LASER DOC

(LGM-701B)

User Manual

Blood Glucose Monitoring System with LASER Lancing Device

Self Test

Thank you for selecting the LGM-701B Blood Glucose Monitoring System with Laser lancing device. Please read this manual thoroughly Before you start testing. It provides all the information you need to use the product. You will get a correct test result by the following instruction of this manual.

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Table of Contents Important Information............................................................................................ 4 Safety Information of LGM-701B with Laser Lancing Device ............................ 6 Principle of LGM-701B ............................................................................................ 8 Package Content ...................................................................................................... 9 System Configuration ........................................................................................... 10 LCD Information .................................................................................................... 11 Install and Charge the Battery ............................................................................ 12 How to use Disposable Cap ................................................................................. 14 Turning On/Off the LGM-701B ............................................................................. 15 How to collect blood sample using laser lancing device .................................. 16 Setting Up Your LGM-701B .................................................................................. 19 Recalling Your Test Results .................................................................................. 21 Check the LGM-701B with the ISOTECH Check Strip....................................... 22 ISOTECH Test Strip ............................................................................................... 23 Important Test Strip Information ........................................................................ 24 Setting Up Code of Test Strip .............................................................................. 25 Performance Checking the LGM-701B and Test Strip ...................................... 26 How to do a control solution test ........................................................................ 27 Starting the Test .................................................................................................... 28 Test Results and Messages................................................................................... 31 Reading Variation Factors ..................................................................................... 32 Error Messages ...................................................................................................... 33 Comparing LGM-701B and Laboratory Results ................................................. 34 Performance Characteristics ................................................................................ 35 General Trobleshooting ......................................................................................... 36 Caring & Handling & Storage ............................................................................... 37 Lens Cleaning......................................................................................................... 38 Safety Feature of Laser Lancing Device ............................................................. 39 Product Specifications ........................................................................................... 40 Conformity Statement .......................................................................................... 42 Warranty Information ........................................................................................... 43 Electromagnetic Compatibility ............................................................................. 45

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Important Information Intended Use The LGM-701B Blood Glucose Monitoring System with Laser lancing device is intended for self-test use for the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for in vitro diagnostic use only. This manual contains everything you need to know about using the LGM-701B. Read it carefully and thoroughly before you begin testing. Please note. The LGM-701B is intended for self-testing. Do not use the system for the diagnosis of diabetes without the guidance of a healthcare professional. Use only fresh capillary whole blood samples for testing. The LGM-701B can only be used with the ISOTECH Test Strip. The use of any other brand strips should not be used under any circumstances. The use of other brands of strips may give inaccurate results. In order to get accurate testing, please do testing between 10~40 (50~104), RH: 10 ~ 90%. Do the test at least 30 minutes after while entering another site with different ambient temperature. Keep your LGM-701B free of dust, water or any other liquid, dont expose it directly to the sun and avoid throwing, shaking, or dropping it, which may damage its internal parts. Dont use your LGM-701B near cellular or cordless telephones, microwave oven or other electrical or electronic equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the LGM-701B. Dont disassemble your LGM-701B.

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Important Information The following list explains the symbols, youll find in the LGM-701B user manual, product packaging and product inserts. For in vitro diagnostic use. This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. Batch Code / Serial Number Consult instruction for use. Manufacturer Expiry date Temperature Limitation Authorized Representative Separate collection for electrical and electronic equipments. Do not re-use. Direct Current Attention! Read instructions before use. LASER Hazard Bio Hazard The LGM-701B was manufactured and supported by ISOTECH and its authorized representative. If you have any questions or concerns, please contact your ISOTECH authorized representative or call us. In Korea contact: Isotech Co., Ltd. 305-509 3rd floor, 692, Gwanpyeong-dong, Yuseong-gu Daejeon, Republic Korea Tel: +82-42-934-1105 / 1152 Fax: +82-42-934-1106 E-mail: isotechckj@paran.com In EU contact : Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 D-66386 of St. Ingbert, Germany

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Safety Information of LGM-701B with Laser Lancing Device The user must check that the LGM-701B functions safely and see that it is in proper working condition before being used. Be sure to read all instructions, warning, cautions before using this product. This product contains high voltage circuit. Do not attempt to remove or open any part of the product case.

Caution

Caution

Caution

Use of damaged or improperly adjusted equipment or improper use of equipment could result in personal injury. Laser lancing device is a class IV laser for perforation of the fingertip to draw a capillary blood sample. Improper use or misuse could result in personal injury. Read all warning and instructions before use. Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. Never attempt to look into the laser aperture. Never attempt to use mirrors or other devices to observe the laser beam or lens. Do not use this product near flammable gases. This product may cause ignition of explosive or flammable gases. The laser may over-heat after radiation repeatedly in a short time, thus reducing efficiency. Allow unit to cool for about 2 minutes.

Caution

Caution

Caution

Caution

Caution

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Safety Information of LGM-701B with Laser Lancing Device Misuse of electrical equipment can cause electrocution, burns, fire and other hazard.

DANGER

Check that the voltage setting matches the supply voltage. Important Use the equipment only for the purpose described in the instructions for use.

Important

Important

Do not use accessories which recommended by the manufacturer.

are

not

supplied

or

Important

Do not use the equipment if it is not working properly, or if it has suffered any damage.

Use only rechargeable, replaceable, type ICR-16340 lithium ion battery with 3.7 Vdc nominal voltages, 650 mAh nominal Important capacities. Use only the battery charger supplied by the manufacturer with your LGM-701B. Use of another charger could result in Important damage to the instrument.

