Dear PRODIGY Voice System Owner:
This manual contains important information you must know about the system. Please read it thoroughly and carefully.
The greatest feature of the Voice system is its speaking function which is an acoustic aid for users especially with visual disability. Please note that this function is optional.
Another unique feature is its autocode function which means no need to calibrate your meter, therefore making it easier for you to monitor your blood glucose at home.
The following basic safety precautions should always be taken.
KEEP THESE INSTRUCTIONS
IMPORTANT SAFETY INSTRUCTIONS 03 IMPORTANT INFORMATION 04 ABOUT ATERNATIVE SITE TESTING (AST) 05 INTRODUCTION OF THE SYSTEM 07
Intended Use Principle of Measurement 07 Contents of the System 08 Appearance and Key Function of the Meter 09 Meter Display Segments 10 Appearance of the Test Strip 11
PREPARATION BEFORE USE 12
Battery Replacement 12 Setting the Meter and Deleting the Memory 14
BEFORE TESTING 18
About Prodigy® Control Solutions 18 Important Control Solution Information 19 How to Perform a Control Solution Test 20 TESTING YOUR BLOOD 23 Testing Procedure 24 Expected Test Results 31
COMPARING METER AND LABORATORY RESULTS 32 USING THE METER MEMORY 33
Viewing Results on the Meter 33 Viewing Results on a Personal Computer 37
CARING FOR YOUR METER AND TEST STRIPS 38
Cleaning 38 Storage 39
PROBLEMSOLVING GUIDE 41
Special Message 42 Error Message 43 Problem in Operation 45
SPECIFICATIONS 47 IMPORTANT INFORMATION
*1: Kahn, R., and Weir, G.: Joslinís Diabetes Mellitus, 13th ed. Philadelphia: Lea and Febiger (1994), 489.
*2: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), 261263.
ABOUT ALTERNATIVE SITE TESTING (AST)
Important: There are limitations for doing AST. Please consult your healthcare professional
What is AST?
Alternative site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels. This system allows you to test on the palm, the forearm, the upper arm, the calf, or the thigh with the equivalent results to fingertip testing.
What is the advantage?
Fingertips feel pain more readily because they are full of nerve endings (receptors). At other body sites, since nerve endings were not so condensed, you will not feel as much pain as at the fingertip.
Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at fingertip reflects these changes faster than capillary blood at other sites. Therefore when testing blood glucose during or immediately after meal, physical exercise,
or any other event, take blood sample from your finger only.
We strongly recommend you do AST ONLY in the following intervals:
Do NOT use AST if:
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained. Blood from the site without rubbing exhibits a measurably different glucose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.
INTRODUCTION OF THE SYSTEM
• Intended Use
The system is intended for use outside the body (in vitro diagnostic use only). It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The system is intended for use in the home and in clinical settings. It should not be used for the diagnosis of diabetes or for the testing of newborns.
AST in this system can be used only during steadystate blood glucose conditions described in the “About AST” section.
• Principle of Measurement
The test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current and displays the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
• Contents of the System
The Prodigy® Voice system consists of three main products: Prodigy® Voice blood glucose meter, Prodigy® Voice test strips, and a Prodigy® control solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
Use only Prodigy® Voice test strips and Prodigy® control solution with Prodigy® Voice meter.
1) Prodigy® Voice Meter 7) Daily log book 2) Prodigy® Voice Test strips 8) Lancing device with clear cap for Alternative Site Testing 3) Sterile lancets 9) Warranty card 4) User’s manual 10) (1) Prodigy® Control Solution 5) Carrying case 11) Prodigy® Voice Manual CD (not shown) 6) Quick Reference Guide 12) (2) 1.5v AAA alkaline batteries (not shown)
Blood Glucose Monitoring System
• Appearance and Key Function of the Meter
2 14 5
610 7 8
• Meter Display Segments
Appears when the meter
is turned on.
