PureSperm®SpeediKit provides all the components required to prepare human sperm for IUI. PureSperm®Unilayer is a sterile (autoclaved SAL-10-3) colloidal silica suspension in an isotonic salt solution optimised for the preparation of human sperm, whereby semen is processed by centrifugation through a single layer of colloid. PureSperm®Wash is a sterile isotonic salt solution optimised for washing the sperm pellet after centrifugation with PureSperm®Unilayer and for transferring the sperm to the uterus.

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Components

- Ions of calcium, carbonate, chloride, magnesium,phosphate, potassium, sodium & sulphate hSA Human serum albumin
- EDTA
- Citrate
- Glucose
- Lactate
- Pyruvate
- HEPES
- WFI quality water
- Silane-coated silica

Contents are tested by human sperm survival only

Tubes and stoppers are 2-cell M.E.A. tested

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Performance characteristics

pH of PureSperm

7.4 - 7.8

pH of PureSperm® Wash

7.3 - 8.5

Osmolality of PureSperm® Unilayer (mOsm/kg H2O)

300 - 310

Osmolality ofPureSperm® Wash (mOsm/kg H2O)

290 - 300

Endotoxin levels (EU/mL)

<1.0

Contents are tested by human sperm survival only

Tubes and stoppers are 2-cell M.E.A. tested

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Storage and Stability

Store at 2 to 30şC and avoid temperatures above or below these values. Under these conditions the contents of the kit have a shelf-life of 18 months. The expiry date is shown on both tubes and cartons. Shelf-life on the product label applies when the product is stored according to manufacturer’s recommendations.

No antibiotics, unstable additives or preservatives have been added by the manufacturer to PureSperm®SpeediKit.

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Precautions and Warnings

• When retrieving the sperm pellet, follow the instructions given in the pack insert to avoid inadvertent contamination

• Use aseptic procedures at all times

• If available, use sealed buckets during centrifugation to avoid creation of aerosols

• Clean accidental spills using a dampened cloth or paper. PureSperm®SpeediKit causes floors and benches to be extremely slippery

• PureSperm®SpeediKit does not represent any kind of fire or combustion hazard. A material safety data sheet is available from the distributor or manufacturer(see nidacon.com)

• Do not use any solution which shows evidence of bacterial contamination

• Do not use contents if tamper-evident seal is broken

• 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

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Reagents and Equipment

• Ready to-use tubes of PureSperm®Unilayer andPureSperm® Wash

• Balance tubes

• Bench top centrifuge with swing out rotor

• Sterile Pasteur pipettes

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Ordering Information

Article No.            Name                             Volume

PSSK-070        PureSperm® SpeediKit         5 patient preps

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