RADIATION PROTECTION Doc.

Ref PDS/RPA
APPAREL AND Rev.03 Dt. 03/05/2017

Product Data Sheet ACCESSORIES Page 1 of 7

1. PRODUCT DESCRIPTION:
Coat Apron
Coat aprons are designed for maximum comfort, minimum fatigue and complete freedom
of movement. Padded shoulders and waist Velcro closure enable even distribution of
apron weight.

Double sided aprons

Double sided aprons provide complete protection to the whole body. These are especially
useful in Cath labs and similar operational areas where the risk from radiation is higher.
And therefore, protection offered is complete.

Skirt and Vest

The skirt and vest as a set allow more freedom of movement vis-a-vis other protective
apparel. The vest is provided with all the features present in a coat apron with Velcro
fastening in front. As the same time, the skirt is conveniently styled and overlaps in front
to ensure double protection of critical areas.

Protective Gloves (Duo)

Protective gloves are intended to be worn by the operator during radiological examinations
or interventional procedures in which the hands & forearms need to be protected whilst in
the radiation beam or high intensities of stray radiation.
Covers the entire hand & at least half of the forearm with washable inner gloves. The
thumb & other figures enclosed separately.
The gloves are covered with high quality detachable covering for easy cleaning and
inspection.
. Allows the hand of the wearer to be closed with ease & to be moved sideways freely from
the wrists. Minimum Lead Equivalence – 0.50 mm Pb
Protective Gloves (Mittens)
Protective Glove with open palm & separated thumb are intended for special procedures
where full perception of touch is essential. Protective gloves are intended to be worn by
the operator during radiological examinations or interventional procedures in which the
hands & forearms need to be protected whilst in the radiation beam or high intensities of
stray radiation.
Covers the entire hand except the palm & the inside of the thumb & covers at least half of
the forearm. Allows the hand of the wearer to be closed with ease & to be moved sideways
freely from the wrists. Minimum Lead Equivalence – 0.25 mm Pb
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Product Data Sheet ACCESSORIES Page 2 of 7

Thyroid Shield
Thyroid shield provides protection to thyroid against scattered x-rays to doctors, nurses
and technologists working with X-rays.

Patient Apron:
Patient Aprons provide complete frontal protection to the lower body.
These are especially useful in Cath labs and similar operational areas
where the risk from radiation is higher. Provided with adjustable back
strap for snug fit.

Dental Apron:
Dental Aprons provide complete frontal protection to the whole body from
the throat down to at least the knees, the entire breast bone and the
shoulders. These are especially useful in dental applications for complete
frontal protection while being X-rayed in a dentist's chair. It is provided with
Velcro so that it can be fixed around patient neck even if patient moves.
Panoramic Apron:
Panoramic Aprons provide complete frontal protection to the whole body.
These are especially useful in dental applications for complete frontal
protection while being X-rayed in a Panoramic X-ray machine. They are
provided with adjustable Velcro panels for improved fit.

Surgical Aprons
Surgical Aprons provide complete frontal protection to the whole body from
the throat down to at least the knees, the entire breast bone and the
shoulders. A single Velcro strap makes this x-ray apron easy to put on and
take off. Adjustable back Velcro keeps apron snug fit. These are specially
designed for surgical theater and are provided with adjustable Velcro panels
for improved fit as well as ease of quick release. Ergonomic design
equitably distributes weight.
Gonad Shield
Ideal to protect the male reproductive organ. Designed for ease of wear &
removal. Adjustable Velcro panels are provided for good fit.
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Product Data Sheet ACCESSORIES Page 3 of 7

Ovarian Shield
Ideal to protect the female reproductive organ. Design for ease of wear &
removal. Adjustable Velcro panels are provided for good fit.

Head Shield
Complete protection to head & ears. Designed for ease of wear & removal.
Adjustable Velcro panels are provided for good fit.

2. Applicable Standards

89/686/EEC: Directive for Personal Protective Equipment

ISO 9001:2008: Quality Management System

EN ISO 13485: 2012: Medical devices – Quality management systems – Requirements for regulatory purposes

EN 61331-1:2014: Protective devices against Diagnostic Medical X-ray radiation.

(Determination of attenuation properties of material)

EN 61331-3:2014: Protective devices against diagnostic medical X-radiation Part 3: Protective clothing, Eyewear and
Protective Patient shields.

