Palmdoc I User Manual
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Palmdoc I User Manual

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Summary of Contents for Palmdoc Palmdoc I

  • Page 1 Let me be your guide.
  • Page 3 Welcome to...

  • Page 5: Table Of Contents

    Contents Page Before you begin ..........Getting to know your system ..... Blood glucose test strips usage – instructions for use ........Prepare for blood sampling ...... Performing blood test ........ Understanding your test result ....Comparing with laboratory results ..

  • Page 6: Before You Begin

    Before you begin Do not use the device if it is not working properly, or if it has suffered any damage. The following basic safety precautions should always be taken. Before using any product to test your blood glucose, read all instructions thoroughly Close supervision is necessary when the and practise the test.
  • Page 7 Altitudes above 3,402 metres (11,161ft) may the amount of glucose in the blood sample. affect the test results. The PalmDoc I meter measures the strength of the electrical current, calculates your blood Temperatures outside the range of 10°C glucose level and then displays your result to 40°C (50°F to 104°F) may affect the...
  • Page 8 Do not use this meter near cellular or substances, plasma or serum will cause cordless telephones in a call, walkie-talkies, incorrect results. garage door openers, radio transmitters, or other electrical or electronic equipment that Severe dehydration and excessive water are sources of electromagnetic, radiation, loss may cause false low results.
  • Page 9 Critically ill patients should not be tested with blood glucose meters. 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, Before you begin...
  • Page 10 Concentrations higher than Concentrations higher than the following values may the following values may Compounds Compounds cause inaccurate results cause inaccurate results Acetaminophen 0.53 mmol/L Hydroxyurea 0.39 mmol/L Ascorbic Acid 0.51 mmol/L 0.28 mmol/L L-dopa Aspirin 3.33 mmol/L Maltose 26.3 mmol/L Bilirubin 1.54 mmol/L Methyldopa...

  • Page 11: Getting To Know Your System

    Getting to know your system Reference: 1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus,13th The PalmDoc I uses the latest technology ed Philadelphia: Lea and Febiger (1994), 489. to provide you with easy and comfortable 2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual.
  • Page 12 The visual display Important: Battery symbol: Appears when the battery Use only PalmDoc Blood Glucose Test Strips is weak and should be replaced. and Control Solutions with your PalmDoc Blood Glucose Meter. Use of other test strips Thermometer symbol: Appears when the...
  • Page 13 Day Month Year Hour Minute Blood drop symbol: Flashes when the meter and test strip are ready for the application of the blood sample. Measurement unit: Appears with the test result. Average: Appears when the meter is in memory mode while recalling 7/15/30/45/90 day test averages.
  • Page 14 The meter Strip slot Battery compartment Holds a PalmDoc blood glucose test strip in Holds one 3V lithium place when you perform battery (battery a blood glucose test. type CR2032). Display Shows test results and messages. Meter label Each meter has a...
  • Page 15 The setting button Button Button Press to enter time Press to increase the value and date setting mode. of the current setting. Button Button Press and hold for 2 seconds Press to enter to turn meter on and off. memory recall mode. Button Button Press to decrease the value...
  • Page 16 Setting time and date Repeat to set the month, year, hour and Your PalmDoc I meter comes with a new battery minute. After the minute setting is set, the (battery type CR2032). Please set the correct display returns to the day setting. Press time and date before you begin to test.
  • Page 17 factory. about 1,000 tests or 12 months when testing 3 times a day. When you turn off the meter or replace the battery, the unit will not be changed. When the battery symbol appears on the meter display, the battery charge is low. You will still Use of the wrong unit of measure may cause be able to test with a low battery, but you misinterpretation of your blood glucose level,...
  • Page 18 How to replace the battery Make sure the meter is turned off. Let the Use the edge of the battery cover to pull front of the meter rest in the palm of your out the battery from the holder. hand. Slide the battery cover open. Getting to know your system...
  • Page 19 Insert a new battery (battery type CR2032), You should hear a beep to indicate correct making sure to align the plus (+) side up. installation. If not, please reinsert the battery correctly, then close cover. Getting to know your system...
  • Page 20 Note: Replacing the battery does not affect Batteries might leak chemicals if not the test results stored in memory; used for a long time. Remove the however, the time and date may need batteries if you are not going to use to be re-set.
  • Page 21 Blood glucose test strips usage Characteristics Each test strip is plasma-calibrated†, requiring a sample volume of 0.5 μL and taking just Test strip handle 5 seconds to return a test result. The test Hold this part to insert the range is 1.1 to 33.3 mmol/L with resolution at test strip into the meter.
  • Page 22 4 ~ 40°C T est results produced on capillary whole (39 ~104°F). Do not freeze it. blood samples by the PalmDoc I system are compared with the results of the S tore test strips in their original vial only. Do corresponding plasma samples tested by not put the test strips in any other container.
  • Page 23 U se test strips immediately after removing P erform blood glucose tests only at a from the vial. temperature between +10°C (50°F) and +40°C (104°F), and relative humidity D o not use test strips after the expiry date. between 10% and 85%. M ake a note of the date on the vial label when you first open it.
  • Page 24 Additional information for healthcare professionals Follow the infection control procedures of your organisation. PalmDoc test strips are not validated for and should not be used for testing venous or Blood glucose test strips usage...

