The SensoCard Plus: Blood Sugar Meter Instruction Manual INTRODUCTION Welcome to the SensoCard Plus Instruction Manual. We’ll take you through the various stages to make sure that you get the very best from your talking blood glucose meter. Firstly, let’s see what you have in each kit. Inside the box you will find a zipped carrying case, a written instruction manual and a leaflet describing the operation of the lancing pen. Unzip the carrying case. Inside you will find the following; The SensoCard Plus Blood Glucose Meter The lancing pen A small plastic packet of sterile lancets One check-strip A carrying wallet for the meter A fold-out instruction manual in pictures THE SENSOCARD PLUS METER The meter is easily held in the palm of the hand. The upper side is flat, the underside is where you will feel the raised loudspeaker. On the upper side you will feel the square display window at the top end. At the bottom right hand corner you will find the on/off switch. We are going to call this the “ok” button. Run your finger along the bottom edge of the meter. You will feel a slot in the middle of the bottom edge of the meter. This is where you will put the testing strips each time you test yourself and the check strip when you test for accuracy from time to time. Run your finger up the right hand edge of the meter. You will feel two buttons on the side towards the top. The lower button we shall call the “down” button. The one above it we shall call the “up” button. Now run your finger down the left hand edge of the meter. Right at the bottom you will feel a small entry hole. This is where you will put the little plastic code card that you will get with every box of testing strips. We will call this hole the code card slot. Finally, although this is very difficult to detect, run your finger along the top edge of the meter. In the top left hand corner you may feel a small hole. This is an infra-red port which can transmit your result to a computer. We shall talk about this feature later on. Turn the meter over. You will feel a raised part, which is round at the bottom end. This is the loudspeaker for the talking function. Below the speaker is the battery storage area. The battery lid is oblong with rounded ends. There is a cut in the lid which will help you to remove it when you come to change the battery. We shall come back to this point later. The calibration of a blood glucose meter is an important issue. Laboratory blood glucose measurements can be made either from whole blood samples or from plasma, which is the liquid part of blood without the red blood cells. Both methods are widely used and neither is more accurate than the other. However, values of plasma measurements are usually 10 – 15% higher than their whole blood equivalents. Doctors have recently decided that home blood glucose meters should be calibrated against the plasma equivalent, rather than against whole blood, so that your day to day reading can be compared with the results obtained from a laboratory. The SensoCard Plus meter is calibrated to what we call plasma equivalent calibration. This means that whilst the meter uses a whole blood sample from your finger it converts the result to the equivalent of a plasma glucose value. If you have been using a meter which has been calibrated to whole blood, you will notice that the values of your blood glucose levels will be around 10% higher when you use the SensoCard Plus meter. If you have any worries about this you should discuss it with your GP or diabetes nurse. Now before we go on to see just what the meter can do, we need to stress two important points. Firstly, the SensoCard Plus meter can only work with the SensoCard test strips. You should never try and use strips from another manufacturer as you will not get an accurate result. As with all home blood glucose meters it uses a blood sample which you get by pricking your finger or palm of your hand with the lancing pen. It will not give accurate results from blood samples taken from a vein, or from treated blood samples such as plasma. THE SENSOCARD PLUS MAIN MENU Press down on the “ok” button at the bottom right hand corner on the upper side of the meter, and keep your finger pressed down. The meter will take you through six different menus. The first point of call is “check mode”. Then “data upload”. The third menu is “date set menu”, followed by “memory erase menu”. Then “unit set menu”, and finally “language set menu”. If you keep your finger on the “ok” button it will start again with “check mode” and so on. When you reach the menu you want, simply lift up your finger. To switch off the meter at any time, take your finger off the “ok” button, and then press it again. The meter will switch off. GETTING YOU STARTED When you get your meter it will be pre-set with the talking function on, speaking English. If you somehow switch this function off, or you accidentally switch to the other programmed language, German, don’t worry. We’ll tell you how to switch it back on a little later. It will also be set with the correct date and time and the measuring units we use, which are millimoles per litre. Firstly, let’s have a look at the SensoCard Test Strip. The test strips are packed into bottles of 25 strips, and sold as two bottles per pack, 50 strips altogether. The strips are sensitive to heat