Operating Manual: Diaspect TM
Operating Manual: Diaspect TM
Operating Manual
This document is protected by copyright.
Table of Contents
1. Intended Use...............................................................................................................................4
2. In Vitro Diagnostic Directive...............................................................................................4
3. Summary and Explanation of the Test..........................................................................4
4. Principles of the Procedure.................................................................................................4
5. The DiaSpect Tm Analyzer..................................................................................................5
5.1 Hemoglobin Measuring System......................................................................5
5.2 Consumables.............................................................................................................5
5.3 Control Material.......................................................................................................6
5.4 Installation and Operation..................................................................................7
5.5 Charging ....................................................................................................................8
5.6 Data Transfer.............................................................................................................9
5.7 Cleaning.......................................................................................................................9
5.8 Calibration and Control.......................................................................................10
5.9 Disposal........................................................................................................................11
5.10 Hazards........................................................................................................................12
5.11 Service and Maintenance....................................................................................13
6. Specimen Collection and Preparation ..........................................................................14
6.1 Capillary Sampling.................................................................................................14
6.2 Venous Sampling....................................................................................................16
6.3 Control Sampling....................................................................................................17
7. Measuring......................................................................................................................................18
8. Troubleshooting Guide.......................................................................................................... 19
9. Results ........................................................................................................................................20
10. Performance Characteristics .............................................................................................20
11. Technical Specifications........................................................................................................ 21
12. Limitations....................................................................................................................................22
13. References....................................................................................................................................22
14. Accessories..................................................................................................................................23
15. Spare parts...................................................................................................................................23
16. Symbols Used.............................................................................................................................24
3
DiaSpect Tm Operating Manual
1. Intended Use
The DiaSpect Tm system is designed for quantitative total hemoglobin
determination in human blood, using capillary, venous or arterial samples in a
specifically designed analyzer, the DiaSpect Tm, using specifically designed
disposable cuvettes, DiaSpect Hemoglobin Cuvettes.
The DiaSpect Tm analyzer is only to be used with DiaSpect Hemoglobin Cuvettes.
The DiaSpect Tm analyzer and the DiaSpect Hemoglobin Cuvettes are for in vitro
diagnostic use only. The DiaSpect Tm analyzer and the DiaSpect Hemoglobin
Cuvettes may only be used by professionals.
4
DiaSpect Tm Operating Manual
1 2 3
1. DiaSpect Tm 2. Operating manual 3. Power supply, adapter
analyzer plug and USB cable
5.2 Consumables
DiaSpect Hemoglobin Cuvettes are packed in resealable bags containing 100 pieces,
5 bags per box. The disposable microcuvette requires <10 μL sample volume and serves
as sample collector and measuring cuvette at the same time.
Cuvettes are ready for use upon removal from the package. The blood sample is
drawn into the cavity by capillary force.
5
DiaSpect Tm Operating Manual
6
DiaSpect Tm Operating Manual
Blinking:
please remove cuvette
Flash symbol
Visible: USB symbol
Connected to power Shows USB connection status
Visible:
Connected to host
Blinking:
Connected to host
7
DiaSpect Tm Operating Manual
5.5 Charging
The DiaSpect Tm analyzer has a built-in rechargeable battery.
The battery can be recharged by connection with the power supply or to a computer via a
USB cable. A USB cable and a power supply for charging the battery are supplied.
1 2 3
Charging by power supply
Charging by computer:
1. Connect the USB cable with the analyzer
2. Connect the USB cable to the USB port of a computer.
1 2
Charging by computer
8
DiaSpect Tm Operating Manual
5.7 Cleaning
1. Pull the backside of the cuvette holder slightly towards you and lift up.
2. Clean the cuvette holder with cold water or a mild detergent, followed by
disinfectant.
3. Reinsert the dry cuvette holder by pressing down until you feel a “click”.
4. Clean device with cold water or mild detergent, followed by disinfectant
1 2 3 4
Do not spray the instrument when cleaning, as this will damage the
instrument!
9
DiaSpect Tm Operating Manual
10
DiaSpect Tm Operating Manual
5.9 Disposal
Used cuvettes
Dispose of used cuvettes in a container for potentially infectious waste.
Consult local environmental authorities for adequate disposal.
DiaSpect Tm Analyzer
If you require DiaSpect Medical to dispose of the instrument and its components,
please return them to:
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany
11
DiaSpect Tm Operating Manual
5.10 Hazards
DiaSpect Tm Analyzer
Avoid strong mechanical shocks to the analyzer.
