Laserdoctor-LGM Operation Manual

8/4/2019 Laserdoctor-LGM Operation Manual

1/48

LASER DOC

(LGM-701B)

User Manual

Blood Glucose Monitoring System with LASER Lancing Device


2/48

-2-

Self Test

Thank you for selecting

the LGM-701B Blood Glucose Monitoring System

with Laser lancing device.

Please read this manual thoroughlyBefore you start testing.

It provides all the informationyou need to use the product.

You will get a correct test resultby the following instruction of this manual.


3/48

-3-

Table of Contents

Important Information............................................................................................ 4

Safety Information of LGM-701B with Laser Lancing Device ............................ 6Principle 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 ................................................. 34Performance 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


4/48

-4-

Important Information

Intended Use

TheLGM-701B Blood Glucose Monitoring System with Laser lancing deviceis intended for self-test use for the quantitative measurement of glucose infresh 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 thediagnosis 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 withdifferent ambient temperature.

Keep your LGM-701B free of dust, water or any other liquid, don t exposeit directly to the sun and avoid throwing, shaking, or dropping it, whichmay damage its internal parts.

Dont use your LGM-701B near cellular or cordless telephones, microwaveoven or other electrical or electronic equipment that are sources ofelectromagnetic radiation, as these may interfere with the properoperation of the LGM-701B.

Dont disassemble your LGM-701B.


5/48

-5-

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, pleasecontact your ISOTECH authorized representative or call us.

In Korea contact:

Isotech Co., Ltd.305-509 3rd floor,692, Gwanpyeong-dong,

Yuseong-gu Daejeon, Republic ofKoreaTel: +82-42-934-1105 / 1152Fax: +82-42-934-1106

E-mail: [email protected]

In EU contact :

Medical Technology PromedtConsulting GmbHAltenhofstrasse 80 D-66386

St. Ingbert, Germany


6/48

-6-

Safety Information of LGM-701B with Laser Lancing Device

Caution

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 usingthis product.

Caution

This product contains high voltage circuit. Do not attempt toremove or open any part of the product case.

Caution

Use of damaged or improperly adjusted equipment or improperuse of equipment could result in personal injury.

Caution

Laser lancing device is a class IV laser for perforation of the

fingertip to draw a capillary blood sample. Improper use ormisuse could result in personal injury. Read all warning andinstructions before use.

Caution

Use of controls or adjustments or performance of proceduresother than those specified herein may result in hazardous laserradiation exposure.

Caution

Never attempt to look into the laser aperture.Never attempt to use mirrors or other devices to observe thelaser beam or lens.

Caution

Do not use this product near flammable gases. This productmay cause ignition of explosive or flammable gases.

Caution

The laser may over-heat after radiation repeatedly in a short

time, thus reducing efficiency. Allow unit to cool for about 2

minutes.


7/48

-7-

Safety Information of LGM-701B with Laser Lancing Device

DANGERMisuse of electrical equipment can cause electrocution, burns,fire and other hazard.

Important

Check that the voltage setting matches the supply voltage.

Important

Use the equipment only for the purpose described in theinstructions for use.

Important

Do not use accessories which are not supplied orrecommended by the manufacturer.

Important

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

Important

Use only rechargeable, replaceable, type ICR-16340 lithium

ion battery with 3.7 Vdc nominal voltages, 650 mAh nominalcapacities.

Important

Use only the battery charger supplied by the manufacturer

with your LGM-701B. Use of another charger could result indamage to the instrument.

Important

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


8/48

-8-

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 fordetermination of capillary blood glucose values. This analysis is based onelectrochemical technology using glucose oxidase that is specific for theblood glucose measurement. When blood sample is applied to the test strip,

the electrons are formed by the reaction between glucose oxidase and bloodglucose. The intensity of the electrons is measured by the meter andcorrelates with the concentration of glucose in the blood sample. Test result

is calibrated to be plasma equivalent.