Dont use the LGM-701B with battery charger connected. Important

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Principle of LGM-701B The LGM-701B is a portable, battery-operated blood glucose monitoring system with laser lancing device for capillary blood collection. Principle of Blood Glucose Monitoring System The LGM-701B is designed to provide an easy, accurate method for determination of capillary blood glucose values. This analysis is based on electrochemical technology using glucose oxidase that is specific for the blood glucose measurement. When blood sample is applied to the test strip, the electrons are formed by the reaction between glucose oxidase and blood glucose. The intensity of the electrons is measured by the meter and correlates with the concentration of glucose in the blood sample. Test result is calibrated to be plasma equivalent. Principle of LASER Lancing Device The LASER Lancing Device relates to a personal portable low-pain blood lancing device, which is capable of lancing from the skin without any pain by using an Er:YAG LASER technology in the medical field, and further by using a laser beam having a wavelength of 2940 nm, which has a strong absorption force with respect to water so that it does not harm the human body. Er:YAG lasers are solid-state lasers whose lasing medium is erbium-doped yttrium aluminum garnet (Er:Y3Al5O12). Er:YAG lasers typically emit light with a wavelength of 2940 nm, which is infrared. It is optically pumped using a Xe flash lamp and consist of a highly reflective optical cavity, as well as a means to supply energy to the Er:YAG rod. The rod allows amplifying light by stimulated emission and consists of two mirrors arranged such that light bounces back and forth, each time passing through the rod. Typically one of the two mirrors, the output coupler, is partially transparent. The output laser beam is emitted through this mirror.

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Package Content LGM-701B consists of several items. Please identify each item of your system and learn what theyre called and how theyre used. These items are included in your system: 1. Blood glucose meter with Laser lancing device 2. ISOTECH Test Strip (10T) 3. ISOTECH Check Strip 4. Disposable Cap (20T) 5. Users Manual (Book) 6. Users Manual (Video CD) 7. Quick Reference Guide 8. Log Book 9. Pouch 10. Battery and Charger 11. ISOTECH Control Solution (optional) 12. Data cable and Glucose data transfer program CD (optional)

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System Configuration

LCD Window Menu Selection Button Search Button (Left/Right) LASER Shoot Button Strip Insertion Hole Strip Remove Lever Charger Connector slot Display glucose result, laser level, strip code, date, symbols and error messages. Used to select memory, average, setting and return normal mode. Used to search data stored in memory, inc/dec laser energy level, strip code and numbers. Used to shoot laser, power on/off or confirm a selected parameters. Insert test strip here. Pull the lever down to remove used strip. Connect the slot to battery charger here. Pull the cover up to shoot the laser. LASER Radiation through the aperture. For the safety of body, normally it covered with safety slide cover. To enable the laser radiation, press the finger plate downward slightly. Slide cover to install battery.

LASER Safety Slide Cover

Finger plate with Aperture

Battery Slot and Cover

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LCD Information

Code Laser mem Avg Check Buzzer symbol Blood symbol Laser symbol mmol/L mg/dL Decimal point Data Field Battery symbol Hour: Minute Month-Day

Indicates that the big number is the code of strip for 3 seconds after strip insertion. Indicates that the safety slide cover is upward and thus laser is ready for use. Indicates a test result stored in memory. Shows average value of test results. Appears during meter testing using check strip. Indicates that the buzzer sound is on. Indicates meter is ready to apply the blood sample. ready Blinking symbol indicates that laser is ready to shoot. Appears when the unit of result is set to mmol/L. Appears when the unit of result is set to mg/dL. Appears when result is set to mmol/L unit. It shows the test result (include HI/LO), strip code number, test record, laser energy level, Error message. Indicates the remains value of battery power. Shows Current Time hh:mm. Shows Current Date mm-dd.

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Install and Charge the Battery The LGM-701B battery is not pre-installed. Before turning on the LGM-701B, user should the battery in the slot of back of LGM-701B. Please check to be sure user has connected the battery properly. Before using the LGM-701B, fully charge the battery by using the follow procedure. Install the Battery Step 1 Turn the meter over. Push battery cover knob and remove the battery cover. Install battery(ICR-16340). Be sure to put battery in correct direction. Close the cover until it snaps into place.

Step 2

Step 3

Charge the Battery Step 1 Step 2 Step 3 Step 4 Step 5 Plug the battery charger into an AC power outlet. Plug the cord from the battery charger into the connector slot on the LGM-701B. Wait until all the LED lights of the battery charger turns green from orange. Unplug connector of the battery charger from connector slot on the LGM-701B Unplug the battery charger from the AC power outlet.

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Install and Charge the Battery If the gauge level (1 to 3) of battery symbol on LCD indicates the level of battery power. When fully charged, level is three , when level is one ; you have to charge the battery as soon as possible. Use only the battery charger supplied by the manufacturer with your LGM-701B. Use of another charger could result in damage to the instrument. Dont use the LGM-701B with battery charger connected. Important Battery must be fully charged prior to first time use. A full recharge takes about 2 hours. Use only rechargeable, replaceable, type ICR-16340 lithium ion battery with 3.7 Vdc nominal voltages, 650 mAh nominal capacities. There is a risk of explosion or fire hazard if the battery is replaced with an incorrect type or charging of non-rechargeable battery.

Caution

Caution

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How to use Disposable Cap To reduce the chance of infection : The disposable cap is for single use only. Important Never share or re-use a disposable cap. Disposable caps are used to collect blood sample and protect the laser components. The disposable caps are designed to: Protect the lens from becoming coated with ablation. Protect the instrument from contact with multiple patients. Only use the disposable caps provided by the manufacturer of the LGM701B. The disposable caps are provided in sanitary, non-sterile packaging. Use of the LGM-701B without a disposable cap will damage the lens and void the warranty.

