Roche | Accu-chek Performa | User manual | Roche Accu-chek Performa User manual

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www.accu-chek.co.uk
HOS 05166624001
Roche Diagnostics Limited
Charles Avenue
Burgess Hill
West Sussex
RH15 9RY
Blood Glucose Management System
Accu-Chek® Performa
User manual for
healthcare professionals
CONTENTS
3
Introduction
4
Staff Responsibilities
5
Protocol
6
About the Accu-Chek® Performa
7
Coding/Calibrating Your Meter
8
Performing an Internal Quality Control Test
Performing a Blood Glucose Test
11
Dosing from a syringe
11
Capillary sampling using the Safe-T-Pro Plus
13
Capillary sampling using the Safe-T-Pro Uno
14
External Quality Assurance Scheme
15
Cleaning & Maintenance
16
Changing the Batteries
17
Contra-indications & Test Interference
18
Display Code Explanation
INTRODUCTION
Roche Diagnostics is part of an international health care organisation
with an outstanding record in scientific achievement and innovative
product development.
Dedicated to achieving the best possible standard of patient care,
we are the largest provider of diabetes products and services
in the world.
Designed to help you
This manual has been compiled by Roche Diagnostics to help you,
the healthcare professional, achieve consistently reliable and
accurate blood glucose results.
The different sections of the manual cover all aspects of working
with Roche Diagnostics blood glucose monitoring systems,
including comprehensive instructions on the use of meters,
troubleshooting and maintenance, safety precautions and quality
control procedures.
We have made this manual as comprehensive as possible, but if you
have any queries please don’t hesitate to contact your Biochemistry
Dept, or Diabetes Specialist Nurse.
The purpose of this manual is to provide
you with the information you need to
achieve accurate results.
Together, we can work in partnership to
ensure the best possible quality of care
for patients.
3
STAFF RESPONSIBILITIES
It is essential that staff undergo formal training and understand the
importance of a strict quality control programme. Use of meters by
untrained staff can adversely affect the treatment of patients.
IMPORTANT: A management or therapeutic decision based
on an unreliable blood glucose result could be fatal.
Recommendations1:
•
All staff who perform blood glucose measurements
must be properly trained to use the equipment
•
Untrained or insufficiently trained staff should not
use a blood glucose meter
•
Quality control (QC) checks should form part of the maintenance
routine, with the biochemistry department directly involved
•
Quality control procedures should aim particularly at maintaining
the competence of all equipment users and ensuring the reliability
of the results being obtained
In the event of an adverse incident
It is the responsibility of anyone operating a blood glucose meter
to implement the following measures following an adverse incident:
•
Report incident to Clinical Advisor, Manager,
DNS or Biochemistry team
•
Quarantine:
Meter, test strips, QC solution and log book
•
Record details of:
Meter serial number, code number of strips and lot number of QC
•
Inform the local Roche Diagnostics representative or
Nurse Educator
•
4
MHRA or IMB may need to be informed
1. Blood Glucose Measurements: Reliability of results produced in extra-laboratory
areas. Department of Health (HN Hazard 87 13)
RECOMMENDED
BLOOD GLUCOSE
MONITORING PROTOCOL
1.
Follow the manufacturer’s guidelines and hospital policy
(standard operating procedure) on testing at all times
2.
Only a healthcare professional who has received appropriate
training may carry out blood glucose monitoring at ward level1,2
3.
Each healthcare professional takes responsibility for ensuring the
quality of all monitoring carried out by her/him, using the
following procedures:
a) Quality control tests must be carried out:
- according to manufacturer’s instructions and hospital policy
- when starting a new pack of Roche test strips
- after changing the meter’s batteries
- after unexpected results, to check technique
- each day the meter is used for patient tests
b) Only one pack of Roche test strips should
be opened at any one time
c) The appropriate pack of Roche test strips must be
stored with the meter for which it has been calibrated
d) The meter must be recalibrated each time a pack
of test strips is renewed
e) All quality control tests must be recorded
in the quality control log book3
4.
A healthcare professional for each ward/department/site should be
designated to ensure that the equipment is correctly maintained
5.
Any sample reading below 2.8 mmol/L or above 20 mmol/L,
or which is not in keeping with the clinical picture, should be
verified by sending a venous specimen of blood to the laboratory
for random blood glucose testing4. Please refer to your own Trust
Blood Glucose Monitoring Policy for additional guidance.
This protocol should be followed in conjunction with the advice
Theguidance
purposecontained
of this manual
and
in NMC. is to provide you with
the information you need to achieve accurate results.
1. NMC (Code of Professional Conduct, 1992)
Together,
can work
in partnership to ensure the best
2.
NMC (Scope forwe
Professional
Practice, 1992)
3.