Principle of LASER Lancing DeviceThe LASER Lancing Device relates to a personal portable low-pain blood

lancing device, which is capable of lancing from the skin without any pain byusing an Er:YAG LASER technology in the medical field, and further by usinga laser beam having a wavelength of 2940 nm, which has a strongabsorption 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-dopedyttrium aluminum garnet (Er:Y3Al5O12). Er:YAG lasers typically emit light

with a wavelength of 2940 nm, which is infrared. It is optically pumpedusing 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 amplifyinglight by stimulated emission and consists of two mirrors arranged such thatlight bounces back and forth, each time passing through the rod. Typicallyone of the two mirrors, the output coupler, is partially transparent. The

output laser beam is emitted through this mirror.


9/48

-9-

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 device2. ISOTECH Test Strip (10T)3. ISOTECH Check Strip4. Disposable Cap (20T)

5. Users Manual (Book)6. Users Manual (Video CD)7. Quick Reference Guide

8. Log Book

9. Pouch10. Battery and Charger11. ISOTECH Control Solution (optional)

12. Data cable and Glucose data transfer program CD (optional)


10/48

-10-

System Configuration

LCD WindowDisplay glucose result, laser level, strip code,date, symbols and error messages.

Menu Selection ButtonUsed to select memory, average, setting and

return normal mode.

Search Button

(Left/Right)

Used to search data stored in memory,

inc/dec laser energy level, strip code andnumbers.

LASER Shoot ButtonUsed to shoot laser, power on/off or confirm a

selected parameters.

Strip Insertion Hole Insert test strip here.

Strip Remove Lever Pull the lever down to remove used strip.

Charger Connector slot Connect the slot to battery charger here.

LASER Safety Slide Cover Pull the cover up to shoot the laser.

Finger plate

with Aperture

LASER Radiation through the aperture. Forthe safety of body, normally it covered withsafety slide cover.To enable the laser radiation, press the finger

plate downward slightly.

Battery Slot and Cover Slide cover to install battery.


11/48

-11-

LCD Information

CodeIndicates that the big number is the code of strip for

3 seconds after strip insertion.

LaserIndicates that the safety slide cover is upward andthus laser is ready for use.

mem Indicates a test result stored in memory.

Avg Shows average value of test results.

Check Appears during meter testing using check strip.

Buzzer symbol Indicates that the buzzer sound is on.

Blood symbol Indicates meter is ready to apply the blood sample.

Laser ready

symbol

Blinking symbol indicates that laser is ready to

shoot.

mmol/L Appears when the unit of result is set to mmol/L.

mg/dL Appears when the unit of result is set to mg/dL. Decimal point Appears when result is set to mmol/L unit.

Data FieldIt shows the test result (include HI/LO), strip code

number, test record, laser energy level, Errormessage.

Battery symbol Indicates the remains value of battery power.

Hour: Minute Shows Current Time hh:mm.

Month-Day Shows Current Date mm-dd.


12/48

-12-

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.

Step 2 Install battery(ICR-16340). Be sure toput battery in correct direction.

Step 3 Close the cover until it snaps into place.

Charge the Battery

Step 1 Plug the battery charger into an AC power

outlet.

Step 2 Plug the cord from the battery charger into

the connector slot on the LGM-701B.

Step 3 Wait until all the LED lights of the batterycharger turns green from orange.

Step 4 Unplug connector of the battery charger

from connector slot on the LGM-701B

Step 5 Unplug the battery charger from the AC

power outlet.


13/48

-13-

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.

Important

Use only the battery charger supplied by the manufacturerwith your LGM-701B.

Use of another charger could result in damage to theinstrument.

Dont use the LGM-701B with battery charger connected. Battery must be fully charged prior to first time use. A full recharge takes about 2 hours.

Caution

Use only rechargeable, replaceable, type ICR-16340 lithium ionbattery with 3.7 Vdc nominal voltages, 650 mAh nominalcapacities.

