FDA-approved Sterile Covers for OEM Medical Devices and Apps

02A-eShield-Sterile-Electronic-Cover-Phone-Web EDIT

Smartphone, Sterile Cover: EC2100

Sterile Covers, Available in 3 Sizes!

The Only FDA Approved Cover for Handheld Devices in a Sterile Field

Design your device or software for use in the sterile field, with eShields™ it’s possible.

With the growing reliance on technology through medical devices in the operating room and sterile fields, proper protective covers are required to maintain a clean and safe environment for patients. eShields™ are designed to help medical device and software manufacturers like you ensure that your products meet the strict requirements for use in the operating room and other sterile fields.

Features & Benefits:

Use Non-Sterile Devices in the Sterile Field
Simplify Regulatory Approvals: FDA Approved
Maintain a Sterile Barrier in Surgery:
Meets ASTM F1670 Standards.
Use Touch Screens Even with Glove
Provide Crystal-Clear Images – Ultra Clear Film

eShield™ Sterile Covers

eShield™ Sterile Covers are made with clear (unpigmented) FDA-approved 1.5 mil, low-density polyethylene (LDPE) plastic resulting in a high clarity barrier with exceptional touch screen performance. Made in the USA. Recyclable. Available for medical devices and softwares.

Smartphone Specifications:

Overall Dimensions:
9” x 14”
(23 cm x 36 cm)
Functional Dimensions:
9” x 4.5”
(23 cm x 11 cm)
Quantity: 25 per Carton
Shipping Carton Dimensions:
14" x 9" x 4"
(36 cm x 23cm x 10 cm)
Shipping Weight: 2lb (0.91kg)
Order Number: EC2100

Product Sheet

View eShield™ Video

How To Use eShield™ Sterile Covers With OEM Devices:

Smart_Phone_Step_1

Step 1: Circulator inserts electronic device into the eShield cover held by scrub person.

Step 2: Scrub person tears off protective cuff and discards.

Smart_Phone_Step_3 Step 3: Scrub person removes adhesive liner.

Smart_Phone_Step_4 Step 4: Scrub person then folds the top portion of cover over at fold line.

Smart_Phone_Step_5 Step 5: Scrub person folds again and seals cover. — The device is now ready for the operating room!

Video: eShield™ Sterile Smartphone Instructions

eShield™ Sterile Resources:

Discover articles, PDF's and other helpful links to learn more about the benefits of our Real Solutions for Real Problems™ for operating rooms and other sterile environments.

Certifications & LInks:
Food and Drug Administration (FDA) 510(k)
FDA 510(k) Premarket Certification - eShield Sterile
U.S. Food and Drug Administration (FDA) Medical Devices
CE Mark Certificate
CE Mark Declaration of Conformity
eShield Sterility, Chemical Composition and Biocompatibility Certificate
WMS ISO 13485:2016 Certificate

eShield™ Sterile User Manuals:
eShield™ Sterile Cover Cell Phone Size
eShield™ Sterile Cover Tablet Size
eShield™ Sterile Cover SLR Camera Size

Adhesive lens rings

Taking photos through your eShield Sterile cover?

Improve the image quality with these adhesive lens rings. Attach them to the surface around the lens of your camera (lens bezel of your digital camera or surface of your smartphone or tablet) to hold the cover flush against the lens opening.

Holds the eShield Sterile cover close against the lens.
Improves image quality and reduces flash bounceback and internal reflections.
Multiple size rings adapt to most digital cameras, smartphones, and tablets.
Available in cartons of 25 sets of rings."

Product Details:

Item:
EC2290
Description:
Camera Adhesive Lens Rings
Product dimensions: 2" x 2"
(51 mm x 51 mm)
Unit of measure: Carton of 25
Carton dimensions:
3" x 3" x 2" (76mm x 76mm x 51 mm)
Carton weight: 1 lb
Caution: Non-sterile

eShield™ Sterile Covers For Medical Devices

Safely Bring Your Medical Device Into The Sterile Field