EKF Diagnostics DiaSpect Tm User manual

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DiaSpect Tm User Manual
Table of Contents
1. Intended Use..............................................................................2
2. Principles of the Procedure ...........................................................2
3. The DiaSpect Tm system ..............................................................3
3.1 DiaSpect Tm Analyzer .........................................................3
3.2 DiaSpect Tm Cuvettes .........................................................3
4. Control Material ..........................................................................4
5. Important Safety Instructions and Notes on Radio Interference ........5
6. Installation and Operation............................................................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 Sampling..............................................................12
7.2 Venous Sampling................................................................14
7.3 Control Sampling................................................................15
8. Measuring ..................................................................................16
9. Troubleshooting Guide................................................................. 17
10. Expected Values .........................................................................18
11. Performance Characteristics .........................................................18
12. Technical Specifications ............................................................... 21
13. Limitations .................................................................................22
14. References .................................................................................23
15. Consumables..............................................................................24
16. Spare parts and Accessories.........................................................24
17. Symbols Used.............................................................................25

DiaSpect Tm User Manual
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1. Intended Use
The DiaSpect Tm system is intended for the in vitro quantitative measurement of
total hemoglobin in non-anticoagulated capillary whole blood and venous whole
blood drawn in K2-EDTA or lithium heparin tubes in point-of-care settings and in
non-anticoagulated capillary whole blood and venous whole blood drawn in K2-
EDTA tubes in blood bank settings. The DiaSpect Tm system consists of the
DiaSpect Tm analyzer and specifically designed disposable cuvettes. The DiaSpect
Tm analyzer is only to be used with DiaSpect Tm Cuvettes.
Caution: Federal law restricts this device for sale by or on the order of a
physician or other licensed practitioner (Rx only).
CLIA Complexity for whole blood: Waived
Laboratories with a Certificate of Waiver 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 Tm system utilizes a broad-
spectrum, multi-chromatic sensor with compensation for turbidity and scattering
which measures the absorbance of whole blood over a wide spectral range. The
light path length through the cuvette cavity, in combination with the DiaSpect Tm
analyzer, determines the exactness of the hemoglobin measurement. The
hemoglobin concentration is calculated from the measured absorbance at multiple
wavelengths.
The cuvettes do not contain any reagent. The system is calibrated against the
hemoglobincyanide (HiCN) method, the international reference method for the
determination of hemoglobin concentration in blood as described in NCCLS/CLSI
H15-A3 and ICSH standard 1995.1,2
The DiaSpect Tm analyzer is factory calibrated and requires no further calibration.

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DiaSpect Tm User Manual
3. The DiaSpect Tm system
3.1 DiaSpect Tm analyzer
Upon delivery, open the carton on a stable surface, remove the instrument and
the accessories, and check that all the components are included and undamaged.
A comprehensive list (with item numbers) of all parts for the DiaSpect Tm system
can be found in sections 15 and 16.
The DiaSpect Tm analyzer can be stored at 0 to 50 °C (32 to 122 °F).
Temperatures 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 temperature before use.
1. DiaSpect Tm
analyzer
2. User Manual
3. Power supply, adapter
plug and USB cable
3.2 DiaSpect Tm Cuvettes
Cuvettes are ready for use upon removal from the package. A sample volume of
10 µL is required to ensure proper filling of the DiaSpect Tm Cuvette. The cuvette
serves as sample collector and measuring cuvette at the same time. The blood
sample is drawn into the cavity by capillary force.

DiaSpect Tm User Manual
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Refer to the product label and package insert of the DiaSpect Tm Cuvettes for
information on storage and expiry. Unused cuvettes should be stored in their
original bag.
DiaSpect Tm Cuvettes Cuvettes in foil bag
4. Control Material
DiaSpect Controls HBT are available to facilitate compliance with local, state
and/or federal regulations or accreditation requirements.
The DiaSpect 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 information on storage and expiry.
Contents: 1.9 mL per vial, 3 vials per package
Package configurations of DiaSpect Control HBT
DiaSpect
Control HBT1
3 x DiaSpect Control HBT-Low
DiaSpect
Control HBT2
3 x DiaSpect Control HBT-Medium
DiaSpect
Control HBT3
3 x DiaSpect Control HBT-High
DiaSpect
Control HBT4
1 x DiaSpect Control HBT-Low
1 x DiaSpect Control HBT-Medium
1 x DiaSpect Control HBT-High

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DiaSpect Tm User Manual
5. Important Safety Instructions and Notes on Radio
Interference
DiaSpect Tm analyzer
Avoid strong mechanical shocks to the analyzer.
Do not expose the analyzer to liquids.
After storage or transport, allow the analyzer to acclimate to its operating
temperature of 10 to 42 °C (50 to 107 °F) to prevent condensation damage.
Do not place the DiaSpect Tm analyzer in direct sunlight or near a heat source.
Do not place the DiaSpect Tm analyzer in, or next to, wet areas such as sinks
or wash basins.
Do 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.
Do not place the power supply near heat sources or expose it to direct sunlight.
Do not use the power supply if its cable has a visible kink in it or becomes
damaged.
Blood
Always handle blood as potentially infectious. Use gloves and avoid direct skin or
mucous membrane contact with donated blood, blood specimens, blood from
transfer pipettes, DIFF-SAFE®blood dispensers, blood from filled cuvettes or
blood on the cuvette holder / DiaSpect Tm analyzer. Dispose of contaminated
items in proper hazardous waste containers.