1: Using This Guide
EDS-MD® Medical Device Server User Guide
16
Warning:
To avoid overloading and overheating, do not use a USB port as a
charger port or a power port for other devices such as a cellular phone,
PDA device, disk drive, etc.
WARNINGS OF NETWORK CONNECTIONS
The integration of the EDS-MD medical device server into an IT network may constitute a Medical
Electrical (ME) System. It is recommended that the system leakage current be measured to verify
that the basic requirement for the safety of the ME System, after installation or subsequent
modification of the system, does not result in an unacceptable risk.
The integration of the EDS-MD into a IT network may result in unforeseen risks associated with
the interconnection of the EDS-MD Programmable Electronic Subsystem (PESS)/Programmable
Electrical Medical Systems (PEMS) to IT Networks. Connection of equipment containing PEMS to
an IT NETWORK/DATA COUPLING that includes other equipment could result in previously
unidentified risks to patients, operators or third parties. The entity accountable for the use and
maintenance of an ME EQUIPMENT or an ME SYSTEM should identify, analyze, evaluate and
control these RISKS. Subsequent changes to the IT NETWORK/DATA COUPLING could
introduce new RISKS and require additional analysis. Changes to the IT NETWORK/DATA
COUPLING include:
Changes in NETWORK/DATA COUPLING configuration
Connection of additional items to the IT NETWORK/DATA COUPLING
Disconnecting items from the IT NETWORK/DATA COUPLING
Update of equipment connected to the IT NETWORK/DATA COUPLING
Upgrade of equipment connected to the IT NETWORK/DATA COUPLING
Equipment Classifications
Classification according to the type of protection against electric shock: Class I Equipment
Classification according to the degree of protection against electric shock: No Applied Parts
Classification according to the degree of protection against ingress of water: IP20
Classification according to the mode of operation: Continuous Operation
Environmental Conditions for Transportation and Storage
An ambient temperature range of -30°C to +80°C
A relative humidity range of 0% to 95%, noncondensing
An atmospheric pressure range of 50 kPa to 106 kPa
Cleaning Instructions
1. Disconnect all cables and unplug AC power cord from the device.
2. Prepare a disinfectant solution using 1 part bleach mixed with 9 parts water.
3. Lightly moisten a tissue with the mild detergent and wipe down only the outside of the device.
4. Allow the device to air-dry or wipe dry with a clean dry tissue before use.
Caution:
To avoid electric shock and for the device to work properly, do not allow
cleaning solution to get inside the device, specifically the interface port
connectors or the power inlet. Do not immerse the device in any liquid.
