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Owner’s Manual

biohazardous and can potentially transmit

infectious diseases, even after you have

performed cleaning and disinfection.

• These devices are intended to be used for

patient self-monitoring and should not be

used to collect blood from more than one

person as this poses a risk of transmitting

blood-borne pathogens such as Hepatitis B

or HIV.

• No modification of this equipment is

allowed.

•

Please discard the product or the

batteries properly according to the

regulations of your country.

• Do not use this meter near cellular or

cordless telephones, walkie talkies, garage

door openers, radio trancimitters, or other

electrical or electronical equipment that

are sources of electromagnetic, radiation,

as these may interfere with the proper

operation of the meter.

For further information, please refer to:

“FDA Public Health Notification: Use of Fingerstick

Devices on More than One Person Poses Risk

Palmdoc 2 User Man.indd 7

24/08/2017 10:49

Содержание PalmDoc II

Страница 1: ...Let me be your guide Palmdoc 2 User Man indd 1 24 08 2017 10 49...

Страница 2: ...Palmdoc 2 User Man indd 2 24 08 2017 10 49...

Страница 3: ...Owner s Manual Palmdoc 2 User Man indd 3 24 08 2017 10 49...

Страница 4: ...onals monitor your blood glucose levels This owner s manual will help you learn how to use your PalmDoc II meter effectively All questions concerning test results should be directed to your healthcare...

Страница 5: ...oid human error due to improper coding Allow you to perform Alternate Site Testing AST Have memory and data management capabilities PalmDoc s software gives you and your healthcare professionals power...

Страница 6: ...Introduction to PalmDoc II Meters 17 18 Intended Use 17 Test Principle 17 18 Contents of the PalmDoc II Meter 18 Setting up the PalmDoc II Meter 19 26 Key Functions of the Meter 19 Meter Display 20 2...

Страница 7: ...6 47 Storing your System 47 Battery 48 Low Battery 48 49 Battery Replacement 49 50 System Troubleshooting 51 57 Special Messages 51 52 Error Messages 52 53 Troubleshooting Guide 54 57 Information Abou...

Страница 8: ...o not use on multiple patients Close supervision is necessary when the device is used by on or near children handicapped persons or invalids Use the device only for the intended use described in this...

Страница 9: ...f this equipment is allowed Please discard the product or the batteries properly according to the regulations of your country Do not use this meter near cellular or cordless telephones walkie talkies...

Страница 10: ...al Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood borne Pathogens 2011 http cdc gov injectionsafety Fingerstick DevicesBGM html DO NOT CHANGE YOUR TREATM...

Страница 11: ...a 0 39 mmol L Ascorbic Acid 0 28 mmol L L dopa 0 51 mmol L Aspirin 3 33 mmol L Maltose 26 3 mmol L Bilirubin 1 54 mmol L Methyldopa 0 13 mmol L Cholesterol 12 9 mmol L Tolbutamide 14 8 mmol L Creatini...

Страница 12: ...hyperglycemia If your results are below 3 3 mmol L or above 13 3 mmol L repeat the test and if the results are still below 3 3 mmol L or above 13 3 mmol L consult your healthcare professional immedia...

Страница 13: ...dy other than your fingertips to check your blood glucose levels PalmDoc II meters allow you to test on your palm forearm upper arm calf or thigh See Figure 1 What is the Advantage Fingertips feel pai...

Страница 14: ...mmediately after a meal physical exercise or stressful event take the blood sample from your fingertip only Use AST only v Two hours or more after your last meal v Two hours or more after taking insul...

Страница 15: ...T rub the puncture site before extracting blood An alternate site device is required to perform AST If you do not have an alternate site device but would like to use one please contact your local dist...

Страница 16: ...st strip The test strip consists of the following parts Absorbent Channel Apply a drop of blood and it will be drawn in automatically Confirmation Window Shows whether enough blood has been drawn into...

Страница 17: ...ps in their original vial only Do not transfer them to a new vial or any other container With clean dry hands you may touch the test strip anywhere on its surface when removing it from the vial or ins...

Страница 18: ...ips 180 days after the first opening date Do not use test strips beyond the expiration date printed on the package After removing the test strip from the vial insert it directly into the meter Do not...

Страница 19: ...d should not be used for the diagnosis of diabetes or for the testing of newborns Consult your healthcare provider if unusual readings occur Test Principle Blood glucose is measured by an electrical c...

