Have you considered ROHS compliance for refurbished medical equipment?

By | Date posted: | Last updated: June 1, 2023
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Introduction

All medical managers of hospitals and other medical organizations must know how their medical system functions. They must be aware of all the risks of their work, especially from their Medical imaging equipment. They must be informed about all regulations and certifications not only related to medical professionals but also related to the medical devices and systems.

The abbreviation ROHS represents an acronym for “Restriction on the Use of Certain Hazardous Substances” which considers the restriction on the use of hazardous substances in electrical and in the electronic equipment under European Union Directive 2002/95/EC (EU ROHS). This regulative is also referred to the upcoming prohibition on sales of some electronic devices which contain certain hazardous substances in California (California ROHS).

The main purpose of the EU ROHS is to restrict the usage of hazardous substances found in electrical and electronic medical equipment. The following hazardous substances are restricted in EU: cadmium, lead, mercury, polybrominated biphenyls, hexavalent chromium, and polybrominated diphenyl ethers.

California ROHS regulative requires DTSC to adopt regulations which prohibit an electronic device from being sold or offered for sale in this state if it is prohibited from being sold or offered for sale in the European Union under EU ROHS.  This is due to the presence of certain heavy metals. In California, the following substances are restricted: mercury, hexavalent chromium, lead, and cadmium.

ROHS compliance: the correlation with used and refurbished equipment

The ROHS or “The restriction of the use of hazardous substances in electrical and electronic equipment” is the latest regulation that comes from the European Union. It is good to know that this directive has become official in 2011 and since then, it is updated into many categories of electronics based on the internal schedule. Those persons who work with medical equipment have the right to know that this regulation to medical devices started June 22, 2014. From this date on, all new, used, and refurbished medical equipment which enters the European market must not have more than the acceptable amounts of the restricted substances.

This seems to be not so good for the manufacturers of medical devices. Major manufacturer companies no longer provide declarations of conformity for their systems which are produced before the compliance date. A declaration of conformity was usually needed for equipment to clear customs. They serve as a given promise from the manufacturer that the systems follow all kinds of regulations and including the ROHS regulative. Without these documents of conformity, some systems might probably have been forbidden access to entry in the European Union.

For the systems which are already imported in the European Union, this is not a big thing. But, if a person has a plan to import a new system, this could be a real problem. That person must be sure and check for certain compliance with any system dealer he works with. This compliance could be a game changer for those companies that deal with the secondary market. Those manufacturers who imported new devices before this regulative, may increase the value of their systems because, it would be more difficult to replace them with the imported systems. The medical industry could also be aware of seeing fewer exports of the European systems as companies try to maintain a local supply.

Summary

The following question comes to mind: “Do ROHS exemptions concern me”? If some document falls under the scope or objectives of equipment given in the ROHS 2 directive, it should precede the regulations according to the new rules and directives. The evaluation must be completed with the assurance that it does not include one or more of the restricted substances above a prescribed amount. Every person who is somehow involved in this field must know the tolerated amount of the substances which are permitted in any homogeneous material.

One must be aware that the regulation legislative may be changed, and he/she must follow if there are any adjustments to the list of substances and/or tolerated amount from time to time. All this is happening with the available scientific and developments in technology. Any person who is involved in this field should be aware of the ROHS directive.

All the persons who are somehow included in this process have the right to check if they match all the given requirements from the ROHS compliance. This is very important if they want to avoid additional problems and concerns.

The ROHS directive includes a few criteria which could be found and checked. Every person must find these criteria and see if he has complete documentation according to the new protocol. If not, he could find a way to arrange the documentation and make sure his permissions would be accepted.

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Why is MRI shielding necessary in refurbished MRI scanner?

By | Date posted: | Last updated: June 1, 2023
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If a person looks for a perfect Magnetic Resonance Imaging for his medical organization, clinic, or hospital, or it is possible that he has already selected it, it is good to consider a few things. One important decision about the unit is the process of selecting and after that installing RS shielding.

This is a great option because it prevents radio frequency waves, some problems with vibration, or noise from entering the MRI.

The mentioned waves could interfere with the operation procedure of the MRI and the result could be the appearance of artifacts in the images or distorted images. It is possible that the signal clutter is caused by things such as television stations, cell phones, steel elevators, subways, traffic to name a few.

The first advice is to hire a person who is the most suitable to perform an inspection and is knowledgeable about MRIs, then comes a professional evaluation of the equipment and room the MRI will be installed before installation. This service person would exactly determine if there is any vibration or some RF problems. If any, he should make necessary service decisions to “shield” the proper room involving the walls, ceilings, floors, and the electrical circuits. It is good to know that one small puncture or eventually open seam can interfere with the quality of the image and result in the damaged image.

What represents an RF shielding and what its purpose is?

