Summary

Many clinicians in small clinics or private practices are looking for a safe and effective method of preparing sperm fro intra-uterine insemination.

They are unsure of their ability to layer a density gradient correctly to achieve optimal results. However, they also know the "swim-up" does not remove sperm with abnormal morphology or damaged DNA, and does not separate out bacteria and viruses from the sperm preparation. So what should the use?

Now there is an alternative method of preparing human sperm for IUI - the PureSperm® SpeediKit. The kit contains sufficient sperm preparation materials for five patients, already dispensed in Type 1 glass centrifuge tubes. In addition, we provide 5 semen collective tubes, one for each patient, and empty tubes to balance the centrifuge rotor. (NOTE: The 5 patient prep kit is temporarily unavailable. The replacement kit PureSperm® SpeediKit, PSSK-140, is a ten-patient kit containing all the materials needed for sperm preparation by the single layer centrifugation method, for intrauterine insemination. The kit consists of all emty vials and PureSperm® UniLayer and PureSperm® Wash supplied in pharmaceutical grade packaging for maintained product quality and safe, long-term storage. )

Components

- Ions of calcium, carbonate, chloride, magnesium,phosphate, potassium, sodium & sulphate

- EDTA
- hSA Human serum albumin
- Citrate
- Glucose
- Lactate
- Pyruvate
- HEPES
- Purified water
- Silane-coated silica

Contents are tested by human sperm survival only

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

Performance Characteristics

pH of PureSperm: 7.4 - 7.8
pH of SpermAssist: 7.3 - 8.5
Osmolality of PureSperm® Unilayer (mOsm/kg H2O): 300 - 310
Osmolality of PureSperm® Wash (mOsm/kg H2O): 290 - 300
Endotoxin levels (EU/mL): <1.0

Contents are tested by human sperm survival only

Tubes and stoppers are M.E.A. tested

Storage and Stability

Store at 2 to 30ºC 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.

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

Ordering Information

Article No. / Name / Volume

PSSK-070 / PureSperm® SpeediKit / 5 patient preps (NOTE: The 5 patient prep kit is temporarily unavailable.)

PSSK-140 / PureSperm® SpeediKit (replacement kit) / 10 patient preps

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