Plasma/Low Hb Photometer - Drug testing supplies from CLIA
Contents
1. Underneath the photometer there is a lid covering the battery compartment which holds five batteries typeR6 or AA Place five batteries type R6 or AA in the battery compartment observing the indication of polarity inthebattery holder Replacethelid New batteries can operate continuously for approximately 100 150 hours If battery powered batteries can be readily conserved by switching off the photometer between measurements NOTE When going from battery power to main power supply turn off the photometer OFF before connecting Consult local environmental authorities for proper disposal of batteries r E MG ain fig il Checking the Photometer Pull out the cuvette holder totheloading position This point which should not be exceeded is easily established by paying attention toa distinct stop Meena oe HE The display shows the letters LH b ls After approximately 15 seconds the indication READY appears on the display together with three flashing dashes The photometer is ready for measurement Plasma Low Hb run Usea Plasma Low Hb Control Solution for checking the photometer Fill the cuvette with the Plasma Low Hb Control Solution See page 10 Place thefilled cuvette into the cuvette holder and carefully push it into the measuring position Slammingthe cuvette holder into place with undue force will cause splashing of the sample material onto the optical surfaces The d2. HemoCue Plasma Low Hb Photometer Operating Manual Contents General Intended Purpose I ntended Use Installation of the Photometer Battery Power Checking the Photometer How to Perform a Plasma Low Hb Determination Filling of Cuvettes Method Principle Storage and environmental requirements The microcuvette The photometer Calibration Sample Material Quality Control Plasma Low Hb Controls Specifications Measuring Range Limitation Warranty Maintenance Technical Service Spare Parts List Technical Data Troubleshooting Guide Addresses O O JO UI UI 12 12 12 12 12 12 12 13 13 13 13 13 Aa RA A GD 20 General Plasma Low HE The HemoCue Plasma Low Hb system consists of disposable Plasma Low Hb microcuvettes containing reagents in dry form and a single purpose designed photometer The microcuvette is used for measuring the sample as reaction vessel and as measuring cuvette No dilution is required Reading of low hemoglobin concentration takes place in the photometer which follows thereaction and presents theresult only when the reaction has stopped The photometer is calibrated at the factory against the hemiglobincyanide HiCN method which is the interna tional reference method for the determination of the total hemoglobin concentration The photometer and a transformer battery eliminator are delivered in a carton Open the carton on a stable surface and lift out
3. Check that the power adapter is batteries need to be replaced securely connected to the photometer 3 Thedisplay is out of order lc Check that the cable is not damaged 2 Turn off the photometer and replace the batteries five type AA 3 The photometer needs service Call your distributor 16 Symptom Explanation aton The display gives erroneous characters The display shows LOWBAT The display does not switch from LHb to READY or from READY to MEASURING Too high or too low values on controls Too high or too low values on samples in comparison with those expected The display is out of order The microprocessor is out of order The batteries need to be replaced If on main power the optronic unit or the circuit board is out of order The magnet in the cuvette holder may be missing The reed switch in the optronic unit is out of order The cuvettes are too old or damaged improper storage The optical eye of the cuvette IS contaminated The control is not mixed well and or not at room tempera ture Air bubbles in the cuvette Theoptronicunit is dirty The quality control is not suitable for the HemoCue system The calibration of the photometer has been changed The cuvettes are too old or damaged improper storage The optical eye of the cuvette IS contaminated Thesample is not mixed well A
4. Drive Lake Forest CA 92630 Phone General 800 881 1611 Orders 800 323 1674 Technical support 800 426 7256 Fax Cust Service 800 333 7043 BERGSTENS HBG LowH GB 900304 050930 Printed on Silverblade proenvironmental paper
5. the photometer and the accessories The photometer may be powered by batteries As with all electronic instrumentation allow the photometer to reach ambient temperature Intended Purpose I ntended Use HemoCue Plasma L ow Hb system is used for quantative determination of low levels of hemoglobin in plasma and serum specimens aqueous solutions or stored or banked erythrocytes using a specially designed photometer the HemoCue Plasma Low Hb photometer and specially designed microcuvettes the HemoCue Plasma Low Hb microcuvettes The HemoCue Plasma Low Hb photometer is only to be used with HemoCue Plasma Low Hb microcuvettes The HemoCue Plasma Low Hb microcuvettes are for in vitro diagnostic use only Installation of the Photometer At theback of the photometer is a power switch and a connector Connect the transformer to the POWER INLET and to the main power supply Turn the switch to the ON position Theletters LH b should now beseen on thedisplay PlawraLon HE If not check the connections to the photometer and to the main power supply If the photometer is still not functioning after these checks turn to Troubleshooting Guide page 16 Bail Thecuvetteholder whichisusedtomovethecuvette in and out of the photometer has three positions Completely pushed in measuring position Pulled out loading position Completely withdrawn for cleaning See maintenance section page 14 Battery Power
