Toto GP0133-A50-01 User manual

Brand: Toto

Model: GP0133-A50-01

Type: User manual

Toto GP0133-A50-01 is an automated lateral turning system that is designed to assist with patient turning and pressure ulcer prevention plans. It is compatible with profiling beds and both standard and alternating pressure relieving equipment. The system 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 lateral turning system platform.

Toto

Lateral Turning System, with Toto

Touch Control Unit

User Guide

www.frontier-group.co.uk

2 3

Kit Contents

Before you start please ensure that you have all the necessary components. If any are

absent, or in case of doubt, please contact Frontier Therapeutics Ltd Customer Services on

+44 (0) 1495 235800.

Toto® Touch Lateral Turning System Labelling

This user guide contains important information on correct usage, handling, cleaning and

decontamination. Please read carefully prior to use.

! IMPORTANT - This indicates a hazardous situation that could result in damage to property if

it is not avoided.

c for 10 minutes or

c for 3 minutes

Max user weightBleaching agent

allowed

Do not pierce

or cut

Do not ironLine dry Refer to user manual

CE Compliant Type BF applied part

Keep dry

Class II equipment

Disposal: do not dispose of this

product as unsorted domestic

waste. It must be sent to a separate

collection facility for recovery

and recycling.

Caution symbol

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. Service indicator.

7. Interface lock indicator.

Toto Touch Control Unit

• 1x Toto Touch Control Unit.

• 1x Control Unit power lead.

• 1x User guide.

Toto Lateral Turning System Platform

• 1x Platform.

• 1x Platform cover.

• 1x CPR deﬂation valve and tubing set.

• 1x Pair of air cells with quick

connectors.

1 2 3 4 5 6 7

4 5

Contents Product Speciﬁcations

Toto Lateral Turning System - Standard: Fully customisable

control unit with a 30° degree tilt.

Toto Lateral Turning System - 45: Fully customisable control

unit with a 45° degree tilt.

Toto Lateral Turning System - XL: Fully customisable control

unit, with an extra wide platform suitable for bariatric patients

with 30° degree tilt.

Product

Depth (ﬂat position - air cells

empty) mm (Inches)

Depth (raised position - air cells

inﬂated) mm (Inches)

CPR Deﬂation Valve Angle of Tilt (°)

Standard 35 (1.4) 185 (7.3) Quick Release Pull Tag 30

45 35 (1.4) 223 (9) Quick Release Pull Tag 45

35 (1.4) 271 (11) Quick Release Pull Tag 30

Product

Weight - kg (lbs)

Maximum User Weight - kg (lbs) Width - mm (Inches) Length - mm (Inches)

Standard 18 (40) 190 (419) 745 (29) 1850 (73)

45 18 (40) 190 (419) 745 (29) 1850 (73)

23 (51) 190 (419) 1067 (42) 1850 (73)

Toto Platform

Toto Touch Control Unit

Speciﬁcations

Dimensions - Width / Depth / Height - mm (Inches)

240 (9.5) x 100 (4) x 200 (8)

Weight - kg (Ibs)

2.2 (4.8)

Rated voltage - EU

220 - 240VAC, 50/60Hz, 0.3A

Rated voltage - USA

110 - 120VAC, 60Hz, 0.3A

Rated input power (VAC)

Protection class

Class II

Power cord length - Meters (Feet)

5 (16.4)

Air output (LPM)

Page 5 Product speciﬁcations

Page 6 Intended use

Page 7 Safety

Page 8 Instructions for use

Page 15 Alarms and Alerts

Page 18 Care

Page 20 Cleaning

Page 22 Warranty

Page 23 Technical Speciﬁcation

6 7

Intended Use

Product Description

Toto is an automated lateral turning system which consists of a Toto Touch Control Unit and a

turning platform with cover.

Designed to assist with patient turning and pressure ulcer prevention plans, the system is based

on inﬂating alternating air cells within the platform. These turn patients laterally via the mattress

surface to a maximum of either 30 or 45 degrees depending on which version is used.

The digital Control Unit provides customised care with a user determined side selection feature

and accurately timed digital inﬂation and rest durations. Sophisticated blockage and air leak alarms

help ensure patient safety, as well as an interface lock to avoid unwanted setting changes.

A convenient therapy pause mode enables patient interaction without having to stop therapy and

a service indicator to maintain performance also comes as standard.

The system is compatible with proﬁling beds and both standard and alternating pressure relieving

equipment. It is also compatible with domestic mattresses, except pocket sprung.

Toto lateral turning system does not replace pressure relieving and redistribution surfaces and is

supplementary to their use.