Caution

There is a risk of explosion or fire hazard if the battery is

replaced with an incorrect type or charging of non-rechargeablebattery.


14/48


15/48

-15-

Turning On/Off the LGM-701B

Important

Before Starting

Before using the LGM-701B, make sure you have read theprevious sections of this manual including warning, caution,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 appearbriefly, 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 forover 2 minutes.

Here are two way of turning ON the LGM-701B.

Keep press the [SHOOT] for 2seconds.

Insert test strip.

Important

Checking the DisplayEach time you turn on the LGM-701B either by inserting a test

strip or pressing the [SHOOT] button, all segments of thedisplay will appear briefly. This tells you that the system isperforming several self-checks to confirm that the LGM-701Bis working properly.

If some segments such as decimal point for mmol/L or datafield for result may not appear, they will cause inaccurate testresults. If some segments may not appear, contact your local

sales representative.


16/48

-16-

How to collect blood sample using laser lancing device

Caution

Laser lancing device is a class IV laser for perforation of the

fingertip to draw a capillary blood sample. Improper use ormisuse could result in personal injury. Read all warning andinstructions before use.

Caution

Before you take the blood sample, Please wash your hands and

the puncture site.Use warm, soapy water, rinse and dry thoroughly.

Step 1

Turn on the LGM-701B

Step 2Raise 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 [] button. Generally the

levels 2 ~ 5 are appropriate for adults.


17/48

-17-


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 energylevel.

When fully charged, the laser ready symbol and green LED blinks andbeep sound.


18/48

-18-


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.

Important

To reduce the chance of infection : Never share a disposable cap with anyone. Always use a new, disposable caps are for single use only. Take the disposable cap out carefully and place it into a

container for cross-contamination.


19/48

-19-

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 displaysSETon data field.

Step 1 : Set the Month

With the Month setting flashing, press [] button until the correct month is display onthe LCD.

Press [SHOOT] to confirm the month adjustmentand the day setting will start flashing.

Step 2 : Set the Day

With the Day setting flashing, press []button until the correct day is display on theLCD.

Press [SHOOT] to confirm the day adjustmentand the hour setting will start flashing.

Step 3 : Set the Hour

With the Hour setting flashing, press []button until the correct Hour is display on theLCD.

Press [SHOOT] to confirm the hour adjustmentand the minute setting will start flashing.

Step 4 : Set the Minute

With the Minute setting flashing, press [] button until the correct minute is display onthe LCD.

Press [SHOOT] to confirm the minuteadjustment and the sound setting will startflashing.


20/48

-20-

Setting Up Your LGM-701B

Step 5 : Set the Sound

With the Buzzer symbol flashing, 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 [] button to change the measurement unit.

Press [SHOOT] to confirm the unit and the yearsetting will start flashing.

Step 7 : Set the Year

With the Big Number setting flashing, press [] button until the correct year is display onthe LCD.

Press [SHOOT] to confirm the year adjustmentand the deleting mode will appear.

Step 8 : Deleting Stored Result

With the dEL setting appear, press []button until the correct [YES] or [NO] is displayon the LCD.

To delete all memory, choose [YES] and Press[SHOOT] to confirm. [oFF] on the LCD will

appear and automatically power off.

Important

The LGM-701B can display test result in milligrams perdeciliter (mg/dL) or millimoles per liter (mmol/L)

Your LGM-701B was set at the factory to the unit generallyused in our country.

It should be changed only on the recommendation of yourhealthcare professional.


21/48

-21-

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-dayaverages of your blood glucose test results.

Recalling Stored ResultStep 1 : Enter the Memory Mode

Turn on the LGM-701B and click [MENU] once to go into memorymode. mem symbol appear on the LCD.

The number of test results stored at memory will display as data fieldfor 1 second.

The last glucose data stored in memory will display with the month-day-hour-minute.

