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DiaSpect Tm User Manual

17. Symbols Used

IP21

Protection of electrical equipment against foreign objects,
water and access

Serial number

In-vitro-Diagnostic Medical Device

Reference Number

Dispose of the instrument in compliance with local
regulations for the disposal of electronic equipment.
Do not put in domestic waste!

Consult Instructions for Use

Caution

Manufacturer

Direct current

Antenna Pole, Shows RF connection status and signal
strength (only with activated Bluetooth

option)

Temperature limitation

Содержание DiaSpect Tm

Страница 1: ...7 6 1 Charging 8 6 2 Data Transfer 9 6 3 Cleaning and Disinfection 9 6 4 Quality Control 10 6 5 Disposal 10 6 6 Service and Maintenance 11 7 Specimen Collection and Preparation 12 7 1 Capillary Sampl...

Страница 2: ...er must follow the manufacturer s instructions for performing the test or the test will no longer be considered CLIA waived 2 Principles of the Procedure Based on a photometric principle the DiaSpect...

Страница 3: ...mperatures of 30 to 70 C 22 to 158 F are temporarily permitted during transport 24 hours max The operating temperature of the instrument is 10 to 42 C 50 to 107 F Allow the analyzer to reach ambient t...

Страница 4: ...aSpect Control HBT is produced in three concentrations that correspond to three known levels of human hemoglobin Refer to the product label and package insert of the DiaSpect Control HBT for further i...

Страница 5: ...not insert anything other than the USB cable into the socket in the back of the analyzer Power Supply Only use the power supply provided with the instrument Do not expose the power supply to liquids...

Страница 6: ...l Interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or televis...

Страница 7: ...yzer does not have an ON OFF switch When not in use the analyzer remains in a low power mode The DiaSpect Tm analyzer may be used as a handheld device Understanding the DiaSpect Tm Display Battery sym...

Страница 8: ...onnected to the power supply 3 Connect the USB cable to the power supply and plug the power supply into a power outlet Charging by power supply Charging by computer 1 Connect the USB cable to the anal...

Страница 9: ...er 6 3 Cleaning and Disinfection 1 Pull the backside of the cuvette holder slightly towards you and lift up 2 Using a swab clean the cuvette holder with cold water or a mild detergent followed by disi...

Страница 10: ...stated on the vial labels If controls are not in range repeat with a new cuvette If values are still out of range contact Technical Support at 1 800 531 5535 6 5 Disposal Used Cuvettes Dispose of use...

Страница 11: ...n 9 If this is not possible return the DiaSpect Tm analyzer to EKF Diagnostics or your local distributor Never open the analyzer or the power supply Any repairs which may be necessary must be carried...

Страница 12: ...rop sits on top of the finger to facilitate filling of the cuvette 4 Apply light pressure towards the fingertip but not past the first knuckle until a blood drop appears Wipe away the first 3 drops an...

Страница 13: ...too hard These factors commonly affect the result Confirmation of an unexpected or unacceptable result can exclude sampling mistakes as the cause As the DiaSpect method is very fast this confirmatory...

Страница 14: ...entle inversion at least 8 times 2 Place a drop of blood on to a hydrophobic surface e g Parafilm using a commercially available transfer pipette or DIFF SAFE Blood Dispenser 3 Fill the cuvette comple...

Страница 15: ...e first drop 2 Dispense a second drop of the control solution on to a hydrophobic surface e g Parafilm Fill the cuvette completely by touching the corner of the cuvette to the drop Do not refill the c...

Страница 16: ...ll remain on the display until replaced by the next measurement To erase the latest result press down on the empty cuvette holder Use only completely filled cuvettes for measuring A filled cuvette sho...

Страница 17: ...mpty cuvette holder The screen should display and a If error persists contact Technical Support at 1 800 531 5535 Error E04 Light source too dark Remove cuvette from cuvette holder Press cuvette holde...

Страница 18: ...tory should establish its own normal range 11 Performance Characteristics a Within Run and Total Precision Repeatability and overall reproducibility of three samples was tested over 20 days b Accuracy...

Страница 19: ...L DiaSpect Tm vs HemoCue Hb 301 linear regression Matrix N Slope 95 CI Intercept 95 CI r Capillary 150 0 9541 0 9134 0 9948 0 2619 0 3496 0 8733 0 967 Venous 147 1 1465 1 1068 1 1863 2 5299 3 4183 2 1...

Страница 20: ...calibrated to the hemiglobincyanide method HiCN while the HemoCue Hb 301 consistently provided results that were higher by approximately 0 6 g dL These results are summarized below The bias of the Di...

Страница 21: ...integrated lithium ion rechargeable batteries Safety Tested in accordance with IEC 61010 Instrument input rating 5 V 100 mA PC 350 mA power supply Power supply input rating 125mA 100 240 V AC 50 60 Hz...

Страница 22: ...g dL Vitamin B12 2500 ng dL Triglyceride 1000 mg dL Lithium Carbonate 23 mg dL Urea 258 mg dL Immunoglobin 500 mg dL Uric Acid 24 mg dL Methyldopa 1 7 mg dL Acetaminophen 2 mg dL Salicylic Acid 100 mg...

Страница 23: ...pretation of Diagnostic Tests A Synopsis of Laboratory Medicine 4th ed Boston Toronto Little Brown and Co 1986 6pp 7 Painter Pennell C Cope June Y Smith Jane L Appendix In Burtis CA Ashwood ER eds Tie...

Страница 24: ...ntrol HBT1 REF 90B 0011 Cat 900 501 DiaSpect Control HBT2 REF 90B 0012 Cat 900 502 DiaSpect Control HBT3 REF 90B 0013 Cat 900 503 DiaSpect Control HBT4 REF 90B 0014 Cat 900 504 16 Spare parts and acce...

Страница 25: ...tic Medical Device Reference Number Dispose of the instrument in compliance with local regulations for the disposal of electronic equipment Do not put in domestic waste Consult Instructions for Use Ca...

Страница 26: ...1 5535 Email techsupport ekfdiagnostics com www ekfusa com This document is protected by copyright It may not be reproduced or distributed to third parties without the prior written consent of EKF dia...

Страница 27: ...27 DiaSpect Tm Notes...

Страница 28: ...28 DiaSpect Tm Notes...

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