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Intended use for Disinfection and Pre-Cleaning before Disinfection

The disinfection process is for preventing potential transmission of infectious
diseases through bloodborne pathogens. The pre-cleaning process is to
ensure the removal of any stains or debris so that effective disinfection can be
achieved for the meter surface.
You should also wash both hands thoroughly with soap and water after han-
dling the meter and test strips.

Disinfection Wipes Material and Where to Buy Them

The materials suitable for

On Call

®

Pro

meter pre-cleaning and disinfection are

listed below.

Disinfect-

ing Wipe

EPA Reg-

istration

No.

Active Ingredients

Where to Purchase

DisCide

Ultra Dis-

infecting

Towelettes

10492-4

Isopropyl alcohol 63.25%
n-alkyl dimethyl benzyl am-

monium chloride 0.12%
n-alkyl dimethyl ethyl benzyl

ammonium chloride 0.12%

Available through

the Palmero Health

Care Company (www.

palmerohealth.com)

or through medical

distributors

PDI Super

Sani-Cloth

Germicidal

Disposable

Wipes

9480-4

Isopropyl alcohol 55%,

n-alkyl dimethyl benzyl

ammonium chlorides 0.25%,

n-alkyl dimethyl ethyl benzyl

ammonium chloride 0.25%

Available through PDI

Healthcare

(www.pdihc.com)

or through medical

distributors

Pre-Cleaning and Disinfection Frequency

Be sure to disinfect and pre-clean the meter after each use. The disinfection

and pre-cleaning frequency depends on your daily usage and should take

place between testing each patient. The meter disinfection process has been

validated for 3 years of meter usage based on ten daily cleaning and

disinfection cycles. A total of 10,950 cleaning and 10,950 disinfection cycles

have been validated to represent cleaning and disinfection after each use over

the lifespan of the

On Call

®

Pro

meter

Although deterioration was not observed during the manufacturer’s validation

of the cleaning and disinfection procedure, you should always inspect the

meter for any signs of deterioration after cleaning and disinfection.
The meter appearance elements visually inspected in the validation testing

include: polymer crazing (thin silver streaks), cracking, swelling, dissolving,

softening and becoming brittle.
The meter functional elements inspected in the validation testing include:

All display segments verified after meter turns on; All meter set up functions

verified including 12 or 24 Hour mode; Year, Month, Date, Hour, Minute; Meal

Marker, Audio, Ketone warning, Daily Control Test Reminder, Hyper warning,

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Summary of Contents for On Call Express Pro

Page 1: ......

Page 2: ...tinuous glucose monitors CGMs nor for use in insulin dose calculations To ensure accurate results from the On Call Pro Blood Glucose Monitoring System please follow these guidelines Use only On Call Pro Blood Glucose Test Strips with the On Call Pro Blood Glucose Meter For in vitro diagnostic use only Test only fresh capillary whole blood samples with the On Call Pro Blood Glucose Test Strips and ...

Page 3: ...Life 1 000 tests for glucose testing not considering data transfer Glucose Units of Measure The meter is preset to mg dL when sold in the United States Memory Up to 300 records with time and date Automatic Shutoff 2 minutes after last action Meter Size 85 0 mm 49 0 mm 16 4 mm Display Size 35 0 mm 32 0 mm Weight 50 0 g with battery installed Operating Temperature 41 113 ºF 5 45 ºC Operating Relativ...

Page 4: ...ming the Quality Control Test 19 Testing Blood 23 Step 1 Getting a Drop of Blood 23 Step 2 Testing Blood Glucose 27 HI and LO Messages 29 Hypo and Hyper Messages 30 Ketone Message 31 Ctl Message 31 Using the Meter Memory 33 Viewing Stored Records 33 Clearing the Memory 35 Transferring Records 35 Maintenance 36 Replacing the Battery 36 Cleaning and Disinfection 37 Suggested Testing Times and Target...

Page 5: ... the system such as On Call Pro Control Solution OptiLance Safety Lancets or On Call Pro Test Strips separately please contact your local distributor or Customer Support at 1 800 838 9502 Please check the list of contents on the outer box for details on which components are included with the meter Getting Started On Call Pro Blood Glucose Meter On Call Pro Blood Glucose Test Strips On Call Pro Glu...

Page 6: ...lable single use auto disabling safety lancets 4 On Call Pro Glucose Control Solution Confirms that the blood glucose monitoring system is properly working Use this solution in place of a blood sample to check the test strips and meter for a pre calibrated reading Three levels of control solution are included in the On Call Pro Glucose Control Solution kit sold separately Control Solution 1 is all...