Step 2: Search the Test Results

Click [] 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 memorymode. Avg symbol appear on the LCD.

The latest 7-days average value of test result stored will be displaywith unit.Step 2 : Select 7/14/30 days Average

Click [] allows you to select the latest 7, 14, or 30-daysaverage 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 memorydeleting mode.

Step 2 : Select YES or No

Click [] 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.


22/48

-22-

Check the LGM-701B with the ISOTECH Check Strip

Note

The ISOTECH Check Strip is used to determine if the LGM-701B

is functioning properly. To perform the test, start with the LGM-701B turned off.

Step 1 : Insert Check Strip

Remove check strip from package andinsert check strip into strip insertionhole.

Step 2: Wait and Confirm

After 3 seconds, LCD shows checkresult YES or No.

If result is YES, LGM-701B isfunctioning properly.

Repeat test once or twice if result isNO.

Note

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


23/48

-23-

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 isautomatically drawn into the reaction cell.

Top EdgeApply the blood sample on top edgeof test strip.

Confirmation WindowCheck here to confirm if enough

blood has been applied.

Contact BarsGently push the test strip with itscontact bars facing up into strip

Insertion hole of LGM-701B.LGM-701B will beep and displaycode number.


24/48

-24-

Important Test Strip Information

Store test strips only in their original bottle in a cool, dry place between8~30 (46~86). Keep away from direct sunlight and heat. Do notrefrigerate.

To avoid damage or contamination, do not transfer test strips to anyother place.

Do not use test strips beyond the expiration date printed on the packagesince they may cause inaccurate results.

After removing a test strip from the bottle, replace the cap immediatelyand close it tightly.

With clean, dry hands, you may touch the test strip anywhere on itssurface.

Use each test strip immediately after removing it form the bottle. Count three months from the date you first open a new bottle of teststrips 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.

Warning

Keep the test strip bottle and strips away from children. The

strip may be choking hazards. Also, the cap may contain dryingagents that are harmful if inhaled or swallowed and may causeskin or eye irritation.


25/48

-25-

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 Stripsfor 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 codenumber on the test strip bottle.

If the two code numbers match, wait until in testing. Wait untilsymbol appears on the LCD to begin the test.

If they do not match, follow Step 3.Step 3 Set Code

Click [] to scroll code numbers up or down. The LGM-701B hasa total of 63 codes.

Stop at correct code number. After selecting correct code number, waitfor 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 teststrip bottle.

Caution

Failure to code the LGM-701B correctly will cause inaccuratetest results.


26/48

-26-

Performance Checking the LGM-701B and Test Strip

ISOTECH Control Solution is used to check that theLGM-701B and the test strips are working together asa system and that you are performing the testcorrectly.

It is very important that you do this simple checkroutinely to make sure you get an accurate result.

ISOTECH Control Solution contains a measuredamount of glucose that reacts with ISOTECH TestStrips.

Compare your control solution test results with therange 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 yourblood.

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.

Caution

The control solution range printed on the test strip bottle is for

ISOTECH Control Solution only. It is not a recommended rangefor your blood glucose level.


27/48

-27-

How to do a control solution test

Step 1 Insert a test strip contact bars facing up into the strip insertion

hole.

Step 2 Be sure the code number on the display matches the codenumber on the test strip bottle.

Step 3 Shake the control solution bottle well.Squeeze the vial, discard the first drop and wipe off the tip.

Step 4 After symbol appears on the display, apply the solution tonarrow tip edge of the test strip until the beeps.

Step 5 LGM-701B begins to count down and the test result will appear.

Step 6 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, repeatthe rest. Out of range results may be caused by one or more of thefollowing: 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

Caution

If you continue to get control solution test results that falloutside 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.


28/48

-28-

Starting the Test

CautionBefore Testing, Wash your hands with warm, soapy water. Rinseand dry thoroughly.

Read this section and the test strip packageinset 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, waituntil in testing.

