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ReadySwim

Intended Use: Summary and Explanation

ReadySwim is a sterile (pasteurised) solution. It is optimised for use in the swim-up method for the selection of motile sperm from liquified human ejaculates, one of the sperm preparation procedures used in Assisted Reproduction Technology (ART).

Components

Sodium Chloride	Potassium Chloride
Magnesium Sulphate	EDTA
Potassium Phosphate, Anhydrous	Glucose
Calcium Chloride, Dihydrate	HEPES
Sodium Bicarbonate	Sodium Lactate
HSA (Human Serum Albumin)	WFI quality water

Performance Characteristics

pH: 7.5-8.5 Osmolality (mOsm/kg H2O): 290-300 Endotoxin levels <1.0 EU/mLRecovery rate of human motile sperm: >10%. Human sperm survival without hyperactivation 18 hours after preparation by swim-up: >80%. Contents are tested by human sperm survival only. Bottles and stoppers are 2-cell M.E.A. tested.

Protein Supplementation

ReadySwim™ contains the component human serum albumin. (HSA). The human serum albumin is manufactured from human blood donated in the United States. The blood donors who supply the human plasma are tested for various viruses before being allowed to donate blood for this purpose. 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. Thereafter, the HSA product is tested again.

The final ReadySwim™ product is pasteurised for the destruction of bacteria and viruses.

Storage and Stability

Store at 2-30º Celsius and avoid temperatures above or below these values.

Under these conditions ReadySwim™ 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 8ºC when not in use.

Precautions and Warnings

When using large bottles, consider decanting ReadySwim™ into smaller sterile containers to reduce the risk of inadvertant contamination.
Use aseptic procedures at all times
Use sealed buckets during centrifugation to avoid creation of aerosols
ReadySwim™ 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
RS-020	ReadySwim™	2 x 20 ml
RS-100	ReadySwim™	100 ml