Frontiermedical toto User manual

Toto® Lateral Turning System, with Toto® Touch Control Unit
Système de latéralisation Toto® avec unité de commande tactile Toto®
Das Toto® System zur seitlichen Umlagerung mit der Toto® Touch-Steuereinheit
Toto® Lateraal kantelsysteem, met Toto® Touch-bedieningseenheid
Sistema de volteo lateral Toto®, con unidad de control Toto® Touch
Sistema per la rotazione laterale Toto®, con unità di controllo Toto® Touch
Toto® Sistem bočnega obračanja, s Toto® krmilno enoto na dotik
Toto®-systemet för lateral vändning med styrenheten Toto® Touch
Sistema de viragem lateral Toto®, com unidade de controlo tátil Toto®
Systém na laterálne otáčanie Toto® s dotykovou ovládacou jednotkou Toto® Touch
Sistem de întoarcere laterală Toto®, cu unitate de control tactilă Toto®
带 Toto® Touch 控制装置的 Toto® 侧翻系统
Toto®     Toto®    
Toto® לש עגמב הרקב תדיחי םע , Toto® לש יבחור בוביס תכרעמ
Toto® 体位変換支援システム (仰臥位から横臥位)、Toto® タッチ コント ロ ー ル 付 き
Toto® 측면 회전 시스템, Toto® 터치 제어 장치 포함
&
Instructions for Use
Version 9.0 2023
www.frontier-group.co.uk
EN
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IT
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PT
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Version 10.0 2023

2
Toto® & Toto® Cradle Symbol Definitions
Contents
UKCA Mark
CE Mark
Fragile handle
with care
Do not pierce
or cut
Maximum
user weight
Unique device
identier
Do not iron
Importer
Atmospheric
pressure limitation
Air leak
Service interval
European
authorised
representative
Manufacturer
Reference
number
Patient
information
website
Refer to
instructions
Serial
number
Ingress
protection
Medical
device
This way up
Date and
country of
manufacture
Temperature
limitation
Lot number
250
Distributor
Keep dry
Humidity
limitation
Refer to
user manual
Recyclable
Line dry
Type BF
applied part
Do not tumble dry
Caution
symbol
Class II electrical
equipment
Bleaching agent
allowes
Disposal
65ºC for 10 minutes or
73ºc for 3 minutes
65
Interface lock
Air hoses blocked
Audio pause
Toto® & Toto® Cradle Symbol Definitions..............................................................................................................4
Kit Contents ..................................................................................................................................................................5
Product Specifications ...............................................................................................................................................5
Intended Purpose........................................................................................................................................................6
Indications.....................................................................................................................................................................6
Contraindications ........................................................................................................................................................6
Warnings and Precautions ........................................................................................................................................ 7
Patient Target Group ................................................................................................................................................. 7
Intended Users ........................................................................................................................................................... 7
Platform Installation and Operating Guide ...........................................................................................................8
Alarms and Alerts...................................................................................................................................................... 10
Cardiopulmonary Resuscitation Emergency Deflation System...................................................................... 11
Inspection and Care .................................................................................................................................................. 11
Fitting and Replacing Damaged Air Cells........................................................................................................... 12
Nature and Frequency of Preventative Maintenance...................................................................................... 12
Cleaning and Disinfection....................................................................................................................................... 12
End of Life Disposal...................................................................................................................................................13
Warranty........................................................................................................................................................................13
Compliance .................................................................................................................................................................13
Technical Specification .............................................................................................................................................14
4

English
Instructions for Use
&

Toto® & Toto® Cradle Symbol Definitions
Contents
UKCA Mark
CE Mark
Fragile handle
with care
Do not pierce
or cut
Maximum
user weight
Unique device
identier
Do not iron
Importer
Atmospheric
pressure limitation
Air leak
Service interval
European
authorised
representative
Manufacturer
Reference
number
Patient
information
website
Refer to
instructions
Serial
number
Ingress
protection
Medical
device
This way up
Date and
country of
manufacture
Temperature
limitation
Lot number
250
Distributor
Keep dry
Humidity
limitation
Refer to
user manual
Recyclable
Line dry
Type BF
applied part
Do not tumble dry
Caution
symbol
Class II electrical
equipment
Bleaching agent
allowes
Disposal
65ºC for 10 minutes or
73ºc for 3 minutes
65
Interface lock
Air hoses blocked
Audio pause
Toto® & Toto® Cradle Symbol Definitions..............................................................................................................4
Kit Contents ..................................................................................................................................................................5
Product Specifications ...............................................................................................................................................5
Intended Purpose........................................................................................................................................................6
Indications.....................................................................................................................................................................6
Contraindications ........................................................................................................................................................6
Warnings and Precautions ........................................................................................................................................ 7
Patient Target Group ................................................................................................................................................. 7
Intended Users ........................................................................................................................................................... 7
Platform Installation and Operating Guide ...........................................................................................................8
Alarms and Alerts...................................................................................................................................................... 10
Cardiopulmonary Resuscitation Emergency Deflation System...................................................................... 11
Inspection and Care .................................................................................................................................................. 11
Fitting and Replacing Damaged Air Cells........................................................................................................... 12
Nature and Frequency of Preventative Maintenance...................................................................................... 12
Cleaning and Disinfection....................................................................................................................................... 12
End of Life Disposal...................................................................................................................................................13
Warranty........................................................................................................................................................................13
Compliance .................................................................................................................................................................13
Technical Specification .............................................................................................................................................14
4

