Page 3
V4/1 – 05853397002 – Schwarz – Whether the Accu-Chek Performa meter is your first blood glucose meter or you have used a meter for some time, please read this booklet carefully before you use your new meter. To use it correctly and dependably, Roche USA –...
Page 4
Testing (AST) section of this booklet for approved alternative sites and associated limitations. The Accu-Chek Performa meter with the Accu-Chek Performa test strips provide a complete test system that is meant for in vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home. The system is not for use in diagnosis or screening of diabetes mellitus.
Page 5
WArning Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition; CLSI document M29-A3, 2005). Why regular Blood glucose Testing is important Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day.
Contents Chapter 1: Understanding Your new System ...................7 The Accu-Chek Performa Meter ........................7 Preparing the Meter for a Test ......................... 9 Adjusting the Time and Date for First Time Use .....................11 Using the Accu-Chek Performa System ......................14 Chapter 2: Testing Your Blood glucose ....................15 Performing a Blood Glucose Test ........................15...
Page 8
Chapter 5: Maintenance and Troubleshooting ..................53 Meter Maintenance ............................53 Changing the Battery .............................54 Cleaning the Meter ............................55 Display and Error Messages ..........................56 Chapter 6: Technical information ......................63 Product Limitations ............................63 Specifications ..............................63 Product Safety Information ..........................65 Discarding the Meter .............................66 Explanation of Symbols ..........................67 Guarantee ..............................68 Additional Supplies ............................68...
Chapter 1: Understanding Your new System The Accu-Chek Performa Meter infrared (ir) Window Power/Set Button Transfers data from the meter Turns the meter on or off to a computer or PDA. and sets options. Code Chip Slot Display Insert code chip here.
Page 10
The code chips that come with Accu-Chek Performa test strips are changing from white to black. Once you receive a black code chip, insert it into the meter. You do not need to change the black code chip again, even if new test strip boxes contain different colored code chips or different code numbers.
The code chips that come with Accu-Chek Performa test strips are changing from white to black. Once you receive a black code chip, insert it into the meter. You do not need to change the black code chip again, even if new test strip boxes contain different colored code chips or different code numbers.
Page 12
noTE • If you see code and a flashing - - - on the display, insert a code chip into the meter. • Do not force the code chip into the meter. There is only one correct way to insert the code chip. •...
Adjusting the Time and Date for First Time Use The meter is preset with the time and date which may need to be adjusted to the local time zone. It is important to set the correct time and date in the meter to use the meter memory or to transfer results to a computer.
Page 14
decrease increase 4. Press and release 5. Press and release to set the 6. Repeat steps 4 and 5 to adjust adjust the minutes. minutes. and set the day, month, and year. 50705_05853397002_EN.indb 12 4/24/12 8:32 AM...
Page 15
7. Press and hold until the flashing test strip symbol appears on the display. The time and date are now set. noTE • After you change the battery, the meter automatically prompts a time and date confirmation when it is turned on.
The code chips that come with Accu-Chek Performa test strips are changing from white to black. Once you receive a black code chip, insert it into the meter. You do not need to change the black code chip again, even if new test strip boxes contain different colored code chips or different code numbers.
Chapter 2: Testing Your Blood glucose Performing a Blood glucose Test noTE • Set up the meter before you perform your first blood glucose test. • Blood samples taken from the palm are equivalent to blood samples taken from the fingertip. For detailed information on how to obtain blood from the palm, refer to the Alternative Site Testing (AST) section, steps 4 and 5.
Page 18
You need the meter, a test strip, a lancing device, and a lancet. 1. Wash and dry your hands. 4. Insert the test strip into the 5. Perform a fingerstick with the meter in the direction of the lancing device. arrows.
Page 19
6. Gently squeeze your finger to 7. Touch the blood drop to the 8. The test result appears on assist the flow of blood. front edge of the yellow the display. Leave the test window of the test strip. Do strip in the meter to mark This helps you get a blood not put blood on top of the...
Marking Blood glucose results You can mark a test result with an asterisk ( ) to indicate a special event such as exercise or an AST result. When you review the test results in memory, the can help you remember what was different about the test result.