  • Page 25: Prepare For Blood Sampling

    Prepare for blood sampling Adjustable lancing device Depth selector Your lancing device and lancets are used to obtain capillary blood samples Lancing device from the testing site. Cocking control Release button Lancet holder Lancet ejector Prepare for blood sampling...
  • Page 26 Important lancing device and lancets information Important: Lancets are for single use only. The meter and lancing device are for single patient use. Keep lancing device and lancets clean. Do NOT share them with anyone Use caution when removing the used lancet including other family members.
  • Page 27 Setting your lancing device Twist off the lancing device cap. Insert a new sterile lancet into the lancet holder. Push down firmly until it is fully seated. Do not twist the lancet. Prepare for blood sampling...
  • Page 28 Twist off the lancet protective cap and Set the lancing level by twisting the depth save it for later use. Replace the lancing selector until the number lines up with the device cap. arrow.To select the best depth: 1-2 for soft or thin skin 3 for average skin 4-5 for thick or calloused skin Prepare for blood sampling...
  • Page 29 Care of the lancing device Clean the lancing 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. To disinfect the lancing device cover, use a disinfectant solution (containing 2000 mg/ dL of chlorine) and immerse for 30 minutes.

  • Page 30: Performing Blood Test

    Performing blood test Wash hands: Wash, clean, rinse and dry hands thoroughly. Warm fingers to increase blood flow. Performing blood test...
  • Page 31 mmol/L Insert test strip: Insert a test strip to turn Wait for blood drop symbol: When it starts on the meter automatically. blinking, the meter is ready for use. Performing blood test...
  • Page 32 Select and lance a puncture site: F or fingertip: Hold the prepared lancing device firmly against the side of your fingertip. Press the release button. F or 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.
  • Page 33 Incorrect Correct Obtain a blood sample: Gently massage your finger to obtain the required blood volume. To perform the test, you need only 0.5 μL of blood sample resting on your Apply blood sample: Apply blood sample fingertip. Do not smear the blood sample. to test strip and the meter will begin the 5 To obtain the most accurate result, wipe off second countdown before displaying result.
  • Page 34 Read test result: Record your test result on the log sheet. Y our blood glucose test result appears along with the unit of measurement, date and time. Performing blood test...
  • Page 35 Remove strip to turn meter off: After use, twist off the lancing device cap. Test results are automatically stored in the Push the exposed tip of the lancet into its meter after removing the test strip to turn protective cap. off the meter.
  • Page 36 Slide 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. Performing blood test...
  • Page 37 Important: The PalmDoc I only requires a tiny sample that the test strip is not filled with blood of blood to perform a test. Choose a when the meter is counting, NEVER try to different puncture spot each time you add more blood to the test strip.

  • Page 38: Understanding Your Test Result

    Understanding your test result The normal blood glucose range is below 5.6 Was the blood sample in sufficient volume mmol/L for a fasting, non-diabetic adult, (i.e. no less than 0.5 μL)? but less than 7.8 mmol/L two hours after meals.* Consult your healthcare professional to Was the test strip used immediately after the find out your target blood glucose value.

  • Page 39: Comparing With Laboratory Results

    The results you obtain from your meter may is “yes”, then perform a validation check of differ somewhat from your laboratory tests the meter using the PalmDoc control solution. due to different factors and conditions. If the control solution test result is within the...
  • Page 40 It is best to fast for at least eight (8) hours You may still have a variation from the result before doing a comparison test. because blood glucose levels can change significantly over short periods of time, Take your meter to the lab. especially if you have recently eaten, exercised, taken medication, or experienced stress .

  • Page 41: Memory Recall

    Memory recall Reference: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), The meter stores a maximum of the 450 most April, 49-51. recent blood glucose test results with date Sacks, D.B.:’‘Carbohydrates.’‘ Burtis, C.A., and Ashwood, and time in its memory. It also provides you E.R.
  • Page 42 The most recent test result with sequence average is calculated from the date of number 1 and the test result will be shown. your latest blood glucose results obtained during the past 7 days. Press button to recall the next older or most-recent test record respectively.