Indications

Toto lateral turning system is suitable for the prevention of pressure ulcers for the following

patients:

• Those identiﬁed as being at moderate to high risk of developing pressure ulcers as deﬁned by

commonly used assessment tools.

• Weighing up to 190kg (419lbs).

• Who are unable to change their position without assistance.

• Identiﬁed as requiring regular turning and who are non-compliant with manual turning schedules.

Contraindications

• Do not use without a suitable pressure redistribution surface & 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.

• Not to be used where patients must be supported by wedges or pillows etc.

Intended Care Setting

Toto Lateral turning system is intended to be used in the following care settings:

• Long term or extended care, such as nursing homes and care homes.

• Home care.

• Hospitals.

Safety

! Warnings and Precautions

Individual patient assessments should be made prior to use and appropriate pressure relieving

devices put in place. Please note the following:

• Caution is advised when using with patients with underlying neurological disorders which may

lead to increased anxiety.

• Unusual body shapes and body postures.

• Other medical devices should be assessed for suitability.

• The Toto lateral turning system should be fully deﬂated when attempting to leave the bed.

• Ensure that the Toto lateral turning system is discontinued or therapy pause mode is engaged

for feeding times to avoid the risk of spillages.

• During hygiene procedures, please use therapy pause mode.

• When elevating a proﬁling bed back rest, raise the knee break ﬁrst.

• Ensure that the surface of the bed frame is clear from debris before placing the Toto lateral

turning system 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 lateral turning system from

operating.

• If mattress overlays are being used, these must be securely fastened to the mattress, not the

Toto lateral turning system platform.

• The Toto lateral turning system 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 lateral turning system platform.

• Evacuation hammocks must be placed between the Toto lateral turning system platform and

the mattress.

• If using bed sides, check for clearance from the top of the mattress to the bottom of the bed

side (minimum of 185mm) and assess for risk of entrapment.

• 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.

• Do not use if mains power lead or plug is damaged.

8 9

Instructions for Use

Platform Installation and Operating Guide

To ensure the system is correctly installed and functions smoothly, please follow this step-by-step

guide.

1. Remove all items from the packaging and inspect for damage.

2. The platform should be placed directly onto the bed frame and underneath the existing mattress.

DO NOT strap or fasten the mattress to the bed frame. (A)

3. Inspect the platform and cover for any visible signs of damage. (B)

4. Ensure the air cells within the platform are secured in position via the Velcro®.

5. Fit the cover and close zip, ensuring the air cell hoses are fed through the apertures at the foot

end of the cover.

Note: The platform cover should be free to move, allowing each side of the platform unrestricted

room to inﬂate.

6. Using the quick connectors, connect the air inﬂation hoses to the air cell hoses - 'Red to Red' -

ensuring the hoses are not twisted or kinked. (C)

7. Check the CPR deﬂation valves are securely in place to ensure no air leaks. (D)

8. Using the bed hooks, hang the Control Unit on footboard of the bed. (E)

9. Using the quick connectors, connect the air inﬂation hoses to the Control Unit - 'Black to Control

Unit' - ensuring the hoses are not twisted or kinked. (F)

10. Connect the Control Unit to the mains power via the cable supplied. (G)

A. The platform should be placed directly

onto the bed frame and underneath the

existing mattress.

B. Inspect the platform for visible signs of

damage.

C. Using the quick connectors, connect

the air inﬂation hoses to the air cell hoses

- 'Red to Red' - ensuring the hoses are

not twisted or kinked.

D. Check the CPR deﬂation valves are

securely in place to ensure no air leaks.

E. Using the bed hooks, hang the Control

Unit on footboard of the bed.

F. Using the quick connectors, connect

the air inﬂation hoses to the Control Unit

'Black to Control Unit' - ensuring the

hoses are not twisted or kinked.

G. Connect the Control Unit to the mains

power via the cable supplied.

Patient Positioning

Patients should be positioned along the centre line of the mattress by aligning the patients nose

with the centre point of the head board. Ensure head and shoulders are supported to prevent neck

roll and pivoting at the hips during use.

For patients lying on their side, if they can self-support and they are in the middle of the bed, Toto

lateral turning system can be used.

If patients cannot control their limbs and bed sides are being used, padding or net inﬁlls are

recommended.

Centre Line

10 11

Instructions for Use

Toto Touch Control Unit Operating Guide

1. Starts, stops and pauses 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 is inﬂated; minimum 30 minutes, maximum 240

minutes.

4. Air cell rest time - Length of time the air cells are deﬂated and the platform is supine; minimum

30 minutes, maximum 240 minutes.

5. Mute and interface lock mode activation.

Turning the Toto Touch Control Unit On

• Press and hold the start / stop button for 3 seconds.

