Palmdoc Palmdoc I, User Manual

Page 1: ...Let me be your guide ...

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Page 3: ...1 Welcome to ...

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Page 5: ...orming blood test 28 06 Understanding your test result 36 07 Comparing with laboratory results 37 08 Memory recall 39 09 Control solution testing 41 10 Caring for your meter and test strip 46 11 About alternative site testing AST 48 12 Display messages and problem solving guide 50 13 Performance characteristics 54 14 System specifications 56 Page Contents ...

Page 6: ...the manufacturer 4 Do not use the device if it is not working properly or if it has suffered any damage 5 Before using any product to test your blood glucose read all instructions thoroughly and practise the test Do all quality control checks as directed and consult a diabetes healthcare professional 6 Keep this guide handy Intended use The system is intended for use outside the body for self test...

Page 7: ...blood sample The PalmDoc I meter measures the strength of the electrical current calculates your blood glucose level and then displays your result in mmol L Caution 1 Do not make any decision of medical relevance without first consulting your medical practitioner 2 Call your doctor immediately if you experience symptoms that are not consistent with your blood glucose test results 3 Altitudes above...

Page 8: ... 1 Apply only capillary whole blood samples to test your blood glucose Applying other substances plasma or serum will cause incorrect results 2 Severe dehydration and excessive water loss may cause false low results If you believe you are suffering from severe dehydration consult your healthcare professional immediately 3 Test results below 3 3 mmol L 1 indicate low blood glucose hypoglycemia Test...

Page 9: ...itically ill patients should not be tested with blood glucose meters 5 Interference Reducing substances occurring in the blood naturally uric acid bilirubin or from therapeutic treatments ascorbic acid acetaminophen will not significantly affect the PalmDoc I test results However elevated concentrations of these substances may affect test results The compounds listed in the table overleaf were fou...

Page 10: ... 000 U dL 0 32 mmol L Hydroxyurea L dopa Maltose Methyldopa Tolbutamide Triglycerides Uric Acid Ibuprofen Icodextrin Pralidoxime Iodide Salicylate Tolazamide Xylose Compounds Compounds Concentrations higher than the following values may cause inaccurate results Concentrations higher than the following values may cause inaccurate results 0 39 mmol L 0 51 mmol L 26 3 mmol L 0 13 mmol L 14 8 mmol L 2...

Page 11: ...elphia Lea and Febiger 1994 489 2 Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 261 263 02 Getting to know your system For In vitro diagnostic use Keep dry Keep away from sunlight Humidity limitation Sterilized using irradiation Lot number Do not reuse Use by Expiry date Manufacturer Temperature limitation Store at EU representative This blood glucose meter test...

Page 12: ... range needed for testing 3 Memory symbol Appears when in memory mode 4 Teststrip symbol Appears when the meter awaits the insertion of a test strip 02 Getting to know your system Important Use only PalmDoc Blood Glucose Test Strips and Control Solutions with your PalmDoc Blood Glucose Meter Use of other test strips and control solutions with this meter can produce inaccurate results ...

Page 13: ... ready for the application of the blood sample 6 Measurement unit Appears with the test result 7 Average Appears when the meter is in memory mode while recalling 7 15 30 45 90 day test averages 02 Getting to know your system Day Month Year Hour Minute 1 2 3 4 5 6 7 ...

Page 14: ...st strip in place when you perform a blood glucose test Display Shows test results and messages Meter label Each meter has a unique serial number on it Do not alter or tear the label off Battery compartment Holds one 3V lithium battery battery type CR2032 The meter 02 Getting to know your system ...

Page 15: ... 2 seconds to turn meter on and off Button Press to decrease the value of the current setting Button Press to increase the value of the current setting Button Press to enter memory recall mode Button While in the setting mode press to exit and return to test display 02 Getting to know your system ...

Page 16: ...confirm and move next to the MONTH setting 5 Repeat to set the month year hour and minute After the minute setting is set the display returns to the day setting Press the OK BUTTON to finish and exit time setting mode Note You can exit the time setting mode at anytime by pressing the OK button while you set the time and date Setting measuring unit The PalmDoc I meters supplied to the UK and Europe...

Page 17: ...um battery battery type CR2032 Battery life will vary depending on usage The battery should last about 1 000 tests or 12 months when testing 3 times a day When the battery symbol appears on the meter display the battery charge is low You will still be able to test with a low battery but you should replace it as soon as possible When the battery symbol is flashing on the meter display the meter wil...

