User Manual
26 Pages
Preview
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pioneering simplicity
Special Products and Service
®
®
Toto Lateral Turning System, with Toto Touch Control Unit
User guide User guide Version 4.0 April 2021 www.frontier-group.co.uk www.easycaresystems.co.uk
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 © 2021 2019 Frontier Therapeutics Limited. All rights reserved.
Easy Care Systems Limited Units 5 and 6 Lower Vicarage Road Southampton Hampshire SO19 7RJ T: 02380 420678 E: [email protected] W: www.easycaresystems.co.uk
Frontier Therapeutics Limited Newbridge Road Industrial Estate, Blackwood, Caerphilly, NP12 2YN, UK +44 (0) 1495 235800 E [email protected]
Version 4.0 April 2021 GP0113_A56_04
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www.frontier-group.co.uk
English
User guide
Toto® Lateral Turning System Labelling
250
65ºc for 10 minutes or 73ºc for 3 minutes
Bleaching agent allowed
Maximum user weight
Do not pierce or cut
Line dry
Do not iron
Keep dry
Refer to user manual
CE Mark
Type BF applied part
! Class II electrical equipment
Caution symbol
Air leak
Air hoses blocked
Service interval
Interface lock
Audio pause
Fragile handle with care
Do not tumble dry
Disposal: Do not dispose of this product as unsorted domestic waste. It must be sent to a separate collection facility for recovery and recycling.
European Authorised Representative
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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 Ltd Customer Services on +44 (0)330 460 6030.
Toto Touch Control Unit
Toto Platform
•
1x Toto Touch control unit.
•
1x Platform including a fitted cover.
•
1x Control unit power lead.
•
1x CPR deflation valve and tubing set.
•
1x User guide.
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1x Pair of air cells with quick connectors.
•
1x 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.
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2
5
1
6. Air leak alarm. 7. Blockage alarm. 3
8. Service indicator. 9. Interface lock indicator.
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6
8
7
9
Contents
Kit Contents
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Product Specifications
7
Intended Purpose
8
Alarms and Alerts
17
CPR Emergency Deflation System
19
Nature and Frequency of Preventative Maintenance
21
Cleaning and Disinfection
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Cleaning Air Filters
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Warranty
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Technical Specification
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Product Specifications
Toto Lateral Turning System - Standard: a fully customisable control unit and patient turning platform.
Toto Platform 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)
Product
Depth (flat position - air cells empty) mm (Inches)
Depth (raised position - air cells inflated) mm (Inches)
CPR Deflation Valve
Standard
35 (1.4)
185 (7.3)
Quick Release Pull Tag
Toto Touch Control Unit Specifications Dimensions (width / depth / height) – mm (inches)
240 (9.5) x 100 (4) x 200 (8)
Weight - kg (lbs)
2.2 (4.8)
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
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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® is an automated lateral turning system supporting healthcare professionals in the regular turning of patients, who are at risk of developing pressure ulcers or injuries. 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 digital control unit, and a multiple patient use turning platform, which is positioned underneath the patients’ mattress to effectively relieve pressure over patients’ most vulnerable areas. The digital control unit provides customised care with a user-determined side selection feature and accurately timed digital 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 meaning management of heavier patients becomes easier and less onerous on staff. Toto can be used in conjunction with support aids and sleep systems, an individual assessment must be carried out to assess for suitability. Bedsides should be used to help prevent patient egress and to increase the feeling of security, see warnings and precautions for further information. Toto does not replace pressure relieving and redistribution surfaces and is supplementary to their use.
Indications Toto is a supplementary device for the prevention of pressure ulcers or injuries 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.
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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 Any change in skin condition that causes concern, should be reported to a healthcare professional.
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.
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Ensure the Toto platform is fully deflated before attempting to leave the bed.
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Engage therapy pause mode during hygiene procedures and when over-bed tables are being used to avoid the risk of spillages.