and mechanical damage, and must be kept in the bottle with the lid firmly shut. Please don’t leave the strips in direct sunlight, or the bottles over a radiator or in freezing conditions. The expiry date of the label is printed on the bottle, please ask someone to check it for you if you are unable to do so yourself. It is most important that the meter is correctly calibrated with the code of the particular strips you are using. There are two ways to do this. Firstly, the easy way. In each bottle of 25 strips you will find a written instruction leaflet, and a plastic strip which we will call the Code Card. The Code Card is wider and longer than the SensoCard test strip, and is square cut at one end and rounded at the other. The rounded end is the handle. The calibration step is quite easy. Press the “ok” button once only. The meter will tell you the code that it is currently set to, and asks you to “insert a reagent strip or press a button”. You should find the “down” button on the right hand edge of the meter – this is the first button you will feel when you slide your finger up from the bottom right hand edge of the meter towards the top. Press this button once. The meter will tell you that you have reached the “code set menu” and asks you to insert the Code Card. Pick up the plastic Code Card by the rounded end and place it at the entrance of the code card slot. This is found at the bottom left hand edge of the meter. Then, in one simple movement push the plastic strip into the slot and pull it out again. If for some reason the movement is not smooth, or there is a delay of more than 60 seconds from reaching the “code set menu” and inserting the code card, the meter will say “error”. You should press the “down” button on the right hand edge of the meter and repeat the process. If the code set has been successful the meter will tell you the code that it is now set to and ask you to “insert the reagent strip or press a button”. You will not need to repeat this step until you use strips from a different bottle. At this stage you should press the “ok” button once and the meter will switch itself off. There is a second way to enter the information. This is a little more complicated, by entering the lot numbers manually. As you will normally use the simple code card setting method we have just used with the Code Card, we have kept aside a chapter towards the end which will contain instructions for rarely used activities. It is important that the test strip is put into the meter correctly – we’ll tell you how you can do this. Open the bottle and take out a strip. Each strip has an “arrow-shaped” end and a “square-cut” end. The square cut end is the end to be inserted into the meter. You apply the drop of blood to the arrow-shaped end. The upper surface of the strip is coloured black, the underneath surface is white. If you are unable to distinguish between these colours, just run your finger lightly along the surface of the strip. The underneath surface is perfectly smooth. However, on the upper surface towards the square-cut end of the strip, you should feel a slight ridge running across the entire width of the strip. So the golden rule – square-cut end into the meter, with the black colour and the ridge uppermost. Place the square cut end of the test strip at the slot in the middle of the bottom edge of the meter and push the strip in as far as it will go. The meter will automatically switch itself on and confirm the lot number of the strip you are using. Make sure that number matches the lot number printed on the bottle. You are now ready to prick your finger to get a drop of blood to put on to the test strip. You may already have a lancing pen from another meter, and if you feel more comfortable using it than the one given with the SensoCard Plus meter, please do so. It is not essential to use the pen in our meter set. However, if you prefer to use the SensoCard Plus lancing pen, let’s take a minute to see how it works. The lancing pen comprises three separate parts. The middle part has two indentations to fit neatly between your thumb and forefinger, and the trigger to release the lancet. The main barrel is the longer of the two other parts and has a smooth base. The top of the lancing pen, what you might call the “sharp end” has an indentation at the very end, and the barrel swivels from right to left. This swivel is to set the correct depth for your finger so that you can obtain a good drop of blood when you prick yourself. There are five depth settings, one to five. Hold the pen firmly by the middle section with the two indentations between your thumb and forefinger. Turn the barrel to the right as far as it will go. You have reached setting number one, which is for very soft skin. Turn the barrel to the left until you feel it engage into a new slot. This is position two, for slightly harder skin. Turn again and you will reach position three, then four, and finally five. Five is for much harder skin. You should decide which setting is most appropriate for your skin. Perhaps starting at number 3 could be a good idea. Open the plastic bag containing the lancets. Each lancet has a square shape, flat at the bottom but with a round swiveling top – this is the protective cover for the lancet. Turn the main barrel of the lancing pen to unscrew it and remove the