Roche CoaguChek XS System User manual

Roche CoaguChek XS System User manual
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®
CoaguChek XS
System
Professional
Training Manual
for Self-Testing
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Table of Contents
Introduction............................................................................................................... 1
1
Overview of Warfarin Therapy and the CoaguChek XS System..................... 3
2
Materials for User Training .................................................................................... 5
3
4
User Selection Guidelines.......................................................................................7
Overview...........................................................................................................................................7
Clinical Study..................................................................................................................................8
Performance Characteristics ....................................................................................................9
Training Users for Self-Testing .............................................................................13
Preparation....................................................................................................................................13
Supplies..........................................................................................................................................13
Training Outline...........................................................................................................................14
Testing the Trainees...................................................................................................................20
Certificate of Completion..........................................................................................................21
Follow-up Visits...........................................................................................................................21
5
Proficiency Checks.................................................................................................23
6
Forms........................................................................................................................ 25
COAGUCHEK, ACCU-CHEK, SOFTCLIX and COAGUWIPE are trademarks of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
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Introduction
Introduction
Roche Diagnostics is pleased to present this guide to assist you in training
individuals in the use of the CoaguChek® XS System. The guide contains a variety
of materials to help you plan the curriculum:
• an overview of the CoaguChek XS System
• a description of training materials available from Roche Diagnostics
• a guide to selecting appropriate individuals to participate in self-testing
• a suggested outline for the training class
• Skills Checklist and Knowledge Test
• Certificate of Completion to be given to trainees
• suggestions for refresher training.
If you have questions, please contact the Roche Diagnostics Technical Service
Center 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.
Obtaining CoaguChek XS
Meters for Users
ii
Roche Diagnostics uses a network of certified national distributors to assist
you with acquiring a CoaguChek XS System for your users. Contact your
Roche Account Manager or the Roche Diagnostics Technical Service Center at
1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year. Potential users who
will be self-testing must have a doctor’s prescription for the CoaguChek XS meter
and complete a training program offered through an approved Roche distributor.
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1
Overview of Warfarin Therapy and the CoaguChek XS System
OVERVIEW
The CoaguChek XS System from Roche Diagnostics measures blood-clotting time
for people who are taking anticoagulation medications such as warfarin (for
example Coumadin®). Warfarin is an oral anticoagulant that changes the
formation of certain blood factors produced in the liver in such a way that the
clotting time is slowed. (Refer to the latest warfarin package insert for
contraindications.) The goal is to prevent clots from forming or moving. At the
same time, however, it is important to avoid excessive anticoagulation, or blood
thinning, which carries a risk of hemorrhage.
People on warfarin therapy must be monitored closely for two reasons. First, as
indicated above, it is very important to keep blood coagulation time within an
optimal therapeutic, or target range. Second, each individual reacts differently to
warfarin, and the medication’s ability to prevent a clot is affected by a person’s
metabolism, diet, and other medications.
The variability of laboratory results due to reagent differences is a common
problem. The CoaguChek XS System minimizes the variability that is seen with
traditional PT/INR assay reagents. Each lot of test strips is compared to a
reference material by Roche Diagnostics. The strips are then assigned a “code,”
which standardizes the reported result via a mathematical algorithm, thus
minimizing lot-to-lot variability. No manual calibration of the system is required;
each lot of strips comes with a code chip that stores the information needed for
automatic calibration.
The CoaguChek XS System offers significant advantages in both convenience
and reliability. It is a hand-held, battery-operated system that can perform a
PT/INR blood test on a fresh whole blood sample from a fingerstick. A test strip
is inserted into the meter and a blood sample applied to the strip. The test result
is displayed in about one minute. The need for trips to the laboratory or for
venipuncture is virtually eliminated.
The CoaguChek System by Roche Diagnostics has been used successfully since
1994 by healthcare professionals in anticoagulation clinics, physicians’ offices,
and home health agencies and since 1997 for self-testing. Now, there is the
CoaguChek XS System available for self-testing. The materials that follow are
designed to help you select appropriate users and train them to use the
CoaguChek XS System properly.
