IQ Messenger Medical

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Critical warnings

37 warnings recorded — scroll inside the panel to see all entries.

CW999
A warning is an alert to potential hazard which could result in serious product damage if proper procedures are not followed.
CW999
Make sure that only authorized personnel use the device.
CW999
Intended users are (Healthcare) professionals and must have sufficient knowledge of English to, understand the instructions for use and to, use the device as it is intended.
CW999
The scope of the CE marking applies to the IQ Messenger Medical applications and software modules defined in the section Compatibel medical interface and interfaces
CW999
Intended users are (healthcare) professionals and must have sufficient knowledge of English to, understand the instructions for use and to, use the device as it is intended.
CW999
Unless all risk control options applied to IQ Messenger Medical, incorporation of IQ Messenger Medical in the medical IT-network will introduce risk that alarm events of medical source devices are not communicated to the user. To minimize this residual risk further, the responsible organisation is strongly advised to perform life cycle risk management for the medical IT-network.
CW999
Monitoring of the IQ Messenger Medical server is required using an SNMP (Simple Network Management Protocol) monitoring solution to track and monitor critical system metrics in real-time, including application services, network bandwidth usage/latency, CPU usage, memory usage and storage utilization. This information is essential for ensuring the optimal performance and availability of the IQ Messenger Medical and diagnosing issues that may arise.
CW999
In addition, the SNMP monitoring solution must be capable of generating alerts and notifications when critical thresholds are exceeded or when system anomalies are detected, enabling IT staff to take proactive measures to prevent downtime and ensure continuous system operation.
CW999
The total average or maximum message transmission time is mainly dependent on the digital bandwidth capacity.
CW999
The IQ Messenger Medical server availability is dependent on both the network and system availability.
CW999
The IQ Messenger Medical server shall always run in High Availability.
CW999
During the cluster failover, it is not possible to process event messages.
CW999
The scope of the CE marking applies to the IQ Messenger Medical applications and to the listed software modules. The listed software modules below are supported by IQ Messenger Medical applications. If a device/version is not listed Distributors must contact the manufacturer. If a device is not listed and yet still is connected IQ Messenger Medical will not be supported.
CW999
The software installation should only be done by the manufacturer or by the Distributor. In some occasions other parties are permitted for installation of the software but only with the assistance of the manufacturer or an authorized person.
CW999
System configuration must be performed only by qualified personnel who are trained and familiar with the IQ Messenger Medical and relevant communication standards, and with local implementation of the medical device aggregator. Improper configuration of the IQ Messenger Medical can cause unexpected and unintended behavior of the system.
CW999
Proof that all preparatory actions have been performed can be found in the about screen: CE marking will be visible. Only when the CE marking is visible in the about screen the device has been configured and verified to work as intended.
CW999
Modifying, deleting or replacing any IQ Messenger Medical server files or changing any of the device settings can result in sub-optimal IQ Messenger Medical server performance, including inhibition of alarm delivery, system time settings and network connection.
CW999
The assigned user has exited the unit.
CW999
Not allowing notification type Critical Alerts for iOS devices can cause alerts without an audible signal resulting in an unnoticed or delayed alert and could result in patient injury.
CW999
The IQ Messenger Medical server is dependent upon the accuracy of your facility’s HL7 ADT solution for patient information shown and send to IQ Messenger Medical applications and or third party devices or systems.
CW999
The assigned user is logged out of, or disconnected from, the IQ Messenger Medical web-based or mobile application
CW999
A user is not assigned to receive alerts from a medical device.
CW999
IQ SmartApp Medical (Android) notify the user and the server in case of low battery on a Google Android device. Apple iOS device do not support this functionality.
CW999
Healthcare professionals must be trained on proper action instructions for alarms, and hospitals must schedule routine equipment inspection and calibration.
CW999
Do not rely solely on the IQ Messenger Medical server and connected web-based and mobile applications, third party mobile or wired devices or systems to indicate medical device alarms. Always continue to monitor at primary, the patient’s medical device and or the medical central station if applicable and respond to the patient primary medical device alarms.
CW999
The IQ Messenger Medical web-based, or mobile application is turned off, being obstructed or without a network connection.
CW999
The IQ Messenger Medical server is dependent upon the accuracy of your facility’s HL7 ADT solution for patient information shown and sends to IQ Messenger Medical applications and or third-party devices or systems.
CW999
The mobile device is turned off or the battery is depleted.
CW999
The mobile device is not receiving communications due to being obstructed or out of wireless coverage range.
CW999
The mobile device is not communicating with the IQ Messenger Medical server.
CW999
The IQ Messenger Medical server is dependent upon the accuracy of your facility’s HL7 ADT solution for patient information shown and sends to IQ Messenger Medical applications and or third-party devices or systems.
CW999
Turning down or off phone ringer/vibrate will preclude IQ Messenger Medical from effectively notifying the user of alerts.
CW999
The mobile device volume is turned down too low or turned off.
CW999
Precautions indicated in the IFU (may) include:
CW999
A caution is an alert to a potential hazard which could result in minor product issues if the proper procedures are not followed.
CW999
Resource allocation must be dedicated to the IQ Messenger Medical server.
CW999
Without the signed quality documentation the device is not fully configured. The Distributor is to provided these documents as per knowledge base article in the partner portal.

Country	On market since	Until
NetherlandsPrimary placement	Jan 29, 2020	Still on market
Belgium	Jan 29, 2020	Still on market

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