barrel. At the top of the exposed pen you will feel the lancet holder, which will spring back if you push it down. Put the flat end of the lancet against the entrance to the lancet holder. Turn it slightly until you feel it engage and then push it in as firmly as it will go. Gently remove the round plastic protection cap from the top of the lancet. Then gently put the loaded barrel into the other half of the pen and turn it to the right until it is fully screwed tight. Finally you have to spring load the pen. Hold the middle section firmly between your thumb and forefinger, and pull the barrel down as far as it will go. You will hear a “click” which will tell you that the spring has engaged. Release the barrel and it will gently spring back to form the complete pen once again. You are now ready to prick your finger to get the blood sample. It is always a good idea to wash your hands thoroughly in warm water before pricking your finger. Firstly, it removes a lot of day to day dust and bacteria, which can help prevent infection. Secondly, it helps promote the supply of blood to your fingers, so that the drop of blood is easier to obtain. So, the lancing pen is loaded and ready to go. And the SensoCard Plus meter is loaded and ready to go. But just to warn you that the meter will automatically switch itself off two minutes after the strip is put into the meter. If the meter switches itself off before you are ready to prick your finger with the lancing pen, just press the “ok” button. The meter will switch itself on again and you are ready to go. So let’s measure your blood glucose level. Simply put the lancing pen to the finger you want to use. You should hold it between the thumb and middle finger – use your forefinger to find the trigger. Press the trigger, and you will feel the small sensation as the lancet pricks your finger. Put the lancing pen down and wipe off the first drop from your finger with a clean tissue. Keep gently squeezing the finger, pick up the SensoCard meter, and guide the arrow-shaped tip of the test strip to the area that you have just pricked. In some blood glucose testing meters, the blood has to be applied to a specific area on the flat part of the strip. With SensoCard Plus, the blood is drawn into the test strip from the very tip of the arrow-shaped end. You only need a tiny amount, so you may find it easier to move the tip of the strip around and across the pricked area. When the meter has sucked up enough blood into the strip you will hear a little “beep”. Within 5 seconds the meter will tell you the level of your blood glucose. The meter will tell you blood glucose levels between 1.1 and 33.3 millimoles per litre. If your value is below 1.1 millimoles per litre, it will say “low value” and the meter will display “Lo” on the screen. If the value is higher than 33.3 millimoles per litre, it will say “high value” and display “Hi” on the screen. High or low values may have serious medical consequences and you should seek medical advice. If nothing happens after 30 seconds, you may have a problem, usually because insufficient blood has been applied to the test strip. We are going to review all of the possible error messages later in the instructions, but in this case the only thing to do is to start again. However if everything has worked according to plan, remove the strip and dispose of the strip in an appropriate container - the meter automatically switches off. If you do not remove the used strip immediately and leave the meter lying idle for 2 minutes it will automatically switch itself off. The value you have generated will automatically be entered into the meters memory – it stores the last 500 measurements. Recently, studies have been made to see if a blood sample can be taken from another part of the body, such as the palm of the hand, the forearm or the earlobe. Taking blood from these alternate sites can be less painful than from the end of the finger. Studies using the SensoCard Plus meter have shown that a blood sample taken from the small mound of flesh on the palm of the hand at the base of the thumb will give the same results as blood from the finger. We do not recommend taking a blood sample from any other part of the body. MAKING SURE YOU GET ACCURATE RESULTS Now, let us turn to quality control. Maintaining top quality of testing with SensoCard Plus is our highest priority. We have two ways to do this. Firstly, you will remember that when you first unzipped the carrying case to look at the contents inside, we told you that there was a check strip in the case. The check strip is kept in a plastic pocket in the side opposite to the side which contains the meter, the lancing pen and the small bag of lancets. You will be able to feel it sticking out of the pocket. Stuck to the plastic wallet next to the check strip you will find a small label which gives you the range that you should expect to see when you carry out a control check. There should be six numbers altogether. Perhaps you could ask somebody to help tell you the control range. To carry out a control check, carry out the following procedure; Take the check strip out of the plastic pocket. The check strip is about 3 cm’s long. The check strip is thick at one end – this is the handle – and thin at the other end – this is the test part. Pick up the check strip