Страница 20: ...th your PalmDoc II meter Using other test strips and control solutions with this meter can produce inaccurate results Contents of the PalmDoc II Meter The PalmDoc II meter is available as a meter only...

Страница 21: ...isplay Guides you through the test using symbols and simple messages Main Button Turns the meter on or performs other functions described in this manual Data Port Port for USB cable connection to your...

Страница 22: ...the meter is in testing mode Blood Drop Symbol Flashes when sample should be applied Unit of Measure Indicates what unit of measure the test result is displayed in Control Solution Test Symbol Shows...

Страница 23: ...ry Temperature Symbol Appears when temperature is outside of operating range Low Battery Symbol Appears when the battery power is low Voice Symbol Shows if audio function is on Day Average Indicates t...

Страница 24: ...ars on display When the test is completed the result appears on the display When you turn off the meter When a used test strip is inserted When blood is applied to the test strip What does the meter s...

Страница 25: ...of the meter Insert two 2 AAA Alkaline batteries and align them properly The meter will turn on and enter Setting Mode STEP 2 Enter Setting Mode If your meter is off press the SET button located in th...

Страница 26: ...P 4 Set the Year Press and release the M button to advance the year With the correct year on the display press the SET button and the date will appear on the display with the month segment flashing Fi...

Страница 27: ...et the Hour Press and release the M button to advance the hour With the correct hour on the display press the SET button and the minutes segment will start flashing See Figure 12 STEP 8 Set the Minute...

Страница 28: ...26 Owner s Manual Setup is now complete OFF is displayed and the meter will turn off See Figure 13 Figure 13 Palmdoc 2 User Man indd 26 24 08 2017 10 49...

Страница 29: ...iquid that contains glucose that will react with test strips and produce a test result You can use either high or normal PalmDoc control solution with your PalmDoc II system Summary PalmDoc control so...

Страница 30: ...d Use within a period of 90 days from the date that you first open it Record the discard date on the control solution bottle when you first open it to serve as a reminder to discard after 90 days For...

Страница 31: ...osed to extreme environmental conditions If you drop the meter If you change the battery in the meter Storage and Handling Store the control solution tightly closed at temperatures between 39 F 4 C an...

Страница 32: ...test strip slot first Push the test strip as far as it will go without bending it The meter turns on automatically STEP 3 Mark as a Control Solution Test After the symbol appears on the display press...

Страница 33: ...strip vials 2 Shake the control solution bottle well then remove cap 3 Squeeze the bottle and discard the first drop then wipe the dispenser tip with clean tissue paper or cotton 4 Squeeze the bottle...

Страница 34: ...r five 5 seconds the control solution test result appears on the display Compare the test result with the range printed on the test strip vial Each vial of PalmDoc Blood Glucose Test Strips may have a...

Страница 35: ...ng section of this manual and repeat the test Results that fall outside of the expected control ranges may indicate An error in performing the test Control solution bottle not shaken well Expired or c...

Страница 36: ...rate Contact Local Distributor If your test strips have been damaged or if you continue to get out of range results it means that the system or the control solution may not be working properly DO NOT...

Страница 37: ...Lancing Device Cover and set the puncture depth to the desired number The Adjustable Comfort Tip offers 5 levels of skin penetration To select the desired depth twist the Adjustable Comfort Tip in ei...

Страница 38: ...lancet Lancets are for single use only do not reuse Avoid getting hand lotion oils dirt or debris in or on the lancets and the lancing device These devices are intended to be used for patient self mon...

Страница 39: ...that the puncture is complete See Figure 22 Sites other Than Your Fingertip Please refer to the About Alternate Site Testing AST Section Please consult your healthcare professional before obtaining bl...

Страница 40: ...dle of the lancet See Figure 25 Always use caution when removing the lancet Discard the lancet according to your local safety regulations Warning The first drop of blood usually contains tissue fluid...

Страница 41: ...gure 26 Voice Speaks Your meter is on Please wait Please apply blood into the test strip STEP 2 Apply Blood Sample When the meter shows the apply blood to the opening of the absorbent channel of the t...

Страница 42: ...aution DO NOT Smear or scrape the blood onto the test strip Apply blood to the test strip when the test strip is not in the meter Put blood or foreign objects into the test strip slot STEP 3 Read Your...

Страница 43: ...t strip carefully to avoid contamination Important If you do not apply a blood sample within 3 three minutes the meter will automatically turn off You must remove the test strip and re insert it again...

