Dear HemoSmart GOLD Owner

Dear HemoSmart GOLD Owner Thank you for choosing the HemoSmart GOLD. All the information that will be needed to use and maintain the HemoSmart GOLD System is included in this manual. Read it carefully before using the system. Utilizing Biosensor Technology, the HemoSmart GOLD System provides an easy and precise way of measuring the level of total hemoglobin in whole blood. The results are referenced by CBC cell counter method, which means the data gathered from the HemoSmart GOLD Screening System is comparable to the results in a clinical laboratory. 1

Intended Use The HemoSmart GOLD is intended for use outside the body (in vitro diagnostic use) and is useful for quantitative measurement of hemoglobin in the range of 4 g/dl to 24 g/dl in capillary (fingerstick) or venous whole blood. HemoSmart GOLD is intended for selftesting for the health of the patient (e.g. anemias (low Hb), erythrocytosis (high Hb), thalassemias (aberrant chain synthesis), and sickling disorders (abnormal complex shape)) by layperson and by health care professional. IMPORTANT: Not intended for use on neonates. 2

Table of Contents Understanding Your New Blood The HemoSmart GOLD Meter... 6 The HemoSmart GOLD Meter Display Screen... 8 The HemoSmart GOLD Hemoglobin Test Strip... 10 The HemoSmart GOLD Control Solution (optional)...11 Adjustable Lancing Device (optional)... 12 Setting Up Your New System Inserting (or Changing) the Battery... 13 Setting the Clock... 15 Back Light... 19 Control Solution Testing Performing a Control Solution Test... 20 Control Solution Trouble Shooting... 27 3

Hemoglobin Testing Coding the Meter... 29 Preparing Your Lancing Device (optional)... 32 Performing a Blood Hemoglobin Test... 34 Understanding Your Test Results... 40 Viewing Stored Readings from Memory... 41 Caring for the Meter Cleaning the Meter... 44 Storage and Precautions... 44 Solving Problems... 46 Product Warranty... 51 Specifications... 52 Symbols Used in this Manual... 54 Supplies... 55 4

Understanding Your New Blood Each Screening System of the HemoSmart GOLD may include the following items: The HemoSmart GOLD Meter User Guide Quick Reference Guide Optional: The HemoSmart GOLD Hemoglobin Test Strip Lancing Device and Lancets HemoSmart GOLD L2 / L3 Hemoglobin Control Solution Note: Contents may change without notice. 5

The HemoSmart GOLD Meter Test Strip Port This is where you insert the test strip and the meter will turn on automatically. Meter Display Large, easy-to-read window guides you through testing, displaying results, and error messages using simple words or symbols. Enter ( ) and Buttons Press and hold ( ) for 2 seconds to turn on or off the meter*, or press ( ) once to set up the meter while the meter is turned on and not being use for testing. Press or to enter control mode with test strip inserted or to navigate the meter setting, stored test values, and averages. 6 Note: When the meter is in an "off" state the internal clock is still running.

Ejection Switch Push to eject used strip. Battery Compartment Hold two 1.5V AAA batteries. Code Card Insertion site for the code card. Data Connection Port This function is not yet available. 7

The HemoSmart GOLD Meter Display Screen BLOOD DROP CLOCK TEST STRIP MEMORY MAIN DISPLAY AREA CTRL BATTERY BLOOD AND CONTROL SOLUTION TESTING ORDER DISPLAY AREA READING UNIT TEMPERATURE 8

MEMORY :... Indicates the number in the display area is a stored test value (see page 41). MAIN DISPLAY AREA :... Displays test results, stored test values, calculated result averages, and messages. BATTERY :... Appears when the battery is low and needs to be replaced. TEMPERATURE :... Appears when it is either too hot or too cold to test (outside the ranges of 10 C~40 C). TEST STRIP :... This icon will flash to prompt you to insert a test strip for testing. BLOOD AND CONTROL SOLUTION TESTING ORDER DISPLAY AREA :... Displayed when viewing testing order of blood and control solution (see page 41). UNIT :... Unit of measurement for your hemoglobin result. CTRL :... This icon indicates a control solution test (see page 20). BLOOD DROP :... This icon will flash to indicate the meters is ready for testing. 9

