Table of Contents
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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.
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
1
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Table of Contents
Related Manuals for EKF Diagnostics DiaSpect Tm
Summary of Contents for EKF Diagnostics DiaSpect Tm
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Page 1: Table Of Contents
DiaSpect Tm User Manual Table of Contents Intended Use ................2 Principles of the Procedure ............2 The DiaSpect Tm system .............. 3 DiaSpect Tm Analyzer ............3 DiaSpect Tm Cuvettes ............3 Control Material ................4 Important Safety Instructions and Notes on Radio Interference ..5 Installation and Operation ............ -
Page 2: Intended Use
DiaSpect Tm User Manual 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. -
Page 3: The Diaspect Tm System
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.). -
Page 4: Control Material
DiaSpect Tm User Manual 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. -
Page 5: Important Safety Instructions And Notes On Radio Interference
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. - Page 6 DiaSpect Tm User Manual FCC statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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Page 7: Installation And Operation
The DiaSpect Tm analyzer comes ready for use. No installation procedure is necessary. The display is always ON. The analyzer does not have an ON/OFF switch. -
Page 8: Charging
DiaSpect Tm User Manual 6.1 Charging The DiaSpect Tm analyzer has a built-in rechargeable battery. The battery can be recharged by connecting to a power supply or to a computer via a USB cable. A USB cable and a power supply for charging the battery are supplied. -
Page 9: Data Transfer
Fully charge the battery after 9 months, whether or not the instrument has been in use. 6.2 Data Transfer The DiaSpect Tm analyzer comes with USB 2.0 and an optional Bluetooth ® function. For additional information on data transfer, please contact the manufacturer. -
Page 10: Quality Control
DiaSpect Tm Analyzer The lithium-ion battery in the DiaSpect Tm analyzer has to be disposed of separately. For disposal of the battery, analyzer and power supply, follow the relevant regional or local waste disposal regulations. If you require the manufacturer to dispose of the instrument and its components, please return them to EKF Diagnostics (see section 6.6). -
Page 11: Service And Maintenance
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, (Section 9). If this is not possible, return the DiaSpect Tm analyzer to EKF Diagnostics or your local distributor. -
Page 12: Specimen Collection And Preparation
7.1. Capillary Sampling With gloved hands, take a DiaSpect Tm Cuvette out of the foil bag and close the bag. Make sure the hand is warm and relaxed. Use the middle or ring finger for sampling. Avoid fingers with rings on. - Page 13 DiaSpect Tm User Manual Repeat Testing Be careful to apply the procedure described in step 1-6 correctly when collecting capillary blood for hemoglobin measurements. The most common causes for erroneous results are choice of an unsuitable size or type of lancet, incorrect capillary sampling technique, restricted capillary blood flow, or the presence of tissue fluid in the sample after pressing the fingertip too hard.
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Page 14: Venous Sampling
If the blood is refrigerated, then the blood should be allowed to reach room temperature before testing. K2-EDTA or lithium heparin tubes may be used. With gloved hands, take a DiaSpect Tm Cuvette out of the foil bag and close the bag. -
Page 15: Control Sampling
If stored refrigerated, allow the control solution to reach room temperature first. With gloved hands, take a DiaSpect Tm Cuvette out of the foil bag and close the bag. Mix the control solution by gentle inversion 5 times immediately before sampling. -
Page 16: Measuring
1 minute after filling. A filled cuvette should be kept in a horizontal position until measurement. 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”... -
Page 17: Troubleshooting Guide
DiaSpect Tm User Manual 9. Troubleshooting Guide Symptom Possible Cause Correction Repeat the sampling. Make sure that Unexpectedly Improper sample the sampling is done correctly. high / low result See 7.1 to 7.3 for more information. Contact Technical Support at... -
Page 18: Expected Values
(0.15, 0.92%) (0.22, 1.41%) b) Accuracy, Point-of-Care The results of the comparison studies between the DiaSpect Tm and the predicate device performed at the point-of-care are summarized in the following table. The study was performed across four external sites. Sample... - Page 19 Venous 1.140 (1.100~1.179) -2.477 (-3.067~-1.895 0.978 The bias of the DiaSpect Tm at the hemoglobin deferral levels for male and female donors was calculated from the regression curves using the Hb 301 as the reference method. DiaSpect Tm Capillary DiaSpect Tm Venous...
- Page 20 The discordance observed was investigated by comparison to a laboratory reference method. In a separate study, 100 capillary and 100 venous samples were tested with the DiaSpect Tm, the HemoCue Hb 301 and the Sysmex XP-300. The DiaSpect Tm was found to be substantially equivalent to the Sysmex XP-300 (calibrated to the hemiglobincyanide method, HiCN), while the HemoCue Hb 301 consistently provided results that were higher by approximately 0.6 g/dL.
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Page 21: Technical Specifications
DiaSpect Tm User Manual 12. Technical Specifications Operating temperature 10 to 42 °C (50 to 107 °F) Operating humidity 0 to 100%, non-condensing 0 to 50 °C (32 to 122 °F) Storage temperature -30 to 70 °C (-22 to 158 °F) during transport, 24 hour max. -
Page 22: Limitations
Ibuprofen 55 mg/dL High WBC Count Disease state Tetracycline 1.5 mg/dL Polycythemia Disease state Ferrous Sulfate 22 mg/dL Sickle Cell Disease state Ammonium 30 mg/dL Ferric Citrate For further limitations of the procedure, see the DiaSpect Tm Cuvettes package insert. -
Page 23: References
HemoCue and two automated haematology analysers in young Laotian children. J Clin Pathol 2018;71:532–538 Other: DiaSpect Tm Cuvettes package insert DiaSpect Control HBT package Insert The following consumables, spare parts and accessories may be used with the DiaSpect Tm analyzer REF 7049-0013-0264 / Cat. 900-001. -
Page 24: Consumables
DiaSpect Control HBT3 REF 90B.0013 / Cat.900-503 DiaSpect Control HBT4 REF 90B.0014 / Cat.900-504 16. Spare parts and accessories Cuvette Holder REF 7049-1011-0145 USB Cable REF 7049-7021-0161 Power supply with US adapter REF 7049-7013-0187 Carrying case for DiaSpect Tm (plastic) REF 7049-8011-0179... -
Page 25: Symbols Used
DiaSpect Tm User Manual 17. Symbols Used Protection of electrical equipment against foreign objects, IP21 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. - Page 26 DiaSpect Tm User Manual USA Contact EKF Diagnostics, Inc. 1261 North Main Street Boerne, TX 78006 Phone 1-800-531-5535 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-diagnostic GmbH.
- Page 27 DiaSpect Tm Notes...
- Page 28 DiaSpect Tm Notes...
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Questions and answers
How to remove err04
To remove error code ERR04 (Light source too dark) on the EKF Diagnostics Tm:
1. Remove the cuvette from the cuvette holder.
2. Press the cuvette holder several times until the screen displays “---” and a “√” appears.
3. If the error persists, contact Technical Support.
This answer is automatically generated