This user guide contains important information on correct usage, handling, cleaning and
decontamination. Please read carefully prior to use.
Kit Contents
Before you start, please ensure that you have all the necessary components listed below. If any are absent,
or in case of doubt, please contact Frontier Therapeutics Limited Customer Services on
[phone].
Toto® Touch Control Unit
• 1x Toto® Touch control unit.
• 1x Control unit power lead.
• 1x User guide.
Product Codes Product Description
4100000 Toto Platform (UK)
4100001 Toto® Platform (International)
4100300 Toto® Platform Transport Bag
5100000 Toto® Cradle Platform (UK)
5100001 Toto® Cradle Platform (International)
5100300 Toto® Cradle Platform Transport Bag
Product Codes Product Description
4000000 Toto® Touch Control Unit
(220V)
4100200 Toto® Touch Control Unit
Transport Bag
Toto® Touch Control Unit Labelling
1. Starts, stops and pauses the control unit.
2. Air Cell side selection.
3. Air Cell inflation time.
4. Air Cell rest time.
5. Alarm mute and interface lock mode.
6. Air leak alarm.
7. Blockage alarm.
8. Service indicator.
9. Interface lock indicator.
Toto® Platform
• 1x Platform or 1x Cradle Platform
including a fitted cover.
• 1x Cardiopulmonary Resuscitation deflation
valve and tubing set.
• 1x Pair of air cells with quick connectors.
• 1x Platform or 1x Cradle Platform Transport
bag.
Product Weight - kg (lbs) Maximum User Weight - kg (lbs) Width - mm
(Inches)
Length - mm
(Inches)
Standard 6.7 (14.7) 250 (551) 745 (29) 1850 (73)
Cradle 8.0 (17.5) 250 (551) 745 (29) 1850 (73)
Toto® Platform
Product Depth (flat position - air
cells empty) mm (Inches)
Depth (raised position - air
cells inflated) mm (Inches) CPR Deflation Valve
Standard 35 (1.4) Primary: 185 (7.3)
Quick Release Pull Tag
Cradle 50 (2.0) Primary: 195 (7.7)
Cradle: 100 (4)
Product Specifications
L
R
L & R
60 min
30 min
120 min
180 min
240 min
60 min
30 min
120 min
180 min
240 min
INFLATE TIME
REST TIME
touch
5

Toto® Touch Control Unit
Specifications
Dimensions (width / depth / height) – mm (inches) 255 (10) x 120 - (5) x 220 (8.5)
Weight - kg (lbs) 2.8 (6)
Rated voltage – UK & EU 220 ~ 240VAC, 50/60Hz, 0.3A
Rated input power (VAC) 20
Protection class Class 2
Power cord length - meters (Feet) 5 (16.4)
Air output (LPM) 11
Intended Purpose
Frequent repositioning of individuals with impaired mobility and the use of an appropriate support surface
are the most significant interventions to prevent pressure damage1-3. This is achieved through individual
patient assessment and the implementation of manual turning plans.
Toto® Standard & Cradle are automated lateral turning system supporting healthcare professionals in the
regular turning of patients, who are at risk of developing pressure ulcers or injuries.
Toto® Cradle has integrated secondary air cell technology designed to prevent any migration users may
experience and provides an increased feeling of security.
Extended periods of lying or sitting on a particular part of the body and failure to redistribute the pressure
on the body surface can result in sustained deformation of soft tissues and, ultimately, in tissue damage4.
Repositioning involves changing the position of the lying or seated individual at regular intervals, with the
purpose of relieving or redistributing pressure and enhancing comfort.
The frequency of repositioning is determined by considering the individuals level of activity to
independently reposition5. The 30-degree side lying position is widely accepted as the optimum position
for pressure ulcer or injury reduction6. Toto® achieves both objectives by allowing for full customisation of
turning frequency, with a 30-degree angle of tilt.
The Toto® system comprises a user programmable control unit, and a multiple patient use turning platform,
which is positioned underneath the patients’ mattress. Toto® is suitable for use with foam mattresses,
alternating air mattresses, low-air loss mattresses and mattress overlays that do not exceed 995mm wide
and 2100mm long.
The control unit provides customised care with a user-determined side selection feature and accurately
timed inflation and rest durations, allowing for patient-prescribed turning intervals. Increased patient safety
is achieved, via a sophisticated yet simple to understand system of integrated alarms and a convenient
therapy pause mode, enables patient interaction without having to stop therapy.
The turning platform operates via discreet air cells which smoothly, gently and consistently turn the patient
laterally via the mattress surface, even when they are asleep. Compatible with profiling beds and both
standard and alternating pressure relieving equipment, the platform provides head to toe peak pressure
redistribution.
The Toto® system has a maximum user weight of 250kg (551lbs) meaning management of heavier patients
becomes easier and less onerous on sta. Toto® can be used in conjunction with support aids and sleep
systems, an individual assessment must be carried out to assess for suitability.
Toto® does not replace pressure relieving and redistribution surfaces and is supplementary to their use.
Indications
Toto® is a suitable supplementary device for the prevention of pressure ulcers for patients:
• Identified as being at moderate to high risk of developing pressure damage.
• Weighing up to 250kg (551lbs).
• That are unable to change their position without assistance.
• Requiring regular turning and who are non-compliant with manual turning schedules.
Contraindications
• Do not use without a suitable pressure redistribution surface and package of care.
• Do not use with patients with unstable spinal cord injuries or who are undergoing traction.
• Do not use with patients with equilibrium disturbances.
Advice for laypersons
Toto® default settings are suitable for most users. Any change in skin condition that causes concern,
should be reported to a healthcare professional.
6

