HemoPoint® H2 Meter User Manual - Drug testing supplies from
Contents
1. If correlation is activated see Section 5 3 1 Information about the Alere HemoPoint H2 Meter you may see or symbols at any position in the data storage This indicates that the real results cannot be shown with the current settings of the correlation function because they exceed the testing range If the estimated_Hem tocrit mode has been activated the hematocrit result will be displayed as well see Section 5 3 8 1 Hematocrit Mode 5 2 2 Printing Out Results In order to print out from memory data storage you must have a printer connected Instructions for this can be found in Section 5 3 8 2 Print Mode You can print out results as follows e From the memory data storage display press the button Options e Select the entry Print using the buttons ry e Confirm the selection with ok to print out the results otherwise press C Esc _ in order not to print Printing out the results can take a few seconds Following printing the Alere HemoPoint H2 Meter changes back TIP again to display the memory data storage 25 2012 Alere All rights reserved 5 2 3 Deleting the Stored Test Data With this function the entire data storage all results is deleted To delete the data storage proceed as follows e From the memory data storage display press the button e Select the entry Delete using the buttons e Confirm the selection with C ox to delete the data stor2. HemoPoint H2 Meter User Manual cw voler Contents 1 Important Information nssssenerrermennsnss 1 1 1 Welcome en EEE H EWE nA UR VER ERA s l VA 1 1 2 Explanation of the Graphic SymbolS ssssssss css lak alk anan dinay aka kk HaWE H EL 1 Wad Safety NOLS POPPRPPRFPPPPFEPFFPEFTEPFOFFEFFEFEEFESPRTEBETFEPFFEEFFTEPFFERFLEFFTESEFEREFTEPERTEFTTFPETFEFFEFLLTERFT 1 2 Intended Use 2 220020a00 00n0nnnnannnannunaunnannunnunnunnunnunannnen 3 Setting UP RES EE NEN YE DE SE EE nn nenn 3 1 Unpacking the Alere HemoPoint H2 Meter 5 3 2 Setting up the Alere HemoPoint H2 Meter 6 3 3 Switching the Alere HemoPoint H2 Meter On and Off 7 3 3 1 Using for the First Time 0 0 0 7 3 3 2 To Operate Using the Power Adaptor sise 7 3 3 3 Battery Operation sssssssssssssssissssssesssssisrssestessesenrssinsssssisrenarecenessise tissage 9 3 34 stand by Mode en dentin Renan mienne 9 3 3 5 Displays and Symbols in the Ready Mode tn Tn T 10 4 Sampling and Testing Procedure 10 4 1 Taking a Sample Z ZZZ ZZ z C 10 4 1 1 Notes on Using the Alere HemoRoint H2 Microcuvette 10 42 Taking a SampleohCapillary BlOOd u 22uursnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 11 4 1 3 Taking a Sample of Venous or Arterial Blood 15 24 2 NR EGE n The Tests she A 16 4 3 Quality ContrOl IPPRRPPRFPPUEREREHEETELPE
3. 13 0 18 0 g dL Female 11 0 16 0 g dL Child 11 0 16 0 g dL Version 2 08 1b Serial No 3005 07 0001 Cust Serv 877 441 7440 Alere HemoPoint H2 User Manual 32 5 3 8 3 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 signals as well as the signals that sound at the end of the current test 5 3 8 4 Setting the Backlight Mode Under Menu sub menu Options sub menu Backlight the backlight can be switched ON or OFF when under battery operation If turned ON the backlight is temporarily switched on for all entries and actions Under electrical power operation the backlight is always on Note The backlight consumes power from the battery and therefore shortens the operation time of the instrument under battery operation 5 3 8 5 Setting the Stand by Time The Alere HemoPoint H2 Meter is equipped with integrated energy management If the Alere HemoPoint H2 Meter is not used for a certain time it switches into the stand by mode see Section 3 3 4 Stand by Mode Under this menu you can set the number of minutes the Alere HemoPoint H2 Meter will remain active ON after which the instrument will switch off Under Menu sub menu Options sub menu Stand by the stand by time can be set according to your preference Use the appropriate arrow key to either incre
4. Receiver Photodiode 350 820 nm Measuring range 0 25 6 g dL Sample material Venous arterial or capillary human blood Sample carrier Alere HemoPoint H2 Microcuvette Sample size 8 UL Linearity Measuring time 022010 H al 08 y d gt 20 0 g dL 0 7 g dL Dependent on concentration 10 60s Memory data storage Up to 4000 results including date and time Alere HemoPoint H2 User Manual 48 Dimensions LxWxH 6 25 in x 6 5 in x 2 5 in Weight 1 3 lbs Power supply AC Power adaptor Input 100 250 V AC 50 60Hz Output 6 VDC Integrated battery Voltage 3 6V Capacity 2000mAh ca 100 h operation time maximal 3W Power typically 1 2 W minimal 30 mW Interface Printer RS 232 C Environmental temperature Room temperature 15 40 C 82 Alere HemoPoint H2 Micr cuvette Type Alere HemoPoint H2 Microcuvette coated with reagents for determining the hemoglobin value in venous arterial or capillary blood Volume in the cuvette cavity 8 uL Sodium desoxycholate sodium Reagents nitrite sodium azide non reactive additives Material Polystyrene Room temperature 15 30 C Storage dry storage in the original containers Dimensions LxWxH 1 5 in x 1 0 in x 0 125 in 49 2012 Alere All rights reserved Reference Range 9 1 No
5. To connect the printer to the Alere HemoPoint H2 Meter a special printer cable Alere item 52217 must be purchased separately from an authorized Alere HemoPoint H2 distributor Please only use the cable intended for this purpose otherwise both the Alere HemoPoint H2 Meter and the WARNING printer may be seriously damaged Alere HemoPoint H2 User Manual 34 Maintenance 6 1 Cleaning and Disinfection of the Instrument 6 1 1 Housing and Touchscreen It is essential to follow the instructions in Section 1 3 Safety Notes Disconnect the power adaptor from the WARNING electrical connection before proceeding Cleaning the housing and touchscreen is best accomplished with a lint free cloth lightly dampened with clean water For more stubborn soiling a mild soap solution may be used For disinfection standard solutions can be used for surface disinfection provided they 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 the WARNING Alere HemoPoint H2 Meter will look unsightly o Before cleaning the touchscreen open the Alere i EO gt HemoPoint H2 Microcuvette holder 1 6 1 2 Alere HemoPoint H2 Microcuvette Holder The Alere HemoPoint H2 Microcuvette holder can be removed from the instrument for cleaning Proceed as follows e Disconnect the power adaptor
6. rau paye An inc 11578 Sorrento Valley Rd 26 San Diego CA 92121 TEL 848 481 5031 FAX 801 720 7658 www cliawaived com Made in Germany 2012 Alere All rights reserved The Alere Logo and Alere are trademarks of the Alere group of companies HemoPoint is a trademark of Stanbio Laboratory L P under license PN 26270 Rev B 2012 12
7. 2217 Alere HemoPoint H2 User Manual 50 Appendix 10 1 Replacement Parts and Consumer Materials Catalog No Description Ordering Alere HemoPoint H2 Microcuvettes 1 kit 80549 2 Containers 50 microcuvettes each 100 tests Alere Hemoglobin Controls 1 set 88772 Set of 2 dropper bottles 1 x Hgb control low 1 x Hgb control high Alere HemoPoint H2 Optics Cleaner 5 pcs 52219 i For cleaning the optical unit 55115 AlereTM Universal Printer 1 pc Thermal printer with power adaptor Printer Cable 1 pc 52217 For connecting the Alere Universal Printer to the Alere HemoPoint H2 Meter 52220 Alere HemoPoint H2 Microcuvette Holder INC 52218 Power Adapt r for the 1 pc Alere HemoPoint H2 Meter 55118 Alere HemoPoint H2 Meter 1 pack 26280 Aler HemoPoint H2 User Manual English 1 pc For Alere HemoPoint H2 Meter 51 2012 Alere Al rights reserved Index Q Accessories Air Bubbles Backlight Battery Battery Operation Blank Reading Charging Charging Procedure Charging Time Cleaning and Disinfection of the Instrument Concentration Data Storage Date Display Contrast Disposal Environmental Temperature Hematocrit Intended Use Interface Keys Buttons 1 34 39 14 15 16 42 33 45 7 9 27 33 37 38 39 40 41 42 44 45 49 9 33 37 41 42 20 7 9 37 38 41 37 38 23 35 10 1
