HemoPoint H2 Meter User Manual Rev B Dec 2012

Contents 1. Important Information... 1 1.1 Welcome ...1 1.2 Explanation of the Graphic Symbols...1 1.3 Safety Notes...1

2. Intended Use... 4 3. Setting Up... 5 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...7

3.3.2 To Operate Using the Power Adaptor...7

3.3.3 Battery Operation...9

3.3.4 Stand-by Mode...9

3.3.5 Displays and Symbols in the Ready Mode...10

4. Sampling and Testing Procedure... 10 4.1 Taking a Sample...10

4.1.1 Notes on Using the Alere HemoPoint® H2 Microcuvette...10

4.1.2 Taking a Sample of Capillary Blood...11

4.1.3 Taking a Sample of Venous or Arterial Blood...15

4.2 Performing the Test...16 4.3 Quality Control...20 4.3.1 AutoCheck...20

4.3.2 Blank Reading...20

4.3.3 Alere HemoPoint® H2 Control Cuvette...21

4.3.4 External Quality Control...22

5. Further Functions... 23 5.1 Touchscreen...23 5.1.1 General...23

5.1.2 Meaning of the Buttons / Navigation...24

5.2 Memory (Data Storage)...24

5.2.1 Displaying Results from Memory...24

5.2.2 Printing Out Results...25

5.2.3 Deleting the Stored Test Data...26

5.3 Menu Functions...26

5.3.1 Information about the Alere HemoPoint® H2 Meter...27

5.3.2 Setting the Date...28

5.3.3 Setting the Time...28

5.3.4 Setting the Units...29

5.3.5 Hgb Mode and Limits...29

5.3.6 Setting the Display Contrast...30

5.3.7 Settings...30

5.3.7.1 Setting the Language...30

5.3.7.2 Setting Date Format...31

5.3.7.3 Setting Time Format...31

5.3.7.4 Setting the Power Frequency...31

5.3.8 Menu Options...31

5.3.8.1 Hematocrit Mode...31 5.3.8.2 Print Mode...32

5.3.8.2.1 Print Mode Examples...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...33

5.3.8.4 Setting the Backlight Mode...33

5.3.8.5 Setting the Stand-by Time...33

5.3.8.6 The Service Menu...33

5.3.9 Information on Contacting Us...33

5.4 Connecting Accessories...34

5.4.1 Connecting a Printer...34

5.4.1.1 Connecting the Printer Cable...34

6. Maintenance... 35 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...36

6.1.4 Power Adaptor...37

6.2 Charging and Care of the Battery...37

6.2.1 Charging Procedure...37

6.2.2 Charging Time...38

6.2.3 Self Discharge...38

6.3 Repairs...38 6.4 Proper Disposal...39

7. Troubleshooting...40 7.1 Problem Solving...40 7.2 Resetting of the Alere HemoPoint® H2 Meter...47

8. Technical Data... 48 8.1 Alere HemoPoint ® H2 Meter...48 8.2 Alere HemoPoint ® H2 Microcuvette...49

9. Reference Range... 50 9.1 Normal Range...50 9.2 Understanding Your Result...50

10. Appendix... 51 10.1 Replacement Parts and Consumer Materials...51

11. Index ... 52 12. Glossary of Symbols... 55 13. Contact Alere... 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 symbol! This symbol 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 errors or damage to the instrument or any accessories used. The TIP symbol! Alongside this symbol we provide useful additional 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.

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© 2012 Alere. All rights reserved.

Danger of Fatal Electric Shock! •

• •

•

Under no circumstances should you open the AC power adaptor. There are no elements inside which require servicing or maintenance. Never use a mechanically damaged AC power adaptor – live connections might be exposed. 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 Section 6. 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 there is a risk of explosion! The instrument is 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.

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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 expressly 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 personnel. Further notes on maintenance can be found in Section 6. Do not force the microcuvette holder! The Alere HemoPoint® H2 Microcuvette holder is very important for the quality of testing. Therefore mechanical force on the holder 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.

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© 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. 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 Waived status as 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.

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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 • • • • • •

One (1) Alere HemoPoint® H2 Meter One (1) Meter User Manual One (1) Quick Reference Guide One (1) Control Cuvette One (1) Optics Cleaner One (1) AC power adaptor

Additional Materials Required but Not Provided • • • • • • •

Latex Gloves Sampling devices for capillary blood collection Biohazardous waste container Alcohol swabs and gauze for cleaning puncture site Alere HemoPoint® H2 Microcuvettes Alere™ Hemoglobin Controls (optional) 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.

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© 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: • • • • •

Avoid direct sunlight Avoid strong electromagnetic fields Avoid direct influence from ionizing radiation Avoid rapid temperature fluctuations (keep away from heaters, open windows, ventilators, fans or air-conditioning, etc.) 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.

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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 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. This procedure is necessary in order for the capacity of the battery to be checked and the charge indicator to function correctly. Further information on this can be found in Section 6.2 “Charging and Care of the Battery”. 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 indicate 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.

Illustration 4: Welcome display screen.

Illustration 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”. 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”).

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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. 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 battery operation, also note the tips in Section 3.2 “Setting up the Alere HemoPoint® H2 Meter”. 3.3.4 Stand-by Mode The meter does not have a separate On/Off-switch. It is designed so that it automatically switches to the Stand-by mode when you are not operating the instrument for a certain time (approximately 5 minutes). The display will go blank in the Stand-by mode. This elapsed time can be changed in Section 5.3.8.5 “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 Alere HemoPoint® H2 Microcuvette holder. • Plug the meter into an electrical power supply.

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© 2012 Alere. All rights reserved.

3.3.5

Displays and Symbols in the Ready Mode

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 particular 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

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Pay attention to the following notes, to preserve the integrity of the Alere HemoPoint® H2 Microcuvette: • •

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. 3. The Alere HemoPoint® H2 Microcuvette is a precision optical 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 with fingers or sharp objects (see Illustration 7). 4. The Alere HemoPoint® H2 Microcuvette is only designed for invitro 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”.

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.

If in doubt, the hands can be warmed in warm water.

Illustration 9: Stimulating the circulation.

3. Lightly massage the fingers, in order to stimulate the circulation. Warning, Risk of Infection! Please wear suitable protective gloves!

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.

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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 fingertip. 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 (2.25 mm).

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.)

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© 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. 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 completely. Repeat the process with a new drop of blood and a new Alere HemoPoint® H2 Microcuvette.

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. 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

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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 inverting 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 Alere HemoPoint® H2 Microcuvette”.

on

Using

the

4. Pipette a sufficient drop of blood on a non-absorbent material (i.e. plastic film). 5. 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 (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.

Illustration 15: Taking a sample of venous or arterial blood.

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© 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 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 completely. 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.

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