Instructions for Use

MESI mTABLET maintenance

10.1 CHARGING THE BATTERY AND STORING

If you wish to use the device on battery power, you must ensure that MESI mTABLET MAINTENANCE the battery is charged regularly. Between use the MESI mTABLET UNIT should be placed on the MESI mTABLET WI-FI DOCKING UNIT to charge its battery.

If the capacity of the battery is significantly decreased after a certain period of intensive use, the battery is most likely worn out and you should contact your dealer or the manufacturer about replacing the battery.

When the device is charging the display on MESI mTABLET UNIT will be displaying charging status.

10.2 CLEANING INSTRUCTIONS

Cleaning the device regularly with a soft, dry or slightly damp cloth – is recommended. Do not use aggressive cleaning agents, volatile liquids or excessive force when cleaning the device.

10.3 PRODUCT LIFE AND STORAGE

If correctly used and maintained the device will have a minimum service life of 5 years. The device can be stored under suitable conditions for a maximum of 5 years. When using the device after storage, we recommend that you carry out a thorough maintenance check on the device.

10.4 NETWORK CONNECTIVITY AND INTEGRATION REQUIREMENTS

The mTABLET may be connected to an IT-NETWORK (e.g., hospital network or cloud infrastructure) to support integration with healthcare information systems, secure data transmission, and remote service access. This section outlines the technical and procedural requirements for safe and effective network integration.

a) Purpose of the mTABLET connection to an IT-NETWORK

The mTABLET connects to an IT-NETWORK to:

  • Synchronize data with cloud services (optional)

  • Exchange patient and measurement data with hospital information systems (HIS/EHR)

  • Enable secure remote maintenance and software updates (where applicable)

b) Required characteristics of the IT-NETWORK

The IT-NETWORK must fulfill the following characteristics:

  • Support for standard TCP/IP communication

  • 2.4GHz or 5GHz Wi-Fi or Ethernet (mTABLET dock)

  • WPA2 or WPA3 encryption (Enterprise or PSK)

  • Sufficient bandwidth for low-latency medical data transmission

c) Required configuration of the IT-NETWORK

The IT-NETWORK should be configured with:

  • DHCP or Static IP assignment

  • Open ports for HTTPS (443), and DNS (53)

  • Allowed outbound access to MESI cloud services (if cloud is used)

  • Correct certificate and identity management (if WPA2-Enterprise or EAP is used)

d) Technical specifications of the network connection, including security specifications

Transport protocols: HTTPS over TLS 1.2 or higher

  • Application protocols: REST API, GDT, HL7, DICOM, XML, JSON or proprietary integration formats

  • Data encryption: all transmitted patient and system data is encrypted in transit

e) Intended information flow

Intended information flow
SourceDestinationData Type
mTABLETEHR/HIS systemsPatient data, test results
mTABLETCloud (MESI)Patient data, test results
Cloud (MESI)mTABLETDevice sync, software updates
HIS/EHRmTABLETPatient demographics, worklist

Information is routed via secure channels and does not traverse public networks unless explicitly configured for cloud operation.

f) Hazardous Situations from IT-NETWORK Failures

The following hazardous situations may arise if the IT-NETWORK does not meet required characteristics:

  • Loss or delay of critical medical data

  • Incomplete synchronization leading to outdated records

  • Unauthorized data access due to misconfigured firewalls or certificates

  • Network downtime causing delayed diagnostics or workflow disruptions

NOTE: In the event of IT-NETWORK failure, the mTABLET continues to operate in standalone mode. All locally stored measurement results and patient data remain accessible to the user directly on the device, ensuring continuity of care even when network connectivity is lost.

Information for the Responsible Organization

The responsible organization (e.g., hospital IT department) is accountable for ensuring that the network environment where the mTABLET operates complies with the following:

  • Proper segmentation and access control for medical devices

  • Secure and reliable wireless or wired infrastructure

  • Routine patching and monitoring of the network and access points

  • Risk assessment when modifying the network or adding new devices

Changes to the network that may impact device performance include:

  • Reconfiguration of switches, firewalls, or Wi-Fi access points

  • Network topology changes or bandwidth limitations

  • Introduction of new connected devices that may overload the infrastructure

NOTE: The mTABLET is validated by the MANUFACTURER for operation over standard networks but is not validated for all possible IT-NETWORK configurations. The final network design and integration remain under the responsibility of the healthcare organization or integrator.

Summary of Network Risks

The MESI mTABLET system depends on secure network communication for functions such as cloud synchronization, analytics, remote configuration, and integration with third-party systems. The following network-related risks have been identified during the cybersecurity threat modeling process:

Summary of Network Risks
RiskThreat CategoryPotential ImpactMitigation Type
Loss or delay of data transmissionDenial of ServiceDelayed synchronization or data upload systemsLocal caching of data, retry mechanisms, offline-first app logic
Incomplete data transfer or interrupted workflowsDenial of ServiceTemporary loss of remote features (e.g., cloud backup, PDF export)Device retains full functionality and data access offline
Unauthorized access to network endpointsSpoofing / Elevation of PrivilegePotential for data leakage or control hijackingTLS 1.2+ encryption, JWT token expiration, API key authentication
Data interception or tamperingTampering / Information DisclosureCompromised data integrity during transmissionHTTPS for all traffic, hashing, replay protection, CSRF mitigation
Audit trail or log integrity compromiseRepudiationDifficulty tracking incidents or user actionsLogging with timestamped source validation, Sentry monitoring
Weak authentication or impersonationSpoofing / Information DisclosureBypass of security controls or unauthorized accessStrong credential handling, 2FA, certificate pinning, no USB debug
Analytics or error reporting unavailabilityDenial of ServiceTemporary loss of insights or usage dataDoes not affect patient care; app continues operating normally

NOTE: Even in the case of full IT-NETWORK failure, the MESI mTABLET remains operational in standalone mode. All locally stored patient data and test results remain accessible directly on the device, ensuring uninterrupted use at the point of care.

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