TEXRAY HeadPeace is a personal protective equipment designed to reduce external x-radiation exposure for healthcare professionals. It is intended for use against ionizing scattered x-radiation and cannot be used for gamma protection. HeadPeace is made from a textile radiation protection material called Texray and is available in three sizes: Small, Medium, and Large. It provides 0.25 mmPb equivalence as measured between 70-110 kV using the narrow beam geometry test method.
TEXRAY HeadPeace is a personal protective equipment designed to reduce external x-radiation exposure for healthcare professionals. It is intended for use against ionizing scattered x-radiation and cannot be used for gamma protection. HeadPeace is made from a textile radiation protection material called Texray and is available in three sizes: Small, Medium, and Large. It provides 0.25 mmPb equivalence as measured between 70-110 kV using the narrow beam geometry test method.
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 condions below
35°C and 85% RH. The product should be carefully placed in a
box during transportaon. For cleaning, wipe the HeadPeace
product by hand using a wet disposable cloth with a soluon 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 inspecon 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
representave.
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 radiaon
protecon 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 internaonal regulaons where applicable. For repairs
or modificaons, please contact your representave or
Texray directly.
CERTIFICATES
HeadPeace is intended to protect against external
irradiaon, described in 3.9.2.2, Annex II, Regulaon (EU)
2016/425, amended also to apply in Great Britain. PPE
provides protecon 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 Examinaon 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
©Texray AB 2022
EC-Type Examinaon by:
SGS Fimko Oy, Takomoe 8,
FI-00380 Helsinki, Finland.
Nofied Body No: 0598.
UKCA Type Examinaon by:
SGS United Kingdom Ltd
Rossmore Business Park
Ellesmere Port, Cheshire CH65 3EN
Nofied 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
informaon before using the product. Please contact us if
you have any quesons.
INTENDED USE
The head protecon HeadPeace, is a Personal Protecve
Equipment (PPE) designed to reduce external x-radiaon
exposure for the cranial area of healthcare professionals
present during radiological examinaons or intervenonal
surgical procedures. The products are intended for use only
against ionizing scaered x-radiaon and must not be used
for gamma protecon, e.g. in Nuclear Medicine.
GENERAL DESCRIPTION
HeadPeace is manufactured using the texle radiaon
protecon material Texray and is available in three different
sizes: Small, Medium and Large. The x-ray (photon)
aenuaon and lead equivalence of HeadPeace has been
determined according to internaonal standard IEC
61333-1:2014, with the narrow beam geometry condion
with an applied x-ray tube voltage range of 70-110 kV.
Correct sizing and fit are required to achieve proper
protecon, and/or to avoid unnecessary stress or creasing,
which may prematurely reduce garment lifeme 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
radiaon condions. It is important to avoid direct beam
exposure during the enre radiological examinaon or
intervenonal 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 radiaon cranial exposure. The company Texray
designs ergonomic products, each product evaluated to ensure
that wearing or using the product under normal, intended
condions does not negavely impact the wearer’s health, or
introduce strain or injury. Wearing the HeadPeace does not
impose any restricons or constraints to its intended users
related acvity. However, for comfort and proper protecon, it
is important that the fit and size are correct for the wearer, see
secon below.
PERSONAL FIT AND SIZING
It is outermost important to idenfy a product that fits personal
demands for size and protecon. The HeadPeace models come
in three different sizes: Small, Medium and Large. Non-opmal
size may lead to inadequate body coverage and discomfort.
HeadPeace can be placed inside or outside the hygiene head
cap, Texray recommends consulng local Hygiene Department
for any local recommendaons. 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 schemac picture for
clarificaon.
RADIATION PROTECTION PERFORMANCE
The radiaon protecon 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
cerfied to be in compliance within an allowed +/- 7%
manufacturing tolerance (as mm Pb equivalence). HeadPeace is
intended to protect against external irradiaon, described in 3.9.2.2,
Annex II, Regulaon (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 recommendaons 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
protecon values, consult your hospital physicist or radiologist.
Their advice will minimize total dose based on equipment, kV,
filtraon, procedure, exposure me, distance, scaer and other
important factors.
TYPE NAME MODEL NUMBER LEAD EQUIVALENCE
[mmPb]
Available
sizes
Head
Protecon
HeadPeace P-HP1025 0,25 mm Pb S, M, L
LABELLING / MARKING
HeadPeace is CE and UKCA marked,
ensuring compliance to European
Union Personal Protecve
Regulaon 2016/425. The CE
(0598) and UKCA (0120) mark can
be found on the PPE lable, which also
idenfies the specific model, size and
radiaon protecon 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
-
1
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2
TEXRAY HeadPeace is a personal protective equipment designed to reduce external x-radiation exposure for healthcare professionals. It is intended for use against ionizing scattered x-radiation and cannot be used for gamma protection. HeadPeace is made from a textile radiation protection material called Texray and is available in three sizes: Small, Medium, and Large. It provides 0.25 mmPb equivalence as measured between 70-110 kV using the narrow beam geometry test method.
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