FAQ

Q1: What are some good Industries and Applications for the innerVision product?

A1: Medical Device Manufacturers:
Catheter Mfg. (Components are in the correct position after assembly)
Stent Mfg. (Looking for the position of the Stent referencing the marker bands on the catheter)
Medical Tube Assemblies (Tube insert depth and seal quality)
Syringe Mfg. (Looking at 5 degrees or more on the angle of the needle after it has been packaged)
Medical Devices that need to be 100% quality assurance after assembly
Surgical Tray Packaging (Verifying that all of the items are in the tray and haven't been damaged during packaging)
Pacemaker Mfg. (Correct placement of the internal components)
Porosity problems (In plastic molded parts for the medical device industry)

Pharmaceutical Manufacturing and Packaging:
Transdermal Packaging (Counting the number of transdermal patches and verifying that the instructions are in the carton after it has been closed)
Bottle filling (Check Levels of pharmaceutical liquids in bottles)
Placement of instructions (Verifying that instructions are in the pharmaceutical package after the package has been sealed)
Checking for damaged components (Verify that all components have not been damaged after packaging)
Blister Packaging (Counting pills, looking for broken pills)

Automotive:
Critical electronic assemblies for automotive (Solder quality, internal pin placement, wire placement, etc.)
Automotive head lights (Air pressure in the bulb, internal weld or solder quality, filament measurement)
Verifying components after assembly (Component placement)

Semiconductor:
BGA Quality (Voids, bridging, Alignment, Coplanarity, Size, roundness, etc.)
Bond Wire (Placement or damage)

Consumable goods:
Golf Balls (Inner core quality)
Bottle Fill levels (Confirming bottle fill levels)
Internal plastic molding issues (Checking for any internal porosity)

Q2: Which agency has responsibility for assuring that the innerVision product is safe to use on a manufacturing floor?

A2: The U.S. Food and Drug Administration (FDA) have responsibility for assuring manufacturers produce cabinet x-ray systems that do not pose a radiation safety hazard. For most electronic products that emit radiation, safety regulation is divided between FDA and state regulatory agencies. Typically, FDA regulates the manufacture of the products and the states regulate the use of the products. For further information on FDA regulations that apply to manufacturers of electronic products that emit radiation (such as a cabinet x-ray system) see the FDA web site (http://www.fda.gov/cdrh/comp/eprc.html).

Q3: Is it safe to stand or walk near an innerVision system while it is producing x-rays?

A3: Yes. Manufacturers are required to certify that their products meet the Federal Radiation Safety Performance Standard for cabinet x-ray systems. Specifically, the standard requires that the radiation emitted from a cabinet x-ray system not exceed an exposure of 0.5 milliroentgens in one hour at any point five centimeters from the external surface. Most cabinet x-ray systems emit less than this limit. In addition, the standard also requires safety features that include warning lights, warning labels and interlocks.
For comparison, the average person in the United States receives a dose of about 360 millirem of radiation per year from background radiation. (Note: 1 milliroentgen of exposure to x-rays will result in approximately 1 millirem of dose. These terms are defined later in this document.) Background radiation is radiation that is always present in the environment. Eighty percent of that exposure comes from natural sources: radon gas, the human body, outer space, rocks, and soil. The remaining 20 percent comes from man-made radiation sources, primarily medical x rays.

Q4: What is the best innerVision product for my application?

A4: It depends on the applications needs. Here are the basic diffences between the innerVision products
i6 = High speed applications (3,600 parts/minute); 7mm – 5.5” FOV
i6H = Higher power to look through denser material; High resolution 5 – 10 microns;
i8 = up to an 8” FOV
i2 = Physical small (20% of the size of the other innerVision products)
i6H3 = It has the highest KV power of the innerVision products (up to 130KV)

Q5: How fast can the product move through the innerVision product?

A5: 250 ft/min – 500 ft/min

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Q6: What is the life of the InnerVision Emitter?

A6: 10,000 hours at the maximum settings before the emitter starts to slowly degrade. Please contact KMV for spare and repair procedures.

Q7: What does the KV and mA setting on the innerVision remote panel stand for?

A7: KV stands for Kilovolts. The max setting on the innerVision i6 product is 50KV. The i6H3 has a max setting of 130KV. mA is milliamps and the maximum setting for the innerVision products is 1 mA.

Q8: Is the innerVision product designed for foreign object detection in the food processing industry?

A8: It depends if the product being inspected needs the innerVision system to analyze the X-ray.

Q9: What kind of materials can the innerVision see through?

A9: It depends on the thickness of the material. The innerVision product is capable of seeing through metals, plastics, paper, water, glass, etc… Please contact KMV to evaluate your application.

Q10: Is the X-ray system on all the time?

A10: Yes, the X-ray tube lasts longer if it stays on and is not turned on and off.

Q11: Are the KV and mA settings set electronically?

A11: Yes they are. This is required if FDA 21 part 11 validation is needed.

Q12: What comes with an innerVision product package?

A12: 1. The innerVision emitter, which produces and controls the X-ray beam.
2. The innerVision lens assembly, which produces the image for the innerVision product for analysis.
3. The innerVision controller, which has Ethernet and digital I/O communication.
4. 3 Meters cables for the three devices
5. Programming software
6. Certifying your innerVision installation per the FDA cabinet X-ray safety guidelines
7. Enclosure design support

Q13: How long are the cables to the controller and emitter and lens assembly?

A13: Three (3) meters is the standard cable length. Five (5) meter cables can be supplied upon request.

Q14: What kind of communication capability does the controller have?

A14: The controller comes with Ethernet PC communications for programming the image software. It also comes with seven (7) user configurable I/O. There is I/O for the safety interlocks as well.

Q15: What is the budgetary cost for the i6 innerVision product?

A15: $100,000 US dollars through December 2005

Q16: What is your standard warranty for the innerVision product?

A16: 1 year for parts and service.

Q17: How does KMV plan to support the innerVision installations in the field?

A17: The first contact will be with the KMV distributor. If the innerVision controller is tied into a customer’s network, our service technicians can trouble shoot the application remotely. Our service technicians are available to support the equipment in the field.

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