natus OBM00042 Instrucciones De Uso página 2

English
Description:
Natus OBM Neonatal Hydrogel Sensors are disposable surface electrodes used as a
non-invasive method of conveying electrical signals from a patient to the Olympic Brainz
Monitor or other amplifiers used for EEG, PSG, evoked potential, or EMG tests.
Intended Use:
The intended use of disposable surface recording electrodes is to stimulate or record
the electrical activity to or from muscles and motor and sensory nerves during nerve
conduction studies, evoked potential studies, or inter-operative monitoring.
Intended User and Target Patient Group:
The product may be used with neonatal patients or infants (defined as birth to 28 days
post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks), under the
direction of a physician.
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 Natus
Neonatal Hydrogel Sensors. See Warnings or Precautions below.
Operating Instructions:
• Open the pouch just before use.
• Prepare the skin prior to application making sure that the site is clean and dry.
• Remove the electrode from its backing cloth.
• Apply to the patient making sure to place even pressure across the electrode.
Understanding Warnings and 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.
Device 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.
Glossary of Symbols:
Standards
Symbol
Reference
-
21 CFR Part
801.109(b)(1)
ISO 15223-1
Symbol 5.1.1
ISO 15223-1
Symbol 5.1.2
ISO 15223-1
Symbol 5.1.6
ISO 15223-1
Symbol 5.1.5
ISO 15223-1
Symbol 5.1.3
2
Standard Title of Symbol
-
Labeling-Prescription devices.
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied.
CAUTION
Device left in place for prolonged periods of time may be associated with skin
redness.
• Do not use the device for prolonged periods of time.
Repositioning of sensor can degrade the signal quality.
• Sensors 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: 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 telecommunications 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 Incorporated DBA Excel-Tech Ltd. (Xltek) 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 Medical Incorporated DBA Excel-Tech Ltd. (Xltek) 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.
Symbol Title as per
Explanation
Reference Standard
An indication of This product is a medical device.
Medical device
Prescription only Indicates the product is authorized for sale by or on the order of a
licensed healthcare practitioner.
Manufacturer Indicates the medical device manufacturer.
Authorized Indicates the Authorized representative in the European Community.
representative in the
European Community
Catalogue number Indicates the manufacturer's catalogue number so that the medical
device can be identified.
Batch or Lot code Indicates the manufacturer's batch code so that the batch or lot can be
identified.
Date of manufacture Indicates the date when the medical device was manufactured.