INVACARE DTEC011338 SoftCloud Air User Manual

INVACARE DTEC011338 SoftCloud Air

Specifications

• Control Unit Specifications: [Insert control unit specifications here]
• Mattress Specifications: [Insert mattress specifications here]
• Environmental Conditions: [Insert environmental conditions here]
• Guidance and Manufacturer’s Declaration: [Insert guidance and declaration here]

Product Information
The alternating mattress system is designed to provide pressure relief and prevent bedsores for individuals who are bedridden or have limited mobility. The system consists of an alternating pressure mattress and a control unit that regulates the airflow to the mattress cells.

Usage Instructions

Safety
Before using the alternating mattress system, read the user manual carefully and ensure that all safety precautions are followed.

• Safety Information: Familiarize yourself with the safety guidelines provided in the manual.
• Labels on the Product: Check for important labels indicating usage instructions and warnings.
• Symbols on the Product: Understand the symbols on the product that convey specific information.

Setup
Follow these steps to set up the alternating mattress system:

1. Safety Information: Ensure the setup area is clear of any obstacles.
2. Installing the Mattress System: Place the mattress on a flat surface and connect it to the control unit.
3. Activating the Control Unit: Turn on the control unit and adjust the settings as required.
4. Removing the Mattress System: Follow the reverse steps to disassemble the system if needed.

After Use
Proper maintenance after use is crucial for the longevity of the alternating mattress system:

• Storage: Store the system in a clean and dry environment when not in use.
• Reconditioning: Follow any reconditioning guidelines provided to maintain performance.
• Disposal: Dispose of the system responsibly following local regulations.

Troubleshooting
If you encounter any issues with the alternating mattress system, refer to the troubleshooting section in the manual for guidance on identifying and repairing faults.

FAQ

• Q: How often should I recondition the mattress system?
  A: Reconditioning frequency may vary based on usage, but it is recommended to follow the manufacturer’s guidelines for optimal performance.

This manual MUST be given to the user of the product. BEFORE using this product, this manual MUST be read and saved for future reference.
© 2023 Invacare Corporation
All rights reserved. Republication, duplication, or modification in whole or in part is prohibited without prior written permission from Invacare. Trademarks are identified by ™ and ®. All trademarks are owned by or licensed to Invacare Corporation or its subsidiaries unless otherwise noted. Making Life’s Experiences Possible is a registered trademark in the U.S.A. This manual MUST be given to the user of the product. BEFORE using this product, this manual MUST be read and saved for future reference.

Introduction

• This user manual contains important information about the handling of the product. To ensure safety when using the product, read the user manual carefully and follow the safety instructions.
• Only use this product if you have read and understood this manual. Seek additional advice from a healthcare professional who is familiar with your medical condition and clarify any questions regarding the correct use and necessary adjustment with the healthcare professional.
• Note that there may be sections in this document, which are not relevant to your product since this document applies to all available models (on the date of printing). If not otherwise stated, each section in this document refers to all models of the product.
• The models and configurations available in your country can be found in the country-specific sales documents.
• Invacare reserves the right to alter product specifications without further notice.
• Before reading this document, make sure you have the latest version. You find the latest version as a PDF on the Invacare website.
• If you find that the font size in the printed document is difficult to read, you can download the PDF version from the website. The PDF can then be scaled on the screen to a font size that is more comfortable for you.
• For more information about the product, for example, product safety notices and product recalls, contact your Invacare distributor. See addresses at the end of this document.
• In case of a serious incident with the product, you should inform the manufacturer and the competent authority in your country.

Symbols in this Document
Symbols and signal words are used in this document and apply to hazards or unsafe practices that could result in personal injury or property damage. See the information below for definitions of the signal words.

• WARNING
  Indicates a hazardous situation that could result in serious injury or death if it is not avoided.

• CAUTION
  Indicates a hazardous situation that could result in minor or slight injury if it is not avoided.

• NOTICE
  Indicates a hazardous situation that could result in damage to property if it is not avoided.

• Tips and Recommendations
  Gives useful tips, recommendations, and information for efficient, trouble- free use.

Other Symbols
(Not applicable for all manuals)

• UK Responsible Person
  Indicates if a product is not manufactured in the UK.

• Triman
  Indicates recycling and sorting rules (only relevant for France).

Compliance

• Quality is fundamental to the company’s operation, working within the disciplines of ISO 13485.
• This product features the CE mark, in compliance with the Medical Device Regulation 2017/745 Class I.
• This product features the UKCA mark, in compliance with Part II UK MDR 2002 (as amended) Class I.
• We are continuously working towards ensuring that the company’s impact on the environment, locally and globally, is reduced to a minimum.
• We only use REACH-compliant materials and components.
• We comply with the current environmental legislations WEEE and RoHS.