Page 18: ...y 1 Make sure the meter is turned off Let the front of the meter rest in the palm of your hand Slide the battery cover open 2 Use the edge of the battery cover to pull out the battery from the holder 02 Getting to know your system ...

Page 19: ...w battery battery type CR2032 making sure to align the plus side up 4 You should hear a beep to indicate correct installation If not please reinsert the battery correctly then close cover 02 Getting to know your system ...

Page 20: ... small children as a safety precaution If the battery is swallowed seek medical assistance immediately 3 Batteries might leak chemicals if not used for a long time Remove the batteries if you are not going to use the device for an extended period i e 3 months or more 4 Please discard the used or dead batteries properly according to the regulations of your country 02 Getting to know your system ...

Page 21: ...I 2747 Glucose Standard which is a NIST traceable glucose standard l The reference instrument used is the YSI 2300 Glucose Analyser which is calibrated by YSI 2747 Glucose Standard 03 Blood glucose test strips usage Test strip handle Hold this part to insert the test strip into the meter Test confirmation window This is where we confirm if enough blood is applied for the test Ensure that it is ful...

Page 22: ...YSI 2300 Glucose Analyser Storage and handling Please take the following precautions to ensure your PalmDoc blood glucose test strips are effective l Prior to first use ensure that the vial is undamaged and closed l Keep the test strip vial out of sunlight and in a cool dry place between 4 40 C 39 104 F Do not freeze it l Store test strips in their original vial only Do not put the test strips in ...

Page 23: ...ds All parts of the test strip should be touched only with dry and clean fingers l Do not bend cut or alter the test strip l Perform blood glucose tests only at a temperature between 10 C 50 F and 40 C 104 F and relative humidity between 10 and 85 Warning l Discard used test strips and lancets responsibly according to your local regulations l Keep test strip vial away from children A child could c...

Page 24: ...ionals 1 Follow the infection control procedures of your organisation 2 PalmDoc test strips are not validated for and should not be used for testing venous or neonatal blood specimens 3 Cholesterol concentrations up to 12 9 mmol L or triglycerides up to 22 6 mmol L do not significantly affect test results However glucose values in specimens beyond these levels should be interpreted with caution 03...

Page 25: ...able lancing device Your lancing device and lancets are used to obtain capillary blood samples from the testing site 04 Prepare for blood sampling Release button Depth selector Cocking control Lancet holder Lancing device cap Lancet ejector ...

Page 26: ...ution when removing the used lancet from the device and when disposing of the used lancet 4 The lancing device and lancets conform to MDD 93 42 EEC Important The meter and lancing device are for single patient use Do NOT share them with anyone including other family members Do NOT use on multiple patients 04 Prepare for blood sampling ...

Page 27: ...ting your lancing device 1 Twist off the lancing device cap 2 Insert a new sterile lancet into the lancet holder Push down firmly until it is fully seated Do not twist the lancet 04 Prepare for blood sampling ...

Page 28: ... use Replace the lancing device cap 4 Set the lancing level by twisting the depth selector until the number lines up with the arrow To select the best depth 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin 04 Prepare for blood sampling ...

Page 29: ... device using a soft cloth with mild soap and warm water as required Use 75 isopropyl alcohol to disinfect the lancing device Carefully dry it Do not immerse it in liquid 2 To disinfect the lancing device cover use a disinfectant solution containing 2000 mg dL of chlorine and immerse for 30 minutes Finally wash with water and wait until it is dry 04 Prepare for blood sampling ...

Page 30: ...28 05 Performing blood test 1 Wash hands Wash clean rinse and dry hands thoroughly Warm fingers to increase blood flow 05 Performing blood test ...

Page 31: ...29 2 Insert test strip Insert a test strip to turn on the meter automatically 05 Performing blood test mmol L 3 Wait for blood drop symbol When it starts blinking the meter is ready for use ...

Page 32: ...ng device firmly against the side of your fingertip Press the release button l For AST Please refer to the About alternative site testing AST section Please consult your healthcare professional before obtaining blood from a site other than your fingertip 05 Performing blood test ...

Page 33: ...sample resting on your fingertip Do not smear the blood sample To obtain the most accurate result wipe off the first drop of blood and gently squeeze another drop of blood 6 Apply blood sample Apply blood sample to test strip and the meter will begin the 5 second countdown before displaying result 05 Performing blood test Incorrect Correct ...