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Materials for User Training
Roche Diagnostics has developed the following materials, provided in the product
care kit, specifically for your use in training new users to self-test with the
CoaguChek XS System:
Training DVD
This program, which runs approximately 15 minutes, provides step-by-step
instruction in setting up the meter, preparing for and performing a fingerstick
blood test, running quality control checks, and cleaning the meter. It is intended
to be the basis of the training session. You may also use the DVD as a trainee
selection aid; individuals who are unsure of what self-testing involves may be
shown the DVD to help them decide if they want to go through training and try
self-testing.
CoaguChek XS System
User Manual
A copy of the manual is provided with each CoaguChek XS Meter. It is intended to
be used as an ongoing reference guide by users, but should also be used in
training to familiarize trainees with the content and structure of the manual and
make them comfortable with referring to it.
Getting Started Guide
A Getting Started reference guide is included in each CoaguChek XS System
Care Kit. It provides an easy reference for testing.
Package Inserts
Both the test strips and lancet device have package inserts with information about
proper storage and use. It is important to call the users’ attention to the inserts
during training.
To order additional copies of any of these materials, or to make comments or
suggestions about the training materials, please contact the Roche Diagnostics
Technical Service Center 1-800-428-4674, 24 hours a day, 7 days a week,
365 days a year.
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User Selection Guidelines
OVERVIEW
It is important that users be screened carefully before beginning a self-testing
program. The following questions are designed to guide the physician, clinic
nurse, or other healthcare professional in determining an individual’s suitability
for self-testing.
Are specific diagnoses more No, the specific diagnosis is not necessarily indicative of who should or should
appropriate for self-testing? not self-test. However, prior to beginning self-testing, users should be stabilized
on anticoagulation medications such as warfarin. People with chronic conditions
(for example, congestive heart failure, atrial fibrillation, prosthetic heart valve
replacement) who will need frequent monitoring over a long period of time are
certainly candidates for self-testing.
What personal
characteristics must the
potential user have?
The person must be reliable, compliance-oriented, and able to follow instructions.
What do I look for in judging Consider the following:
• Does the person keep appointments?
these characteristics?
• Does he or she comply with medication dosing and other elements of the
treatment regimen?
• Is he or she capable of understanding the importance of testing and the details
of the testing procedure?
• Are vision and motor skills adequate?
What else should I consider? Look for motivated individuals who want to take an active part in managing their
condition. Lifestyle factors may be important; people who travel, work, or find it
difficult to get to the laboratory may be especially motivated to learn self-testing.
Which individuals probably
should not self-test?
• It is up to the attending physician to determine which individuals are eligible for
self-testing.
• Refer to the test strip package insert for current limitations of procedure.
Is it appropriate to train
a third-party tester?
6
Motivated parents of children who need testing or caregivers for other individuals
(for example, a spouse) may be trained. The caregiver should be screened using
the same criteria.
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User Selection Guidelines
Once the potential user has
passed the initial screening,
what do we do next?
Clinical Study Information
8
User Selection Guidelines
Explain to the person in general terms what will be involved and provide an
opportunity to ask questions. If he or she expresses interest, send a copy of the
training DVD home or show it in the office. Stress that this overview is only
intended to give a better idea of what self-testing involves and that more detailed
training and follow-up support will be provided. Each potential user will be
instructed on the fingerstick procedure and perform a fingerstick as part of the
screening. If the person wants to continue participation after seeing the DVD and
performing a fingerstick, he or she should be enrolled in a training class.
There were 107 people enrolled. A total of 88 people completed all four visits to
the site. The reasons for drop-outs were as follows:
Reason for Drop-Out
Felt it was too stressful
Didn’t have time
Didn’t want to use meter on his own
Didn’t think he could learn to use meter
Was having knee surgery
Study terminated prior to Visit 4
Unknown
Disqualified due to target INR range outside of study protocol
A clinical study was conducted by Roche Diagnostics consisting of four visits to
the clinical site. Informed consent and randomization occurred at Visit 1. Testing
began at Visit 2. Ninety-one individuals completed at least one visit after Visit 1.
The following table outlines the demographic information for the users who
completed at least one visit after Visit 1.