Warnings and Precautions
Individual patient assessments should be made prior to use and appropriate pressure redistributing devices
put in place. Please note the following:
• Unusual body shapes and postures should be assessed prior to use.
• Caution is advised when using with patients with underlying neurological disorders which may lead to
increased anxiety.
• Other medical devices should be assessed for suitability.
• Ensure the Toto® platform is fully deflated before attempting to leave the bed.
• Engage therapy pause mode during hygiene procedures and when over-bed tables are being used to
avoid the risk of spillages.
• When elevating a profiling bed back rest, raise the knee break first.
• Ensure the surface of the bed frame is clear from debris before placing the Toto® platform, as this can
damage the coating of the cover.
• The system should not be used without a mattress.
• Do not strap the mattress to the bed frame as this will prevent Toto® from operating.
• If mattress overlays are being used, these must be securely fastened to the mattress, not the Toto® platform.
• Toto® can be used with positioning systems, bed levers and linen cradles, if their support frame fits
horizontally across the bed. These must be positioned under the Toto® platform.
• Evacuation hammocks must be placed between the Toto® platform and the mattress.
• If using foot board protectors, assess for compatibility.
• Do not place the control unit directly underneath the bed frame if placing on the floor to avoid lowering the
bed onto the control unit.
• Use only with the supplied AC power lead and with correct fuse fitted. Should there be a need to replace
the fuse, ensure only the correct fuse rating is used (3A).
• The use of bed rails should depend on the findings of an individual risk assessment. If the use of bed rails
is deemed to be required, assess for the risk of entrapment. Always follow the manufacturer’s instructions.
• When Toto is deflated and in the flat position, the distances between the top of the uncompressed mattress
and bed rail should be as follows;
• Top of the bed rail ≥220mm (Diagram 1).
• Bottom of the bed rail ≤120mm (Diagram 2).
• When inflated, assess the distance between the tilted sides of the mattress and the bed rail. This should
be ≤120mm (Diagram 3).
• Assess for risk of entrapment.
Patient Target Group
Immobile and less mobile patients who are at risk of developing pressure ulcers or injuries, who require
regular turning and those who may be non-compliant with manual turning schedules.
Intended Users
Intended for use in home and professional healthcare facilities by medically trained and untrained users.
There are no special skills required to operate or use Toto®. More information can be found online at
www.frontier-group.co.uk.
DIAGRAM 1. VIEW FROM SIDE
Bed Sides
≥ 220mm
Mattress / Support Surface
Toto Platform
Bed Frame
DIAGRAM 2. VIEW FROM SIDE
Bed Sides
≤ 120mm
Mattress / Support Surface
Toto Platform
Bed Frame
DIAGRAM 3. HEAD SIDE
≤ 120mm
Bed Sides
Toto® Platform
Bed Frame
Mattress or
Support Surface
7
Warnings and Precautions
Individual patient assessments should be made prior to use and appropriate pressure redistributing devices
put in place. Please note the following:
• Unusual body shapes and postures should be assessed prior to use.
• Caution is advised when using with patients with underlying neurological disorders which may lead to
increased anxiety.
• Other medical devices should be assessed for suitability.
• Ensure the Toto® platform is fully deflated before attempting to leave the bed.
• Engage therapy pause mode during hygiene procedures and when over-bed tables are being used to
avoid the risk of spillages.
• When elevating a profiling bed back rest, raise the knee break first.
• Ensure the surface of the bed frame is clear from debris before placing the Toto® platform, as this can
damage the coating of the cover.
• The system should not be used without a mattress.
• Do not strap the mattress to the bed frame as this will prevent Toto® from operating.
• If mattress overlays are being used, these must be securely fastened to the mattress, not the Toto® platform.
• Toto® can be used with positioning systems, bed levers and linen cradles, if their support frame fits
horizontally across the bed. These must be positioned under the Toto® platform.
• Evacuation hammocks must be placed between the Toto® platform and the mattress.
• If using foot board protectors, assess for compatibility.
• Do not place the control unit directly underneath the bed frame if placing on the floor to avoid lowering the
bed onto the control unit.
• Use only with the supplied AC power lead and with correct fuse fitted. Should there be a need to replace
the fuse, ensure only the correct fuse rating is used (3A).
• The use of bed rails should depend on the findings of an individual risk assessment. If the use of bed rails
is deemed to be required, assess for the risk of entrapment. Always follow the manufacturer’s instructions.
• When Toto is deflated and in the flat position, the distances between the top of the uncompressed mattress
and bed rail should be as follows;
• Top of the bed rail ≥220mm (Diagram 1).
• Bottom of the bed rail ≤120mm (Diagram 2).
• When inflated, assess the distance between the tilted sides of the mattress and the bed rail. This should
be ≤120mm (Diagram 3).
• Assess for risk of entrapment.
Patient Target Group
Immobile and less mobile patients who are at risk of developing pressure ulcers or injuries, who require
regular turning and those who may be non-compliant with manual turning schedules.
Intended Users
Intended for use in home and professional healthcare facilities by medically trained and untrained users.
There are no special skills required to operate or use Toto®. More information can be found online at
www.frontier-group.co.uk.
DIAGRAM 1. VIEW FROM SIDE
Bed Sides
≥ 220mm
Mattress / Support Surface
Toto Platform
Bed Frame
DIAGRAM 2. VIEW FROM SIDE
Bed Sides
≤ 120mm
Mattress / Support Surface
Toto Platform
Bed Frame
DIAGRAM 3. HEAD SIDE
≤ 120mm
Bed Sides
Toto® Platform
Bed Frame
Mattress or
Support Surface
7