The HemoSmart GOLD Hemoglobin Test Strip 10 Contact Points Insert this end to the test strip port on the meter Sampling End Apply blood or control solution here The HemoSmart GOLD Hemoglobin Test Strip is a biosensor-based test strip uniquely designed to specifically detect total hemoglobin in whole blood using the HemoSmart GOLD Meter. The test strips come in a moisture-proof, light-protected bottle or individually foil wrapped. It is important the bottle or foil is kept well sealed at all times. Replace cap immediately after taking a strip out of the bottle. IMPORTANT: Be sure to use only the HemoSmart GOLD Hemoglobin Test Strip with the HemoSmart GOLD Hemoglobin Meter. Other brands of test strips will not work with the meter. The HemoSmart GOLD Hemoglobin Test Strip is sensitive to moisture and light, it is important to close the vial cap of the test strip bottle tightly after each use. DO NOT leave any test strips outside the bottle or foil while not in use. Carefully discard used test strips and lancets in proper waste containers. Do Not reuse test strip. Test strip is for single use only.

The HemoSmart GOLD Control Solution (optional) Solution with standard concentration of reactive substance in hemoglobin. It is required to perform the Control Solution Testing on page 20. Use the solution to check for system accuracy, practice test procedure, and when using a new lot of HemoSmart GOLD Hemoglobin Test Strip. Store the HemoSmart GOLD Control Solution at 4 C to 30 C (39 F to 86 F). See the HemoSmart GOLD Control Solution insert for more information. Please contact your local supplier to order control solution. 11

Adjustable Lancing Device (optional) Release Button Adjustable Cap Depth Indicator Protective Cover Sterile Lancet Lancet Holder The HemoSmart GOLD kit includes an adjustable 5 setting lancing device and sterile lancets. You can adjust the puncture depth of your lancing depth according to the thickness of your skin, from the lightest (1) to the deepest (5). If you are not sure which depth suits you, we recommend you start from depth 2. 12

Setting Up Your New System Inserting (or Changing) the Battery The battery needs to be inserted before using your HemoSmart GOLD Meter for the first time or when the icon appears on the meter display. Material you will need: Two 1.5V AAA batteries. Your HemoSmart GOLD Meter Step 1. Press firmly on the battery cover and slide in the direction of the arrow to open the cover. 13

Step 2. Insert new batteries. If there are old batteries in the compartment, take them out. Insert new batteries. Step 3. Replace the battery cover. NOTE: When you change the battery, the meter automatically prompts you to check the time and date when turned on either by inserting a test strip or pressing. If it is correct, press again to exit; if the time and date are not correct, see page 15 for Setting the Clock. The date and stored results will not be erased when the batteries are being changed. Discard used batteries according to your local regulation. Batteries might leak chemicals if not used for a long time. Remove the battery if you are not going to use the device for an extended period. 14

Setting the Clock Material you will need: Your HemoSmart GOLD Meter Begin Set Up Step 1. Press and hold to enter to turn on meter. If error messages (Er 1, Er 3, etc.) appears, see Solving Problems on page 46. Step 2. After a flashing test strip icon appears on the meter display screen, press once meter display screen will show. 15

Set Year Step 3. Press and the current year will flash. Use the or buttons to select the correct year. Press button to confirm your choice and to advance to set the month. Set Month Step 4. The current month will flash. Use the or buttons to select the correct month. Press button to confirm your choice and to advance to set the day. Set Day Step 5. The current day will flash. Use the or buttons to select the correct day. Press button to confirm your choice and to advance to set the 12- hour or 24-hour time format. 16

Set 12-hour or 24-hour Time Format Step 6. The time format will flash. Use the or buttons to select the time format of your choice. Press button to confirm your choice and to advance to set the hour. Set Hour Step 7. The current hour will flash. Use the or button to select the correct hour. Press button to confirm your choice and to advance to set the minutes. Set Minutes Step 8. The current minutes will flash. Use the or buttons to select the correct minutes. Press button to confirm your choice and exit time set up. 17

