OneTouch UltraLink Owner's Booklet

Important Information

about your OneTouch ®
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

Wireless (RF) operating range:
* Your Medtronic partner device must be within 4 feet of your meter to receive a blood glucose test result.
Separation distance from other
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)
in wireless (RF) communication:

System accuracy:

Analytical Performance Characteristics
The accuracy of the OneTouch ® UltraLink
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
Within ±5 mg/dL Within ±10 mg/dL
85/150 (56.7%) 137/150 (91.3%)
System Accuracy Results for Glucose Concentrations ≥75 mg/dL
Within ±5% Within ±10%
234/660 (35.5%) 464/660 (70.3%)
System Accuracy Results across the entire Glucose Range
Within ±15 mg/dL or ±20%
802/810 (99.0%)
These results indicate that the OneTouch
† 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
# of # of Slope
Subjects Tests (mg/dL)
135 810 0.970
Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouch

Precision

Within Run Precision (100 venous blood tests)
Target Mean Standard
Glucose Glucose deviation
(mg/dL) (mg/dL) (mg/dL)
40 50.78 1.56
100 108.84 2.26
130 136.12 2.26
200 210.08 3.01
300 305.66 4.07
Results show that the greatest variability observed (of two lots tested) is 3.1% or less.
Customer Service contact information
Customer Service is available 24 hours a day, 7 days a week,
toll free at 1866 621-4846.
UltraLink ™ Blood Glucose
™
Maximum 4 feet*
Minimum 12 inches**
Minimum 3 seconds
Maximum 60 seconds
™ Blood Glucose Monitoring System was assessed by comparing blood glucose test results on 135 subjects, with those obtained
Within ±15 mg/dL
149/150 (99.3%)
Within ±15%
608/660 (92.1%)
® UltraLink ™ Blood Glucose Monitoring System meets the ISO 15197 requirements for accuracy.
Intercept 95% CI
(mg/dL) Slope
-2.77 (0.960, 0.979) (-4.75, -0.80)
Total Precision (200 control solution tests)
Coefficient Glucose
of variation level
(%) (mg/dL)
3.07 Low
Normal
2.08
1.66 High
1.43
1.33
†
Within ±20%
653/660 (98.9%)
95% CI Std. Error
Intercept (S y.x )
14.98 0.981
® UltraLink™ Meter compares well with a laboratory method.
Mean Standard Coefficient
Glucose deviation of variation
(mg/dL) (mg/dL) (%)
47.52 1.42 2.99
116.22 2.23 1.92
339.71 6.61 1.95
TM Blood Glucose
Monitoring
System
†
2
R
© 2008 LifeScan, Inc. Milpitas, CA 95035 USA
Rev. date: 04/2008 AW 06563301A