B. Inspect the platform for
damage and ensure the air
cells are secured in position
via the popper fastenings
by unzipping the cover and
visually inspecting.
C. Ensure that the air hoses are
connected by visually inspecting
their yellow and blue quick
connectors.
E. Check that the CPR
emergency deflation valve is
securely closed and there are no
air leaks.
F. Using the bed hooks, hang
the control unit on the bed
foot board, ensuring it is
securely in place.
D. Connect the air inflation
and air cell hoses using
the red quick connectors,
ensuring that they are not
twisted or kinked.
H. Connect the control unit to
the mains power via the lead
supplied.
G. Reattach the CPR air hoses at
the foot end of the platform to
the control unit using the black
quick connectors, ensuring they
are not twisted or kinked.
Patient Positioning
Position supine patients along the centre line of the mattress by aligning the patient’s nose with the centre of
the headboard. Ensure the head and shoulders are supported preventing neck rolling and pivoting at the hips.
Toto® is indicated for side lying if patients can self-support, and they are in the middle of the bed.
When using bedside, consider the use of padding, bumpers, or net infills.
A. Remove the mattress and
place the rolled platform at the
foot end of the bed. Roll out until
it is fully extended and positioned
centrally to the bed frame.
Instructions for Use
Before use, please read the following instructions. Should you have any queries, please contact Frontier
Therapeutics Limited on [phone] or visit our website www.frontier-group.co.uk.
Platform Installation and Operating Guide
To ensure the system is correctly installed and functions smoothly, follow this step-by-step guide.
1. Remove all items from packaging and inspect for damage.
2. Remove the mattress and place the rolled platform at the foot end of the bed. Roll out until it is fully
extended and positioned centrally to the bed frame (A).
3. Inspect the platform for damage and ensure the air cells are secured in position via the popper fastenings
by unzipping the cover and visually inspecting (B).
4. * Ensure that the air hoses are connected by visually inspecting their yellow and blue quick connectors
(C).
5. If required, re-fit the cover and close the zip ensuring the CPR air hoses are fed through the opening at
the foot end of the cover. Please Note: The platform cover should be free to move, allowing each side
of the platform unrestricted room to inflate.
6. Connect the air inflation and air cell hoses using the red quick connectors, ensuring that they are not
twisted or kinked (D).
7. Check that the CPR emergency deflation valve is securely closed and there are no air leaks (E).
8. Replace the mattress on top of the platform. DO NOT strap or fasten the mattress to the bed frame.
9. Using the bed hooks, hang the control unit on the bed foot board, ensuring it is securely in place (F).
10. Reattach the CPR air hoses at the foot end of the platform to the control unit using the black quick
connectors, ensuring they are not twisted or kinked (G).
11. Connect the control unit to mains power via the lead supplied (H).
* Only applicable for Toto® Cradle.
Centre Line
8

