ARJOHUNTLEIGH Bari-Breeze User Manual

Contents Introduction...1 About this Manual... 1 About Bari-Breeze... 1 Bari-Breeze Mattress... 2 Clinical Applications...5 Indications... 5 Contraindications... 5 Precautions for Use... 5 Installation and Setup...6 Warnings... 6 Installation... 6 CPR Facility...8 Controls, Alarms and Indicators...9 Controls and Indicators... 9 Alarms... 10 Operation...11 Initial Power Up... 11 Comfort Controls... 11 Static Mode... 11 Turn Options... 12 Turn Times... 12 To Deflate and Store the Bari-Breeze Mattress... 12 Decontamination...13 Troubleshooting Guide...14 Spare Parts...16 Warranty and Service...17 Technical Data...18

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General Safety Before you connect the system pump to a mains socket, read carefully all the installation instructions in Section 3 - Installation. The system has been designed to comply with regulatory safety standards including: • EN60601-1:1990/A13:1996 • UL60601-1 1st Edition • CAN/CSA C22.2 No 601.1-M90 Safety Warnings • The cover of this product is vapour permeable but not air permeable and may present a suffocation risk. It is the responsibility of the care provider to ensure that the user can use this product safely. • Electrical equipment may be hazardous if misused. The front and rear case of the pump unit should only be separated by authorised technical personnel. • Do not use the pump in the presence of flammable gases such as anaesthetic agents. Precautions For your own safety and the safety of the equipment, always take the following precautions: • Keep the pump away from sources of liquids and do not immerse in water. • Do not expose the system, especially the mattress, to naked flames, such as cigarettes etc. • Do not store the system in direct sunlight. • Switch off the electrical supply to the pump by disconnecting the pump from the mains socket before cleaning and inspection. • Ensure the system is clean and dry prior to storage. • Never use sharp objects or electrically heated under blankets on or under the system. • Store the pump and mattress in the protective bags supplied. • Only the pump and mattress combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if the incorrect pump or mattress combinations are used.

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Caution Electromagnetic compatibility (EMC). This product complies with the requirements of applicable EMC Standards. The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance.

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1. Introduction About this Manual

This manual is your introduction to the Bari-Breeze® system. Use it to initially set up the low air loss system, keep it as a reference for day-to-day routines, and as a guide to maintenance.

About Bari-Breeze

The Bari-Breeze is designed to maintain a constant low pressure support surface. Bolsters situated along each side of the mattress are designed to provide comfort and support for patients when the system is operating in Turn mode. A single safety air pad provides protection from the effects of bottoming out. By controlling the level of pressure in all of the cells, consistent levels of turn are achieved whilst maintaining the integrity of the support surface in contact with the patient. The Bari-Breeze pump is fully programmable and provides the following modes of operation: • Static Mode (Default) - When Turn therapy settings

are set to , the system remains flat, providing a continuous low pressure surface. • Turn (Rotation) Mode - Provides an angled support surface to assist with nursing procedures. • Firm Mode (Maxflow) - Provides a firm support surface (for 15 minutes) to facilitate nursing procedures and/or patient handling. The Bari-Breeze cover is water resistant and vapour permeable to enhance patient comfort whilst protecting the cells from ingress of contaminants. The cover is simple to clean in situ, but may easily be removed for laundering, preventing cross contamination. In the event of cardiac arrest the mattress replacement can be easily deflated to allow cardiac resuscitation procedure (CPR) to be performed.

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Bari-Breeze Mattress

Cover

Pump Connector

Safety Air Pad Plug

A self contained mattress replacement system with easily detachable components for cleaning.

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Cells Tubeset

21 polyurethane cells approximately 200mm (8”) high providing support to the patient. Manufactured from material to reduce accidental kinking.

Tubeset Connector/CPR

Located at the pump end of the tubeset is a specially designed twin snap lock connector. This design helps prevent accidental disconnection of the mattress from the pump. Releasing the connector allows the air to escape from the cells in approximately 10 seconds to facilitate CPR.

Cover

The mattress is totally enclosed in a double zipped cover. The top and sides of the cover are constructed from a two-way stretch and water resistant material, which is vapour permeable for maximum patient comfort. The base of the cover is constructed from a tough abrasion resistant material and is fitted with bed attachment straps.

