ELPRO LIBERO ITS User manual

Operations Manual LIBERO ITS | Profile A003 Version 3 | May 2019 LIBERO ITS | Page 1 / 4
Operations Manual
LIBERO ITS
Profile A003
CONTACT
ELPRO-BUCHS AG Tel. [phone]
Langaeulistrasse 45 [email protected]
9470 Buchs SG www.elpro.com
Switzerland
Note: All information in this document is correct at the time of publication. Due to continuous product
development, we reserve the right to change this information. All changes are subject to change
management according to ISO 9001:2015. Major changes in functionality and the technical specifications
are communicated and described in release notifications.

Operations Manual LIBERO ITS | Profile A003 Version 3 | May 2019 LIBERO ITS | Page 2 / 4
Safety Instructions
Battery
Button cell lithium battery:
Lithium, manganese dioxide
Non-rechargeable button cell battery contained in equipment UN3091 (IATA compliant)
No shipping declaration required (exempt from DGR declaration)
Material Safety Data Sheet is available at ELPRO on request.
Environmental Conditions
Temperature Do not expose to extreme hot temperatures outside specification (risk of gas explosion).
Microwave Do not expose to microwave radiation (risk of battery explosion).
Shocks Avoid violent knock and blows (risk of damage to the battery / short circuit).
Water / Humidity Ensure controlled non-condensing environment (risk of short circuit since LIBERO ITS has
no protection against ingress of water).
IR radiation Avoid exposure to IR radiation (heat and superheated steam can result in deformation of
the case).
X-ray Avoid long-term exposure to X-ray (risk of harm to LIBERO ITS). Tests of short x-ray
exposures as part of transportation processes (airports, customs) have been performed
and documented (available at ELPRO).
Intended Use
All electrical devices produced by ELPRO-BUCHS AG are for commercial use LIBERO ITS are for commercial use
(“business to business”) exclusively.
Disposal
Do not throw LIBERO ITS into fire, the battery could explode.
This product has to be disposed of according to WEEE (Waste Electrical and Electronic Equipment, 2012/19/EU) or
according to the local regulations. The device may be returned at own cost to any ELPRO subsidiary for proper
recycling.
Applicable Documents
The actual Technical Specifications for LIBERO ITS can be retrieved from www.elpro.com

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

Operations Manual LIBERO ITS | Profile A003 Version 3 | May 2019 LIBERO ITS | Page 4 / 4
Specification
Technical Specification (in detail can be retrieved from http://www.elpro.com/liberoits)
Operating range -30 °C..+70 °C
Measurement accuracy ±0.4 °C typ.
Measurement interval 1 minute
Battery life runs for up to 5 years
Programmable alarms 6 temperature alarm levels with alarm delay options (single or cumulative)
Expiry date (start before) 24 months from production
Configuration Profile ID A003 –No Freeze
The Configuration Profile can be identified via the first four characters of the Device ID
=> In this example A0010000001 => Profile A001)
5 Profile Text
6 Line 1 Standard (shown on device label and Vali dation certificate)
7 Line 2 No Freeze (shown on device label and Vali dation certificate)
8 Line 3 above 0 °C (shown on device label and Vali dation certificate)
9 Line 4 10min sin. (shown on device label and Vali dation certificate)
10 Button instruction line 1
Press for status (shown on device label; depending on LED-option)
11 Button instruction line 2
Hold 3 seconds (shown on device label; depending on Stop-option)
12 Button instruction line 3
to read-out (shown on device label; depending on Stop-option)
13
14 Start Delay (0 minutes to 45 days) 30
15
Alarm Conditions Zone Event Mode
in °C time
minutes
hours
days
single or
cumulative
0 minutes cumulative
10 minutes single
0 minutes cumulative
22
23
24
25
26
27 Box label Line 1 (included in data matrix on box, and visible on box)
28 Box label Line 2 (included in data matrix on box, and visible on box)
29 Box label Line 3 (included in data matrix on box, and visible on box)
Stop-options
never stop statistics
Note: Option "stop statistics all owed" does not allow download duri ng transit
Logistics
Standard
above 0 °C (10min)
Device Options
LED-Blinking
blink status on request
Note: Option "always blink alarm status" reduces battery life
Download options
read-out possible
20
Lower Zone
L1
n/a
21
Ultimate lower limit
L2
Good-Zone
G
No Alarm
0.0
16
Ultimate upper limit
H3
n/a
17
High-Zone 2
H2
n/a
18
High-Zone 1
H1
n/a
19
Temperature
Allowed Time
Logging
minutes