3. COMPOSITION

X-ray Attenuating Material: The flexible Vinyl impregnated with lead / lead free metal particles. 3 types as per
composition of attenuating material – Leadlite, Ultralite & Zerolead

Covering Material (outer and inner): Water repellent nylon fabric

4. BASIC HEALTH SAFETY REQUIREMENT

The Basic health and safety requirements assessed as given in annex II of the 89/686/EC directive. Risk analysis is
about safety and health, in detail is done by manufacturer’s representatives, radiologists, and radiographers, and
documented in BHSR. Considering this analysis, there are no risks associated during its use, about safety and health
of the patient or user.
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Product Data Sheet ACCESSORIES Page 4 of 7

5. LEAD EQUIVALENCE:

Sr. Minimum Lead

Products Standard
No. Equivalence
1 Surgical Apron 0.25, 0.35, 0.50 EN 61331-3 :2014
2 Dental Apron 0.35, 0.50 EN 61331-3 :2014
3 Patient Apron 0.50, 1.0 EN 61331-3 :2014
4 Panoramic apron 0.25,0.35,0.50 EN 61331-1 :2014
5 Head Shield 0.25,0.35,0.50,1.0 EN 61331-1 :2014
6 Gonad Shield 0.50, 1.00 EN 61331-3 :2014
7 Ovarian Shield 1.00 EN 61331-3 :2014
8 Coat Apron 0.25,0.35, 0.50 EN 61331-3 :2014
0.25/0.25,0.35/0.35, EN 61331-3 :2014
9 Double Side Apron 0.50/0.50, 0.50/0.25,
0.50/0.35, 0.35/0.25
0.25/0.25,0.35/0.35, EN 61331-3 :2014
10 Skirt & Vest 0.50/0.50, 0.50/0.25,
0.50/0.35, 0.35/0.25
11 Thyroid Shield 0.35,0.50 EN 61331-3 :2014
0.25,0.35,0.50 EN 61331-3 :2014
12 Protective
Gloves(Mittens)
13 Protective Gloves(Duo) 0.50 EN 61331-3 :2014

6. DIMENSIONS:

Standard Size Letter Symbol Dimensions

A B C
Small Very Short SV 90
Short SS 100
Medium SM 110 60 100
Long SL 120
Extra Long SE 130
Medium Very Short MV 90
Short MS 100
Medium MM 110 60 110
Long ML 120
Extra Long ME 130
Large Short LS 100
Medium LM 110
75 120
Long LL 120
Extra Long LE 130
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Dimension A is Length from the middle of shoulder to the lower edge.

Dimension B is the Width of the front panel and the width of back panel of closed Protective aprons with
fasteners at the sides.
Dimensions X is the firth of closed Protective aprons with a fastener in the middle of the front or the back.
Dimensions A, B and C are minimum dimensions.
Glove - Mittens
Lead equivalent Available Length of the Half circumference of Half circumference
thickness in Size glove in cm the glove on cuff / of the hand of the
mm Pb palm in cm user in cm

0.25 L 38 18.5 / 14 9

0.35 L 38 18.5 / 14 9

0.50 L 38 18.5 / 14 9

Glove - Duo
Lead equivalent Available Length of Half circumference Half
thickness in Size the glove in of the glove on cuff circumference of
mm Pb cm / palm in cm the hand of the
user in cm

0.50 L 38 18.5 / 14 9

7. INSTRUCTIONS FOR RECYCLING, SAFE DESTRUCTION AND DISPOSAL

Due to the high content of metallic lead / lead free contained in the vinyl sheeting any waste lead / lead free
material should be disposed of in registered landfill sites in accordance with the local authority regulations.
The material should not be disposed of by incineration and use of self-contained breathing apparatus is
recommended if the sheeting is ignited by an internal fire. Core material is recyclable.

8. SERVICE LIFE:

The service life of protective apparel depends on use and care and varies enormously. If the protective
apparel a) is damaged physically causing breakage or holes in protective material (which can be
determined by physical observation or by testing against x-ray radiation), or, b) protection material is
hardened, due to migration of lead particles (which can be determined by physical observation or by
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Product Data Sheet ACCESSORIES Page 6 of 7

noticing an uneven thickness in top portion and bottom portion of the apparel), then the protective apparel
should not be used anymore.