Alternative Site Testing (AST) You have the option of obtaining a blood sample from other sites on your body besides the fingertip. Alternative sites include the palm, forearm, upper arm, thigh, and calf. The two palm testing sites are the fleshy areas under the thumb (thenar) and under the little finger (hypothenar).
Page 22
WArning • Do not change your therapy because of just one blood glucose result. • NEVER ignore symptoms of low or high blood glucose. • If your blood glucose result does not match how you feel, perform a fingertip or palm test to confirm your test result.
Page 23
You need the meter, a test strip, a lancing device designed for AST, and a lancet. 1. Prepare the lancing device. 3. Insert the test strip into the 4. Press the lancing device firmly meter in the direction of the against a fleshy area on the arrows.
Page 24
noTE • If the blood drop is too small, reapply pressure to get a sufficient blood drop. • After a successful test, the meter turns off 5 seconds after the test strip is removed. 5. Trigger the lancing device 6. Touch the blood drop to the 7.
Unusual Blood glucose results If your blood glucose result does not match how you feel, check this list to help solve the problem. Troubleshooting Checks Action 1. Check if the test strips were expired. Discard the test strips if they are past the use by date.
6. Check if the meter and test strips are working Perform a control test. See Chapter 4, Performing a properly. Control Test, for instructions. 7. If you are still unsure of the problem … Contact Roche. Symptoms of Low or High Blood glucose Being aware of the symptoms of low or high blood glucose can help you understand your test results and decide what to do if they seem unusual.
Chapter 3: Meter Memory, Setup, and Data Transfer Memory Storing Blood glucose and Control results The meter automatically stores up to 500 blood glucose results with the time and date of the test result. You can review them at any time. Test results are stored from the newest to the oldest. It is very important to set the correct time and date in the meter.
Page 28
noTE • The memory is not lost when the battery is replaced; however, confirm that the time and date are still correct (see Chapter 3, Setting the Time and Date). • Once 500 blood glucose or 20 control results are in memory, adding a new result causes the oldest one to be deleted.
Viewing Blood glucose results With the meter on or off, press and release to enter memory. The most recent test result appears on the display. • To view previous test results in order, press . • To view the 7, 14, or 30 day averages, press . 50705_05853397002_EN.indb 27 4/24/12 8:32 AM...
Meter Setup Using the Set-Up Mode The following features can be customized as required. Time and date Set the time and date. Beeper Select on or oFF. Test reminders Select on or oFF. If you select on, choose 1 to 4 times a day for a test reminder.
Setting the Time and Date decrease increase 1. Press and release to turn 2. Press and hold until set-up 3. Press and release the meter on. appears on the display. decrease or increase the hour. The flashing test strip symbol The hour flashes.
Page 32
4. Press and release to set 5. Repeat steps 3 and 4 to adjust 6. To set up more options, press the hour. and set the minutes, day, and release . To exit, press month, and year. and hold until the flashing The minutes flash.
Setting the Beeper on or off The meter has the beeper preset to on. Setting the beeper to oFF does not affect test results. The beeper is helpful because it prompts you: • to apply blood or control solution to the test strip. •...
Page 34
1. Press and release to turn 2. Press and hold until set-up 3. Press and release the meter on. appears on the display. repeatedly until the flashing beeper symbol and on or oFF The flashing test strip symbol appear on the display. appears on the display.
Page 35
4. Press and release to switch between on 5. To set up more options, press and release . To and oFF. exit, press and hold until the flashing test strip symbol appears on the display. 50705_05853397002_EN.indb 33 4/24/12 8:32 AM...
Setting Test reminders A test reminder: • beeps at the same time each day to remind you to perform a test. • beeps every 2 minutes up to 3 times. • turns off by inserting a test strip or pressing any button. •...
Page 37
noTE • If a test was performed within 30 minutes of a test reminder, the test reminder does not occur. • If the meter is on at the test reminder time, the test reminder does not occur. • Exposure to cold conditions may disable test reminders until the meter is turned on. •...
Page 38
When setting the time for a test reminder, the bell symbol and set-up remain on the display. 1. Press and release to turn 2. Press and hold until set-up 3. Press and release the meter on. appears on the display. repeatedly until the bell symbol, oFF, and the flashing The flashing test strip symbol...
