Use Instructions

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Category Specification
Long Term Storage: Up to 36 months at 22 +/- 6 degrees C, stored in supplier’s
ambient environment.
Normal Operating Conditions: The battery shall meet all performance
requirements over a temperature range of 35 to 41°C inclusive.
Current
Consumption
Lowest Usage Current Consumption: < 200 nA
Communication Standby Current Consumption: < 500 nA
Low Resolution Mode Current Consumption: < 15µA.
Medium Resolution Mode Current Consumption: <2000µA
High Resolution Mode Current Consumption: <2000µA
Mode of Operation
Five (5) Modes of Operation for the CTE implant (without patient
involvement):
Deep Sleep Mode;
Standby Mode;
Low Resolution Mode (Step count);
High Rate Mode;
Six Degree of Freedom (6DOF) Mode.
Continuous Sampling:
Step Counting and detection of significant motion;
Detection of linear acceleration and angular rate of motion;
Collection of acceleration data at high sampling rates (up to 800 Hz).
Safe Storage and
Transport
Temperature Range
Temperature, Storage: 15C to 25C.
Temperature, Transportation Environmental: Per ISTA 3A, method ASTM
D4332.
Safe Storage and
Transport Relative
Humidity
Relative Humidity, Storage: 10% to 90%.
Relative Humidity, Transportation Environmental: Per ISTA 3A, method
ASTM D4332.
Protection from
Electric Shock
Standard (e.g., 60601-, Type, e.g., BF)
Physician Instructions for Use
DRAFT