NOTE: Anytime during set up, you may either press to exit, or insert a HemoSmart GOLD Hemoglobin Test Strip and begin testing. The changes you have done so far will be memorized by the meter. Begin testing (see Hemoglobin Testing on page 28 ), or press and hold to enter to standby mode. 18

Back Light When you turn on meter by pressing strip, the back light will turn on. button or inserting test NOTE: Back light will not turn off when you test your hemoglobin result. When you view your meter memory or when you do clock setting, back light will turn off if there is no further action over 15 seconds. To turn back-light on, press either or button. 19

Control Solution Testing Performing a Control Solution Test The purpose of the control solution testing is to validate the performance of the HemoSmart GOLD using the testing solution with a known range of hemoglobin. You should perform control solution testing when: Using the meter for the first time. You open a new bottle of HemoSmart GOLD Hemoglobin Test Strip. You left the cap on the test strip vial open for a while. You dropped the meter. You suspect your HemoSmart GOLD Hemoglobin Meter and HemoSmart GOLD Hemoglobin Test Strip are not working properly. The Hemoglobin test results do not reflect how you feel. You want to practice the testing procedure. 20

IMPORTANT: Use only the HemoSmart GOLD Hemoglobin Control Solution (L2 and L3) with the HemoSmart GOLD Hemoglobin Test Strip. Other brands of control solution will produce inaccurate result. Always check the expiration date. DO NOT use control solutions if expired. Mark the newly opened bottle of control solution with the date opened; discard any unused control solution 2 months after opening. DO NOT FREEZE. Store the control solutions at room temperature 4 C~30 C (39 F~86 F). Materials you will need: HemoSmart GOLD Hemoglobin Control Solution (L2 and L3) Your HemoSmart GOLD Hemoglobin Meter A new HemoSmart GOLD Hemoglobin Test Strip Code Card IMPORTANT: Please make sure the HemoSmart GOLD Meter is properly coded. Refer to Coding the Meter on page 29. 21

Step 1. Insert the code card to code card port. The screen will then display the current code number being used. Verify that code number on screen is the same with the code number printed on the strip package. 22 Step 2. Insert a HemoSmart GOLD Hemoglobin Test Strip into the meter with the blood sample reaction zone facing up. Make sure the test strip contact points are inserted all the way into the meter. Close the test strip bottle immediately after you take out a strip. IMPORTANT: Do not use test strip that has expired. Check the expiration date that is printed on the test strip bottle and its package. Use each test strip immediately after removing it from the bottle. After removing a test strip from the bottle, replace the bottle cap immediately and close it tightly. Do not use wet or damaged test strips. Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool

place. Record the date opened on the test strip bottle label when you first open it. 2 months after first opened date, discard the bottle and any remaining test strip. Make sure you are testing in an environment that is between 10 C~40 C (50 F~104 F), and allow 10 to 15 minutes for it to reach the new temperature before use. Your meter will not begin testing if it detects it is outside this temperature range. Must insert test strip to the bottom. Must see a flashing blood drop icon if the test strip has been inserted to the bottom. Step 3. The meter will enter the main mode. If error messages (Er 1, Er 3, etc.) appear, see Solving Problems on page 46 for trouble shooting. Step 4. Wait for the flashing blood drop and test strip icons on upper-left side of the meter display screen. 23

Suitable for Storage Temper Use within 3 month before the expir Step 5. Press the button once to enter L2 control solution testing and twice to enter L3 control solution testing. A ctl and L2 (or L3) will appear next to the test strip icon on the meter display screen, indicating that the meter is in control solution testing. If you decide not to do a control solution test, press the or button until the ctl disappear from the meter display. Step 6. Squeeze a drop of hemoglobin control solution (L2 or L3) onto a clean, dry, non-absorbent surface. Do not apply control solution to the test strip directly from the bottle. Replace the bottle cap on the control solution bottle immediately after use. Step 7. While holding the meter, touch the control solution to the edge of the sampling end of the test strip, and the control solution will be automatically pulled into the reaction area of the test strip. 24