NMC
(Standards
for
Records
&
Record
1992) patients with diabetes.
possible quality of care Keeping,
for those
4. NMC (Exercising Accountability, 1992)
5
ABOUT THE
ACCU-CHEK ®
PERFORMA
Back view of meter
Front view of meter
Display
Meter Serial Number
Code Chip Slot
Battery Compartment
Left Buttons
Right Buttons
Code Chip
Test Strip Slot
Code Number
Golden End
(Electrodes)
On/Off/Set Button
Yellow
Window
Top view
of meter
6
Test Strip
Test Strip
Container
CODING/CALIBR ATING
YOUR METER
When to code/calibrate
Before you use your meter for the first time and every time
you open a new box of test strips, you need to code/calibrate
the meter to match the strips.
Each code/calibration key provides your meter with the specific
information it needs to accurately measure blood glucose.
Do not use any other code/calibration key, except the
one that arrives in the box with the pot of test strips.
Installation of Code/Calibration Key
A code key is properly installed when it snaps into place.
You will need to insert a new code key:
•
Whenever one of these displays appear
See pages 17
and 18 for a
full description
of the error
messages.
•
Whenever you open a new box of strips:
1.
Make sure meter is turned OFF
2.
Turn meter over so that you are looking at the back
3.
Remove old code key if one is installed and discard
4.
Insert new code key until it snaps into place
5.
Turn meter ON. A 3-digit code number appears.
This number must match the code number on your
vial of test strips. If it does not, repeat steps 1-5
NOTE : Always perform a QC test with each new pot of strips.
7
PERFORMING AN
INTERNAL QUALIT Y
CONTROL TEST
What are Internal Quality Control Tests?
They ensure that your system is working properly, that you are doing a
test correctly, and the meter is providing accurate and reliable results.
When should I check my meter?
•
•
•
•
•
•
Before using your meter for the first time
When you open a new vial of test strips
If you leave the cap off the vial of test strips
If you drop the meter
If the result does not agree with the clinical picture
If you have repeated a test and the blood glucose result is still lower
or higher than expected
•
•
•
When you want to check the performance of the meter and test strip
In line with the quality control policy in your organisation
After changing the battery
What do I need?
The Accu-Chek Performa automatically detects when you perform an
internal quality control test. To perform a QC test, you need:
•
•
•
Accu-Chek® Performa Meter
Accu-Chek® Performa Test strips
Accu-Chek® Performa Glucose Control Solutions
(Control 1 and Control 2)
•
Log book
NOTE: When you open a new bottle of glucose
control solution, write the expiry date on the label.
Opened QC bottles are only good for three months.
8
PERFORMING
A QUALIT Y
CONTROL TEST
1.
Insert a test strip into the meter.
The meter turns on.
2.
1.
Make sure the code number on the display matches the code
number on the test strip container. If you miss seeing the code
number, take the test strip out and reinsert it into the meter.
3.
2.
Select the control solution you want to test. You will enter the level
later in the test.
4.
Put the meter on a flat surface, like a table.
5.
Remove the control bottle cap. Wipe the tip of the bottle with
OR
a tissue.
6.
3.
Squeeze the bottle until a tiny drop forms at the tip. Touch the drop
to the front edge of the yellow end of the test strip. When you see
flash, you have enough control solution in the test strip. Wipe the tip
of the bottle with a tissue then cap the bottle tightly.
7.
4.
A result appears on the display, along with a control bottle symbol
and a flashing “L”. Do not remove the test strip yet. Press
once to
mark it as Level 1. If you tested the Level 2 control, press
a
second time.
8.
Press
9.
“OK” and the control result alternate on
5.
to set the level in the meter.
the display if the result is in range. The
range is printed on the test strip
container label. “ERR” and the control
result alternate on the display if the result
is not in range. Remove the test strip and
6.
discard it.
10.
Record result in QC log book.
7.
8.
9
PERFORMING AN
INTERNAL QUALIT Y
CONTROL TEST
What if the result is not within
the acceptable range?
If the result is not within the acceptable range.
Check the following:
•
Did you use control solutions or test strips that
were past their expiration date?
•
Did you leave the cap off the vial of test strips
or glucose control solutions?
•
Did the code in the meter match the code on the test strip vial
label?
•
•
Did you follow the testing steps exactly?
Did you use the correct QC solution (L1 with Control 1 or
L2 with Control 2)?
•
•
Did you select the appropriate control result level (L1 or L2)?
Did you wipe the tip of the QC solution bottle before use?
If your QC fails, first repeat the test. If the result is still not acceptable ,
do not use meter and contact your biochemist or DSN
10
PERFORMING A
BLOOD GLUCOSE TEST
Capillary sampling using the
Safe-T-Pro Plus/Uno
1.
Wash hands thoroughly. Put gloves on
2.
Clean the side of the patients’ finger using soap and water (rinse well)
or gauze swabs. Ensure that the finger is thoroughly dry
3.
