INSTRUCTIONS FOR USE
ISSUE # 6 01/2021
MindPeace™
0598
Serial Number MP______________
| S | M | L | |
| 0.35 mm Pb |
DEAR USER,
We are pleased that you have decided to use MindPeace a Texray® product. The products ThyroPeace MP, MindPeace mini, and MindPeace are manufactured with high accuracy and will last for many years if used and maintained correctly. We advise you to carefully read the following information before using the product. Please contact us if you have any questions.
INTENDED USE
The thyroid collar family MindPeace is a Personal Protective Equipment (PPE) designed to reduce external x-ray radiation exposure for the thyroid gland, neck, and bottom cranial area of healthcare professionals performing or are present during radiological examinations or interventional surgical procedures. The products are intended for use only against ionizing scattered x-radiation and must not be used for gamma protection in Nuclear Medicine.
GENERAL DESCRIPTION
MindPeace is a product family of thyroid collars based on Texray radiation protection material and is available in three different designs- ThyroPeace MP, MindPeace mini, and MindPeace. All three designs are available in three different sizes. The Thyropeace MP has a classic design to reduce radiation exposure to the thyroid gland. MindPeace mini has a front-faced protection flap in order to reduce the radiation exposure of the bottom cranial area whereas MindPeace has an extended protection flap in order to more efficiently reduce front- and side-faced radiation exposure of the bottom cranial area.
The x-ray (photon) attenuation and lead equivalence of Texray, MindPeace has been determined according to international standard IEC 61333-3:2014, with the modified broad beam geometry condition with an applied x-ray tube voltage range of 60-110 kV. Correct sizing and fit are required to achieve proper protection, and/or to avoid unnecessary stress or creasing, which may prematurely reduce garment lifetime and durability.
WARNING: This product shall not be used for Nuclear Medicine and similar to the stated lead equivalence is invalidated by the use of most gamma radiation conditions. It is important to avoid direct beam exposure during the entire radiological examinations or interventional procedures. It is not possible for Texray to warn the consumer about every possible danger related to using the product and the consumer must use his or her own common sense and good judgment when using the product.
LABELLING/MARKING
MindPeace is CE marked, ensuring compliance with European Union Personal Protective Regulation 2016/425. The CE mark (CE0598) can be found on the PPE label, which also identifies the specific model, size, and radiation protection level of your product. The product type and size are indicated on the first page of this document and on the product label. For pictures, see the front page.
| TYPE | NAME | MODEL NUMBER | LEAD EQUIVALENCE [mmPb] | Available sizes |
| Thyroid collar | ThyroPeace MP (without flap) | P-MP1035 | 0,35 mm Pb | S, M, L |
| Thyroid collar | MindPeace mini (with front faced flap) | P-MP2035 | 0,35 mm Pb | S, M, L |
| Thyroid collar | MindPeace (with front and side facing flap) | P-MP3035 | 0,35 mm Pb | S, M, L |
Examples of inside labels:
| MindPeace mini Texray AB Model: P-MP2035 www.texray.io Texray AB, Stena Center, 412 92 Goteborg, Sweden | MindPeace Texray AB Model: P-MP3035 www.texray.io Texray AB, Stena Center, 412 92 Goteborg, Sweden | ThyroPeace MP Texray AB Model: P-MP1035 www.texray.io Texray AB, Stena Center, 412 92 Goteborg, Sweden |
| Thyroid collar Texray AB mmPb 0,35/60-110 kV, 6,6 kgsm IEC 61331-3:2014 Size:  SN: MP 0598 Rx only | Thyroid collar Texray AB mmPb 0,35/60-110 kV, 6,6 kgsm IEC 61331-3:2014 Size: SN: MP 0598 Rx only | Thyroid collar Texray AB mmPb 0,35/60-110 kV, 6,6 kgsm IEC 61331-3:2014 Size: SN: MP 0598 Rx only |
The thyroid collar label states: Thyroid collar Texray¹) H²) mm Pb 0,35³)/60 110⁴) 6,60⁵). IEC 61331-3:2014. Where:
- name or trademark of MANUFACTURER,
- for THYROID COLLAR,
- LEAD EQUIVALENT;
- X-RAY TUBE VOLTAGE range;
- AREA DENSITY;
- year of publication of this standard.
