Ambu Neuroline Monopolar Needle Electrodes Instructions
- June 12, 2024
- Ambu
Table of Contents
Ambu Neuroline Monopolar Needle Electrodes
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 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 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.
Contrindications
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 Monopolar Needle Electrodes are sterile, single-use
products which penetrate patient skin and muscle.
The needle electrodes have a pre-attached lead wire for connection to
neurological acquisition system.
The 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 Monopolar Needle Electrodes come in different needle lengths and diameters. A protective tube is ensuring protection of the needle.
Explanation of symbols used
Symbol indication| Description| Symbol indication|
Description
---|---|---|---
| Country of Manufacturer| | Electrical Safety Type BF Applied Part
| Medical Device| | Packaging level ensuring sterility
| Do not use if the product sterilization barrier or its packaging is damaged
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 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
74325-36/40| Dark Grey| 25| 0.35| 29 G
74338-36/40| Light Green| 38| 0.35| 29 G
74338-45/40| Dark Green| 38| 0.45| 26 G
74350-45/40| Dark Yellow| 50| 0.45| 26 G
74375-50/40| Dark Red| 75| 0.50| 25 G
Pre-attached lead wire length: 76 cm.
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).
Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
T +45 72 25 20 00
ambu.com