| Recording Options | Single Use, Single-Use with User Programmable Overwrite, or Multiple Use |
| Temperature Measurement Range | -30°C to +70°C |
| Temperature Accuracy Range |
- ±0.5°C from -10°C to +45°C (±0.9°F from +14°F to +113°F)
- ±1.0°C from -30°C to -10°C (±1.8°F from -22°F to +14°F)
- ±1.0°C from +45°C to +70°C (±1.8°F from +113°F to +158°F)
|
| Temperature Resolution | 0.1°C / °F over full temperature measurement range |
| Memory Storage Capacity | 16,000 data points |
| Battery Life / Type | 12 month operating life / CR2450 3.0v lithium coin cell battery – non-replaceable |
| Data Sampling Interval | Programmable from 1 minute up to a maximum of 30 minutes |
| Environmental Protection | IP64 (with protective cap over USB connector) |
| Start Up Delay | 0 minutes to 24 hours |
| Programmable Alarm Types | High and low limits / Six alarm types including MKT and duration; Single event (continuous) or cumulative |
| LCD Display |
- OK (✓), Alarmed (✗) status;
- Running, Start-up delay, Stopped status;
- Trip summary statistics (average, minimum, maximum);
- Current temperature reading;
- Marked event
|
| Start Up and Stop Options | Button Press or using TempTale® App: immediate or delayed start (start-up delay duration set by Quality) |
| Connection | Bluetooth® Low Energy / USB 2.0 |
| Automatic Data File | Encrypted PDF report (export via the mobile app or with the USB interface without any additional software requirement) |
| Software |
- ColdStream® Select Software 2.2 or higher (ColdStream Select is built to comply with FDA 21 CFR Part 11,EC Annex 11 and cGxP);
- TempTale Manager® Desktop Software 9.0 or higher
|
| Supported Mobile App | TempTale® Mobile App (iPhone 7 or newer running iOS 11 or higher, Android 7.1 or higher, Bluetooth 4.2-5.1)
|
| Calibration | 3-point NIST® traceable Certificate of Calibration onboard each monitor |
| Quality Assurance Certifications | CE, UKCA, MIC, FCC, RTCA-D016ØG, WEEE, RoHS, Response time tested to U.S. Pharmacopeia (USP) <1118> and EN/12830 standards
|
| Dimensions | 108 mm L x 53 mm W x 7 mm H (4.3 in L x 2.1 in W x .28 in H) |
| Weight | 40 g (1.4 oz) |
| BLE Gateway Temperature | -20°C to +55°C (use gateway inside a cold room with cellular connectivity) |
| BLE Gateway Internet access | Cellular (CAT-M1 for 4G/5G networks, and 2G) |
| BLE Gateway Read Range | Approx. 20 – 30 meters (65 – 100 feet) (clear line of sight) |
| BLE Gateway Storage Capacity | Can queue up to 50 BLE monitor encrypted records |