Warranty Information

• We provide a manufacturer’s warranty for the product per our General Terms and Conditions of Business in the respective countries.
• Warranty claims can only be made through the provider from whom the product was obtained.

Limitation of Liability
Invacare accepts no liability for damage arising from:

• Non-compliance with the user manual
• Incorrect use
• Natural wear and tear
• Incorrect assembly or set-up by the purchaser or a third party
• Technical modifications
• Unauthorized modifications and/or use of unsuitable spare parts

Service Life
The expected service life of this product is five years when used daily and following the safety instructions, maintenance intervals, and correct use, stated in this manual. The effective service life can vary according to frequency and intensity of use.

Safety

Safety Information
Education, clinical judgment, and action-based planning based on vulnerability are fundamental factors in the prevention of pressure injuries. A range of assessment scales can be used as a formal method of assessing risk from pressure injury development and should be used in conjunction with an informal assessment (informed nursing judgment). Informal assessment is considered to be of greater importance and clinical value.

WARNING!
Risk of Serious Injury or Damage
Improper use of this product may cause injury or damage.

• If you are unable to understand the warnings, cautions or instructions, contact a healthcare professional or provider before attempting to use this equipment.
• Do not use this product or any available optional equipment without first completely reading and understanding these instructions and any additional instructional material such as user manual, service manual or instruction sheet supplied with this product or optional equipment.

WARNING!
Risk of fire or explosion!
A cigarette can burn a hole in the bed surface and cause damage to the device. Also, patient clothing, bed sheets, etc. may be combustible and cause a fire. Failure to observe this warning can result in a severe fire, or property damage and cause physical injury or death.

• Take special care in oxygen-rich environments.
• Do not smoke.

WARNING!
Risk of Developing Pressure Injuries
The device delivers effective pressure redistribution when the support surface is covered with a cotton, cotton combination or linen bed sheet, and any one of these is the only item deployed between the support surface and the user.

• Bed sheets must be loosely fitted, with creases smoothed out.
• Ensure that the support surface in contact with the user is kept free from crumbs and other food debris and that drip cables, stents, and other foreign objects do not become entrapped between the support surface and the user.
• Heated-over blankets must only be used in consultation with a qualified healthcare professional, as an increase in temperature can increase the risk of developing pressure injuries.

CAUTION!
Risk of Injury
Non-original or wrong parts may affect the function and safety of the product.

• Only use original parts for the product in use.
• Due to regional differences, refer to your local Invacare catalog or website for available options or contact your Invacare distributor. See addresses at the end of this document.

Labels on the Product
The labels shown are for exemplification purposes alone. Note that the labels on your product might differ slightly from these examples.

Control Unit

Mattress / Cover
Since the identification labels on the mattress and cover may change depending on the model and date of manufacture, the labels for these components are not shown. For explanations of the symbols, which are printed on the mattress and cover, refer to the section Symbols on the product in this document.

Symbols on the product * Minimum/maximum user weight per model, see chapter Technical Data.

Product Overview

Intended Use

• This pressure redistribution mattress and control unit is intended to be used in conjunction with an appropriately sized bed frame.
• The mattress when in dynamic mode offers alternating pressure support.
• This product delivers effective pressure redistribution to users when the support surface is covered with a cotton, cotton combination, or linen bed sheet, and any one of these is the only item deployed between the support surface and the user.
• The Softcloud Top is an overlay mattress.
• The Softcloud Air is a mattress replacement system.

Intended Users

• Intended users are adults and adolescents with restricted or limited mobility and or activity in a hospital, long-term care or home care setting.

Indications

• Suitable for supporting the management of all categories of pressure injuries when combined with an individual and comprehensive pressure injury protocol.
• Suitable for use in-home care, residential, nursing, and acute care settings.

Contraindications

• Not suitable for users with unstable spinal cord fractures and/or cervical traction.
• Always consult a physician before using this device.

Product Description
The following components are included within the scope of delivery:

A| Mattress System including mattress base, CPR tag, connector, handle with transport cap attached, top cover with zip.
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B| Digital Control Unit
C| Carry Bag
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D| User Manual
| Medical Grade Power Cord (not shown)

• The control unit provides the air supply to the mattress. It is controlled via a touch panel. There is a visual and audible warning when pressure fails or power is interrupted.
• The control unit redistributes the pressure by alternately inflating and deflating cells. This enables a frequent repositioning of the pressure.

Control Unit

• A Power button
• B Lock / Unlock button
• C Alternation failure indicator
• D Low-pressure indicator
• E-Service indicator
• F Power loss indicator
• G Audible warning mute button
• H Max. firmness button
• I Pressure settings
• J Mode button and indicator

Mattresses
SoftCloud Top
The mattress overlay comprises of a support surface with single air cell layer which is to be used as an overlay only.
The mattress overlay includes three static head cells to provide static “pillow” support for optimum user comfort, while air pressure in the other cells is alternated.