Demographic
Total number of users
Caregivers
Males
Females
Age range
Mean Age
Age 65 – 69 years
Age 70 – 74 years
Age 75 years and up
Education LevelEighth grade or less through
advanced college degree
Median Education Level
On warfarin 3 – 12 months
On warfarin 1 – 2 years
On warfarin 3 – 5 years
On warfarin > 5 years
Atrial fibrillation
Valve replacement
Stroke/stroke prevention
DVT
Other heart conditions
Other clotting disorders
Number
91
4
51
40
32 – 89
64 years
16
13
16
91
Percent
100%
4.4%
56%
44%
100%
N/A
17.6%
14.3%
17.6%
100%
Some college
19
22
23
27
38
25
7
5
6
10
N/A
20.9%
24.2%
25.3%
29.7%
41.8%
27.5%
7.7%
5.5%
6.6%
11%
3
# of Subjects
2
3
1
1
1
1
7
3
PERFORMANCE CHARACTERISTICS
Measuring Range:
The CoaguChek XS System has a PT/INR measuring range of 0.8–8.0 INR and
9.6–96.0 seconds.
Accuracy:
A study was conducted comparing test results obtained by trained users with
those obtained by healthcare professionals, when both were using the
CoaguChek XS System. The correlation was very good, as indicated by the
following statistics: N=463, Slope=1.000, Intercept=0.0 and Correlation
Coefficient=0.977. This study shows that trained users are able to obtain results
that are as accurate as those obtained by healthcare professionals trained in the
use of the CoaguChek XS System.
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User Selection Guidelines
User Selection Guidelines
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9
8
Precision:
N = 297
PB: y = 1.154x - 0.2
Slp CI (1.111,1.198)
Int CI (-0.3, -0.2)
Correlation = 0.934
7
6
5
4
3
2
1
0
A study was conducted and the precision of duplicates for capillary blood
results was calculated for both trained users and healthcare professionals. The
following results were obtained:
N
Mean
SD
CV
0
1
2
3
4
5
6
7
8
9
10
3
User
Results
214
2.57
0.13
5.13
Professional
Results
249
2.52
0.13
5.36
This study shows that trained users are able to obtain results that are as precise as those
obtained by healthcare professionals trained in the use of the CoaguChek XS System.
During the study, the following error rates were observed:
10
N = 463
PB: y = 1.000x + 0.0
Slp CI (1.000,1.030)
Int CI (-0.05, 0)
Correlation = 0.977
9
8
7
6
Visit 1
Error 6
Test Strip Interference 0.8%
Error 5
Blood Application
31.7%
Error 4
Test Strip Unusable
0.8%
Error 000 Time Exceeded
1.5%
Error QC Quality Control Failure 1.1%
Unknown Error
1.1%
5
4
Visit 2
0.9%
23.9%
0.0%
1.3%
0.0%
0.0%
Visit 3
0.5%
18.9%
2.8%
0.0%
0.0%
0.5%
Overall
0.7%
25.2%
1.1%
1.0%
0.4%
0.6%
3
2
1
0
10
0
1
2
3
4
5
6
7
8
9
10
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Training Users for Self-Testing
PREPARATION
The suggested time for each training session is two hours. If you prefer, you may
break this into two one-hour sessions. Some trainers have found that it works well
to have one educational session and one hands-on practice session. However the
training is scheduled, it is important to allow plenty of time for trainees to practice
the testing procedure and ask questions.
Training is mandatory. Users should not be permitted to take a meter home
without satisfactorily completing a training session and passing the Knowledge
Test and Skills Checklist.
Schedule training in a room free of distractions and with adequate facilities for
trainees to take notes and practice with the meters.
Limit training classes to small groups so trainees can have individual attention
during the practice session. It may be helpful to have an assistant.
Organize the presentation, gather the needed supplies, and make sure the meters
are operational.
SUPPLIES
CoaguChek XS Testing
Supplies
(one set for each trainee
plus one for demonstration)
• CoaguChek XS System Care Kit, consisting of:
• CoaguChek XS Meter
• 4 AAA batteries
• CoaguChek XS System User Manual
• CoaguChek XS System Getting Started Guide
• CoaguChek XS System Prothrombin Time Self-Testing Log Book
• ACCU-CHEK® Softclix lancet device and lancets
• CoaguChek XS System Training DVD
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Training Users for Self-Testing
Training Users for Self-Testing
• CoaguChek XS System Test Kit, consisting of:
• A container of test strips
Introduction and Overview
of Training Session
1. Explain the importance of regular PT/INR testing.
2. Review the policy for certification. Explain that each trainee will be asked to
successfully complete a Knowledge Test and Skills Checklist.