Page 7: ... For more information please refer to Guideline for Isolation Precautions Preventing Transmission of Infectious Agents in Healthcare Settings 2007 at the Centers for Disease Control website http www cdc gov hicpac 2007ip 2007isolationprecautions html 3 The meter should be disinfected after use on each patient This Blood Glucose Monitoring System may only be used for testing multiple patients when ...

Page 8: ...r reads the test strips and displays the blood glucose concentration Use these diagrams to become familiar with all the parts of the meter Strip Port Liquid Crystal Display LCD Right u Button Strip Ejector Battery Cover Left u Button Data Port ...

Page 9: ... forward to discard the used test strip Note Dispose of blood samples and materials with care Treat all blood samples as if they are infectious materials Follow proper precautions and the guidelines of your institution Obey all local regulations when disposing of blood samples and materials Battery Cover Remove the battery cover to install one CR 2032 coin cell battery Data Port Sends information ...

Page 10: ...is below the Hypoglycemia low blood sugar target level that you have set Hyper Symbol Appears when the blood glucose concentration is above the Hyperglycemia high blood sugar target level that you have set Measurement Unit Only mg dL will be displayed on the meter It cannot be adjusted Battery Symbol Warns when you should replace the battery After Meal Symbol Appears when after meal test results a...

Page 11: ...ck the meter by running a quality control test Refer to Performing the Quality Control Test on page 19 for instructions Do not take the meter apart This will void the warranty Refer to the Cleaning and Disinfection section on page 37 for details on cleaning and disinfecting the meter Keep the meter and all associated parts out of the reach of children Note Follow proper precautions and all local r...

Page 12: ...n here IMPORTANT Apply the sample only to the sample tip of the test strip Do not apply blood or control solution to the top of the test strip This may result in an inaccurate reading Hold the blood drop to the sample tip of the test strip until the check window is completely full The meter will then begin to count down If you applied blood but do not see the count down start you may reapply a sec...

Page 13: ...into the meter strip port may result in reading errors Special Instructions for Test strips in the Vial Do not use test strips after the unopened expiration date printed on the vial Note All expiration dates are printed in Year Month format 2015 01 indicates January 2015 A new vial of test strips may be used for 6 months after being first opened After 6 months they will expire Write the opened exp...

Page 14: ...Your patient is in a fasting state You are testing a patient before their meal Two hours have passed since your patient s last meal Two hours have passed since your patient s last insulin dosing Two hours have passed since your patient s last physical activity Use fingertip testing when It is less than two hours since your patient s last meal It is less than two hours since your patient s last ins...

Page 15: ...peration Before using a new box of test strips When you suspect that the meter or test strips are not working properly When you suspect that the test results are inaccurate or if they are inconsistent with how the patient feels When you suspect the meter is damaged After cleaning the meter At least once a week According to the guidelines of your institution Refer to Perfomring the Quality Control ...

Page 16: ...trip vial or on the foil pouch are not recommended ranges for the blood glucose level of a patient Personal blood glucose target ranges should be determined by a physician Do not touch the test strip with the tip of the control solution bottle Use only the On Call Pro brand of control solution with the On Call Pro glucose meter Please contact your local distributor or Customer Support at 1 800 838...

Page 17: ...n provided in the On Call Pro meter box Please find the additional battery in the box and when a new battery is need ed install it according to the following steps 1 Turn over the meter Slide the battery cover in the direction of the arrow to open it 2 Insert a fresh CR 2032 3 0V coin cell battery with the plus side facing up 3 Close the battery cover until it snaps shut Installing the Battery ...

Page 18: ...o set the year month and date Note The clock needs to be reset after replacing the battery 3 Date The year will appear at the top of the display Press the left button to increase the year Once you have selected the correct year press the right button to save your choice and start setting the month Press the left button to increase the month Then press the right button to save your choice and start...

Page 19: ...ll be displayed as shown below Press the left button to switch between turning the meal marker On and Off Press the right button to confirm your selection 6 Audio Feature The meter comes with the audio feature enabled There will be a short beep when it is turned on after sample detection and when the result is ready The meter will sound three short beeps to sound a warning when an error has occurr...

Page 20: ...to ensure the system is operating properly and will help you to abide by your institution s quality control procedures if applicable When set to On the reminder will prompt you to perform a control solution test every 24 hours If a control test has not been conducted within 24 hours of the previous test Ctl will flash on the screen along with the control solution symbol and test reminder symbol Yo...