Safety Air Pad

A 50 mm (2”) thick sub-mattress made of a single airfilled cell enclosed in the base to support the patient in the event of loss of air pressure in the mattress.

Bolsters

Two safety side air bolsters provide comfort and support during Turn mode.

Safety Air Plug

The safety air plug is used to deflate both the side bolsters and safety air pad. It is located close to the tubeset/pump connector.

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Bari-Breeze Pump

Mounting Hooks

Integrated mounting hooks fitted to the rear casing allow easy positioning of the pump from the bed foot rail.

Keypad

The keypad is angled to provide the user with a clear visual display. An LED display and individually illuminated control buttons give precise indications of the status of the system at any point in time.

LED Display

Highly visible and bright 7 segment blue LED digital display panel.

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2. Clinical Applications Indications

The Bari-Breeze system is indicated for patients weighing between 22-455Kgs (50-1000 lbs), including those assessed to be at high risk of developing pressure ulcers and for all grades of pressure ulcer up to and including grade 4 (EPUAP, 1998)1 for Europe, (NPUAP, 1989)2 for USA.

Contraindications

Patients with unstable spinal fractures should not be placed on the Bari-Breeze system.

Precautions for Use

In the case of patients with unstable fractures advice should be obtained from the appropriate physician before using the Bari-Breeze system.



A risk assessment tool combined with clinical judgement should be used when determining a patient’s level of risk of developing pressure ulcers. Patient risk assessment should be an ongoing process as changes in the patient’s condition may increase or decrease their risk level.



The above are guidelines only and should not replace clinical judgement or experience.

1. European Pressure Ulcer Advisory Panel (1998). Pressure Ulcer Treatment Guidelines, British Journal of Nursing 7(r5):888-9. 2. National Pressure Ulcer Advisory Panel (1989), Clinical Practice Guideline, Number 3, AHCPR, US Department of Health & Human Services, 1992.

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3. Installation and Setup Warnings

The following warnings should be taken note of before installing the Bari-Breeze system. WARNING

The Bari-Breeze system must be installed on bed frames that are equipped with Safety Sides. Please raise safety sides on the bed and lock them in position after the patient is on the mattress. NEVER LEAVE A PATIENT UNATTENDED ON THE MATTRESS SYSTEM WITH THE SAFETY SIDES IN THE DOWN POSITION. WARNING Never use sharp objects or electrically heated underblankets on or under the mattress. WARNING Make sure that the mains power cable is positioned to avoid causing a hazard and is clear of moving bed mechanisms or other possible entrapment areas. Installation

The following components should be found within your Bari-Breeze packaging: • Bari-Breeze Mattress Replacement • Pump • User Manual • Power Cord 1. Before using the Bari-Breeze mattress replacement system, please remove all other mattress systems from the bed. 2. When installing the Bari-Breeze mattress, care should be taken such that the mattress is placed directly on the bed frame.



Make sure that the tubeset end of the mattress is towards the foot end of the bed.

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3. There are ten nylon black straps with buckles, on the base of the mattress. Loop each strap around the bed frame and fasten it securely to the bed frame using the buckle.



If the bed can be profiled to any position (i.e. raised or lowered), attach the mattress to the movable parts of the bed only. 4. Open the hooks on the back of the pump and suspend the pump from the bed foot rail. If the bed you are using does not have a foot rail, place the pump on its base (not on its back where the filter is located) on a flat surface underneath the bed near the foot of the bed frame.



Care should be taken such that the air inlet vent on the pump is not covered, and the pump is not placed on the floor in such a manner that it is a hazard.

5. Plug the power cord into the pump and press it in place. Uncoil the power cord and plug the cord into a properly grounded AC power source. 6. Securely attach the pump connector onto the pump until it clicks, and make sure the side bolster and safety air pad plug is secure.



Care should be taken such that the mattress hose is freely suspended without being pinched or kinked. 7. If not already fitted, place the protective cover over the mattress and secure in position. Make sure the ArjoHuntleigh logo is uppermost and at the foot end of the mattress. 8. Push the Power/Standby button to turn the pump on and enter the required therapy settings, see “Controls, Alarms and Indicators” on page 9. 9. Unzip the cover and ensure the cells, side bolsters, and the base pad are all fully inflated. Refit cover. 10. Place a bed sheet loosely over the mattress before use.