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When elevating a profiling bed back rest, raise the knee break first.
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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.
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The system should not be used without a mattress.
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Do not strap the mattress to the bed frame as this will prevent Toto from operating.
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If mattress overlays are being used, these must be securely fastened to the mattress, not the Toto platform.
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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.
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Evacuation hammocks must be placed between the Toto platform and the mattress.
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If using foot board protectors, assess for compatibility.
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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.
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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).
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The use of bedsides or bed rails is recommended.
•
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)
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Bottom of the bed rail <120mm (Diagram 2)
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When inflated, assess the distance between the tilted side of the mattress and bed rail. This should be <120mm. (Diagram 3)
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Assess for risk of entrapment
≥ 220mm
Bed Sides Mattress / Support Surface Toto Platform Bed Frame
DIAGRAM 1. VIEW FROM SIDE
Bed Sides Mattress / Support Surface Toto Platform
≤ 120mm
Bed Frame
DIAGRAM 2. VIEW FROM SIDE
≤ 120mm
Bed Sides Mattress / Support Surface Toto Platform Bed Frame
DIAGRAM 3. VIEW FROM HEAD
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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 https://www.frontier-group.co.uk.
Instructions for Use Before use, please read the following instructions. Should you have any queries, please contact Frontier Therapeutics Ltd. on +44 (0) 330 460 6030 or visit our website www.frontiergroup.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. 3. Ensure the air cells within the platform are secured in position via the popper fastenings by unzipping the cover and visually inspecting. 4. If required, re-fit the cover and close the zip ensuring the air cell 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. 5. 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. 6. Check the CPR deflation valves are securely in place to ensure no air leaks. 7. Replace the mattress on top of the platform. DO NOT strap or fasten the mattress to the bed frame. 8. Using the bed hooks, hang the control unit on the bed footboard. 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. 10. Connect the control unit to mains power via the lead supplied.
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.
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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 the bed footboard.
G. Connect the control unit to the mains power via the lead supplied.
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 selfsupport, and they are in the middle of the bed. When using bedsides, consider the use of padding, bumpers or net infills.
Centre Line
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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.
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.
INFLATE TIME
2
180 min 120 min
L&R
touch
4
240 min
1
60 min 30 min
R
L
5 30 min 60 min 120 min 180 min 240 min
3
REST TIME
Turning the Toto Touch Control Unit On •
Press and hold the start/stop button (1) 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.
INFLATE TIME
240 min
1
180 min L&R
touch
R
120 min 60 min 30 min
30 min 60 min 120 min 180 min 240 min
L
REST TIME
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Air Cell Inflation Selection •
Press the side selection button (2) 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.
INFLATE TIME
2
240 min 180 min 120 min
L&R
touch
60 min 30 min
R
30 min 60 min 120 min 180 min 240 min
L
REST TIME
Changing the Air Cell Inflation Time •
•
Press the inflate time button (3) 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 the lit option LED’s.
INFLATE TIME
240 min 180 min 120 min
L&R
touch
60 min 30 min
R
L
30 min 60 min 120 min 180 min 240 min
3
REST TIME
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Changing the Air Cell Rest Time •
•
Press the rest time button (4) 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 the lit option LED’s.
INFLATE TIME
4
240 min 180 min L&R
touch
R
120 min 60 min 30 min
30 min 60 min 120 min 180 min 240 min
L
REST TIME
Once settings have been selected, lock the interface by pressing the interface lock button (5), confirmed by the padlock LED (9) 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 (1) 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 (5), repeat this process until Therapy Pause Mode is no longer required.
•
To deactivate, press the start/stop button (1). A single beep confirms deactivation and the control unit returns to the previously selected settings. INFLATE TIME
240 min
1
180 min L&R
touch
R
120 min 60 min 30 min
5 30 min 60 min 120 min 180 min 240 min
L
REST TIME
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Interface Lock The interface lock prevents any unwanted changes to the control unit settings. •
Press and hold the alarm mute button (5) for four seconds.
