Frontiermedical Toto Manual De Instrucciones página 14

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.
Toto® Touch complies with the following EU Directives and Harmonised Standards:
Directive
MDR 2017/745
Restriction of the use of
certain hazardous substances
(RoHS) Directive. 2011/65/EU
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 Technical Specifications
Power input - UK & EU
Fuse rating
Compressor
Air distributor
Control system
Power consumption
Cycle control
Cycle time
Pressure setting
Piping output
Platform and Air Cell Material
Max. load on platform
PU Cover Material
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
Harmonised Standard
EN 60601-1:2006/A1:2013
(Electrical Safety)
EN 60601-1-2:2007/
AC:2010 (EMC)
EN 50581:2012
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)
Distributor valve supplying air to the inflatable cells
Adjustable 30 > 240 minutes
140mmHg to 160mmHg
2
Nylon and thermoplastic polyurethane (TPU)
250Kg
Polyurethane transfer coating on weft knitted polyester fabric
Temperature range: 10ºC to 40ºC
Relative humidity range: 30% to 70%
Atmospheric pressure range: 70kPa to 106kPa
Temperature range: -10ºC to 60ºC
Relative humidity range: 10% to 70%
Atmospheric pressure range: 70kPa to 106kPa
Class II equipment - Type B applied part - IP21
14
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