  • Page 43: Control Solution Testing

    7, 15, 30, 45 and 90 days amount of glucose that will react with the preceding the current date and time PalmDoc test strips. By testing your control settings. Change battery or reset meter solution and comparing the test results with time and date won’t affect their average...
  • Page 44 After changing the batteries. using your own blood. Important control solution information When should the control solution test be Use only PalmDoc control solution. Check performed? the expiry date on the control solution Whenever you suspect that the meter or bottle.
  • Page 45 Please contact your local distributor if you need to purchase control solution. 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...
  • Page 46 Squeeze a drop of control solution: Shake Apply control solution: Apply the drop to control solution bottle well. Remove the cap. the opening of the strip absorbent channel Squeeze bottle, discarding the first drop until the confirmation window is filled. The and wipe off the dispenser tip with a clean meter will begin to count down from 5 to 1.
  • Page 47 Nornal 4.7-7 Note: 7.8-14.4 Do not apply the control solution directly to the test strip. Overdosed solution may give inaccurate result. Repeat test if the result falls outside the control range stated on the test Check if the test result is in range: After the strip label.

  • Page 48: Caring For Your Meter And Test Strip

    Caring for your meter and test strip agent, then dry the device with a soft and dry cloth. Do not flush with water. To avoid getting dirt, dust or other contaminants on the meter or test strips, Do not use organic solvents to clean the please wash and dry your hands thoroughly meter.
  • Page 49 2. Strip U se each test strip immediately after S torage condition: 4°C~40°C (39°F~104°F), removing it from the vial. and 10~85% relative humidity. D o not bend, cut, or alter a test strip in D o not freeze. Store your test strips in their any way.

  • Page 50: About Alternative Site Testing (Ast)

    About alternative site testing (AST) What is the advantage of AST? Fingertips feel pain more readily because they Note that there are important limitations when are full of nerve endings (receptors). At other doing AST. Please consult your healthcare body sites, nerve endings are not so numerous professional before you perform AST.
  • Page 51 Use AST only: How to accurately use AST In a pre-meal or fasting state (more than 2 hours since the last meal). Stimulate blood Two hours or more after taking insulin. perfusion by rubbing Two hours or more after exercise. the puncture site for During steady state blood glucose 20 or more seconds...

  • Page 52: Display Messages And Problem-Solving Guide

    Display messages and problem- solving guide mmol/L mmol/L The following are some meter displays that help to identify certain Display check. Moving strip. Blinking blood drop. states or problems which may be experienced by users. It must be noted If some parts of The meter is awaiting The meter is ready that improper use of...
  • Page 53 mmol/L mmol/L Test result is higher Test result is lower Battery is low. Battery is dead. than 33.3mmol/L. than 1.1mmol/L. High or low blood glucose levels can indicate a Replace battery soon. Replace battery now. possibly serious medical condition. If this is not confirmed by the way you feel, review proper testing procedure and perform a control test.
  • Page 54 Temperature is above Insufficient blood Temperature is Used strip, moistened the operating range. sample. below the operating strip or defective range. meter. The meter will not work when outside its Insert a new test strip Please repeat the operating temperature range. Move to an and test again.
  • Page 55 No responses when strip is inserted No responses when blood sample is applied into the meter. to the strip. There are multiple potential causes: Maybe: Battery is dead. Blood volume is not sufficient. Wrong strip was inserted. Meter is defective. Meter is defective.

  • Page 56: Performance Characteristics

    Repeatability Performance characteristics Blood Glucose 1.7~ 2.9~ 6.2~ 8.4~ 14.0~ (mmol/L) 13.9 22.2 Pooled Mean 11.2 18.0 Precision (mmol/L) Standard deviation (SD) for each glucose CV (%) 6.5% 4.5% 3.9% 3.3% 2.6% concentration < 5.55 mmol/L and coefficient of variation (CV) for each glucose concentration ≥...
  • Page 57 The PalmDoc I Blood Glucose Monitoring mmol/L). System meets the requirements for System Accuracy as stated in ISO 15197:2013. The study shows that the PalmDoc I compares well with the laboratory method. User Performance A study evaluating glucose values from...

  • Page 58: System Specifications

    System specifications Model name PalmDoc I Assay method Electrochemical biosensor Test sample Capillary whole blood Test result Referenced to plasma glucose value Alternative site testing YES (palm, forearm, upper arm, calf, or thigh) Sample size 0.5 L (Auto insu cient blood detection)
  • Page 59 Sample size 0.5 L (Auto insu cient blood detection) Measuring time 5 seconds Measuring range 1.1~33.3 mmol/L Acceptable hematocrit range 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...
  • Page 60 OK Biotech Co., Ltd. No. 91, Sec. 2, Gongdao 5th Road, 30070 Hsinchu City, TAIWAN MDSS GmbH Schiffgraben 41, 30175 Hannover, GERMANY 10-62-6510-0103 V2-OCT15...

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