SENS001B01
Introducing the TempTale® Ultra Probeless Dry Ice monitor—a compact USB temperature datalogger that
can be placed directly into dry ice environments as low as -95ºC.
This new datalogger can be programmed with up to six temperature alarms, including MKT and
duration. The integrated USB connector provides fast and easy download of data, and automatically
generates a secure PDF report and encrypted data file when connected to a USB port on a PC. These
files can be subsequently downloaded, viewed and archived in Sensitech’s TempTale Manager® Desktop
(TTMD) software or ColdStream® Cold Chain Manager private cloud database application—built to
comply with FDA 21 CFR Part 11 and EC Annex 11. Furthermore, the TempTale Ultra Probeless Dry Ice
monitor meets IATA’s 2018 Dangerous Goods Regulations 59th Edition and thus requires no additional
shipment labeling.
TempTale® Ultra Probeless Dry Ice Features
• Monitor temperatures as low as -95°C
• Place directly into dry ice environment in contact with product
• 3-Point NIST traceable calibration certificate accessible in TTMD or ColdStream software
• Large LCD screen provides clear indication of alarm status and trip statistics
• Program up to six alarms, including MKT and Trip Duration
• Flashing LEDs clearly indicate Start/Stop modes and Alarm status inside and outside of dry ice
environments
• Download directly to PC via integrated USB connector
• Configurable PDF options such as, time zone, language and PDF/A file format
• Add shipment information prior to shipping to display on PDF report and in software when monitor
is downloaded
• Write-protected flash drive for virus protection
TempTale Manager® Desktop Software
TempTale Manager® Desktop (TTMD) is a robust, multi-lingual, Windows-based software application
used for configuring, downloading and archiving time and temperature data collected from TempTale
temperature monitors. The power of TTMD software lies in its intuitive user interface that allows
users
to effortlessly analyze trip data in order to make high-quality shipment disposition decisions, and
ensure that Standard Operating Procedures (SOPs) are delivering acceptable results.
Sample running display Current temperature reading, no alarm
Sample stopped display Alarmed, total time above high limit
ColdStream® Cold Chain Manager Software
ColdStream® Cold Chain Manager (CCM) is a validated, hosted and secure relational database
application that is easily accessible via the Internet for query, reporting and analysis of stored
data. ColdStream CCM provides centralized storage for time and temperature records in a secure, 21
CFR Part 11 compliant repository. The hosted database application enables robust cold chain data
analysis, reporting, and opportunities for process improvement.
TempTale® Ultra Probeless Dry Ice Specifications
Monitoring Recording Options Single Use, Single Use with User Programmable Overwrite
Operating Range -95°C to +30°C (-139°F to +86°F)
Measurement Range -90°C to +30°C (-130°F to +86°F)
Temperature Accuracy Range ±1.0°C from -90°C to +30°C (±1.8°F from -130°F to +86°F)
Temperature Resolution 0.1°C over full temperature measurement range
Data Storage Capacity 16,000 data points (16K)
Operating Life / Battery Type • 30 days of continuous exposure to dry ice temperatures at or
below -80°C
• Two (2) TL-2450 3.6v coin cell lithium batteries—non-replaceable
Data Sampling Interval Programmable from 30 seconds up to a maximum of 15 minutes in 30
second increments
Start Up Delay 0 minutes to 24 hours in 30 second increments
Programmable Alarms • Programmable high and low limits ? alarm is triggered when temperature
exceeds set limits
• Up to six alarms (single temperature limit, temperature range, dual temperature range, MKT,
duration)
Alarm Delay Time Thresholds Single event (continuous), cumulative
LCD Indicators • Started, start-up delay, running, stopped
• Alarm status: OK (✔), Alarmed (?)
• Trip summary data (average, minimum, maximum)
• Current temperature reading
• Time remaining / time elapsed against alarm thresholds
• Total Time Above High/Low Alarm limits
LED Indicators • Blinking Startup LED
• Blinking Stop LED
• File generation in process
• Printer-ready mode activated for printing of PDF report to USB printer
Start Up Options Manual push button or automatic launch option
Typical Dimensions 108mm L x 50.2mm W x 15.2mm H
Weight Approximately 65 g (2.3 oz)
PDF Languages English, German, French, Spanish, Chinese
PDF File Formats PDF or PDF/A
IP Rating IP64 (with silicon cap on)
Time Accuracy ± 5 minutes per month when exposed to temperatures at or above -90°C
Quality Assurance Certifications • CE, RTCA – D016ØG compliant, RoHS compliant,
Response time tested to U.S. Pharmacopeia (USP) <1118> and EN 12830 standards
• 3-point NIST® Traceable Certificate of Calibration
• Validation Manual
Data Analysis Software TempTale® Manager Desktop Software 8.3 or higher ColdStream® Cold
Chain Manager Software 1.8B or higher
Minimum System Requirements Windows PC w/ Windows 7 or higher; Adobe Reader 9.0 or higher
Computer Interface USB 2.0, A-type plug
Ship Air in Accordance With 2018 IATA Dangerous Goods Regulations 59th Edition