9. SHELF LIFE

Not Applicable

10. CLEANING AND DISINFECTING:

 Fresh stains or marks on cloths can be removed with a soft cloth using lukewarm water and soap solution.
After wet cleaning slow it to dry at room temperature.
 It is advisable to clean and maintain apparel once in a moth or as per usage.
 To disinfect the apparel, use alcohol free liquid disinfectant.

NOTE: All models of Thyroid shields are customizable.

11. Product Reference codes

RPA Product codes for Product Product codes Front Back (mm) kVp range
Leadlite codes for for Zerolead (mm)
Ultralite
Panoramic PN25LL PN25UL PN25ZL 0.25 - 50-110
Apron
Panoramic PN35LL PN35UL PN35ZL 0.35 - 50-150
Apron
Panoramic PN50LL PN50UL PN50ZL 0.50 - 50-150
Apron
Double sided DSA2525LL DSA2525UL DSA2525ZL 0.25 0.25 50-110
Apron
Double sided DSA3535LL DSA3535UL DSA3535ZL 0.35 0.35 50-150
Apron
Double sided DSA5050LL DSA5050UL DSA5050ZL 0.50 0.50 50-150
Apron
Double sided DSA3525LL DSA3525UL DSA3525ZL 0.35 0.25 50-150
Apron
Double sided DSA5035LL DSA5035UL DSA5035ZL 0.50 0.35 50-150
Apron
Double sided DSA5025LL DSA5025UL DSA5025ZL 0.50 0.25 50-110
Apron
Coat Apron CA25LL CA25UL CA25ZL 0.25 - 50-110
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Product Data Sheet ACCESSORIES Page 7 of 7

RPA Product Product Product codes Front Back (mm) kVp range
codes for codes for for Zerolead (mm)
Leadlite Ultralite
Coat Apron CA35LL CA35UL CA35ZL 0.35 - 50-150
Coat Apron CA50LL CA50UL CA50ZL 0.50 - 50-150
Skirt & Vest SKV2525LL SKV2525UL SKV2525ZL 0.25 0.25 50-110
Skirt & Vest SKV3535LL SKV3535UL SKV3535ZL 0.35 0.35 50-150
Skirt & Vest SKV5050LL SKV5050UL SKV5050ZL 0.50 0.50 50-150
SKV5035LL SKV3525LL SKV3525UL SKV3525ZL 0.35 0.25 50-150
Skirt & Vest SKV5035LL SKV5035UL SKV5035ZL 0.50 0.35 50-150
Surgical Apron SA25LL SA25UL SA25ZL 0.25 - 50-110
Surgical Apron SA35LL SA35UL SA35ZL 0.35 - 50-150

Surgical Apron SA50LL SA50UL SA50ZL 0.50 - 50-150

Protective PG50LL PG50UL PG50ZL 0.50 - 60-150
Gloves(duo)
Protective Gloves PGM25LL PGM25UL PGM25ZL 0.25 - 60-150
(Mittens)
Protective Gloves PGM35LL PGM35UL PGM35ZL 0.35 - 60-150
(Mittens)
Protective Gloves PGM50LL PGM50UL PGM50ZL 0.50 - 60-150
(Mittens)
Gonad Shield GS50LL GS50UL GS50ZL 0.50 - 60-150
Gonad Shield GS100LL GS100UL GS100ZL 1.00 - 60-150
Patient Apron PA50LL PA50UL PA50ZL 0.50 - 60-150
(Gonad)
Patient Apron PA100LL PA100UL PA100ZL 1.00 - 60-150
(Gonad)
Ovarian Shield OS100LL OS100UL OS100ZL 1.00 - 60-150
Thyroid Shield TS35LL TS35UL TS35ZL 0.35 - 50-150
Thyroid Shield TS50LL TS50UL TS50ZL 0.50 - 50-150
Dental Apron DA35LL DA35UL DA35ZL 0.35 - 70-80
Dental Apron DA50LL DA50UL DA50ZL 0.50 - 70-80
Head Shield HS25LL HS25UL HS25ZL 0.25 - 60-120
Head Shield HS35LL HS35UL HS35ZL 0.35 - 60-120
Head Shield HS50LL HS50UL HS50ZL 0.50 - 60-150
Head Shield HS100LL HS100UL HS100ZL 1.00 - 60-150