Page 21: ...evel The proper hyperglycemia blood glucose level for each patient should be determined by their physician 10 Hypo Indicator The meter comes with the Hypo indicator feature dis abled Press the left button to turn the Hypo indicator On or Off Press the right button to confirm your selection When the Hypo in dicator is Off pressing the right button will go to the Test Reminder set up When the Hypo i...

Page 22: ...n pressing the right button will go to the set up of the time for the second Test Reminder Press the left button to adjust the second Test Reminder time Press the right button to confirm the second Test Reminder time and then go to the third Test Reminder set up Repeat the same set up procedure for Test Reminder 3 4 and 5 After finishing the fifth Test Reminder set up it will then end the setup mo...

Page 23: ...ng to the guidelines of your institution 1 Insert a test strip into the strip port contact bars end first and facing up It will turn on the meter and display all the display segments If the audio option is on the meter will beep signaling the meter is turned on 2 Check the display to confirm that all the display segments turn on Next a dash will move across the display 3 Following this display che...

Page 24: ...olution to the test strip directly from the bottle If you applied the control solution sample but do not see the count down start you may reapply a second drop within 3 seconds 6 Once a sufficient sample has been applied the meter display will count down from 3 to 1 Then the result and a control solution symbol will be displayed on the screen The control solution test results should be within the ...

Page 25: ...e in which you are testing is between 50 and 104 F 10 40 C Make sure that the test strip vial and control solution bottle have been tightly capped Confirm that you are using the On Call Pro brand of control solution Make sure that you followed the test procedure correctly After checking all of the conditions listed above repeat the quality control test with a new test strip If your results still f...

Page 26: ... system to test blood as the system may not be working properly If you cannot fix the problem please contact Technical Support at 1 800 838 9502 Please contact your local distributor or Customer Support at 1 800 838 9502 for information on ordering the On Call Pro Glucose Control Solution kit The kit contains Control Solution 0 Control Solution 1 and Control Solution 2 Note on the Material Safety ...

Page 27: ...e using the single use safety lancet for blood sampling wash both hands with soap and warm water and disinfect the puncture site with a topical skin antiseptic such as an alcohol swab Then dry both hands and the test site thoroughly Make sure there is no alcohol soap or lotion on the test site Note Never share safety lancets between mulple patients Cross use of the safety lancet may cause transmis...

Page 28: ...before testing each patient 2 Carefully remove the protective cap While holding the body of the device twist the protective colored cap 360 Note Do not put your thumb on the colored button while removing the protective cap This may cause misfires 3 Press the safety lancet against side of fingertip and press the colored button firmly Note Before using the single use disposable lancet for blood samp...

Page 29: ...ind that obtaining blood from these sites is less painful than from the fingertip IMPORTANT There are important differences among forearm palm and fingertip samples that you should know You should consult your patient s doctor before choosing to perform forearm or palm testing When blood levels are changing rapidly such as after a meal an insulin dose or exercise blood from the fingertips may show...

Page 30: ... free of visible veins and hair Note To bring fresh blood to the surface of the puncture site massage the puncture site vigorously for a few seconds until you feel it getting warm 2 Remove the protective cap While holding the body of the device twist the colored protective cap 360 Place the single use safety lancet against the puncture site Press the lancet against the puncture site press the colo...

Page 31: ...o ensure no inappropriate segments or icons are permanently turned on 3 Following this display check the system will enter the test mode The display will show the date and time and the strip icon with the blood sample icon blinking to indicate that the test strip is inserted correctly and a drop of blood can be added If the test strip has been inserted incorrectly the meter will not turn on The me...

Page 32: ...ng the 7 14 30 60 and 90 day averages If a result is marked by accident press the left button to unmark the result After marking the invalid result with a pound sign press the right button to confirm the invalid result After marking the invalid result run the test again with a new test strip When the meal marker feature is turned on the test result is displayed together with a suggested default me...

Page 33: ...lay refer to HI and LO messages below 6 Record the results in accordance with your institution s requirements and compare them to the target goals set by the treating physician Refer to Suggested Testing Times and Target Goals on page 40 for more details on the target blood glucose level goals 7 Slide forward the strip ejector to discard the used test strip Note Dispose of blood samples and materi...

Page 34: ...u should contact the treating physician immediately or follow your institution s guidelines If LO appears on the display the measured concentration value is below 20 mg dL The test should be retaken to ensure that no mistake was made in the procedure If you are certain the meter is functioning properly and no mistakes were made in the procedure and your patient s blood glucose is still consistentl...

