How Supplied; Device Details; Cleaning The Control Unit - Boston Scientific EKOS Control System 4.0 User Manual

Table 9.
Recommended separation distances between portable and mobile RF communication equipment and the Control Unit
The Control Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled� The customer
or the user of the Control Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Control Unit as recommended below, according to the maximum output
power of the communications equipment�
Rated maximum output
power of transmitter
W
0,01
0,1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer�
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies�
NOTE 2: These guidelines may not apply in all situations� Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people�

HOW SUPPLIED

This product is supplied non-sterile and is intended for multiple use�

Device Details

Do not use if package is damaged or unintentionally opened before use�
Do not use if labeling is incomplete or illegible

Cleaning the Control Unit

Warning: The reusable Connector Interface Cable and Control Unit are NOT STERILE� Use caution if maintaining a sterile operating field
after connecting to the EKOS Device� Failure to do so could result in patient infection�
Warning: Thoroughly clean the Control Unit and Connector Interface Cable after each use� When cleaning, adhere to the following guidelines
(see Cleaning the Control Unit Section):
• Follow all cleaning instructions provided in these Instructions for Use�
• Turn off the Control Unit and unplug it from the power source before cleaning�
• Only use the recommended cleaning agents�
• Do not spray cleaners directly onto the Control Unit or Connector Interface Cable�
• Do not expose the Control Unit or the Connector Interface Cable to autoclaving or other sterilizers�
Failure to follow these cleaning guidelines could result in infection to the patient or equipment damage�
Clean the Control Unit and Connector Interface Cable(s) after each use�
1� Turn OFF the Control Unit�
2� Unplug the power cord from the wall outlet�
3� Disconnect the power cord and Connector Interface Cable(s) from the Control Unit�
4� Wipe the Control Unit and cables with:
• An approved cleaning and disinfection hospital wipe or
• A mild cleaning solution applied with a damp soft cloth followed by application of a disinfection solution
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d = 1.17√P
0�12
0�37
1�17
3�70
11�7
19
m
80 MHz to 800 MHz
d = 1.17√P
0�12
0�37
1�17
3�70
11�7
800 MHz to 2,5 GHz
d = 2.33√P
0�23
0�74
2�33
7�37
23�3
Black (K) ∆E ≤5.0