Displays glucose results. A decimal point appears when the measurement unit is mmol/L.
Indicates that the displayed result is an average.
Flashes when it is
ready to apply the
Indicates if audio
function is on or off.
Appears with the test result either in mg/dL
Appears when doing a control solution test. The result will not be stored in the memory.
Appears when the
test result is equal or
higher than 240mg/dL
Appears when you review the memory.
Appears when the
battery power is low.
• Appearance of the Test Strip
Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent channel of the test strip and is automatically drawn into the reaction cell where a chemical reaction takes place.
The test strip consists of the following parts:
See pages 24~29, “TESTING YOUR BLOOD”, section for complete instructions.
PREPARATION BEFORE USE
• Battery Replacement
Your meter comes with two (2) 1.5V AAA size alkaline batteries. The meter will alert you when the power is getting low by displaying two different messages:
symbol appears together with other display messages: the meter is functional and the result remains accurate, but it is time to change the batteries.
Voice SPEAKS: “Battery is low, please replace.”
symbol appears with the “Eb” symbol, “Error” and “low”: the batteries can not provide enough power to do a test. You must change the batteries immediately. (Whole screen is blinking).
Voice SPEAKS: “Battery is dead, please replace.”
To replace the batteries, make sure that the meter is turned off.
|Press the edge of the||Remove the old||Close the battery|
|battery cover and lift||batteries and replace||cover. If the batteries|
|it up to remove.||with two (2) new||are inserted correctly,|
|1.5V AAA size||you will hear a|
|alkaline batteries.||“beep” sound.|
As with all small objects, the batteries should be kept away from small children as a safety precaution. If the batteries are swallowed, seek medical assitance immediately.
• Setting the Meter and Deleting the Memory
Your meter comes with the time, date, unit of measurement, unit of temperature preset, speaking function and memory deletion. If you need to set these parameters, please follow steps below.
STEP 1 Set the Year
Press the “Up” or “Down” button until the desired year appears. Press the S button and then the month segment flashes.
Voice SPEAKS: “Youarenowinsetting mode.Theyear is2007.”
STEP 2 Set the Month
Press the “Up” or “Down” button until the desired month appears. Press the S button and then the day segment flashes.
Voice SPEAKS: “The month is November”
STEP 3 Set the Day
Press the “Up” or “Down” button until the desired day appears. Press the S button and then the hour segment flashes.
Voice SPEAKS: “The day is the 18th.”
STEP 4 Set the Hour
Press the “Up” or “Down” button until the desired hour appears. Press the S button and then the minute segment flashes.
Voice SPEAKS: “The hour is 10 PM.”
STEP 5 Set the Minutes.
Press the “Up” or “Down” button until the desired minute appears. Press the S button and then the current unit of measurement flashes.
Voice SPEAKS: “The minute is 08.”
STEP 6 Select mg/dL or mmol/L
Press the “Up” or “Down” button to select the unit of measurement you want to use. Press the S button and then the current unit of temperature flashes.
The milligram per deciliter (mg/dL) is the standard unit in the United States. The millimole per liter (mmol/L) is the standard unit in Canada. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.
STEP 7 Select “ ºF ” for Fahrenheit or “ ºC ” for Celsius
Press the “Up” or “Down” button to select the unit of temperature you want to use. Press the S button and the meter will display “VOL”, “
” and a flashing number.
Voice SPEAKS: “Temperture unit is degrees Fahrenheit.”
STEP 8 Select Speaking Function & Volume
Press the “Up” and “Down” buttons until you hear the desired speaking volume. Number 0 indicates that the speaking function is turned off, where “
Voice SPEAKS: “Voice volume is 7.”
STEP 9 Delete the Memory
When “dEL” and blinking “
Voice SPEAKS: “Delete memory record function. Press “up” button to clear all records. Are you sure you want to delete ALL records? Press “up” button again to clear all records.”
