TEXRAY MindPeace Extended Thyroid Collar Instructions
- June 9, 2024
- TEXRAY
Table of Contents
TEXRAY MindPeace Extended Thyroid Collar
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 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, e.g. in Nuclear Medicine.
GENERAL DESCRIPTION
MindPeace is a product family of thyroid collars based on Texray radiation protection material and are available in three different designs- ThyroPeace MP, MindPeace mini and MindPeace. All three designs are available in three different sizes: Small, Medium and Large. The Thyropeace MP has a classic design to reduce radiation exposure of 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 as 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 examination or interventional procedure. It is not possible for Texray to warn the consumer about every possible danger related to use of the product and the consumer must use his or her own common sense and good judgment when using the product.
LABELLING / MARKING
TYPE| NAME| MODEL NUMBER| LEAD EQUIVALENCE
[mmPb]
| Available sizes
---|---|---|---|---
Thyroid collar| ThyroPeace MP (without flap)| P-MP1035 P-MP1050| 0,35 mm Pb
0,50 mm Pb
| S, M, L
Thyroid collar| MindPeace mini (with front faced flap)| P-MP2035 P-MP2050| 0,35
mm Pb
0,50 mm Pb
| S, M, L
Thyroid collar| MindPeace (with front and side faced flap)| P-MP3035 P-MP3050|
0,35 mm Pb
0,50 mm Pb
| S, M, L
MindPeace is CE and UKCA marked, ensuring compliance to European Union Personal Protective Regulation 2016/425. The CE mark (0598) and UKCA (0120) 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.
Example of the inside label
The thyroid collar label states MindPeace Texray AB1 mm Pb 0,352/60 – 1103 6,604. IEC 61331-3:20145.
Where
- MANUFACTURER,
- 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 or 0,50 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 within an allowed +/- 7% manufacturing tolerance (as mm Pb equivalence). MindPeace is intended to protect against external irradiation, as 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 total dose based on
equipment, kV, filtration, procedure, exposure time, distance, scatter and
other important factors.
ERGONOMIC USE
Tray’s design process includes designing the products for ergonomics and
ensuring 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
thyroid-, neck- and cranial exposure. Wearing the MindPeace does not impose
any restrictions or constraints to its intended users related activity.
However, for comfort and proper protection, it is important that the fit and
size are correct for the user, see 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 local Hygiene Department for any local
recommendations. Before sterile dressing, apply MindPeace around your neck by
opening the fastening device, using both hands. Please check that the lower
part of MindPeace is facing downwards. Adjust the fastening device so that the
product is tight and comfortable around your neck, see front page for the
schematic picture, for clarification.
CARE, MAINTENANCE AND INSPECTION
The Warranty of the product is 2 year from date of purchase. 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 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, 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 dissemble, 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, described in
3.9.2.2, Annex II, Regulation (EU) 2016/425, amended also to apply in Great
Britain. PPE provides protection to the thyroid-, neck- and bottom cranial
area with a lead equivalence of 0,35 or 0,50 mm Pb: broad beam geometry*
60-110kV, IEC 61331-3:2014.
- EC-Type and UKCA Examination approved.
- 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 [email protected]
- Tray AB 2022
- EC-Type Examination by: SGS Fimko Oy, Takomotie 8,
- FI-00380 Helsinki, Finland. Notified Body No: 0598.
- UKCA Type Examination by:
- SGS United Kingdom Ltd Rossmore Business Park Ellesmere Port, Cheshire CH65 3EN Notified Body No: 0120