One should consider the fact that a shield is a leak-proof box which is an essential part and it encloses the created signals. This unit is made out of soldered copper, non-oxidizing aluminum or galvanized steel. The best materials which are at the same time the cheapest ones are galvanized steel and copper.  Copper can cost double and is the primary cost, those persons who are needing to spend a little less can substitute galvanized steel. Another great thing to keep in mind is that using a cooper RF Shields does not cost as much for maintaining over time because it is a proven that the repairs are minimal. It is also good to know that other materials are not utilized because of the drawbacks such as ease of handling or some other modifications, the price, and corrosion.

The main purpose of RF shielding is to block some specific radio waves which may distort the images created by the MRI. These specific radio waves could be different based upon the type of MRI device which is installed. This may serve as an example, the performance which is required of an MRI shield is to accomplish 100 dB or RF signal attenuation at 100 MHz

Another great function of RF shielding is the prevention of electromagnetic radiation that is generated by the MR scanner from provoking an interference with the medical devices found nearby.

All persons who consider this process on their MRI devices must find specialized companies to do this evaluation. They know the best design and building oversight for the new RF-shielded room. The most suitable room is constructed of three components:

  • Outer shell made for structural support
  • A middle metallic RF-shield
  • An interior layer which is made of finish materials

Other important considerations for the process of MRI Shielding

In addition to all mentioned above, there are several other considerations one needs to do for an optimal and at the same time, safe MRI shield process. At first, a person may involve magnetic shielding in order to contain the magnetic field generated by the MRI. This means to prevent it from interference with surrounding areas. Keep in mind that this shielding procedure is not adequate for every system, but it is often overlooked and inspected when making a plan of the shield enclosure design. All persons should think about magnetic shielding as extremely dangerous.  When controlled tests are performed, it is necessary to notice the physics and the power level of these types of machines.

One must think well about the fact that MRI shielding, and the RF shield enclosure design is a very critical analyses of well-functioning MRI devices.

Summary

Without a doubt, The MRI scanner are very powerful medical devices, and it is important to remember that they are also quite sensitive. There are cases, an external interference could have a huge influence on the ability of the MRI device to provide qualitative and diagnostically acceptable images. Because of this reason, MRI imaging rooms are in a special need of an effective radio-frequency shield for obtaining optimal MRI performance.

If a person is creating a medical imaging room he would need a plan for the room’s MRI shielding and RF shield enclosure design. But in a case where the person is furnishing an old area with a new MRI device, he should make an analysis of the effectiveness of the shield and if it matches with the new technology.

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Difference between Analog and Digital Mammography Equipment

By | Date posted: | Last updated: June 1, 2023
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Before introducing the features of the analog and digital mammography machines, let’s take a quick review of the mammography procedure. It is important to know that mammography is a type of breast imaging procedure that utilizes low dose x-rays for cancer detection. These medical devices continue to be the leading thing when it comes to the early detection and prevention of the breast cancer. You must remember that mammography is a great process because it could detect the changes in breast tissues up to two years before it comes palpably.

As the technology marks rapid progress, the mammography devices also have changed in a great direction. This means that the analog mammography equipment was the general and standard option for many years before. Decades ago, the FDA approved the application of the first full-field digital mammography device and with this step started the revolution of the imaging technology. This step also improved drastically the quality of the images. Before several years, the 3D mammography unit was available on the market. The new mammography unit comes with more advanced features and provides the best image quality.

Difference between analog and digital mammography devices

Keep in mind that analog mammography unit utilizes a low dose of radiation that provides high-quality x-rays. This machine can also detect changes of 1-2 mm. Another thing to consider is that this type of mammography machine captures the x-rays beams on specific film cassettes, and the result is a film which shows the breast from many different angles.

When it comes to the digital mammography, the device captures the x-ray beams on a digital detector. Then it converts the x-rays beams into electronic signals which are later transferred to a computer. Finally, the computerized photos are becoming available for a review on a special monitor with high-resolution. After this, the digital photos could be analyzed by radiologists utilizing the tools and other options offered by the imaging program.

 

The advantages of digital and analog mammography devices

The positive features of digital mammography units

  • It provides more efficient effect because the images are available on the computer
  • The images are shown immediately on the monitor and if they are not good the clinician can repeat the imaging procedure
  • The digital detector gives crisp photos even in the situation of larger breasts
  • The clinician can easily transfer the images for a consultative opinion
  • The clinician can perform an easy analysis of the images
  • Lower radiation doses over 30-40% over the analog devices
  • Early cancer detection, even in the patients with denser breasts
  • It can work well with CAD (computer-aided detection) devices

 

The positive features of analog mammography units

  • They are much more affordable for small hospitals and medical centers
  • The images from analog machines could be transformed into digital with a CR and later saved as DICOM
  • Repairs to these devices are less costly because they don’t have a digital detector which is a fragile and expensive part
  • Because these mammography devices are easy to maintain it is also easier to find a great company for providing a service contract