Page 39
4. Press and release 5. Press and release to set 6. Press and release switch between on and oFF. your choice. adjust the hour. If you select on, the hour flashes. A-1 and the bell 7. Press and release to set symbol remain on the display.
Page 40
8. Press and release 9. Press and release to set the 10. To adjust and set additional select 00, 15, 30, or minutes. test reminders, follow steps 45 minutes. These are the 4–9. To exit, press and hold The bell symbol, oFF, and the only choices.
Setting the Hypoglycemic (Hypo) Alert The hypo alert can be set to a level between 60 and 80 mg/dL or 3.3 and 4.4 mmol/L to let you know when your blood glucose is possibly too low. WArning This function is not a substitute for hypoglycemia training by your healthcare professional. Consumers: Before you set the hypo alert, talk to your healthcare professional to help you decide what blood glucose level is your hypoglycemic level.
Page 42
1. Press and release to turn 2. Press and hold until set-up 3. Press and release the meter on. appears on the display. repeatedly until oFF and the flashing appear on the The flashing test strip symbol display. appears on the display. 50705_05853397002_EN.indb 40 4/24/12 8:32 AM...
Page 43
4. Press and release to switch between on 5. Press and release to set your choice. and oFF. If you select on, flashes. The display shows 70 mg/dL or 3.9 mmol/L. 50705_05853397002_EN.indb 41 4/24/12 8:32 AM...
Page 44
6. Press and release to adjust the level. 8. Press and hold until the flashing test strip symbol appears on the display. The set-up mode is complete. To turn the meter 7. Press and release to set the level. off, press and release . 50705_05853397002_EN.indb 42 4/24/12 8:32 AM...
Transferring Your results to a Computer or PDA You can transfer your stored results to a computer to track, identify patterns, and print. Transferring Data Directly to a Computer or PDA Using Specialized Software and infrared Cable WArning Individual patient results cannot be identified, so transferring data from meters used for multiple-patient testing is NOT recommended.
Page 46
5. Locate the infrared (IR) window on the top of the meter. infrared (ir) window 6. Locate the IR window on either the infrared cable (computer) or PDA. 7. Put the meter on a flat surface and point the 2 IR windows toward each other. They should be 3–10 cm apart.
Chapter 4: Control Testing Why Perform Control Tests Performing a control test lets you know the meter and test strips are working properly. You should perform a control test when: • you open a new test strip box. • you left the test strip container open. •...
• Do not use control solution that is past the use by date. • Refer to the control solution package insert for control solution storage conditions. • The meter automatically recognizes the Accu-Chek Performa control solution. • The control results are not displayed in memory.
Performing a Control Test You need the meter, a test strip, and control solution Level 1, Level 2, or both. The control level is printed on the bottle label. 1. Check the use by date on the 2. Insert the test strip into the 3.
Page 50
4. Put the meter on a flat surface, such as a table. 5. Remove the bottle cap. Wipe the tip of the bottle with a tissue. 50705_05853397002_EN.indb 48 4/24/12 8:32 AM...
Page 51
6. Squeeze the bottle until a tiny drop forms at 7. Wipe the tip of the bottle with a tissue. Cap the the tip. Touch the drop to the front edge of bottle tightly. the yellow window of the test strip. Do not put control solution on top of the test strip.
Page 52
9. Press and release to set the control level in the meter. 10. Remove and discard the used test strip. oK and the control result alternate on the display if the control result is in range. Err and the control result alternate on the display if the control result is not in range.
Understanding out-of-range Control results If the control result is out of range, check this list to help solve the problem. Troubleshooting Checks Action 1. Check if the test strips or control solutions were Discard the test strips or control solutions if either is expired.
Page 54
6. Check if you followed the directions. See Chapter 4, Control Testing, and repeat the control test. Contact Roche if you still have problems. 7. Check if you chose the correct control solution If you chose the wrong control solution level, you level, either 1 or 2, when you performed the can still compare the control result to the range control test.
Chapter 5: Maintenance and Troubleshooting Meter Maintenance The meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong (see Chapter 5, Display and Error Messages). If you drop the meter or think it is not giving accurate results, contact Roche.