Toto® Touch Control Unit Operating Guide
1. Start, stop and pause the control unit.
2. Air cell side selection - Left only, Right only or Both.
3. Air cell inflation time - Length of time the air cell remains inflated; minimum 30 minutes, maximum
240 minutes.
4. Air cell rest time - Length of time the air cells remain deflated and the platform is flat; minimum 30
minutes, maximum 240 minutes.
5. Alarm mute and interface lock mode activation.
Turning the Toto® Touch Control Unit On
• Press and hold the start/stop button for three seconds.
• A single beep confirms activation along with default lit LEDs.
• Note the system default settings below; these can be changed as appropriate.
o Air cell side selection - both sides.
o Air cell inflation time - 120 minutes.
o Air cell rest time - 120 minutes.
• The pump automatically inflates the left side of the platform; this can be changed as appropriate.
Air Cell Inflation Selection
• Press the side selection button to scroll through the three available options:
o Left and right air cell (Default).
o Right air cell only.
o Left air cell only.
• Side selection refers to the patient’s side, as standing at the foot end of the bed.
• A single beep confirms activation along with a lit LED.
Changing the Air Cell Inflation Time
• Press the inflate time button to scroll through the five available options:
o 30 minutes.
o 60 minutes.
o 120 minutes (Default).
o 180 minutes.
o 240 minutes.
• A single beep confirms activation along with a lit LED.
Changing the Air Cell Rest Time
• Press the rest time button to scroll through the five available options:
o 30 minutes.
o 60 minutes.
o 120 minutes (Default).
o 180 minutes.
o 240 minutes.
• A single beep confirms activation along with a lit LED.
Once settings have been selected, lock the interface by pressing the interface lock button confirmed
by the padlock LED turning on and a double beep (see Interface Lock).
Therapy Pause Mode
The therapy pause mode temporarily deactivates all control unit functions, returning the platform to a
flat position.
• Press the start/stop button a single beep confirms activation.
• The currently selected side selection, inflate and rest time LEDs flash when active.
• For safety, the alarm activates after 10 minutes. To continue in this mode for another 10 minutes, press
the Alarm Pause button , repeat this process until Therapy Pause Mode is no longer required.
• To deactivate, press the start/stop button . A single beep confirms deactivation and the control
unit returns to the previously selected settings.
L
R
L & R
60 min
30 min
120 min
180 min
240 min
60 min
30 min
120 min
180 min
240 min
INFLATE TIME
REST TIME
touch
9

Interface Lock
The interface lock prevents any unwanted changes to the control unit settings.
• Press and hold the alarm mute button for four seconds.
• Confirmed by the padlock LED and a double beep.
• When the interface is locked, only the alarm mute button is operational.
• To deactivate, press and hold the alarm mute button for four seconds.
• Deactivation is confirmed by the padlock LED turning o, and a double beep.
Alarm Mute Control Button
When activated, the alarm can be paused for up to 10 minutes while troubleshooting, after which time, the
alarm recommences if the problem remains.
• To mute the alarm, press the alarm mute button .
If a new alarm condition occurs when paused, the initial alarm terminates and a new alarm will activate.
Alarms and Alerts
The Toto® Touch control unit has three integrated alarms and one information alert to ensure patient safety
and ecacy.
Alarms and Alerts Alarm
Condition
Indicated by an audible alarm and:
Air Leak Alarm - The pressure in the
system has fallen below the minimum
operational requirements, i.e. an air leak.
Low priority Air Leak LED permanently lit yellow
(when activated) (6).
Blockage Alarm - Airflow between the
control unit and the platform is prevented,
i.e. a blocked air hose.
Low priority Blockage LED permanently lit yellow
(when activated) (7).
Service Interval - Service required; default
at one-year use. n/a Service LED permanently lit amber (8) (NO AUDIBLE alarm).
Power Loss Alarm
Power to the control unit has been
interrupted.
Low priority Audible alarm, no LED lit.
Initialisation Failure
Control unit fails to start n/a All ‘Inflate time LEDs’ and ‘Rest time LEDs’ flashing (when activated).
The sound pressure level of the alarm audio or the reminder audio signal ranges from 55dB-85dB.
The alarm frequency is 2000HZ.
While troubleshooting, the alarm can be muted for up to 10 minutes. If the fault is not corrected during this
time, the alarm re-activates.
If a new alarm condition occurs within 10 minutes, mute will cease, and the new condition will generate an
alarm.
Please Note:
• The corresponding alarm indication LED remains lit when the alarm is muted.
• If the alarm condition is corrected while muted, the LED and mute will automatically terminate.
• The alarm audio signal comes from a speaker, and the reminder audio signal comes from a buzzer.
• Alarm activation may take up to two minutes from when the alarm state occurs.
L
R
L & R
60 min
30 min
120 min
180 min
240 min
60 min
30 min
120 min
180 min
240 min
INFLATE TIME
REST TIME
touch
10