Step 2 Open the laser aperture and set laser energy level

Open the laser aperture by raising gently the safety slide cover fullyupward until beeps.

Set laser energy level by click []. Generally the levels 2~5 areappropriate for adults.


29/48

-29-

Starting the Test

Step 3 Insert Disposable Cap and Position the Finger

Grasp a rectangle plate of the disposable cap and insert the cap intothe 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 energylevel.

When fully charged, the laser ready symbol and green LED blinks andbeep 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 acontainer.

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.


30/48

-30-

Starting the Test

Step 6 Apply Blood Sample

After Shoot the laser, current strip code will bedisplayed again.

And thus its ready to set strip code again. Ifyou change the strip code again you must set

the code within 3 seconds before symbol

blink.

When the symbol blinking, LGM-701B isready for testing.

Apply the collected blood sample to narrow tipedge of the test strip until the beeps.

It through its capillary fills up its confirmationwindow 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, yourblood 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 yoursystem.

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 capcarefully.

Caution

If confirmation window hasnt filled

in time because of abnormalviscosity or insufficient volume, Er4

message will appear. GOOD Insufficient


31/48

-31-

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 yourtesting results, repeat the test with a new strip. You can also run a

performance check with your ISOTECH check strip and ISOTECH controlsolution to check your LGM-701B and strip. If the test result still remainsunusually 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 thismanual, contact your healthcare professional immediately.

LO Message

The LGM-701B displays results between 20 and600 mg/dL (1.1 to 33.3 mmol/L).

If your test result is below 20mg/dL (1.1mmol/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 healthcareprofessional.

HI Message

If your test result is above 600 mg/dL (33.3mmol/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 healthcareprofessional.

Expected Test Results

Time of dayRange without diabetes

(mg/dL) / (mmol/L)Your target range

(mg/dL) / (mmol/L)

Before breakfast (70-105) / (3.9-5.8)

Before lunch or dinner (70-110) / (3.9-6.1)

1 hour after meals Less than (160) / (8.9)

2 hours after meals Less Than (120) / (6.7)

Between 2 and 4 AM Greater than (70) / (3.9)

Source: Krall, L.P., Beaser, R.S. (1989). Joslin Diabetes Manual.

Philadelphia: Lea and Febiger. P138.


32/48

-32-

Reading Variation Factors

An abnormally high or low red blood cell count (hematocrit levels over60% or below 20%) may produce inaccurate results.

A normal red blood cell count is in the 30-50% range. It may be below orover 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) indicatehigh blood glucose levels (hyperglycemia).

Severe dehydration (excessive water loss) may cause false low results. Ifyou believe you are suffering from severe dehydration, consult yourphysician immediately.

Caution

Consult your healthcare professional immediately if you haveproperly followed all the testing instructions and:

You consistently receive hypoglycemia or hyperglycemiaresults,

You are suffering from severe dehydration, or Your symptoms are not consistent with your blood glucose

test results.


33/48

-33-

Error Messages

Message Possible Cause Action

Test Strip has been used. Use a new strip

Blood sample applied

before symbolappeared.

Repeat test with new strip.

Wait until symbolappears before applying

sample.

Temperature out-siderecommended rangeduring test.

Take system where

temperature is withinoperating range (10~40(50~104) and repeattest after 30 minutes.

The blood sample did notfill the reaction cell of thetest strip during

measurement because ofabnormally high viscosity

or insufficient volume.

Repeat test with new test

strip and adequate bloodsample.Contact your healthcareprofessional if problem

persists after testingseveral times.


34/48

-34-

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 LGM-701B may differ somewhat from your laboratory result due to normalvariation. LGM-701B results can be affected by factors and conditions that

do not affect laboratory results in the same way (See test strip packageinsert for typical accuracy and precision data). To make an accuratecomparison between LGM-701B and laboratory results, follow the guidelinesbelow.