NOTICE!

• Do not use the SoftCloud Top overlay without an afoam mattress as a base.

SoftCloud Air

• The mattress comprises high-density cells which all feature a permanently inflated internal cell to prevent the patient from “bottoming out” in the event of low pressure.
• The mattress includes three static head cells to provide static “pillow” support for optimum user comfort, while air pressure in the other cells is alternated.

Setup

Safety information
WARNING!
Electrical shock hazard!

• Do not remove the control unit shroud.
• Refer to qualified service personnel.
• Before performing any maintenance to the control unit, disconnect the power lead from the wall outlet.
• Do not insert items into any openings of the control unit. Doing so may cause fire or electric shock by shortening the internal components.
• The control unit must be kept away from all heat sources and radiators during operation.
• Connect the equipment to a two- or three-prong wall outlet using the five-meter power lead provided with the product.
• Position the device in such a way that ensures access to the power switch and CPR Connector at all times.

WARNING!
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.

• Do not modify this equipment without the authorization of the manufacturer.

WARNING!
Risk of entrapment!
Patient entrapment with the bedside rails may cause injury or death. A thorough patient assessment should be completed and monitored and the equipment should be used as specified and maintained to reduce the risk of entrapment. Variations in bedside rail dimensions, and mattress thickness, size, and density could increase the risk of entrapment.

• The mattress must fit the bed frame and side rails to prevent patient entrapment. Follow the bed manufacturer’s instructions.
• After any adjustments, repair or service and before use, make sure all attaching hardware is tightened securely. Side rails with dimensions different from the original equipment supplied or specified by the bed manufacturer may not be interchangeable and may result in entrapment or other injury.

WARNING!
This mattress is recommended to be installed on medical bed frames of an appropriate size with bedsides or assist rails, to accommodate the mattress. It is preferred that the rails are in the raised position whenever the patient is on the bed. Healthcare professionals assigned to each case should make the final decision on whether assist rails are warranted after assessing the patient’s risk of entrapment.
Controls on the footbed end may be obstructed by the control unit on a few bed frames. It may be necessary to relocate the control unit.

• Before placing the patient on the bed, check that the connector and power cord are clear of moving bed components.
• Operate all motorized bed frame functions through their full range of motion to be certain that there is no pulling, interference or pinching.
• Take care when positioning connectors and cables to eliminate the risk of tripping hazards or strangulation.

NOTICE!
Inappropriate handling can damage the mattress cover.

• It is recommended that two people lift/carry mattresses.
• Avoid contact with jewelry, nails, abrasive surfaces, etc.
• Do not drag mattresses.
• Avoid contact with walls, door frames, door catches or locks, etc.
• Do not transport in roll cages unless completely protected from the sharp edges of the cage.

Installing the Mattress System
NOTICE!

• Remove all packaging before use.
• Keep all packing materials and instructions in the carry bag provided in case the product has to be shipped to an Invacare Service Centre.
• Carefully remove the control unit, mattress, and accessories from the shipping cartons.
• Inspect all items for any damage that may have occurred during shipping. Any damaged or missing parts must be reported to an Invacare Service Centre immediately.

NOTICE!

• Ensure that the foot bed end is robust enough to support the control unit safely.
• Ensure there are no sharp objects which may come into contact with the mattress system.
• Check that the attachment of the mattress does not interfere with the movement or operation of the bed.
• Do not secure straps to bed side rails as straps will tear.
• Ensure that the positioning of the system does not interfere with the ability to disconnect the electrical power.
• Prior to activation ensure the CPR valve located near the head end of the mattress is fully engaged and that the mattress connector is firmly connected to the control unit.

SoftCloud Top

1. Remove all covers and sheets from the mattress of the bed.
2. Place the overlay directly on the foam base which is placed upon the frame of the bed.
3. Position the overlay top cover facing upwards and air hoses at foot of bed for control unit positioning.
4. Attach to the mattress of the bed with the elastic bands.

SoftCloud Air

1. Remove all covers, sheets and mattress from the bed.
2. Place the mattress directly on the frame of the bed.
3. Position the mattress top cover facing upwards and air hoses at foot of bed for control unit positioning.
4.  On a standard bed, attach to the bed by securing the two adjustable straps under each end of the bed. Ensure buckles are securely fastened and straps are pulled tight. Or
   On a profiling bed, secure the two adjustable straps around the moveable sections of the bed.

Activating the control unit

1. Position the control unit by hanging the hooks over the Position the control unit by hanging the hooks over the CAUTION!

