cardiovascular disease (e.g., Marcumar) or thrombocytic aggregation inhibitors (e.g., ASS100 = time-released aspirin), or patients occasionally taking aspirin for pain relief.
Small bruises can also be due to too little or too much pressure when positioning the injector on the gingiva. 

Swelling is observed in a few cases, which might also be caused by the local anaesthetic itself (preservatives).  

Bleeding usually does not occur. As with needle injections, INJEX might cause some damage to the uppermost capillaries. In rare cases, this might cause a pin-sized drop of blood to emerge at the injection site. This is especially the case if the patient has been taking medication to treat cardiovascular disease (e.g., Marcumar, ASS100 = time-released aspirin) or normal aspirin for pain relief. 

The recommended basic dosage is 0.3 ml per injection. A second injection to prolong the effect can be administered at any time. The local anaesthetic dose is still lower than with a conventional syringe in spite of the second injection. 

Less than 0.3 ml for the initial injection is not sufficient and the degree of anaesthesia is too low, just as with conventional infiltration anaesthesia.  

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds 

Injecting with INJEX provides a therapeutic window larger than with conventional infiltration anaesthesia due to the better distribution within the tissue. 

After anaesthetizing with INJEX, numerous procedures may be performed on the teeth such as fillings, extractions, or polishing. Small gum procedures may also be carried out as part of a periodontal or orthodontic treatment.  Do not use for wisdom teeth.

It is recommended to use a probe to check the anaesthesia depth before commencing treatment. An additional injection may be administered if necessary. 

SiliTop is a cap affixed to the ampoule head before the injection developed especially for dental applications. It prevents pressure sensations that might be caused by the injector impulse when activating the trigger.  

Using INJEX without SiliTop is not recommended because SiliTop ensures the accurate, safe, and gentle positioning of the INJEX injector.  . 

Each ampoule of the INJEX system may be filled with max 0.3 ml of anaesthetic. A dose of 0.3 ml is recommended for dental applications.  

All routine treatments such as (simple) fillings, endodontic measures, preparations, extractions, etc. may be performed, except on wisdom teeth.  Smaller periodontal procedures as well as sub gingival wiring performed by orthodontists are possible as well. Treatment may last up to approx. 20 minutes without administering additional doses.

Especially children but also very sensitive and very anxious adults may exhibit panicked behavior when faced with needle injections. Since this reaction usually results in a sudden and jerky motion, the risk of injury for patient as well physician or dental staff is higher.
The INJEX system eliminates this risk since it does not feature a needle. 

The transporter adapter is a sterile disposable product and can be used only with one cylinder cartridge to prevent contamination as well as diminishing functionality. Dispose of the adapter when the medication cartridge is empty. The local anaesthetic may crystallize within the adapter if the same adapter is used with additional medication cartridges. This can impair the transfer to the INJEX ampoule. 

A modified injection angle results in an enlarged medication injection point. This may lead to increased bleeding and risk of haematoma. 

Medications licensed for subcutaneous use can be administered with the needle-free INJEX.
The main applications for the INJEX system at present are diabetes (subcutaneous administration of insulin), the prevention of thrombosis (by means of Heparin) and local anaesthesia (e.g. prior to venous catheterisation, prior to minor surgical procedures or for dental infiltration anaesthesia). Other applications for INJEX are the treatment of dupuytren´s disease or homeosiniatry. Please note the technical reports for these mentioned applications.

When applied correctly the injection with INJEX is virtually painless. The sensation can be described as a short slight pressure on the skin surface. As pain is felt individually one cannot state a general and obliging assertion. As fluid is pressed under the skin the patient will sense the injection with INJEX more or less, depending on the volume and the individual sensibility. Patients generally assesse the sting from a needle as more unpleasant than the injection with INJEX.
(literature review: DENNE et al., 1992, TEINTZ et al., 1991, RESMAN et al., 1985)
The micro orifice of the ampoule has a diameter of 0.18 mm. Currently, the thinnest needle has a comparatively thick diameter of 0.25 mm. 

No. In order to guarantee sterility and function, the ampoules are intended to be used once only. 

SiliTop is a cap affixed to the ampoule head before the injection developed especially for dental applications. It prevents pressure sensations that might be caused by the injector impulse when activating the trigger.  

SiliTop is a cap affixed to the ampoule head before the injection developed especially for dental applications. It prevents pressure sensations that might be caused by the injector impulse when activating the trigger.

 Adapter, ampoules, and SiliTop are sterile products for single-use only. 

After anaesthetising with INJEX, numerous procedures may be performed on the listed teeth (primary dentition 55-85, upper jaw 15-25, lower jaw 33-43) such as fillings, extractions, or polishing. Small gum procedures may also be carried out as part of a periodontal or orthodontic treatment. 

Infiltration anaesthesia using INJEX is possible wherever the injector can be vertically applied to the firm gingiva surrounding the tooth to be anaesthetized. This applies to the following adult teeth: upper jaw region 15-25 and lower jaw region 33-43. The vertical application of INJEX is possible with virtually all teeth of a child's primary dentition (upper jaw region 55-65 and lower jaw region 75-85). 

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds. 

Injection should be performed into the firm gingiva.
Injecting into the free gingiva may result in intraligamentous injection and damage to the tooth support apparatus due to the applied pressure.
Injecting into the periodontal membrane fold of the mucosa allows rapid penetration of the local anaesthetic into the infra-orbitale foramen. This should be prevented as well.  