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 levelscan change significantly over short periods, especially if you have recently

eaten, exercised, taken medication, or experienced stress. In addition, ifyou 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 fora 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 ameter result to be different from a laboratory result.

Reference1. 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.


35/48

-35-

Performance Characteristics

Accuracy

Whole blood glucose test results were compared with YSI-2300 glucoseanalyzers.

Accuracy results for glucose concentration 75 mg/dL (4.2 mmol/L)

Within 5% Within 10% Within 15% Within 20%

112/172(65.1%) 158/172(91.9%) 170/172(98.8%) 172/172(100%)

Slopey-intercept

Correlation coefficient(r)Number of samples

Range tested

0.9684.389 mg/dL (0.25 mmol/L)

0.995200

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/dLBlood 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 PrecisionControl Average 46.9 mg/dL(2.63 mmol/L) SD=2.0 mg/dLControl 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%


36/48

-36-

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. IfLGM-701B doesnt power, battery may be low. Charge the battery using

charger.

LGM-701B does not countdown from five-to-one (5-to-1) afterapplying 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 testwith 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.


37/48

-37-

Caring & Handling & Storage

Caring for LGM-701B

Do not disassemble your LGM-701B. If you have any questions, pleasecontact 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 orextremely high or low temperature.

Do not expose your LGM-701B, test strips and control solution to anenvironment 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.


38/48

-38-

Laser Lens Cleaning

If you notice a reduction of performance in the laser lancing device oryou feel a sharp pain or blood sample cannot obtained, the laser lensmay need cleaning.

Clean the lens every month or after 50 shooting or every time thedisposable 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 Remove the disposable cap or raise the safety slide cover

(Interlock).

Step 2 Moisten the cotton bud with alcohol.

Step 3 Gently insert the cotton bud into the laser lens surface.

Step 4 Touch the lens and wipe softly in a circular motion.

Step 5 Let stand the lens to dry for 5 minutes.


39/48

-39-

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 slidecover for open the laser aperture, finger plate for ready to radiation andShoot button for laser radiation.

In order to operate the laser lancing device, first, raise the safety slidecover, second, insert the disposable cap into the finger plate and press thecap downward with fingertip, third, press the SHOOT button for radiation.

Laser Lancing Device Information and Safety Label


40/48

-40-

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 perPulse

Adjustable in 8 steps (Min : 80 mJ / Max : 350 mJ)

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 Class IV Medical Laser

FDA Classification Class II Medical Device

Applied PartClassification

BF

MDD Classification IIa according to Rule 6 of MDD, annex IV

IVDD Classification List B according to IVDD

Operation Classification Intermittent


41/48

-41-

Product Specifications

Electrical Specification

Battery Power 3.7 Vdc, 650 mAh

Charging Power 4.2 Vdc, 2.94 W

Battery Charger Input : 100 - 240V~, 50/60 Hz, 120 mA

Output : 4.2 Vdc, 700 mAModel : TA-50AManufacturer : MNK Inc (Korea)

Normal Environment Condition

Indoor use

Altitude up to 2000 mTemperature 5 to 40

Maximum relative humidity 80% from temperature up to 31 decreasing

linearly to 50% relative humidity at 40.

Overvoltage category IPollution degree 2

Battery Specification

Model ICR-16340

Manufacturer Shaghai Chenrong Electronics Co., Ltd.

Type Lithium Ion Rechargeable Battery

Rate 3.7 Vdc, 650 mAh

Caution

Use only rechargeable, replaceable, type ICR-16340 lithium ion

battery with 3.7 Vdc nominal voltages, 650 mAh nominalcapacities.

Caution

There is a risk of explosion or fire hazard if the battery is

replaced with an incorrect type or charging of non-rechargeablebattery.


