Codman EDS 3 - Page 4

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ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
CODMAN
®
EDS 3
™
Leveling Device
Description
The CODMAN
®
EDS 3™ Leveling Device is a nonsterile accessory designed for
use with the CODMAN EDS 3 CSF External Drainage System. The CODMAN
EDS 3 Leveling Device is required to assist inthe optimal leveling of the
CODMAN EDS 3 System.
The EDS 3 Leveling Device consists of a laser-pointing device permanently
encasedin a mounting bracket that allows for attachment to and use with
theCODMAN EDS 3 System.
Please see the label affixed to the leveling device (Figure 1), which reads:
LASER RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
Diode Laser
Maximum Output <1 mW
Wavelength 630–680 nm
EN/IEC 60825-1 Ed.2.0:2007
EN/IEC 60825-1 Ed.3.0:2014
This device complies with 21 CFR Part 1040.10 and 1040.11 except for
deviations pursuant to Laser Notice no. 50, dated June 24, 2007
Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield, MA 02048 – USA
MANUFACTURED: MONTH YEAR
WARNING: Read the instructions for use (IFU) accompanying the
CODMANEDS 3 CSF External Drainage System before using the
systemortheleveling device.
Indications for Use/Intended Purpose
The leveling device is indicated for use only with the CODMAN EDS 3 CSF
External Drainage System.
Contraindications
There are no known contraindications for use of this device.
Precautions
Do not stare into the laser beam.
Laser light, when reflected from a mirror-like surface, can be dangerous.
Use of controls or adjustments or performance of procedures other than
thosespecified herein may result in hazardous radiation exposure.
Magnetic Resonance Imaging (MRI) Information
CAUTION: Remove the Laser Leveling Device (catalog no. 82-1733) from
the EDS 3 System before entering the MRI suite.
The Laser Leveling Device is MR unsafe. Read the instructions packaged
withthe EDS 3 System for MRI information about the other components of
thesystem.
Instructions for Use
Leveling the EDS 3 Device in relationship to the floor
1. Attach the leveling device to the CODMAN EDS 3 CSF External Drainage
System by sliding the securing tab over the slot on the System (Figure 2).
Note: Point the laser on the leveling device toward the patient.
2. Level the CODMAN EDS 3 System on the IV pole as follows (Figure 3):
a. Loosen the gray screw and rotate the assembly to level
(centerbubbleinglasstube).
b. Once level, secure the CODMAN EDS 3 System into position
bytightening thegray screw.
Leveling the EDS 3 Device in relationship to the patient
1. Secure the CODMAN EDS 3 Leveling Device to the EDS 3 System pointing
thelaser on the leveling device toward the patient.
2. Level the unit on the IV pole as follows:
a. Press the button on the laser pointer once to turn on. The laser beam
emits from the pointer.
b. Direct the laser beam toward the patient.
c. Loosen the blue screw and adjust the height of the EDS 3 System
(Figure5), centering the laser pointer to the patient’s external auditory
meatus for ventricular drainage (Figure 6) or to the lumbar catheter exit
site for lumbardrainage. This represents the “zero” reference point.