Step 1

Prepare disposable cap.

Step 2

Open the safety slide cover. You can see the finger plate with aperture.

Step 3

Grasp a rectangle plate of the disposable cap and insert the cap into the groove on the finger plate.

Step 4

To Enable laser radiation, press the cap downward slightly with the fingertip.

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Turning On/Off the LGM-701B Before Starting Before using the LGM-701B, make sure you have read the previous sections of this manual including warning, caution, Important battery charge, and disposable caps. Power ON If you want to turn on the LGM-701B, please keep pressing the [SHOOT] button for 2 seconds. Another way of turning on the LGM-701B is to insert the test strip into strip insertion hole. The LGM-701B is power on, and all segments of the display will appear briefly, you can hear a beep sound. Power OFF If you want to turn off the LGM-701B, please keep pressing the [SHOOT] button for 2 seconds. Auto Power OFF The LGM-701B will power off automatically if you dont operate it for over 2 minutes. Here are two way of turning ON the LGM-701B.

Keep press the [SHOOT] for 2 seconds.

Insert test strip.

Checking the Display Each time you turn on the LGM-701B either by inserting a test strip or pressing the [SHOOT] button, all segments of the display will appear briefly. This tells you that the system is performing several self-checks to confirm that the LGM-701B is working properly. Important If some segments such as decimal point for mmol/L or data field for result may not appear, they will cause inaccurate test results. If some segments may not appear, contact your local sales representative.

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How to collect blood sample using laser lancing device Laser lancing device is a class IV laser for perforation of the fingertip to draw a capillary blood sample. Improper use or misuse could result in personal injury. Read all warning and instructions before use. Before you take the blood sample, Please wash your hands and the puncture site. Use warm, soapy water, rinse and dry thoroughly.

Caution

Caution

Step 1 Turn on the LGM-701B Step 2 Raise the safety slide cover Open the laser aperture by raising gently the safety slide cover fully upward until you hear a beep sound. The [Laser] / [Code] symbol and energy level value appear on the LCD. Orange LED lighting on the [SHOOT] button. Energy level range is from level [1] to level [8].

Step 3 Set Laser Energy Level Set laser energy level by clicking [<] or [>] button. Generally the levels 2 ~ 5 are appropriate for adults.

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How to collect blood sample using laser lancing device Step 4 Insert Disposable Cap Grasp a rectangle plate of the disposable cap and insert the cap into the groove on the finger plate.

Step 5 Position the Fingertip Place a finger tip on top of the disposable cap. Step 6 Charge the Laser Press the disposable cap downward slightly with the fingertip. Starts the laser charge cycle and laser ready symbol appear on the LCD and green LED lighting on the [SHOOT] button. Charging the laser take about 3~15 seconds depending on the energy level. When fully charged, the laser ready symbol and green LED blinks and beep sound.

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How to collect blood sample using laser lancing device Step 7 Shoot the Laser With the fingertip and LGM-701B stand firmly, shoot by clicking [SHOOT] button with another free hand. After shooting, beep sound and laser ready symbol and green LED light stop to blink.

Step 8 Collect the Blood Sample Gently massage the finger to obtain the required blood volume. A drop of capillary blood should appear at the puncture site

Step 8 Discard Disposable Cap Remove the disposable cap from the finger plate and it into a container. Step 9 Close the Safety slide cover. To reduce the chance of infection : Never share a disposable cap with anyone. Always use a new, disposable caps are for single use only. Important Take the disposable cap out carefully and place it into a container for cross-contamination.

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Setting Up Your LGM-701B When you turn on the LGM-701B for the first time, the LCD will show following default setting value. Display format for the date: 12-12 (month-date) Display format for time: 12:12 PM (hour: min) Unit of result: mg/dL To set the parameter, you must enter the setting mode. Turn on the LGM-701B and just click [MENU] button 3 times. If you want to exit the setting mode, press [MENU] button. Now the LGM-701B is in setting mode and displays SET on data field. Step 1 : Set the Month With the Month setting flashing, press [<] or [>] button until the correct month is display on the LCD. Press [SHOOT] to confirm the month adjustment and the day setting will start flashing. Step 2 : Set the Day With the Day setting flashing, press [<] or [>] button until the correct day is display on the LCD. Press [SHOOT] to confirm the day adjustment and the hour setting will start flashing. Step 3 : Set the Hour With the Hour setting flashing, press [<] or [>] button until the correct Hour is display on the LCD. Press [SHOOT] to confirm the hour adjustment and the minute setting will start flashing. Step 4 : Set the Minute With the Minute setting flashing, press [<] or [>] button until the correct minute is display on the LCD. Press [SHOOT] to confirm the minute adjustment and the sound setting will start flashing.

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Setting Up Your LGM-701B Step 5 : Set the Sound With the Buzzer symbol flashing, press [<] to sound OFF or press [>] to sound ON. When sound on, buzzer symbol will appear. Press [SHOOT] to confirm the sound selection and the unit setting will start flashing. Step 6 : Set the Unit of Measurement With the mg/dL symbol flashing, press [<] or [>] button to change the measurement unit. Press [SHOOT] to confirm the unit and the year setting will start flashing. Step 7 : Set the Year With the Big Number setting flashing, press [<] or [>] button until the correct year is display on the LCD. Press [SHOOT] to confirm the year adjustment and the deleting mode will appear. Step 8 : Deleting Stored Result With the dEL setting appear, press [<] or [>] button until the correct [YES] or [NO] is display on the LCD. To delete all memory, choose [YES] and Press [SHOOT] to confirm. [oFF] on the LCD will appear and automatically power off. The LGM-701B can display test result in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L) Your LGM-701B was set at the factory to the unit generally used in our country. It should be changed only on the recommendation of your healthcare professional.