8. EKA R k R nA RA RAA SAR 5 3 7 4 Setting the Power Frequency 31 5 3 8 Menu Options nennen 31 5 3 8 1 Hematocrit Mode cccciccisccnessetsestessessasenssecsacesesssaseseesesvesersetteareassers 31 5 39 82 Print MOG iis 5 sa sesni nan cana nani xa engen 32 5 9 8 2 1 Print Mode EXam pl St ipne lsa M la b da da kana k B kek erk n di Kanal Rai 32 5 3 8 2 1 1 Hgb Limit Mode Off Hematocrit On 32 5 3 8 2 1 2 Hgb Limit Mode On Hematorcrit On 32 5 3 8 3 Setting the Tone Signal sise 33 5 3 8 4 Setting the Backlight Mode sis 33 5 3 8 5 Setting the Stand by Time 5 3 8 6 The Service Menu l anw FL 5 3 9 Information on Contacting US PN Z CI ZA 5 4 Connecting Accesbories Sy BAM AL 5 4 4 0nn tting arini NH 5 4 1 1 Connecting the Printer Cable 6 Maintenance SR HHHH 6 1 Cleaning and Disinfection of the Instrument 35 6 1 1 Housing and Touchscreen 35 6 1 2 Alere HemoPoint H2 Microcuvette Holder 35 6 1 3 Optical Unit 5sssssisssrsssssssecssessrsssennnssanessosssasersensesipsssns sreres na nennen armer 36 6 1 4 Power dapfor sun0u une east 37 6 2 Charging and Care of the Battery rnsossesessesnennosnnonsanonnonnennennsnnsnsortonnnsnnen 37 6 2 1 Charging Procedufe 2 2 nn a E dernier 37 6 2 2 Charging Time 6 2 3 Self Discharge 23 TCP ANS ER ae ce s
9. and the Alere HemoPoint H2 Meter checks the optical performance of the measuring system and automatically becomes ready for a new cuvette to be inserted If you do not want to perform another test simply close the Alere HemoPoint H2 Microcuvette holder again The test cycle will be cancelled 4 3 Quality Control 4 3 1 AutoCheck The Alere HemoPoint H2 AutoCheck performs an internal check of the meter s optic system every time the Alere HemoPoint H2 Microcuvette holder is opened If regulatory quality control checks are required the quality control check should be performed using Alere Hemoglobin Controls 4 3 2 Blank Reading All the optical and mechanical components involved with the measuring cycle are carefully manufactured with extremely small tolerances This is essential for the proper function of the Alere HemoPoint H2 Meter Always carry_out a blank reading whenever you have removed the Alere HemoPoint H2 Microcuvette holder i e cleaning replacing with a new Alere HemoPoint H2 Microcuvette holder A blank reading can be performed as follows 1 Open the Alere HemoPoint H2 Microcuvette holder completely i The text in the display reads Add Cuvette TIP 2 Close the Alere HemoPoint H2 Microcuvette holder without inserting a cuvette In this case the meter does not start testing After approx l 2 3 seconds the display will read Open Holder If the instrument does not s
10. from a cold to a warm environment i e after storage or transport condensation can form both on the inside and the outside of the Alere HemoPoint H2 Meter Wait at least 1 hour before you connect the Alere HemoPoint H2 Meter to a power supply As the built in battery has not yet been charged the Alere HemoPoint H2 Meter must first be connected to the power adaptor supplied and plugged into an electrical socket until the battery is completely charged WARNING This procedure is necessary in order for the capacity of i the battery to be checked and the charge indicator to function correctly Further information on this can be found TIP in Section 6 2 Charging and Care of the B ttery 3 3 2 To Operate Using the Power Adaptor Use the power adaptor to operate the Alere HemoPoint H2 Meter noting the following steps when connecting the power adaptor 1 Insert the small round plug on the connecting cable of the power adaptor into the appropriate socket 6VDC at the back of the Alere HemoPoint H2 Meter Illustration 3 Connecting the power adaptor 2 Next insert the power adaptor plug into an appropriate electrical socket The Alere HemoPoint H2 Meter itself does not have a power On Off switch 7 2012 Alere All rights reserved Please be patient after plugging the Alere HemoPoint H2 Meter into the electrical socket It may be 4 or 5 seconds before anything appears on the display This does not i
11. from the electrical connection before proceeding e Open the Alere HemoPoint H2 Microcuvette holder until you feel a resistance and the holder will not extend further e Press down the silver pin on the left hand side bottom of the Alere HemoPoint H2 Microcuvette holder with a ball point pen and draw the Alere HemoPoint H2 Microcuvette holder forward at the same time 85 2012 Alere All rights reserved Illustration 32 Removing the Alere HemoPoint H2 Microcuvette holder The Alere HemoPoint H2 Microcuvette holder can now be cleaned with a mild soap solution For disinfection standard solvent free preparations can be used To replace the Alere HemoPoint H2 Microcuvette older simply push it in the correct position into the opening in th om engages H2 Microcuvette e holder that could leave scratches on its surface WARNING 6 1 3 Optical Unit The optical unit is situated inside the Alere HemoPoint H2 Meter and has no direct contact with the Alere HemoPoint H2 Microcuvette therefore no routine cleaning is needed Cleaning the optical unit can become necessary if the measured maximum light intensity of the photometric light source no longer achieves the appropriate level required for testing The optical unit should be cleaned when the following error message is displayed Dirty Optics Use Optics Cleaner see Illustration 33 Display screen Measurement Error f Measurement Error Illustrati
12. less frequently have been placed under the menu item Options 5 3 8 1 Hematocrit Mode Display of an estimated hematocrit value can be activated in Menu sub menu Options sub menu Hematocrit The hematocrit value will be calculated using the formula Hct F x Hgb g dL with F 2 94 A true hematocrit test is not determined with this system The use of this formula is allowed only within the normal hemoglobin range means from 12 0 g dL 7 44 mmol L 18 0 g dL 11 16 mmol L If the Hgb result is outside this range then the estimated hematocrit result will not be calculated and N A will appear WARNING 31 2012 Alere All rights reserved 5 3 8 2 Print Mode To print out test result s and result s from the memory data storage the Alere HemoPoint H2 Meter printer function must be turned on Under Menu sub menu Options sub menu Print Mode select Standard to turn on the print function 5 3 8 2 1 Print Mode Examples 5 3 8 2 1 1 Hgb Limit Mode Off Hematocrit On Alere HemoPoint H2 Name __________ Dias 2 ee 14 09 11 04 08pm Hgb 16 7 g dL Hotini 49 Version 2 08 1b Serial No 3005 07 0001 Cust Serv 877 441 7440 5 3 8 2 1 2 Hgb Limit Mode On Hematorcrit On Value is in the normal range Alere HemoPoint H2 Nam cz EDEL IDE N 14 09 11 04 08pm Hgb 16 7 g dL Hct 49 Hgb Limits Male
13. operated with the power Error message adaptor Voltage too low e Wrong power adaptor connected 41 2012 Alere Al rights reserved Problems with QC Measurements and Sample Measurements e Defective or superimposed Alere HemoPoint H2 Microcuvette e Air bubbles in the Alere HemoPoint H2 Microcuvette e Sampling error See Section 4 1 Taking a Sample e Wrong or unsuitable control blood Incorrect control level e Alere HemoPoint H2 Microcuvette holder not Test results are not realistic properly engaged replace Alere HemoPoint H2 Microcuvette holder see Section 6 1 2 Alere Control blood test result is out HemoPoint H2 Microcuvette of range Holder e Dirty Optical unit clean optical unit see Section 641 8 Optical Unit Alere HemoPoint H2 Mictocuvette is not correctly positioned into the Alere HemoPoint H2 Microcuvette holder e The Alere HemoPoint H2 Meter must be only used with Alere HemoPoint H2 Microcuvettes Error and Information Messages Information message Ambient temperature is too high i Operate the instrument within Temp too high the correct temperature range Information message e Ambient temperature is too low Operate the instrument within Temp too low the correct temperature range e Low battery operation time Power the instrument from the power Information message adaptor to recharge the battery If the battery i
14. the Alere HemoPoint H2 Control Cuvette out of the storage box and place it in the Alere HemoPoint H2 Microcuvette holder 3 Close the Alere HemoPoint H2 Microcuvette holder completely 21 2012 Alere Al rights reserved The Alere HemoPoint H2 Meter tests the Alere HemoPoint H2 Control Cuvette and shows the result after TIP a few seconds 4 Compare the result with that stated on the storage box label The result must lie within the stated range Record the control result If the Hgb result falls outside the range of the Alere E HemoPoint H2 Control Cuvette there is evidently a problem Please consult Section 7 Troubleshooting in TIP this regard Ifthe original control cuvette is lost or damaged a new Alere HemoPoint H2 Control Cuvette must be assayed Please contact Alere Technical Support at 1 866 216 0073 to discuss options for replacing your Alere HemoPoint H2 Control Cuvette 4 3 4 External Quality Control lf additional quality control is required by local or other regulations external control material may be used For this purpos we recommend the use of Alere Hemoglobin Controls There are a variety of hemoglobin controls on the market today Alere only recommends the us amp of the Alere Hemoglobin Controls since we cannot guarantee the compatibility Of other brands of controls on the Alere HemoPoint H2 System Thoroughlysmix the controls before use see the control packag
