Therefore, in order that the requirements of the FAA (AC91.21-1A) and the
CAA (AIL0176 and AWN 12 appendix 39) can be met by operators using
Tempus 2000 on their aircraft, RDT has:
- Tested Tempus 2000 to ensure that it complies with all the relevant sections of
RTCA DO-160 E as well as those for electromagnetic compatibility (EMC)
- Designed a proprietary lithium-ion battery that is certified to the most rigorous standard for the use of lithium batteries for aviation applications (BS 2G 239)
- Documented all the information relevant to the design, construction and testing of Tempus 2000 and its battery in a Declaration of Design and Performance (DDP). The DDP is provided to client's technical representatives to enable them to easily ensure the aircraft carrying Tempus 2000 continues to meet its operational regulations
Delivery Documentation
Tempus 2000 is provided with a Certificate of Conformity which declares
that Tempus 2000 conforms to the specifications laid down in an associated DDP.
The DDP is provided to the client's relevant technical/engineering contact.
US Regulatory Compliance
RDT's products have been cleared to market (510k) in the USA by the FDA.
In addition, RDT's manufacturing facility complies with the cGMP requirements
of US 21 CFR Part 820.
European Regulatory Compliance
Tempus 2000 is CE marked under the European Medical Devices Directive
(MDD - Directive 93/42/EEC).
RDT and its products have been independently certified to meet the requirements of the
Directive under Annex II - Full Quality Assurance. Consequently, RDT's design and
manufacturing facility is certified under the internationally recognised quality assurance
standards ISO9001:2000 and ISO 13485:2003.
Safety
RDT's products are certified to the relevant international safety standards such as IEC60601-1 for the General Requirements for Safety of Medical Electrical Equipment, IEC60601-1-1 for
the Requirements for Medical Electrical Systems - Medical Electrical Equipment, IEC60950
for the Safety of Informational Technology Equipment.
EMC
RDT's products are certified to the relevant international standards for general
electromagnetic compatibility (EMC) such as IEC60601-1-2:2001 for the EMC requirements for
Electromedical Equipment, CISPR 11 and the US 47 CFR Part 15 (FCC).
Environmental
In addition to meeting the rigorous testing requirements for use in an aircraft cabin, Tempus 2000 also meets the water ingress test of IEC529 IPX1 (rainfall).
Communications
- Satellite - There are no specific regulatory or conformance requirements for products using satcoms networks. However, please note that Tempus 2000 has been designed to transmit voice and data communications using all types of satellite channels.
- GSM/WiFi - The GSM and WiFi interfaces used in Tempus 2000 are certified for compliance with the requirements of all major market places e.g. the US FCC (US 47 CFR Parts 15C and 24) and the EU RTTE Directive. The interfaces also meet the following standards:
GSM - 3GPP TS 51.010-1, ETSI EN 301 489-1, ETSI EN 301 489-7, ETSI EN 301 511.
WiFi - ANSI C63.4:2001, ETSI EN 300 328, ETSI EN 301 489-1 and ETSI EN 301 489-17.
Data Security
RDT's products comply with the requirements of the US Health Insurance and
Portability Act (HIPAA) and include proprietary hardware-based encryption technology in
addition to the 128bit software-based security encryption required by the US Centres for
Medicare and Medicaid Services.
Furthermore at all stages where patient data is handled i.e. from collection and
transmission through to display, storage and retransmission to the client's own physician
over the web, RDT's technology ensures issues of access, authenticity and security
are never compromised.
In addition, RDT's products meet the requirements of the UK Data Protections Act.
Regulatory Requirements in Other Areas
Please note that RDT's manufacturing quality systems registration (detailed above) combined with the standards that Tempus 2000 is certified to, enable RDT to quickly and easily register Tempus 2000 for sale in other countries and regions.
Deliveries to clients in states outside North America and Europe for example: Australia,
New Zealand, the countries of the Gulf Region, Japan and other Far Eastern states and Canada, can be made within the standard delivery time for the device.
