Stanbio HemoPoint-H2 User Manual
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Stanbio HemoPoint-H2 User Manual

Hemoglobin photometer
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  • Page 3 HemoPoint ® Hemoglobin Photometer User’s Guide...
  • Page 4 Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006 U.S.A. Tel: (830) 249-0772 Fax: (830) 249-0851 e-mail: stanbio@stanbio.com HemoPoint H2 Photometer manufactured in Germany for: ® Stanbio Laboratory, Boerne, Texas U.S.A. Revised: 10. May 2010 Software-Version: From 2.04.0 Subject to modifications.

  • Page 5: Table Of Contents

    Table of contents 0. Table of contents TABLE OF CONTENTS ..........1 IMPORTANT INFORMATION ......... 5 ! ..............5 ELCOME ......5 XPLANATION OF THE GRAPHIC SYMBOLS .............. 5 AFETY NOTES INTENDED USE .............. 8 SET UP ................9 ........9 NPACKING THE PHOTOMETER ........
  • Page 6 Table of contents 5.2.2 Printing out results ..........33 5.2.3 Deleting the stored test data ......... 33 ............34 ENU FUNCTIONS 5.3.1 Information about the photometer ......35 5.3.2 Setting the date ............. 36 5.3.3 Setting the time ............. 37 5.3.4 Setting the units.............
  • Page 7 Table of contents 6.2.3 Self discharge ............51 ..............51 EPAIRS ............51 ROPER DISPOSAL TROUBLESHOOTING ..........52 ............52 ROBLEM SOLVING ......... 57 ESETTING OF THE PHOTOMETER TECHNICAL DATA ............58 ® ........58 OINT PHOTOMETER • • ..........59 ICROCUVETTE REFERENCE RANGE ...........

  • Page 9: Important Information

    It is essential that you read the following notes, in order to avoid risks to persons and damage to the photometer and other equipment. Stanbio Laboratory does not accept responsibility for damage arising from non-observance of the following notes. HemoPoint H2 User’s Guide...
  • Page 10 Important information Follow the user’s guide! Each time the photometer is used, precise knowledge and attention to these operating instructions is required. Only use the HemoPoint H2 system for the purpose which will be described in ® WARNING! Section 2. Danger of fatal electric shock! Under no circumstances should you open the AC power adaptor.
  • Page 11 Only use original equipment! Only attach equipment that is expressly approved for use with the HemoPoint H2. Stanbio does not guarantee the function of the ® instrument when other equipment is used. Never open the photometer! There are no parts in the photometer that require customer maintenance.

  • Page 12: Intended Use

    This test system has been approved for use in laboratories with Waived status as defined in 452 CFR 493.15(c)(a). STANBIO LABORATORY, LP DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES OF THE MERCHANTABILITY AND FITNESS PERTAINING TO THIS PRODUCT WHICH ARE NOT...

  • Page 13: Set Up

    Set up 3. Set up Unpacking the photometer Before you set up the HemoPoint H2 photometer, first check that ® all the items are present and undamaged (see Illustration 1). Illustration 1: (1) HemoPoint H2 photometer and (1) AC power adaptor. ®...

  • Page 14: Setting Up The Photometer

    ® Why Register your HemoPoint ® Returning the completed Warranty Registration Card will activate your warranty and allow Stanbio to provide you with the latest product updates and improvements. Even easier – Go to www.stanbio.com/warranty.php and register your HemoPoint H2 online! ®...

  • Page 15: Switching The Photometer On And Off

    Set up Place the photometer on a level counter adjacent to a power socket. Make sure there is enough room for the cuvette holder to be freely accessible. Illustration 2: Setting up the photometer. Switching the photometer on and off 3.3.1 Using for the first time Allow the photometer to reach room temperature!

  • Page 16: To Operate Using The Power Adaptor

    Set up As the built-in battery has not yet been charged, the photometer must first be connected to the power adaptor (supplied) and plugged into an electrical socket until the battery is completely charged. This procedure is necessary in order for the capacity of the battery to be checked and the charge indicator to function correctly.
  • Page 17 Set up 2. Next, insert the power adaptor plug into an appropriate electrical socket. The photometer itself does not have a power On/Off switch. Please be patient after plugging the photometer into the electrical socket. It may be 4 or 5 seconds before anything appears on the display.