System Error Trouble Shooting Guide
Problem Cause Initial Checks / Trouble Shooting
No LEDs lit; no
audible alarm
heard.
• Control unit may
not be attached to a
power source.
• The fuse may need
replacing.
1. Check that the mains power outlet is live and active.
2. Check the control unit is switched on.
3. If following points 1 and 2 does not resolve the problem,
switch o and unplug the control unit:
- Check the mains plug fuse (3A).
- Check the control unit fuse (1A).
4. Restart the control unit.
If the problem persists, contact Frontier Therapeutics
Limited Tel: [phone] for assistance.
Air-leak alarm
LED (6) lit
permanently
yellow with an
audible alarm.
• Pressure has
fallen below the
minimum operational
requirements.
1. Press the alarm pause button.
2. Check the Cardiopulmonary Resuscitation valve is
closed and correct.
3. Check all air cells and hoses for any air leakage.
4. Resolve and wait for the alarm to reset.
If the problem persists, contact Frontier Therapeutics
Limited Tel: [phone] for assistance.
Blockagealarm
LED (7) lit
permanently
yellow with an
audible alarm.
• Airflow obstruction
between the control
unit and the platform.
1. Press the alarm pause button.
2. Check for twists or kinks in the air hoses between the
platform and control unit.
3. Resolve and wait for the alarm to reset.
If the problem persists, contact Frontier Therapeutics
Limited Tel: [phone] for assistance.
Service LED (8)
permanently lit
amber.
• Service required. Please contact Frontier Therapeutics Customer Services
for support Tel: [phone]
The Control Unit continues to function even though the
service LED remains lit.
Interfacepanel
is lit but
unresponsive.
• Interface panel is
locked. 1. Check that screen lock LED is lit amber (9). 2. Press and hold the alarm mute button for four seconds
to deactivate.
If the problem persists, contact Frontier Therapeutics
Limited Tel: [phone] for assistance.
An audible
alarm is
sounding; no
LEDs lit.
• Loose or absent
power lead.
• Mains power
accidentally turned
o.
• Mains power failure.
1. Reconnect mains power lead to the control unit.
2. Check the mains power wall switch is turned on.
3. Attempt to restart the control unit.
If the problem persists, contact Frontier Therapeutics
Limited Tel. [phone] for assistance.
Do not open the control unit. Opening the unit could cause personal injury or equipment damage.
NB. The Toto® Touch control unit completes self diagnostic evaluation on start up.
Cardiopulmonary Resuscitation Emergency Deflation System
The Toto® system features a quick release Cardiopulmonary Resuscitation deflation valve which allows for
rapid deflation for emergency procedures.
In the event of an emergency, firmly pull and release the yellow tab.
To re-inflate the system, replace the Cardiopulmonary Resuscitation tag ensuring both sealing connectors
are firmly attached and restart the Toto® Touch control unit
Cardiopulmonary Resuscitation
Deflation Valve Closed. Cardiopulmonary Resuscitation
Deflation Valve Open.
Inspection and Care
The Toto® lateral turning system cover, platform assembly, air cells, Cardiopulmonary Resuscitation deflation
valve and tubing set and control unit each have a unique GS1 compliant barcode which should be retained
and used in the event of a warranty claim. NEVER remove these labels.
Cover
Regularly inspect the outer and inner surfaces of the cover for signs of damage.
Report damaged covers to the ward or department manager or appropriate healthcare
professional.
11

Withdraw damaged covers from service and replace.
Check zip fasteners for function and integrity.
Platform
Regularly inspect the interior and exterior of the platform, ensuring that the poppers and air cells are intact.
Ensure the platform has not drifted out of position and the air hoses are not blocked, kinked or twisted.
Fitting and Replacing Damaged Air Cells
In the event of an air cell puncture or leak, either or both air cells can be replaced. Please contact Frontier
Therapeutics Customer Services for replacement parts Tel: [phone].
1. Switch o the control unit and disconnect from mains power.
2. Disconnect the CPR air hoses from the foot end of the platform using the red quick connectors.
3. Unzip and pull back the cover revealing the platform.
4. Determine the faulty air cell and remove by unfastening the popper fastenings.
5. * Disconnect the air hoses at the head end of the platform using the yellow and blue quick connectors.
6. Unthread the CPR air hoses and red quick connectors from their securing loops at the foot end of the
platform.
7. * Unthread the air hoses with the yellow and blue quick connectors at the head end of the platform from
their respective securing loops.
8. Inspect the platform for other signs of damage, including the potential source of the damage.
9. Fit the new air cell ensuring it is in-line with the correct section, and in the correct orientation with the
red CPR air hose quick connectors at the foot end of the platform. Secure in place with the popper
fastenings.
10. Thread the CPR air hose and red quick connector through its securing loop at the foot end of the
platform.
11. * Thread the air hose connections through their respective securing loops at the head end of the platform
and reconnect using the yellow and blue quick connectors.
12. Re-fit the cover and close the zip ensuring the hose with the red quick connectors that attach to the CPR
air hoses are fed through the opening at the foot end of the cover.
13. Re-attach the CPR air hoses at the foot end of the platform using the red quick connectors, ensuring
theyare not twisted or kinked.
* Only applicable for Toto® Cradle.
Nature and Frequency of Preventative Maintenance
Inspection and Care of the Toto® Touch Control Unit
The Toto® Touch control unit is designed to be reliable and long lasting, with few parts requiring
maintenance.
A routine service is required when the service light illuminates. Please refer to the Toto® Service,
Maintenance and Repair Manual for further information. Supporting videos are also available.
Clean air filters at least every 12 months by removing and running under clean water and allowing to dry.
Inspections should be undertaken to note any visible signs of damage.
In the event of product failure, please contact Frontier Therapeutics Limited for advice and
recommendations on service and repair.
Although there are no requirements for Portable Appliance Testing, guideline recommendations indicate
that extension leads and portable electrical equipment should be re-tested every six months. Please refer to
local guidance.
An electrical safety test in accordance with BS EN 62353:2014 Medical Electrical Equipment - Recurrent Test
and Test After Repair of Medical Electrical Equipment, should be carried out after maintenance, inspection,
servicing and repair, and before the control unit is sent out to, or returned to a user.
Cleaning and Disinfection
All components of the system can be cleaned with detergent and water to remove any visible
contaminationand chemically disinfected with chlorine. The following represents guidance on the correct
cleaning and decontamination process but does not replace local policy and guidelines.
Toto® Lateral Turning System Platform Cover
Keeping a cleaning record is recommended as the Toto® system is suitable for re-use.
Light and Heavy Soiling
Decontaminate with a 0.1% (1,000ppm) - 1% (10,000ppm) Chlorine solution.
Rinse with clean water and wipe down with a single-use, non-abrasive cloth and thoroughly dry.
Do not apply a 1% chlorine-based solution for more than two minutes, doing so may cause long term
damage.
Prolonged use of alcohol-based cleaning agents may reduce the life of the product.
If used, thoroughly rinse with clean water and allow to dry before use.
Machine Washing Instructions
Cleaning and disinfection may be achieved by laundering at temperatures not exceeding 65ºC
fortenminutes or 73ºC for three minutes.
12