• About Prodigy® Control Solutions
PRODIGY® control solutions contain a known amount of glucose that reacts with Prodigy® test strips. By testing your control solution and comparing the test results with the expected range printed on the test strip vial label, you can make sure that the meter and the test strips are working properly 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 accurate results.
How often should the control solution test be performed?
When should the control solution test be performed?
The control solution range printed on the test strip vial is for Prodigy® control solutions only. It is used to test meter and test strip performance. It is not recommended range for your blood glucose level.
• How to Perform a Control Solution Test
STEP 1 Insert the Test Strip
Insert a test strip with contact bars end first and facing up, into the test slot. The meter turns on automatically and displays the followings in sequence:
“CHK”and“ ” “ ” “ ” andflashing“ ”
Voice SPEAKS: “Thank you for using Prodigy Voice.” Test Strip inserted. Today’s date is (Today’s date; Example: November 18th, 2007). The time is (The time it is at time of test, Example: 10:08AM). Prodigy Voice works only with the Prodigy Voice test strips. Please apply blood to the test strip.”
STEP 2 Press the button
While the “ ” symbol appears on the display, press the “M” button and then “CTL” will appear on the display. With the “CTL” symbol on the display, the meter will not store your test result in memory.
Voice SPEAKS: “You are now in control solution mode.”
If you decide not to perform a control solution test, press the “M” button again, and the “CTL” symbol will disappear, you are now in the testing mode.
Voice SPEAKS: “You are now in testing mode.”
At this point you may test your blood glucose or turn the meter off by removing the test strip.
STEP 3 Apply Control Solution
Shake the control solution bottle well. Remove the cap. Squeeze the bottle, discard the first drop and wipe off the dispenser tip with a clean tissue paper or cotton swab. Squeeze a drop on a clean nonabsorbent surface or on your finger tip first. Then, apply the drop to the test strip absorbent channel, (where it meets the narow channel) until the drop is drawn into the test strip and the confirmation window is filled. The meter begins to count down.
Voice SPEAKS: “Now testing.”
CAUTION: To avoid contaminating the control solution with the content of the test strip, you have to place a drop of control solution on a clean surface or on your clean finger tip first, then touch the strip to the drop.
DO NOT APPLY THE CONTROL SOLUTION
DIRECTLY TO THE TEST STRIP!
STEP 4 Read and Compare the Result
After counting from 6 to 0, the test result of control solution is shown on the screen. Compare this result with the range printed on the test strip vial. It should fall within this range.
Voice SPEAKS: “Your blood glucose is sevemty two
milligrams per deciliter.”
If test results fall outside the range printed on the test strip vial, check the section of “Problem in Operation” section in troubleshooting guide and repeat the test. If you continue to get outofrange results, it means that the system may not be working properly. Do NOT test your blood glucose. If you are unable to resolve the problem, contact the Technical Support line at 8002432636.
TESTING YOUR BLOOD
Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test:
A. Blood Glucose Meter
B. Test Strip
C. Lancing Device
D. Sterile Lancet
E. Clear Cap (For AST use) C
To reduce the chance of infection:
• Testing Procedure
STEP 1 Set the Lancing Device
Insert a lancet in the adjustable lancing device.
Screw off the cap of lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully seated.
Twist and pull the protective cap until it separates from the lancet.
Replace the lancet device cap. Turn the cap until it is snug but not too tight.
The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip in either direction until the number lines up with the Arrow. Select the best depth:
12 for soft or thin skin,
3 for average skin,
45 for thick or calloused skin.
Cock the lancing device
Slide the ejection/cocking control back until it clicks. If it does not click the device may have been cocked when the lancet was inserted.
AST Alternative Site Testing
* Blood from sites other than the fingertip
A clear cap, included in the kit, makes it easier to get a drop of blood for AST. When you want to obtain blood from sites other than the finger, replace the lancet device cap with the clear cap. Turn the clear cap until it is snug but not too tight, and then slide the ejection/cocking control back until it clicks.