• A single beep will conﬁrm activation and the start / stop green LED will be lit.

• Note the system default setting will automatically be selected.

o Air cell inﬂation - Both sides

o Air cell inﬂation time - 120 minutes

o Air cell rest time - 120 minutes

• The pump will engage and the patients left air cell will start to inﬂate.

Air Cell Inﬂation Selection

• Press the Air Cell side selection button to scroll through the three available options:

o Left and Right air cell

o Left air cell only

o Right air cell only

• Note: Refers to patient’s side, as stood at the foot end of the bed.

• A single beep and a lit green LED identiﬁes the selected option.

12 13

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

o 180 minutes

o 240 minutes

• A single beep and a lit green LED identiﬁes the selected option.

• Note: 120 minutes is the default setting.

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

o 180 minutes

o 240 minutes

• A single beep and a lit green LED identiﬁes the selected option.

• Note: 120 minutes is the default setting.

Therapy Pause Mode

The Therapy pause mode temporarily deactivates all Control Unit functions, returning the platform

to a ﬂat position allowing for patient interactions such as feeding and hygiene requirements.

• Press the start / stop button a single beep will conﬁrm activation.

• The start / stop LED will ﬂash when active and all other LED’s will turn o.

• After 10 minutes in Therapy Pause Mode the alarm will sound. To continue in this mode, press

the Alarm mute button to silence.

• The Control Unit will remain in Therapy pause mode for a further 10 mins. The process may be

repeated until no longer required.

• To deactivate, press the start / stop button. A single beep conﬁrms deactivation and the Control

Unit returns to its previously selected settings.

Interface Lock

The interface lock prevents any unwanted changes to the Control Unit settings.

• Press and hold the Alarm Mute button for four seconds.

• The padlock LED will light amber and a double beep heard, conﬁrming activation.

• When locked, only the Alarm Mute button will remain operational.

• To deactivate, press and hold the Alarm MUTE button for four seconds.

• The padlock LED will turn o and a double beep heard.

Start / Stop LED will be ﬂashing light shows

control unit is in ‘Therapy Mode’

14 15

Mute Control Button

The alarm can be muted for up to 10 minutes while trouble shooting is conducted. After 10 minutes,

if the fault has not been rectiﬁed, the alarm will reactivate.

• To mute the alarm, press the Alarm Mute Button this is conﬁrmed with a single Beep.

Alarms and Alerts

The Toto Touch Control Unit has ﬁve integrated system error indicators

System Error Indicators Indicated by an audible beep and:

Low system pressure

Pressure in the system has fallen below the minimum

operational requirements.

Five ‘Rest time LEDs’ ﬂashing (when activated).

High system pressure

Air ﬂow between the Control Unit and platform is

prevented.

Five ‘Inﬂate time LEDs’ ﬂashing (when activated).

Service interval

Service required default at one-year use.

Service LED permanently lit amber

(No audible alarm).

Power Failure

Power to the Control Unit has been interrupted.

Audible beep, no LED lit.

Initialisation Failure

Control unit fails to start.

Five ‘Inﬂate time LEDs’ and Five ‘Rest time LEDs’

ﬂashing (when activated).

16 17

! If the problem persists, contact Frontier Therapeutics Ltd Tel. +44 (0) 1495 235800 for

assistance. Do not open the Control Unit. Opening the unit could cause personal injury or

equipment damage.

CPR Emergency Deﬂation System

CPR Deﬂation Valve Open

The Toto lateral turning system features a quick release CPR deﬂation valve which allows for rapid

deﬂation for emergency procedures.

The CPR deﬂation valve can be found on the air hoses between the Toto Touch Control Unit and

the platform, clearly marked with a yellow tab.

In the event of an emergency, ﬁrmly pull and release the yellow tab.

To re-inﬂate the system after the CPR tag has been removed, replace the CPR tag ensuring both

sealing connectors are ﬁrmly attached, and restart the Toto Touch Control Unit.

All ﬁve Inﬂate Time

LEDs are ﬂashing, an

audible beep can be

heard. (E - I)

• Air Flow between the

Control Unit and platform

is obstructed.

1. Press the Alarm Mute 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 Ltd Tel. +44 (0) 1495 235800 for

assistance.

Service LED

permanently lit

Amber. (O)

• Service required. • Indicates the need of periodic maintenance.

Please contact Frontier Therapeutics Customer

Services for support Tel. +44 (0) 1495 235800

! The Control Unit will continue to function even

though the service LED remains lit.

Interface panel is lit

but unresponsive.

• Interface panel is locked. • Press and hold ALARM MUTE button for 4 seconds.

