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4.3
Error Message
Error
Message
Situation
Solution
The server
encountered
an error
When an error has occurred at server and the
mobile request cannot be executed
Contact service desk and
enquire.
No data to
send
When no data has been recorded because there
is an error with time of gateway device and the
test ends as soon as it has been started
Reinstall App
Failed to
connect to
service
When mobile device cannot access server due
to network error
Re-try after moving to
area with LTE or Wifi
connection
4.4
Maintenance
For cleaning, gently wipe with a soft dry cloth after using the S-PATCH 3. Please attempt to keep S-
PATCH3-CARDIO dust free. S-PATCH is waterproof. But it should be kept dry. This device does not
have serviceable components.
Do not disassemble, crush, puncture, short external contacts or circuits, dispose of in fire or water.
4.5
Specification of External Device connection
The S-Patch3 is connected to the Android Application. The data indicating the status of the device is
transmitted to the application from the device.
A.
The required specification of the interface and IT -Network that combines PEMS
1)
Main Device / Mobile App interface
Data format: Bluetooth
Mobile Application: Application on based Android
Device status information
Device information (Bringing information when connecting to BLE)
Battery information (Receiving information periodically)
Data to Device – Data Channel
Transmits the data to the device
B.
Technical specification about network connection of PEMS including security features.
1)
Mobile Application is designed to not-affect by an external virus infiltration. But if infected with
virus, Operating System may be a loss of storage data. Therefore, in the case of virus infection it
should be operated by an antivirus program.
2)
Specification of Network connection
Communication protocol: the protocol between the main unit and the mobile app is a BLE
central (Mobile) – peripheral (main unit) communications and they communication with security
requirements defined in the BLE Protocol Stack.
C.
Responsibility Organization
– connection of the PEMS to an it-network that includes other equipment could result in
previously unidentified risks to patients, operators or third parties;
– the responsible organization should identify, analyze, evaluate and control these risks;
– subsequent changes to the it-network could introduce new risks and require additional
analysis; and
– changes to the it-network include:
• changes in the it-network configuration;
• connection of additional items to the it-network;
• disconnecting items from the it-network;
• update of equipment connected to the it-network; and
• upgrade of equipment connected to the it-network.
