INSTRUCTIONS FOR USE
Ambu® Neuroline Twisted Pair
Subdermal Needle Electrode Single-use
Contents
Important information – Read before use
Read these safety instructions carefully before using the Ambu® Neuroline Twisted Pair Subdermal Needle Electrodes. The instructions for use may be updated without further notice. Copies of the current version are available upon request. Please be aware that these instructions do not explain or discuss clinical procedures. They describe only the basic operation and precautions related to the operation of the needle electrodes. There is no warranty on the Ambu Neuroline Twisted Pair Subdermal Needle Electrodes.
1.1. Intended use
The Ambu Neuroline Twisted Pair Subdermal Needle Electrodes are 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.
1.2. Indications for use
Ambu Neuroline Twisted Pair Subdermal Needle Electrodes are indicated when there is a need to obtain electrical activity from the brain, nerves and muscles as part of neurophysiological examinations or monitoring eg. Electromyography (EMG), Electroencephalograhpy (EEG), Evoked Potentials (EP). Ambu Neuroline Twisted Pair Subdermal Needle Electrodes can also be used during Intra Operative Monitoring (IOM).
1.3. Intended patient population
The Ambu Neuroline Twisted Pair Subdermal Needle Electrodes can be used for infants, children, adolescents and adults (from 29 days and up).
1.4. Intended user/use environment
The intended users are healthcare professionals trained in proper placement and use in relevant neurophysiological examinations.
The needle electrodes are for use in hospital/clinic settings.
1.5. Contra indications
None known.
1.6. Clinical benefits
Single-use application minimises the risk of cross-contamination of the patient.
1.7. Warnings and cautions
WARNINGS
- The Ambu Neuroline Twisted Pair Subdermal Needle Electrodes are for single-use only. Reuse on other patients may lead to cross-contamination.
- Do not use the needle electrode if the individual pouch is damaged or has been opened to minimize the risk of an adverse biological event.
- Do not use the needle electrodes for electrical stimulation or during defibrillation as this may lead to tissue burn or electrical shock.
- Do not use the needle electrodes on infected skin as this may lead to tissue infection.
CAUTIONS
- The Ambu Neuroline Twisted Pair Subdermal Needle Electrodes are only to be used by healthcare professionals trained in proper placement and use in relevant neurophysiological examinations, and made familiar with the content of this manual, as incorrect use may harm the patient/user.
- Do not soak, rinse or sterilize the needle electrodes as these procedures may leave harmful residues or cause malfunction of the device. The design and materials used are not compatible with conventional cleaning and sterilization procedures.
- The needle electrodes shall be used with caution on patients with known risk of hemorrhagic complications as they can experience excessive bleeding.
- During surgical procedures, the needle electrodes should be placed as far as possible from the equipment which generates electromagnetic interference (EMI) to minimize unwanted radiofrequency interference (RFI). Unwanted RFI may result in distorted signals with artifacts/noise.
- Simultaneous use of needle electrodes with a surgical equipment operating at high frequency may result in electrical shock. The needle electrodes should be placed as far as possible from the electro-surgical area to minimize unwanted RF current flow.
- The needle electrodes shall be administered to and removed from patients with caution by manipulating the needle and not the lead wire, to minimize the risk of distorted signals with artifacts/noise.
- US Federal law restricts the device for sale only by, or on the order of, a physician.
1.8. Potential adverse events
Temporary pain, discomfort, mild bleeding, mild tenderness and/or bruising.
1.9. General notes
If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority.
Device description
The Ambu Neuroline Twisted Pair Subdermal Needle Electrodes are sterile, single-use products which penetrate patient skin into subdermal tissue. The needle electrodes include two separate needles each attached to a lead wire with a connector. The two pre-attached lead wires are twisted. Each lead wire carries a standard DIN 42802 1.5 mm pin connector for connection to neurological acquisition system.
The needle electrodes must only be used with neurological acquisition systems in compliance with standard IEC 60601 with a Type BF Amplifier Input.
The Ambu Neuroline Subdermal Needle Electrodes come in different lead wire lengths and lead wire color combinations. Protective tubes ensure protection of the needles.
Explanation of symbols used
| Symbol indication | Description | Symbol indication | Description |
 |
ountry of Manufacturer |  |
Packaging level ensuring sterility |
 |
Medical Device |  |
Electrical Safety Type BF Applied Part |
 |
Do not use if the product sterilization barrier or its packaging is damaged |  |
MR Unsafe |
A full list of symbol explanations can be found on ambu.com/symbol-explanation.
Product use
Peel the sterile pouch open.
- Connect the needle electrode to the neurological acquisition system.
- Remove the protection tubes.
- After use, dispose the needle electrode according to local hospital procedures to minimize the risk of cross-contamination.
NOTE: In case of device malfunction, it is recommended to have additional needle electrodes available.
Technical product specifications
5.1. Specifications
| Item no. | Lead wire | Item no. | Lead wire |
| 74612-100/1/20 | 1000 mm | 74612-100/2/20 | 1000 mm |
| 74612-150/1/20 | 1500 mm | 74612-150/2/20 | 1500 mm |
| 74612-200/1/20 | 2000 mm | 74612-200/2/20 | 2000 mm |
| 74612-250/1/20 | 2500 mm | 74612-250/2/20 | 2500 mm |
| ead wire colors: Red, Blue, Green, Yellow, Orange. | Lead wire colors: Lilac, Grey, Brown, Pink, Beige. | ||
Each lead wire color is paired respectively with a White and a Black lead wire. Each box contains 2 of each color combinations.
Duration of use
Duration of use is up to 8 hours.
Sterilization
Sterilized by Ethylene oxide sterilization (ETO).
Storage temperature
The product shall be stored at 10 to 25 °C. (50 to 77 °F).
5.2. MRI Safety information
The Ambu Neuroline Twisted Pair Subdermal Needle Electrodes are classified as MR unsafe.
Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
T +45 72 25 20 00
ambu.com
0227 – V04 – 2022/04 – Printed in Malaysia. TCC 11161
Ambu® is a registered trademark of Ambu A/S, Denmark
Ambu A/S is certified according to ISO 13485