Frequently asked questions Ｑ&Ａ

QThe expiration date is approximately two years, and I believe it was stated that this would change depending on usage, but is it correct to understand that the more you use it, the more it will wear out?

AIt is true that the more you use it, the more it wears out, but the 2-year warranty is based on the assumption that it will be used every day, which is the most common use. As stated in the instruction manual, if it becomes dirty or there is a risk of infection, we recommend disinfecting it with alcohol or other disinfectants each time, and if you use it every day, we recommend dry cleaning it about once a month.

If you wear an MRI protector over your examination gown, sweat and dirt will not adhere to the lining, so dry cleaning is not a problem even after dirt becomes noticeable. However, if you wear the MRI protector directly, sweat and dirt will adhere to the lining, and the silver fibers in the inserted electromagnetic shield will chlorinate and sulfurize, causing deterioration. In fact, in one case where cleaning had not been done for nearly two years, performance degradation below the specified level was observed.

QTo take an extreme example, does this mean that if you reduce the frequency of use, such as by limiting the occasions on which you use it, the expiration date may be extended?

AAt Sumitomo Hospital, where we co-developed the MRI protectors, they are in use almost daily, and they are still in use without any problems after three years. If handled correctly, the shelf life will be longer.

We will inform you of the end of the manufacturer's warranty period, but we believe that it is okay to replace the protector once the area where the MRI protector was worn becomes faintly visible in the actual image. In that case, we ask that you use it at your own risk.

QThe maintenance type says low-temperature sterilization (gas sterilization), but the only sterilization available at the hospital is EOG sterilization (ethylene oxide gas sterilization), which is a sterilization process at 55°C for 4 hours. Is that okay?

AThere are no problems with sterilization at high temperatures other than 100°C or above, so there is no problem with EOG (ethylene oxide gas) sterilization as specified.

QCan I put it in a regular washing machine?

ARegarding washing in a washing machine, the metal fibers inserted (electromagnetic shielding material MGnet) may deteriorate, resulting in a drop in performance, so we recommend dry cleaning with petroleum-based detergents.

Regarding maintenance times, we recommend that you perform maintenance whenever the product becomes dirty, and at least once a month if you use the product continuously every day.

QIs it okay to wear gloves to protect the inside of the mittens (the part that touches the skin) from getting dirty?

AThere is no problem. After installation, squeeze the opening to eliminate any gaps and be sure to seal it with the stopper.

QIs the roll sheet effective just by covering or placing it on the patient?

AAlthough it is somewhat effective, it is better to wrap it around to eliminate gaps. There is no problem with the sheet type no matter how many times it is wrapped around.

QRegarding storage method, do I need to store the product in the bag it came in each time?

AIf you use it every day, there is no problem if you hang it on a hanger. Even in hospitals where it is used frequently, it is still being used without any problems even after 3 years on a hanger. If you will not be using it for a long period of time, please clean it and store it in the airtight bag that was included when it was delivered.

QRecently, magnetic nails used in nail art and some gel nails have been made magnetic, making it impossible to undergo MRI scans, which is a problem. Are there any gloves that can protect hands from changes in the magnetic field and RF to avoid this?

AThe mass of the iron sand used in magnetic nails is small and the surface is coated, so there is no problem with suction. The iron sand contained in gel nails is a magnetic metal component, so there is a risk of heat generation and discoloration during MRI imaging, but wearing the mittens reduces the risk of heat generation and discoloration, and imaging is possible without removing the nail. In clinical use to date and in hospitals that have actually purchased the mittens, they have been attached to metallic nail art, including magnetic nails, rings, and wrist fixators, and imaging has been performed without any problems. There have been zero cases of problems with this type of use in the past four years. An increasing number of hospitals are now introducing the mittens for similar purposes.

QWhen taking an image with the hand wearing mittens and held out to the side of the body, other parts (where the mittens touch) also turn black and the image cannot be captured. Is there any way to deal with this?

AWe recommend that you place a cushion between your thighs and hands, leaving a gap of about 5 cm. Also, if you are imaging the hip joints, thighs, or pelvis (but not the chest), you may want to place your hands toward your chest. There is no need to elevate your hands.

QCan I wear the mittens while wearing a metal watch?

ABasically, if the metal is non-magnetic, there is no problem if you use mittens. As for watches, the effects of magnetic fields are more of a concern than the effects of electromagnetic waves, so it is better to remove them. If you cannot remove rings or nails, you can use them safely if you use mittens.

QCan patients with pacemakers have MRI scans if they wear protective gear?

AIn theory, we believe that there is no problem even if a pacemaker is implanted. If the pacemaker setting is turned off, there is almost no effect. However, since we have not conducted actual clinical trials, we cannot guarantee safety for pacemakers that are not MRI compatible at present. However, even if the pacemaker is MRI compatible, the risk can be reduced by using an MRI protector. Also, even if the pacemaker is MRI compatible, 3T MRI is often not used, so we recommend wearing an MRI protector when using 3T.

QRegarding wearable devices other than pacemakers, the 24-hour real-time blood glucose monitoring device (Abbott FreeStyle Libre) currently needs to be removed before examinations such as MRI, but would it be possible to accommodate this with a roll-sheet type device?

AThere have been cases in the past where measurements were taken of the FreeStyle Libre itself, but this was not verified during MRI imaging. According to the Libre instruction manual, the electromagnetic noise that affects the Libre is 30mA (37.7μT) for the fluctuating magnetic field of the power supply frequency (50/60Hz) and 10V/m for radiated RF (80M-2.7GHz), so it must be removed before an MRI scan.