Step 8. The screen will begin to count down. After 5 seconds, the control solution testing result will appear on the meter display screen. Step 9. Compare the reading on the screen to the corresponding control range printed on the test strip bottle or its package. When the control solution test result is outside of range, meter screen will indicate HI or LO at the left bottom corner of the screen. If the reading does not fall within the control range printed on the test strip bottle or its package or if the screen show high or low, see Control Solution Trouble Shooting on page 27. NOTE: Control solution testing results will be stored into the meter s memory and indicated by ctl icon. Replace the bottle cap on the control solution bottle immediately after use. 25

Step 10. Eject the test strip into a proper waste basket. The meter will time-out after 2 minutes of inactivity. Step 11. Perform other levels of control solution testing by repeating the above step. IMPORTANT: Do not reuse test strips. 26

Control Solution Trouble Shooting If your control solution testing is out of range (too high or too low), it may be caused by the following: Possible Causes Wrong brand of control solution being used Expired or contaminated control solution or damaged test strips Meter malfunction Control solution not at room temperature What you can do Make sure you are using HemoSmart GOLD Hemoglobin Control Solution (L2 and L3). Make sure the testing environment is between 10 C~40 C (50 F~104 F). Check the expiration and open bottle date on both control solution and test strips. Repeat the test using a new test strip. If the result is still out of range, use a new bottle of control solution and retest. Please call your authorized dealer in your country with questions and concerns. 27

Hemoglobin Testing Materials you will need: Your HemoSmart GOLD Meter A new HemoSmart GOLD Hemoglobin Test Strip Lancing device with a clean, unused lancet Before you begin, make sure: Set up your meter properly and run a control test. See Setting Up Your New System on page 13 and Control Solution Testing on page 20 for details. Wash your hands and testing site thoroughly with soap plus warm water, and dry well. You are testing in an area between the temperature ranges of 10 C~40 C (50 F~104 F). Your meter will not test outside of this range and will display. Move the meter into an area that is between 10 C~40 C (50 F~104 F), and let it sit for 10 to 15 minutes before testing again. 28

Coding the Meter Before you can begin testing on your HemoSmart GOLD Meter, you must code the meter. Coding the meter ensures accurate test results when you perform a test. A new code card is packaged along with each box of HemoSmart GOLD Hemoglobin Test Strip. Materials your will need: A code card for the HemoSmart GOLD Hemoglobin Test Strip A HemoSmart GOLD Hemoglobin Test Strip Your HemoSmart GOLD Meter NOTE: Make sure the HemoSmart GOLD Hemoglobin Test Strip is not expired. Check the test strip expiration date on the box and the test strip bottle. The month printed refers to the end of the month. 29

Step 1. Locate the code card ( ) in the package of test strip. Step 2. Verify that the code number on the code card matches the code number on the test strip package. Step 3. Insert the code card with the code number facing up firmly and completely into the code card port on the backside of the meter. The code number displayed on the meter should match the code number on the code card and on the front of the test strip package. Step 4. Obtain a test strip ( ) and insert the strip into the test strip holder located at front upper of the meter. The meter will turn on with a beep sound. Close the test strip bottle immediately after you take out a strip. 30

Step 5. A 3-digit code number will display on the meter screen. Verify the code number on the screen with that on the code card and that on the test strip package. All three sets of numbers should be the same. NOTE: 1. The code card found in the HemoSmart GOLD Hemoglobin Test Strip package is for use with that particular package only. Different packages of HemoSmart GOLD Hemoglobin Test Strip and other brands of test strips will produce inaccurate results. 2. Re-coding needs to be done when a new package of test strip is opened for use. 3. Code number displayed on screen not matching the code number printed on the test strip bottle or package will create an inaccurate test result. 31

