Warnings and Cautions

Two types of messages appear in this User Manual:

1. A warning is an instruction that, if not followed, could cause severe injury to a user, patient, or another person, or could lead to clinical misdiagnosis and loss or damage of patient-related data.

2. A caution is a direction that, if not followed, could cause damage to the IT equipment on which the device software is installed, or other equipment and goods, or could cause environmental pollution.

WARNING: Do not use this device before reading this manual thoroughly and understanding all that it entails.

WARNING: The X-trodes system is aimed for research purposes only and should be used by researchers only. The X-trodes system is not a medical device and is not intended for medical use.

WARNING: The electrode patch should not be used if there is skin allergy, injury, lesions, open wounds, infected or inflamed skin.

WARNING: The X-trodes DAU should not be used during charging. Wait until the LED indicator status is “Green” and detach the DAU from the charging cable before using the DAU.

WARNING: The proper use of the X-trodes device requires the user to be competent in both hands, read and comprehend instructions, and see the visual indicators.

WARNING: The X-trodes device should not be used in proximity to a Magnetic Resonance Imaging system.

WARNING: The electrode patch is intended to be adhered to skin for up to 24 hours. Do not leave it on the patient for longer durations.

WARNING: The electrode patch is intended for single use.

WARNING: Do not use the X-trodes device if it appears to be damaged in any way.

CAUTION: The device should be used within safe operating ambient temperatures from 5°C to 40°C (41°F to 104°F).

CAUTION: Do not attempt to charge the device if the ambient temperature is above 40°C (104°F).

CAUTION: Changes or modifications to the X-trodes systems or its operation not expressly approved by X-trodes Ltd., can affect the safety and effectiveness of the system and will void the systems’ warranty.

CAUTION: Inspect and clean the device with 70% alcohol wipes.

CAUTION: The device may not charge properly if in direct sunlight or if the ambient temperature is above 30°C (86°F).

CAUTION: Do not expose the X-trodes device to excessive water.

CAUTION: The maximum distance between the device and the tablet should not exceed 8 meters (26 feet).

Recommendation: The device includes a 32GB V30 speed class MicroSD card. If you choose to replace the MicroSD card, verify that it is formatted as FAT32 with 64kb allocation unit size.

Recommendation: The electrode patch should be applied to the clean skin.

Recommendation: Remove the electrode patch and store your X-trodes device in the case provider.

Recommendation: Other BT devices should be turned off before starting the recording session.

Recommendation: Do not use the X-trodes device with unauthorized patch that is not an X-trodes product.

Recommendation: Do not re-use the X-trodes patch if it was completely detached from the skin during the test. Use the spare patch if needed.