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 place the power supply near to 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 filled cuvettes or
blood on the cuvette holder/DiaSpect Tm analyzer.
12
DiaSpect Tm Operating Manual
If damaged, the cuvette holder, USB cable, adaptor plug and the power supply can be
replaced by the user.
Should the DiaSpect Tm analyzer fail to function as intended, try to solve the issue by
using the troubleshooting guide, see 8. If this is not possible, return the DiaSpect Tm
analyzer to the manufacturer.
Any repairs which may be necessary must be carried out by the manufacturer
or by authorized personnel only.
Failure to follow the specific operating instructions may result in warranty services offered
by the manufacturer being restricted.
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany
13
DiaSpect Tm Operating Manual
Take a Diaspect Hemoglobin cuvette out of the foil bag and close the bag.
1. Make sure the hand is warm and relaxed. Use the middle or ring finger for sampling.
Avoid fingers with rings on.
3.G ently massage the finger towards the tip to increase blood flow.
4. Make the incision on the side of the finger tip. Use the ‘upward side’ of the finger
to facilitate filling of the cuvette.
1 2 3 4
5. A
pply light pressure towards the fingertip until a blood drop appears.
Discard the first 3 drops and make sure there is a free blood flow before filling the
cuvette with the sample drop.
6. Be sure to have a sufficient sized blood drop to fill the cuvette.
Avoid contaminating the outside of the optical eye of the cuvette.
Fill the cavity of the microcuvette completely by touching the corner of the cuvette
to the blood drop. Do not refill the cavity of the microcuvette.
14
DiaSpect Tm Operating Manual
7. If a cuvette cannot be filled in one continuous process, or if the cuvette contains air
bubbles, discard the cuvette and use a new one. Wipe off excess blood outside of the
microcuvette with a dry tissue. Do not wipe the filling slit of the microcuvette!
This can draw the blood out from the cavity!
5 6 7
Repeated testing
Hemoglobin measurements from capillary samples may sometimes be misleading due to
sampling mistakes.
The most common causes for deviating results are choice of an unsuitable size or type
of lancet, incorrect capillary sampling technique, restricted capillary blood flow, or the
presence of extracellular fluid in the sample after pressing the fingertip too hard.
These factors commonly affect the result towards too low results. Confirmation of an
unexpected or unacceptable result can exclude potential pre-analytical factors as the
cause. As the DiaSpect method is very fast, this confirmatory test can preferably be done
using the same incision, as long as there is still a free flow of blood.
If the blood flow has stopped, another incision should be made for the confirming sample.
Record all results from repeated sampling, including relevant information about the
reason for re-testing.
15
DiaSpect Tm Operating Manual
Take a DiaSpect Hemoglobin Cuvette out of the foil bag and close the bag.
1. The blood must be well mixed prior to sampling. Mix by gentle inversion
at least 8 times.
3. Avoid contaminating the outside of the optical eye of the cuvette. Fill the
cavity of the microcuvette completely by touching the corner of the cuvette
to the blood drop. Do not refill the cavity of the microcuvette.
4. W
ipe off excess blood outside of the microcuvette with a dry tissue.
Do not wipe the filling slit of the microcuvette! This can draw the blood out
from the cavity!
8x
1 2 3 4
16
DiaSpect Tm Operating Manual
1. T
he DiaSpect Tm system can be verified by use of DiaSpect Control HBT
Allow the control solution to reach room temperature first.
Mix the control solution by gentle inversion before sampling.
Open the vial and discard the first drop.
Take a Diaspect Hemoglobin cuvette out of the foil bag and close the bag.
3. W
ipe off excess control solution outside of the microcuvette with a dry tissue.
Do not wipe the filling slit of the microcuvette!
This can draw the control solution out from the cavity!
1 2 3
17
DiaSpect Tm Operating Manual
7. Measuring
2. Press down gently until you feel a “click” and hold in position until you hear a beep.
3. T
he hemoglobin value will be displayed instantly. Pull out the cuvette quickly. Dispose
of the used cuvette in a container for potentially infectious waste. Record the test result
as soon as the checkmark is shown.
4. The result will remain on the display until replaced by the next measurement. To erase
the latest result, simply make a “blank” measurement by pressing down the empty
cuvette holder.
1 2 3 4
Use only completely filled cuvettes for measuring. A filled cuvette should be analyzed
within 1 minute after filling. A filled cuvette should be kept in a horizontal position until
measurement. Do not re-measure a cuvette.