• A test strip code chip
• The test strip package insert
Other Supplies
• Alcohol wipes
• Cotton balls or tissue
• Pre-packaged towelettes such as CoaguWipes® or 10% bleach solution
(1 part bleach to 9 parts water)
• Biohazard waste and sharps containers for disposal of supplies and lancets
used during practice
• Disposable gloves for instructor and assistants to wear when assisting
trainees in practicing fingersticks
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CoaguChek XS System
Training DVD
Show the 15-minute Training DVD, which gives an overview of the testing
procedure, built-in quality control testing, and maintenance.
Review of CoaguChek XS
System and Operating
Guidelines
1. Review components of the CoaguChek XS Meter
• Display panel
• M (memory) button
• ON-OFF button
• DVD player
• Test strip guide cover
• TV monitor
• Test strip guide
• Sufficient copies of the class outline, Knowledge Test, Skills Checklist, Log
Book, Certificate of Completion, and key sections of the CoaguChek XS System
User Manual, especially the Error Messages section
• Battery compartment cover
• Code chip slot
• SET button
• Data port
TRAINING OUTLINE
User Training
CoaguChek XS System
3. Review the agenda for the training session. (This outline may be copied and
distributed to attendees as a detailed reference.)
Topic
Time to Present/Practice
Introduction and Overview of Training Session
5 minutes
CoaguChek XS System Training DVD
15 minutes
Review of CoaguChek XS System and Operating Guidelines
10 minutes
Review System Set-Up
5 minutes
Testing Fingerstick Samples
(including practice and completion of Skills Checklist)
40 minutes
Documenting Results on Log Book
5 minutes
Review Built-In Quality Control
10 minutes
Cleaning the CoaguChek XS System
5 minutes
Knowledge Test
10 minutes
Local Information and Wrap-Up
10 minutes
2. Review contents of the Test Kit
• A container of 6 test strips
• The test strip code chip
• The test strip package insert
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3. Review operating conditions of the meter and proper storage conditions of test strips
• Operate meter at room temperature, 65˚ to 90˚ F (18˚ to 32˚ C).
• Operate meter with 10% to 85% relative humidity, without condensation.
• Avoid bright sunlight.
• Operate the meter on a flat surface, free of vibrations.
• Use well-protected carrying case.
• Read the information packaged with the test strips regarding up to date
product specifications and limitations.
• Read the latest warfarin package insert for contraindications.
Review System Set-Up
1. The CoaguChek XS System uses four AAA alkaline batteries, inserted into the
battery compartment on the back of the meter. Explain the importance of
entering the correct date and time. (Each time you run a test, the meter
compares its date with the test strip’s expiration date. If the test strip is expired,
the meter displays an error message and prevents you from running a test.)
2. Discuss the purpose of the code chip included with each test kit. The code
number on the test strip container must match the code chip number.
3. Review how to insert the code chip. Make sure the meter is off. Insert the code
chip with the code number facing up until it snaps into place.
4 Explain that the meter has set-up options that users will not be asked to change.
Appropriate settings have been programmed before they receive their meters.
Testing Fingerstick Samples
(including practice and completion
of Skills Checklist)
Important: If a caregiver assists with the testing procedure, it is recommended that
the caregiver wash hands thoroughly and wear disposable gloves to prevent
contact with the blood sample.
1. Review supplies needed for performing a self-test:
• CoaguChek XS meter
• Container of test strips
• Test strip code chip
16
• ACCU-CHEK Softclix lancet device and lancet
4
2. Review how to prepare the lancet device.
Users pull off the cap and insert a new lancet. Provide these instructions: Twist
off the lancet’s protective cap. Put the cap back on the lancet device. To place
the cap back on, line up the notch on the cap with the center of the semicircle. Turn the dial so that the center of the semi-circle points to 5. (The lancet
device has multiple depth settings, so the user can use the setting that works
best. The higher the number, the deeper the penetration. The first time a
person uses it, try a depth setting of 5. If the blood drop you get is not
sufficient, try a higher setting.)