Drying
To avoid shrinkage, line dry in a clean indoor environment. Thoroughly dry before re-fitting to the
Toto® platform.
Do not mangle or iron.
Platform, Cabling, Control Unit and Air Hoses
Before cleaning, disconnect from the mains power supply.
The platform, cabling, control unit and air hoses can be wiped clean with alcohol wipes and a chlorine
derivative. Take care when wiping the control unit not to allow liquids to enter through any openings.
End of Life Disposal
Cared for correctly the Toto® system is long lasting and durable. The control unit has a life expectancy of up
to 5 years.
To minimise hazards to health and the environment, and to ensure the device is recycled, dispose of at a
separate collection facility for electrical and electronic equipment in accordance with the Waste Electrical
and Electronic Equipment Directive, and as denoted by the wheelie bin symbol marked on the product.
At the end of its life, clean and disinfect the platform according to the instructions and dispose of with non-
hazardous clinical waste.
Storage
When not in use, the Toto® lateral turning system should be stored in a secure location away from the public
using the transport bag supplied.
• Do not drag.
• Never store other items on top of the Toto® platform.
• Do not store next to radiators or other heating devices.
• Do not store in damp conditions.
Warranty
The Toto® system warranty is valid for two years from the time of shipping. In the event of a defect or fault,
please contact Frontier Therapeutics Customer Services on Tel: [phone] or email: info@
frontier-group.co.uk immediately.
Frontier Therapeutics Limited guarantees the equipment is free from defects in material and workmanship,
under regular use and service.
During the warranty period, any product that has become defective due to faulty workmanship or material
will be replaced as deemed appropriate by Frontier Therapeutics Limited, without charge for parts or labour.
During this time, a loaned control unit will be made available if required.
If the product is damaged due to an accident, negligence or misuse, the product warranty will be forfeited.
No unauthorised alterations are permitted. Both warranty and fire retardancy certification will be null and
void if non-Frontier Therapeutics Limited spares or replacement parts are used.
Frontier Therapeutics Limited will not accept responsibility for damage caused by misuse, negligence,
accidental damage nor non-observance of the instruction set out in this document.
This warranty does not aect your statutory rights.
Fire Testing
The Toto® platform meets the requirements of BS 7175:1989 Section 2 Methods of test for the ignitability of
bedcovers and pillows by smouldering and flaming ignition sources.
BS EN 597-1:2015. Furniture. Assessment of the ignitability of mattresses and upholstered bed frames.
Ignition source smouldering cigarette. BS EN 597-2:2015. Furniture. Assessment of the ignitability of
mattresses and upholstered bed frames. Ignition source: match flame equivalent.
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).
13

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 Harmonised Standard Referenced EMC Emission Standards
MDR 2017/745 EN 60601-1:2006/A1:2013
(Electrical Safety)
EN 60601-1-2:2007/
AC:2010 (EMC)
EN 55011:2009/A1:2010 Class B (RF)
EN 61000-3-2:2014 (Harmonics)
EN 61000-3-3-2013 (Flicker)
Restriction of the use of
certain hazardous substances
(RoHS) Directive. 2011/65/EU
EN 50581:2012 N/A
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,
eectiveness, 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 AC 220-240VAC 50Hz, 0.2A
Fuse rating T1AL250V
Compressor SAA-1
Air distributor Timing motor working as a rotary valve
Control system Digital control system
Power consumption 14 Watt (typical) / 20 Watt (maximum)
Cycle control Distributor valve supplying air to the inflatable cells
Cycle time Adjustable 30 > 240 minutes
Pressure setting 140mmHg to 160mmHg
Piping output 2
Platform and Air Cell Material Nylon and thermoplastic polyurethane (TPU)
Max. load on platform 250Kg
PU Cover Material Polyurethane transfer coating on weft knitted polyester fabric
Operating environment Temperature range: 10ºC to 40ºC
Relative humidity range: 30% to 70%
Atmospheric pressure range: 70kPa to 106kPa
Storage/Transportation Temperature range: -10ºC to 60ºC
Relative humidity range: 10% to 70%
Atmospheric pressure range: 70kPa to 106kPa
Classification IEC60601-1 Class II equipment - Type B applied part - IP21
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 eect 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
14

