User's Guide

is broken, the sensor and the needle can be exposed to contamination. A sensor and needle

exposed to contamination can cause site infection if inserted into the body.

Do not change or modify the Simplera™ sensor. Changing or modifying the sensor can result

in improper insertion, pain, or injury.

Do not let children hold the Simplera™ sensor without adult supervision. Do not let children

put any part of the sensor in their mouth. This product poses a choking hazard for young

children that can result in serious injury or death.

Watch for bleeding at the insertion site on top of the Simplera™ sensor. If bleeding occurs,

apply steady pressure with a sterile gauze pad or clean cloth placed on top of the sensor for

up to three minutes. If bleeding continues, is significantly visible on top of the sensor, or if

there is excessive pain or discomfort after insertion, follow these steps:

1. Remove the Simplera™ sensor and continue to apply steady pressure until the bleeding

stops.

2. Dispose of the Simplera™ sensor. See Disposal, page 15.

3. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation.

If there is redness, bleeding, irritation, pain, tenderness, or inflammation, contact a

healthcare professional.

4. Insert a new Simplera™ sensor in a different location.

Some skin care products, such as sunscreens and insect repellents, can damage the

Simplera™ sensor. Do not allow skin care products to touch the sensor. Wash hands after

using skin care products before touching the sensor. If any skin care products touch the

sensor, immediately wipe the sensor with a clean cloth.

Report any adverse reactions associated with the Simplera™ sensor to 24‑Hour Technical

Support. Adverse reactions can cause serious injury.

Exposure to magnetic fields and radiation

Do not expose the Simplera™ sensor to Magnetic Resonance Imaging (MRI) equipment,

diathermy devices, or other devices that generate strong magnetic fields (for example,

x‑ray, CTscan, or other types of radiation). Exposure to strong magnetic fields has not been

evaluated and can cause the sensor to malfunction, result in serious injury, or be unsafe.

IEC 60601‑1‑2: 4th Edition; Special EMC Precautions for Medical Electrical

Equipment

• Special Precautions regarding Electromagnetic Compatibility (EMC): This body worn

device is intended to be operated within a reasonable residential, domestic, public

or work environment where common levels of radiated “E” (V/m) or “H” fields (A/m)

exist, such as cellular phones, Wi‑Fi™, Bluetooth® wireless technology, electric can

openers, microwave and induction ovens. This device generates, uses, and can radiate