If the DiaSpect Tm analyzer has been out of use for a couple of hours, an error code
may appear after the first measurement. Remove the filled cuvette, make a “blank”
measurement by pressing down the empty cuvette holder and then reinsert the filled
cuvette for measurement.
18
DiaSpect Tm Operating Manual
8. Troubleshooting Guide
Perform a “blank”
measurement*. If error persists
Error E04 Lightsource too dark
contact the DiaSpect Tm
customer service department.
Perform a “blank”
measurement*. If error persists
Error E05 Lightsource too bright
contact the DiaSpect Tm
customer service department.
19
DiaSpect Tm Operating Manual
The end of a measurement is signaled by a “beep”. The hemoglobin value will instantly
be displayed by the DiaSpect Tm analyzer. Record the result as soon as the checkmark is
displayed.
The hemoglobin value is displayed in g/dL by default. The result can also be displayed in
g/L or mmol/L.
Please contact the manufacturer if you require a change of the measuring units.
The DiaSpect Hemoglobin Cuvettes have a between lot imprecision of <0.1 g/dL
(< 1 g/L) hemoglobin.
20
DiaSpect Tm Operating Manual
Protection class IP 21
The DiaSpect Tm analyzer complies with IEC 61326-2-6 for group 1, class B equipment
regarding electromagnetic compatibility, emission and interference immunity.
21
DiaSpect Tm Operating Manual
12. Limitations
The DiaSpect Tm analyzer is only to be used with DiaSpect Hemoglobin Cuvettes.
Neither the DiaSpect Hemoglobin Cuvettes nor the DiaSpect Tm analyzer may be used for
any purposes other than those specified.
Results deviating from the expected value should be confirmed with a laboratory
reference method.
WBC > 100x109/L (21-110x109/L), Triglycerides > 10 mM (3.0-11.1 mM), PLT > 750 x109/L
(598-794 x109/L), Microcytes < 80 fl (63-79 fl), Hb in Plasma > 10 g/L (1.0-11 g/L),
COHb > 7 % ( 2.2-7.2 %), Bilirubin > 50 μmol/L ( 57-357 μmol/L), low sO2 (Oxyhemoglobin)
< 50% (50-71%) have not been found to interfere (tested range in brackets).
A limited number of samples from individuals with sickle cell have been tested,
the results were not influenced.
The DiaSpect Tm analyzer and the DiaSpect Hemoglobin Cuvettes may only be used by
professionals.
13. References
1..NCLLS document H15-A3, Reference and Selected Procedures for the Quantitative Determination of
Hemoglobin in Blood; Approved Standard-Third Edition
2..Recommendations for reference method for haemoglobinometry in human blood (ICSH standard
1995) and specifications for international haemiglobincyanide standard (4th edition)
3. Dacie and Lewis, Practical Haematology, 11th edition, 2012
4..Fandek N, Moreau D, Newell K C, Ofner A, eds. Clinical Laboratory Tests - Values and Implications.
2nd ed. Springhouse: Springhouse Corporation, 1995: 328pp.
5. D
. eMott Wayne R, Tilzer Lowell L, Hematology. In: Jacobs DS, DeMott WR, Finley PR, Horvat RT,
Kasten Jr BL, Tilzer LL, eds. Laboratory Test Handbook. Hudson: Lexi-Comp, 1992: 517-626.
6..Wallach J. eds. Interpretation 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. Tietz
Textbook of Clinical Chemistry. Philadelphia: WB Saunders, 1994: 2161-2217.
8..Tietz N, ed. Clinical Guide To Laboratory Tests, WB Saunders, 1983: 258-259.
Other:
− DiaSpect Hemoglobin Cuvette package insert
− DiaSpect Control HBT package Insert
22
DiaSpect Tm Operating Manual
The following accessories and spare parts may be used with the Diaspect Tm analyzer REF 90C.0100.
14. Accessories
DiaSpect Hemoglobin Cuvette REF 90C.0001
DiaSpect Control HBT1 REF 90B.0011
DiaSpect Control HBT2 REF 90B.0012
DiaSpect Control HBT3 REF 90B.0013
DiaSpect Control HBT4 REF 90B.0014
Carrying case for Diaspect Tm (plastic) REF 7049-8011-0179
23
DiaSpect Tm Operating Manual
Reference number
Manufacturer
Class II equipment
Biohazard
Direct current
24
DiaSpect Tm Notes
25
DiaSpect Tm Notes
26
DiaSpect Tm Notes
27
Sales
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany
Tel.: +49 (0) 39203 511 0
www.ekfdiagnostics.com
90C.0100B1 GB-01-20160730