RECISPERME - Cryo Bio System
Contents
1. Ref 015859 Cryoe Bio System Groupe I M V Technologies Instructions for use RECISPERME Sterile disposable sperm collection vessel GENERAL INFORMATION AND INTENDED USE RECISPERME is a medical device designed for collection of sperm for spermogram sperm culture spermocytogram insemination in vitro fertilization The innovative design of the Cryo Bio System RECISPERME allows sperm to be collected directly into a tube eliminating the need for sample transfer for quantification and further preparation CAUTION The user should carefully read the entire Instructions for Use and be trained in the correct procedure before using RECISPERME WARNING Do not use RECISPERME if the product or the packaging has been opened and or damaged as the sterility and the integrity of the product can no longer be guaranteed Store in a clean and dry environment away from direct light and heat sources DESCRIPTION RECISPERME is composed of four parts a funnel a 10 mL tube with a blue colored stopper a support and an adhesive cover RECISPERME is individually packed and supplied sterile in box of 20 units INSTRUCTIONS FOR USE 1 Pre weigh the entire patient labeled device or only the tube plugged with blue stopper into its support and note the weight 2 After ejaculation directly into the funnel the adhesive cover can be placed over the funnel to avoid contamination 3 Leave the de2. vice standing on its support to allow the sperm to flow from the funnel into the tube 4 Disconnect the funnel and close the tube with the blue stopper 5 Weigh the device in the same configuration as it has been pre weighed in point 1 to calculate the volume assuming the density of human sperm to be 1g mL WHO laboratory manual for the Examination and processing of human semen Fifth edition 6 Discard the support and funnel as biological hazard waste SHELF LIFE Three years from date of manufacture see expiration date printed on the label DISPOSAL AFTER USE Please follow specified legal guidelines for disposal of contaminated medical waste QUALITY ASSURANCE Cryo Bio System products are manufactured from biocompatible materials and designed for medically assisted reproduction Sterilization is done by irradiation Cryo Bio System s Quality Assurance System is ISO 13485 2003 certified Cryoe Bio System Groupe M V Technologies Poe Bio System Groupe IMV Technologies ZI n 1 Est 61300 SAINT OUEN SUR ITON FRANCE Ph 33 0 233 346 464 Fax 33 0 233 341 198 www cryobiosystem com CE LOT 0459 R f rence Batch code m i E STERILE R Factory Re manufacturing Use by Sterilized by dat irradiation Q p See instructions for use Do not reuse Edition 07 2013
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