6. he OFF position Plas Low Fb e air 11 Method Principle Vanzetti G Am J Lab Clin Med 67 116 1966 Sodium deoxycholate hemolyses the erythrocytes and hemoglobin is released Sodiumnitriteconverts hemoglobin to methemoglobin which together with sodium azide gives azidemethemoglobin The absorbance is measured at two wavelengths 570 and 880 nm The absorbance at 570 nm is used for thedetermination of hemoglobin concentration and the absorbance at 880 nm is used to compensate for a certain degree of turbidity Storage and environmental requirements The microcuvette The photometer Calibration Sample Material 12 The microcuvettes are to be stored dry at room temperature 15 30 C 59 86 F The expiration date is printed on each container Once opened the microcuvettes are stable for three months Always keep the containers closed The photometer can be stored at 0 50 C 32 122 F The operating temperature is 15 40 59 104 F Allow the photometer to reach ambient tempera ture before use Thephotometer should not be operated at high gt 90 noncondensing humidity The photometer is delivered factory calibrated against the hemiglobincyanide HiCN method recommended by the International Committee for the Standardization of Hemoglobin ICSH for determination of the total Hemoglobin concentra tion Acceptable sample material includes plasma and serum specimens aqueos solu
7. heoptronic unit is out of Call your distributor order ERROR 903 Disturbances on main power Change the wall socket or use battery supply power Theoptronic unit is out of The photometer needs service order Call your distributor ERROR 906 Unstable blank value Turn off the photometer and allow it to The photometer might be cold reach room temperature If the problem continues call your distributor ERROR 907 1 The battery power is too low The batteries need to be replaced Turn off the photometer and replace the batteries five type AA Usethe main power supply ERROR 908 1 The absorbance is too high Check that the photometer and the Light blocking item in the cuvettes are used according to the cuvette holder operating manual and the instructions for use The photometer needs service Call your distribuyor ERROR 916 The signal from the Filter visually turbid samples before compensating wavelength is analysis too high This may be a result of high turbidity in the sample ERROR HHH 1 Displayed value is above 30 0 g L Check expiry date for the cuvettes 3 00 g dL 3000 mg dL For samples with values above 1 90 mmol L 30 0 g L 3 00 g dL 3000 mg dL 1 90 mmol L use the HemoCue B Hemoglobin system No characters on the 1 Thereis no power supply to the Check that the power adapter is display photometer connected to the main power supply 2 If on battery power the
8. ipe off the ex cess sampleon the outside of the cuvette Makesure that no sample is drawn out of the cuvette during this procedure The filled cuvette should be visually inspected to check that the cuvette is properly filled i e completely filled up to the edge and without air bubbles in the optical eye 10 Place thefilled cuvette into the cuvette holder and carefully push it into the measuring position The filled cuvette should be analyzed immediately and at the latest within 1 minute after filling Filled cuvettes are to be kept lying down NOTE Slammingthecuvetteholder intoplacewith undue force will cause splashing of the sample material onto the optical surfaces Itisimportant that the cuvette holder is completely dry since fluid between the holder and cuvette can withdraw sample from the cuvette by capillary action In less than 1 minute the result is displayed The result will remain on the display as long as the cuvette holder is in its measuring position The cuvetteshould bedisposed of after themeasurement Although the reagents are present in the micro cuvette in extremely low quantities consult local environmental authorities for proper disposal Always handle blood specimens with care as they may be infectious The cuvette cannot be remeasured If ERROR code appears turn to Troubleshooting Guide page 16 When the measurement procedure has been completed turn the photometer s power switch to t
9. ir bubbles in the cuvette The optronic unit is dirty The calibration of the photometer has been changed L 2 The photometer needs service Call your distributor The photometer needs service Call your distributor Turn off the photometer and replace the batteries five type AA The photometer needs service Call your distributor Call your distributor The photometer needs service Call your distributor Check the expiry date and storage of the cuvettes Remeasure the sample with a new cuvette Make sure that the control is mixed well and at room temperature Check the cuvette for air bubbles Remeasure the sample with a new cuvette Clean the optronic unit using the HemoCue Cleaner See Quality Control page 13 See also instruction from the manufacturer of the control Call your distributor Check the expiry date and storage of the cuvettes Remeasure the sample with a new cuvette Make sure that the sample is mixed well Check the cuvette for air bubbles Remeasure the sample with a new cuvette Clean the optronic unit using the HemoCue Cleaner Call your distributor 17 18 19 HemoCue Manufacturer HemoCue AB Box 1204 SE 262 23 Angelholm Sweden Phone 46 431 45 82 00 Fax 46 431 45 82 25 E mail info hemocue se www hemocue com HemoCue Distributor USA HemoCue Inc 40 Empire