   • Ensure the air hose does not kink between the bed frame and the control unit.

2. Connect the mattress connector to the control unit.
   NOTICE!
   Ensure that the power cord is in good condition.

3. Insert the power cord into the control unit then plug into a grounded 220V 50Hz electrical outlet.

4. Press the power button for approximately three seconds to activate the control unit.
   The pressure LEDs will flash indicating the system has activated.
   NOTICE!
   Before pump activation ensure the CPR valve located near the head end of the mattress is fully engaged.
   Ensure that the mattress connector is firmly connected to the control unit.

5. Allow approximately 30 minutes for the mattress to fully inflate. Once ready, you should see the fourth pressure LED plus alternating mode LED illuminate to indicate that the system is ready for use (system automatically defaults to Alternating Mode after start-up). For further details see 5.3 Using the mattress system, page 10.

6. Once the Mattress is fully inflated the bedding can be placed. Fit sheets loosely enough to allow for free movement of the mattress air cells.

7. Ensure each sheet corner is placed through the retaining buckle.

Removing the mattress system

1. Switch off the control unit and disconnect from mains supply A.
2. Remove the mattress connector B from the control unit and disconnect the CPR tag C.
3. Place control unit and power cord on top of the mattress and detach mattress from the bed frame.
4. Once air has been released from all cells, roll up the mattress and return all items to the carry bag for safekeeping.

NOTICE!

• Always follow the correct procedure when switching off the control unit. When the unit is switched off, it will issue a power loss alert. This alert can be canceled by pressing the power button for a minimum of two seconds.
• Prior to restarting the system, ensure the CPR tag is replaced and all sealing connectors are firmly attached; and that the mattress connector is replaced and firmly connected to the control unit.
• Use target design to line up each plug with its corresponding socket.

Usage

Safety Information
WARNING!
Insufficient repositioning of the patient can lead to tissue compression and potential injury formation.
To relieve pressure, it is very important for the patients to reposition themselves, or to be repositioned, regularly.

• Before using the product, always consult a qualified healthcare professional for clinical judgment.
• Monitor the patient frequently.

CAUTION!

• Make sure that the printed side of the mattress cover always faces upwards.
• Ensure that the distance between the surface of the mattress and the top of the side rail is at least 220 mm.

CAUTION!
Risk of damage to the mattress
If holes are present in the mattress cover, there is a risk that liquids may ingress and contamination may occur.

• Ensure that the mattress is not jammed or damaged by sharp edges.
• Do not place hypodermic needles, venflons, scalpels or other similarly sharp objects on or under the mattress.
• Do not use electrically heated blankets directly on or under the mattress.
• Ensure that all venflons are taped down correctly with no sharp edges exposed.
• When using bridging boards or other patient transfer aids, check for any sharp edges or burrs before use.
• When using the mattress on a profiling bed ensure that the knee break is used before the backrest.
• Attach medical equipment including infusion pumps and monitors to appropriate bed accessories.
• Avoid cigarette burns and pet claws puncturing the mattress cover.

Operating the Control Unit
Turning On and Off the Power

1. Press power button for approximately three seconds to turn on or off the power.

Switching the Mode

1. Press the mode button to switch between Alternation Mode (alternative cells cyclically inflating and deflating) and Static Mode (all cells fully inflated with no dynamic alternation). The bright LED indicates the active mode.
2. To activate or inactivate the CLP function (Continuous Low Pressure), press the mode button for two seconds.

Changing the pressure settings
Five pressure settings are available from soft (15 mmHg) to firm (55 mmHg) with steps of 10 mmHg.
When using the CLP function, the five pressure settings are from 15 mmHg to 23 mmHg with steps of 2 mmHg.

1. Press the Plus button (+) to increase pressure.
2. Press the Minus button (-) to decrease pressure.

The bright LEDs indicate the selected setting.
Locking and Unlocking buttons

1. Press Lock / Unlock button for approximately three seconds to lock all buttons on the control unit.
   A beep sounds and the amber LED illuminates to indicate the system is locked.

2. To unlock, press again for at least three seconds (beep sounds and amber LED turns off).

The control unit will automatically unlock in the event of a power failure.

Muting Audible Warning Signals
An audible warning signal can be muted while resolving the cause of the failure. If not resolved, the audible warning signal will resume after 17±3 minutes.

1. Press the mute button to mute an audible warning signal.

Enabling Rapid Inflation to Maximum Pressure

1. Press Max. firmness button to enable rapid inflation to maximum pressure (60 mmHg). To disable maximum pressure, press the button again for three seconds.
2. If not disabled, after 30±3 minutes the system will automatically revert back to alternation mode with medium pressure, for patient safety.