42/48

-42-

Conformity Statement

Isotech Co., Ltd. declares that the LGM-701B Blood Glucose Monitoring system withLaser Lancing Device meet the CE Mark Requirements according to Annex IV of theIn Vitro Device Directive IVDD 98/79/EEC, Annex II of the Medical Device DirectiveMDD 93/42/EEC and following standards:

EN ISO 13485:2003

Quality Systems Medical devices - Particular requirementsfor the application of EN ISO 9001

ISO 15197: 2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managingdiabetes mellitus

ANSI/ASQC Q10013 Guide lines for Developing Quality ManualsEN ISO 9001: 2008 Quality SystemsANSI/ASQC Q9001 ISO 900 StandardEN 376: 2002 Information supplied by the manufacturer with in vitro

diagnostic reagents for self-testingEN 13532: 2002 General requirements for in vitro diagnostic medical devices

for Self testingEN 13612: 2003 Performance evaluation of in vitro diagnostic medical devicesEN 13640: 2002 Stability testing of in vitro diagnostic medical devicesEN ISO 14971:2007

Medical devices - Application of risk management to medicaldevices

ISO/DIS 17511:2003

In vitro diagnostic medical devices - Measurements ofquantities in samples of biological origin - Metrologicaltraceability of values assigned to calibrators and controlmaterials

IEC 61010-1 2n ed.2001-02

Safety requirements for electrical equipment formeasurement, control and laboratory use - Part 1: Generalrequirements

IEC 61010-2-101=: 1st ed. 2002-01

Safety requirements for electrical equipment formeasurement, control and laboratory use - Part 2: Particularrequirements for in vitro diagnostic (IVD) medicalequipment.

IEC 61326-1: 2005 Electrical equipment for measurement, control andlaboratory use - EMC requirements

EN 60068-2-64:2009

Environmental testing Part 2. Test method Test Fh. Vibration,broad-band random (digital control) and guidance

EN 60601-2-22EN 60601-1EN 60601-1-2

Safety requirements of Medical Electrical Equipment

EN 60825-1 Safety of Laser products, part 1EN 61000-4-2 ESD Immunity Test

EN 61000-4-3 RF Immunity Test

Isotech Co.,Ltd. is registered with TUV registration number CE0123.This product is in conformity with performance standards for laser products under21 CFR 1040, except with respect to those characteristics authorized by Variancenumber 98V0868 effective Oct. 30, 1998.In lieu of the requirement referred to in provisions of 21 CFR 1040.10(f) (3) and1040.10(f) (4) of the performance standard for laser products the followingcondition shall apply to the LGM-701B Blood Glucose Monitoring system with LaserLancing Device manufactured under this variance:


43/48

-43-

Warranty Information

Manufacturers Warranty

ISOTECH Co., Ltd. warrants that the LGM-701B Meter shall be free ofdefects in material and workmanship in normal use for a period of One (1)

years. The meter must have been subjected to normal use. The warrantydoes 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 ormeter 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 meterpart along with proof of purchase to your nearest ISOTECH AuthorizedWarranty Station.

Important!The device could be sent back to the manufacturer for recyclingor proper disposal after their useful lives.

Alternatively the device shall be disposed in accordance withnational laws after their useful lives.


44/48

-44-

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 ofyour LGM-701B.

Name :

Sex : Age :

City : Country :

Phone Number :

Healthcare professional Who Recommended :

Store / Pharmacy Name Where Purchased :

Date of Purchase :

Lot / Serial No. :


45/48

-45-

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 modeMode 2 : Laser lancet and blood glucose meter

According to the operating conditions specified by the manufacturer, the batterycharger 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 insuch an environments.

Emission test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 2 The LGM-701B must emit electromagnetic energy

in order to perform its intended function. Nearbyelectronic equipment may be affected.

RF emissions

CISPR 11

Class A The LGM-701B may be used in all household type

premises, including those directly connected tothe public low-voltage power supply network that

supplies building used for domestic purposes.Harmonicemissions

IEC 61000-3-2

Class A

Voltagefluctuations

Flicker emissionsIEC 61000-3-3

Complied

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 insuch an environments.

