Does the system come with a warranty?

Yes- the system comes with a comprehensive two (2) year warranty. BCSI also offers three (3) different levels of customer support packages.  Please ask a representative for more information.

How often do you have to service it?

The only normal user service activity required is to replace the QC standard once a year.  The hardware has no moving parts.  The sensing chemistry for the system is built in the disposable sensors such that the hardware does not require factory servicing to continue operating.

How long does it take to set up the system prior to each cycle?

The day before each cycle starts, it takes 1-2 minutes to prepare a sensor with media and begin the overnight equilibration.  Another 1-2 minutes are needed to run a QC test at the start of the cycle followed by starting the pH test with the newly equilibrated sensor.

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Why is site standardization so important?

Site Standardization is done when you first install the SAFE Sens systems.  It is used to correct for three key variables: Media type, Elevation, and Fiber optic installations.  Each of these three components have measurable impacts on the pH readings from SAFE Sens but they are easily corrected for with the site standardization protocol.

What’s the variability of the measurements?

Repeatability of pH readings is excellent, less than 0.03 pH units. 

How do you know it is accurate?

Our company, Blood Cell Storage, Inc. (BCSI) is a world leader in pH measurement for the blood industry.  The SAFE Sens IVM is a direct derivative of our pH SAFE Reader used with thousands of platelets storage bags.  Our design and production are controlled according to our ISO-9001 certification.  As such the system accuracy is fully controlled.

How frequently do I use the System Alignment Tool?

We recommend using the System Alignment Tool (QC Standard) once a week.  This is easiest to do after each weekly testing cycle so that any deviation from sensor to sensor can be accommodated.

What is the System Alignment Tool or QC Standard? Cost? Lifetime?

The System Alignment Tool (QC Standard) is a small, passive device that attaches to the fiber probe.  Please see your representative for local pricing.  It lasts for a full twelve (12) months.

How much does service cost?

Should something go wrong with the unit in the first two years after purchase, all repair is covered.  After that period of time your Customer Support Management Program (CSMP) determines cost.  Please ask a representative for more information.

Do you need to send the device back for factory calibration?

No, The hardware has no moving parts.  The sensing chemistry for the system is built in the disposable sensors such that the hardware does not require factory servicing to continue operating.

Which medias have you used?

Origio, Sage, Cook, Vitrolife, Medicult and others.  It is recommended to run the site standardization protocol again if you decide to change from one media vendor to another.

How long does the light source last?

Forever, it is based on LED technology. Any ‘decay’ in output is adjusted during the QC cycle.  The IVM is designed with a 5 year lifetime.

How long does the sensor last?

The sensor will last seven (7) days with the normal 30 minute testing frequency.

Can the sensor be reused?

No, the sensor is a disposable.  After the 7-day use it should be discarded.

Can it measure more frequently?

Yes, the IVM measures every 30 minutes as standard or every 1 minute for research applications.

How long will it last at 1 minute frequency?

With 1 minute testing the sv1 sensors will last 3 days.

Is the sensor or any components of the system Embryotoxic?

No.  According to Mouse Embryo Assay (MEA) testing on each batch of sensors, they are not Embryotoxic.  Likewise representative samples of the fiber optic components used in the system and the system alignment tool (QC standard) were tested and found to be not Embryotoxic.

How long does equilibration take?

Sensor setup is done with un-equilibrated media and oil.  The sensor is then placed in the incubator overnight so it is properly equilibrated and ready for monitoring the next day (16 to 24 hours later).  This allows time for the sensor wetting between two (2) and four (4) hours and also for CO2 adsorption into media approximately twelve (12) hours.image002

Why does the sensor need to equilibrate?

It is common knowledge that when media is first placed in a dish it is at the wrong temperature and is not in an optimal CO2 gas environment.  The Sensor also needs time to go from the dry state to the fully wet state.

How much does it cost?

It is priced competitively against other pH monitoring technologies.  Additional configurations or monitoring options are available.  Please see a representative for local pricing.

Can I calibrate it?

The SAFE Sens IVM does not need to be calibrated, as each lot of sensors comes certified from the Manufacturer with a pHID code.  The SAFE Sens IVM has a System Alignment Test to double check the optical performance of the system.  This QC procedure takes less than thirty (30) seconds.

Do I need a computer to use SAFE Sens IVM?

No, the unit provides visual presentation of the current pH value on demand.

Can I save the data?

Yes, either to a locally connected computer or to a computer over a network connection.

Can I see trends of pH readings from the SAFE Sens IVM?

Yes a basic pH trending software package is provided with the device for network connected SAFE Sens IVMs.

Is the sensor sterile?

Yes, the sensor is provided with a Sterility Assurance Level of 10-3.

What is the pHID?

The pHID is the certification code for the sensor provided by the manufacturer.

What is the cost of the replaceable sensor?

The sensor is priced competitively against other pH monitoring technologies.  Please see a representative for local pricing.

Can the System Alignment Tool (QC Standard) be used with more than one IVM?

The System Alignment Tool (QC Standard) may be used to align up to twenty (20) IVMs.

Are you FDA, CE certified?

The system is CE safety certified.  It is a laboratory monitoring device and does not require medical device certification.

Can you add SAFE Sens IVM to an existing incubator?

For large format incubators, absolutely.  For benchtop incubators, the TrakStation is required.

What is the difference between sensors?

The SAFE Sens IVM uses the sv1 sensor.  The TrakStation uses the sv2 sensor.