Ambu Twisted Pair Subdermal Needle Electrode Instructions
- June 13, 2024
- Ambu
Table of Contents
Ambu Twisted Pair Subdermal Needle Electrode
Instructions for use
Twisted Pair Subdermal Needle Electrode
Recommended Applications
Twisted Pair Subdermal electrode has leadwire with touch proof safety
connector DIN 42-802.
Twisted Pair Subdermal electrode is designed for direct connection with IEC
60601-1 compliant Evoked Potentials (EP), Intra-Operative Monitoring (IOM) or
other Neurophysiological equipment with DIN 42-802 input socket.
Intended Use
The Ambu® Neuroline Twisted Pair Subdermal Needle Electrode is intended for
use with recording, monitoring and stimulation equipment for the purpose of
recording of biopotential signals for example:
Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential
signals. The electrodes are sterile and for single use only.
The Twisted Pair Subdermal electrodes should be used by health care
professionals trained in performing neurophysiological examinations. The
Twisted Pair Subdermal electrode is for use in hospital/clinic settings.
Precautions
- For single use only. Reuse of the product can cause contamination, leading to infections.
- The needle electrode shall be administered to and removed from patients by manipulating the needle and not the leadwire.
- DO NOT soak, rinse, or sterilize this device as these procedures may leave harmful residues or cause malfunction of the device. The design and material used are not compatible with conventional cleaning and sterilization procedures.
- During surgical procedures, the electrodes should be placed as far as possible from the equipment which generates electromagnetic interference (EMI) to minimize unwanted radiofrequency interference (RFI).
- Simultaneous use of needle electrode with a surgical equipment operating at high frequency may result in burns at the site where needle electrode is applied. The needle electrodes should be placed as far as possible from the electro-surgical area to minimise unwanted RF current flow.
- Do not use if individual pouch is damaged or has been opened.
- Do not reuse.
- Rx only
Sterilization/Sterilisation
Sterilized/Sterilised by Ethylene oxide sterilization/sterilisation (ETO).
Packaging
One pair of needle electrode in a pouch. Do not use if package is damaged.
Directions for use
-
Peel the sterile pouch open and remove the single use needle electrode.
-
Place the lead wire connector in the equipment and remove the protective tube.
-
After use, dispose of the needle electrode in a designated container.
Do not reuse or re-sterilize/re-sterilise.
Ambu® is a registered trademark of Ambu A/S, Denmark
Ambu A/S is certified according to ISO 13485
Customer Support
Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
+45 72 25 20 00 Tlf.
+45 72 25 20 50 Fax
www.ambu.com