10. isplay now shows MEASURING and three fixed dashes The photometer is measuring Flasmatl cour HE s r Inless than oneminutethephotometer displays the result Comparethis valuetothe assigned value on the Plasma Low Hb Control solution vial If the result is out of range refer to Troubleshooting Guide page 16 How to Perform a Plasma Low Hb Determination Sample material See page 12 Turnthe switch atthe back of the photometer to the position ON Pare hir Pull out the holder to the loading position This is noted by adistinct stop which should not beexceeded ua The display shows LHb and after 15 seconds READY with three flashing dashes Take the cuvette out of the container Hold the cuvette by therear winged end Reseal thecontainer immediately The microcuvettes are to be stored dry at room temperature 15 30 C 59 86 F Once opened the microcuvettes are stable for three months see page 12 Filling of Cuvettes Use a pipette to place a large drop of well mixed sample on a hydrophobic surface for example a pieceof plasticfilm Thecuvettecan befilled directly from a tube if the tube is not to be used for further analyses Visually turbid samples should be filtered before analysis using a 0 2 um filter Introduce the cuvette into the middle of the drop in such a way that the cuvette is filled in one step It should never be topped up Using laboratory tissue carefully w
11. otometer is only to be used with HemoCue Plasma Low Hb micro cuvettes The HemoCue Plasma Low Hb microcuvettes are for in vitro diagnostic use only For further limitations of the procedure see HemoCuePlasmaLow H bmicrocuvetteinstructions for use Warranty The photometer carries a 24 month warranty from the day of recei pt 13 Maintenance Thephotometer is designedtowork for along period of time without any direct service No preventative maintenanceis needed for theelectroniccomponents of the photometer At the end of each days use remove the cuvette holder and clean with alcohol or a mild soap solu tion Thecuvetteholder can also beautoclaved Itis important that the holder is completely dry before being replaced in the photometer Todeantheoptronicunit usetheH emoCueCleaner Follow the instructions in the package The cover may be cleaned with alcohol or mild soap solution No instrument modifications i e recalibration should be performed Technical Service After the warranty period service repair is made at fixed prices Spare Parts List The HemoCue Plasma Low Hb Photometer is Con structed with few parts The following spare parts are available Cover Transformer Cuvette holder Technical data Voltage 6 9 VDC Current input 100 mA Pollution degree Over voltage category 2 The instrument is tested according to EN 61010 1 lEC 61010 1 and amendments 1 and 2 and EN 60601 1 2 and complie
12. s with IVD Medical Device Directive 98 79 E C Theinstruments is mar ked with CE Dimensions 16 0 cm x 21 0 cm x 9 0 cm Weight 1 Kg Transformer CE marked 230 V AC 50 Hz Output 6 V DC 350 mA For the USA market please use transformer Input 120 V AC 105 135 60 Hz Output 6V DC 500 mA UL filenumber E199967 N Volume 1 Symbols used CE CE mark y Only valid within the European Community 3 Indicates separate collection for waste of electrical and electronic equipment Manufactured by HemoCue AB Angelholm Sweden 14 15 Trouble Shooting Guide If you are unable to resolve the problem by following this Troubleshooting Guide please call your distributor symptom Explanation an The photometer May bean occasional fault Turn off the photometer and switch it on shows ERROR and again after 30 seconds a digit code 900 908 Take a new cuvette and repeat the measurement If the problem continues see specific error code below ERROR 900 No stable endpoint within the la Check expiry date for the cuvettes time range lb Take a new cuvette and repeat the The cuvette is unstable measurement The circuit board is out of 2 The photometer needs service order Call your distributor ERROR 901 or 902 Light intensity of the diodes Clean the optronic unit using the are too low This is often the HemoCue deaner result of dirt in thelight path The photometer needs service T
13. tions or stored or banked erythrocytes which contains low concentra tions of hemoglobin such as irrigating fluid used during surgery or erythrocyte suspension media All specimens must be allowed to reach room temperature before use Visually turbid samples should be filtered before analysis with a 0 2 um filter Quality Control Two levels of liquid control is recommended to be run on the day of use or as required by accrediting agencies or local policy NOTE A control cuvette is not included in the HemoCue Plasma Low Hb system Plasma Low Hb control analysis Allow the control to reach room temperature and mix it well before use Assay this control sample by filling and reading the cuvette as previously described If the result is not within the range repeat the analysis using the same control solution If the result is still out of range perform the assay with a new control If this result is out of range refer to Troubleshooting Guide page 16 Specifications For performance characteristics see HemoCue Plasma Low Hb microcuvette instructions for use Measuring Range The system is linear between 0 3 30 0g L 0 03 3 00 g dL 30 3000 mg dL 0 02 1 90 mmol L Caution should be taken when evaluating instru ment readings below 0 3 g L 0 03 g dL 30 mg dL 0 02 mmol L Results above 30 0 g L 3 00 g dL 3000 mg dL 1 90 mmol L will display an error code HHH Limitation The HemoCue Plasma Low Hb ph
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