Operations Manual LIBERO ITS | Profile A003 Version 3 | May 2019 LIBERO ITS | Page 3 / 4
Description
LIBERO ITS is a device for continuously monitoring temperature and calculating remaining stability budget of
pharmaceutical products or clinical studies along the entire supply chain. LIBERO ITS is thin and small enough to go
on clinical kits and sales units and durable enough to stay on the pharmaceuticals during the entire shelf life of up
to 5 years. LIBERO ITS manages deviations up to 6 alarm zones. The alarm status is always visible and can be
extracted by a smartphone app. LIBERO ITS is compatible with ELPRO’s cold chain database liberoMANAGER.
IMPORTANT: LIBERO ITS monitors temperature exposure and not the product quality. Its purpose is to indicate if
product quality evaluation/testing is required. LIBERO ITS shall only be applied on outer packaging –
avoid usage on pharmaceutical primary packaging (such as blood bags or plastic vials).
Instructions
Storage
Store LIBERO ITS in a controlled environment and activate it prior to the “Start before” date.
Check Configuration Profile and press button before usage for 1 second
=> LED blinks orange (2x ●●): Indicator is ready for use
If LED blinks orange (1x ●; idle) or LED does not blink (○; expiry date or lifetime exceeded): do not use indicator
Indicator usage
1) Break tab to start the LIBERO ITS and enclose it with the product
=> Green LED indicates start (3x3 times blinking ●●●○●●●○●●●)
Alarm activation delay may be indicated by green LED (●●● 3 times blinking every 30 seconds)
2) During temperature monitoring, alarm status can be detected by pressing button for 1 second
=> Green LED (1x ●) indicates OK status
=> Red LED (1x ●) indicates ALARM status (irreversible)
ELPRO recommends to the customer to check the alarm status on a regular basis
A stopped indicator shows additionally an orange LED (1x ●●- OK status / 1x ●●- ALARM status)
3) If configured, stop indicator by pressing button for 3 seconds
=> Green & Orange LED (3 times blinking ●●○●●○●●) indicates stop - OK status
=> Red & Orange LED (3 times blinking ●●○●●○●●) indicates stop - OK status
Smartphone app for read-out
1) Download and install smartphone app “LIBERO ITS”
=> Available for iOS (App Store) or Android (Google Play Store) operating systems
2) Start smartphone app and follow instructions
=> Press button on LIBERO ITS for 3 seconds to transfer alarm statistics (LED flickering ●●●)
Use indoor (<800 lux) and avoid backlighting or direct sunlight on the LIBERO ITS
Keep the smartphone stable and avoid trembling
If web communication is filtered by a firewall, ensure that ports 50002 / 4003 are open and the domain
“elpro.com” can be reached
3) Add relevant product information and proceed
=> Upload and archive record in liberoMANAGER database
=> Create and send PDF report
ELPRO recommends to upload and archive every report in liberoMANAGER database