Important

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Recalling Your Test Results Your LGM-701B stores the 250 most recent blood glucose results with date and time in its memory. It also provides you with 7, 14 and 30-day averages of your blood glucose test results. Recalling Stored Result Step 1 : Enter the Memory Mode Turn on the LGM-701B and click [MENU] once to go into memory mode. mem symbol appear on the LCD. The number of test results stored at memory will display as data field for 1 second. The last glucose data stored in memory will display with the monthday-hour-minute. Step 2: Search the Test Results Click [<] or [>] allows you to search the glucose test results. Step 3 : Exit from Memory Mode Just click [MENU] to exit. Browsing Average Result Step 1 : Enter the Average Mode Turn on the LGM-701B and click [MENU] twice to go into memory mode. Avg symbol appear on the LCD. The latest 7-days average value of test result stored will be display with unit. Step 2 : Select 7/14/30 days Average Click [<] or [>] allows you to select the latest 7, 14, or 30-days average value of the test results. Step 3 : Exit from Average Mode Just click [MENU] to exit. Deleting Stored Result To delete all past stored test results, follow this procedure. Step 1 : Enter Delete Mode Turn on the LGM-701B and click [MENU] several times to set memory deleting mode. Step 2 : Select YES or No Click [<] or [>] to select yes or no. To delete all memory, choose [YES] and press [SHOOT]. All past stored results and their dates and times will be deleted. If you dont want to delete the memory, choose [NO] and press [SHOOT] to return setting mode.

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Check the LGM-701B with the ISOTECH Check Strip The ISOTECH Check Strip is used to determine if the LGM-701B is functioning properly. To perform the test, start with the LGM701B turned off.

Note

Step 1 : Insert Check Strip Remove check strip from package and insert check strip into strip insertion hole. Step 2: Wait and Confirm After 3 seconds, LCD shows check result YES or No. If result is YES, LGM-701B is functioning properly. Repeat test once or twice if result is NO.

Note

If you continue to receive out of range check result, contact your local ISOTECH sales representative.

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ISOTECH Test Strip The LGM-701B measures the amount of glucose in capillary whole blood. Blood is applied to the top edge of the ISOTECH Test Strip and is automatically drawn into the reaction cell.

Top Edge Apply the blood sample on top edge of test strip.

Confirmation Window Check here to confirm if enough blood has been applied.

Contact Bars Gently push the test strip with its contact bars facing up into strip Insertion hole of LGM-701B. LGM-701B will beep and display code number.

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Important Test Strip Information Store test strips only in their original bottle in a cool, dry place between 8~30 (46~86). Keep away from direct sunlight and heat. Do not refrigerate. To avoid damage or contamination, do not transfer test strips to any other place. Do not use test strips beyond the expiration date printed on the package since they may cause inaccurate results. After removing a test strip from the bottle, replace the cap immediately and close it tightly. With clean, dry hands, you may touch the test strip anywhere on its surface. Use each test strip immediately after removing it form the bottle. Count three months from the date you first open a new bottle of test strips and write this date on the label. Throw test strips and bottle away after this discard date. Apply only fresh capillary whole blood and ISOTECH Control Solution to the test strip. Do not bend, cut, or modify test strips in any way. ISOTECH Test Strips are for single use only. Never reuse a test strip that has had either blood or control solution applied to it. Refer to additional information in the ISOTECH Test Strip package. Keep the test strip bottle and strips away from children. The strip may be choking hazards. Also, the cap may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.

Warning

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Setting Up Code of Test Strip Each time you turn on the LGM-701B either by inserting a test strip or pressing the [SHOOT] button. Code numbers are used to calibrate the LGM-701B with ISOTECH Test Strips for accurate results. You must code the LGM-701B before using it for the first time and then every time you change to another bottle of test strips. Step 1 Insert Test Strip Gently push test strip into strip insertion hole until beep sound. The [Code] symbol appears on the LCD. Currently code number will appear for 3 seconds. Step 2 Match the Code Numbers Compare the code number on the LGM-701B display with the code number on the test strip bottle. If the two code numbers match, wait until in testing. Wait until symbol appears on the LCD to begin the test. If they do not match, follow Step 3. Step 3 Set Code Click [<] or [>] to scroll code numbers up or down. The LGM-701B has a total of 63 codes. Stop at correct code number. After selecting correct code number, wait for 3 seconds until symbol appears on the LCD. When the symbol appears, LGM-701B is ready for testing.

Note

Each time you test, check to be sure that the code number on the LGM-701B display matches the code number on the test strip bottle. Failure to code the LGM-701B correctly will cause inaccurate test results.

Caution

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Performance Checking the LGM-701B and Test Strip ISOTECH Control Solution is used to check that the LGM-701B and the test strips are working together as a system and that you are performing the test correctly. It is very important that you do this simple check routinely to make sure you get an accurate result. ISOTECH Control Solution contains a measured amount of glucose that reacts with ISOTECH Test Strips. Compare your control solution test results with the range printed on the test strip bottle label. Before you use the LGM-701B to test your blood for the first time, practice the procedure using control solution. When you can do three tests in a row that are within the range, you are ready to test your blood. When to do a control solution test When you begin using a new bottle of test strip. Do the test once a week. Whenever you suspect that the LGM-701B or test strip are not working properly. If your blood glucose test results are not consistent with how you feel. If you drop the LGM-701B. Important Control Solution Test Information Use only ISOTECH Control Solution. Check the expiry date on the control solution bottle. Do not use if expired. Count three months from the date you first open a new bottle and write this date on the label. Control solution, LGM-701B and test strips should be at room temperature before testing. After squeezing, wipe off the tip to avoid contamination. Store control solution closed at temperature between 10~40 (50~104). Do not refrigerate. The control solution range printed on the test strip bottle is for ISOTECH Control Solution only. It is not a recommended range for your blood glucose level.