Changing the Battery 1. Open the battery door on the 2. Remove the old battery. back of the meter by pushing the tab in the direction of the 3. Insert the new battery with the (+) side facing up. arrow and pulling the door up. 4.
Cleaning the Meter Make sure to keep the meter free of dust. If you need to clean or disinfect it, follow these guidelines carefully to help you get the best performance possible. Do not • Make sure the meter is off •...
Display and Error Messages WArning Never make therapy decisions based on an error message. Contact Roche if you have any concerns. The meter will not turn on or the The meter is in set-up mode, waiting display is blank. for you to change or confirm settings. •...
Page 59
Blood glucose may be lower than the The meter is ready for a drop of measuring range of the system (see blood or control solution. Chapter 2, Unusual Blood Glucose Results). The test result was marked. Blood glucose may be higher than the measuring range of the system (see Chapter 2, Unusual Blood Glucose Results).
Page 60
This message may appear when Blood glucose is below the defined using a white code chip in the meter. hypoglycemia (low blood glucose) It means the test strips expire at level. the end of the current month. At the end of the month, discard the code chip and any remaining test strips.
Page 61
The code chip is incorrect. Turn the meter off and insert a new code chip. Your blood glucose may be extremely high or a meter or a test strip error has occurred. • If your test result matches how you feel, contact your healthcare professional immediately. •...
Page 62
Not enough blood or control solution Blood or control solution was applied was drawn into the test strip for to the test strip before the flashing measurement or was applied after drop symbol appeared on the display. the test had started. Discard the test Discard the test strip and repeat the strip and repeat the test.
Page 63
The temperature is above or below The time and date settings may the proper range for the system. be incorrect. Make sure the time Refer to the test strip package insert and date are correct and adjust, if for system operating conditions. necessary.
Page 64
noTE • Contact Roche if a display or error message reappears. • Contact Roche if any other error message appears. 50705_05853397002_EN.indb 62 4/24/12 8:32 AM...
Chapter 6: Technical information Product Limitations Read the literature packaged with the test strips and control solutions for the latest information on product specifications and limitations. Specifications Blood volume Refer to the test strip package insert. Sample type Refer to the test strip package insert. Test time Refer to the test strip package insert.
Page 66
Approx. 62 g (with battery) Construction Hand-held Protection class Meter type The Accu-Chek Performa meter is suitable for continuous operation. Control solution storage conditions Refer to the control solution package insert. Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2.
Performance Analysis Refer to the test strip package insert. Test Principle Refer to the test strip package insert. Product Safety information WArning • Choking hazard. Small parts. Keep away from children under the age of 3 years. • Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use the meter close to sources of strong electromagnetic radiation.
Discarding the Meter WArning • During blood glucose testing, the meter itself may come into contact with blood. Used meters therefore carry a risk of infection. Before discarding the meter, remove the battery or batteries. Discard used meters according to the regulations applicable in your country. Contact the local council and authority for information about correct disposal.
Explanation of Symbols These symbols may appear on the packaging, on the type plate, and in the instructions for the Accu-Chek Performa meter. Consult instructions for use Caution, refer to safety-related notes in the instructions for use accompanying this product.
The statutory provisions on rights in consumer goods sales in the country of purchase shall apply. Additional Supplies Test Strips Accu-Chek Performa test strips Control Solutions Accu-Chek Performa control solutions 50705_05853397002_EN.indb 68 4/24/12 8:32 AM...
information for Healthcare Professionals WArning Healthcare Professionals: Follow the infection control procedures appropriate for your facility. Refer to the test strip package insert for additional healthcare professional information. Sample Handling Always wear gloves when handling blood-contaminated items. Always adhere to the recognized procedures for handling objects that are potentially contaminated with human material.
Page 72
recommending Alternative Site Testing to Patients Decisions about whether to recommend Alternative Site Testing (AST) should take into account the motivation and knowledge level of the patient and his or her ability to understand the considerations relative to diabetes and AST. If you are considering recommending AST for your patients, you need to understand that there is a potential for a significant difference between fingertip or palm test results and test results obtained from the forearm, upper arm, thigh, or calf.
Need help?
Do you have a question about the Performa and is the answer not in the manual?
Questions and answers