Promote blood flow to the site by allowing the arm to hang down by
the side for a few seconds and then flex arm and fingers. If the hand is
very cold, allow it to warm up before trying to obtain a blood sample
4.
Check expiry date of strips. Switch meter on
5.
Check that the code on the meter matches the code on the vial of
test strips you are using
6.
Open test strip vial and remove the test strip. Replace vial cap
7.
Within 30 seconds, insert test strip (yellow window facing up) into test
strip slot. The test strip symbol stops flashing and a blood drop will
appear on the display
8.
Twist off protective cap until loose (do not pull off until loose)
9.
Firmly place lancet against side of finger and press firing button
10.
Once used, the lancet will permanently retract into its protective case.
Safe-T-Pro Plus and Uno lancets are single use devices; dispose of whole
device into a sharps bin
11.
Allow 5 seconds to elapse after pricking the finger and then rather than
squeeze at the site of puncture, milk the blood down the hand towards
the finger
12.
Touch the drop to the front edge of the yellow window of the test strip.
Do not put blood on top of the test strip. When you see flash. you
have enough blood on the test strip.
NOTE: If you can still see yellow on the test strip after a second drop of
blood is applied, remove the strip and repeat the test with a new strip. If the
test pad is not completely covered with blood you may get an innacurate result.
13.
The purpose
of this manual
is to provide
you with
Record
result immediately
using appropriate
documentation
the information you need to achieve accurate results.
14.
Remove and dispose of test strip and any soiled materials in line with
Together, we can work in partnership to ensure the best
your policy on clinical waste
15.
Switch off meter
possible quality of care for those patients with diabetes.
11
Dosing from a syringe
1.
Transfer pipettes, small capillary tubes, adjustable volume pipettors
(i.e. Eppendorf pipettes) and syringes may be used to apply venous,
arterial and capillary blood to the test strip
2.
Check expiry date of strips. Switch meter on
3.
Check that the code on the meter matches the code on the vial of
test strips you are using See image A
4.
Open test strip vial and remove the test strip. Replace vial cap
5.
Within 30 seconds, insert test strip (yellow window facing up) into test
strip slot. See image B
The test strip symbol stops flashing and a blood drop will appear on
the display
6.
Touch the drop to the front edge of the yellow window of the test strip.
Do not put blood on top of the test strip. When you see
flash. you
have enough blood on the test strip.
NOTE: If you can still see yellow on the test strip after a second drop of
blood is applied, remove the strip and repeat the test with a new strip
7.
Record result immediately using appropriate documentation
8.
Remove and dispose of test strip and any soiled materials in line
with your policy on clinical waste
9.
12
Switch off meter
The purpose of this manual is to provide you with
the information you need to achieve accurate results.
Together, we can work in partnership to ensure the best
possible quality of care for those patients with diabetes.
E XTERNAL
QUALIT Y ASSUR ANCE
(EQA) SCHEME
Roche Diagnostics have the largest EQA scheme using the nationally
accredited Quality Laboratory (QL) at the University Hospital of Wales.
The EQA scheme is available to any hospital using a Roche Blood
Glucose monitoring system.
How does the scheme work?
Samples are sent from QL to a central administrative site on a
regular basis. These should be tested exactly the same way as
a sample from a patient. When the results are returned to the
laboratory or logged on the website, the accuracy of your meter can
be checked. This then forms part of the audit of the Blood Glucose
testing procedure.
What to do when an EQA sample arrives
1.
Complete and return the test on the same day
2.
Use samples as if they were a normal blood sample
3.
Carefully remove the lid
4.
Gently squeeze bulb of pastette and draw sample
into tube up to level shown
5.
Gently squeeze bulb of pastette to form a large hanging drop
6.
Apply drop to test strip as you would a patient sample
7.
Ensure that entire test area is completely covered
8.
Record result on Roche Diagnostics reporting labels supplied,
and return to lab
9.
Safely dispose of excess sample and pastette
IMPORTANT: Use sample and return on the same day
13
CLE ANING &
MAINTENANCE
Cleaning
•
The meter should be cleaned regularly, in line with the policy in
your organisation
•
•
Always switch the meter off before cleaning
Wipe with a slightly moist cloth and mild cleaning agent
Do not let liquid drip into the meter and take special
care to keep moisture out of the code key slot and
the test strip guide
Storage
•
•
•
Keep your meter in the workstation to protect it from damage
Keep the meter free from dust
Protect the meter from extremes of temperature and humidity
Display Check
This verifies that all parts of the display are working
•
•
•
Make sure that the meter is off
Press and hold down the ON/OFF button
The display should look exactly like the picture on the left
(if it does not, contact your biochemistry department or your DNS)
14
CHANGING
THE BAT TERIES
Warning Signs
When a battery symbol appears on the display, your
battery is weak and has only enough power to run a
few more tests.