Caution

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How to do a control solution test Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Insert a test strip contact bars facing up into the strip insertion hole. Be sure the code number on the display matches the code number on the test strip bottle. Shake the control solution bottle well. Squeeze the vial, discard the first drop and wipe off the tip. After symbol appears on the display, apply the solution to narrow tip edge of the test strip until the beeps. LGM-701B begins to count down and the test result will appear. Compare the result with range printed on the test strip bottle. The result should fall within this range.

Comparing control solution results If test results deal outside the range printed on the test strip bottle, repeat the rest. Out of range results may be caused by one or more of the following: Error in performing the test. Failure to shake the control solution bottle well. Expired or contaminated control solution. Control solution that is too warm or too cold. Failure to discard the first drop of control solution and wipe the tip clean. Improper coding of the LGM-701B. LGM-701B malfunction If you continue to get control solution test results that fall outside of the range printed on the bottle, the system may not be working properly. Do not use the LGM-701B. Please contact your authorized representative.

Caution

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Starting the Test Before Testing, Wash your hands with warm, soapy water. Rinse and dry thoroughly.

Caution

Read this section and the test strip package inset carefully before testing. Make sure you have all items needed to test. LGM-701B Test Strips Disposable Cap Step 1 Insert Test Strip and Match the Code Numbers Gently push test strip into strip insertion hole until beep sound. The [Code] symbol appears on the LCD. Currently code number will appear for 3 seconds. Compare the code number on the LGM-701B display with the code number on the test strip bottle. If the two code numbers match, wait until in testing.

Step 2 Open the laser aperture and set laser energy level Open the laser aperture by raising gently the safety slide cover fully upward until beeps. Set laser energy level by click [<] or [>]. Generally the levels 2~5 are appropriate for adults.

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Starting the Test Step 3 Insert Disposable Cap and Position the Finger Grasp a rectangle plate of the disposable cap and insert the cap into the groove on the finger plate. Place a finger tip on top of the disposable cap.

Step 4 Shoot the Laser Press the disposable cap downward slightly with the fingertip. Starts the laser charge cycle and laser ready symbol appear on the LCD and green LED lighting on the [SHOOT] button. Charging the laser take about 3~15 seconds depending on the energy level. When fully charged, the laser ready symbol and green LED blinks and beep sound. Shoot by clicking [SHOOT] button with another free hand.

Step 5 Discard Disposable Cap and Close Safety Slide Cover Remove the disposable cap from the finger plate and it into a container. Close the safety slide bar. You can skip step 5 procedures and go to step 6 to measure the amount of glucose. When you finished the measurement, you can discard disposable cap and close safety slide cover.

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Starting the Test Step 6 Apply Blood Sample After Shoot the laser, current strip code will be displayed again. And thus its ready to set strip code again. If you change the strip code again you must set the code within 3 seconds before symbol blink. When the symbol blinking, LGM-701B is ready for testing. Apply the collected blood sample to narrow tip edge of the test strip until the beeps. It through its capillary fills up its confirmation window partially or fully depending on the quantity of blood sample. The blood sample must be at least 0.5 uL in volume to fill the confirmation window. After 5 seconds of countdown from 5 to 1, your blood glucose test result will be display on data field of LCD. Blood glucose test results are automatically stored in the memory. You may also record them in the logbook provided with your system. Step 7 Used strip Disposal Dispose of used test strip in a container. Pull the lever down to eject the used test strip directly into a container.

Caution

It is important to discard the used test strip and disposable cap carefully.

Caution

If confirmation window hasnt filled in time because of abnormal viscosity or insufficient volume, Er4 message will appear.

GOOD

Insufficient

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Test Results and Messages Blood glucose test results are shown on the LGM-701B as mg/dL or mmol/L, depending on which unit of measurement you have chosen. If you blood glucose result is unusually high or low, if you question your testing results, repeat the test with a new strip. You can also run a performance check with your ISOTECH check strip and ISOTECH control solution to check your LGM-701B and strip. If the test result still remains unusually high or low, contact your healthcare professional immediately. If you are experiencing symptoms that are not consistent with your blood glucose test results and you have made sure to follow all instructions of this manual, contact your healthcare professional immediately. LO Message The LGM-701B displays results between 20 and 600 mg/dL (1.1 to 33.3 mmol/L). If your test result is below 20mg/dL (1.1 mmol/L), [Lo] will appear on the LCD. Please repeat your test again by a new strip. If you still get [Lo] result, you should immediately contact your healthcare professional. HI Message If your test result is above 600 mg/dL (33.3 mmol/L), [HI] will appear on the LCD. Please repeat your test again by a new strip. If you still get [HI] result, you should immediately contact your healthcare professional. Expected Test Results Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 and 4 AM Range without diabetes (mg/dL) / (mmol/L) (70-105) / (3.9-5.8) (70-110) / (3.9-6.1) Less than (160) / (8.9) Less Than (120) / (6.7) Greater than (70) / (3.9) (1989). Joslin Diabetes Manual. Your target range (mg/dL) / (mmol/L)

Source: Krall, L.P., Beaser, R.S. Philadelphia: Lea and Febiger. P138.