Using the mattress system
Establishing Pressure (supine / face up position)

1. When the mattress is fully inflated place the user onto the mattress.
2. Press the Pressure button to select the best setting for effective pressure relief and support, based on patient weight and comfort requirements.
3. Assess whether the patient is comfortable and the system is functioning correctly by performing a ‘bottoming out’ test.
4. The Auto adjust function is always in use when the system is operational.

Note
The system runs on the chosen setting but when the user changes and stays in a new position the pressure in the mattress can adjust (higher/lower). The sensor in the control unit will react and adjust the pressure if required to compensate for the new position.

Bottoming Out Test
When altering the pressure setting, ensure the patient is not ‘bottoming out’ (insufficiently supported by the air cells and therefore coming in contact with bed base).

1. Ensure the system is in alternation mode but is not undergoing an alternation.
2. With the patient lying in a supine position, unzip top cover just past the sacral (bottom) region.
   • a. For SoftCloud Air: Slide your hand along a deflated cell under the patient’s sacral area (bottom). The inner static cell will remain inflated but your hand should slide easily between patient and the base.
   • b. For SoftCloud Top: Slide your hand along a deflated cell under the patient’s sacral area (bottom). Your hand should slide easily between the patient and the base.
3. If hand can pass under the patient then the patient is adequately suspended and pressure can be lowered.
4. Repeat the Bottoming Out test after the pressure has been lowered.

In the event of a system malfunction, the alarm will activate and pressure LEDs will flash.

Establishing Pressure (inclined position)
The Auto Adjust function is always in use when the system is operational. The system runs on the chosen setting but when the user changes and stays in a new position the pressure in the mattress can adjust (higher/lower). The sensor in the control unit will react and adjust the pressure if required to compensate for the new position.

NOTICE!

• Return to the original pressure setting when the patient returns to the supine position, and perform a Bottoming Out test.
• Wait a minimum of 10~12 minutes between pressure adjustment and patient assessment, as it may take a full cycle for the system to adjust to any new setting.

CPR Procedure

1. Firmly pull the yellow rapid-release CPR tag A from the side of the mattress to deflate the whole system.

2. Switch off the control unit.
   The mattress will start to deflate.

3. When CPR is complete replace the yellow CPR Tag ensuring the sealing connectors are firmly attached and restart the control unit following chapter “Activating the control unit”. Using the target design to line up each plug with it’s corresponding socket.

NOTICE!

• Wait for the mattress system to gain optimal pressure.
• Perform a “bottoming out” test after inflating the mattress following rapid deflation.

Audible Warning Functions

• The audible warning LED flashes, and an audible warning sounds, to indicate that the control unit or mattress pressure has failed. The LED will remain illuminated until appropriate pressure is restored. The audible warning can be silenced by pressing the audible warning mute button.
• The system has four different audible warning signals and one service indicator, identified by five different symbols. The symbols are illustrated below.

silence) and a flashing LED light when there is no alternation. The LED light will change to a fixed light within 5 min.
| Low Pressure| Indicates that pressure has fallen below the tolerance limit (below setting pressure –5 mmHg) or more. This will trigger the audible warning (press the mute button to silence) and a flashing LED light. The LED light will change to a fixed light within 7 min.
Display| Audible Warning Signal| Description
---|---|---
| Power failure| Indicates no pressure output due to mains power failure. This will trigger the audible warning (press mute

button to silence) and a flashing LED light. The LED light will change to a fixed light within 3 seconds.

When the power is back on, the audible warning and the LED light will revert to normal mode.

| Initial failure (the mute button LED will be constantly lit)| Indicates that the system did not complete initialization within 50

minutes, the mute button LED light will have a fixed light.

| Service indicator| Indicates that service is needed, the LED light will have a fixed light. This will occur when the control unit has been running for approximately 9000 hours.

If an audible warning activates and the system fails to inflate or loses pressure, refer to the section “Identifying and repairing faults”.

Transporting a patient on the mattress

1. Before patient transport, press the Mode button and wait at least 12 minutes for cells to inflate to maximum pressure.
   If a quicker response is required (up to 5-10 minutes), then use the Max Firmness button.

2. Once mattress pressure has reached maximum inflation, press the Power button to switch off the control unit. Switch off mains supply and unplug the power cord.

3. Remove the connector from the control unit and allow air to escape for a few seconds before inserting the transport cap into the connector air outlets to seal the system. This release softens the mattress surface for pressure relief and comfort. Ensure the cap is firmly secured across both air hose outlets.

CAUTION!
Air pressure is released from all internal static cells as well as alternating sections.

• Regularly perform a “bottoming out” test to ensure the patient is appropriately supported.