by the handle and you should feel that it is smooth on the underside but ridged on the upper side. So the golden rule, again, for the check strip, is that the upper surface of the handle will not be smooth – rather ridged in the middle, and the end that needs to go into the meter will be thinner and more flexible. Make sure your meter is turned off. Press and hold the “ok” button and very shortly the meter will tell you that you have reached the “check mode”. Take your finger off the button. Put the check strip into the slot into the bottom of the meter where you usually put the test strips. The meter will immediately tell you the value it has calculated. Compare this value with the range value printed on the plastic part where the check strip is usually kept. If the value is within the range quoted, all is well, and the meter is working perfectly. If however, the value you are told is either higher or lower than the range listed on the plastic there could be possible damage to your meter. Another way of testing your meter is to use the SensoCard Lo and Hi Control Pack. This is sold separately and can be bought from your local distributor. Open the bottle and take out a strip, just as you did when you tested your blood glucose level. Remember the golden rule – square-cut end into the meter, with the black colour and the ridge uppermost. Press the “ok” button until you reach “check mode” and take your finger off the button. Just as before place the square cut end of the test strip at the slot in the middle of the bottom edge of the meter and push the strip in as far as it will go. Unscrew the top of the SensoCard Lo Control Solution. Gently squeeze the bottle and put a drop of the solution onto the tip of your finger, and treat it just as if you had pricked your finger with the lancet, by sucking it up with the arrow-shaped tip of the test strip. Within 5 seconds the meter will tell you the level of glucose in the solution. Make a note of the level. Remove the test strip and dispose of it like before. Open the bottle and take out another test strip and repeat the entire process using the bottle of SensoCard Hi Solution. Once again make a note of the level and dispose of the test strip. Printed on the side of the test strip bottle you will find the measuring range of both the low and hi controls. You will find that this measuring range will vary from batch to batch of test strips so it is important to make sure you know the measuring range for the particular batch of strips you are using. Both values that you have just measured should fall within these measuring ranges – you may need to ask somebody to help you as the print is unfortunately quite small. If the result of the control values is not between the values on the bottle you should stop using the meter immediately and call our helpline on 01792 229333 for advice. THE SENSOCARD PLUS MAIN MENU IN DETAIL Earlier in this tape we showed you how to enter the main menu of the meter. Just to refresh your memory - press down on the “ok” button at the bottom right hand corner on the upper side of the meter, and keep your finger pressed down. The meter will tell you about six different menus. Pressing and holding down on the “ok” button, the first point of call will be “check mode”. We covered this in the last section “making sure you get accurate results”. Press the “ok” button again and the meter will switch off. Pressing and holding down the “ok” button, the second point of call will be “data upload”. The letters PC will appear on the screen. In PC mode, data stored in the meter’s memory can be downloaded to a computer. To download data an additional adapter called LiteLink is needed to establish a data communication connection between your PC and the SensoCard Plus meter. The LiteLink adapter together with the data communication control programme is available separately from your distributor. All the information on data downloading, installation and operational settings are contained on a CD which comes with the LiteLink adapter. The third point of call is the “date set menu”. It is important to set the time correctly, in order to keep an accurate record of your test results. Your meter should already be set with the correct time and date, but you may need to change it, for example if you go away on holiday, or changing from winter to summer time. So let’s set the date and time. We shall set four values, for the hour, minute, month and day. Press and hold down on the “ok” button until you hear “date set menu”, and release the "ok" button. You will hear the command “hour”. You can set the hour either as a 24 hour clock, or as “am” or “pm”. Press the “up” button on the right hand edge of the meter repeatedly. The meter will count from one to twenty four and then go on to the hours in “am” or “pm”. When you reach the hour setting you prefer, press the “ok” button. You will hear the command “minute”. Once again, press the “up” button until you reach the correct minute, and then press the “ok” button. You will then hear the command “month”. Again, press the “up” button until you reach the correct month and press the “ok” button. The final command you will hear is “day”. Press the “up” button until you reach the correct day. Then press the “ok” button again. The meter will then tell you the date and time you have