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Reading Variation Factors An abnormally high or low red blood cell count (hematocrit levels over 60% or below 20%) may produce inaccurate results. A normal red blood cell count is in the 30-50% range. It may be below or over the normal range in newborns, pregnant women, or those suffering from serious anemia. Test results below 70 mg/dL (3.9 mmol/L) indicate low blood glucose levels (hypoglycemia). Results above 240 mg/dL (13.3mmol/L) indicate high blood glucose levels (hyperglycemia). Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from severe dehydration, consult your physician immediately. Consult your healthcare professional immediately if you have properly followed all the testing instructions and: You consistently receive hypoglycemia or hyperglycemia results, You are suffering from severe dehydration, or Your symptoms are not consistent with your blood glucose test results.

Caution

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Error Messages Message Possible Cause Action

Test Strip has been used.

Use a new strip

Blood sample before appeared.

Repeat test with new strip. applied Wait until symbol symbol appears before applying sample.

Temperature recommended during test.

Take system where out-side temperature is within range operating range (10~40 (50~104 ) and repeat test after 30 minutes. Repeat test with new test strip and adequate blood sample. Contact your healthcare professional if problem persists after testing several times.

The blood sample did not fill the reaction cell of the test strip during measurement because of abnormally high viscosity or insufficient volume.

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Comparing LGM-701B and Laboratory Results Test results from the LGM-701B and laboratory are both expressed in plasma-equivalent units. However, the results you obtain from your LGM701B may differ somewhat from your laboratory result due to normal variation. LGM-701B results can be affected by factors and conditions that do not affect laboratory results in the same way (See test strip package insert for typical accuracy and precision data). To make an accurate comparison between LGM-701B and laboratory results, follow the guidelines below. Before you go to the lab: Perform a control solution test to make sure that the LGM-701B is working properly. It is best to fast for at least eight hours before doing comparison tests. Take your LGM-701B with you to the lab. While at the lab: Make sure that the samples for both tests are taken and tested within 15 minutes of each other. Wash your hands before obtaining a blood sample. Use only fresh capillary blood obtained from the fingertip. You may still have a variation from the result because blood glucose levels can change significantly over short periods, especially if you have recently eaten, exercised, taken medication, or experienced stress. In addition, if you have eaten recently, the blood glucose level from a fingers tick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein used for a lab test. Therefore, it is best to fast for 8 hours before doing comparison tests. Factors such as the amount of red blood cells in the blood (a high or low hematocrit) or the loss of body fluid (several dehydration) may also cause a meter result to be different from a laboratory result. Reference 1. Surwit, R.S., and Feinglos, M.N.: Diavetes Forecast (1988), Apr, 49-51. 2. Sacks, D.B.: Carbohydrates. Burtis, C.A., and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.

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Performance Characteristics Accuracy Whole blood glucose test results were compared with YSI-2300 glucose analyzers. Accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L) Within +5 mg/dL (Within +0.28 mmol/L) 21/28(75.0%) Within +10 mg/dL (Within +0.56 mmol/L) 28/28(100.0%) Within +15 mg/dL (Within +0.83 mmol/L) 28/28(100%)

Accuracy results for glucose concentration >75 mg/dL (4.2 mmol/L) Within 5% 112/172(65.1%) Within 10% 158/172(91.9%) Within 15% 170/172(98.8%) Within 20% 172/172(100%)

Slope y-intercept Correlation coefficient(r) Number of samples Range tested

0.968 4.389 mg/dL (0.25 mmol/L) 0.995 200 27-553 mg/dL (1.51-30.1 mmol/L)

Precision This study shows the CV (correlation variation) is less than 5%. Within Run Precision Blood Average 45.8 mg/dL(2.56 mmol/L) SD=1.1 mg/dL Blood Average 76.5 mg/dL(4.28 mmol/L) CV=1.5% Blood Average 137.3 mg/dL(7.69 mmol/L) CV=2.2% Blood Average 228.4 mg/dL(12.79 mmol/L) CV=2.2% Blood Average 355.7 mg/dL(19.92 mmol/L) CV=2.9% Total Precision Control Average 46.9 mg/dL(2.63 mmol/L) SD=2.0 mg/dL Control Average 117.3 mg/dL(6.57 mmol/L) CV=2.6% Control Average 321.7 mg/dL(18.02 mmol/L) CV=3.1%

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General Troubleshooting LGM-701B does not turn on after test strip insertion. Remove test strip from insertion hole. Reinsert. Make sure LGM-701B is on by pressing [SHOOT] Button for 2 seconds. If LGM-701B doesnt power, battery may be low. Charge the battery using charger. LGM-701B does not countdown from five-to-one (5-to-1) after applying blood sample. Check test strip confirmation window for adequate blood sample. Repeat test with new test strip. Test result not consistent with your expectation. Ensure test strip bottle and LGM-701B code numbers match. Repeat test with new test strip. Make sure sample was applied in time. Repeat test with new test strip. Draw sample from another fingertip or alternate site. Repeat test with new test strip. Laser does not Shoot Check the safety slide cover and press disposable cap firmly. Wait until LED flashes and beeps. Blood sample cannot obtained Increase laser energy level. Select a less calloused fingertip site. The laser may over-heat after discharging repeatedly in a short time, thus reducing efficiency. Allow unit to cool for 2 minutes. Blood gathering is painful Reduce the laser energy level. Do not reuse disposable cap. Laser lens is dirty. It requires periodic cleaning with a cotton bud.