Maintenance

Inspection
It is recommended to check mattresses (air cells and cover) for strike-through (this may include fluid ingress, stains, rips or damage) after the release of each patient or after each period of use by a suitably qualified and competent person.
Check mattresses

1. Unzip the cover completely.
2. Check for any staining on the white underside of the cover.
3. Check for any staining on the internal elements.
4. Replace any stained items and dispose of as per local authority procedure.

Cleaning and Disinfection
General Safety Information

CAUTION!
Risk of Contamination

• Take precautions for yourself and use appropriate protective equipment.

CAUTION!
Risk of Electric Shock and Product Damage

• Switch off the device and disconnect from the mains, if applicable.
• When cleaning electronic components consider their protection class regarding water ingress.
• Make sure that no water splashes to the plug or the wall outlet.
• Do not touch the power socket with wet hands.

NOTICE!
Wrong fluids or methods can harm or damage the product.

• All cleaning agents and disinfectants used must be effective, and compatible with one another and must protect the materials they are used to clean.
• Never use corrosive fluids (alkalines, acid etc.) or abrasive cleaning agents. We recommend an ordinary household cleaning agent such as dishwashing liquid, if not specified otherwise in the cleaning instructions.
• Never use a solvent (cellulose thinner, acetone etc.) that changes the structure of the plastic or dissolves the attached labels.
• Always make sure that the product is completely dried before being use again.

For cleaning and disinfection in clinical or long-term care environments, follow your in-house procedures.

Cleaning Intervals
NOTICE!
Regular cleaning and disinfection enhance smooth operation, increase the service life and prevent contamination.
Clean and disinfect the product

• regularly while it is in use,
• before and after any service procedure,
• when it has been in contact with any body fluids,
• before using it for a new user.

NOTICE!

• Keep a cleaning record as part of cleaning the system.

Cleaning Instructions
NOTICE!

• The product does not tolerate cleaning in automatic washing plants, with high-pressure cleaning equipment or steam.

A cleaning record should be kept as part of cleaning the system.

Cleaning control unit

1. Wipe down the control unit casing and hose fittings with a damp cloth and suitable detergent.
2. Using a nylon brush, gently clean all crevices as they can harbor microorganisms.
3. Wipe off the control unit casing and hose fittings with a damp cloth to remove all detergent.
4. Air dry all treated surfaces.

Cleaning hangers

1. Wipe down the exterior of the hangers periodically, using a damp cloth and suitable detergent.

Cleaning covers
(Removal of contaminants such as dust and organic matter)

1. Remove all covers for laundering.
2. Launder the covers with maximum temperature as stated on the product label, using a diluted detergent solution (Instructions on label).

NOTICE!
Washing at higher temperatures will cause shrinkage.

Drying covers

1. Hang covers from a line or bar and drip dry in a clean indoor environment or tumble dry on a low heat setting.

NOTICE!

• Tumble dry setting must not exceed 40 °C.
• Do not tumble dry for longer than 10 minutes.
• Dry thoroughly before use.

Disinfection Instructions
NOTICE!

• Only use disinfectants and methods approved by your local infection control institution and follow your local infection control policy.
• Additional information on recommended disinfectants can be found on https://vah-online.de/en/for-users.

Disinfecting the Control Unit

1. Wipe down all generally accessible surfaces with a cloth and disinfectant.
2. Allow the product to air-dry.

Disinfecting the Air Cells
NOTICE!

• Do not disconnect the pipes from individual air cells.
• Do not machine wash or dry the air cells.

1. Disconnect air cells from the base by unfastening the press studs at each end.
2. Disconnect air pipes from main air hoses.
3. Slide each cell out from the cell straps.
4. Swab with a cloth damped with warm water containing an appropriate disinfectant (dependent on infection control protocols and local market requirements).
5. Dry thoroughly with a soft cloth before refastening.

Service
NOTICE!

• The service indicator will be activated when the control unit has been running for approximately 9.000 hours, indicating that service is needed.

NOTICE!

• Do not attempt to repair or service the control unit yourself! Always contact an authorized service technician.

Replacing the air filter
NOTICE!
Good filter maintenance is critical to maintaining your mattress system in optimal operating condition. Failure to keep the filters clean will result in system downtime and increase repair costs. It is recommended that the air filter is replaced annually. Replacement air filters are available from an Invacare Service Centre.

1. Turn off the power supply to the control unit.
2. Disconnect the power cord 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 shroud. Remove and discard the filter and attach it with a new filter.
5. Re-attach the air filter shroud to the control unit.
   The control unit is now ready for re-connection.

Replacing fuse
CAUTION!

• Ensure the replacement of fuses is carried out per local legislation.
• Always use the same fuse rating when replacing a defective fuse.