Instruct the user to press the plunger. A yellow dot appears in the release
button, telling the user that the device is ready. Tell the user to set it aside while
preparing for the fingerstick.
3. Review how to prepare for a fingerstick, instructing the user to:
• Wash the hand in warm, soapy water. This cleans and warms the hand.
• Massage the finger from its base.
• Let the hand hang loosely at his or her side for 10 to 30 seconds.
• Use these techniques until the fingertip has good color.
4. Review testing procedures, instructing the user to follow this process:
• The correct code chip must be in the meter. The code chip
automatically provides the meter with the information that is specific to
each lot of test strips. Each box of test strips comes with a matching
code chip. Every time users open a new box of test strips, they will
replace the code chip.
• Take a strip out of the test strip container. Close the container tightly.
• Slide the test strip into the meter’s test strip guide in the direction of the
arrows until it stops. The meter will turn on and the code number of the
inserted code chip will flash on the display.
• Be sure the code number on the display matches the number on the
test strip container, then press M.
• After M is pressed, an hourglass appears as the meter warms up. A
flashing test strip and blood drop appear when the meter is ready for a
sample. The user has 120 seconds to apply a blood drop to the test strip.
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5. Review collecting and applying the sample, instructing the user to follow
this process:
4
the user is to do if the doctor is not immediately available. The user’s
doctor should write these immediate follow-up values and follow-up
instructions in the appropriate section of the user’s Log Book.
• Massage the finger from the base until there is increased color in the
fingertip. Keeping the hand down, press the tip of the lancet firmly
against the side of the fingertip. Press the release button.
NOTE: Be sure the meter is properly set up, including date, time, and units of
measurement, before the training session ends.
• The meter must be on a table. Find the target area on the test strip.
• Within 15 seconds of sticking the fingertip, apply the blood drop from
the fingertip to the target area from the side. See the user manual for
more information.
Review Built-In
Quality Control
• Hold the blood drop to the test strip until the meter beeps. The flashing
blood drop symbol will disappear and the result will appear on the
display, which takes about a minute. Do not add more blood or touch
the test strip.
When the quality control test runs, the letters QC flash on the meter’s display.
When the quality control test is finished, a check mark (√) appears following the
letters QC. Then the meter continues to run the blood test.
• If the meter displays an error message rather than a test result, refer to
the Error Messages section of the user manual to learn what to do next.
The built-in quality control helps you know that your test strip has not been damaged.
If you receive a test error, look in the manual for an explanation of all test errors.
• To run a new test, use a new test strip and a different finger.
6. Review final testing steps, instructing the user to:
• Record the result in the Log Book. The meter will automatically store
100 results, with the date and time, in its memory.
• Clean up: remove the lancet from the lancet device. Place the used test
strip and lancet in a puncture-proof waste container with a lid. Turn the
meter off. If the meter is dirty, wipe it with a lint-free tissue and an
approved cleaning solution.
The CoaguChek XS System has built-in quality control functions in the meter and
test strips. The meter automatically runs its own quality control test as part of every
blood test, so you never have to run quality control tests with liquid quality controls.
Cleaning the CoaguChek
XS System
Review cleaning procedures with the user, instructing them to follow this process:
A user should clean the meter whenever it looks dirty or each time he or she
opens a new box of test strips, whichever the user prefers.
Use only the following products to clean the meter:
• pre-packaged bleach towelettes such as CoaguWipes® or 10% bleach
solution (1 part bleach and 9 parts water)
• Always call the doctor with test results.
• 70% isopropyl alcohol solution
• If the result is outside the therapeutic range, call the doctor
immediately.
• lint-free tissues
• cotton swabs.
Do not spray any cleaning solution on the meter. Never use a spray of any type.
7. Review the procedure to follow if the test results are not in the accepted
PT/INR range:
18
• Explain to the user that a PT/INR result outside the therapeutic range is
a result that is above or below the immediate follow-up values set by
their doctor or designated healthcare professional. The user must
contact his or her doctor immediately if this occurs. Include clear
instructions on how the user is to contact his or her doctor and what
To clean the exterior of the meter:
1. With the meter turned off, wipe the meter’s exterior clean.
2. With a lint-free tissue, dry the meter.
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CERTIFICATE OF COMPLETION
To clean the test strip guide:
1. Open and clean the cover. With the meter turned off, use your
thumbnail to open the cover of the test strip guide by pressing its front
edge upward. Move the cover safely away from the meter. Then rinse
the cover with water or wipe it clean.
