Installation, Operation, and Performance Qualification
Installation of the Instrument
Instrument Description
The ELITechGroup FreezePoint
according to directive 98/79/EC for the measurement of the total osmolality of aqueous solutions such as
human blood, urine, semen, drip solutions and other samples.
It provides a measure of the contribution of the various solutes that are present in a solution to the overall
osmotic pressure of the solution.
Instrument Identification
Manufacturer
Model
Serial Number
Thermistor probe No
Power
Frequency
Power Consumption
Dimension
Weight (Without Printer)
Firmware Verification
A microcontroller monitors the unit's functions based on the program flow. The assembly code has been
validated prior to the release. Documentation, including source code, will be held for at least 10 years from
code release in design history files (DHF). No firmware is offered separately with the instrument.
Display
Ver: ..................................
COMMENTS
..........................................................................................................................................................................
..........................................................................................................................................................................
..........................................................................................................................................................................
..........................................................................................................................................................................
Date ............................
Completed by ..............................................
Date ............................
Verified by ..............................................
Freezing Point Osmometer is a non-invasive in-vitro diagnostic system
®
ELITechGroup Inc.
.......................................
.......................................
.......................................
100-240 VAC
50-60 Hz
80 VA (max)
W 8.1 in (205 mm) x D 8.7 in
(220mm) x H 14.2 in (360 mm)
14.3 lbs (6.5 kg)
Firmware
TEC
Ver: ..................................
.......................................
.......................................
.......................................
Interface
Ver: ..................................
Date Verified
Printer (If Applicable)
Ver: ..................................
117