EKF Diagnostics Stanbio HemoPoint H2, User Manual

Page 1: ...tics for life Stanbio 1261 North Main Street Boerne TX 78006 Email sales2 ekfdiagnostics com 1 830 249 0772 Fax 1 830 249 0851 www ekfusa com 3072E 001 3072E 001 01 HemoPoint H2 Hemoglobin Analyzer Di...

Page 2: ...HemoPoint H2 Hemoglobin Analyzer User Manual...

Page 3: ...Diagnostics Inc EKF Diagnostics Inc 1261 North Main Street Boerne Texas 78006 U S A Tel 830 249 0772 Fax 830 249 0851 e mail stanbiolab ekfdiagnostics com HemoPoint H2 Analyzer manufactured in German...

Page 4: ...4 3 3 4 Stand by mode 14 3 3 5 Displays and symbols in the ready mode 15 4 SAMPLING AND TESTING PROCEDURE 16 4 1 TAKING A SAMPLE 16 4 1 1 Notes on using the microcuvette 16 4 1 2 Taking a sample of ca...

Page 5: ...PRINT MODE 42 5 4 1 Header Example 42 5 4 2 Hgb limit mode On Hematocrit On 43 5 5 EXPANDED PRINT MODE 43 5 5 1 Header Example 43 5 5 2 Hgb limit mode On Hematocrit On 43 5 5 2 1 Setting the tone sign...

Page 6: ...OOTING 53 7 1 PROBLEM SOLVING 53 7 2 RESETTING OF THE ANALYZER 58 8 TECHNICAL DATA 59 8 1 HEMOPOINT H2 ANALYZER 59 8 2 N X T MICROCUVETTE 60 9 REFERENCE RANGE 61 9 1 NORMAL RANGE 61 9 2 UNDERSTANDING...

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Page 8: ...l warns of situations or actions that could lead to serious damage to the health of the user or a patient The WARNING symbol This symbol warns about incorrect handling that could cause measuring error...

Page 9: ...installed Check that the AC voltage and frequency printed on the AC power adaptor label match your electrical socket and whether the shape and configuration of the plug contacts are compatible for thi...

Page 10: ...require customer maintenance Repairs can only be carried out by EKF Diagnostics personnel Further notes on maintenance can be found in Section 6 Do not force the cuvette holder The cuvette holder is...

Page 11: ...cordance with the current regulations applicable to your establishment The HemoPoint H2 system is designed for use in medical practices and in clinical laboratories to assist in medical diagnostic inv...

Page 12: ...hat all the items are present and undamaged see Illustration 1 Illustration 1 1 HemoPoint H2 analyzer 1 AC power adaptor and 1 control cuvette Materials provided One 1 HemoPoint H2 Analyzer One 1 AC p...

Page 13: ...d improvements Even easier Go to www stanbio com warranty php and register your HemoPoint H2 online What is your voltage Check that the AC voltage and frequency printed on the AC adaptor label match y...

Page 14: ...lyzer on and off 3 3 1 Using for the first time Allow the analyzer to reach room temperature Changing from a cold to a warm environment i e after storage or transport condensation can form both on the...

Page 15: ...Charging and care of the battery 3 3 2 To operate using the power adaptor Use the power adaptor to operate the analyzer noting the following steps when connecting the power adaptor 1 Insert the small...

Page 16: ...analyzer Following this initialization phase the display illuminates and a welcome screen appears briefly after which the instrument is ready to operate Illustration 4 Welcome display screen Illustrat...

Page 17: ...l operate for a period of at least 100 hours Tips on charging the battery and battery maintenance can be found in Section 6 2 Charging and care of the battery To avoid problems while testing during ba...

Page 18: ...H2 User Manual 15 Touch the Touchscreen Open or close the cuvette holder Plug the analyzer into an electrical power supply 3 3 5 Displays and symbols in the ready mode Illustration 6 Display in ready...

Page 19: ...Each microcuvette can only be used once The microcuvette is designed for single use The cuvette is coated during manufacturing with all the reagents necessary for determining the hemoglobin concentra...

Page 20: ...he microcuvette is a precision optical component The microcuvette is analyzed optically in the HemoPoint H2 analyzer The measured absorption is proportional to the hemoglobin concentration The light f...

Page 21: ...y There should be good blood circulation in the hand from which you wish to take blood i e it should be warm and relaxed If in doubt the hands can be warmed in warm water Illustration 9 Stimulating th...

Page 22: ...uncture site 4 Disinfect the puncture site and allow to dry Illustration 11 Sticking the finger 5 Press lightly on the fingertip and puncture with a suitable sampling device on the side of the fingert...