Audible beep, no

LEDs lit.

• Accidental removal of

power cord.

• Accidental mains wall

power turned o.

• Mains power failure.

• Reconnect mains power lead cable to Control Unit.

• Check mains power wall switch is turned on.

CPR Deﬂation Valve Closed CPR Deﬂation Valve Open

System Error Trouble Shooting Guide

System Error

Indicator

Cause Initial Checks / Trouble Shooting

No LEDs lit and no

audible beeps can be

heard.

• Control Unit may not

be attached to a power

source.

• Fuse may need replacing.

1. Check the Control Unit is connected to a mains

power outlet and is switched on.

2. Check the Control Unit is switched on.

3. Switch o, unplug the Control Unit:

- Check the mains plug fuse (3 AMP).

- Check Control Unit fuse (1 AMP).

4. Restart Control Unit.

! If the problem persists, contact Frontier

Therapeutics Ltd Tel. +44 (0) 1495 235800 for

assistance.

! Do open the Control Unit. Opening the unit could

cause personal injury or equipment damage.

All ﬁve Rest Time

LEDs are ﬂashing, an

audible beep can be

heard. (J - N)

• Pressure has fallen below

the minimum operational

requirements.

1. Press the Alarm Mute button.

2. Check the CPR valve is properly closed, ensuring all

sealing connectors are fully pressed in.

3. Check each air cell is securely attached to the

connecting air cell hose.

4. Check all air cells, and hoses for any air leakage.

! If the problem persists, contact Frontier

Therapeutics Ltd Tel. +44 (0) 1495 235800 for

assistance.

18 19

Care

Inspection and care of the platform and cover

Inspect the inner and outer surfaces of the cover and zip fasteners regularly for signs of damage.

Damaged covers should be reported to the ward or department manager or relevant healthcare

professional.

Torn covers should be withdrawn from service, and replacements sought.

Regularly inspect the interior and exterior of the platform, ensuring that the hinges and air cells

remain intact.

The labels on the Toto lateral turning system cover, platform and Control Unit have a unique batch

number which should be retained and used in the event of a warranty claim. NEVER remove the

labels.

Regularly check that the platform has not drifted out of position and the hoses are not blocked,

kinked or twisted.

Fitting / Replacing Damaged Air Cells

In the event of puncture or leak, it is possible to replace either or both air cells. Please contact

Frontier Therapeutics Customer Services for replacement parts Tel: +44 (0) 1495 235800.

1. Switch o the Control Unit and disconnect from mains.

2. Disconnect the air hoses to the platform using the quick connectors.

3. Unzip and pull back the cover revealing the platform.

4. Determine the faulty air cell and remove by unfastening the Velcro® straps.

5. Inspect the platform for other signs of damage, including what could have caused air cells to

have become damaged.

6. Using the Velcro® straps, ﬁt the new air cell ensuring it is in-line with the correct section.

7. Replace the cover ensuring correct orientation and feed air cell hoses through apertures at the

bottom of the cover.

8. Reattach the hoses using the quick connectors - 'Red to Red' - ensuring they are not twisted or

kinked.

Disposal

! IMPORTANT In order to minimise hazards to health and the environment and ensure that

materials can be recycled, this product should be disposed of at a separate collection facility for

waste electronic equipment. The Wheelie Bin symbol marked on the product is there to remind

you.

Storage Guidance

When not in use, the Toto lateral turning system should be stored in a secure location away from

the public.

It is recommended that the Toto platform is handled by a minimum of two people.

• Do not drag.

• Never store other items on top of the Toto platform.

• Place a protective covering over the platform and do not store directly on the ﬂoor.

• Do not store next to radiators or other heating devices.

• Do not allow sharp objects to penetrate the cover.

• Do not store in damp conditions.

• Remove the cover during transportation and storage.

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.

Air ﬁlters should be cleaned at least every 24 months and inspections should be undertaken noting

any visible signs of damage.

In the event of product failure, please contact Frontier Therapeutics for advice and recommendations

on service and repair.

Although there are no requirements for PAT testing, guideline recommendations indicate:

• Class II moveable equipment such as extension leads and portable electrical equipment should

be tested every six months. This is the responsibility of the operator alone.

Please refer to local guidance.

20 21

Cleaning

Toto Lateral Turning System Platform Cover

Keeping a cleaning record is recommended as the product is suitable for re-use.

Light Soiling

! IMPORTANT In the absence of gross contamination or unusual risk, the removal of dirt and

spillages with a neutral detergent and warm water should be sucient. A 0.1% hypochlorite solution

(1,000ppm) may also be used. Ensure that the cover is rinsed with clean water using a single use,

non-abrasive cloth and thoroughly dried. Ensure adequate ventilation.