“Rx only” states that Federal law in the United States restricts this device to be sold by or on the order of a physician in that market.
Not made with natural rubber latex
RADIATION PROTECTION PERFORMANCE
The radiation protection of this product is set at 0,35 mm Pb equivalence as measured between 60-110kV using the modified broad beam geometry test method of Standard IEC/EN 61331-3:2014 and is certified to be in compliance with an allowed +/- 7% manufacturing tolerance (as mm Pb equivalence). MindPeace is intended to protect against external irradiation, described in 3.9.2.2, Annex II, Regulation (EU) 2016/425, and is categorized as category III according to Annex I Risk categories of PPE, (EU) 2016/425.
RECOMMENDATIONS AND LIMITATIONS OF USE
The recommendations given below are general and may be subject to local statutory or safety /use procedures mandated within your facility. If in doubt about proper usage or garment protection values, consult your hospital physicist or radiologist. Their advice will minimize the total dose based on equipment, kV, filtration, procedure, exposure time, distance, scatter, and other important factors.
ERGONOMIC USE
Texray’s design process includes designing the products for ergonomics, and to ensure that wearing or using the product under normal, intended conditions does not negatively impact the wearer’s health, or introduce strain or injury. MindPeace is based on the unique patented, lead-free, and woven composite core material Texray and is designed to reduce x-ray radiation thus minimizing the thyroid-, neck- and cranial exposure. Wearing the MindPeace does not impose any restrictions or constraints on its intended user’s related activity. However, for comfort and proper protection, it is important that the fit and size are correct for the user, see the section below.
PERSONAL FIT AND SIZING
It is outermost important to identify a product that fits personal demands for size and protection. The MindPeace models come in three different neckline sizes: Small, Medium, and Large. Non-optimal size may lead to inadequate body coverage and discomfort. MindPeace shall be placed within the sterile barrier and Texray recommends consulting the local Hygiene Department for any local recommendations.
Before sterile dressing, apply MindPeace around the neck with an open hook and loop, using both hands. Please check that the lower part of MindPeace is facing down. Adjust the hook and loop so that the product is tight and comfortable around the neck, see the front page for a schematic picture, for clarification.
CARE, MAINTENANCE, AND INSPECTION
The Warranty of the product is 1 year from the date of purchase. The special structure of the garment allows MindPeace to be folded. We recommend storage and usage in normal conditions below 35°C and 85% RH. The garments should be carefully placed in a box during transportation.
For cleaning, wipe the MindPeace product by hand using a wet disposable cloth with a solution of lukewarm water and soap. Let it dry on a flat surface or hanging. Rubbing on the same spot will ruin the fabric and shall not be performed. Regular inspection of the garment, at least annually, is recommended and local guidelines shall be followed. Control that seam integrity and product surface are intact and check for other anomalies. If damaged, the product shall be disposed of and replaced. Contact your Texray representative.
WARNING: Do not iron, do not dry-clean, do not autoclave, do not use bleach, do not use alkali detergents, and do not use alcohol or alcohol-based products. Avoid contact with hot surfaces or long direct exposure to hot sunlight, avoid contact with sharp objects. It is important not to modify or change the product as this may affect its radiation protection performance and invalidate the warranty. Do not disassemble, saw, cut, or pulverize the product.
DISPOSAL AND REPAIR
Disposal of this product shall follow local, state, and federal or international regulations where applicable. For repairs or modifications, please contact your representative or Texray directly.
CERTIFICATES
MindPeace is intended to protect against external irradiation, as described in 3.9.2.2, Annex II, Regulation (EU) 2016/425. PPE provides protection to the thyroid-, neck, and bottom cranial area with a lead equivalence of 0,35 mm Pb: broad beam geometry* 60-110kV, IEC 61331-3:2014.
MindPeace is FDA-registered.
ADDITIONAL INFORMATION
For US Limited Warranty, and other technical data please visit the Texray website link: www.texray.io/techdata
Texray AB
Stena Center
412 92 Göteborg
Sweden
www.texray.io
[email protected]
©Texray AB 2021
EC-Type Examination by:
SGS Fimko Oy, Takomotie 8,
FI-00380 Helsinki, Finland.
Notified Body No: 0598.
Revolutionary radiation protection garments – Texray