Page 35: ...guidelines Ctl Message If Ctl flashes on the screen along with the control solution symbol and test reminder symbol the Daily Control Test Reminder is on and is being activated because a control test has not been conducted within 24 hours of the previous test If the Daily Control Test Reminder flashes on screen when the meter is turned on enter control solution mode by pressing the right button Yo...

Page 36: ...low below 30 hematocrit levels can cause false results Consult with your patients physician to find out their hematocrit level The system is tested to accurately read the measurement of glucose in whole blood within the range of 20 600 mg dL Fatty substances have no major effect on test results These include triglycerides up to 3 000 mg dL or cholesterol up to 500 mg dL Ascorbic acid vitamin C doe...

Page 37: ...lucose test is completed and the test strip is still inserted in the meter pressing the right button will also enter the memory mode If you marked the test result as a before meal result after meal result or invalid result with pound sign the word MEM will also appear with the symbol on the display 2 If you are using the meter for the very first time the meter display will show three dashed lines ...

Page 38: ...verages only include the test results that have been marked as before meal Post meal averages only include the test results that have been marked as after meal General 7 14 30 60 and 90 day averages include all blood glucose results 6 If there are fewer than 7 14 30 60 and 90 days in memory all the readings without the pound sign currently stored in memory will be averaged If you are using the met...

Page 39: ...t without deleting the recorded data press the right button This will turn the meter off without deleting any data Transferring Records The meter can transfer stored test results to a Windows based personal computer PC using an optional data transfer cable and software package To make use of this feature you will need the On Call Diabetes Management Software available from http www oncallmeters co...

Page 40: ...e meter will not function until the battery is replaced Instructions 1 Turn the meter off before removing the battery 2 Turn the meter over then slide the battery cover in the direction of the arrow to open it 3 Remove and discard the old battery Insert a new CR 2032 3 0 V coin cell battery in the battery carrier Make sure the plus side is facing up 4 Close the battery cover and make sure that it ...

Page 41: ...stains or debris This pre cleaning will pre pare the meter surface for disinfection After pre cleaning please use another wipe to disinfect the meter Wipe the entire meter thoroughly and leave the surface wet accord ing to the contact times listed below Disinfection Wipe EPA Registration No Contact Time DisCide Ultra Disinfecting Towelette 10492 4 1 minute PDI Super Sani Cloth Germicidal Disposabl...

Page 42: ...e 0 25 Available through PDI Healthcare www pdihc com or through medical distributors Pre Cleaning and Disinfection Frequency Be sure to disinfect and pre clean the meter after each use The disinfection and pre cleaning frequency depends on your daily usage and should take place between testing each patient The meter disinfection process has been validated for 3 years of meter usage based on ten d...

Page 43: ... be thoroughly washed with soap and water before proceeding to the next patient For more information refer to FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm and CDC Clinical Reminder Use of Fingerstick Devices on More t...

Page 44: ...atient s diabetes medication You think the patient s blood glucose levels may be too low or too high The patient is ill or feeling uncomfortable over long periods of time Expected blood glucose levels for people without diabetes2 Suggested Testing Times and Target Goals Time of Day Patient s Target Range Waking up Fasting level Before meals 2 hours after meals Bedtime 2 AM to 3 AM Other 1 Jennifer...

Page 45: ...nes Before going to the lab Bring the meter test strips and control solution with you Make sure the meter is clean Perform a quality control test to make sure the meter is working properly Comparisons will be more accurate if the patient does not eat for at least four hours before testing Eight hours is preferable At the lab Wash the patient s hands before obtaining a blood sample Take blood sampl...

Page 46: ... calibration check error Turn off meter or remove test strip and then turn on meter again to retest If the problem persists please contact Technical Support at 1 800 838 9502 Test strip was removed during the test Repeat the test and ensure the test strip remains in place Sample was applied to the test strip too soon Repeat the test and apply sample after blood drop test strip symbol appears Test ...

Page 47: ...er Please make sure you use the On Call Pro test strip with the On Call Pro Blood Glucose Meter If the problem persists please contact Technical Support at 1 800 838 9502 Test strip damaged or calibration error Please test again by using a new strip If the problem persists please contact Technical Support at 1 800 838 9502 Communications failure There is an error in transferring data to the PC See...

Page 48: ...for any reason other than obvious abuse within the first three 3 years from purchase we will replace it with a new meter free of charge For your records also write the purchase date of your product here Date of purchase _______________________________________________ Note This warranty applies only to the meter in the original purchase and does not apply to the batteries supplied with the meter Wa...

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