Heavy Soiling

! IMPORTANT In cases of gross contamination, the Toto lateral turning system platform cover

should be cleaned ﬁrst with detergent and water and then with a 0.1% hypochlorite solution

(1,000ppm). Rinse well with clean water and wipe down with a single use, non-abrasive cloth and

thoroughly dry. Ensure adequate ventilation.

! IMPORTANT If required, a 1% hypochlorite solution (10,000ppm) and cold water may be applied

for no more than two minutes.

Machine Washing Instructions

! IMPORTANT Disinfection may be achieved by laundering at temperatures not exceeding 65ºC

for 10 minutes or 73ºC for three minutes.

Protect, Rinse and Dry - BHTA guidance on the care, cleaning and inspection of healthcare

mattresses. (January 2012 - BHTA HM 0112)

Drying

To avoid shrinkage, line dry in a clean, indoor environment. Covers must be thoroughly dried

before re-ﬁtting to the Toto platform.

Do not mangle or iron.

Platform, Cabling, Control Unit and Air Hoses

Before cleaning, disconnect from mains power supply.

The platform, cabling, Control Unit and air hoses can be wiped clean with alcohol wipes and/or a

chlorine derivative. Care should be taken when wiping the Control Unit not to allow liquids to enter

through any apertures.

Cleaning Air Filters

1. Switch o the power supply to the Control Unit.

2. Disconnect the power lead and air hoses.

3. Place the Control Unit on a ﬂat surface with its back panel uppermost (place a soft cloth under

the unit to prevent scratches).

4. Carefully remove the air ﬁlter cover located on the back panel of the Control Unit (x1).

5. Remove and clean the ﬁlter with clean water and allow to fully dry.

6. Reﬁt the air ﬁlter cover to the Control Unit.

7. The Control Unit is now ready for re-use.

22 23

Warranty

The Toto lateral turning system warranty is valid for one year from time of shipping. If a

defect or fault is discovered, please contact Frontier Therapeutics Ltd Customer Services on

Tel: +44 (0) 1495 235800 or email: [email protected] immediately.

Frontier Therapeutics Ltd guarantees the equipment is free from defects in material and

workmanship, under normal 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 Ltd, 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 Ltd spares or replacement parts are used.

Frontier Therapeutics Ltd will not accept responsibility for damage caused by misuse, negligence,

accidental damage nor non-observance of the instruction set out within this document. This

warranty does not aect your statutory rights.

Fire Testing

The Toto lateral turning system platform meets the requirements of ‘The Furniture & Furnishings

(Fire) (Safety) Regulations 1988’. Meeting the requirements of BS 7175: 2008 for medium hazards.

Standards and Regulation

This Active Class II Device complies with the requirements of the MDD 93/42/EEC (as amended).

The Control Unit is tested to EC Directive 2004/108/EEC and EN 55011.

Other Standards

ISO 9001:2015 Quality Management Systems

ISO 13485:2016 Medical Devices - Quality Management Systems

No modiﬁcation of this equipment is allowed.

Technical Speciﬁcation

Toto Touch Technical Speciﬁcations

Power input - Europe AC 220 - 240VAC 50Hz, 0.2A

Power input - USA AC 100 - 120VAC 60Hz, 0.3A

Fuse rating T1AL250V

Compressor SAA-1

Air distributor Timing motor working as rotary valve

Control system Digital control system

Power consumption 14 Watt (typical) / 20 Watt (maximum)

Operation mode Non-continuous

Cycle control Distributor valve supplying air to the inﬂatable cells

Cycle time Adjustable 30 > 240 minutes

Pressure setting 120mmHg ± 10mmHg

Piping output 2

Max. load on platform 190Kg

Operating environment Air humidity 30% to 70%

Ambient temperature 10ºC to 40ºC Altitude ≤ 2000m

Storage/Transportation Environment air humidity 10% to 70%

Ambient temperature -10°C to 60°C Altitude ≤ 2000m

Classiﬁcation Class II equipment

Type B applied part

IP44

Toto lateral turning system is covered by UK patent no. GB 2449318

Toto lateral turning system is a registered trade mark of Frontier Therapeutics Ltd

Frontier Therapeutics Limited

Newbridge Road Industrial Estate,

Blackwood, Caerphilly

NP12 2YN United Kingdom

+44 (0) 1495 235800

[email protected]

www.frontier-group.co.uk

Tel:

Email:

Toto GP0133-A50-01 User manual

Toto GP0133-A50-01 User manual

Toto GP0133-A50-01 User manual

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