TEXRAY Head Peace Comfortable Head Protector Instructions

: June 5, 2024
: TEXRAY

Table of Contents

INTENDED USE
GENERAL DESCRIPTION
LABELLING/MARKING
RADIATION PROTECTION PERFORMANCE
RECOMMENDATIONS AND LIMITATIONS OF USE
ERGONOMIC USE
PERSONAL FIT AND SIZING
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

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.