TEXRAY Head Peace Comfortable Head Protector Operating instructions

Brand: TEXRAY

Model: Head Peace Comfortable Head Protector

Type: Operating instructions

TEXRAY Head Peace Comfortable Head Protector offers reliable cranial protection against external x-radiation for healthcare professionals during radiological examinations or interventional surgical procedures. Its unique lead-free Texray material provides 0.25 mmPb equivalence, certified according to IEC 61331-1:2014 standards. Available in three sizes (S, M, L), it ensures a comfortable and proper fit for optimal protection.

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

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.

TEXRAY Head Peace Comfortable Head Protector Operating instructions

TEXRAY Head Peace Comfortable Head Protector Operating instructions

TEXRAY Head Peace Comfortable Head Protector Operating instructions

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