PROTECH MEDICAL Proguard Balance Vest Apron Instructions
- June 14, 2024
- PROTECH MEDICAL
Table of Contents
PROTECH MEDICAL Proguard Balance Vest Apron
PRODUCT INFORMATION
LEAD GARMENTS & ACCESSORIES INSTRUCTIONS FOR USE (IFU)
INTENDED USE
- Lead Garments are worn by healthcare professionals to protect them from the harmful effects of X-ray radiation during medical & other procedures requiring the use of X-ray/fluoroscopy.
- Lead garments are usually worn in combination with other products to provide complete protection from X-rays.
You must ensure that your lead garment fits correctly and is properly worn for effective protection.
CAUTION
- Always check to ensure your lead garment is in good, working condition and has not been scratched or punctured.
- Pin holes or other damage to the protective core material can compromise protection and use of Lead Garments should cease immediately until it has been properly repaired or replaced.
PROTECTION & COMPLIANCE STANDARDS
- EN 61331-1:2014 : (EU) Protective devices against Diagnostic Medical X-ray radiation. (Determination of attenuation properties of material)
- EN 61331-3:2014: (EU) Protective devices against diagnostic medical X-radiation Part 3: Protective clothing, Eyewear, and Protective Patient shields.
- ASTM 2547-18: (USA) Standard test method for determining the attenuation properties in a primary x-ray beam of materials used against radiation.
REGULATORY INFORMATION
UKCA TYPE EXAMINATION
X-ray protection Garments and related accessories (“PPE”) described above
conform with the provisions of Regulation (EU) 2016/425 and Regulation (EU)
2016/425 as brought into UK Law and amended; the models satisfy the
requirements of the manufacturer’s technical and quality management
specifications with testing based upon IEC 61331-1:2014, IEC 61331-3:2014 and
applicable FDA regulations and ASTM testing standards. This is identical to
the PPE which BTTG, Approved Body #0338 (6 Wheel Forge Way, Trafford Park,
Stretford, Manchester M17 1EH, United Kingdom), performed the EU Module B
type-examination on and issued the EU type-examination Certificate #523415/1.
The PPE is subject to the conformity assessment procedure set out in
Regulation (EU) 2016/425 as brought into UK Law and amended, Module D
(Certificate #54180) under the surveillance of the Approved Body BTTG,
Approved Body # 0338, performed at Protech Leaded Eyewear, Inc. DBA Protech
Medical, 1360 N Killian Dr. Unit 2, Lake Park, Florida 33403.
EU TYPE EXAMINATION
X-ray protection Garments and related accessories (“PPE”) described above are
in conformity with the provisions of Regulation (EU) 2016/425 and the models
satisfy the requirements of the manufacturer’s technical and quality
management specifications with testing based upon IEC 61331-1:2014 and IEC
61331-3:2014. This is identical to the PPE which Shirley Technologies (Europe)
Limited, Notified Body 2895 (Port Tunnel Business Park, Office 13 Unit 21,
Dublin 17, ROI), performed the EU Module B type-examination on and issued the
EU type-examination Certificate #SH00791. The PPE is subject to the conformity
assessment procedure set out in Regulation (EU) 2016/425, Module D
(Certificate #SH00654) under surveillance of the notified body Shirley
Technologies (Europe), Limited, notified body number 2895, performed at
Protech Leaded Eyewear, Inc. DBA Protech Medical, 1360 N Killian Dr. Unit 2,
Lake Park, Florida 33403.
GENERAL INFORMATION
Upon receipt, please inspect the Lead Garment for damages (holes, cuts, tears,
rips, undone seams). Protech uses crush-proof boxes when shipping its Lead
Garments, but accidents do happen! Sizing and other Lead Garment information
may vary based on customization or special requests. For additional product
details, please refer to the lead garment’s sewn-on label or other included
documentation.
PACKAGING & STORAGE
- Keep Lead Garments out of direct sunlight and prolonged exposure to extreme heat.
- You may roll Lead Garment and transport it in a Protech duffle bag or box, but never sharply fold or crease your Lead Garment.
- Always store Lead Garment on an appropriate metal hanger or lay flat on the ground or a countertop if the hanger is not available.
- Do not subject to extreme temperatures. Store at 70-80°F (21-27°C). Temperature limits approximately 60-100°F (16-38°C).
MAINTENANCE & REPAIRS
Maintenance : It is important to establish a consistent, deep-cleaning schedule to mitigate the risk of pathogen transmission.
Lead garments should be wiped clean after each use. Most dirt and stains (blood, bodily fluids, barium contrast media) on Lead Garment fabrics can be cleaned by using room temperature water along with the following cleaning solutions:
- mild diluted soap,
- alcohol or ammonium-based wipes,
- and highly diluted Clorox hydrogen peroxide (not recommended for long-term use).
To apply cleaning fluid, please use a cloth or wipe and always use room temperature water.
Examples of approved cleaners include PDI Sani-Cloth® AF3 Germicidal Disposable Wipes, PDI Super Sani-Cloth® Germicidal Disposable Wipes, and CaviCide® wipes.
DO NOT : Do not use petroleum-based cleaning solvents. Do not machine wash or dry. Do not use hot or warm water. Do not iron or autoclave.
NOTE:
- Protech’s lead garment inspection software can help record the results of annual PPE (garment) inspections.
- Repairs: For repairs, alterations, trade-ins, recovery, and other services, please contact Protech or your local representative.
DISPOSAL
Users must dispose of Lead Garments and accessories by complying with local,
state, federal, or international regulations where applicable.
WARRANTY POLICY
- Protech’s Lead Garments are warranted to be free of defects in materials and workmanship to the original purchaser for two years. If a defect appears, a return request must be made with Protech or an authorized reseller.
- Protech will issue an RMA form to be completed and submitted along with the return of merchandise. All returns must be accompanied by an RMA with a valid RMA #. All returns will be evaluated and examined.
- Protech will either repair or replace the defective item or part without charge to the purchaser.
This warranty is void when the product has been tampered with, when repairs or attempted repairs have been made by unauthorized persons, or when the item has been subject to misuse, abuse, or damage in transit.
PROTECH LED EYEWEAR INC, DBA PROTECH MEDICAL 1360 North Killian Drive, Unit 2 Lake Park, FL 33403, USA
- Website : protechmed.com
- Phone : 561.627.9769
- Email ( USA ): sales@protechmed.com
- Email ( Intl.): global@protechmed.com
DOC #: AP.A2a (v2-rev15)
Protech Medical – Lead Garment & Accessories IFU
06.09.2023 QM – JP
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