Topical anaesthesia is usually not required for adult patients. Patients tolerate positioning the INJEX ampoule very well due to the special SiliTop. Children or very sensitive adults might require some topical anaesthesia first (e.g., lidocaine gel) to reduce the topical pressure sensation when positioning the injector. 

Additional doses (within the scope of the respective limit dosage) may be administered with INJEX as soon as necessary as long as conditions for a proper injection exist. The proven shorter dispersion time facilitates subsequent dosing, saves time, and provides a greater therapeutic effective window. 

No, the utilized materials are not suitable for autoclave treatment. Adapter, ampoules, and SiliTop are sterile products for single-use only. The injector, the reset box, and the transporter are designed for multiple-use and need not be sterilized since they are not in direct contact with the patient.  

Using INJEX to inject into inflamed and/or infected gums should be avoided since it can cause increased bleeding or spread germs. The same guidelines and preventative measures as with conventional injections are to be observed when injecting with INJEX into an inflamed area as part of an emergency treatment. Antibiosis is recommended. 

Using INJEX to inject into inflamed and/or infected gums should be avoided since it can cause increased bleeding or spread germs. The same guidelines and preventative measures as with conventional injections are to be observed when injecting with INJEX into an inflamed area as part of an emergency treatment. Antibiotics are recommended. INJEX should not be used on wisdom teeth.

If more than one shoot is necessary, there should be 2 prefilled ampoules available. The reset of the injector is not lavish. There are nurses, who can do this very quickly. Many dentists invest in 2 or 3 injectors, to safe time. 2 – 3 injectors prepared with prefilled ampoules are optimal for every treatment. 

Is the word „edema“the correct characterisation? A swelling can be seen in very few cases, when the injection site is producing an allergic reaction on the preservatives of the local anaesthetic agent. 

The Injectors trigger has a „press point“. This point has to be found and it’s position has to be trained. If you start pressing the trigger from this point, you will get a proper injection. The injector will not start producing uncontrolled movements, because the trigger will not perform two different movements. 

Swelling is observed in a few cases, which might also be caused by the local anaesthetic itself (preservatives).  

Bleeding usually does not occur. As with needle injections, INJEX might cause some damage to the uppermost capillaries. In rare cases, this might cause a pin-sized drop of blood to emerge at the injection site. This is especially the case if the patient has been taking medication to treat cardiovascular disease (e.g., Marcumar, ASS100 = time-released aspirin) or normal aspirin for pain relief. 

The recommended basic dosage is 0.3 ml per injection. A second injection to prolong the effect can be administered at any time. The local anaesthetic dose is still lower than with a conventional syringe in spite of the second injection. 

Less than 0.3 ml for the initial injection is not sufficient and the degree of anaesthesia is too low, just as with conventional infiltration anaesthesia.  

The local anaesthetic becomes effective more quickly than after a conventional injection. The injected area is anaesthetized after just a few seconds 

Injecting with INJEX provides a therapeutic window larger than with conventional infiltration anaesthesia due to the better distribution within the tissue. 

It is recommended to use a probe to check the anaesthesia depth before commencing treatment. An additional injection may be administered if necessary. 

Each ampoule of the INJEX system may be filled with max 0.3 ml of anaesthetic. A dose of 0.3 ml is recommended for dental applications.  

The transporter adapter is a sterile disposable product and can be used only with one cylinder cartridge to prevent contamination as well as diminishing functionality. Dispose of the adapter when the medication cartridge is empty. The local anaesthetic may crystallize within the adapter if the same adapter is used with additional medication cartridges. This can impair the transfer to the INJEX ampoule. 

A modified injection angle results in an enlarged medication injection point. This may lead to increased bleeding and risk of haematoma. 

Medications licensed for subcutaneous use can be administered with the needle-free INJEX.
The main applications for the INJEX system at present are diabetes (subcutaneous administration of insulin), the prevention of thrombosis (by means of Heparin) and local anaesthesia (e.g. prior to venous catheterisation, prior to minor surgical procedures or for dental infiltration anaesthesia). Other applications for INJEX are the treatment of dupuytren´s disease or homeosiniatry. Please note the technical reports for these mentioned applications.

When applied correctly the injection with INJEX is virtually painless. The sensation can be described as a short slight pressure on the skin surface. As pain is felt individually one cannot state a general and obliging assertion. As fluid is pressed under the skin the patient will sense the injection with INJEX more or less, depending on the volume and the individual sensibility. Patients generally assesse the sting from a needle as more unpleasant than the injection with INJEX.
(literature review: DENNE et al., 1992, TEINTZ et al., 1991, RESMAN et al., 1985)
The micro orifice of the ampoule has a diameter of 0.18 mm. Currently, the thinnest needle has a comparatively thick diameter of 0.25 mm. 

No. In order to guarantee sterility and function, the ampoules are intended to be used once only. 

Bruising at the point of administration cannot be completely ruled out even with needle-free systems.
This can rarely occur in patients regularly taking anticoagulants for the treatment of cardiovascular diseases (e.g. Marcumar; ASS 100 = retarded Aspirin) or occasionally normal Aspirin to alleviate pain.
Smaller bruises can appear at the beginning due to insufficient or excessive pressing of the INJEX onto the skin. 

No, the utilized materials are not suitable for autoclave treatment. Adapter, ampoules, and SiliTop are sterile products for single-use only. The injector, the reset box, and the transporter are designed for multiple-use and need not be sterilized since they are not in direct contact with the patient.