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Description:
Snap Electrodes are used in conjunction with Snap Leads and
amplifiers for monitoring electromyogenic and physiologic data signals
commonly recorded from chest, extremities and faces of patients.
Intended Use:
Evoked potential Disposable Snap Electrodes are intended to be used
with compatible 1.5 mm touch proof snap electrode leads for testing
of the electrical activity from the brain, spinal nerves, or sensory
receptors in response to specific external stimulation.
Intended User and Target Patient Group:
The product is for use only under the direction of trained medical
professionals in acquiring electrophysiologic signals. For use on
Infants.
Clinical Benefits:
Facilitates obtaining the recording of an EEG/PSG study to detect any
irregularities indicative of various brain or sleep disorders.
Contraindications and Side Effects:
There are no known contraindications or side effects for procedures
performed with Disposable Snap Electrodes. See Warnings or
Precautions below.
Operating Instructions:
• Open the pouch just before use.
• Prepare the electrode site prior to application.
• Connect the appropriate snap lead to the snap connector on the
electrode.
• Remove the electrode from its backing.
• Apply to the patient making sure to place even pressure across the
entire electrode area.
• Electrodes can be used to record or stimulate.
• Re-seal pouch after each use.
• Once recording is complete, detach and discard the disposable snap
electrode.
Understanding Cautions Statements:
CAUTION
Refers to a hazardous situation that could result in minor or
moderate injury or material damage if not avoided.
• Information on how the hazardous situation is avoided.
Warnings and Precautions:
CAUTION
Device dropped or damaged in transit/use could lead to loss of
function or delayed diagnosis.
• Inspect the device prior to each use and do not use if damaged.
Electrode reused on another patient leads to cross infection or loss
of performance.
• Do not reuse or sterilize.
Data cannot be recorded due to improper placement leading to
delay in procedure.
• Assure proper connections and check signal quality before using.
Electrodes left in place for prolonged periods of time may be
associated with skin redness.
• Do not use the electrodes for prolonged periods of time.
Repositioning of electrode can degrade the signal quality.
• Electrode should be replaced if the adhesive no longer provides a
uniform connection to the skin surface.
Modifications to the device can affect function and performance.
• Do not modify this equipment without authorization of the
manufacturer.
Environmental Specifications:
Operating Conditions:
• Temperature: +10°C (+50°F) to +30°C (+86°F)
• Relative Humidity: 20% to 80%
• Pressure: 70 kPa to 106 kPa
Storage Conditions:
• Temperature: 0°C (+32°F) to +30°C (+86°F)
• Relative Humidity: 20% to 80%
• Pressure: 50 kPa to 106 kPa
Compliance Standards:
• ISO 10993-1:2018 Biological evaluation of medical devices — Part 1:
Evaluation and testing within a risk management process
• ETS 300 019-2-1 Environmental Engineering (EE); Environmental
conditions and environmental tests for telecommunication
equipment; Part 2-1: Specification of environmental tests; Storage
• ETS 300 019-2-2 Environmental Engineering (EE); Environmental
conditions and environmental tests for telecommunications
equipment; Part 2-2: Specification of environmental tests;
Transportation
• ASTM D4169-16 Standard Practice for Performance Testing of
Shipping Containers and Systems for Vibration
• EN 60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 Ed. 3.1
clause 8.5.2.3
Disposal Instructions:
Following use, dispose of adhesive electrodes with infectious waste.
Disclaimer:
Natus Medical Denmark Aps is not responsible for injury, infection or
other damage resulting from the use of this product.
Any serious incident that has occurred in relation to the device should
be reported to Natus Manufacturing Limited and the competent
authority of the Member State in which the user and/or patient is
established.
Refer to the Natus website for an electronic copy of this document.
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