Sepal Reproductive Devices

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PureSperm® Sperm Gradient

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SpermAssist

Intended Use: Summary and Explanation

SpermAssist™ is a sterile (pasteurised) solution, optimised for extending semen or the sperm pellet recovered from a PureSperm® density gradient or a ReadySwim™ swim-up preparation, for use in intra-uterine insemination or as a sperm maintenance medium.

Performance Characteristics

pH:	7.5 - 8.5
Osmolality (mOsm/kg):	290-300
Endotoxin levels	<1.0 EU/mL
Recovery rate of human motile sperm:	>10%
Human sperm survival without hyperactivation
18 hours after preparation by gradient:	>60%
Contents are tested by human sperm survival only.
Bottles and stoppers are 2-cell M.E.A. tested

Components

Sodium Chloride	Sodium bicarbonate
Potassium Chloride	HEPES
Lactate	EDTA
Sodium pyruvate	Glucose
Human serum albumin	WFI quality water
Magnesium sulphate	potassium dihydrogen phosphate

Protein Supplementation

SpermAssist™ contains the component human serum albumin. (hSA). The human serum albumin is manufactured from blood donated in the United States. The blood donors who supply the plasma are tested for various viruses before being allowed to donate blood. Each plasma donation is individually tested for ALT, HBs antigen, HIV-1/2 antibody and HCV antibody by ELISA. Only those plasma donations found non-reactive for those antibodies have been used for the manufacture of the hSA component. The plasma pool is tested again before manufacture of the hSA product. The final SpermAssist™ product is pasteurised for the destruction of bacteria and viruses.

Storage and Stability

Store unopened bottles at ambient temperature (2 to 40°C ) and avoid temperatures above or below these values. Under these conditions SpermAssist™ has a shelf-life of 12 months. The expiry date is shown on both bottles and cartons. Open and close bottles aseptically. After opening store at 2 to 8°C when not in use.

Precautions and Warnings

Use aseptic procedures at all times.
Use sealed buckets during centrifugation to avoid creation of aerosols.
SpermAssist™ does not represent any kind of fire or combustion hazard. A material safety data sheet is available from the manufacturer or distributor.
Do not use any solution which shows evidence of bacterial contamination.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Please check for regulatory compliance governing the use of ART products in your country.

Ordering Information

product #	product name	order multiple
SA-020	SpermAssist™	2 x 20 ml