Страница 44: ...Memory Mode While the meter is turned off press and hold the M button to turn the meter on Press the M button again to enter memory mode The 7 day average will appear indicating that you are in the m...

Страница 45: ...blood glucose tests have been performed e g 41 41 tests in the last 15 days The 30 45 90 day averages show the same information STEP 3 Recalling Individual Test Results After the 90 day average the m...

Страница 46: ...ry Mode Press and hold the M button for four 4 seconds to exit memory mode at any point Voice Speaks Please insert the test strip Important If you do not press any buttons for one 1 minute the meter w...

Страница 47: ...Data Port Auto electrode inserting detection Auto sample loading detection Auto reaction time count down Auto insufficient blood detection Temperature warning Acceptable Hematocrit Range 35 50 Operati...

Страница 48: ...ust blood or control solution inside the meter through the test strip port or the data port Never spray cleaning solution on the meter or immerse it in any liquid Lancing Device Wipe your PalmDoc lanc...

Страница 49: ...is completely dry before reattaching it to the device Please contact your local distributor if you have any questions Storing Your System PalmDoc II meters do not require special maintenance Store th...

Страница 50: ...time Warning Batteries can explode or leak and cause burns if installed backwards disassembled charged or exposed to water fire or high temperatures Low Battery The meter will alert you when the power...

Страница 51: ...cover STEP 2 Remove the old batteries and replace with new ones Be sure to align the batteries properly STEP 3 Close the battery cover If the meter does not power on after you have replaced the batte...

Страница 52: ...e kept away from small children If the battery is swallowed seek medical assistance immediately Remove the batteries if you are not going to use the device for a long period of time i e 3 months or mo...

Страница 53: ...ion under Action in the Error Messages section If you continue to have a problem please refer to the Troubleshooting Guide section If you follow the actions recommended but the problem is not resolved...

Страница 54: ...nal What it means Appears when the batteries cannot provide enough power for a test Action Replace the battery immediately What it means Appears when inserting a used test strip Action Test with a new...

Страница 55: ...e meter and test strip are within the operating temperature range What it means Insufficient blood sample Action Insert a new test strip Message Description Only the most common error messages are lis...

Страница 56: ...y end entering into the test strip port first Defective meter Please contact your local distributor for assistance v The test does not start after applying the sample Insufficient blood Repeat the tes...

Страница 57: ...fter Repeat the test with a automatic shut off new test strip Apply Two 2 minutes after sample only when the user action symbol appears on the display Defective meter Please contact your local distrib...

Страница 58: ...the test again Expired or Check the expiration contaminated date and the discard date control solution of the control solution Control solution that Control solution is too warm or too cold should com...

Страница 59: ...57 Owner s Manual Probable Cause Actions Meter malfunction Please contact your local distributor for assistance v The control solution test is out of range Palmdoc 2 User Man indd 57 24 08 2017 10 49...

Страница 60: ...as well as important information on limitations To make an accurate comparison between meter and laboratory results follow the guidelines below Before you go to the laboratory Perform a control solut...

Страница 61: ...u 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 test 2 Therefore it is best to fast for eight...

Страница 62: ...r each glucose concentration 100 mg dL 5 55 mmol L is 5 0 mg dL 0 278 mmol L and 5 0 respectively Intermediate precision Control Solution Level mmol L Low 1 7 2 8 Normal 5 3 8 0 High 15 6 23 3 Pooled...

Страница 63: ...and 28 mmol L Within 0 83 mmol L or 15 590 600 98 3 The PalmDoc II Blood Glucose Monitoring System meets the requirements for System Accuracy as stated in ISO 15197 2013 User Performance A study eval...

Страница 64: ...62 Owner s Manual of the medical laboratory values at glucose concentrations at or above 5 55 mmol L Palmdoc 2 User Man indd 62 24 08 2017 10 49...

Страница 65: ...tion Temperature limitation Use by Manufacturer Batch code Catalog number Serial number Sterilized using irradiation The blood glucose meter test strips and control solution fulfil the requirements of...

Страница 66: ...64 Owner s Manual Palmdoc 2 User Man indd 64 24 08 2017 10 49...

Страница 67: ...65 Owner s Manual Palmdoc 2 User Man indd 65 24 08 2017 10 49...

Страница 68: ...66 Owner s Manual 10 62 6910 0103 V2 OCT15 Palmdoc 2 User Man indd 66 24 08 2017 10 49...

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