Page 34: ...od glucose test result appears along with the unit of measurement date and time Record your test result on the log sheet 05 Performing blood test 6 7 8 9 10 11 12 13 1 5 1 6 1 7 1 8 1 9 1 10 1 11 1 12 Glucose Test Record Before Meal ...

Page 35: ...y stored in the meter after removing the test strip to turn off the meter Discard the used strip safely in a puncture resistant container 9 After use twist off the lancing device cap Push the exposed tip of the lancet into its protective cap 05 Performing blood test ...

Page 36: ...de the lancet ejector forward and dispose of the used lancet in an approved container Discard the used lancet according to your country s safety regulations Replace the lancet device cap 05 Performing blood test ...

Page 37: ... fill the test strip confirmation window before the meter begins to count down If you find that the test strip is not filled with blood when the meter is counting NEVER try to add more blood to the test strip Discard the test strip and retest with a new one 4 If you do not apply a blood sample within three 3 minutes meter will automatically turn off You must remove the test strip and re insert it ...

Page 38: ...with your previous results check the following 1 Was the blood sample applied to the test strip immediately after the blood was drawn from the finger 2 Was the blood sample in sufficient volume i e no less than 0 5 μL 3 Was the test strip used immediately after the test strip was taken out from the vial 4 Was the test strip vial cover tightly closed 5 Was the test strip used before the expiry date...

Page 39: ... Diabetes Association http www diabetes org diabetes basics prevention pre diabetes diagnosis html 07 Comparing with laboratory results The results you obtain from your meter may differ somewhat from your laboratory tests due to different factors and conditions Meter results can be affected by factors and conditions that do not affect laboratory tests in the same way To make an accurate comparison...

Page 40: ...an change significantly over short periods of time especially if you have recently eaten exercised taken medication or experienced stress1 In addition if you have eaten recently the blood glucose level from a finger stick can be up to 3 9 mmol L higher than blood drawn from a vein venous sample used for a lab test2 Therefore it is best to fast for eight hours before doing comparison tests Factors ...

Page 41: ...mum of the 450 most recent blood glucose test results with date and time in its memory It also provides you with 7 15 30 45 and 90 day averages of your blood glucose test results You can review the individual or average test results by entering the memory mode Recalling individual test results 1 While the meter is turned off press the button for 2 seconds to turn on the meter 2 When you hear the b...

Page 42: ...ividual test result you can press button to review average 2 The 7 day average will appear 07 displays on the meter indicating that you are reviewing 7 day average The 7 day average is calculated from the date of your latest blood glucose results obtained during the past 7 days 3 Press or button the 15 30 45 and 90 day averages will appear in order 4 Press to exit and return to recalling individua...

Page 43: ...lly 09 Control solution testing not included PalmDoc control solution contains a pre set amount of glucose that will react with the PalmDoc 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 ...

Page 44: ...nmental conditions 4 If you drop the meter 5 After changing the batteries Important control solution information 1 Use only PalmDoc control solution Check the expiry date on the control solution bottle Do not use if expired 2 The control solution meter and test strips should be at room temperature 20 30ºC 68 86ºF before testing 3 Shake the bottle before use discard the first drop of control soluti...

Page 45: ...al distributor if you need to purchase control solution 2 The control solution range printed on the test strip vial is for PalmDoc control solution only It is used to test meter and strip performance It is not the recommended range for your blood glucose level How to perform a control test 1 Insert test strip Insert a new test strip into the strip slot The meter will activate 09 Control solution t...

Page 46: ...penser tip with a clean tissue paper or cotton swab Squeeze a drop of control solution on a clean bottle cap fingertip or another non absorbent surface 3 Apply control solution Apply the drop to the opening of the strip absorbent channel until the confirmation window is filled The meter will begin to count down from 5 to 1 09 Control solution testing ...

Page 47: ...nted range Note 1 Do not apply the control solution directly to the test strip Overdosed solution may give inaccurate result 2 Repeat test if the result falls outside the control range stated on the test strip label If a subsequent test continues to produce an out of range result the meter or test strip may be faulty DO NOT use the system Contact us for assistance 09 Control solution testing Norna...

Page 48: ...ng required 1 To clean the meter exterior wipe with a cloth moistened with tap water or a mild cleaning agent then dry the device with a soft and dry cloth Do not flush with water 2 Do not use organic solvents to clean the meter Your meter is a precision instrument Please handle it with care Storage and handling 1 Meter l Storage condition 20 C 50 C 4 F 122 F below 90 relative humidity l Always st...

