Assuring Data Integrity
Data Sciences International provides high-accuracy measurement products. In order to maintain product accuracy, DSI hardware must be properly maintained and calibrated. DSI recommends that users calibrate their hardware annually; including signal conditioners, amplifiers and writers.
Calibration Certification
DSI provides Certificates of Calibration at the time of purchase for all DSI hardware. Calibration of hardware is valid for 1 year, upon which the user can return the hardware to DSI for re-calibration. The Calibration and Service Department at DSI will recalibrate your DSI hardware to meet published product specifications. Calibrations will be NIST traceable and performed according to DSI's Quality System procedures. Upon calibration, DSI will provide a Certificate of Calibration with data results for your quality records; recalibration of DSI hardware will be warranted for a period of 1 year. Maintaining up-to-date calibrations will provide assurance that DSI hardware continues to provide accurate and reliable study data.
Calibration Intervals
The accuracy of electronic and mechanical components used in all hardware drifts over time. The effects of time in use as well as environmental conditions may add to this drift – eventually, causing uncertainty in the product's ability to accurately measure. To align drift and continually ensure the accuracy of data, DSI recommends performing annual calibration on its DSI hardware.
Products Requiring Annual Calibration
- ACQ-7700 Signal Conditioners◦7700 Chassis
- Universal Signal Conditioners
- Bridge Signal Conditioners
- Advanced Basic Signal Conditioners
- Transducer Signal Conditioners
- Universal XE Signal Conditioners
- Carrier Signal Conditioners
- Isolated Defibrillation Protected ECG Probe
- 12 Lead ECG Amplifier
- ACQ-16
- 6600 Amplifiers
- AC/DC Amplifiers
- Differential Pressure
- Temperature
- Transducer
- Bioelectric
- ECG/Biotach
Note: This list may not necessarily reflect new products. If you are unsure if your product requires annual calibration, please contact Data Sciences International.
Authorized Calibration and Service Center
The DSI Calibration and Service Department is the only authorized calibration and service center for DSI hardware. Only DSI has the technical capability and tools required to calibrate and ensure that products meet published specifications.
GLP Users
*Good Laboratory Practice (GLP), section 58.63, requires that laboratories conduct routine maintenance and calibration of equipment used for GLP studies; maintenance and calibration of equipment must be conducted according to a set schedule. DSI recommends that Standard Operating Procedures (SOPs) include requirements for annual calibration of DSI hardware in order to comply with GLP regulations and ensure integrity of GLP data.
___________________________________________________________________________________
DSI products are not intended for the purposes of diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or used as a life support device. Use of DSI products are solely for the purposes of conducting life science research.
_____________________________________________
*Good Laboratory Practices, Section 58.63 Maintenance and Calibration of Equipment [43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002].
Section 58.63(a) "Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated and/or standardized.
Section 58.63(b) "The written standard operating procedures required under 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment...".