BP800 - Leaflets - Troubleshooting
Question & Answer - English
| Question | Answer |
| What is the typical lead time to register your products in a new market/country? | 3-6 Month on average; is country dependent though. |
| Which country regulatory labels(e.g., CE, FDA, etc.) have your Connected Care Devices passed? | CE. Registrations are done by the manufacturers themselves. |
| What is the medical device class (per country) | EU BP800: 93/42/EEC (MDD) - IIA, 98/79/EC (IVDD) - IIB BG800: 98/79/EC (IVDD) - IIB |
| Please outline the product and IT service model (as well as service engineer coverage/per country) | We currently have no SE in country. We focus on the development of the solution and partner with healthcare-IT players in countries, whom we support to service their customers with PGHD/IoT data feed. |
| Describe clinical fields / use cases where Connected Care Devices are applicable | 3 major use cases: - hospital or clinic discharge - clinical trials or digital therapeutic solution (pharma) - long-term chronic conditions (primary care or telemedicine) |
| Please briefly describe technical set-up per device | Our devices are home use devices (operated by the patient on his own). All devices are connected via 3G. For the setup of the connection, no special configuration is required apart from the mapping of the patient to a particular device that happens in a caregiver-system . The latter is done either in our SaaS platform by the caregiver or in a 3rd party healthcare system. |
| Please indicate how to assign a patient dynamically to a device (via Barcode-Scanner, NFC, Multiple-Assignment Patient - Device, manual choice via UI, etc.) | Manually or via Barcode-Scanner, no multiple assignments are supported |
| How is the connection chain to eHealth Solutions and which connection standards are supported (GSM, WLAN, Bluetooth Continua, HL7 FHIR, https, etc.)? | The connection to eHealth Solutions happens via GSM (3G) and https. We do not support WLAN or Bluetooth: we simplify the patient experience with an autonomous device w/ a SIM in it. Support of Continua, HL7 and FHIR are WIP in R&D. To be discussed specifically. |
| Please describe how the authentification of the Device towards eHealth Solutions is performed? | The authentification of the device is performed based on SIM card as well as specific device identifiers |
| Are the devices powered by battery/wall power? | some battery only, some both (e.g. rechargeable battery) |
| In case of battery powered devices: how long is the estmated battery life time? Who would replace the battery if needed? | >=250 measurements; battery is replaced or charged by the user (patient) |
| Which languages are supported with Connected Care Devices (user interface, manual, documentation)? | English / German / French / Italian Other are possible. |
| What is the difference between the BC800 3G Version 1 and Version 2. | The V2 can do the following things: -The voltage is shown on the ELIOT Manage platform. As well as the quality of the 3G signal. -You can schedule a sync call, where the device periodically goes online and sends a message, if the device hasn’t been used after a certain amount of time. -The bug, where the device hasn’t transmitted measurement, when the batteries where low, has been fixed. |
| Where can you find the IMEI number? | The IMEI is only printed on back of the device and has 15 digits. The IMEI is not identical as the Serial Number, which can be found on the device and its packaging. |
How to setup a sync ping
You can setup a recurrent event where the device will come online "on it's own" and sends the following informations:
- Latest measurements (if any)
- Battery strength
- Signal strength
Prerequisites: BC800 V2
HowTo:
Open the Eliot Device Manager
The following example sets a daily interval. If there is no connection it retries 3 times.
NOTE: The sync call only gets active after the next successfull measurement !
This function shortens the battery power of the device.