  • Page 18: Battery Operation

    Set up 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”.

  • Page 19: Displays And Symbols In The Ready Mode

    Set up (approximately 5 minutes). The display will go blank in the Stand- by mode. This elapsed time can be changed in Section 5.5.2.3 “Setting the Stand-by time”. The Stand-by mode reduces power usage to a minimum. There are (3) three ways of switching the instrument ON again: Touch the Touchscreen Open or close the cuvette holder Plug the photometer into an electrical power supply...

  • Page 20: Sampling And Testing Procedure

    Sampling and testing procedure 4. Sampling and testing procedure Taking a sample 4.1.1 Notes on using the microcuvette optical eye Illustration 7: n•x•t microcuvette The microcuvette is the most sensitive component in the HemoPoint H2 system. It is therefore necessary to handle the ®...

  • Page 21: Taking A Sample Of Capillary Blood

    Sampling and testing procedure agent. This drying agent assures that any moisture is readily absorbed during storage. Pay attention to the following notes, to preserve the integrity of the cuvettes: Store the cuvettes only in the original container and at room temperature (59-86°F / 15-30°C).
  • Page 22 Sampling and testing procedure Illustration 8: Preparing to take a blood sample. 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.
  • Page 23 Sampling and testing procedure Warning, risk of infection! Please wear suitable protective gloves! DANGER! Only use the middle or ring finger. The patient should not be wearing a ring on the finger used for sampling. Illustration 10: Disinfecting the puncture site. 4.
  • Page 24 Sampling and testing procedure Sticking the fingertip on the side is less painful and the blood flow is better. To ensure to have a spontaneous flow of blood use a sampling device with a proper depth size (2.25 mm). Illustration 12: Blotting the first drop of blood. 6.

  • Page 25: Taking A Sample Of Venous Or Arterial Blood

    Sampling and testing procedure 7. Hold the center of the cuvette in the middle of the drop of blood and wait until the cuvette is filled completely. DO NOT fill from the side as this could create air bubbles in the cuvette optic window and result in an erroneous result.
  • Page 26 Sampling and testing procedure 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 inverting by hand).

  • Page 27: Performing The Test

    Sampling and testing procedure carefully wiping off with a gauze or lint-free tissue (see Illustration 14). Please note, do not remove any blood from the 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. WARNING! The cuvette sample can now be tested immediately or within 10 minutes.
  • Page 28 Sampling and testing procedure Illustration 17: Display “Add Cuvette”. The instrument will check the optical performance of the measuring system. This process takes approx. 1 – 2 seconds. Release the cuvette holder and do not touch it again until the process is finished and an audible signal (beep) occurs.
  • Page 29 Sampling and testing procedure In case you wish to change or cancel the selected patient type, simply touch the “Patient Type” button and make another selection. Illustration 19: Display after a patient type (male) is chosen. Illustration 20: Inserting the cuvette. 3.
  • Page 30 Sampling and testing procedure 4. Push gently on the cuvette holder and it will close automatically. DO NOT force! 5. Testing of the cuvette begins automatically (see Illustration 21). Ensure the cuvette holder closes completely, otherwise the cuvette will not be positioned correctly in the photometer and this will cause an incorrect result.
  • Page 31 Sampling and testing procedure 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 photometer changes to the ready mode display.

  • Page 32: Quality Control

    H2 AutoCheck performs an internal check of the ® photometers optic system every time the cuvette holder is opened. If regulatory quality control checks are required, the quality control check should be performed using Stanbio liquid controls. 4.3.2 Blank reading...
  • Page 33 Sampling and testing procedure purpose, we recommend the use of Stanbio HemoPoint ® Hemoglobin Controls. Instructions for ordering can be found in Section 10.1 “Replacement parts and consumer materials”. There are a variety of hemoglobin controls on the market today.

  • Page 34: Further Functions

    Further functions 5. Further functions Touchscreen 5.1.1 General The photometer 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. Illustration 23: Divided touchscreen.