Immunity

Test

IEC 60601

Test level

Compliancelevel

Electromagnetic environment

guidance

Electrostaticdischarge(ESD

)IEC 61000-4-2

6 kV contact

8 kV air

Complied Floors should be wood, concrete orceramic tile. If floors are covered

with synthetic material, therelative humidity should be at least

30%

Electrical fasttransient /

burstIEC 61000-4-4

2 kV for power

supply lines1 kV for

input/outputlines

Complied Main power quality should be thatof a typical commercial or hospital

environment.

Surge

IEC 61000-4-51 kV lines to

lines

2 kV lines to

earth

Complied Mains power quality should be that

of a typical commercial or hospitalenvironment.

Voltage dips, 95% Complied Mains power quality should be that


46/48

-46-

shortinterruptions

and voltagevariations onpower supplyinput linesIEC 61000-4-11

dip in UT) for 0.5cycle

40% UT (60%dip in UT) for 5cycle70% UT (30%dip in UT) for 25cycle95%dip in UT) for 5sec

of a typical commercial or hospitalenvironment. If the user of the

LGM-701B requires continuedoperation during power mainsinterruptions., it is recommendedthat the LGM-701B be poweredfrom an uninterruptible powersupply or a battery.

Powerfrequency(50/60 Hz)magnetic fieldIEC 61000-4-8

3 A/m Complied Power frequency magnetic fieldsshould be at levels characteristic ofa typical location in a typicalcommercial or hospitalenvironment.

Conducted RFIEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms150 kHz to 80MHz

3 V/m80 MHz to 2.5

GHz

3 V

3 V/m

Portable and mobile RF

communications equipment shouldbe used no closer to any part of

the LGM-701B, including cables,than the recommended separationdistance calculated from theequation applicable to thefrequency of the transmitter.

Recommended separation distance

PV

d ]5.3

[1

PE

d ]5.3[1

80 MHz to 800 MHz

PE

d ]7

[1

800 MHz to 2.5 GHz

Where P is the maximum outputpower rating of the transmitter inwatts(W) according to thetransmitter manufacturer and d isthe recommended separationdistance in meters(m)Field strengths from fixed RF

transmitters, as determined by anelectromagnetic site survey1),

should be less than the compliancelevel in each frequency range2).

Interference may occur in thevicinity of equipment marked withthe 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 propagationis affected by absorption and reflection from structures, objects and people.


47/48

-47-

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. Toassess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength inthe location in which the LGM-701B is used exceeds the applicable RF compliancelevel above, the LGM-701B should be observed to verify normal operation. Ifabnormal performance is observed, additional measures may be necessary, such asreorienting or relocating the LGM-701B.

2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile RFcommunications equipment and the LGM-701B

The LGM-701B is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or the user of the LGM-701B

can help prevent electromagnetic interference by maintaining a minimum distancebetween portable and mobile RF communications equipment and the LGM-701B asrecommended below, according to the maximum output power of the communicationsequipment.

Rated maximumoutput power of

transmitterW

Separation distance according to frequency of transmitterM

150 kHz to 80 MHz

PV

d ]5.3

[1

where V1 = 3 V

80 MHz to 800 MHz

PE

d ]5.3

[1

where E1 = 3 V/m

800 MHz to 2.5 GHz

PE

d ]7

[1

where E1 = 3 V/m

0.01 0.1167 0.1167 0.233

0.1 0.369 0.369 0.7381 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 recommendedseparation distance d in meters (m) can be estimated using the equation applicable tothe frequency of the transmitter, where P is the maximum output power rating of thetransmitter 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.


48/48

ISOTECH Co., Ltd.305-509 3rd floor692, Gwanpyeong-dong,

Yuseong-gu Daejeon,Republic of Korea

Medical Technology PromedtConsulting GmbH

Altenhofstrasse 80 D-66386St. Ingbert, Germany

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

Documents

Laserdoctor-LGM Operation Manual