5 5 Preparing Your Lancing Device (optional) Step 1. Unscrew the adjustable cap of the lancing device and insert the lancet by pushing down firmly until it is fully seated. 3 4 Step 2. Twist the protective cover off from the lancet. Twist the adjustable cover back clockwise onto the lancing device. NOTE: For fingertip testing, use the blue adjustable cap. Step 3. Adjust the puncture setting on the adjustable cap for the puncture depth level (1 is the lightest and 5 is the deepest). 3 4 32

Step 4. With one hand holding the adjustable cap, pull back the lancing device with your other hand until your hear a click sound. The lancing device is now ready for blood sampling. IMPORTANT: Use a new sterile lancet every time you test to avoid cross contamination. If alcoholic wipes are used to cleanse the fingers, make sure the area is dry before the blood sample is obtained. The lancets are for single used only. Do not reuse lancet. 33

Performing a Blood Hemoglobin Test Step 1. After coding the meter, the meter will perform a self-test for ambient temperature. If the temperature is below or above operation range, the screen will display the flashing symbol of thermometer. When the temperature is within the testing range of 10 C to 40 C (50 F to 104 F), the screen will show and the meter is ready to test. NOTE: If the temperature is outside of the operating range, the meter needs to be moved to an area that is within the meter's operating range of 10 C to 40 C (50 F to 104 F) and allow 10 to 15 minutes for it to reach the new temperature before use. Measurement outside the temperature range will affect accuracy of test result. Step 2. Take out a HemoSmart GOLD Hemoglobin Test Strip from the test strip bottle and close the bottle immediately. Insert the test strip to turn on the meter. 34

IMPORTANT: Check the expiration date printed on the test strip bottle and its package. Do not use expired test strips. Use each test strip immediately after removing it from the bottle. Do not use wet or damaged test strips. Keep away from direct sunlight and heat. Store the test strip bottle in a dry, cool place. Record the date opened on the bottle label. Discard the bottle and any remaining test strip after 2 months from date of opening. Must insert test strip to the bottom. Must see a flashing blood drop icon if the test strip has been inserted to the bottom. Step 3. Wait for the flashing blood drop and test strip icons to appear on the middle of the meter display screen. 35

5 3 4 Step 4- obtain blood sample For Fingertip Testing: Hold the lancing device (use the blue cap) against the side of your fingertip and press the release button to create a puncture. TIP: Gently massage your hand and finger toward the puncture site to form a drop of blood (approximately: ). Do not milk or squeeze around the puncture site. Lance the side of your fingertip to avoid soreness. To avoid calluses, choose a different lancing site each time. 36

NOTE: If fresh venous whole blood is to be used, perform venipuncture and collect the sample in an anticoagulant-free plastic syringe. Step 5. Gently bring the test strip and touch the drop of blood at a slight angle. The test strip acts like a straw to pull the blood in. Keep the test strip in the blood drop until the meter beeps to indicate the test strip has enough blood to test. NOTE: If a sample is obtained from a venipuncture, apply a blood drop (free of bubbles) to the test strip from the stopper. 37

Step 6. The screen will start to count down. After 5 seconds, your hemoglobin testing result will appear on the meter display screen. Your test result will be automatically stored into the meter memory. CAUTION: If you see HI or LO displayed, your blood hemoglobin level may be above 24 g/dl or below 4 g/dl. Test again using fingertip testing, DO NOT test on palm or forearm. If you still receive the same result, call your physician or healthcare professional immediately. Step 7. Eject the used test strip into a proper wastebasket. The meter will time-out after 2 minutes of inactivity. 38 Step 8. Remove the used lancet from your lancing device according to instructions and discard into proper wastebasket.