15. 0 22 25 26 30 35 37 38 1 2 3 5 7 9 11 14 16 18 21 23 30 319 34 37 18 19 20 28 31 33 38 44 46 47 48 33 45 9 23 35 37 20 22 30 39 40 4 19 29 30 31 46 Alere HemoPoint H2 User Manual 54 Glossary of Symbols Do not reuse Catalog number VW Contains sufficient for lt N gt tests A Caution Consult Accompanying Documents Use by CE Consult instructions for use In vitro diagnostic medical device Contents LOT Batch code Manufacturer 30 C 15 C I Store at 15 30 C Waste Electronics and Electronic Equipment 55 2012 Alere All rights reserved Contact Alere Alere Technical Support Contact one of the following Alere Technical Support Care Centers or your local distributor if you have any questions regarding the use of your Alere product You may also contact us at www alere com Region Phone E Mail Address US 1 866 216 0073 HemoPoint H2 Support alere com Alere Customer Support Contact the following Alere Support Care Center or your local distributor for order and billing assistance You may also contact us at www alere com Phone E Mail Address 1 877 441 7440 option 1 clientservices alere com Alere HemoPoint H2 User Manual 56 Limited Warranty FOR THE APPLICABLE WARRANTY PERIOD ALERE WARRANTS THAT EACH PRODUCT SHALL BE I OF GOOD QUALITY AND FREE OF MATERIAL DEFECTS
16. 17 18748 50 8 19 24 25 26 28 29 31 32 34 45 46 48 11 15 28 30 31 45 47 48 30 44 19 39 30 49 16 19 25 31 32 4 57 34 49 17 23 29 30 31 Alere HemoPoint H2 User Manual 52 Language Linearity Maintenance Measuring Procedure Measuring Range Measuring Time Menu Functions Microcuvette Microcuvette Holder Moisture Navigation Optical Eye Print Mode Printer Printer Connecting Cable Procedure Sampling Procedure Testing Puncture Site Quality Control Reference Range Repairs Reset Button Results Displaying Results Printing 53 O 2012 Alere All rights reserved 30 45 48 2 3 9 35 48 48 48 8 26 3 4 5 9 10 11 13 21 35 36 39 42 43 44 48 49 51 3 6 9 14 16 17 18 19 20 21 35 36 42 43 44 51 10 24 1A 25 32 1 19 25 29 34 46 49 51 34 46 51 8 10 12 13 42 43 8 10 43 5 12 13 20 22 50 3 39 47 19 24 25 28 34 Safety Notes Sample Carrier Sample Material Sample Size Self Discharge Service Menu Set Up Stand by Storage Symbols Danger Symbol Tip Symbol Warning Symbol Testi g Cycle Time Tone Signal Touchscreen Troubleshooting Units 1 35 37 39 40 48 43 48 48 38 33 5 8 9 33 44 3 7 8 10 19 21 22 24 25 26 28 29 31 32 34 45 46 48 49 1 8 10 19 25 55 1 2 12 37 39 40 1 7 8 9 12 13 17 2
17. 3 8 4 Setting the Backlight Mode Tone Signal Does Not Work or Does Not Work Properly Tone signal is set incorrectly Adjust the tone signal see Section 5 3 8 3 Setting the Tone Signal Display Texts are Not Shown in your Language Language is set incorrectly Reset the language see Section 5 3 7 1 Setting the Language Time Displayed is Incorrect Time is setfincorrectly Date Shown in the Printout or Data Storage is Incorrect or Will Not be Displayed as Expected Date setting is incorrect Reset the time See Section 5 3 3 Setting the Time Reset the date see Section 5 3 2 Setting the Date Date format is set incorrectly Set the date format see Section 5 3 7 2 Setting Date Format Time Shown in the Printout or 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 45 2012 Alere All rights reserved Time Shown in the Printout or Data Storage is Incorrect or Will Not be Displayed as Expected Set the time format Time format is set incorrectly see Section 5 3 7 3 Setting Time Format Incorrect Units are Shown Set the units of measurement Setting of units is incorrect see Section 5 3 4 Setting the Units Printer Does Not Print Connect to an Alere Unive
18. Il FUNCTION IN ACCORDANCE WITH THE MATERIAL SPECIFICATIONS REFERENCED IN THE PRODUCT MANUAL AND III APPROVED BY THE PROPER GOVERNMENTAL AGENCIES REQUIRED FOR THE SALE OF PRODUCTS FOR THEIR INTENDED USE the LIMITED WARRANTY IF THE PRODUCT FAILS TO MEET THE REQUIREMENTS OF THE LIMITED WARRANTY THEN AS CUSTOMER S SOLE REMEDY ALERE SHALL EITHER REPAIR OR REPLACE AT ALERE S DISCRETION THE PRODUCT EXCEPT FOR THE LIMITED WARRANTY STATED IN THIS SECTION ALERE DISCLAIMS ANY AND ALL WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NON INFRINGEMENT REGARDING THE PRODUCT ALERE S MAXIMUM LIABILITY WITH ANY CUSTOMER CLAIM SHALL NOT EXCEED THE NET PRODUCT PRICE PAID BY CUSTOMER NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION LOSS OF BUSINESS PROFITS DATA OR REVENUE EVEN IF A PARTY RECEIVES NOTICE IN ADVANCE THAT THESE KINDS OF DAMAGES MIGHT RESULT The Limited Warranty above shall not apply if the Customer has subjected the Product to physical abuse misuse abnormal use use inconsistent with the Product Manual or Insert fraud tampering unusual physical stress negligence or accidents Any warranty claim by Customer pursuant to the Limited Warranty shall be made in writing within the applicable Limited Warranty period 57 2012 Alere All rights reserved cw voler
19. Point H2 Meter to the current time can be found under Menu sub menu Time Setting the time is important 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 Setting Time Format The functions of the individual buttons can be found in Section 5 3 2 Setting the Date Alere HemoPoint H2 User Manual 28 5 3 4 Setting the Units The function of setting the units can be found under Menu sub menu Unit This gives you the ability to set the test unit for the hemoglobin value you wish to use This setting influences all test displays including the results in the memory data storage and the printer Illustration 29 Display screen Unit You can select the following units e mmol L e g dL default e g L A als Select the appropriate entry using the arrow buttons Press this button to reject the selection Press this button to confirm the selection 5 3 5 Hgb Mode and Limits The function of enabling the Hgb mode and setting the limits can be found under Menu sub menu Hgb limits This gives you the ability to enable or disable the Hgb mode and to set the normal range limits of each patient group This setting influences all test displays including the results in the memory data storage and the printer Limits can be set for the follo
20. RFERRENEEEEEFEELRTELFFEUUFEEEOEEPFEEEAFEFPEFELEREUEFEEECEFELPFEECHEEBERER 20 433 1 AutoCheck ei n k ra ae 20 4 32 Blank ROAGING tes secciseteesssieuss sensed ac bada i day d hana g z w ha d wana ga b h b ba Zina uli hak a 20 4 3 3 Alere HemoPoint H2 Control Cuvette ss 21 4 3 4 External Quality Control sise 22 5 Further FURCHONS remets 23 5 1 Touchsere ea EEN DEI Wak Es rese 5 1 1 General 5 1 2 Meaning of the Buttons Navigation uurseuesssersnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 24 9 2 Memory Data Storage ES EEN Er ira 24 5 2 1 Displaying Results from Memory taandas 24 5 2 2 Printing Out Results 5 2 3 Deleting the Stored Test Data ssssssisssasssssacssassssarssnsesanssissensanecse 26 5 3 Menu Function St ds yp s n s an kaka ail s re xis ka saa aaan naa aa waa a ak aa awa kak daa saa e dan E senc Henna arte san 26 5 3 1 Information about the Alere HemoPoint H2 Meter 27 5 3 2 Setting the Date 5 3 3 Setting the Time 5 3 4 Setting the Units 5 3 5 Hgb Mode ndiLimits 4 ioe Dad aia kak k ewana een 29 5 3 6 Setting the Display Contrast 523 0 Settings i xizak sn mirn nisran l nana nin yi k k zan kan usa d na nan dan w d sence Hd EWAR Sa RE ba dada k 5 3 7 1 Setting the Language 5 3 7 2 Setting Date Format 5 9 1 32 Setting Time FONMMAL i cas s k srta iha d ssas dE