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Caring & Handling & Storage Caring for LGM-701B Do not disassemble your LGM-701B. If you have any questions, please contact your local authorized distributor. Please use your LGM-701B. Avoid throwing, shaking, or dropping it, which may damage its internal parts. Clean the LGM-701Bs surface with a soft cloth slightly dampened with water. Do not use industrial solvents for cleaning the LGM-701B. Do not wash or pour liquid into the LGM-701B. Handling & Storage Handle your LGM-701B with care and protect it from direct sunlight or extremely high or low temperature. Do not expose your LGM-701B, test strips and control solution to an environment of high humidity, such as bathroom, kitchen, etc. Store and transport the LGM-701B in a dry place between -10~50 (14~122). Keep your LGM-701B free of dust. It is recommended to use the carrying case. Put your system in an appropriate operation environment at least 30 minutes before testing.

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Laser Lens Cleaning If you notice a reduction of performance in the laser lancing device or you feel a sharp pain or blood sample cannot obtained, the laser lens may need cleaning. Clean the lens every month or after 50 shooting or every time the disposable cap is replaced. Using cotton bud with alcohol and rubbing the laser lens very softly. Do not use industrial solvents for cleaning the laser lens. Step 1 Step 2 Step 3 Step 4 Step 5 Remove the disposable cap or raise the safety slide cover (Interlock). Moisten the cotton bud with alcohol. Gently insert the cotton bud into the laser lens surface. Touch the lens and wipe softly in a circular motion. Let stand the lens to dry for 5 minutes.

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Safety Feature of Laser Lancing Device The laser lancing device includes several safety features designed to prevent unwanted injury to the patient or operator. For additional safety information, contact ISOTECH Co., Ltd. Laser lancing device have three safety interlock switch. That is Safety slide cover for open the laser aperture, finger plate for ready to radiation and Shoot button for laser radiation. In order to operate the laser lancing device, first, raise the safety slide cover, second, insert the disposable cap into the finger plate and press the cap downward with fingertip, third, press the SHOOT button for radiation. Laser Lancing Device Information and Safety Label

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Product Specifications Blood Glucose monitoring system Result Range 20 to 600 mg/dL (1.1 to 33.3 mmol/L) Calibration Plasma-equivalent Sample Fresh capillary whole blood Sample Size Minimum 0.5 micro liter Test Time 5 seconds Assay Method Glucose oxidase biosensor Glucose Units Either mg/dL or mmol/L Memory 250 blood glucose results Laser Lancing Device Wavelength 2940 nanometers (Er:YAG) Repetition Rate Single shot operation Pulse Width 250 microseconds (typical) Spot Size 0.15 millimeters (typical) Energy per Adjustable in 8 steps (Min : 80 mJ / Max : 350 mJ) Pulse Resting interval 2 minutes (typical) Physical Specification Dimension 124(H) X 63(W) X 27(D) Weight 170 g (battery included) Power Source One rechargeable 3.7 V Li-ion battery (ICR-16340) Battery life 100~150 laser shoot at full charge(depend on energy level) Operating Range 10 ~ 40 (50 ~ 104) / 10 ~ 90%RH Storage/Transport -10 ~ 50 (14 ~ 122) / 10 ~ 90%RH Classifications CDRH Classification FDA Classification Applied Part Classification MDD Classification IVDD Classification Operation Classification

Class IV Medical Laser Class II Medical Device BF IIa according to Rule 6 of MDD, annex IV List B according to IVDD Intermittent

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Product Specifications Electrical Specification Battery Power Charging Power Battery Charger 3.7 Vdc, 650 mAh 4.2 Vdc, 2.94 W Input : 100 - 240V~, 50/60 Hz, 120 mA Output : 4.2 Vdc, 700 mA Model : TA-50A Manufacturer : MNK Inc (Korea)

Normal Environment Condition Indoor use Altitude up to 2000 m Temperature 5 to 40 Maximum relative humidity 80% from temperature up to 31 decreasing linearly to 50% relative humidity at 40. Overvoltage category I Pollution degree 2 Battery Specification Model Manufacturer Type Rate ICR-16340 Shaghai Chenrong Electronics Co., Ltd. Lithium Ion Rechargeable Battery 3.7 Vdc, 650 mAh

Caution

Use only rechargeable, replaceable, type ICR-16340 lithium ion battery with 3.7 Vdc nominal voltages, 650 mAh nominal capacities. There is a risk of explosion or fire hazard if the battery is replaced with an incorrect type or charging of non-rechargeable battery.

Caution

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Conformity Statement
Isotech Co., Ltd. declares that the LGM-701B Blood Glucose Monitoring system with Laser Lancing Device meet the CE Mark Requirements according to Annex IV of the In Vitro Device Directive IVDD 98/79/EEC, Annex II of the Medical Device Directive MDD 93/42/EEC and following standards: EN ISO 13485: 2003 ISO 15197: 2003 ANSI/ASQC Q10013 EN ISO 9001: 2008 ANSI/ASQC Q9001 EN 376: 2002 EN 13532: 2002 EN 13612: 2003 EN 13640: 2002 EN ISO 14971: 2007 ISO/DIS 17511: 2003 IEC 61010-1 2nd ed. 2001-02 IEC 61010-2-101 =: 1st ed. 2002-01 IEC 61326-1: 2005 EN 60068-2-64: 2009 EN 60601-2-22 EN 60601-1 EN 60601-1-2 EN 60825-1 EN 61000-4-2 EN 61000-4-3 Quality Systems Medical devices - Particular requirements for the application of EN ISO 9001 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus Guide lines for Developing Quality Manuals Quality Systems ISO 900 Standard Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing General requirements for in vitro diagnostic medical devices for Self testing Performance evaluation of in vitro diagnostic medical devices Stability testing of in vitro diagnostic medical devices Medical devices - Application of risk management to medical devices In vitro diagnostic medical devices - Measurements of quantities in samples of biological origin - Metrological traceability of values assigned to calibrators and control materials Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2: Particular requirements for in vitro diagnostic (IVD) medical equipment. Electrical equipment for measurement, control and laboratory use - EMC requirements Environmental testing Part 2. Test method Test Fh. Vibration, broad-band random (digital control) and guidance Safety requirements of Medical Electrical Equipment Safety of Laser products, part 1 ESD Immunity Test RF Immunity Test

