Nexleaf ColdTrace

Target SDGs

Market Suggested Retail Price

$77.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

Ministries of Health, local organizations, NGOs and development agencies

Competitive Landscape

Direct competitors include Coolar, 3rd Stone Design Stone Cold Solar, Sure Chill Vaccine Refrigerator BLF100 DC, Vaccine Refrigerator BFRV55, and Arktek Passive Vaccine Storage Device.

Manufacturing/Building Method

Manufactured in India^{Interview with company representative}

Intellectural Property Type

Select Type

User Provision Model

Distributed through National Health Systems, local organizations, NGOs and development agencies

Distributions to Date Status

14,204 devices across 10 countries, including:

29 health facilities in Mozambique
50 clinics in Kenya and 10 in Ethiopia
13,000 devices in India
Introduced in Tanzania for national scale

Design Specifications

• Product type: Remote Temperature Monitoring System
• Display medium: LCD, Computer, Phone, Tablet
• Mode of operation: Electronic
• Minimum temperature: -30ºC
• Maximum temperature: +55ºC
• Main material: Polycarbonate and ABS
• Dimensions: 140 mm x 150 mm x 30 mm
• Accuracy: 0.5ºC
• Min logging interval: 1 minute
• Power source: Rechargeable and Replaceable battery
• Alarm type: Acoustic
• Battery type: Li-ion
• User interface: Web Based
• Battery shelf life: 2
• Programmability: Remotely programmable
• Memory capacity: 5 years

ColdTrace transmits data and provides real-time temperature alerts through audio alarm, SMS (text message), and email.

Its technical features include dual SIM capacity, battery, external antenna and data upload through GPRS and SMS.

Customer supplies SIM cards and SMS gateway services. Other components and services are available for an additional fee, including additional sensor cables (CT5 has 5 ports), solar installation kit, data analytics tools, language customization, and data integration with existing systems (e.g. LMIS). Price per unit cost can be paid all at once rather than yearly payments.

Product Schematics

Technical Support

Trained local ColdTrace technicians

Nexleaf provides remote and in-person technical support in addition to warranty services for replacement components. When organizations implement projects with the device, Nexleaf provides customer service and training on the device, dashboard use, and troubleshooting.^{Interview with company representative}

Replacement Components

Replacement components such as batteries and sensors are provided to customers upon request.^{Interview with company representative}

Lifecycle

The expected lifetime of the device is 5 years. The estimated lifetime of the replaceable battery is 2 years. They offer a 3-year warranty on the device (excluding accessories).^{Interview with company representative}

Manufacturer Specified Performance Parameters

Real-time temperature data provided by ColdTrace can be used to:

• Identify chronically failing fridges
• Remotely diagnose certain common causes of fridge failure using temperature data signatures
• Fix fridges remotely with a simple phone call to the health facility
• Verify fixes conducted remotely or in person by following temperature data closely after a fridge repair

Vetted Performance Status

Results of an RCT analysis using RTM monitoring, 30DTR and stem thermometers: RTM monitoring (ColdTrace) achieved the highest total uptime. RTM monitoring also had the shortest facility average for total time spent in ColdTrace cold alert and WHO freeze alarm states. Group 1 also spent the lowest percent of total time in WHO freeze alarm state: 0.55% versus 1.9% for 30DTR and 2.3% for stem thermometers.⁴

Safety

ColdTrace received Performance, Quality and Safety certification on July 20th, 2016 from the World Health Organization (WHO) and is now listed in the WHO’s PQS Catalogue as number E006/039.

Complementary Technical Systems

Dashboard features include equipment performance and power availability summary reports on any device. Alerts for each sensor can be configured remotely, allowing one ColdTrace5 unit to monitor up to 5 CCE per site.  Multiple users can access the dashboard without any software installation.

Academic Research and References

Compliance with regulations

ColdTrace received Performance, Quality and Safety certification on July 20th, 2016 from the World Health Organization (WHO) and is now listed in the WHO’s PQS Catalogue as number E006/039.

ISO 9001:2008

The device has also undergone calibration and accuracy testing in an ISO/IEC 17025:2005 accredited laboratory and is CE marked.^{Interview with company representative}

Evaluation methods

Randomized Control Trials to evaluate uptime, which is the time spent between 2° C and 8° C

Other Information

Nexleaf Analytics: RTM Increases Uptime and Decreases Freezing Duration in Vaccine Refrigerators: A Randomized Control Trial Analysis.

Nexleaf Analytics (2017): ColdTrace: Real-time data for Immunization and Beyond.

Nexleaf Analytics (2015): ColdTrace Year One: Feedback from the Field.

Sheets M. (2014): Vaccine Refrigeration & Thermal Stability. Topics in Bioengineering