21. The Alere HemoPoint H2 System is designed for use in medical practices and in clinical laboratories to assist in medical diagnostic investigations In addition it can be used in emergency and intensive care units and in medical facilities such as blood banks This test system has been approved for use in laboratories with Waivedssta tuseas defined in 452 CFR 493 15 c a ALERE DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES OF THE MERCHANTABILITY AND FITNESS PERTAINING TO THIS PRODUCT WHICH ARE NOT EXPRESSLY DETAILED IN THIS USER MANUAL OR A WRITTEN AGREEMENT BETWEEN THE BUYER AND SELLER OF THIS PRODUCT ALERE MAINTAINS THAT THIS PRODUCT CONFORMS TO THE INFORMATION CONTAINED IN THIS USER MANUAL PURCHASER MUST DETERMINE THE SUITABILITY OF THE PRODUCT FOR THEIR PARTICULAR USE USE ONLY IN ACCORDANCE WITH THIS USER MANUAL AND OTHER LABELING INSTRUCTIONS Alere HemoPoint H2 User Manual 4 Setting Up 3 1 Unpacking the Alere HemoPoint H2 Meter Before you set up the Alere HemoPoint H2 Meter first check that all the items are present and undamaged see Illustration 1 Illustration 1 1 Alere HemoPoint H2 Meter and 1 AC power adaptor Materials Provided e One 1 Alere HemoPoint H2 Meter e One 1 Meter User Manual e One 1 Quick Reference Guide e One 1 Control Cuvette e On 1 Opties Cleaner One 1 AC power adaptor Additional Materials Required but Not Provided e Latex Gloves e Sampling devices for capi
22. age otherwise press C Esc in order to not delete r After deleting the instrument changes back again to display memory data storage Empty 5 3 Menu Functions The Alere HemoPoint H2 Meter has various possible settings that can be accessed through the menu function Access to the menu is possible only if op6 H2 Meter is s in the ready mode Illustration 27 Display screen ready mode Menu Press this button to access the Menu You will see the following screen display Illustration 28 Display screen Menu Alere HemoPoint H2 User Manual 26 Press this button to scroll up to desired menu entry Press this button to scroll down to desired menu entry level or to leave the menu Press this button to select the next lower menu level to adjust settings or to display information Press this button to select the next higher menu 5 3 1 Information about the Alere HemoPoint H2 Meter Information about the Alere HemoPoint H2 Meter and the status of various components can be found under the menu item Info You can scroll up or down with the arrow buttons With this button you Can Jeave ithe information OK display again The following information is displayed Test Count Total Total number of tests performed on this instrument Today Number of tests performed today Battery Number of tests performed using battery power Battery Remaining battery charge Pat Number
23. aintenance can be found in Section 6 2 Charging and Care of the Battery TIP To avoid problems while testing during battery operation also note the tips in Section 3 2 Setting up the Alere WARNING HemoPoint H2 Meter 3 3 4 Stand by Mode The meter does not have a separate On Off switch Jt is designed so that it automatically switches to the Stand by mode wh n you are not operating the instrument for acertain time approximately 5 minutes The display will gosblank in the Stand by mode 2 This elapsed time can be changed in Section 5 3 8 5 Setting the Stand by Time TIP The Stand by mode reduces power usage to a minimum There are 3 three ways of switching the instrument ON again e Touch the Touchscreen e Open or close the Alere HemoPoint H2 Microcuvette holder e Plug the meter into an electrical power supply 9 2012 Alere All rights reserved 3 3 5 Displays and Symbols in the Ready Mode Battery charging AC power gt Battery status Current time Ready Mode Information Memory data storage button Menu button Illustration 6 Display in ready mode Open Holder Sampling and Testing Procedure 4 1 Taking a Sample 4 1 1 Notes on Using the Alere HemoPoint H2 Microcuvette Illustration 7 Microcuvette The Alere HemoPoint H2 Microcuvette is the most sensitive component in the Alere HemoPoint H2 System It is therefore necessary to handle the cuvette carefully paying pa
24. an nas se ne T 6 4 Proper DISP68Al u ame ee 39 Troubleshooting 40 TA PROBISMESONING BEPPFRRRFEPFFEPUFFPEPPFEPPFFEFFFEFEFTSEFFEFSTFLELTEPLFFFECFFESRTEBTLEPFFFESTESEFFFFEFLETTEFFEFER 40 7 2 Resetting of the Alere HemoPoint H2 Meter 47 8 Technical Data 2z 0000 00000annann ann nun ann ka ku kk au nn 8 1 Alere HemoPoint H2 Meter 8 2 Alere HemoPoint H2 Microcuvette 9 Reference Range ss msnnnnnnnnnnneene 9 1 Normal RANG E s xa y k ne kayan di titre ne net a s n Na back br be r Va Ea n HE kan b d 50 9 2 Understanding Your RSS UNE s saae lalan kd kan kya kd k Raa nd n S RAN DE Elena 50 10 ADDO T LX scores susn din kana nennen 51 10 1 Replacement Parts and Consumer Materials ss sssssesesisressenrearrenreerrnnreerrnerenns 51 MNAE A es 52 12 Glossary of Symbol 55 13 Contact Alere ccccceecesccneeceeceeseneseneceeseasensceeseenseneeeees 56 Important Information Before installing and using the printer please read the following items carefully 1 1 Welcome Congratulations on purchasing the Alere HemoPoint H2 System Before you begin using your new Alere HemoPoint H2 System we strongly recommend you read this manual completely with particular attention to the following section with its introductory explanations and safety notes 1 2 Explanation of the Graphic Symbols The DANGER sym
25. ase or decrease the Stand by time in increments of 1 minute Illustration 30 Display screen Stand by 5 3 8 6 The Service Menu Under Menu sub menu Options sub menu Service this menu item is intended for an authorized Alere Technical Service representative only 5 3 9 Information on Contacting Us Information on how to contact Alere if you need further help or if you wish to place an order is found under Menu sub menu Contact This information can also be found in Section 13 Contact Alere 83 2012 Alere All rights reserved 5 4 Connecting Accessories The Alere HemoPoint H2 Meter is equipped with a serial interface at the back of the instrument accessory interface Illustration 31 Interface socket T M Only instruments specifically intended for the purpose should befeonnectedfte this interface socket using the appropriate connecting cable To avoid short circuits keep WARNING sharp metallic objects away from the sockets 5 4 1 Connecting a Printer The Alere HemoPoint H2 Meter supports the connection of the Alere Universal Printer Alere item 55115 The Alere Universal Printer can be ordered through your authorized Alere distributor With the use of a printer you can print each patient s test result immediately or print patient result s from memory data storage later see Section 5 2 2 Printing Out Results 5 4 1 1 Connecting the Printer Cable
26. bol STOR This symbol warns of situations or actions that could lead DANGER 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 errors or damage to the instrument or any WARNING j accessories used The TIP symbol i Alongside this symbol we provide useful additional TIP information about the current matter 1 3 Safety Notes It is essential that you read the following notes in order to avoid risks to persons and damage to the meter and other equipment Alere does not accept responsibility for damage arising from non observance of the following notes Follow the User Guide Each time the meter is used precise knowledge and attention to these operating instructions is required Only use the Alere HemoPoint H2 System for the purpose which will be described in Section 2 WARNING 1 2012 Alere All rights reserved DANGER WARNING DANGER WARNING Danger of Fatal Electric Shock e Under no circumstances should you open the AC power adaptor There are no elements inside which require servicing or maintenance e Never use a mechanically damaged AC power adaptor live connections might be exposed e The AC power adaptor is not waterproof Therefore never let liquids come into contact with it A lightly dampened cloth however can be used to clean it when disconnected Please see the notes on care in S
27. e insert for directions Compare the values obtained with the Alere Hemoglobin Controls against the stated reference values If the Hgb i result falls outside the range of the Alere Hemoglobin TIP Controls there is evidently a problem Please consult Section 7 Troubleshooting in this regard Alere HemoPoint H2 User Manual 22 Further functions 5 1 Touchscreen 5 1 1 General The Alere HemoPoint H2 Meter has been equipped with a touchscreen The touch sensitive surface is divided into various individual segments According to the current operating mode these segments can be defined as operating buttons 1M Individual segment Active toych are egdom Illustration 24 Divided touc The buttons im the lower W are enlarged to allow easy operation s can be s i tration 24 the sensitive area of these buttons extends he middle of the display so it is not difficult to operate them Atouchscreenis a delicate electronic component Therefore please note the following instructions Only touch the touchscreen lightly with fingertips e Avoid sharp objects such as ball point pens fingernails etc e Only clean the touchscreen with a soft cloth that is lightly dampened with water or a mild cleaning solution Follow the instructions given in Section 6 1 Cleaning and Disinfection of the Instrument WARNING 23 2012 Alere All rights reserved 5 1 2 Meaning of the Buttons Navigation Software bu
