TEXRAY HeadPeace Comfortable Head Protector Instructions
- June 9, 2024
- TEXRAY
Table of Contents
TEXRAY HeadPeace Comfortable Head Protector
DEAR USER,
We are pleased that you have decided to use headpiece, a Texray® product.
Headspace is 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 head protection HeadPeace is a Personal Protective Equipment (PPE) designed to reduce external x-radiation exposure for the 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
HeadPeace is manufactured using the textile radiation protection material Texray and is available in three different sizes: Small, Medium, and Large. The x-ray (photon) attenuation and lead equivalence of HeadPeace have been determined according to international standard IEC 61333-1:2014, with the narrow beam geometry condition with an applied x-ray tube voltage range of 70-110 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
HeadPeace is CE and UKCA marked, ensuring compliance to European Union
Personal Protective Regulation 2016/425. The CE (0598) and UKCA (0120) marks
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.
”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 0,25 mm Pb equivalence as
measured between 70-110 kV using the narrow beam geometry test method of
Standard IEC 61331-1:2014 and is certified to be in compliance with an allowed
+/- 7% manufacturing tolerance (as mm Pb equivalence). HeadPeace 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
HeadPeace is based on the unique patented, lead-free, and woven composite core
material Texray, and is designed to reduce x-ray radiation cranial exposure.
The company Texray designs ergonomic products, each product evaluated 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.
Wearing the HeadPeace does not impose any restrictions or constraints to its
intended user’s related activity. However, for comfort and proper protection,
it is important that the fit and size are correct for the wearer, 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 HeadPeace models come in three different sizes: Small,
Medium and Large. Non-optimal size may lead to inadequate body coverage and
discomfort. HeadPeace can be placed inside or outside the hygiene head cap,
Texray recommends consulting local Hygiene Department for any local
recommendations. Apply HeadPeace towards the forehead with an open hook and
loop, using both hands. Adjust the hook and loop on the back of your head so
that the product is tight and comfortable on the head, see the schematic
picture for clarification.
CARE, MAINTENANCE, AND INSPECTION
The Warranty of the product is 2 year from the date of purchase. The special structure of Texray allows HeadPeace to be folded. We recommend storage and usage in normal conditions below 35°C and 85% RH. The product should be carefully placed in a box during transportation. For cleaning, wipe the HeadPeace 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 ruins the fabric and shall not be performed. Regular inspection of the product, 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, and 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
HeadPeace 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 cranial area with a lead equivalence
of 0,25 mmPb: narrow beam geometry 70-110 kV, IEC 61331-1:2014.
EC-Type and UKCA Examination approved. HeadPeace 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 info@texray.io
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