Guardian^® RT uses a proven and reliable technology

Diabetologists throughout the world have been using the Medtronic MiniMed subcutaneous glucose sensor since 1999. To date, over 150'000 people with diabetes of all ages have benefited from the additional insight into glycaemic patterns beyond the standard A1c and finger pricks and have received improved treatment thanks to the CGMS system [Ref.1].

Based on this proven sensor technology Guardian^® RT system displays real time glucose levels continuously and reliably alerts patients of dangerous hypo- and hyperglycaemic levels as they occur [Ref.2, 3].

How does it work?

The Guardian^® RT works on the principle of correlation between interstitial and capillary glucose concentration. Glucose freely diffuses through the vascular wall, thus glucose equilibrium is established between blood and interstice.

Only if the blood sugar increases or decreases dramatically, both values can briefly be different until the concentration in the interstice catches up. Boyne et al (2000) and Rebrin et al (1999) found that subcutaneous sensor measurements of the glucose concentration are reliable indicators of the blood sugar level and readings are unaffected by either endogenous or exogenous insulin fluctuation and without correction for the delay to re-establish the equilibrium condition.

A subcutaneous microsensor with a platinum electrode measures the current produced by the reaction of glucose oxidase and glucose nanoamps (nA). Within the measuring range of 40-400mg/dl, (2.2 - 22.2 mmol/l) the current has a linear correlation with the glucose concentration.

Generally, a current value is constantly available at the sensor. Every five minutes, the calculated average sensor signal is transmitted via a digitally encoded RF signal to the monitor, which converts it to a glucose concentration value based on the calibration algorithm value currently in effect. This provides 288 glucose values per 24 hours.

Product Specifications

The following tables list Monitor and Transmitter performance specifications

Monitor performance specifications

Component	Performance Specifications
Glucose Measurement Range	40-400 mg/dl (2.2-22.2 mmol/l)
Typical Operating Range	6 feet (2 meters)
Display	Liquid crystal display (LCD)
Display Window	Length: 1.40 inches (3.56 centimeters) Height: 0.70 inches (1.78 centimeters)
Dimensions	Length: 3.56 inches (9.04 centimeters) Height: 2.77 inches (7.04 centimeters) Width: 0.86 inches (2.18 centimeters)
Weight	4 ounces (114 grams)
Limited Warranty	1 year
System Memory	Stores up to 21 days of data
Alarms	Audible (50 decibels @ 1 meter) Vibrate (Counter Weight: 2.6 grams) Axial Shaft Displacement:1.5 mm Torque Generated at Nominal Motor Speed: 25 N.cm min (equivalent to the vibration mode on a personal pager)
Backlight	Electroluminescent (EL) Panel
Power Supply	2 AAA alkaline batteries
Battery Life	Exceeds one month under anticipated normal use
Case Material	High impact ABS/polycarbonate composite
Safety Checks	Diagnostic signals verify proper Sensor and measurement system operation
Operating Conditions	Temperature: 0 to +50 degrees Celsius (+32 to +122 degrees Fahrenheit). Relative Humidity: 10% to 95% with no condensation
Storage Conditions	Temperature: -20 to +55 degrees Celsius (-4 to +131 degrees Fahrenheit) Relative Humidity: 10% to 100% with condensation
Approved Cleaners	A mild household liquid detergent diluted with water, a quaternary ammonia solution, or isopropyl alcohol on a wipe.
Approved Disinfectants	10% bleach solution, 3% hydrogen peroxide solution, or 70% isopropyl alcohol.

Transmitter performance specifications

Component	Performance Specifications
Biocompatibility	Complies with ISO 10993-1 for long-term body contact
Operating Conditions	Temperature: 0 to +50 degrees Celsius (+32 to +122 degrees Fahrenheit) Relative Humidity: 10% to 95% with no condensation
Transmitter Life	1 year under anticipated normal use conditions
Transmitter Frequency	418 MHz (U.S. and Canada) or 433.92 MHz (International), 1mWerp, 20k5A1D Modulation
Storage Conditions	Temperature: -20 to +55 degrees Celsius (-4 to +131 degrees Fahrenheit) Relative Humidity: 10% to 100% with condensation
Approved Cleaners	A mild household liquid detergent diluted with water, a quaternary ammonia solution, or isopropyl alcohol on a wipe. (DO NOT place liquids into either connector.)
Approved Disinfectants	Tap water, 10% bleach solution, 3% hydrogen peroxide solution, 70% isopropyl alcohol.

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