Ambu 0221 Neuroline Inoject Needle Electrodes Instructions
- June 12, 2024
- Ambu
Table of Contents
Ambu 0221 Neuroline Inoject Needle Electrodes
Important Information – Read before use
Read these safety instructions carefully before using the Ambu® Neuroline
Inoject™ 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 Inoject Needle Electrodes.
Intended use
Electromyography (EMG) Needle Electrodes designed for Botulinum Toxin therapy during nerve block procedures. For single-use only.
Indications for use
The Ambu Neuroline Inoject Needle Electrodes are indicated for EMG guided injection of Botulinum Toxin for nerve block procedures.
Intended patient population
The Ambu Neuroline Inoject Needle Electrodes can be used for children, adolescents and adults (from 2 years and up).
Intended user
The intended users of the Ambu Neuroline Inoject Needle Electrodes are healthcare professionals trained in neurophysiological examinations.
Contra indications
None known.
Clinical benefits
Single-use application minimises the risk of cross-contamination of the patient.
Warnings and cautions
WARNINGS
- The Ambu Neuroline Inoject 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 Inoject Needle Electrodes are only to be used by healthcare professionals trained in performing neurophysiological examinations and made familiar with the content of this manual, as incorrect use may harm the patient/user.
- Ambu Neuroline Inoject Needle Electrodes shall only be used with a standard male luer lock syringe following standard EN ISO 80369-7. Use with other syringes may cause malfunction of the device.
- Ambu Neuroline Inoject Needle Electrodes are not to be used to administer other substances than Botulinum Toxin. Use with other medications may cause malfunction of the device.
- 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 Inoject Needle Electrodes are sterile, single-use products
which penetrate patient skin and muscle.
The needle electrodes can be connected to a luer lock syringe for injection of
Botulinum Toxin.
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 Inoject 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.
-
Connect syringe to needle electrode for injection of Botulinum Toxin.
-
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 | Diameter |
|---|---|---|---|
| mm | mm | Gauge | |
| 74425-30/10 | Dark Grey | 25 | 0.30 |
| 74430-36/10 | Dark Purple | 30 | 0.36 |
| 74435-40/10 | Dark Blue | 35 | 0.40 |
| 74438-45/10 | Dark Green | 38 | 0.45 |
| 74450-50/10 | Dark Yellow | 50 | 0.50 |
| 74475-55/10 | Dark Red | 75 | 0.55 |
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).
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>