  • Page 35: Meaning Of The Buttons / Navigation

    Further functions 5.1.2 Meaning of the buttons / Navigation Software button, calls appropriate Function function such as Memory or Menu. “UP” button, selects the next higher listed item or increases the numerical value. “DOWN” button, selects the next lower listed item or decreases the numerical value.
  • Page 36 Further functions You will see the following screen display, for example: Illustration 25: Display screen, data storage. 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.

  • Page 37: Printing Out Results

    Further functions If the estimated Hematocrit 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.

  • Page 38: Menu Functions

    Further functions Confirm the selection with , to delete the data storage, otherwise press , in order not to delete. After deleting, the instrument changes back again to display memory (data storage) – “Empty”. Menu functions The photometer has various possible settings that can be accessed through the menu function.

  • Page 39: Information About The Photometer

    Further functions Press this button to scroll up to desired menu entry. Press this button to scroll down to desired menu entry. Press this button to select the next higher menu level, or to leave the menu. Press this button to select the next lower menu level, to adjust settings, or to display information.

  • Page 40: Setting The Date

    = 1 and n = 0 (factory defaults) the function is not active The correlation can only be enabled by authorized personnel on special request. Contact Stanbio Laboratory’s Technical Service Department for additional information. - SPN - The current Service Process Number, needed by Servicing 5.3.2...

  • Page 41: Setting The Time

    Further functions 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 photometer to the current time can be found under “Menu”, sub-menu “Time”.

  • Page 42: Hgb Mode And Limits

    Further functions You can select the following units: mmol/L g/dL (default) 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”.

  • Page 43: Settings

    Further functions 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, WARNING! the instrument must be reset.

  • Page 44: Setting Time Format

    Further functions 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: 12 hours (default) 24 hours 5.3.7.4 Setting the power frequency...

  • Page 45: Setting The Print Mode

    In the expanded-print mode you have the possibility to separate single records and to assign them to patient records. Standard print mode 5.4.1 Header (Example) Stanbio Laboratory www.stanbio.com Version…: X.XX.x Serial No.: 3008-09-0001 Cust.Service: (866) 782-6246 Tech.Service: (800) 531-5535 Hgb Limits: Male…..: 13-18 g/dL...

  • Page 46: Hgb Limit Mode (On), Hematocrit (On)

    -------------------------------------------------------------- 1. 01/01/09 12:03pm 15.0 g/dL F 45% 2. 01/01/09 12:03pm 13.2 g/dL F 40% Expanded print mode 5.5.1 Header (Example) Stanbio Laboratory www.stanbio.com Version…: X.XX.x Serial No.: 3008-09-0001 Cust.Service: (866) 782-6246 Tech.Service: (800) 531-5535 Printed one time a day, after changing the print mode or after changing the date.

  • Page 47: Setting The Tone Signal

    Further functions 5.5.2.1 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.

  • Page 48: The Service Menu

    5.5.3 Information on contacting us Information on how to contact Stanbio 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 10.2 “Further information”.

  • Page 49: Connecting A Printer

    H2 photometer supports the connection of a ® Seiko Model No. DPU-414 serial printer. The DPU-414 can be ordered through an authorized Stanbio Laboratory 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”).
  • Page 50 Further functions The printer cable is equipped at one end with a 9-pin serial plug to connect with the printer and at the other end with a 7 pole mini –DIN plug to connect to the interface socket of the HemoPoint ®...

  • Page 51: Maintenance

    Maintenance 6. Maintenance 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 electrical connection before proceeding. WARNING! Cleaning the housing and touchscreen is best accomplished with a lint-free cloth, lightly dampened with clean water.

  • Page 52: Optical Unit

    Maintenance Illustration 33: Removing the cuvette holder. The cuvette holder can now be cleaned with a mild soap solution. For disinfection, standard solvent-free preparations can be used. To replace the cuvette holder, simply push it in the correct position into the opening in the housing until it engages. Please wait until the cuvette holder is completely dry before replacing it.

  • Page 53: Power Adaptor

    Stanbio distributor. Please follow the instructions for use that can be found in the package insert that comes with the Cleaner or go online to www.stanbio.com Tech Support, “Routine Cleaning of the HemoPoint H2” for step- ®...

  • Page 54: Charging Procedure

    Maintenance operation. As with many other components, the battery will lose capacity over time. Frequent partial discharging and re-charging accelerates this process. By observing 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.

