DOC-1138 Declaration of Conformity Radio Equipment Compliance

Product catalog summary

Manufacturer Information:
RRR Manufacturing Pty Ltd, located at 2-6 Skinner Avenue, Riverwood, NSW 2210, Australia, is responsible for the product CellAED®, an Automated External Defibrillator.

Part 1: European Commission Compliance
The product complies with the Radio Equipment Directive (RED) 2014/53/EU. The European representative is mdi Europa GmbH in Germany. The product is classified as Equipment Class 1 and applies to all batches. The software version is CellAED® 2.2, version 1.3.X. The battery model is CP651848 with Li-MnO2 features, nominal voltage of 12V, and a rated capacity of 1200 mAh. The wireless module is a SARA-U201 GSM/UMTS transceiver, certified under ATCB023842 issue 7.
Standards Applied:

Article 3.1(a): EN 50566:2017, IEC 60601-1:2014, EN 62209-2:2010, EN 62311:2008, EN 62368-1:2014
Article 3.1(b): EN 60601-1-2:2015, EN 301 489-1: v2.2.3 (2019-11), EN 301 489-52: v1.1.0 (2016-11)
Article 3.2: EN 301 511: v12.5.1 (2017-03), EN 301 908-1: v11.1.1 (2016-07) & v13.1.1 (2019-11), EN 301 908-2: v11.1.2 (2017-08)

Part 2: United Kingdom Compliance
The product complies with the UK Radio Equipment Regulations 2017. The UK responsible person is Psephos Limited, located in Brighton, East Sussex, United Kingdom. The classification and scope application are the same as for the European Commission.
Standards Applied:

Article 6-(1) (a): EN 50566:2017, IEC 60601-1:2014, EN 62209-2:2010, EN 62311:2008, EN 62368-1:2014
Article 6-(1) (b): EN 60601-1-2:2015, EN 301 489-1: v2.2.3 (2019-11), EN 301 489-52: v1.1.0 (2016-11)
Article 6-(2): EN 301 511: v12.5.1 (2017-03), EN 301 908-1: v11.1.1 (2016-07) & v13.1.1 (2019-11), EN 301 908-2: v11.1.2 (2017-08)

The declaration is signed on behalf of RRR Manufacturing Pty Ltd by the Chief Compliance Officer, who is responsible for the issuance and maintenance of this Declaration of Conformity.

Catalog excerpts

DOC-1138 Declaration of Conformity Radio Equipment Compliance-1

DOC-1138 Declaration of Conformity Radio Equipment Compliance RRR Manufacturing Pty Ltd 2-6 Skinner Avenue Riverwood, NSW 2210 Australia

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DOC-1138 Declaration of Conformity Radio Equipment Compliance-2

DOC-1138 Declaration of Conformity Radio Equipment Compliance All supporting documentation is retained under the premises of the manufacturer.

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DOC-1138 Declaration of Conformity Radio Equipment Compliance-3

DOC-1138 Declaration of Conformity Radio Equipment Compliance Part 1 European Commission: The object is in conformity with the relevant statutory requirements: Radio Equipment Directive (RED) 2014/53/EU

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DOC-1138 Declaration of Conformity Radio Equipment Compliance-4

DOC-1138 Declaration of Conformity Radio Equipment Compliance Part 2 United Kingdom: The object is in conformity with the relevant statutory requirements: UK Radio Equipment Regulations 2017

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DOC-1138 Declaration of Conformity Radio Equipment Compliance-5

DOC-1138 Declaration of Conformity Radio Equipment Compliance Signed for on behalf of RRR Manufacturing Pty Ltd who are responsible for the issuance, maintenance, extension, suspension or withdrawal of this Declaration of Conformity. /rl— Chief Compliance Officer /-/2. - 2- 0 2.2— Date

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