Technical Specification - Frontiermedical toto Mode D'emploi

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 14971:2012 Medical Devices.
Application of Risk Management to Medical Devices. BS EN ISO 15223-1:2016 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.
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 Ltd.
If any Frontier Therapeutics Ltd. product ever malfunctions and may have caused or contributed
to the death or severe injury of a patient, Frontier Therapeutics Ltd. and your local competent
authority should be notified immediately by telephone, fax or written correspondence. 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 Ltd. 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 Harmonised Standard
MDD 93/42/EEC and MDR 2017/745 EN 60601-1:2006/A1:2013 (Electrical
Safety)
EN 60601-1-2:2007/AC:2010 (EMC)
Restriction of the use of certain EN 50581:2012
hazardous substances (RoHS)
Directive. 2011/65/EU
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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Toto Touch Technical Specifications
Power input - UK & EU
Fuse rating
Compressor
Air distributor
Control system
Power consumption
Operation mode
Cycle control
Cycle time
Pressure setting
Piping output
Max. load on platform
Operating environment
Storage/Transportation
Classification IEC60601-1
References
1. Boyko TV, Longaker MT, Yang GP. Review of the current management of pressure ulcers. Adv Wound Care 2018;7:57–67.
2. de Oliveira KF, Nascimento KG, Nicolussi AC, Chavaglia SRR, de Araujo CA, Barbosa MH. Support surfaces in the prevention of pressure ulcers
in surgical patients: an integrative review. Int J Nurs Pract 2017;23.
3. Rae KE, Isbel S, Upton D. Support surfaces for the treatment and prevention of pressure ulcers: a systematic literature review. J Wound Care
2018;27:467–74.
4. Defloor T, De Bacquer D, Grypdonck MHF. The effect of various combinations of turning and pressure reducing devices on the incidence of
pressure ulcers. Int J Nurs Stud, 2005; 42(1):37-46
5. European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and
Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline. Emily Haesler (ed). EPUAP/NPIAP/PPPIA: 2019.
Guideline 5.2 Repositioning Frequency
6. European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and
Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline. Emily Haesler (ed). EPUAP/NPIAP/PPPIA: 2019.
Guideline 5.8 Repositioning Individuals in Bed
AC 220-240VAC 50Hz, 0.2A
T1AL250V
SAA-1
Timing motor working as a rotary valve
Digital control system
14 Watt (typical) / 20 Watt (maximum)
Non-continuous
Distributor valve supplying air to the inflatable cells
Adjustable 30 > 240 minutes
Minimum 140mmHg
2
250Kg
Temperature range: 10ºC to 40ºC
Relative humidity range: 30% to 70%
Atmospheric pressure range: 700hPa to 1060hPa
Temperature range: -10ºC to 60ºC
Relative humidity range: 10% to 70%
Atmospheric pressure range: 700hPa to 1060hPa
Class II equipment
Type B applied part
IP21
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