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HeadPeace

TEXRAY HeadPeace Operating instructions

  • Hello! I've reviewed the instructions for the Texray HeadPeace P-HP1025, a head protection device designed to reduce x-ray radiation exposure. This document details important information on its use, care, and maintenance, including cleaning and inspection guidelines, as well as its radiation protection capabilities and warnings about improper handling. I'm ready to answer your questions about this product.
  • What is the warranty period for the HeadPeace product?
    How should the HeadPeace product be cleaned?
    What is the lead equivalence of the HeadPeace?
    What should I do if the product is damaged?
INSTRUCTIONS FOR USE
ISSUE # 12 05/2022
CARE, MAINTENANCE AND INSPECTION
The Warranty of the product is 2 year from date of purchase.
The special structure of Texray allows HeadPeace to be folded.
We recommend storage and usage in normal condions below
35°C and 85% RH. The product should be carefully placed in a
box during transportaon. For cleaning, wipe the HeadPeace
product by hand using a wet disposable cloth with a soluon of
lukewarm water and soap. Let it dry on a flat surface or
hanging. Rubbing on the same spot ruin the fabric and shall not
be performed. Regular inspecon 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
representave.
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 radiaon
protecon performance and invalidate warranty. Do not
dissemble, saw, cut or pulverize the product.
DISPOSAL AND REPAIR
Disposal of this product shall follow local, state and federal
or internaonal regulaons where applicable. For repairs
or modificaons, please contact your representave or
Texray directly.
CERTIFICATES
HeadPeace is intended to protect against external
irradiaon, described in 3.9.2.2, Annex II, Regulaon (EU)
2016/425, amended also to apply in Great Britain. PPE
provides protecon 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 Examinaon approved.
HeadPeace is FDA registered.
ADDITIONAL INFORMATION
For US Limited Warrenty, and other technical data please
visit Texray website link: www.texray.io/techdata
0.25 mm Pb
S M L
Serial Number HP_______________
Texray AB
Stena Center
412 92 Göteborg
Sweden
www.texray.io
[email protected]
©Texray AB 2022
EC-Type Examinaon by:
SGS Fimko Oy, Takomoe 8,
FI-00380 Helsinki, Finland.
Nofied Body No: 0598.
UKCA Type Examinaon by:
SGS United Kingdom Ltd
Rossmore Business Park
Ellesmere Port, Cheshire CH65 3EN
Nofied Body No: 0120
DEAR USER,
We are pleased that you have decided to use HeadPeace,
a Texray® product. HeadPeace is manufactured with high
accuracy and will last for many years if used and maintained
correctly. We advise you to carefully read the following
informaon before using the product. Please contact us if
you have any quesons.
INTENDED USE
The head protecon HeadPeace, is a Personal Protecve
Equipment (PPE) designed to reduce external x-radiaon
exposure for the cranial area of healthcare professionals
present during radiological examinaons or intervenonal
surgical procedures. The products are intended for use only
against ionizing scaered x-radiaon and must not be used
for gamma protecon, e.g. in Nuclear Medicine.
GENERAL DESCRIPTION
HeadPeace is manufactured using the texle radiaon
protecon material Texray and is available in three different
sizes: Small, Medium and Large. The x-ray (photon)
aenuaon and lead equivalence of HeadPeace has been
determined according to internaonal standard IEC
61333-1:2014, with the narrow beam geometry condion
with an applied x-ray tube voltage range of 70-110 kV.
Correct sizing and fit are required to achieve proper
protecon, and/or to avoid unnecessary stress or creasing,
which may prematurely reduce garment lifeme 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
radiaon condions. It is important to avoid direct beam
exposure during the enre radiological examinaon or
intervenonal 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 judgement when
using the product.
ERGONOMIC USE
HeadPeace is based on the unique patented, lead-free and
woven composite core material Texray, and is designed to
reduce x-ray radiaon cranial exposure. The company Texray
designs ergonomic products, each product evaluated to ensure
that wearing or using the product under normal, intended
condions does not negavely impact the wearer’s health, or
introduce strain or injury. Wearing the HeadPeace does not
impose any restricons or constraints to its intended users
related acvity. However, for comfort and proper protecon, it
is important that the fit and size are correct for the wearer, see
secon below.
PERSONAL FIT AND SIZING
It is outermost important to idenfy a product that fits personal
demands for size and protecon. The HeadPeace models come
in three different sizes: Small, Medium and Large. Non-opmal
size may lead to inadequate body coverage and discomfort.
HeadPeace can be placed inside or outside the hygiene head
cap, Texray recommends consulng local Hygiene Department
for any local recommendaons. Apply HeadPeace towards the
forehead with open hook and loop, using both hands. Adjust the
hook and loop on the back of your head so that the product is
ght and comfortable on the head, see schemac picture for
clarificaon.
RADIATION PROTECTION PERFORMANCE
The radiaon protecon of this product is set at 0,25 mmPb
equivalence as measured between 70-110 kV using the narrow
beam geometry test method of Standard IEC 61331-1:2014 and is
cerfied to be in compliance within an allowed +/- 7%
manufacturing tolerance (as mm Pb equivalence). HeadPeace is
intended to protect against external irradiaon, described in 3.9.2.2,
Annex II, Regulaon (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 recommendaons 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
protecon values, consult your hospital physicist or radiologist.
Their advice will minimize total dose based on equipment, kV,
filtraon, procedure, exposure me, distance, scaer and other
important factors.
TYPE NAME MODEL NUMBER LEAD EQUIVALENCE
[mmPb]
Available
sizes
Head
Protecon
HeadPeace P-HP1025 0,25 mm Pb S, M, L
LABELLING / MARKING
HeadPeace is CE and UKCA marked,
ensuring compliance to European
Union Personal Protecve
Regulaon 2016/425. The CE
(0598) and UKCA (0120) mark can
be found on the PPE lable, which also
idenfies the specific model, size and
radiaon protecon level of your
product. The product type and size
are indicated on the first page of this
document and on the product lable.
”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.
HeadPeace
Texray AB
Model: P-HP1025
www.texray.io
Texray AB, Stena Center,
412 92 Goteborg, Sweden
0,25 mmPb, narrow beam,
70-110 kV, IEC 61331-1:2014
Size:
SN: HP
Rx only
/