1.
Inserting a battery
1.
Push the recessed plastic tab of the battery compartment forward
(toward the arrow) to flip open the battery door
2.
2.
Insert the battery into the compartment with “+” side facing you
3.
Snap battery cover back into place
Useful information: Your meter takes one 3-volt alkaline battery
type 2032 (CR 2032, DL 2032)
15
( TEST INTERFERENCES)
IMPORTANT. A minority of your patients may be affected
by the following test interferences
Substance
Interference Limit
Interference due to treatments
Therapeutic Range
Icodextrin / Maltose*
> 0.38 mmol/L
Treatments containing
Icodextrin / Maltose
N/A
*EXTRANEAL™
*OCTAGAM™, Gammagard
(for patients on CAPD)
(i.v. human immunoglobulin preparation)
Interference due to medical conditions
Physiologic Range
Galactose
> 0.44 mmol/L
< 0.28 mmol/L
Lipids
> 39.6 mmol/L
0.34 - 3.70 mmol/L (TRIG)
Haematocrit
No effect with Haematocrits between 10% & 70%
Contra-indications
Severe dehydration, Hypotension, Shock
Peripheral circulatory failure
Hyperosmolar non-ketotic coma (HONK)
Diabetic ketoacidosis (DKA)
}
The recommendation from the
MHRA is that a venous sample
should be sent to the laboratory
for verification
• Patients receiving intravenous infusion treatments containing maltose
(inc. EXTRANEAL™ or OCTAGAM™) should not be tested using Performa
blood glucose monitoring system.
IN THE EVENT OF AN
ADVERSE INCIDENT:
1. Report incident to Clinical
Advisor, Manager, DNS or
Biochemistry team.
2. Quarantine meter, test strips, QC
solution and log book. Also record
details of the serial number of the
meter, code number of the strips
and lot number of QC.
3. Check and retain the log book (i.e.
are the controls within range?).
4. Inform the local Roche Diagnostics
representative or Nurse Educator.
5. MHRA or IMB may need to be
informed.
16
• The above-mentioned substances cause interference to glucose measurements
obtained using the Performa blood glucose monitoring system.
DISPL AY CODE
E XPL ANATION
Screen messages
Never make treatment
decisions based on an
error message. If you
have any concerns, call
Roche Diagnostics.
The meter will not turn on or the display is blank.
• Battery is dead – Insert new battery
• Display is damaged – Call Roche Diagnostics
• Meter is defective – Call Roche Diagnostics
• Extreme temperatures – move the meter to a
more temperate area
Battery power
is low.
Change the
battery soon.
The meter is
ready for you
to insert a
test strip.
The meter is
ready for a
drop of
blood or
control
solution.
The meter is in
set-up mode,
waiting for
you to change
or confirm
settings.
Blood glucose
may be higher
than the
measuring
range of the
system.
This test result
was flagged.
The meter is not
coded or the
code chip is not
inserted. Turn
off the meter
and recode it.
Blood glucose
may be lower
than the
measuring
range of the
system.
Blood glucose
is below the
defined hypo
(low blood
glucose) level.
The test strips will expire at the end of the month.
Before the end of the month, insert a new code chip
from a new box of test strips and ensure the code
chip number matches the code number on the test
strip container. Make sure the time and date in the
meter are correct.
17
Meter Errors
DISPL AY CODE
E XPL ANATION
18
The test strip is
damaged. Remove
the test strip and
reinsert it, or
replace it if
damaged.
If the message
reappears, call
Roche Diagnostics.
The code chip is
incorrect. Turn off
the meter and
insert a new code
strip. If this does
not fix the
problem, call
Roche Diagnostics.
An error
occurred
during the
test. Discard
the test strip
and repeat
the test.
Not enough blood
or control solution
was drawn into the
test strip for
measurement or was
applied after the test
has started.
Discard the test strip
and repeat the test.
The code chip is
from an expired
lot of test strips.
Ensure the code
chip number
matches the code
number on the
test container.
Make sure the time
and date in the
meter are correct.
Blood or
control
solution was
applied to the
test strip
before the
flashing drop
appeared on
the display.
Discard the
test strip and
repeat the test.
An electronic error occurred or,
in rare cases, a used test strip
was removed and reinserted.
Turn the meter off and on, or
take the battery out for a few
seconds and reinsert it. Perform
a blood glucose or control test.
If the problem persists, call
Roche Diagnostics.
The temperature is above or
below the proper range for the
meter (6 to 44ºC). Move to an
area between 6 and 44ºC, wait
five minutes and repeat the
test. Do not artificially heat or
cool the meter.
The battery is almost out of
power. Change the battery now.
The time and date settings may
be incorrect. Make sure the time
and date are correct.
19
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