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User safety

Indications: Paradigm 522/722

Pump

The Paradigm MMT-522 and MMT-722 pumps are indicated for the continuous delivery of insulin, at set and

variable rates, for the management of diabetes mellitus in persons requiring insulin.

Sensor and transmitter

The sensor and transmitter components are indicated for continuous or periodic monitoring of glucose levels

in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).

It alerts if a glucose level falls below or rises above preset values. Values are not intended to be used directly

for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required.

All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on

Paradigm 522/722 pump system values.

Indications: Paradigm 522K/722K (pediatric version)

Pump

The Paradigm MMT-522K and MMT-722K insulin infusion pumps are indicated for the continuous delivery of

insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Sensor and transmitter

The Paradigm REAL-Time system (pediatric version) consists of the Paradigm MMT-522K or MMT-722K insulin

infusion pumps, the MMT-7002 or MMT-7003 glucose sensor, and the MMT-7703 transmitter. Use of the

MMT-522K and MMT-722K insulin pumps with the optional sensor and transmitter components is indicated for

continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high

blood glucose episodes in children and adolescents (ages 7 through 17). The system provides an alert if glucose

levels fall below or rise above preset values. Glucose values provided by the system are not intended to be

used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may

be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter

and not on the sensor glucose readings provided by the Paradigm REAL-Time system.

Introduction

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