 

The disadvantages of digital and analog mammography devices

The negative features of digital mammography units

  • More expensive than conventional analog mammography machines
  • The digital detector is fragile and if it breaks, the repair would cost more
  • These devices are more sensitive to the ambiance of changing temperatures
  • They provide a lower spatial resolution
  • There are manufacturers who don’t want to provide contracts over the service

 

The negative features of analog mammography units

  • Less detailed than digital counterparts
  • These devices use a film which needs to be inserted in a CD reader to transform the image into a digital This way, it takes a longer time to receive the needed image
  • There are two systems that are working together so, if one fails, the whole procedure needs to be “down”
  • It is difficult to archive the images unless you have a CR
  • The sale of these units is decreasing and because of this it may be difficult to find some parts for repairing

 

How to choose which one is most suitable for your medical practice

It is more than obvious that the managers of the hospitals should take a close look at all advantages and disadvantages of both, analog and digital mammography equipment. This way, they will find out which machine suits them and their solution. They also need more advice from a proper manufacturer who will determine which device is the best option for the Clinique. He will also give more information about the financial benefit and the service benefit when purchasing new or refurbished mammography equipment.

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How to Keep Your MRI Scanner Operating Up to Date with Preventive Maintenance

By | Date posted: | Last updated: June 1, 2023
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Preventive Maintenance (PM) is very important for all types of MRI scanners. This is especially considered when signing a contract with the vendor when you decide to purchase a new MRI device. Take a close look so you can notice what is covered and what’s not. When this verbiage, that is maintenance and or warranties, it is vital to focus on it.  In a case where preventive maintenance is not included, it is something you simply must organize for yourself. But, before this understand that all PMs are formed equal and you have all updates for a year, however, there are some concerns which need to be addressed.

All managers of medical hospitals and organizations who have bought an MRI machine want to make sure that it functions well. The good thing about this is that there is a way to avoid or eventually prevent an anything happening of an unexpected and unwanted event, by reason and knowing all about your MRI preventive maintenance manual. It is good to know that preventive maintenance occurs before a problem with the MRI is detected, so it won’t have to break down unexpectedly. This is the most important way to protect this type of investment.

Essential aspects of the MRI machine that requires preventive maintenance

  • Engineer Training: It is one of the most important things when it comes to the service staff. You have to ask if the service engineer is well-educated in your specific system model and manufacturer. All MRI devices have calibrations and other tests which are specific to the selected unit. The manager must make sure that the chosen engineer is more than just familiar and competent with the MRI he/she is working with.  The engineer should be certified on your MRI knowledge.
  • Cold head Coverage. The price of the scanner’s cold head repair could be very high when the manager considers parts, engineering expenses, and labor. Make sure that the cold head service is included in the quarterly MRI preventive maintenance because in most of the cases it is not. In some cases, the cold head is termed Cryocooler. It is good to know that it requires the right service by a well-educated engineer. The cold head and the compressor are essential components to the magnets operations. Again, you must find the right engineer who has specific education and training on those units to be performing the preventive maintenance on them. A preventive maintenance check-up is good to be scheduled quarterly, just like the general visit of the MRI PM. The preventive maintenance can prevent high CCU pressures, a daily boil off one percent or more, or cold head knocking or banging.
  • Chiller Service. When reading the contract and when buying an MRI device, also look for this service be involved in the quarterly preventive maintenance. In some of the contracts, this service may not be included. You have to know that the chiller is a separate device from the MRI machine and that’s why it may not be included in the entire service contract. The manager would want to contact a local HVAC team to support and maintain the chiller. It is very important to keep up periodic maintenance on your chiller. Another thing to consider is that all the cold water which provides cooling to the electronics and cabinets are produced by this piece. When this cooling stops, you would likely start to obtain error messages such as “over-temp-error” or “gantry overheat fault”. This will lead to a much higher risk of burning out other components and boards. Every manufacturer of equipment related to chillers for MRI needs a slightly different PM. This means that the chiller equipment models from the same producer may need different PM procedures. The chiller section cools the Helium loop which performs the actual cooling of the magnet. But, keep in mind that there are systems which provide direct cooling to some parts in order to cool electronics and cabinets.
  • ACR Accreditation. Another interesting thing is that if you get preventive maintenance it may not meet the ACR standards. Many of these systems take the Picker Proview. 23& Open MRI is getting the biggest thing of the MRI worl ACR image quality standards are higher than before and they are making the older systems difficult to pass the checks. Keep in mind that ACR is not a synonym to OEM spec.

Summary

All mentioned questions about the maintenance of your MRI machine may vary. This depends on the MRI service contract provider. The most important thing is to ask the manufacturer just to be sure that the pro-owned and refurbished MRI scanner will obtain the care it needs to provide the care patients need. Take a close look at the contract and see which of these areas are covered.

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