entered. Please check it. If it is correct, press the “ok” button for the final time. This will enter the information into the meter and at the same time switch it off. If for some reason the date and time has not been entered correctly, you must complete the whole date and time setting process again – switch the meter off and start the whole process again. All data in the meters’ memory can be deleted. Press the “ok” button. Keep it pressed till you hear “memory erase menu”. To avoid data loss by mistake, memory deletion will only be implemented after entering this menu followed by pressing the “down” button and then the “up” button located on the right edge of the meter in that order. After deletion of data in the memory the meter switches off automatically. If you get into the “memory erase menu” by mistake, don’t worry. Just press the “ok” button and the meter will switch itself off without losing any data. The fifth point of call is the “unit set menu” You will remember that we will have pre-set your meter to read your blood glucose level in millmoles per litre. If for some reason you need to change the reading value to milligrams per deciliter you can do this quite easily. Press the “ok” button until you reach “unit set menu” and take your finger off the button. The meter will tell you that the current unit is millimoles per litre. Press the “up” button located on the right edge of the meter. The meter will then tell you that the current unit is milligrams per deciliter. Press the “ok” button again. This will store the change in the meter and switch the meter off. Finally, the sixth menu is the “language set menu”. Again, your meter will have been preset to speak in english. You can change the language to german or switch off the loud speaker quite easily. Press the “ok” button until you reach “language set menu”. Take your finger off the button and the meter will say “english”. Press the “up” button located on the right edge of the meter. The meter will say “deutche” (pronounced doytcher). If you want to stay in this language then press the “ok” button. The meter will store the command and switch itself off. However if you press the “up” button again after the meter says “deutche” then you will hear nothing. The word “Off” will appear on the screen. If you press the “ok” button at this time then the command will be stored and the meter will switch itself off. You will almost certainly need the help of a sighted person to restore the speaking meter to the language of your choice. Simply ask that person to hold the meter and keep there finger pressed firmly on the “ok” button until the word “Set” appears on the screen together with an image of a small loudspeaker. Then press the “up” button on the right edge of the meter once to return to the “english” setting (and again if you prefer the “german” setting) and then press the “ok” button again to switch the meter off. ACCESSING THE MEMORY You can check any of your previous results quite easily by entering the memory mode. Switch the meter on by pressing the “ok” button once. The meter will tell you the code that it is currently set to, and asks you to “insert a reagent strip or press a button”. Press the “up” button on the right hand edge of the meter. The meter will tell you that you have entered the memory mode and tell you the value of your last reading and the time and date that it was made. If you press the “down” button on the right hand edge of the meter once it will tell you the value of the previous reading. Pressing it again will tell you the value of the reading before that. If you keep on scrolling with the “down” button you will go back in time as far as you want - until you reach the 500th result that is. As you use the meter to generate a new value, and the memory is full, it will delete the oldest result and add your new result to the memory bank. If you press the “ok” button again it will tell you the average value of your readings over the last seven days. By pressing the “up” button on the right hand edge of the meter it will then tell you the average value of your readings over the last fourteen days and by pressing it for a second time it will tell you the average over the last 28 days. Press the “ok” button and you will exit the memory and the meter will tell you to “insert the reagent strip or press a button.” So you are now ready to measure your glucose or you can switch the meter off. TROUBLESHOOTING Once in a while something just doesn’t go quite right. The meter will spot any problems immediately and alert you to take appropriate action. The first problem concerns the batteries. The batteries may be flat and the meter simply doesn’t work or the meter will tell you about “ERROR 6” which means the batteries are low. We will tell you how to replace the batteries towards the end of this section. If you hear “ERROR 0” this means the meter is damaged and should be returned to your distributor. If you hear “ERROR 2: THE REAGENT STRIP HAS BEEN REMOVED” this means that the test strip has been removed from the meter during measurement. You should repeat the test with a new strip. If you hear “ERROR 3: USED REAGENT STRIP” this means that you have accidentally used an old strip. Remove the old strip and test again with a new strip. If you hear “ERROR 5” it is highly likely that your meter is