STEP 2 Insert Test Strip
Insert a test strip with contact bars end first and facing up, into the test slot. The meter turns on automatically and displays the followings in sequence: “CHK”and“ ” “ ”
“ ”, and flashing “ ”
Voice SPEAKS: “Thank you for using Prodigy Voice. Test Strip Inserted. Today’s date is (today’s date). The time is (the time). Prodigy Voice works only with the Prodigy Voice test strips. Please apply blood into the test strip.”
STEP 3 Get a Drop of Blood
Select the puncture site either in fingertip or in other parts (AST). Wash your hands and the puncture site. Use warm, soapy water. Rinse and dry thoroughly.
Hold the lancing device firmly against the side of your finger. Press the release button. You wia click, indicating that the puncture is complete.
• Gently Massage the Area
Do not smear the blood sample. To obtain best accurate Correct results, the first drop of blood should be discarded with a clean tissue paper or cotton. Use the second drop of blood for testing. The required blood sample in 0.6 microliter in volume.
WARNING: The first drop of blood usually contains tissue fluid and serum, which may affect the result. It should be
• Sites other than fingertip
Please refer to the of “About AST” section for available testing sites. Please consult your health care professional before obtaining blood from sites other than your fingertips.
WARNING: The system requires a very small blood drop to perform a test. You can obtain it from a fingertip. Choose a different spot each time you test. Repeated punctures in the same spot may cause soreness and calluses.
Before you decide to do palm testing, please consult your health care professional.
STEP 4 Apply Blood into the Test Strip
When “ ” is flashing on the screen, apply your blood to the absorbent channel of the test strip until the confirmation window is fully covered with blood. The meter then begins to count down automatically.
Voice SPEAKS: “Now Testing.”
STEP 5 Obtain an Accurate Result in 6 Seconds
The result of your blood glucose test is shown after the meter counts from 6 to 0. This reading is automatically stored in the meter.
Voice SPEAKS: “Your blood glucose is ninetytwo milligrams per deciliter.”
STEP 6 Eject the Used Test Strip
After finishing the measurement, you can either take out the used strip by simply pushing up the StripEject button or remove the test strip directly with your hand. “OFF” is shown after the used strip is ejected and the meter will shut off automatically afterward.
Voice SPEAKS: “Have a nice day.”
Please make sure the eject button is pointed into a disposal container.
• Expected Test Results
Blood glucose monitoring plays an important role in diabetes control. A longterm study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%*3. The results you get with the PRODIGY Voice system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
|Time of day||Plasma glucose range||Your target range|
|(mg/dL) for people||(mg/dL)|
Fasting and before meal Less than 110
2 hours after meals Less than 140
Bedtime Not specified
Between 2 AM and 4AM Not specified
Source: ADA Clinical Practice Recommendations 2003 Please work with your doctor to determine a target range that works best for you.
*3: American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).
COMPARING METER AND LABORATORY RESULTS
The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter 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, and for important information on limitations). To make an accurate comparison between meter and laboratory results, follow the guidelines below.
Before you go to the lab:
While at the lab:
Make sure that the samples for both tests (the meter test and the lab test are taken and tested within 15 minutes of each other).
You may still have a variation from the result because blood glucose levels can change significantly over short periods of time, especially if you have recently eaten, exercised, taken medication, or experienced stress*4. In addition, if you have eaten recently, the blood glucose level from a finger stick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for a lab test*5. Therefore, it is best to fast for eight 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 (severe dehydration) may also cause a meter result to be different from a laboratory result.
*4: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 4951. *5: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz Textbook of Clinical Chemistry. Philadelphia:
W.B. Saunders Company (1994), 959.