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4. CPR Facility IMPORTANT In the event of cardiac arrest, depress the two release catches on the tubeset/pump connector, and at the same time pull the tubeset out and away from the pump.

Located on the right hand side of the pump is a CPR device marked with an arrow. In the event of cardiac arrest, press the two quick release catches on the tubeset/pump connector, and simultaneously pull the hose away from the pump. To reinflate the mattress

1. Switch the pump into standby mode and reconnect the tubeset and safety air pad plug if removed. Switch the pump on and reset the therapy settings.

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5. Controls, Alarms and Indicators Controls and Indicators LED Display

Comfort Control (Firm)

Comfort Control (Soft)

Turn Angle Button/Indicator Turn Time Button/Indicator

Turn Options Button/Indicator Max Flow (Fast Inflate)

Lock Out Button/Indicator Power/Standby

Standby

Power/Standby

When the pump has power but is in Standby mode, the 7 segment LED display will show a single bar. Press the Power/Standby button to turn the pump on.

Press to enable maximum air flow from the pump. A blue LED on the button will indicate that Max Flow is active. When used during mattress installation, the mattress will inflate to its normal size within 60 seconds. If Max Flow ‘F’ is selected when the system is operating in Turn mode then Turn mode will be deselected and the indicator will show . Unless deactivated, Max Flow will remain active for 15 minutes. After this, the comfort level will revert to the previous setting, and remain in Static mode. Turn Options The button selects the turn settings of the mattress. Each press of the button selects the next setting. For instance, to change the mattress from Bi-lateral Turn ( ) to Static ( ) position, press the button twice until is selected. In Left Turn ( ) mode the right air cushions in the mattress will be held at a constant high pressure, and the left air cushions will be held at a constant low pressure. This process is reversed for the Right Turn ( ) mode. When is selected, the system will alternate between left and right turn, stopping in the central (dwell) position. During this time the display will show ‘d’. Max Flow



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Turn Times

The time selected for the turn is the amount of time (in minutes) the mattress will remain in each position during the selected turn sequence.

Turn Angle

Four settings are available to select the amount of turn given to the patient. These are selected using the turn angle button , where 4/4 is equal to approximately 40 degrees.

Comfort Control Level

These controls adjust the firmness of the mattress. Using the button reduces the pressure setting, and the button increases it. The current comfort level (1-9) will be displayed in the LED display.

Lock Out

Pump functions (including power/standby switch) can can be locked out to prevent unintentional change of modality / cell pressures. To activate, press the lock button for approximately 2-3 seconds until the blue LED illuminates. To deactivate, press and hold the lock out button until the LED turns off.

Alarms Power Fail

In the event of a power fail situation, the pump will alert the carer by flashing the amber Power Fail LED and sounding the buzzer. Once the power is restored to the pump the alarm will cease and the pump will return to its previous operating settings.

Low Pressure

In the event of hose disconnection, an ‘L’ and ‘P’ will alternate on the LED display (representing "Low Pressure") while the buzzer sounds to alert the carer to the alarm condition. Once the hose is reconnected, the alarm will cease and the pump resume its previous therapy settings.

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6. Operation Before using the Bari-Breeze mattress system, make sure it has been installed correctly in accordance with “Installation and Setup” on page 6, and ensure that the side bolster and base plug is secure in the connector at the foot end of the mattress. Initial Power Up



Press the power/standby button to turn the pump on. An audible beep will sound and the current comfort level, turn time, turn mode, and turn angle will be displayed.

These may reflect the therapy settings that were applied last time the system was in use. Comfort Controls

Once the mattress is fully inflated and with the patient in position, adjust the comfort controls to the desired level. Perform a four finger check as follows: Place four fingers between the air cushions directly underneath the sacral region of the patient's body.



There should be a minimum of 4 finger width clearance between the bottom of the patient and the safety air pad.

Recommended Pressure Settings

For extra firm support during patient handling or nursing procedures, it is recommended to set the mattress ). pressure to maximum by pressing MAX FLOW ( When the patient is to be placed in the gatched position, it is also recommended to press the button to ensure the patient does not bottom out. In the case of a patient who has an above average weight to height ratio, it is recommended to increase the pressure/comfort level accordingly. Static Mode Max Flow

Pressing the button sets the blower to maximum flow, fully inflating the mattress overriding the comfort control. This feature is only available in static mode. If pressed during Turn mode, it will revert the system to Static mode and return the patient to a central position. Comfort settings however, are retained. Max Flow inflates the mattress to maximum pressure for

15 minutes, and this will be indicated by a blue LED and an ‘F’ being shown in the LED display.

