Ambu Neuroline Monopolar Needle Electrode Instruction Manual
- June 12, 2024
- Ambu
Table of Contents
**Ambu Neuroline Monopolar Needle Electrode Instruction Manual
**
Important information – Read before use
Read these safety instructions carefully before using the Ambu® Neuroline
Monopolar 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 discussclinical
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 Monopolar Needle Electrodes.
Intended use
The Ambu Neuroline Monopolar Needle Electrodes are made for muscle activity
recording for Electromyography (EMG) applications. The needle electrodes are
for single-use only.
Indications for use
The Ambu Neuroline Monopolar Needle Electrodes are indicated for examination
of the electrical activity in skeletal muscles.
Intended patient population
The Ambu Neuroline Monopolar Needle Electrodes can be used for infants,
children, adolescents and adults (from 29 days and up).
Intended user
The intended users of Ambu Neuroline Monopolar Needle Electrodes are
healthcare professionals trained in Electromyography (EMG) procedures.
Contra indications
None known.
Clinical benefits
Single-use application minimizes the risk of cross-contamination of the
patient.
Warnings and cautions
WARNINGS
- The Ambu Neuroline Monopolar 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 as this may lead to tissue burn.
- Do not use the needle electrodes on infected skin as this may lead to tissue infection.
CAUTIONS
- The Ambu Neuroline Monopolar Needle Electrodes are only to be used by healthcare professionals trained in performing Electromyography (EMG) procedures 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 use, the needle electrodes should be placed as far as possible from the equipment generating electromagnetic interference (EMI) to minimize unwanted radiofrequency interference (RFI). Unwanted RFI may result in distorted signals with artifacts/noise.
- US Federal law restricts the device for sale only by, or on the order of, a physician.
Potential adverse events
Temporary pain, discomfort, mild bleeding, mild tenderness and/or bruising.
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 Mono polar Needle Electrodes are sterile, single-use products which penetrate patient skin and muscle. It shall be connected to Ambu Neuroline Mono polar Cable 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 Mono polar Cable carries a standard DIN 42802 1.5 mm pin connector. The Ambu Neuroline Mono polar Cable can be reused up to 500 times. The Ambu Neuroline Mono polar Needle Electrodes come in different needle lengths and diameters. A protective tube is ensuring protection of the needle.
Explanation of symbols used
Country of Manufacturer
Medical Device
Do not use if the product sterilization barrier or its packaging is damaged
Electrical Safety Type BF Applied Part
Packaging level ensuring
sterility
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 matching Ambu Neuroline Monopolar Cable which carries the connection to the neurological acquisition system.
-
Remove the protection tube.
-
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
Specifications
| Item no. | Color | Length mm | Diameter |
|---|---|---|---|
| mm | Gauge | ||
| 74225-36/40 | Dark Grey | 25 | 0.35 |
| 74238-36/40 | Light Green | 38 | 0.35 |
| 74238-45/40 | Dark Green | 38 | 0.45 |
| 74250-45/40 | Dark Yellow | 50 | 0.45 |
| 74275-50/40 | Dark Red | 75 | 0.50 |
Duration of use
Duration of use is up to 2 hours.
Sterilization
Sterilized by Ethylene oxide sterilization (ETO).
Storage temperature
The product shall be stored at 10 to 25 °C (50 to 77 °F).
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>