USING THE METER MEMORY
• View Results on the Meter
The Prodigy® Voice stores the 450 most recent blood glucose test results with date and time in its memory. It also provides you with 7, 14, 21, 28, 60 and 90 day averages of your blood glucose test results. You can review the test results in memory with these easy steps.
1. Recall the Stored Test Results
STEP 1. When the meter is off, press and release the M button. The screen shows “
”. Press the M button again, “1” appears first and then the latest glucose result along with date and time will be shown on the screen.
Voice SPEAKS: “Thank you for using Prodigy Voice. Today’s date is (today’s date). The time is (the time). Press “M” key for memory recall mode.”
STEP 2. Press the “Up” and “Down” button to recall the test results stored in the meter.
Voice SPEAKS: “Memory RecordforAugust23rd,2007.8:36AM.Your blood glucose was 80 milligrams per deciliter.”
STEP 3. Exit the memory mode, press and hold down the “M” button and the meter will be turned off.
Voice SPEAKS: “Have a nice day.”
If you leave the meter alone without any action for 3 minutes, the meter will turn off automatically.
2. Read the Average of Blood Glucose Results STEP 1. When the meter is off, press and release the M button. The screen shows “
”. Keep pressing the “M” button for 23 seconds, until blinking “
” appears. Release the “M” button and then the 7day average result will appear on the screen.
Voice SPEAKS: “Thank you for using Prodigy Voice. Today’s date is (today’sdate).Thetimeis (thetime). Press “M” key for memory recall mode.”
STEP 2. Press the “Up” and “Down” buttons to review the 14, 21, 28, 60 and 90 day average. Like the 7day average, the 14day average and the times of performing test in the past 14 days will be shown on the screen.
Voice SPEAKS: “The fourteen day average is eightythree milligrams per deciliter for eightyseven records.”
STEP 3. Exit the memory mode, press and hold down the “M” button, and the meter will turn off.
Voice SPEAKS: “Have a nice day.”
Voice SPEAKS: “No memory record available.”
• Any time you want to exit the memory mode, keep pressing the M button for 5 seconds or leave it without any action for 3 minutes. The meter will turn off automatically.
• Viewing Results on a Personal Computer
Results in memory can be transmitted to a personal computer. Prodigy Diabetes Management Software and an Interface Cable are required before installation. The software can be downloaded from www.prodigymeter.com. The interface cable is an optional accessory. To learn more about Prodigy Diabetes Management Software or to obtain an Interface Cable sold separately, please contact your local retailer or distributor.
STEP 1 Install Software
Install Prodigy Diabetes Management Software on your Computer by following the instructions provided on Prodigy’s website: www.prodigymeter.com
STEP 2 Connect to Personal Computer
Connect the Interface Cable to your computer. With the meter turned off, connect the Interface Cable to the Data Port of the meter. Which is hidden by a plastic cover on the bottom right side panel of the meter. “PC” will appear on the display, indicating that the meter is ready to transmit data.
STEP 3 Transmit Data
Follow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the cable and the meter will automatically turn off.
While the meter is connected to the PC, it is unable to perform a blood glucose test.
CARING FOR YOUR METER AND TEST STRIPS
To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
Your meter does not require special maintenance. As long as no blood or control solution comes in direct contact with the meter, there is no special cleaning required.
Your meter is a precision instrument. Please handle it with care.
1. Meter Storage
2. Strip Storage
3. Control solution storage
The following is a summary of some display messages and symbols. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message. In the event of a problem, refer to the information under “action”.
