Further Information; Technical Specification - Frontiermedical toto 4100000 Guia Del Usuario

Compliance
The Toto System conforms to MDD 93/42/EEC and MDR 2017/745 and the following standards:
BS EN ISO 9001:2015 Quality Management Systems. BS EN 13485:2016 Medical Devices. Quality
Management Systems. Requirements for Regulatory Purposes. BS EN 14971:2019 Medical Devices.
Application of Risk Management to Medical Devices. BS EN ISO 15223-1:2021 Medical Devices.
Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied. General
Requirements. BS EN ISO 10993-5:2009 Biological Evaluation of Medical Devices. Tests for In Vitro
Cytotoxicity. BS EN 10993-10:2013 Biological Evaluation of Medical Devices. Tests for Irritation and
Skin Sensitization.
The control unit is tested to EU Directive 2014/30/EU and BS EN 62353:2014 Medical Electrical
Equipment – Recurrent Test and Test After Repair of Medical Electrical Equipment.
Manufactured to comply with EN 60601-1 (Safety) and EN 60601-1-2 (EMC);
IEC/EN 60601-1; IEC /EN 60601-1-11; IEC/EN 60601-1-8.
Restriction of the use of certain hazardous substances (RoHS) Directive. 2011/65/EU.
Toto DOES NOT incorporate as an integral part. A substance, which used separately may be
considered to be a medicinal product as defined by European Communities medicinal products
Directive (Directive 2001/83/EC, as amended) and Human Medicines Regulation 2012 (SI 2012/1916).
Toto DOES NOT incorporate as an integral part any substance or human blood derivative as defined
in point 10 of article 1 European Communities medicinal products Directive (Directive 2001/83/EC, as
amended), nor is it manufactured utilising tissues of animal origin as defined by the same directive.
No modification of this equipment is allowed.
Complaints and Adverse Events Reporting
Any healthcare professional (e.g., customer or user of this system of products) who has any complaints
or who have experienced any dissatisfaction in the product quality, identity, durability, reliability,
safety, effectiveness, and performance should notify the distributor or Frontier Therapeutics Limited.
If any Frontier Therapeutics Limited product ever malfunctions and is suspected to have caused
or contributed to the death or severe injury of a patient, Frontier Therapeutics, your physician,
distributor and your local competent authority should be notified immediately. When filing a
complaint, provide the component(s) name and number, lot number(s), your name and address, the
nature of the complaint, and notification of whether or not a written report from the distributor is
requested.

Further Information

If further information is needed or required, contact Frontier Therapeutics Limited on
Tel: +44 (0) 330 460 6030 or visit our website www.frontier-group.co.uk.

Technical Specification

Toto Touch complies with the following EU Directives and Harmonised Standards:
Directive
MDD 93/42/EEC
MDR 2017/745
Restriction of the
use of certain
hazardous
substances (RoHS)
Directive. 2011/65/
EU
Harmonised Standard
EN 60601-1:2006/A1:2013
(Electrical Safety)
EN 60601-1-2:2007/AC:2010 (EMC)
EN 50581:2012
Referenced EMC Emission Standards
EN 55011:2009/A1:2010 Class B (RF)
EN 61000-3-2:2014 (Harmonics)
EN 61000-3-3-2013 (Flicker)
N/A
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