IMPORTANT: Used lancets and strips are biohazard materials and can transmit blood-born disease. Dispose them according to local government regulations to avoid injury or contamination. 39

Understanding Your Test Results Ideal range for male is 13-18 g/dl, Ideal range for female is 12-16 g/dl. If the result is lower than 13 g/dl and 12 g/dl for male and female, it could be low hemoglobin or iron deficiency anemia. If the result is higher than 21 g/dl and 19 g/dl for male and female, it could be erythrocytosis. If the result is higher than 21/19 (g/dl) or lower than 13/12 (g/dl), please contact your physician or healthcare professional immediately. 40

Viewing Stored Readings from Memory Your HemoSmart GOLD Meter automatically stores up to 100 test and control results with date and time. You will need to set your meter date and time before using the memory and day averaging function, see Setting Up Your New System on page 13. The meter will not memorize any test or control results if the date and time are not set. Material you will need: Your HemoSmart GOLD Hemoglobin Meter Step 1. Turn on the meter by pressing and holding the button. Step 2. The meter will display the main mode. If error messages (Er 1, Er 3, etc.) appear, see Solving Problems on page 46 for trouble shooting. 41

Step 3. After the flashing test strip icon appears, press the button once, and the mem will appear at the middle of the display screen. Press to select the mem mode. Step 4. Press to view your result, from the most recent to the oldest. The meter will display the testing result of blood or control solution order. When the memory displays L2 or L3, it indicates the testing result of control solution. When less than 100 results are stored in the meter s memory, nil will appear after the last recorded test result. 42

NOTE: Control testing results will be flagged by a ctl icon. When there are no memorized results stored in the meter, the display screen will show nil. If the meter s memory already has 100 test results, adding a new test result will cause the oldest one to be deleted. Memorized test results will not be erased when changing batteries. After you finish viewing memory, either begin testing by inserting a HemoSmart GOLD Hemoglobin Test Strip. see Hemoglobin Testing on page 28, or press the button to enter standby mode. 43

Caring for the Meter Caring your HemoSmart GOLD Meter is easy. Follow these simple guidelines to keep your HemoSmart GOLD Meter working properly. 44 Cleaning the Meter If the meter gets dirty, use a moist (NOT WET) lint-free cloth dampened with a mild detergent. Do not use glass or household cleaners on the meter. Do not try to clean the test strip holder. Do not contaminate the strip holder with blood or control solution. Storage and Precautions Handle the meter with care; severe shock, such as dropping the meter, could damage the electronics. The meter and the test strips are designed to be used within the temperature ranges between 10 C~40 C (50 F~104 F). Avoid leaving the meter in extremely hot or cold place, such as near a heat source or in an extremely hot or cold car. Do not store or use the meter or test strips where they may be exposed to high humidity levels, such as in a bathroom or kitchen.

Always close bottle cap immediately after removing a test strip and make sure it is closed tightly. Do not take the meter apart. Doing so will void the warranty. Do not use this meter in a dry environment, especially if synthetic materials are present. Synthetic clothes, carpets, etc., may cause damaging static discharges in a dry environment. Do not use this meter near cellular or cordless telephones, walkie-talkies, garage door openers, radio transmitters, or other electrical or electrical equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the meter. 45

Solving Problems This section details the significant display screen messages and error codes you will encounter when using your HemoSmart GOLD Meter and HemoSmart GOLD Hemoglobin Test Strip. Message What it Means What You Should Do Meter failure Reinstall the battery and turn on the meter again. If problem persists, please call your authorized dealer in your country with questions and concerns. Used or contaminated test strip Repeat the test with a new test strip. Wait until you see the flashing blood drop icon before you add blood or control solution sample. 46

Message What it Means What You Should Do Not enough sample on the test strip to start Remove the test strip and repeat the test with a new test strip. See Performing a Blood Hemoglobin Test on page 34. Remove test strip during count down Expired test strip Repeat the test with a new test strip. If problem persists, please call your authorized dealer in your country with questions and concerns. Check if meter s date and time is set up correctly, see Setting the Clock on page 15. Check the test strip bottle and verify the expiration date. Check the code number on both the meter display screen and the test strip bottle or its package to make sure they match. 47

Message What it Means What You Should Do Low battery Change the battery according to Inserting (or Changing) the Battery on page 13. Temperature out of range Move the meter into an area that is between 10 C~40 C (50 F~104 F), and allow 10 to 15 minutes for it to reach the valid temperature. The hemoglobin result lower than 4 g/dl Wash and dry your hands and repeat the test using a new test strip. If the result is still LO, contact your physician or healthcare professional immediately. 48