Isotech Co.,Ltd. is registered with TUV registration number CE0123. This product is in conformity with performance standards for laser products under 21 CFR 1040, except with respect to those characteristics authorized by Variance number 98V0868 effective Oct. 30, 1998. In lieu of the requirement referred to in provisions of 21 CFR 1040.10(f) (3) and 1040.10(f) (4) of the performance standard for laser products the following condition shall apply to the LGM-701B Blood Glucose Monitoring system with Laser Lancing Device manufactured under this variance:

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Warranty Information Manufacturers Warranty ISOTECH Co., Ltd. warrants that the LGM-701B Meter shall be free of defects in material and workmanship in normal use for a period of One (1) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter. Any claim must be made within the warranty period. The ISOTECH will, at its discretion, repair or replace a defective meter or meter part that is covered by this warranty. As a matter of warranty policy, ISOTECH will not reimburse the consumers purchase price. Obtaining Warranty Service To obtain warranty service you must return the defective meter or meter part along with proof of purchase to your nearest ISOTECH Authorized Warranty Station. Important! The device could be sent back to the manufacturer for recycling or proper disposal after their useful lives. Alternatively the device shall be disposed in accordance with national laws after their useful lives.

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Warranty Card
LGM-701B Blood Glucose Monitoring System with LASER Lancing Device Thank you for purchasing our product. Please complete and mail this warranty card within 30 days of purchase of your LGM-701B. Name : Sex : City : Phone Number : Healthcare professional Who Recommended : Store / Pharmacy Name Where Purchased : Date of Purchase : Lot / Serial No. : Age : Country :

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Electromagnetic Compatibility (EMC)

The LGM-701B complies to the requirements of the electro-magnetic compatibility (EMC) when used with the following cables and operating mode : Battery charger cable : 1.2 m Mode 1 : Battery charge mode Mode 2 : Laser lancet and blood glucose meter According to the operating conditions specified by the manufacturer, the battery charger is connected to the equipment only for battery charging. Guidance and declaration of the maker electromagnetic emissions The LGM-701B is intended for use in the electromagnetic environment specified below. The customer or the user of the LGM-701B should assure that it is used in such an environments. Emission test Compliance Electromagnetic environment - guidance RF emissions Group 2 The LGM-701B must emit electromagnetic energy CISPR 11 in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions Class A The LGM-701B may be used in all household type CISPR 11 premises, including those directly connected to the public low-voltage power supply network that Harmonic Class A supplies building used for domestic purposes. emissions IEC 61000-3-2 Voltage Complied fluctuations Flicker emissions IEC 61000-3-3 Guidance and declaration of the maker electromagnetic immunity The LGM-701B is intended for use in the electromagnetic environment specified below. The customer or the user of the LGM-701B should assure that it is used in such an environments. Compliance Immunity IEC 60601 Electromagnetic environment level Test Test level guidance Electrostatic 6 kV contact Complied Floors should be wood, concrete or discharge(ESD 8 kV air ceramic tile. If floors are covered ) with synthetic material, the IEC 61000-4-2 relative humidity should be at least 30% Electrical fast 2 kV for power Complied Main power quality should be that transient / supply lines of a typical commercial or hospital burst environment. 1 kV for IEC 61000-4-4 input/output lines Surge 1 kV lines to Complied Mains power quality should be that IEC 61000-4-5 lines of a typical commercial or hospital environment. 2 kV lines to earth Voltage dips, <5% UT (>95% Complied Mains power quality should be that

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short interruptions and voltage variations on power supply input lines IEC 61000-411

Power frequency(50/ 60 Hz) magnetic field IEC 61000-4-8

dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle <5% UT (>95% dip in UT) for 5 sec 3 A/m

of a typical commercial or hospital environment. If the user of the LGM-701B requires continued operation during power mains interruptions., it is recommended that the LGM-701B be powered from an uninterruptible power supply or a battery.

Complied

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of the LGM-701B, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3V 3 V/m

3.5 ] P V1 3.5 d [ ] P 80 MHz to 800 MHz E1 7 d [ ] P 800 MHz to 2.5 GHz E1 d [

Where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1), should be less than the compliance level in each frequency range2). Interference may occur in the vicinity of equipment marked with the following symbol :

NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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1) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LGM-701B is used exceeds the applicable RF compliance level above, the LGM-701B should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the LGM-701B. 2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the LGM-701B The LGM-701B is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LGM-701B can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the LGM-701B as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter M Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz output power of transmitter W

d [

3.5 ] P V1

d [

3.5 ] P E1

d [

7 ] P E1

where V1 = 3 V where E1 = 3 V/m where E1 = 3 V/m 0.01 0.1167 0.1167 0.233 0.1 0.369 0.369 0.738 1 1.167 1.167 2.333 10 3.69 3.69 7.378 100 11.667 11.667 23.33 For transmitter rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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ISOTECH Co., Ltd. 305-509 3rd floor 692, Gwanpyeong-dong, Yuseong-gu Daejeon, Republic of Korea Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 D-66386 St. Ingbert, Germany

2009 ISOTECH Co., Ltd. All rights reserved. ARTJ10 Rev. 0 08. 09