  • Page 55: Self Discharge

    Section 7 “Troubleshooting”. If you require assistance, contact Stanbio’s technical service department (see Section 10.2 “Further information”). Proper disposal It is the responsibility of the user to arrange proper disposal of the individual components.

  • Page 56: Troubleshooting

    Troubleshooting 7. Troubleshooting Before you call Stanbio’s technical service department or send the instrument in for repair, please try to define or solve the problem with the help of this section. Care! Danger of fatal electric shock! It is essential to follow the instructions in Section 1.3 “Safety notes”.
  • Page 57 - Defective power adaptor. ->Contact Stanbio Technical Support. Error message Disconnect the wrong adaptor immediately “Wrong power supply" and connect with the correct Stanbio adaptor. Error message When operated with the power adaptor: "User error, voltage too - Wrong power adaptor connected.
  • Page 58 - Cuvette holder not properly engaged; replace cuvette holder (see Section 6.1.2 “Cuvette holder”). - Ambient temperature too high. - Defective optical unit -> Contact Stanbio Technical Support. Error message -At least 4,000 test values have been stored. "Memory is full"...
  • Page 59 Troubleshooting Display screen is hard to read. Display contrast setting Reset the display contrast (see Section 5.3.6 “ is unsuitable. Setting the display contrast”). Instrument will not switch on. Battery is discharged. Plug in the power adaptor. Software does not Carry out a “Reset”...
  • Page 60 (see Section 5.6.1 “Connecting a printer”). Printer not “online”. Switch the printer to online mode (see operating instructions for the printer). Incorrect, or incorrectly Use an original printer cable from Stanbio or connected, printer check that the plug contacts are correctly cable. seated (see Section 5.6.1.1 “Connecting the printer...

  • Page 61: Resetting Of The Photometer

    Troubleshooting Resetting of the photometer The “Reset” serves to transfer the photometer 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 photometer.

  • Page 62: Technical Data

    Photodiode 350 – 820 nm Measuring range 0 – 25.6 g/dL Sample material Venous, arterial, or capillary human blood. Sample carrier Stanbio n•x•t Microcuvette. Sample size 8 μL 0- 20.0 g/dL ± 0.3 g/dL Linearity >20.0 g/dL ± 0.7 g/dL Measuring time Dependent on concentration, 10 –...

  • Page 63: N•X•T Microcuvette

    Technical data Weight 1.3 lbs. Power supply AC Power adaptor: Input: 100- 250 V AC / 50-60Hz Output: 6 VDC Integrated battery: Voltage: 2.4 V Capacity: 1500 mAh (ca. 100 h operation time) Power maximal: typically: 1.2 W minimal: 30 mW Interface Printer (RS 232 C) Environmental...

  • Page 64: Reference Range

    Reference range 9. Reference range Normal range Different blood hemoglobin values have been reported in the (1,2,3,4) literature 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 –...

  • Page 65: Appendix

    Appendix 10. Appendix 10.1 Replacement parts and consumer materials Catalog No. Description Ordering HemoPoint H2 n•x•t Microcuvettes 3015-100 ® 1 kit 2 Containers @ 50 cuvettes each (100 tests) HemoPoint H2 n•x•t Microcuvettes 3015-200 ® 1 kit 4 Containers @ 50 cuvettes each (200 tests) HemoPoint 3060-601 ®...

  • Page 66: Further Information

    Further information If you have any questions over and above this user’s guide, we would be pleased to help. Here is all the important contact information: Main address: Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006 U.S.A. Telephone: (830) 249-0772 / (866)782-6246...

  • Page 67: Index

    Index Index accessories · 5, 44, 51 environmental temperature · 59 air bubbles · 21, 22, 53 hematocrit · 40 backlight · 43 battery · 12, 14, 35, 49, 50, 51, 52, 54, 59 battery operation · 14 intended use · 8 blank reading ·...
  • Page 68 Index navigation · 31 safety notes · 5, 47, 49, 51, 52 sample carrier · 58 sample material · 58 sample size · 58 sampling procedure · 16 optical eye · 16 self discharge · 51 service menu · 44 set up ·...
  • Page 69 HemoPoint H2 User’s Guide ®...

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