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Frontier Therapeutics Limited
Innova One, Tredegar Business Park,
Tredegar, Blaenau Gwent NP22 3EL
United Kingdom.
Tel: [phone]
Email: [email protected]
www.frontier-group.co.uk
Frontier Medical Group GmbH.
Geschäftsstelle Deutschland
Nußbaumallee 27 A, 14050 Berlin
Deutschland
Tel: [phone]
Email: [email protected]
www.frontier-medical-germany.de
Toto lateral turning system is protected by one or more patents or trademarks.
Further information can be found at https://bit.ly/3LlF29z.
Toto lateral turning system is a registered trade mark of Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited All rights reserved.
EN
Le système de latéralisation Toto® est protégé par un ou plusieurs brevets ou marques déposées.
Plus d’informations sur https://bit.ly/3LlF29z.
Le système de latéralisation Toto® est une marque déposée de Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited. Tous droits réservés.
FR
Das Toto-System zur seitlichen Umlagerung ist durch eines oder mehrere Patente oder Handelsmarken
geschützt.
Weitere Informationen finden Sie unter https://bit.ly/3LlF29z.
Das Toto-System zur seitlichen Umlagerung ist eine eingetragene Handelsmarke von Frontier Therapeutics
Limited.
© 2022 Frontier Therapeutics Limited. Alle Rechte vorbehalten.
DE
Het Toto laterale kantelsysteem wordt beschermd door een of meer patenten of handelsmerken.
Meer informatie vindt u op https://bit.ly/3LlF29z.
Het Toto Laterale kantelsysteem is een gedeponeerd handelsmerk van Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited Alle rechten voorbehouden.
NL
El sistema de volteo lateral Toto está protegido por una o más patentes o marcas registradas.
Encontrará más información en https://bit.ly/3LlF29z.
El sistema de volteo lateral Toto es una marca registrada de Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited Todos los derechos reservados.
ES
Il sistema per la rotazione laterale Toto è protetto da uno o più brevetti o marchi commerciali.
Ulteriori informazioni sono disponibili sul sito https://bit.ly/3LlF29z.
Il sistema per la rotazione laterale Toto è un marchio registrato di Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited. Tutti i diritti riservati.
IT
Sistem bočnega obračanja Toto® je zaščiten z enim ali več patenti in blagovnimi znamkami.
Več informacij je na voljo na strani https://bit.ly/3LlF29z.
Sistem bočnega obračanja Toto® je registrirana blagovna znamka družbe Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited Vse pravice pridržane.
SL
Toto-systemet skyddas av ett eller flera patent eller varumärken.
Mer information finns på https://bit.ly/3LlF29z.
Toto är ett registrerat varumärke som tillhör Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited Med ensamrätt.
SV
O sistema de viragem lateral Toto está protegido por uma ou mais patentes ou marcas registadas.
Pode encontrar mais informações em https://bit.ly/3LlF29z.
O sistema de viragem lateral Toto é uma marca registada da Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited Todos os direitos reservados.
PT
Systém laterálneho otáčania Toto je chránený jedným alebo viacerými patentmi alebo ochrannými známkami.
Ďalšie informácie nájdete na adrese https://bit.ly/3LlF29z.
Systém laterálneho otáčania Toto je registrovaná ochranná známka spoločnosti Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited. Všetky práva vyhradené.
SK
Sistemul de întoarcere laterală Toto este protejat de unul sau mai multe brevete sau mărci comerciale.
Informații suplimentare pot fi găsite la https://bit.ly/3LlF29z.
Sistemul de întoarcere laterală Toto este o marcă comercială înregistrată a Frontier Therapeutics Limited
© 2022 Frontier Therapeutics Limited Toate drepturile rezervate.
RO
Toto 侧翻系统获一项或多项专利或商标保护。
更多信息请访问 https://bit.ly/3LlF29z。
Toto 侧翻系统是 Frontier Therapeutics Limited 的注册商标
© 2022 Frontier Therapeutics Limited，保留所有权利。
ZH
.           Toto    
.https://bit.ly/3LlF29z :         
Frontier Therapeutics Limited      Toto    
.   Frontier Therapeutics Limited 2022 ©
AR
.םיירחסמ םינמיס ידי לע וא רתוי וא דחא טנטפ ידי לע תנגוהמ דצל הייטהל Toto תכרעמ
.https://bit.ly/3LlF29z רתאב ףסונ עדימ לבקל ןתינ
Frontier Therapeutics Limited לש םושר ירחסמ ןמיס אוה Toto Lateral Turning System
.תורומש תויוכזה לכ Frontier Therapeutics Limited 2022 ©
HE
Toto 体位変換支援システム (仰臥位から横臥位) は、1 つ以上の特許または商標で保護されています。
詳細は https://bit.ly/3LlF29z を参照してください。
Toto 体位変換支援システム (仰臥位から横臥位) はFrontier Therapeutics Limited の登録商標です。
© 2022 Frontier Therapeutics Limited All rights reserved.
JA
Toto 측면 회전 시스템은 한개이상의 특허 또는 상표에 의해 보호됩니다.
자세한 정보는 https://bit.ly/3LlF29z에서 확인할 수있습니다.
Toto 측면 회전 시스템은 Frontier Therapeutics Limited의등록 상표입니다.
© 2022 Frontier Therapeutics Limited 모든 권리 보유.
KO
Version 10.0 2023
GP0133_A56_10