User's Manual

1.5 Product Specifications

Battery lifetime: Variable. Approximately 50 tests.

Mode of operation: Continuous

Operating Conditions:

Operating temperature: 65 to 82°F (18 to 28 °C)

Operating humidity: 10% to 80% (non-condensing)

Degree of protection against ingress of water: Ordinary equipment

Power supply: AC: Input 120V

4 AA Alkaline 1.5-volt batteries

Output: 6V @ 700 mA

Battery voltage: 6V @ 700 mA

Result range: A1c values 5% to 14% are reported.

Sample type: Fingerstick (fresh capillary) whole blood samples

Sample volume: 4 micro liters

Reader Storage and transportation

Temperature: 0° F to 131°F (-17° C to 55°C)

Humidity: l0% - 80% (non-condensing)

Atmospheric pressure: 500 hPa -1060 hPa

• Equipment complies with EM 61010-1

• Classification is with respect to electric shock, fire, and mechanical hazards only

in accordance with EN61010-1.

• Internally powered and Class II equipment.

• Type BF patient applied parts.

• System complies with EN 61326.

• EN61326-1 EMC Medical Products Warning: This equipment generates, uses,

and can radiate radio frequency energy and, if not installed and used in

accordance with the instructions, could cause interference to adjacent equipment.

There is no guarantee that interference will not occur in a particular installation if

the instructions are not followed. The user can determine if the interference is

caused by the equipment by turning the unit off. If interference is caused by the

equipment, you should try moving the equipment away from the other unit.

• This device complies with Part 15 of the FCC rules. Operation is subject to the

following two conditions : (1) This device may not cause harmful interference,

and (2) this device must accept any interference received, including interference

that may cause undesired operation.

1.6 Symbols and Explanations

In vitro Diagnostic: The Avie™ A1c system is for in vitro diagnostic use onl