28. ection 6 e Only use the AC power adaptor in a socket that has been properly 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 this connection Not to be used in areas where theres a risk of explosion The instrumentis not approved for use in areas where there is a risk of explosion Keep the meter away from liquids The Alere HemoPoint H2 Meter is not waterproof Fluids entering the instrument could destroy the electrical and optical components in the meter A lightly dampened cloth however can be used for cleaning Please see the notes on care in Section 6 Alere HemoPoint H2 User Manual 2 3 WARNING Allow the instrument to reach room temperature Particularly on changing from a cold into a warm environment i e after storage or transport condensation can form inside and on the outside of the instrument Wait an appropriate time approx 1 hour before you connect to the main power supply or switch on the instrument Only use original equipment Only attach equipment that is expressiy approved for use with the Alere HemoPoint H2 System Alere does not guarantee the function of the instrument when other equipment is used Never open the meter There are no parts in the meter that require customer maintenance Repairs can only be carried out by Alere personne
29. es you the ability to set the Alere HemoPoint H2 Meter to the language you wish to use The following languages are supported e English default e German e Spanish The function of the individual keys can be found in Section 5 3 4 Setting the Units Alere HemoPoint H2 User Manual 30 5 3 7 2 Setting Date Format Under the Menu sub menu Settings sub menu Date Format the output format of the date can be set This affects the output of data record in the memory data storage and the printout of the results The following settings are supported e DD MM YY Day Month Year e MM DD YY Month Day Year default e DD MM YY Day Month Year e YY MM DD Year Month Day 5 3 7 3 Setting Time Format Under Menu sub menu Settings sub menu Time Format the output format of the time can be set This affects the output of data records in the memory data storage and the printout of the results The following settings are supported e 12 hours default e 24 hours 5 3 7 4 Setting the Power Frequency Under Menu sub menu Settings sub menu Frequency the frequency of the electrical current can be t In the United States 60 Hz is the norm The following settings are supported e 50 Hz e 60 Hz default The function of the individual keys can be found in Section 5 3 4 Setting the Units 5 3 8 Menu Options To keep the main menu clear all functions that are used
30. how Open Holder there is possibly a malfunction Please consult Section 7 Troubleshooting Alere HemoPoint H2 User Manual 20 4 3 3 Alere HemoPoint H2 Control Cuvette The Alere HemoPoint H2 Control Cuvette supplied with the Alere HemoPoint H2 Meter can be used for a simple check of the Alere HemoPoint H2 Meter s calibration l lllustration 23 Control cuvette The Hgb value and the permitted deviation of the Alere HemoPoint H2 Control Cuvette are stated on the storage soox label All Alere HemoPoint H2 Meters have a specific calibration due to the tolerances in the mechanical andi electronic components The Alere HemoPoint H2 Control Guvette is only calibrated for the instrument with which it is delivered i e the Hgb value stated on the storage box label is only valid for that onetAlere HemoPoint H2 Meter and could lead to completely different results on another Alere HemoPoint H2 Meter If you have several Alere HemoPoint H2 Meters keep track of each Alere HemoPoint H2 Control Cuvette for each Alere HemoPoint H2 Meter When not being used keep the Alere HemoPoint H2 Control Cuvette in the original storage box It is optimally protected there against breakage and contamination WARNING To test the Alere HemoPoint H2 Control Cuvette proceed as follows 1 Open the Alere HemoPoint H2 Microcuvette holder completely and wait until the meter displays Add Cuvette 2 Take
31. ical component The Alere HemoPoint H2 Microcuvette is analyzed optically in the Alere HemoPoint H2 Meter The measured absorption is proportional to the hemoglobin concentration The light from the light source should penetrate through the sample to the photo detector with the least possible influence from the Alere HemoPoint H2 Microcuvette Therefore it is important not to touch the optical eye of the cuvette withifingers Or sharp Objects see Illustration 7 4 The Alere HemoPoint H2 Microcuvette is only designed for in vitro testing 5 The reagents that coat the inner walls of the Alere HemoPoint H2 Microcuvette are harmful and must not be swallowed 4 1 2 Taking a Sample of Capillary Blood 1 Take out a Alere HemoPoint H2 Microcuvette from the original container and immediately close the lid Please note Section 4 1 1 Notes on Using the Alere HemoPoint H2 Microcuvette WARNING Illustration 8 Preparing to take a blood sample 11 2012 Alere All rights reserved 2 Make sure that your patient is sitting comfortably There should be good blood circulation in the hand from which you wish to take blood i e it should be warm and relaxed TIP If in doubt the hands can be warmed in warm water Illustration 9 Stimulating the circulation 1M 3 Lightly massage the fingers in order pyrene s we wal ease r suitable protective gloves DAN a Only use the middle or ring finger The pa
32. ity is completely filled and free of air bubbles DO NOT try and top off Alere H2 Microcuvette if not filled completely Repeat the pro eons of blood m Pan le ahd a new Alere Illustration 14 Removing excess blood 8 In order to avoid contamination of the Alere HemoPoint H2 Microcuvette holder remove excess blood from the outside of the Alere HemoPoint H2 Microcuvette by carefully wiping off with a gauze or lint free tissue WARNING Please note do not remove any blood from the Alere HemoPoint H2 Microcuvette cavity DO NOT try and top off Alere HemoPoint H2 Microcuvette if not filled completely Repeat the process with a new drop of blood and a new Alere HemoPoint H2 Microcuvette Alere HemoPoint H2 User Manual 14 The Alere HemoPoint H2 Microcuvette sample can now be tested immediately or within 10 minutes DO NOT read Alere HemoPoint H2 Microcuvette after 10 minutes For further steps please read Section 4 2 Performing the Test 4 1 3 Taking a Sample of Venous or Arterial Blood The Alere HemoPoint H2 Meter can be used for determination of hemoglobin in venous or arterial blood samples if the blood collection date is not longer than 24 hours and the sample was stored refrigerated 2 8 C Prepare the sample for testing as follows 1 Remove sample tube from the refrigerator and bring it to room temperature 15 30 C 2 Mix the sample well i e by a mechanical rotator or by i
33. l Further notes on maintenance can be found in Section 6 Do not force the microcuvette holder The Alere HemoPoint H2 Microcuvett holdertis very important for the quality of testing Therefore mechanical force ongthe Mholde should be avoided and only the designated Alere HemoPoint H2 Microcuvettes should be used For cleaning purposes the Alere HemoPoint H2 Microcuvette holder can be removed from the Alere HemoPoint H2 Meter after a mechanical locking device is released Notes on this can be found in Section 6 2012 Alere All rights reserved Intended Use The Alere HemoPoint H2 System is intended for the quantitative determination of hemoglobin Hgb in whole blood of adults infants and children in a professional point of care setting It consists of a dedicated meter and individual single use Alere HemoPoint H2 Microcuvettes filled with reagents Using the Alere HemoPoint H2 Microcuvette a small amount of arterial venous or capillary blood is taken up by capillary action The filled Alere HemoPoint H2 Microcuvette is inserted into the Alere HemoPoint H2 Meter the color produced by the chemical reaction in the Alere HemoPoint H2 Microcuvette is measured and the Hgb value is displayed The Alere HemoPoint H2 Microcuvettes are intended to be used only once and must be disposed after use as potentially infectious waste in accordance with the current regulations applicable to your establishment