Never try to disassemble the meter in any circumstances. If you encounter any error messages not listed below or if you have followed the actions recommended but the problem remains unsolved, please call the Technical Support 18002432636.
|MESSAGE||WHAT IT MEANS||ACTION|
|Appears when your result is below measurement limit, which is less than 20 mg/dL. (1.1 mmol/L)||This indicates hypoglycemia (low blood glucose.) You should immediately treat hypoglycemia as recommended by your healthcare professional.|
|Appears when your result is above measurement limit, which is higher than 600 mg/dL. (33.3 mmol/L)||This indicates severe hyperglycemia (high blood glucose). Please seek medical assistance immediately.|
|KETONE? appears when your||This indicates there is a|
|result is equal or higher than||possibility of ketone accumulation|
|240 mg/dL. (13.3 mmol/L)||if you have Type 1 diabetes. Please seek medical assistance immediately.|
|MESSAGE||WHAT DOES METER SAY?||WHAT IT MEANS||ACTION|
|Battery is dead. Please replace.||Appears when the batteries cannot provide enough power for a test.||Replace the batteries immediately.|
|Strip has been used. Please replace.||Appears when inserting a used test strip.||Test with a new test strip.|
|The room temperature is out of range. Thus unable to measure.||Appears when ambient temperature is below system operation range. 50º F (10º C)||System operation range is 50ºF~104ºF (10ºC~40ºC). Repeat the test after the meter and test strip have reached the above temperature.|
|Appears when ambient temperature is above system operation range. 104º F (40º C)|
|MESSAGE||WHAT DOES METER SAY?||WHAT IT MEANS||ACTION|
|Please ensure proper operation then try again.||Remove the strip after applying blood to the absorbent channel.||Re-test with a new test strip.|
|Please remove strip.||Test strip is inserted after the meter turns off.||Remove the test strip.|
|Meter malfunction. Please contact local distributor.||Problem with the meter.||Review the instructions and re-test with a new test strip. If the above steps do not work, please contact technical support for help.|
|PROBABLE CAUSE||WHAT TO DO|
|Battery exhausted.||Replace the batteries.|
|Battery incorrectly installed or absent. Test strip inserted upside down, incompletely or incorrectly.||Check that the battery is correctly installed. Insert the test strip correctly with the contact bars end first and facing up.|
|Defective meter.||Please contact Technical Support for help.|
|PROBABLE CAUSE||WHAT TO DO|
|Insufficient blood sample.||Repeat the test using a new test strip with larger volume of blood sample.|
|Defective test strip.||Repeat the test with a new test strip.|
|Sample applied after automatically shut off (3 minutes after last user action).||Repeat the test with a new test strip. Apply sample only when flashing blood symbol appears on the display.|
|Defective meter.||Please contact Technical Support for help.|
|POSSIBLE CAUSE||WHAT TO DO|
|Error in performing the test.||Read the instruction thoroughly and repeat the test again.|
|Did not shake the control solution bottle very well.||Shake the control solution vigorously and repeat the test again.|
|Expired or contaminated control solution.||Check the expiration date or the discarded date of the control solution.|
|Control solution that is too warm or too cold.||Control solution, meter, and test strips should come to room temperature (6877ºF /2025ºC) before testing.|
|Test strip deterioration.||Repeat the test with a new test strip.|
|Meter malfunction.||Please contact Technical Support for help.|
Model No.: 51900
Dimension & Weight: 3.74”(L) x 2.17”(W) x 0.71(H) 2.6 oz.
95mm(L) x 55mm(W) x 18mm(H), 75 g
Power Source: two(2) 1.5V AAA alkaline batteries
Memory: 450 measurement results with date and time
External output: RS232 PC interface
Auto electrode inserting detection
Auto sample loading detection
Auto reaction time countdown
Auto turnoff after 3 minutes without action
Operating Condition: 50ºF~104ºF (10ºC~40ºC), below 85% R.H. (noncondensing)
Storage/Transportation Condition: 39.2ºF~104ºF (4ºF~40ºF), below 85% R.H.
Measurement Units: either mg/dL or mmol/L
Measurement Range: 20~600mg/dL (1.1~33.3mmol/L)
The specifications may be changed without prior notice.
The device has been certified to meet the electrical and safety requirements of: IEC 606011, EN 606011, IEC 610101, EN 610101, EN 610102101, EN 6060112, EN 61326.