Message What it Means What You Should Do The hemoglobin result higher than 24 g/dl No memorized results in the meter Wash and dry your hands and repeat the test using a new test strip. If the result is still HI, contact your physician or healthcare professional immediately. Check if the date and time on your meter is set up. See Setting Up Your New System on page13. Start testing your blood hemoglobin, see Hemoglobin Testing on page 28. Not coded with a code card Code your meter with a HemoSmart GOLD code card, see Coding the Meter on page 29. 49

Message What it Means What You Should Do The control solution result lower than specified control range The control solution result higher than specified control range Wash and dry your hands and repeat the test using a new test strip. If the control solution result is still LO, contact your authorized dealer in your country. Wash and dry your hands and repeat the test using a new test strip. If the control solution result is still HI, contact your authorized dealer in your country. 50

Product Warranty Apex Biotechnology Corporation warrants the HemoSmart GOLD Meter to be free of defects in workmanship and materials under normal use for a period of two (2) years from the date of purchase to the consumer. The liability of Apex Biotechnology Corporation is limited to repair or replacement and in no event shall Apex Biotechnology Corporation be liable for any collateral or consequential damages or loss. Instruments subjected to misuse, abuse, neglect, unauthorized repair or modification will be excluded from this warranty. This guarantee specifically excludes expendables and consumables. All warranty claims must be directed to the Apex Biotechnology Corporation authorized dealer responsible for the sale of the system. The warranty applies only to the original purchaser of the system. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. 51

Specifications Test Strips: HemoSmart GOLD Hemoglobin Test Strip Test Range: 4-24 g/dl Sample Volume 1 μl Reading Time 5 Seconds Blood Source: Capillary and venous whole blood Display Type: Large LCD screen Memory: 100 test results Dimension: 124L x 75W x 30H (mm) Weight: 120 g (Without battery) Power Supply: Holds two 1.5V AAA batteries Operating Temperature: 10 C to 40 C (50 F to 104 F ) Relative Humidity: Less than 85% (Storage, Operating and Transportation) Storage / Transport Condition: 4 C to 50 C (39 F to 122 F) for meter 4 C to 30 C (39 F to 86 F) for test strip 52

Electromagnetic Compatibility: This equipment is complying with EMC requirement of EN 61326-2-6 Water Repellent: IPX4 NOTE: For more information regarding the test strips, see the test strip package insert found in each box of test strips. Applied Product Standards: EN 61010-1 EN 60601-1 EN 60601-1-2 EN 61326-2-6 EN 61010-2-101 EU directive/classification: 98/79/EC; Self-testing Classification according to IEC/EN 60601-1: IPX4, not evaluated as AP/APG equipment, continuous operation. For additional information, refer to the HemoSmart GOLD Hemoglobin Test Strip insert. 53

Symbols Used in this Manual Use-by date Batch code Temperature limit Consult instructions for use In vitro diagnostic medical device Caution Catalogue number Keep away from sunlight Do not reuse Manufacturer Authorized representative in the European community 54

Supplies S25009 HemoSmart GOLD Simple S25010 HemoSmart GOLD Basic S25015 HemoSmart GOLD Basic (carrying case) S5640158 HemoSmart GOLD Hemoglobin 10's Test Strips S5640159 HemoSmart GOLD Hemoglobin 25's Test Strips S5640254 HemoSmart GOLD Hemoglobin 25's Test Strips S5640214 HemoSmart GOLD Hemoglobin 2x25's Test Strips Individually foil wrapped S5640215 HemoSmart GOLD Hemoglobin 10's Test Strips S5640216 HemoSmart GOLD Hemoglobin 25's Test Strips S5640255 HemoSmart GOLD Hemoglobin 25's Test Strips S5640217 HemoSmart GOLD Hemoglobin 50's Test Strips S5800112 HemoSmart GOLD Hemoglobin Control Solution 65235000004 Lancing Device 80050000009 Sensorex 50's 55

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