34. llary blood collection e Biohazardous waste container e Alcohol swabs and gauze for cleaning puncture site e Alere HemoPoint H2 Microcuvettes e Alere Hemoglobin Controls optional e Alere HemoPoint H2 Optics Cleaner What is your Voltage Check that the AC voltage and frequency printed on the AC adaptor label match your electrical socket and whether the shape of the plug is compatible for this connection If not do not connect the Alere HemoPoint H2 Meter to the electrical socket under any circumstances Contact Alere in this case WARNING 5 2012 Alere All rights reserved 3 2 Setting Up the Alere HemoPoint H2 Meter Select a suitable place for setting up the Alere HemoPoint H2 Meter according to the following criteria e Avoid direct sunlight e Avoid strong electromagnetic fields e Avoid direct influence from ionizing radiation e Avoid rapid temperature fluctuations keep away from heaters open windows ventilators fans or air conditioning etc e Avoid wet areas i e wash basins Place the Alere HemoPoint H2 Meter on a level counter adjacent to a power socket Make sure there is enough room for the microcuvette holder to be freely accessible Illustration 2 Setting up the Alere HemoPoint H2 Meter Alere HemoPoint H2 User Manual 6 3 3 Switching the Alere HemoPoint H2 Meter On and Off 3 3 1 Using for the First Time Allow the Alere HemoPoint H2 Meter to reach room temperature Changing
35. mpletely Repeat the process with a new drop of blood and a new Alere HemoPoint H2 Microcuvette The Alere HemoPoint H2 Microcuvette sample can now be tested immediately or within 10 minutes DO NOT read Alere HemoPoint H2 Microcuvette 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 Illustration 16 Opening the Alere HemoPoint H2 Microcuvette holder Alere HemoPoint H2 User Manual 16 1 Open the Alere HemoPoint H2 Microcuvette holder completely D 10 00a Add Cuvette Illustration 17 Display Add Cuvette e The instrument will check the optical performance of l the measuring system This process takes approx 1 2 seconds Release the Alere HemoPoint H2 Microcuvette holder and do not touch it again until the process is finished and an audible signal beep occurs 2 If you have the Hgb limit mode activated and set the 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 occufs Select the patient type by touching the appropriate button If youkSelect NO then no patient range will be displayed or printed with the result Illustration 18 Display to select Patient Type In case you wish to change or cancel the selected patient type sim
36. ndicate a fault but is related to various initialization steps within the Alere HemoPoint H2 Meter Following this initialization phase the display illuminates and a welcome screen appears briefly after which the instrument is ready to operate mopoint H2 Alere V X XXX Xx d Illustration 4 Welcome display screen Battery charging AC power N Battery status Current time Ready Mode 7 A p Information storage button Menu button lllustration 5 Display in ready mode Open Holder The individual symbols and their meanings are explained in Section 3 3 5 Displays and Symbols in the Ready Mode Now you can either start your testing view results in the memory or carry out adjustments in the Menu You can find tips on this in Sections 4 Sampling and Testing Procedure 5 2 Memory Data Storage and 5 3 Menu Functions TIP If the Alere HemoPoint H2 Meter is not in use for some time it switches into the energy saving Stand by mode see Section 3 3 4 Stand by Mode Alere HemoPoint H2 User Manual 8 3 3 3 Battery Operation The Alere HemoPoint H2 Meter automatically switches to battery operation when you unplug the power adaptor from the electrical socket or from the instrument assuming of course that the battery is sufficiently charged When the battery is fully charged it will operate for a period of at least 100 hours 1 Tips on charging the battery and battery m
37. ng a few golden rules you can considerably influence the life span of the battery 6 2 1 Charging Procedure To maintain the battery s full capacity the battery should always be discharged as completely as possible before being recharged again The instrument is designed so that 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 TIP fully discharged 37 2012 Alere All rights reserved Illustration 34 Display screen when battery is discharged 6 2 2 Charging Time The battery charging time depends on the charge remaining and can be fully charged in 9 hours hi If you recharge it overnight the battery will be fully charged and ready for use TIP After recharging it is not necessary to disconnect the Alere HemoPoint H2 Meter from the electrical connection Over one battery is impossible O yeu lt 6 2 3 Self Discharg A Self dis harging is atypica y of batteries Even when you are not t using the inst e battery slowly discharges and later reaches the deeply ed phase which can damage the battery i IMPORTANT Te Fully charge the battery at least once a month Alere HemoPoint H2 User Manual 38 6 3 Repairs It is essential to follow the instructions in Section 1 3 DANGER Safety Notes Gro Care Danger of fatal electric shock If you
38. nstrument can only be operated Battery is defective when powered with the power adaptor Perform a reset of the instrument Software does notirespond see Section 7 2 Resetting of the Alere HemoPoint H2 Meter Battery Problems A battery problem was found Following this message the battery is switched off The Error message instrument can only be operated Defective battery when powered with the power adaptor gt Contact Alere Technical Support The battery has been switched off by the instrument The instrument i can only be powered with the No battery symbol displayed power adaptor gt Contact Alere Technical Support Alere HemoPoint H2 User Manual 40 Battery Problems e Always leave the instrument connected to the power adaptor until the charging The battery operation time is too process has been completed short The instrument switches off e The battery has deteriorated without previous warning and should be replaced gt Contact Alere Technical Support Power Adaptor Problems e Power adaptor not powered from the electrical source e Instrument plug not connected e Wrong power adaptor e Defective power adaptor No plug symbol displayed gt Contact Alere Technical Support Error message Disconnect the wrong adaptor a j immediately and connect with the Wrong power supply correct adaptor When
39. nverting by hand 3 Take out a Alere HemoPoint H2 Microcuvette from the container and immediately close the lid Please note Section 4 1 1 Notes on Using the Alere HemoPoint H2 Microcuvette s WARNING 4 Pipett sufficient drop of blood on a non absorbent material i e plastic film 5 Holdhthe center of the Alere HemoPoint H2 Microcuvette in the middle of the drop of blood and wait until the Alere HemoPoint H2 Microcuvette is filled completely see Illustration 15 DO NOT fill from the side as this could create air bubbles in the Alere HemoPoint H2 Microcuvette optic window and result in an erroneous result Be Illustration 15 Taking a sample of venous or arterial blood 15 2012 Alere All rights reserved Ensure that the Alere HemoPoint H2 Microcuvette cavity is completely filled and free of air bubbles DO NOT try and top off Alere HemoPoint H2 Microcuvette if not filled WARNINGI completely Repeat the process with a new drop of blood and a new Alere HemoPoint H2 Microcuvette 6 In order to avoid contamination of the Alere HemoPoint H2 Microcuvette holder remove excess blood from the outside of the Alere HemoPoint H2 Microcuvette by carefully wiping off with a gauze or lint free tissue see Illustration 14 Please note do not remove any blood from the Alere HemoPoint H2 Microcuvette cavity DO NOT try and top off the Alere HemoPoint H2 Microcuvette if not filled WARNING co
