MaxRay Cocoon State Approval
The MaxRay Cocoon is FDA Approved but each state has their own approvals as well for Handheld X-Ray Units. Please check your states Approval Status.
Handheld Policy 420-3-26-.03(5)(b) § Handheld Exams; the following documents are required: – A layout of where the mobile or portable machines are used. – REQUEST FOR HANDHELD EXEMPTION form. – A statement of training for the proper use of the handheld device, for each operator.
R12‐1‐610.01. Hand‐held Intraoral Dental Radiographic Unit Requirements For Use A. Registrants are subject to the following requirements for Intraoral dental radiographic units designed to be operated as a hand‐held unit: 1. For all uses: a. Operators of hand‐held intraoral dental radiographic units shall be specifically trained to operate such equipment. b. A hand‐held intraoral dental radiographic unit shall be held without any motion during a patient examination. A tube stand may be utilized to immobilize a hand‐held intraoral dental radiographic unit during patient examination. c. The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand‐held intraoral radiographic unit. 2. Additional requirements for operatories in permanent facilities: a. Hand‐held intraoral dental radiographic units shall be used for patient examinations in dental operatories thatmeet the structural shielding requirements specified by the Agency or by a qualified health or medical physicist. b. Hand‐held intraoral dental radiographic units shall not be used for patient examinations in hallways and waiting rooms. B. Hand‐held units may only be used in a manner as specified on the registration issued.
1. The portable dental X‐ray system being used has received FDA approval and is being used in a manner consistent with that approval; 2. A backscatter shield provided by the manufacturer, which provides not less than 0.25 mm lead equivalent, must be permanently affixed in place at all times; the X‐ray system may not be used if this component becomes broken or dislodged; 3. Personnel monitoring devices must be worn by all individuals operating portable dental X‐ray systems. The personnel monitoring must be evaluated on a monthly basis, and records must be available for review by the Department; 4. All personnel must receive training in the safe use of these X‐ray systems; records of training must be available for review by the Department.Must wear personal monitoring device (Nomad, monitoring device not required)
Must apply for variance.
Contact Delaware Radiology Board: (302)744-4546
A Dosimeter is Required for use.
1. Portable equipment shall be used only for examinations where it is impractical for medical purposes, to transfer the patient to the x‐ray suite. 290‐5‐22‐.04 (4) (g) 2. When this portable device is used, a pistol grip and a permanently attached back scatter device must be part of the equipment. The operator shall not be able to remove either the grip or the back scatter device. 3. All operators will wear a lead apron when making exposures. 4. If any operator has a need to use a portable handheld dental machine on a regular basis (see reference no. 1) they shall be provided with a dosimetry badge. 5. Equipment shall be secured against unauthorized use by a key or password.
The operator shall use a lead apron and thyroid collar while operating a handheld dental xray unit.
Must e‐mail/call Dave Nauth (317) 233-7563 [email protected] a letter requesting a variance. Also must use an apron.
Office must apply for waiver.
Dosimeter Required, Apron Required, See vendor requirement: Must request an exemption send request in writing to: Kentucky Radiation Health, 275 E Main St.,
Mailstop: HS1C-A, Frankfort, KY 40621, Fax 502-564-1492
Must keep shield in place, Use in treatment area, wear dosimeter badge, must submit statement regarding storage, Dr. must submit training certificate.
Cleared by regulation. Must apply for variance.
Contact Maryland Radiology Board at (410) 537-3186
(F) Hand ‐Held Intraoral Dental Radiographic Units (1) For all uses:
(a) Operators of hand‐held intraoral dental radiographic units shall be specifically trained to operate such equipment.
(b) When operating a hand‐held intraoral dental radiographic unit, operators shall wear a lead apron and thyroid collar, unless otherwise authorized by the Agency or a qualified health or medical physicist.
(c) A hand‐held intraoral dental radiographic unit shall be held without any motion during a patient examination. A tube stand may be utilized to immobilize a hand‐held intraoral dental radiographic unit during patient examination.
(d) Unless otherwise authorized by the Agency, a hand‐held intraoral dental radiographic unit shall be used with a secondary radiation block.
(e) The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand‐held intraoral radiographic unit.
(2) Additional requirements for operatories in permanent facilities:
(a) Hand‐held intraoral dental radiographic units shall be used for patient examinations in dental operatories that meet the structural shielding requirements specified by the Agency or by a qualified health or medical physicist.
(b) Hand‐held intraoral dental radiographic units shall not be used for patient examinations in hallways and waiting rooms.
May be able to apply for variance.
Does require variance (recommend the office request variance prior to purchase)
Contact Minnesota Radiology Board at (651) 201-4533
May apply for variance. Contact Mississippi Radiology Board at (601) 987-6893
May be able to apply for variance. Call Nebraska Radiology Board at (402) 471-0560
Must get a variance: Justification for use, commitment to safety and security and training. Contact New Mexico Radiology Board at (505) 753-7256
Registration Form: https://www.env.nm.gov/nmrcb/documents/RadiationProducingMachineRegistration_RADServices_FinalApril2013.pdf
- Operator must wear a lead apron.
- Facility must register the machines with this Section within 30 days of initial activation
- Operators of the unit must complete the training provided by the manufacturer prior to use
- A record of training must be retained for each operator (This should be a printed certificate)
- Each operator must be authorized to utilize x-ray equipment in NC
Personnel monitoring must be worn by operators during use of the unit
Lead aprons or whole body protective barriers of not less than 0.25 mm lead equivalent must be utilized by the operator
- The registrant’s Written Radiation Safety Program must address use of the hand-held machine
- The unit must be secured when not in use to prevent exposure by a non-authorized user
- The back scatter shield must be in place for use of the device
- At a minimum, E or F Speed Film or a digital sensor should be used for dental exams
- A copy of this letter must be maintained by the registrant
See Part F Apendix D of RI x‐ray regulations for specifications for hand‐held use.
Dosimeter Badge Required for use for (1) Year.
Contact Tennessee Radiology Board (615) 532-0399 for questions.
(12) Hand‐held Portable Dental X‐ray Systems. (a) X‐ray equipment designed to be hand‐held shall comply with Section R313‐28‐31, excluding Subsection R313‐28‐31(5), and with Section R313‐28‐80, excluding Subsections R313‐28‐80(7)(b) and R313‐28‐80(11)(b). (b) Protective shielding of at least 0.5 millimeter lead equivalence shall be provided for the operator to protect the operator’s torso, hands, face, and gonads from backscatter radiation. If the protective shielding is a backscatter shield attached to the x‐ray unit, the shield shall be positioned as close to the patient as possible and the operator shall take care to remain in a protective position. (c) Portable radiation machines designed to be hand‐held are exempt from Subsection R313‐28‐35(7). The portable radiation machines shall be held by the tube housing support or handle and shall be used in accordance with the manufacturer’s operating procedures. (d) In addition to the requirements of Subsection R313‐28‐350(1), each operator shall complete the training program supplied by the manufacturer prior to using the x‐ray unit.
Records of training shall be maintained on file for examination by an authorized representative of the Director.
Must request variance, dosimeter, each user must read and make themselves familiar with the device. Contact Virginia Radiology Board at (804) 864-8170
Apron may be required. Contact Washington Radiology Board at (360) 236-3267
Apron may be required. Contact Wyoming Radiology Board at (307) 777-4951
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