Page 49: ...ghtly l You may touch the test strip anywhere with clean dry hands when removing it from the vial or inserting it into the meter l Use each test strip immediately after removing it from the vial l Do not bend cut or alter a test strip in any way l Keep strip vials away from children since the cap and the test strip can be potential choking hazards If swallowed please seek medical assistance immedi...

Page 50: ... advantage of AST Fingertips feel pain more readily because they are full of nerve endings receptors At other body sites nerve endings are not so numerous and you will not feel as much pain as you will experience at the fingertip When should I use AST Food medication illness stress and exercise can affect blood glucose levels Capillary blood at the fingertip reflects these changes faster than capi...

Page 51: ...to believe you have hypoglycemia or hyperglycemia 2 Your routine glucose results are often fluctuating 3 You are pregnant How to accurately use AST Stimulate blood perfusion by rubbing the puncture site for 20 or more seconds prior to blood extraction Clinical tests demonstrate that blood from a site that hasn t been rubbed exhibits a measurably different glucose concentration than blood from the ...

Page 52: ...that improper use of the system may cause inaccurate results without producing any error message 12 Display messages and problem solving guide Display check If some parts of the display are not working contact us for help mmol L Moving strip The meter is awaiting the insertion of a test strip mmol L Blinking blood drop The meter is ready for applying blood to test strip Message Actions ...

Page 53: ...sibly serious medical condition If this is not confirmed by the way you feel review proper testing procedure and perform a control test Repeat blood test if the display still appears please call for medical assistance immediately Test result is lower than 1 1mmol L Battery is dead Replace battery now Battery is low Replace battery soon Message Actions ...

Page 54: ...d wait at least 30 minutes Do not artificially heat or cool the meter Insufficient blood sample Insert a new test strip and test again Temperature is above the operating range Used strip moistened strip or defective meter Please repeat the test with a new test strip If you still see the same results contact us for help 12 Display messages and problem solving guide Message Actions ...

Page 55: ...lease take these given actions 1 Replace the battery 2 Insert the test strip correctly 3 Contact us for help No responses when blood sample is applied to the strip Maybe 1 Blood volume is not sufficient 2 Meter is defective Please repeat the test with sufficient blood volume If you still see the same results please contact us for help 12 Display messages and problem solving guide ...

Page 56: ... 2 5 5 6 19 6 SD 3 0 3 0 8 1 CV 3 0 2 3 Repeatability Blood Glucose mmol L 1 7 2 8 2 9 6 1 6 2 8 3 8 4 13 9 14 0 22 2 Pooled Mean mmol L 2 2 4 6 7 2 11 2 18 0 SD 2 6 3 7 5 1 6 6 8 4 CV 6 5 4 5 3 9 3 3 2 6 System Accuracy System accuracy results for glucose concentration 5 6 mmol L Within 0 28 mmol L Within 0 56 mmol L Within 0 83 mmol L 114 180 63 3 172 180 95 6 180 180 100 System accuracy results...

Page 57: ...ser Performance A study evaluating glucose values from fingertip palm forearm upper arm calf and thigh capillary blood samples obtained by 100 lay persons showed the following results 100 within 15 mg dL 0 83 mmol L of the medical laboratory values at glucose concentrations below 100 mg dL 5 55 mmol L and 95 within 15 of the medical laboratory values at glucose concentrations at or above 100 mg dL...

Page 58: ... 1 1 33 3 mmol L Acceptable hematocrit range 35 50 Operating condition 10 C 40 C 50 F 104 F between 10 85 R H Storage transportation condition 4 C 40 C 39 F 104 F between 10 85 R H Memory capacity 450 test results with time and date Average calculation 7 15 30 45 and 90 days Power supply One 3 volt lithium battery battery type CR2032 Battery life Approximately 1 000 tests Meter dimensions 95 mm L ...

Page 59: ...suring range 1 1 33 3 mmol L Acceptable hematocrit range 30 60 Operating condition 10 C 40 C 50 F 104 F between 10 85 R H Storage transportation condition 4 C 40 C 39 F 104 F between 10 85 R H Memory capacity 450 test results with time and date Average calculation 7 15 30 45 and 90 days Power supply One 3 volt lithium battery battery type CR2032 Battery life Approximately 1 000 tests Meter dimensi...

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