List Of Symbols - Integra Codman DirectLink ICP Manual De Instrucciones

EN – ENGLISH

List of Symbols

The following symbols may be present on the product, the
product package/label, or in this manual.
Prescription device only (USA)
ARROW BUTTON for calibrating patient monitor
ZERO BUTTON for zeroing ICP sensor prior
to implantation
Patient Monitor output connector
Extension Cable input connector
Electrostatic sensitive devices
Follow instructions for use
50°C
Temperature limitations
0°C
85%
Humidity limitations
15%
Date of manufacture
Caution
Double insulation
Type BF applied part
Manufacturer
Catalogue number
Quantity
Serial number
Underwriters' Laboratories
Electrical and electronic equipment. Return waste
to collection system or treatment and recycling
facilities. Applicable in the EU. Follow disinfection
instructions before return.
Protection against vertically falling water drops
MR Unsafe
Fragile, handle with care
Keep dry
Made In
Instructions for Use
Materials Required
DirectLink Module
Patient Monitor
DirectLink Patient Monitor Interface Cable (compatible with
Patient Monitor)
CODMAN MICROSENSOR ICP Transducer (in unopened sterile
package)
DirectLink ICP Extension Cable
A Connect the DirectLink Module to the Patient Monitor
1 Select the DirectLink Patient Monitor Interface Cable that
is compatible with the patient monitor that will be used.
2 Visually inspect the cable, connectors, and connector
pins for signs of damage. Do not use if damaged. Make
sure that the connector pins and internal portions of the
connector are dry and free of visible debris prior to use.
3 Attach the interface cable to the DirectLink and then
to an available invasive pressure input channel on the
patient monitor, as outlined in Steps 3.1 through 3.3:
3 1 Hold the module with its front panel facing up.
Align the cable's connector so that the "fin" of the
strain relief points downward. Align the cable to the
signal output receptacle on the module, marked
with the symbol
3 2 Firmly push the cable connector into the receptacle
until it fully engages and locks in place.
CAUTION: Align the "fin" of the strain relief of the
interface cable with the receptacle on the module
as outlined in Step 3 1 before pushing these parts
together DO NOT twist the connector after
pushing it in part way Twisting the connector in
this manner will damage the pins and can lead to
product malfunction
3 3 Attach the other end of the interface cable to the
available invasive pressure input channel connector
of the patient monitor. Refer to the manual for your
patient monitor. Use the cable management strap
to reduce any excessive length of interface cable.
4 The DirectLink Module self-test will run automatically;
LEDs will switch on and off sequentially. At the end of the
self-test, the amber LED alone will remain illuminated,
indicating that the module is ready for the next step.
Proceed to Section B. Calibrate the Patient Monitor.
CAUTIONS:
• Do not press any buttons during the DirectLink self-test
or the self-test will incorrectly detect a failure condition
• If the amber LED does not illuminate, do not use
the DirectLink Module; contact your local Integra
representative for a replacement module
Note: Whenever the amber status LED is steady, the DirectLink
Module sends a full scale signal greater than 250 mmHg to the
patient monitor to indicate that a zeroed ICP sensor is not yet
connected to the system. Some patient monitors might display
an "over range" pressure message.
4
(see Detail "D" in Figure 2).