1. Turn off the power supply to the control unit.
2. Remove the power cord from the electrical socket on the side of the control unit.
3. Insert a flat screwdriver into the small cutout above the power cord inlet.
4. Pull the screwdriver carefully to open the plastic carrier.
5. Remove and discard the “blown” fuse.
6. Insert a new fuse and close the plastic carrier.
7. Reverse steps four to one to reinstate the fuse carrier.
   See also the section “Activating the control unit” for more information.

After Use

Storage
NOTICE!

• Store the device in a dry environment.
• Store the device within a protective cover.
• Carefully roll up the device and store it on a clean, dry (off-floor) surface with no sharp edges to prevent possible damage.
• Never store other items on top of a device.
• Do not store devices next to radiators or other heating devices.
• Protect the device from direct sunlight.

For environmental conditions for storage, see “Environmental conditions”.

Reconditioning
This product is suitable for reuse. To recondition the product for a new user, carry out the following actions:

• Inspection according to the service plan
• Cleaning and disinfection

For detailed information about inspection, cleaning and disinfection, refer to 6 Maintenance, page 13.

Disposal

WARNING!
Environmental Hazard
The device contains batteries.
This product may contain substances that could be harmful to the environment if disposed of in places (landfills) that are not appropriate according to legislation.

• DO NOT dispose of batteries in normal household waste.
• DO NOT throw batteries into a fire.
• Batteries MUST be taken to a proper disposal site. The return is required by law and free of charge.
• Only dispose of discharged batteries.
• Cover terminals of lithium batteries before disposal.
• For information on the battery type see the battery label or Chapter 9 Technical Data, page 17.

Be environmentally responsible and recycle this product through your recycling facility at its end of life. Disassemble the product and its components, so the different materials can be separated and recycled individually. The disposal and recycling of used products and packaging must comply with the laws and regulations for waste handling in each country. Contact your local waste management company for information.

Troubleshooting

Identifying and Repairing Faults
WARNING!
Electric shock hazard!
Opening the control unit could cause personal injury or equipment damage. – Do not try to open the control unit.

NOTICE!
If the problem is not resolved, contact an Invacare provider or Invacare representative.

attached to a power source

A fuse may need replacing in the control unit

| 1.      Check that the control unit is connected to mains power outlet with the correct voltage.

2.       Check that the control unit is switched on.

3.      Check the mains plug fuse. Check both control unit fuses (1 amp slow blow fuse) – fuses can be released using a screwdriver to push and turn.

The patient is sinking or “bottoming out” whilst lying flat on the Mattress| The pressure may be set too low for the patient’s weight| 1.       Increase the pressure setting by pressing up the pressure arrow.

2.       To check effective system performance, perform a “bottoming out” test. See section “Using the mattress system”.

Audible Warning Mute LED lights up permanently

| Initial failure| 1.       Mute the audible warning and turn off power.

2.      Check that the handle is intact, ensuring all four sealing connectors are firmly attached to control unit and air hoses. Check the CPR Tag is attached and all four sealing connectors are firmly secured.

3.      Check all air hoses along the inside of the mattress – each should be firmly connected. Check each air cell is securely attached to its connecting air pipe.

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

5.       Turn on Power.

Low-pressure indicator LED lights up

+ audible warning

| Pressure too low| 1.       Mute the audible warning and turn off power.

2.      Check that the handle is intact, ensuring all four sealing connectors are firmly attached to control unit and air hoses. Check the CPR Tag is attached and all four sealing connectors are firmly secured.

3.      Check all air hoses along the inside of the mattress – each should be firmly connected. Check each air cell is securely attached to its connecting air pipe.

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

5.      Check that the air filter shroud is correctly secured and the air filter is clean.

6.       Turn on Power.

Alternation Failure indicator LED lights up

+ audible warning

| Alternating Mode Failure (no alternation)| 1.       Mute the audible warning and turn off power.

2.      Disconnect the air hoses to reduce pressure – reconnect when pressure has decreased.

3.      Restart the system by switching the power button off and on. The system automatically starts in Static Mode and will switch to Alternating Mode when operational pressure is reached.

4.       Reset the personal settings.

Power loss indicator LED lights up

+ audible warning

| Power failure| 1.       Mute the audible warning.

2.      Check that the power cable is firmly plugged into the mains outlet and the control unit. Check that the mains power is switched on.

3.      Check both control unit fuses (1 amp slow blow fuse) – fuse can be released using a screwdriver to push and turn.

If power is restored within 20 minutes of failure, the system will run an initial start up sequence before returning to the last settings.

Service Indicator LED lights up

| Service needed| 1.  Contact an Invacare provider or Invacare representative.

There is no risk for continued use even if the Service Indicator LED lights up.