Page 23: ...tte completely Avoid milking For additional information about obtaining a capillary blood sample read the latest CLSI guideline Order information may be found at www clsi org Illustration 13 Filling t...

Page 24: ...cuvette cavity DO NOT try and top off cuvette if not filled completely Repeat the process with a new drop of blood and a new cuvette The cuvette sample can now be tested immediately or within 10 minut...

Page 25: ...create air bubbles in the cuvette optic window and result in an erroneous result Illustration 15 Taking a sample of venous or arterial blood Ensure that the cuvette cavity is completely filled and fr...

Page 26: ...or within 10 minutes DO NOT read cuvette after 10 minutes For further steps please read Section 4 2 Performing the test 4 2 Performing the test Hgb limit mode ON with the Hematocrit mode ON Illustrat...

Page 27: ...he normal range for each patient type see Section 5 3 5 Hgb mode and limits the display will show the Patient type buttons that can be selected before testing occurs Select the patient type by touchin...

Page 28: ...Illustration 20 making sure the microcuvette is properly inserted into the holder 4 Push gently on the cuvette holder and it will close automatically DO NOT force 5 Testing of the cuvette begins autom...

Page 29: ...t result 6 Read the test result You can now make a note of the result s Pressing the OK button is not absolutely necessary It merely produces a confirmation of the result while the analyzer changes to...

Page 30: ...der closed when analyzer is not in use When the holder is opened a new testing cycle is started and the analyzer checks the optical performance of the measuring system and automatically becomes ready...

Page 31: ...sting After approx 2 3 seconds the display will read Open Holder If the instrument does not show Open Holder there is possibly a malfunction Please consult Section 7 Troubleshooting 4 3 3 Control cuve...

Page 32: ...t of the storage box and place it in the cuvette holder 3 Close the cuvette holder completely The analyzer tests the control cuvette and shows the result after a few seconds 4 Compare the result with...

Page 33: ...6 dropper bottles 3 x Hgb control low 3 x Hgb control high Instructions for ordering can be found in Section 10 1 Replacement parts and consumer materials There are a variety of hemoglobin controls o...

Page 34: ...nlarged to allow easy operation As can be seen in Illustration 24 the sensitive area of these buttons extends into the middle of the display so it is not difficult to operate them A touchscreen is a d...

Page 35: ...s the menu screen or rejects changes OK OK button selects the next lower menu screen or confirms a selection Fu n ction Shows a button that is inactive 5 2 Memory data storage The instrument is equipp...

Page 36: ...Escape to leave the memory data storage Op tion s Press this button to select the menu Options In this menu you will find additional functions for printing and for deleting results Further informatio...

Page 37: ...results as follows From the memory data storage display press the button Op tion s Select the entry Print using the buttons Confirm the selection with OK to print out the results otherwise press ES C...

Page 38: ...gain to display memory data storage Empty 5 3 Menu functions The analyzer has various possible settings that can be accessed through the menu function Access to the menu is possible only if the analyz...

Page 39: ...ion about the analyzer and the status of various components can be found under the menu item Info You can scroll up or down with the arrow buttons OK With this button you can leave the information dis...

Page 40: ...connecting the HemoPoint H2 to a PC can be found under Menu sub menu Connect The InterLink Lite software program and a PC cable are required for this function to operate properly see Section 10 1 Rep...

Page 41: ...tant for the correct relationships of the results from the memory data storage or for printing out the results The format to enter the time depends on the time format setting see Section 5 3 7 3 Setti...

Page 42: ...ces all test displays including the results in the memory data storage and the printer Limits can be set for the following groups of patients Adult Male 13 18 g dL default Adult Female 11 16 g dL defa...

Page 43: ...The HemoPoint H2 analyzer supports various languages The function of setting the language can be found under Menu sub menu Settings sub menu Language This gives you the ability to set the analyzer to...

Page 44: ...ult The function of the individual keys can be found in Section 5 3 4 Setting the units 5 3 9 Menu options To keep the main menu clear all functions that are used less frequently have been placed unde...

Page 45: ...get a simple and compact printout of the results from the memory data storage including all available information in list form In the expanded print mode you have the possibility to separate single re...

Page 46: ...Setting the tone signal Under Menu sub menu Options sub menu Tone the signal can be switched ON or OFF This adjustment affects the button No Date Time Hgb Hct 1 01 01 09 12 03pm 15 0 g dL F 44 2 01 0...

Page 47: ...therefore shortens the operation time of the instrument under battery operation 5 5 2 3 Setting the stand by time The HemoPoint H2 is equipped with integrated energy management If the analyzer is not...

