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Ophthalmic Eye Sphere and Conformer Sterilization Instructions

Gulden Ophthalmics Eye Spheres and Conformers are non sterile. Eye Spheres and Conformers may be sterilized with ethylene oxide (EtO) under the following conditions:

Parameters Temperature Pre-Vacuum Relative Humidity Humidty Dwell Sterilant Gas EtO Concentrate Exposure time Post Vacuum (2 times) Mechanical Aeration temperature	Value 130 ± 5°F / 54 ± 3°C 24 - 26 inHg / 610 - 660 mmHg 60 ± 10% RH 30 - 45 minutes 100 % EtO 600 ± 30 mg/Liter 2 hours ± 5 minute 24 - 25 inHg / 610 - 660 mmHg 110 - 124°F / 43 - 51°C
Residuals after 48 hours minimal Aeration time	EO < 250ppm ECH < 250ppm EGly < 5000ppm
Residuals after 72 hours recommended Aeration time	EO < 250ppm ECH < 250ppm EGly < 5000ppm

OR

Sterility assurance level (SAL) of 10-6 was achieved for Gulden eye spheres and conformers when processed according to STERRAD's instructions through a short full cycle in the STERRAD 100S Sterilization System.

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WEEE Compliance:
Hilco Europe are complying with the WEEE regulations by contracting-out our obligations to a Compliance Scheme. If you are a customer of Hilco Europe and have waste electrical or electronic equipment of our origin to dispose of, the return path for this WEEE will be through our compliance scheme provider who will arrange to pick up the waste from your premises. To arrange collection of this waste please contact us.