2. Clean the test strip guide. Clean the easily accessible areas with a
cotton swab. Do not insert any objects into the test strip guide.
3. Allow the test strip guide to dry, with the cover off, for about 10
minutes.
Each trainee who successfully completes the class and the tests should be given
a certificate. A certificate that can be copied as needed is included in the Forms
section at the back of this binder.
FOLLOW-UP VISITS
Remind all trainees they are required to return for two follow-up visits where they
will demonstrate their knowledge of self-testing with the CoaguChek XS System.
4. Close the cover, and make sure it snaps into place.
TESTING THE TRAINEES
1. Complete the Skills Checklist, included in this package, after observing each
trainee during the hands-on practice session. One or more assistants may be
helpful in completing the checklists without slowing down the class.
2. Have trainees complete the Knowledge Test, included in this package, at the
end of the training presentation and practice sessions.
3. Score the test with the answer key and review any areas of confusion.
4. Develop a plan before the training class for remedial action if trainees do not
perform adequately on either of the tests. In some cases, it may be necessary
to return the trainee to a laboratory testing regimen.
The Skills Checklist and Knowledge Test master forms can be copied as needed
and are included in the back of this manual.
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Proficiency Checks
After completing the training class and beginning self-testing, users should be
monitored periodically by a trained healthcare professional to be sure their testing
technique is correct and the meter is performing properly. Suggested frequency
for monitoring is every six months. The following procedure may be useful:
• Establish a reminder system that prompts you to contact each user at
6-month intervals.
• Make an appointment for the user to come to the clinic or office.
• Ask the user to bring the CoaguChek XS meter, testing supplies, and
Log Book.
• During the interview, record your observations on the 6-month
Performance Evaluation form.
• Inspect the meter thoroughly.
• Observe the user cleaning the CoaguChek XS meter. If necessary, stress
the importance of maintaining a regular cleaning schedule.
• Observe the user performing a blood test. If necessary, offer
suggestions for improvement. A 2-week follow-up is recommended
whenever competency needs reassessment.
• The healthcare professional will perform a user blood test after the
trainee performs a self-test. The test should match within 30%; this
verifies that the meter is performing properly. If this test indicates a
problem with the meter or test strips, repeat the test. If the result is still
in question, please contact the Roche Diagnostics Technical Service
Center 1-800-428-4674, 24 hours a day, 7 days a week, 365 days a year.
• If the test result is within range and the user performs all tests
satisfactorily, make an appointment for six months in the future.
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Forms
Follow-up for People Who Are Self-Testing
OVERVIEW
Introduction
The following forms are included as part of the CoaguChek XS System training for
self-testing.
These forms should be used as originals. Please feel free to copy them as needed.
• Skills Checklist
• Knowledge Test
• Answer Key
• Certificate of Completion
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COAGUCHEK XS SYSTEM SKILLS CHECKLIST
Trainer should check each activity as it is demonstrated or described.
