AW 06563301A
Wireless (RF) operating range:
Maximum 4 feet*
* Your Medtronic partner device must be within 4 feet of your meter to receive a blood glucose test result.
Separation distance from other
Minimum 12 inches**
wireless (RF) devices:
** The use of cell phone within 12 inches of your meter or Medtronic partner device may interfere with the transmission of blood glucose test results to the partner device. Other types of
wireless devices that are in use nearby may also prevent or delay the transmission of test results. Moving away from or turning off these interfering devices may allow communication.
Expected delay (latency range)
Minimum 3 seconds
in wireless (RF) communication:
Maximum 60 seconds
System accuracy:
Analytical Performance Characteristics
The accuracy of the OneTouch
®
UltraLink
™
Blood Glucose Monitoring System was assessed by comparing blood glucose test results on 135 subjects, with those obtained
using a YSI Model 2300 Glucose Analyzer. Six results were obtained for each subject (each tested in duplicate with test strips from 3 separate lots. ) The following results
were obtained:
System Accuracy Results for Glucose Concentrations <75 mg/dL
System Accuracy Results for Glucose Concentrations
≥
75 mg/dL
System Accuracy Results across the entire Glucose Range
These results indicate that the OneTouch
®
UltraLink
™
Blood Glucose Monitoring System meets the ISO 15197 requirements for accuracy.
† ISO 15197 Minimum Acceptable Accuracy Requirements:
•
95% of individual glucose results must fall within ±15 mg/dL of the YSI reference at glucose concentrations <75 mg/dL
•
95% of individual glucose results must fall within ±20% of the YSI reference at glucose concentrations
≥
75 mg/dL
Regression Statistics
Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouch
®
UltraLink™ Meter compares well with a laboratory method.
Precision
Results show that the greatest variability observed (of two lots tested) is 3.1% or less.
Within ±5 mg/dL
Within ±10 mg/dL
Within ±15 mg/dL
†
85/150 (56.7%)
137/150 (91.3%)
149/150 (99.3%)
TM
Blood Glucose
Monitoring
System
Important Information
about your OneTouch
®
UltraLink
™
Blood Glucose
Monitoring System
Please read this addendum carefully and keep it with the printed Owner’s Booklet.
Información importante
acerca de su Sistema de supervisión de glucosa en
sangre OneTouch
®
UltraLink
™
Por favor lea cuidadosamente este apéndice y manténgalo con el Manual del
propietario impreso
.
Additional information about wireless (RF) communication
Confirmation that a blood glucose test result has been received by your partner device
When the partner device is idle (at the Home Screen), it will beep or vibrate when it receives a blood glucose reading from the meter. The reading will
appear on the partner device screen. See your partner device manual for more information.
Pairing (linking) your meter and Medtronic partner device
Programming your meter ID links your partner device to the meter. If you do not “link” the meter to your partner device, you will enter your blood glucose
readings manually. Each meter has its own unique ID. This helps ensure only partner devices with your unique meter ID can automatically receive blood
glucose test results from your meter.
Partner devices without your unique meter ID cannot receive your blood glucose test results.
“Automatic” Transmission of Blood Glucose Test Results
Blood glucose test results will be transmitted automatically if the PUMP COMM feature on your meter is turned on. Note that the PUMP COMM feature
is turned on when you first receive your meter.
If the PUMP COMM feature is turned off, your test results will not be transmitted automatically, and you will need to manually enter test results into
your partner device.
Additional information about your meter and testing materials
Disposal of used test strips and lancets
Used test strips and lancets may be considered biohazardous waste in your area. Be sure to follow your health care professional’s recommendations or
your local regulations for proper disposal.
Control solution
Use OneTouch
®
Ultra
®
Control Solution with your meter system. For information on a second level of control solution, contact Customer Service
at 1 866 621-4846.
Additional Technical Specifications
Within ±5%
Within ±10%
Within ±15%
234/660 (35.5%)
464/660 (70.3%)
608/660 (92.1%)
Within ±20%
†
653/660 (98.9%)
Within ±15 mg/dL or ±20%
802/810 (99.0%)
Customer Service contact information
Customer Service is available 24 hours a day, 7 days a week,
toll free at 1866 621-4846.
© 2008 LifeScan, Inc. Milpitas, CA 95035 USA
Rev. date: 04/2008 AW 06563301A
# of
Subjects
# of
Tests
Slope
(mg/dL)
Intercept
(mg/dL)
95% CI
Slope
95% CI
Intercept
Std. Error
(Sy.x)
R
2
135
810
0.970
-2.77
(0.960, 0.979)
(-4.75, -0.80)
14.98
0.981
Target
Glucose
(mg/dL)
Mean
Glucose
(mg/dL)
Standard
deviation
(mg/dL)
Coefficient
of variation
(%)
40
50.78
1.56
3.07
100
108.84
2.26
2.08
130
136.12
2.26
1.66
200
210.08
3.01
1.43
300
305.66
4.07
1.33
Within Run Precision (100 venous blood tests)
Glucose
level
(mg/dL)
Mean
Glucose
(mg/dL)
Standard
deviation
(mg/dL)
Coefficient
of variation
(%)
Low
47.52
1.42
2.99
Normal
116.22
2.23
1.92
High
339.71
6.61
1.95
Total Precision (200 control solution tests)
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