too close to another electrical device with a strong electromagnetic field, such as a mobile telephone. You should move away from these interfering instruments and test again. If you hear “ERROR 7” this means that you have unfortunately been unable to draw enough blood up into the strip. The meter is programmed to beep once when it has sufficient blood to carry out a measurement and when you hear the beep you can remove the strip away from your finger. But every once in a while it can beep and then discover that it just does not have quite enough blood to test. Unfortunately you can not use the strip again – even though you couldn’t apply sufficient blood the meter will recognize it as a used strip and you should dispose of the strip and start the process again with a new strip. If you hear “ERROR 8” it is telling you that for some reason the test was not preformed properly. You should repeat the test with a new test strip. SensoCard Plus is designed to work within a comfortable temperature range. If the temperature drops below 15 degrees centigrade then it will tell you “ERROR 9”. It will also tell you “ERROR 9” if the temperature is above 35 degrees centigrade. When you hear the “ERROR 9” message you should move the meter to a more comfortable temperature and wait at least 30 minutes before using it again. Once in a while, you may get an unexpected result. High or low results which are incorrect may have serious medical consequences. If your blood glucose is unusually high or low, or if you question your results, repeat the test with a new strip. You must consult your GP or diabetes nurse before making any significant changes to your diabetes medication. If you do get an unexpected result, you can “mark” the result. This will stop the reading being included in the 7-14-28 day calculation, as it could have a significant effect on these values. To mark the result, press the “down” button on the right hand edge of the meter after the result has been announced. The meter will tell you that it has given a “marked result”. Readings may be affected by dehydration, leading to low results. Abnormally high concentrations of Vitamin C (Ascorbic Acid) may lead to high results. The red blood cell volume in your blood, known as the haematocrit, has an influence on values. This is particularly important for those patients on dialysis, when the haematocrit level can vary. Again, your GP or diabetes nurse can advise you on this issue. If you have any doubts at all about problems with your SensoCard Plus meter you should contact your distributor immediately for advice. Our helpline number in the UK is 0191 564 2036, or +44 191 564 2036 if calling from outside the UK. SETTING THE CODE STRIP MANUALLY In the case of a missing or damaged Code-Card, you will need to set the strip code manually. The code of each lot is printed on the side of each bottle of strips, and can be either three numbers, or a digit and two numbers. You may need to ask someone to help you find the code as the amount of information that we have to put on the bottle can make it difficult to read. Press the “ok” button once. The meter will tell you the code that it is currently set to, and asks you to “insert a reagent strip or press a button”. Now press the “down” button on the edge of the SensoCard Plus. The meter will tell you “code set menu, insert the code card”. Press the “down” button once more. The meter will tell you the current code, and the first of the three digits or numbers will start to flash. You can now adjust the code value of the first digit by pressing the “up” and “down” buttons on the edge of the SensoCard Plus. The meter will tell you each digit it has reached. When you find the required digit press “ok”. The second digit or number will then start to flash, and you should repeat the process as before. Press the “ok” button once more and the third digit or number will flash. When you find the correct third digit or number press the “ok” button for the final time. The meter will then tell you the code that you have set – please check for a final time that it matches the code on the bottle of strips. You can then proceed to measure your glucose level, or switch the meter off. BATTERY REPLACEMENT You will almost certainly need the help of a sighted person with battery change. Ask the person to turn the SensoCard Plus meter so the speaker is pointing upwards. This is the tricky bit - ask them to put their fingernail or the tip of a plastic card into the cut in the battery lid and gently lift it off. Now turn the SensoCard Plus over on to the palm of the hand - the batteries will fall out. Put two CR2032 batteries into the correct slots – these batteries can be purchased at any electrical supply shop. The right slot is negative and the left slot is positive. Make sure the batteries are positioned properly. Finally, click the battery cover back into its place and check the ability of the equipment to operate by switching the meter on. If the meter does not turn back on please repeat the process and make sure the batteries have been inserted correctly. EXTRA HELP If you have a query about your diabetes, Diabetes UK has a careline to give support and information. The number is 020 7424 1030. Of course you can always contact your GP, or the diabetes specialist nurse who will work with your GP.