Technical Data

Control Unit Specifications

the inflatable cells
Cycle Time| 12 minutes
Supply Voltage| 220-240V 50/60Hz
Air Capacity| 10 lpm
Noise level| Below 30dB
Fuse Rating| 1A / 250V
Battery Source| VARTA, V80H, 1.2 V DC, 70 mAh
Power Rating| max.     1A
Control Unit Dimensions: Length

Width Height

| ****

123 (±10) mm

243 (±10) mm

250 (±10) mm

Control unit weight| 2.4 kg
Hose Connection| Push on connection handle
Emergency| CPR Tag
Mode of Operation| Non-continuous
Degree of protection| IP21 — Protected against solid objects over 12.5 mm e.g. hands, large tools.

Protected against vertically falling drops of water or condensation.

Mattress Specifications

cell) including 3 static head cells
Cell Height| 130 mm| 180 mm
Mattress Dimensions: Length

Width Height

| ****

2000 mm

830 mm

130 mm

| ****

2000 mm

880 mm

130 mm

| ****

2000 mm

830 mm

180 mm

| ****

2000 mm

880 mm

180 mm

Mattress weight| 5.5 kg| 6.5 kg| 8.2 kg| 10.2 kg
Minimum/Maximum User Weight| 0 – 200 kg
Cell Material| 0.15 mm TPU film laminated on 210 denier nylon fabric
---|---
Base Material| Nylon fabric 420 denier with a 0.1 mm TPU coating
Cover Material| 100% Polyurethane surface, 100% Polyester inside

Environmental Conditions

non-condensing

| 10% – 70%,

non-condensing

Atmospheric pressure| 70 – 106 kPa| 70 – 106 kPa

Guidance and Manufacturer’s Declaration
The mattress system is intended for use in the electromagnetic environment specified below. The customer or the user of the mattress system should ensure that it is used in such an environment.

Electromagnetic Emissions

Emission test| Compliance| Electromagnetic environment – guidance
---|---|---
RF emissions CISPR 11| Group 1| The mattress system use RF energy only for their internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The mattress system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions

IEC 61000-3-3

| Complies

Electromagnetic Immunity

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact

±15 kV air

| ±8 kV contact

±15 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/ burst

IEC 61000-4-4

| ±2 kV for power supply lines| ±2 kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge

IEC 61000-4-5

| ± 1 kV line(s) to line(s)| ±1 kV differential mode| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| <5% UT (>95% dip in UT)

for 0.5 cycle

40% UT (60% dip in UT)

for 5 cycles

70% UT (30% dip in UT)

for 25 cycles

| <5% UT (>95% dip in UT)

for 0.5 cycle

40% UT (60% dip in UT)

for 5 cycles

70% UT (30% dip in UT)

for 25 cycles

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the mattress system requires continued operation during power mains interruptions, it is recommended that

the mattress system be powered from an uninterruptible power supply or a battery.

 | <5% UT (>95% dip in UT)

for 5 sec

| <5% UT (>95% dip in UT)

for 5 sec

|
Power frequency (50 Hz) magnetic field

IEC 61000-4-8

| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Conducted RF

IEC 61000-4-6

| 3 Vrms

150 kHz to 80 MHz

| 3 Vrms| Portable and mobile RF communications equipment should be used no closer to any part of the CT515, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d = 1.167√P

d = 1.167√P 80 MHz to 800 MHz d = 2.333√P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya), should be less than the compliance level in each frequency rangeb).

Interference may occur in the vicinity of equipment marked with the following symbol:

Radiated RF IEC 61000-4-3| 3 V/m

80 MHz to 2.5 GHz

| 3 V/m
Recommended separation distances between portable and mobile RF communications equipment and the mattress system Alternating Control Unit

The mattress system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the mattress system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the mattress system as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of the transmitter (W)| Separation distance according to frequency of the transmitter (m)
 | 150 kHz to 80 MHz

d = 1.167√P

| 80 MHz to 800 MHz

d = 1.167√P

| 800 MHz to 2.5 GHz

d = 2.333√P

0.01| 0.117| 0.117| 0.233
0.1| 0.369| 0.369| 0.738
1| 1.167| 1.167| 2.333
10| 3.689| 3.689| 7.379
100| 11.667| 11.667| 23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Australia:
Invacare Australia Pty. Ltd. Unit 18/12 Stanton Road, Seven Hills, NSW 2147, Australia
Phone: 1800 460 460 Fax: 1800 814 367 orders@invacare.com.au www.invacare.com.au

Invacare UK Operations Limited Pencoed Technology Park, Pencoed Bridgend CF35 5AQ
UK
Invacare Portugal, Lda
Rua Estrada Velha 949
4465-784 Leça do Balio
Portugal

References

• | Invacare GB
• | Invacare DK
• | Invacare ES
• | Invacare IT
• | Invacare PT
• | Invacare SE

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