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  3. Head Peace Comfortable Head Protector
Head Peace Comfortable Head Protector

TEXRAY Head Peace Comfortable Head Protector Operating instructions

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INSTRUCTIONS FOR USE
ISSUE # 6 01/2021
Texray AB
Stena Center
412 92 Göteborg
Sweden
www.texray.io
[email protected]
©Texray AB 2021
EC-Type Examinaon by:
SGS Fimko Oy, Takomoe 8,
FI-00380 Helsinki, Finland.
Nofied Body No: 0598.
CARE, MAINTENANCE AND INSPECTION
The Warranty of the product is 1 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. 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 Examinaon approved.
Monitored by: SGS Fimko Oy, Takomoe 8,
FI-00380 Helsinki, Finland.
Nofied Body No: 0598.
HeadPeace is FDA registered.
ADDITIONAL INFORMATION
For US Limited Warrenty, and other technical data please vist
Texray website link: www.texray.io/techdata
0.25 mm Pb
S M L
Serial Number HP______________
0598
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
performing or are present during radiological
examinaons or intervenonal surgical procedures. The
product are intended for use only against ionizing
scaered x-radiaon and must not be used for gamma
protecon 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
modified broad 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ons or intervenonal procedures.
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.
LABELLING / MARKING
HeadPeace is CE marked,
ensuring compliance to European
Union Personal Protecve
Regulaon 2016/425. The CE
mark (CE0598) can be found on
the PPE label, 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 label.
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
modified narrow beam geometry test method of Standard
IEC/EN 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 are 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.
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
0598
Rx only
TYPE NAME MODEL NUMBER LEAD EQUIVALENCE
[mmPb]
Available
sizes
Head Protecon HeadPeace P-HP1025 0,25 mmPb S, M, L
“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.
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.
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