Assembles Equipment
❏ CoaguChek XS meter
COAGUCHEK XS SYSTEM SKILLS CHECKLIST
Recalls Results from Memory ❏ Correctly recalls results stored in memory
Problem Solving
❏ Refers to Error Messages in the user manual when a problem occurs
Cleaning
❏ States minimum cleaning frequency
❏ Container of test strips
❏ Test strip code chip
❏ ACCU-CHEK Softclix lancet device and lancet
❏ Demonstrates exterior cleaning procedure as stated in the user manual
Reviews Procedure
❏ Properly cleans test strip guide
❏ States when coding is needed
❏ Turns meter off before inserting or removing code chip
❏ Removes old code chip if one is installed
Battery Replacement
❏ Demonstrates removal and replacement of batteries
❏ Inserts new code chip until it snaps into place
Trainee Name: ________________________________________________________
Performs Test Procedure
❏ Properly prepares lancet device
Training Date: ________________________________________________________
❏ Turns meter on
Training Site: ________________________________________________________
❏ Inserts test strip
❏ Obtains blood sample correctly
❏ Applies blood to test strip correctly
Trainer Name: ________________________________________________________
Trainer Signature: ________________________________ Date: ________________
❏ Reads result
❏ Records result
❏ Tries to correct any problem should there be an error message, using the
solutions described in the user manual
❏ Is aware of the 24-hour Technical Service number at 1-800-428-4674 if
problem persists
❏ Properly discards used test strip and blood-drawing supplies
COAGUCHEK, ACCU-CHEK, SOFTCLIX and COAGUWIPE are
trademarks of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
COAGUCHEK, ACCU-CHEK, SOFTCLIX and COAGUWIPE are
trademarks of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
ROC270037 34690 CoagXS PT Mn 1F
4/18/07
8:05 AM
Page 28
COAGUCHEK XS SYSTEM KNOWLEDGE TEST
COAGUCHEK XS SYSTEM KNOWLEDGE TEST
12. What would cause Error 3 to appear on the display?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Mark “T” if the statement is true and “F” if the statement is false.
_____ 1. When coding the CoaguChek XS Meter, you must use the code chip
from the same test strip container that you are using.
_____ 2. After removing a test strip from the container, it is important to close the
cap tightly.
13. What would cause Error 5 to appear on the display?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
_____ 3. When performing a blood test, it is important to hold the finger to the
strip until the meter beeps.
_____ 4. The sample must be applied to the test strip within five minutes of
removing it from the container.
14. After inserting a test strip, the code flashes on the display. What is the next step?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
_____ 5. INR is a reporting format that stands for International Normalized Ratio.
_____ 6. Every time a blood test is performed, the meter also performs a built-in
quality control test.
_____ 7. If the built-in quality control test fails, the meter will still give a test result.
15. Why is it important to apply blood to the test strip within 15 seconds of sticking
_____ 8. The most recent user result appears first when reviewing memory.
the finger?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
_____ 9. CoaguChek XS test strips may be stored at room temperature until the
expiration date printed on the container.
_____10. The CoaguChek XS Meter stores up to 50 results with time and date.
Please answer the following questions:
COAGUCHEK is a trademark of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
11. What is used to clean the exterior of the CoaguChek XS Meter?
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
Trainee Name: ________________________________________________________
Training Date: ________________________________________________________
Training Site: ________________________________________________________
COAGUCHEK is a trademark of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
Trainer Name: ________________________________________________________
Trainer Signature: ________________________________ Date: ________________
ROC270037 34690 CoagXS PT Mn 1F
4/18/07
8:05 AM
Page 30
®
CoaguChek XS
System
ANSWER KEY
For CoaguChek XS System Knowledge Test
1. T
2. T
3. T
Certificate of Completion
presented to
4. F – The sample must be applied to the test strip within 10 minutes of
removing the strip from the container.
5. T
6. T
for successfully completing Self-Testing training on the
7. F – If the built-in quality control does not pass, a flashing “QC” will appear on
the display.
CoaguChek® XS System
8. T
9. T
10. F – The CoaguChek XS Meter stores up to 100 test results with time and date
Dated:_________________________________
11. The CoaguChek XS Meter can be cleaned with 10% bleach solution or 70%
isopropyl alcohol.
12. Error 3 indicates that the strip is expired. Ensure that the date is set correctly
on the meter. If it is incorrect, set the correct date. If the date is correct, turn
the meter off and remove the code chip and the test strip. Use the code chip
and a test strip from a new box of test strips.
Certified Training Consultant
13. Error 5 indicates an error applying blood to the test strip. It is caused by not
having a large enough drop of blood. When applying blood to the test strip,
massage your finger until you have a good blood drop and hold your finger
against the test strip until the meter beeps.
COAGUCHEK is a trademark of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
14. Confirm that the code flashing on the display matches the code on the
container of test strips you are using. Then press the M button to continue
the testing process.
15. After 15 seconds your blood may begin to clot, which could lead to an
incorrect result.
COAGUCHEK is a trademark of Roche.
©2007 Roche Diagnostics. All rights reserved.
04999096001-0207
ROC270037 34690 CoagXS PT Mn 1F
4/18/07
8:05 AM
Page 32
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
www.coaguchek.com
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