The CODMAN® EDS 3™ Leveling Device is a non-sterile accessory designed for use with the CODMAN EDS 3 External CSF Drainage System. It is essential for optimal leveling of the CODMAN EDS 3 system.
Function Description
The EDS 3 Leveling Device consists of a laser-pointing device permanently encased in a mounting bracket. This design allows for its attachment to and use with the CODMAN EDS 3 system. The primary function of the device is to assist in accurately leveling the EDS 3 system relative to both the floor and the patient, ensuring precise positioning for ventricular or lumbar drainage. The laser pointer emits a beam that helps healthcare professionals align the system's "zero" reference point with anatomical landmarks on the patient.
Important Technical Specifications
- Laser Radiation: Class 2 Laser Product
- Laser Type: Diode Laser
- Maximum Output: <1 mW
- Wavelength: 630-680 nm
- Compliance: EN/IEC 60825-1 Ed.2.0:2007, EN/IEC 60825-1 Ed.3.0:2014, and 21 CFR Parts 1040.10 and 1040.11 (except for deviations per Laser Notice No. 50, dated June 24, 2007).
- MRI Compatibility: The laser leveling device (Catalog No. 82-1733) is not MR-safe and must be removed from the EDS 3 system before entering an MRI environment. Refer to the EDS 3 system's instructions for MRI information regarding other components.
- Manufacturing Information: Manufactured by Integra LifeSciences Production Corporation, 11 Cabot Boulevard, Mansfield, MA 02048 USA. The manufacturing date (MONTH YEAR) is indicated on the device label.
Usage Features
The leveling device is used to align the CODMAN EDS 3 system in two main steps:
-
Leveling relative to the floor:
- Attach the leveling device to the CODMAN EDS 3 external drainage system by sliding the securing tab over the slot on the system (Figure 2).
- Note: Point the laser of the leveling device towards the patient.
- Level the CODMAN EDS 3 system on the IV pole (Figure 3) by loosening the gray screw and rotating the assembly until the bubble in the glass tube is centered.
- Once leveled, secure the CODMAN EDS 3 system by tightening the gray screw.
-
Leveling relative to the patient:
- Secure the CODMAN EDS 3 leveling device to the EDS 3 system with the laser pointing towards the patient.
- Level the unit on the IV pole as follows:
- Press the button on the laser pointer once to turn it on. The laser beam will emit from the pointer.
- Direct the laser beam towards the patient.
- Loosen the blue screw and adjust the height of the EDS 3 system (Figure 5) so that the laser pointer is centered on the patient's external auditory meatus for ventricular drainage (Figure 6) or on the lumbar catheter exit site for lumbar drainage. This position represents the "zero" reference point.
- The laser beam will automatically turn off after 30 seconds. To reactivate, press the button again.
- Remove the leveling device from the EDS 3 unit after use.
Maintenance Features
- Laser Care: Protect the laser from exposure to water, dust, heat, or direct sunlight, as these can damage it. Avoid dropping the laser leveling device or subjecting it to stress, which could also cause damage.
- Battery Check: If the laser does not function, unscrew the end cap and check the polarities of the batteries. Reposition the batteries if necessary.
- Product Lifetime: Do not use the EDS 3 leveling device if a visual inspection indicates damage that could affect its functionality.
- Reporting Serious Incidents: Any serious incident related to the device involving the user and/or patient must be reported to the manufacturer and the competent authority of the member state where the user and/or patient resides.
Integra LifeSciences Corporation ("Integra") exercises reasonable care in material selection and manufacturing. Integra warrants that these products conform to the limited product warranty provided in the product labeling or applicable product catalog. This warranty is exclusive, and Integra disclaims all other warranties, expressed or implied, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Integra is not liable for incidental or consequential loss, damage, or expense arising directly or indirectly from the use of these products. Integra neither assumes nor authorizes any person to assume any other or additional liability or responsibility in connection with these products.
CODMAN is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. EDS 3 is a trademark of Integra LifeSciences Corporation or its subsidiaries.
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