•
Confirmed by the padlock LED (9) 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 (5) for four seconds.
•
Deactivation is confirmed by the padlock LED (9) turning off, and a double beep.
INFLATE TIME
240 min 180 min L&R
touch
R
120 min 60 min 30 min
5 30 min 60 min 120 min 180 min 240 min
L
REST TIME
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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 (5).
If a new alarm condition occurs when paused, the initial alarm terminates and a new alarm will activate.
INFLATE TIME
240 min 180 min L&R
touch
R
120 min 60 min 30 min
5 30 min 60 min 120 min 180 min 240 min
L
REST TIME
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Alarms and Alerts The Toto Touch control unit has three integrated alarms and one information alert to ensure patient safety and efficacy. Alarms and Alerts
Alarm Condition
Air Leak Alarm The pressure in the system has fallen below the minimum operational requirements, i.e. an air leak.
Low priority
Blockage Alarm Airflow between the control unit and the platform is prevented, i.e. a blocked air hose.
Low priority
Indicated by an audible alarm and:
Air Leak LED permanently lit yellow (when activated) (6).
Blockage LED permanently lit yellow (when activated) (7).
Service Interval Service required; default at one-year n/a use.
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 150HZ to 1000HZ. While troubleshooting, the alarm can be muted for up to 10 minutes. If the fault is not corrected during this time, the alarm reactivates. 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 remainder audio signal comes from a buzzer. Alarm activation may take up to two minutes from when the alarm state occurs.
INFLATE TIME
240 min 180 min L&R
touch
R
120 min 60 min 30 min
5 30 min 60 min 120 min 180 min 240 min
L
REST TIME
17
6 7
8
System Error Trouble Shooting Guide Problem No LEDs lit; no audible • alarm heard. •
Cause
Initial Checks / Trouble Shooting
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 off 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 Ltd Tel. +44 (0)330 460 6030 for assistance.
Air-leak alarm • LED (6) lit permanently yellow with an audible alarm.
Pressure has fallen below the minimum operational requirements.
1. 2. 3. 4.
Press the alarm pause button. Check the CPR valve is closed and correct. Check all air cells and hoses for any air leakage. Resolve and wait for the alarm to reset.
If the problem persists, contact Frontier Therapeutics Ltd Tel. +44 (0)330 460 6030 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 Ltd Tel. +44 (0)330 460 6030 for assistance.
Service LED (8) • permanently lit amber.
Service required.
Please contact Frontier Therapeutics Customer Services for support Tel. +44 (0)330 460 6030 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 Ltd Tel. +44 (0)330 460 6030 for assistance.
An audible alarm is sounding; no LEDs lit.
• • •
Loose or absent power lead. Mains power accidentally turned off 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 Ltd Tel. +44 (0)330 460 6030 for assistance.
Do not open the control unit. Opening the unit could cause personal injury or equipment damage. NB. The Toto Touch control unit self calibrates on start up.
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8
7
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CPR Emergency Deflation System The Toto system features a quick release CPR 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 CPR tag ensuring both sealing connectors are firmly attached and restart the Toto Touch control unit.
CPR Deflation Valve Closed
CPR Deflation Valve Open
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Inspection and Care The Toto lateral turning system cover, platform assembly, air cells, CPR 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. 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: +44 (0)330 460 6030. 1. Switch off the control unit and disconnect from mains power. 2. Disconnect the air hoses from 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 popper fastening. 5. Inspect the platform for other signs of damage, including the potential source of the damage. 6. Fit the new air cell ensuring it is in-line with the correct section and secure in place with the popper fastening. 7. Replace the cover ensuring correct orientation and feed air cell hoses through the opening at the bottom. 8. Reattach the hoses using the quick connectors - ‘Red to Red’ - ensuring they are not twisted or kinked.
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