40. of new test results number of test results Serial number of the Alere HemoPoint H2 Meter Model No Model number of the Alere HemoPoint H2 Meter Software Version Electronic hardware Mechanical hardware 27 2012 Alere Al rights reserved Adaptation Correlation function to conform the output of results with different devices and or methods y m x n m correlation factor n offset if m 1 and n 0 factory defaults the function is not active The correlation can only be enabled by authorized personnel on special request Contact Alere Technical Service Department for additional information The current Service Process Number needed by Servicing 5 3 2 Setting the Date The function of setting the current date can be found under Menu sub menu Date Setting the date is important for the correct relationships of the results from the memory data storage or for printing oubtthe results The format to enter the date depends on the date format setting see Section 5 3 7 2 Setting Date Format The arrow buttons increase or decrease the numerical value in each case Press this button to reject the entry and to leave the ESC adjustment Press this button to confirm the current setting and to access the next entry After entering the last value the settings are stored and you leave the adjustment menu 5 3 3 Setting the Time The function of setting the Alere Hemo
41. oint H2 Microcuvette Dirty Optical unit clean unit see Section 6 1 3 Optical Unit Internal problem of instrument operation not possible Contact AlereTM Technical Support Display Screen is Hard to Read Display contrast setting is unsuitable Reset the display contrast see Section 5 3 6 Setting the Display Contrast Instrument Will Not Switch On Battery is discharged Plug in the power adaptor Software does not respond Carry out a Reset see Section 7 2 Resetting of the Alere HemoPoint H2 Meter Instrument does not react when connected to the power adaptor Check the connections and that all plug contacts are correctly seated Stand by time is unsuitable Instrument Switches Off Too Quickly or Too Slowly Reset the stand by time see Section 5 3 8 5 Setting the Stand by Time Battery is discharged Display shows nothing Instrument Does Not React to Opening or Closing the Cuvette Holder Connect the power adaptor Software does not react Carry out a Reset see Section 7 2 Resetting of the Alere HemoPoint H2 Meter Alere HemoPoint H2 User Manual 44 Background Illumination Does Not Work Power adaptor is not connected Connect the power adaptor Backlight illumination is not turned on under the battery backlight mode Turn the backlight mode on see Section 5
42. on 33 Display screen Measurement Error Alere HemoPoint H2 User Manual 36 For cleaning the optical unit the use of a special Alere HemoPoint H2 Optics Cleaner is recommended You received an Alere HemoPoint H2 Optics Cleaner in your Alere HemoPoint H2 System kit Additional Alere HemoPoint H2 Optics Cleaners can be obtained through an authorized Alere distributor Please follow the instructions for use that can be found in the package insert that comes with the Alere HemoPoint H2 Optics Cleaner Cleaning the optical unit is a delicate operation inside the instrument Please do not use any cleaning agents other WARNING than original Alere HemoPoint H2 Optics Cleaner 6 1 4 Power Adaptor Care Danger of fatal electric shock STOR It is essential to follow the instructions in Section 1 3 Safety notes Disconnect the power adaptor from the DANGER i electrical connection before proceeding The power adaptor can be cleaned and disinfected in the same way as the instrument housing see Section 6 1 1 Housing and Touchscreen 6 2 Charging and Care of the Battery The Alere HemoPoint H2 Meteris equipped with a NiMH Nickel Metal Hydride battery The capacity of the battery is calculated on the basis of being sufficientfor 100 hours of measuring operation As with many other components the battery will lose capacity over time Frequent partial discharging and re charging accelerates this process By observi
43. ply touch the Patient Type button and make another selection EB 10 00a Add Cuvette Patient type M Illustration 19 Display after a patient type male is chosen 17 2012 Alere Al rights reserved Illustration 20 Inserting the cuvette 3 Insert the appropriate patient microcuvette example Male into the Alere HemoPoint H2 Microcuvette holder as shown in Illustration 20 making sure the Alere HemoPoint H2 Microcuvette is properly inserted into the holder 4 Push gently on the Alere HemoPoint H2 Microcuvette holder and it will close automatically DO NOTforce 5 Jlesting of the Alere HemoPoint H2 Microcuvette begins automatically See Illustration 21 Ensure the Alere HemoPoint H2 Microcuvette holder closes completely otherwise the Alere HemoPoint H2 Microcuvette will not be positioned correctly in the Alere WARNING HemoPoint H2 Meter and this will cause an incorrect result EB 10 00a Testing uu Illustration 21 Display during the testing cycle The testing time varies according to the hemoglobin concentration and can take between 10 60 seconds TI Alere HemoPoint H2 User Manual 18 19 15 6 g dL MH Hct 46 Patient Types M Male F Female C Child Symbols for exceeding Hgb limits H Result above upper limit threshold L Result below lower limit threshold Illustration 22 Display showing the test result 6 Read the test re
44. r instrument does not function as expected i e if the measured results are not credible or you are getting incorrect reports from the instrument try to solve the problem initially with the aid of Section 7 Troubleshooting If you require assistance contact Alere Technical Service department at 1 866 216 0073 6 4 Proper Disposal It is the responsibility of the user to arrange proper disposal of the individual components e The Alere HemoPoint H2 Microcuvettes and containers for potentially infectious solutions Hemolysate control bloods etc must be disposed of in accordance with the regulations in force in your establishment e The Alere HemoPoint H2 Meter and electronic accessories must be disposed oflaccording to the regulations for the disposal of electronic components after removing the battery e The battery must be disposed of according to the regulations for the disposal of old batteries 39 2012 Alere All rights reserved Troubleshooting Before you call Alere Technical Service department or send the instrument in for repair please try to define or solve the problem with the help of this section Gro Care Danger of fatal electric shock It is essential to follow the instructions in Section 1 3 DANGER Safety Notes 7 1 Problem Solving No Display No Response to Entries Power the instrument with the Battery is empty power adaptor allow the battery to recharge completely I
45. rmal Range Different blood hemoglobin values have been reported in the literature 1 2 3 4 Adult Males 13 0 18 0 g dL Adult Females 11 0 16 0 g dL Children 2 yrs to teenage 11 0 16 0 g dL Infants post natal 10 0 14 0 g dL The highest Hgb concentrations are usually measured in neonates Due to the wide range of conditions dietary geographical smoking exercise recumbency etc which affect reference values it is recommended that each laboratory establish its own expected ranges 9 2 Understanding your Result Hemoglobin is the oxygen carrying pigment and main component of red blood cells Low hemoglobin levels may indicate anemia recent hemorrhage or fluid retention Elevated h moglobin levels may indicate hemoconcentration from polyeythemia or dehydration 1 Fandek N Moreau D Newell KC Ofner A eds Clinical Laboratory Tests Values and Implications 2nd ed Springhouse Springhouse Corporation 1955 328pp 2 Demott 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 3 Wallach J eds Interpretation of Diagnostic Tests A Synopsis of Laboratory Medicine 4th ed Boston Toronto Little Brown and Co 1986 6pp 4 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
46. rsal printer Incorrect type of printer i i see Section 5 4 1 Connecting a Printer Switch th printer to online mode Printer not online see operating instructions for the printer Use an original printer cable from Alere or check that the plug contacts are correctly seated see Section 5 4 1 1 Connecting the Printer Cable Incorre tm r incorrectly connected printer cable Alere HemoPoint H2 User Manual 46 7 2 Resetting of the Alere HemoPoint H2 Meter The Reset serves to transfer the Alere HemoPoint H2 Meter to its default settings without changing user specific settings significantly The settings for contrast date and time are lost The reset button can be found on the underside of the Alere HemoPoint H2 Meter Reset button ah Illustration 35 Location of the reset button To reset the Aler HemoPoint H2 Meter simply press the button using a narrow object such as a ballpoint pen or paperclip Le HemoPoint H2 V X XXX Xx Illustration 36 Confirmation display Reset 47 2012 Alere Al rights reserved Technical Data 8 1 Alere HemoPoint H2 Meter Measuring procedure Optical absorption photometry Source Dual Color LED 570 880 nm Dominant wavelength of source 1st wavelength 570 5 nm 2nd wavelength 880 10 nm Spectral half value width of the source ist wavelength 15 3 nm 2nd wavelength 50 nm
