TEXRAY Head Peace Comfortable Head Protector Instructions
- June 5, 2024
- TEXRAY
Table of Contents
Head Peace Comfortable Head Protector
Instruction Manual 0598
Serial Number HP__
DEAR USER,
We are pleased that you have decided to use a 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 headpiece is a Personal Protective Equipment (PPE) designed to reduce external x-radiation exposure for the cranial area of healthcare professionals performing or are present during radiological examinations or interventional surgical procedures. The product is intended for use only against ionizing scattered x-radiation and must not be used for gamma protection in Nuclear Medicine.
GENERAL DESCRIPTION
headspace 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
modified broad 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
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
headspace 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.
headpiece
Tray AB
Model: P-HP1025
www.texray.io
Tray AB, Stena Center, 412 92
Goteborg, Sweden
0,25 mmPb, narrow beam,
70-110 kV, IEC 61331-1:2014
Size:
SN: HP
0598 Rx only
“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.
TYPE| NAME| MODEL NUMBER| LEAD EQUIVALENCE [mmPb]|
Available sizes
---|---|---|---|---
Head Protection| headpiece| P-HP1025| 0,25 mmPb| 5, M, L
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 modified narrow beam geometry test method of Standard IEC/EN 61331-1:2014 and is certified to be in compliance within an allowed +/- 7% manufacturing tolerance (as mm Pb equivalence). headspace 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
headspace 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 headpiece 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 headpiece models come in three different sizes: Small,
Medium and Large. Non-optimal size may lead to inadequate body coverage and
discomfort. headspace can be placed inside or outside the hygiene head cap,
Texray recommends consulting the 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 schematic picture for clarification.