Page 48: ...item is intended for an authorized EKF Diagnostics technical service representative only 5 5 3 Information on contacting us Information on how to contact EKF Diagnostics if you need further help or i...

Page 49: ...are required see section 10 1 Replacement parts and consumer materials for ordering information Please refer to the InterLink Lite Software User Manual for further instructions 5 6 2 Connecting a prin...

Page 50: ...uthorized EKF Diagnostics distributor Please only use the cable intended for this purpose otherwise both the analyzer and the printer may be seriously damaged The printer cable is equipped at one end...

Page 51: ...hey do not contain alcohol or other solvent The housing is equipped with a high quality lacquered surface Please do not use any harsh cleaning agent or solvent otherwise the surface can be damaged and...

Page 52: ...not use any cleaning agent for cleaning the cuvette holder that could leave scratches on its surface 6 1 3 Optical unit The optical unit is situated inside the analyzer and has no direct contact with...

Page 53: ...side the instrument Please do not use any cleaning agents other than original HemoPoint H2 Optics Cleaner 6 1 4 Power adaptor Care Danger of fatal electric shock It is essential to follow the instruct...

Page 54: ...hat the battery will immediately recharge when it is connected to the power adaptor To conserve the battery capacity from time to time leave the instrument in battery operation mode until it is almost...

Page 55: ...nstrument try to solve the problem initially with the aid of Section 7 Troubleshooting If you require assistance contact EKF Diagnostics technical service department see Section 10 2 Further informati...

Page 56: ...n 7 2 Resetting of the analyzer Battery problems Error message Defective battery A battery problem was found Following this message the battery is switched off The instrument can only be operated when...

Page 57: ...ot properly engaged replace cuvette holder see Section 6 1 2 Cuvette holder Dirty Optical unit clean unit see Section 6 1 3 Optical unit Control cuvette is not correctly positioned into the cuvette ho...

Page 58: ...tion 4 1 Taking a sample Defective or superimposed microcuvette Error message Dirty Optics Use Optics Cleaner Dirty Optical unit clean unit see Section 6 1 3 Optical unit Cuvette holder not properly o...

Page 59: ...e correctly seated Instrument switches off too quickly or too slowly Stand by time is unsuitable Reset the stand by time see Section 5 5 2 3 Setting the stand by time Instrument does not react to open...

Page 60: ...r data storage is incorrect or will not be displayed as expected Time is set incorrectly Reset the time see Section 5 3 3 Setting the time Time format is set incorrectly Set the time format see Sectio...

Page 61: ...user specific settings significantly The settings for contrast date and time are lost The reset button can be found on the underside of the analyzer Illustration 37 Location of the reset button To re...

Page 62: ...ctral half value width of the source 1st wavelength 15 3 nm 2nd wavelength 50 nm Receiver Photodiode 350 820 nm Measuring range 0 25 6 g dL Sample material Venous arterial or capillary human blood Sam...

Page 63: ...ce Printer RS 232 C Environmental temperature Room temperature 15 30 C 8 2 n x t Microcuvette Type Microcuvette coated with reagents for determining the hemoglobin value in venous arterial or capillar...

Page 64: ...nd main component of red blood cells Low hemoglobin levels may indicate anemia recent hemorrhage or fluid retention Elevated hemoglobin levels may indicate hemoconcentration from polycythemia or dehyd...

Page 65: ...rol Cuvette For check of HemoPoint H2 meter serial specific 1 pc G3250 001 Printer DPU 414 Thermal printer with power adaptor and interface cable 1 pc 3150 001 Printer Power Adaptor 1 pc 3175 001 Prin...

Page 66: ...ould be pleased to help Here is all the important contact information Main address EKF Diagnostics Inc 1261 North Main Street Boerne Texas 78006 U S A Telephone 830 249 0772 866 782 6246 Fax 830 249 0...

Page 67: ...ion of the instrument 48 control cuvette 9 28 cuvette holder 7 11 15 21 22 23 24 25 26 27 28 29 48 49 D data storage 27 32 33 34 35 59 date 37 40 58 display contrast 39 56 disposal 52 E environmental...

Page 68: ...irs 52 reset button 58 results displaying 26 32 33 printing 34 S safety notes 5 sample carrier 59 sample material 59 sample size 59 sampling procedure 17 21 self discharge 51 service menu 45 setting u...

Page 69: ...Index HemoPoint H2 User Manual 66...

Page 70: ...tics for life Stanbio 1261 North Main Street Boerne TX 78006 Email sales2 ekfdiagnostics com 1 830 249 0772 Fax 1 830 249 0851 www ekfusa com 3072E 001 3072E 001 01 HemoPoint H2 Hemoglobin Analyzer Di...