47. rticular attention to the following conditions 1 Each Alere HemoPoint H2 Microcuvette can only be used once The Alere HemoPoint H2 Microcuvette is designed for single use The cuvette is coated during manufacturing with all the reagents necessary for determining the hemoglobin concentration in the blood sample As soon as the blood is taken into the Alere HemoPoint H2 Microcuvette a reaction occurs within 1 minute 2 The Alere HemoPoint H2 Microcuvette is sensitive to moisture The Alere HemoPoint H2 Microcuvette will absorb moisture therefore the cuvettes are supplied in a special airtight container that contains a drying agent This drying agent assures that any moisture is readily absorbed during storage Alere HemoPoint H2 User Manual 10 Pay attention to the following notes to preserve the integrity of the Alere HemoPoint H2 Microcuvette e Store the cuvettes only in the original container and at room temperature 59 86 F 15 30 C Only remove one cuvette at a time from the container and then immediately close the lid Make sure that the lid is completely closed by pressing it down as far as it will go The Alere HemoPoint H2 Microcuvette shelf life is reduced once the lid is opened See the Alere HemoPoint H2 Microcuvette container label for additional information Please make a note of the date of opening on the container label WARNING 3 The Alere HemoPoint H2 Microcuvette is a precision opt
48. s not recharged the instrument will switch off after a while Low battery Alere HemoPoint H2 User Manual 42 Error and Information Messages e Wrong or unsuitable sample material see Section 8 Technical Data e Wrong sampling see Section Measured value too high 4 1 Taking a Sample Defective or superimposed Alere HemoPoint H2 Microcuvette Error message e Dirty Optical unit clean unit See Section 6 1 3 Optical Unit e Alere HemoPoint H2 Microcuvette holder not properly opened or closed repeat testing procedure e Alere HemoPoint H2 Error message Microcuvette holder not um sen properly engaged replace Alere nn in ee HemoPoint H2 Microcuvette holder see Section 6 1 2y Alere HemoPoint H2 Microcuvette Holder Ambient temperature too high Defective optical unit gt Contact Alere Technical Support At least 4 000 test values have been stored Error message Memory is full gt Delete memory Error message CRC ROM operation not possible Internal problem of instrument CRC RAM gt Contact Alere Technical Support CRC EEProm 43 2012 Alere Al rights reserved Error message Defective electronics Alere HemoPoint H2 Microcuvette in the closed Alere HemoPoint H2 Microcuvette holder when the instrument is switched on remove the Alere HemoP
49. sult 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 meter changes to the ready mode display Opening the Alere HemoPoint H2 Microcuvette holder will start a new testing cycle The hemoglobin result is displayed with the selected patient type and may be marked with an H High or L Low if the result falls outside the selected patient normal range An estimated Hematocrit result will be displayed if the Hct mode is activated see Section 5 3 8 1 Hematocrit Mode The measured result s is stored and can be recalled later from thes memory data storage which can hold up to 4000 patient results see Section 5 2 1 Displaying Results from Memory If you have connected a printer the current test result will be printed out immediately Further information about connecting a printer can be found in Section 5 4 1 Connecting a Printer If you prefer the display shows the result in another type of unit you can change it as described in Section 5 3 4 Setting the Units 7 Open the Alere HemoPoint H2 Microcuvette holder take out the used Alere HemoPoint H2 Microcuvette and dispose properly see Section 6 4 Proper Disposal Keep the Alere HemoPoint H2 Microcuvette holder closed when meter is not in use 2012 Alere All rights reserved When the holder is opened a new testing cycle is started
50. tient should not be wearing a ring on the finger used for sampling Illustration 10 Disinfecting the puncture site Alere HemoPoint H2 User Manual 12 4 Disinfect the puncture site and allow to dry E Illustration 11 Sticking the finger 5 Press lightly on the fingertip and puncture with a suitable sampling device on the side of the fingertip a Sticking the fingertip on the side is less painful and the blood flow is better To ensure having a spontaneous flow of blood use a sampling device with a proper depth size TIP 7M 2 25 mm com Illustration 12 Blotting the first drop of blood 6 Blot away the first drop of blood then if necessary press gently once again to get a drop of blood which is large enough to fill the Alere HemoPoint H2 Microcuvette 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 13 2012 Alere All rights reserved Illustration 13 Filling the cuvette 7 Hold the center of the Alere HemoPoint H2 Microcuvette in the middle of the drop of blood and wait until the Alere HemoPoint H2 Microcuvette is filled completely DO NOT fill from the side as this could create air bubbles in the Alere HemoPoint H2 Microcuvette optic window and result in an erroneous result WARNING Ensure that the Alere HemoPoint H2 Microcuvette cav
51. tton calls up appropriate function such as Memory or Menu UP button selects the next higher listed item A or increases the numerical value DOWN button selects the next lower listed item or decreases the numerical value ESC button leaves the menu screen or rejects changes OK button selects the next lower menu screen ee ne or confirms a selection MK __ Shows a button that is inactive 5 2 Memory Data Storage The instrument is equipped with data storage which can store up to 4000 results 1M 5 2 1 Displaying Results from Memo y el com Access to the data age i b if lere HemoPoint H2 Meter is i e read Illustration 25 Display screen ready mode Open Holder Press this button to display the test data You will see the following screen display for example Illustration 26 Display screen data storage Alere HemoPoint H2 User Manual 24 The entry displayed is the most recent result Press this button to display preceding results until you reach the first entry on the list Press this button to display successive results until you reach the last entry on the list ES Press this button Escape to leave the memory data storage Press this button to select the menu Options er In this menu you will find additional functions for printing and for deleting results Further information in this regard can be found in Sections 5 2 2 and 5 2 3
52. wing groups of patients e Adult Male 13 18 g dL default e Adult Female 11 16 g dL default e Child 11 16 g dL default Limits can be set within 5 25 5 g dL 0 31 15 81 mmol L 29 2012 Alere All rights reserved While the Hgb limits mode is activated the lower limits E must show different values than the upper limits of all groups of patient Otherwise the Hgb limits mode will ne be inactive 5 3 6 Setting the Display Contrast The LCD display contrast is strongly dependent for technical reasons on the environmental temperature You can set the contrast by entering Menu sub menu Contrast Default setting is 3 Higher numbers will darken the screen Please be very careful when setting the contrast At certain temperatures you can no longer read anything on the display under certain conditions with some contrast settings Should you accidentally store these settings by pressing the OK button the instrument must be reset You can read about this in Section 7 Troubleshooting WARNING The function of the individual keys can be found in Section 5 3 2 Setting the Date 5 3 7 Settings In this menu sometgeneral format settings can be found 5 3 7 1 Setting the Language The Alere HemoPoint H2 Meter supports various languages The function of setting the language can be found under Menu sub menu Settings sub menu Language This giv
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