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Five Questions to Ask When Buying a Dental Intraoral X-Ray Unit

Five Questions to Ask When Buying a Dental Intraoral X-Ray Unit

Whether you are installing a dental intraoral x-ray in a new office, or you need to replace an old unit, it’s helpful to go into the process eyes wide open. In many cases, the questions below can be answered by the company providing your dental intraoral x-ray. However, it helps to understand all the requirements so that there are no surprises that cause delays or additional costs.

1. Does it matter whether it’s a DC or AC x-ray ?

To answer this, it’s worth a quick explanation of the fundamental difference between a DC x-ray and an AC x-ray. Both types of wall mounted intraoral x-rays in a dental office are powered by basic AC electricity that comes from the wall. The difference between a DC x-ray and an AC x-ray lies in what they do with that incoming electricity.

The incoming AC electricity is seen as a sine wave: it has pulses that go up and down. The power level (or intensity) of the x-ray generated by an AC x-ray matches this sine wave shape, and the actual x-ray power coming out of the machine oscillates at 60 times per second – like the input electricity.

A DC dental intraoral x-ray changes this input DC electricity so that the x-ray coming out of the unit is a single pulse that maintains more of a consistent power level through the entire exposure. On to the highest point and then dropes off to zero.

This difference in the profile of the x-ray output results in two subtle effects.

First, the “up and down” nature of the AC x-ray output creates more radiation when all other parameters are equal. Every time the power level is below a certain threshold, it is emitting radiation that is not having an impact on image quality . In other words, there is a small dose to the patient, but because it is below the sensitivity threshold of the film or sensor that’s capturing the image, it has no impact on the image. and you get an error from the software. For AC x-ray, the power level is dipping below this threshhold 60 times per second, and therefore is emitting more of this soft radiation than a DC intraoral x-ray.

Second, there may be less consistent image quality when all other parameters are equal. If your exposure is 0.04 seconds in duration , that’s only 2.5 “pulses” with an AC x-ray (because they occur 60 times per second). However, depending on the exact timing, the reality of that particular exposure could be 3 “peaks” and 2 “valleys”, or could be the other way around. This difference can create a slight inconsistency in the amount of exposure the sensor or film actually receives. In other words, two exposures taken with exactly the same parameters may have slightly different levels of energy applied to the sensor for an AC x-ray.

You may ask: why would anyone buy an AC x-ray? there is a price advantage with the AC x-ray. It cost less.And is older technology.

2. Do I need a different dental intraoral x-ray if I am using film instead of digital sensors? The short answer is: No.

Typically, the amount of x-ray energy required to generate ideal images with film is higher than that required for a digital sensor. However, almost all intraoral x-ray units today have the ability to adjust settings. For most intraoral x-ray units, increasing the output power is done by simply switching the unit to a mode that increases the time (or duration) of the exposures (typically this is shown in milliseconds, or ms).

If you are using film, the ideal parameters would also vary depending on which type of film you use (D speed, E speed, F speed, etc). Film speeds labelled as “slower” (like D-speed) require more energy to create the image than “faster” film speeds (like F-speed).

3. What shielding is required in My Dental Office for an Intraoral X-Ray Unit ? The official requirements will vary by state or County. However, here are some guidelines to consider.

The two most common characteristics of the office that are typically specified as requirements for intraoral x-ray operation are distance and wall material (sometimes referred to as “distance and density”). The reason for this is that these are two very effective protections against radiation.

Sometimes simply having 6 feet spacing between the intraoral x-ray and an operator is sufficient and no walls are required. Sometimes, a basic wall (typically referred to as “drywall” or “gypsum”) is required to separate the x-ray and the operator. Typically, most states will have some variation of these requirements. Rarely are lead-lined walls required for intraoral x-rays in dental offices. However, some state may require this if there is a very high volume of exposures being taken.

4. Can I have my repair person install my intraoral x-ray ? Most states require that the intraoral x-ray be installed by a person who has registered with the state as a qualified installer. Therefore, if your repair guy has registered, then: “yes”. Otherwise, you want to make sure you are using a Manufaturer certified installer.

One of the ways the FDA monitors this is through a form that is filled out by the installer called the FDA 2579 form. The installer is required to complete this form, and then send one copy to the FDA and one copy to the state. A third copy is provided to the office, which is responsible for keeping a copy of this form to document that the piece of equipment was properly installed. Handheld Dental X-Ray Units do not need to be installed. they are not a permanent fixture.

5. Do I need a wall-mounted unit, a mobile unit, or a handheld unit ? This is a fundamental question that depends on your office needs. Handheld and mobile x-rays offer some economies of scale as they can be shared between rooms. However, there are performance aspects of a wall-mounted and a mobile unit that are often preferable to a handheld x-ray. there are tradeoffs: Mobile units are very heavy and bulky, hard to move around, or travel with. Handheld units are light weight and easy to travel with.

The intraoral dental x-ray is a critical component to a busy dental practice. Understanding some of key components involved in having a new intraoral x-ray installed in your office will help your team make sure there are no surprises.

If you have any questions about this process, please give us a call to talk to one of our specialists.

FDA probes illegal sale of handheld dental x-ray units

The U.S Food and Drug Administration (FDA) is warning dental and veterinary professionals not to purchase or use certain potentially unsafe handheld dental x-ray units that are sold online by manufacturers outside the U.S. and directly shipped to U.S. customers.

The FDA is concerned that these devices may not be safe or effective and could expose users and patients to unnecessary and potentially harmful x-rays. The units have not been reviewed by the FDA and do not meet FDA radiation safety requirements, the agency noted in a press release issued February 10.

The Washington State Department of Health alerted the FDA after tests on a device purchased online revealed it did not comply with x-ray performance standards.

As a result, the FDA is investigating the extent of the problem and is notifying state regulatory authorities, dental professional organizations, and other health organizations about the safety risks. To date, no adverse events have been reported.

A handheld dental x-ray unit is a small, portable device that is intended for dental x-ray examinations. Use of these devices requires a prescription from a licensed practitioner, the FDA noted.

All units that have been cleared by the FDA bear a permanent certification label/tag, a warning label, and an identification (ID) label/tag on the unit.

The certification label should state "This product complies with 21 CFR 1020.30 - 1020.31," "This product complies with 21 CFR Subchapter J," or other similar language.

The warning label must be on the x-ray panel of the unit and state these exact words: "This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

The ID label must contain the following:

The full name and address of the manufacturer of the unit
The place of manufacture
The month and year of manufacture
"Healthcare professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health.

To ensure this, users should take the following steps:

Verify the presence of required labels on the device.
Ask vendors whether the device has been reviewed and cleared by the FDA.
Access the FDA Medical Device Approvals and Clearances searchable database to verify that the x-ray unit has been cleared by the FDA.
Contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet the FDA's requirements.