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To cancel Max Flow and to enter Turn mode settings, button once. To continue Max Flow for press the more than 15 minutes, press once to cancel, and quickly again to enter Max Flow for a further 15 minutes. After 15 minutes, Max Flow is automatically cancelled.



For extra firm support during patient addition/removal, wound care, patient turning, or patient hygiene procedures, it is recommended to set the mattress pressure to max by pressing button. Turn Options



Uni-Lateral Turn

To enter uni-lateral Turn mode, press the button to cycle through until or is indicated, this is confirmed by the illuminated blue LED.

Bi-lateral Turn

To enter bi-lateral Turn mode, press the button until is indicated, this is confirmed by the illuminated blue LED.

Selecting Max Flow will cancel any Turn options set, resulting in the system returning to the Static ( ) setting. Turn Times



To set therapy turn times, press the button until the desired time is indicated, this is confirmed by the illuminated blue LED.

Turn times are only considered when the pump is operating in Turn mode.

To Deflate and Store the Bari-Breeze Mattress To deflate the Bari-Breeze mattress:

1. Activate the CPR control to deflate the mattress. 2. Remove the side bolster and safety air pad plug from the connector on the mattress hose assembly. To store the mattress

Following deflation: Roll the mattress from the head end toward the foot end, ensuring the tubeset lies safely within the mattress.

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7. Decontamination The following processes are recommended, but should be adapted to comply with the local or national guidelines (Decontamination of Medical Devices) which may apply within the Healthcare Facility or the country of use. If you are uncertain, you should seek advice from your local Infection Control Specialist. The Bari-Breeze system should be routinely decontaminated between patients and at regular intervals while in use; as is good practice for all reusable medical devices. WARNING Remove the power cord from the mains supply before cleaning and decontamination. Caution Do not use Phenol-based solutions or abrasive compounds or pads during the decontamination process as these will damage the surface coating. Do not boil or autoclave the cover. Avoid immersing electrical parts in water during the cleaning process. During Use

It is recommended that were practical, all parts of the system (including mattress, top cover, pump, and tubeset) should be cleaned weekly whilst in use.

To clean

Wipe all exposed surfaces with a cloth which has been moistened in simple detergent and water. Ensure to remove any organic debris that may be adherent to the surfaces. Dry.

To disinfect

Wipe all cleaned surfaces with a solution which contains a chlorine-releasing agent diluted up to a strength of 10,000 parts per million (depending on local policy): an example is sodium hypochlorite. Dry. Alternatively use a cloth moistened with alcohol (70%) and allow to air dry.

Laundering

The mattress cover can be easily unzipped for complete removal to allow laundering at 65°C for 10 minutes or 80°C for 3 minutes to achieve thermal disinfection. This complies with HSG (95) 18 Hospital Laundry arrangements for used and infected linen (UK) 1995. DO NOT TUMBLE DRY COVERS ABOVE 30°C.

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8. Troubleshooting Guide The following table contains fault symptoms, their possible causes and suggests steps to rectify the problem. These may occur during initial installation and power up. Symptom

Possible Cause

Check

Action

Pump keyboard does not respond.

Lock out is on preventing set up.

Lock out button LED illuminated.

Press and hold the lock button until the LED extinguishes.

Mattress does not inflate when the system is switched on.

Pump is left in standby mode, indicated by a single dash on the LED display.

If the pump is plugged into a power socket, a dash will be visible on the LED display to indicate standby mode. Check status of LED display.

Turn on the pump unit.

Blower failure within pump unit.

Check to ensure blower is generating airflow through the manifold connector.

If blower has failed call a Service Engineer to replace the blower/pump unit.

Hose-set connection not correctly fitted.

Check to ensure the hose connector clicks into place.

Re-connect hose connection to pump, ensuring firm fitment.

Bolster/SubMattress plug not fitted correctly or failing.

Check plug is fitted correctly in hose manifold.

Ensure plug is firmly located.

No turn angle set.

Therapy Settings.

Firm inflate activated.

Maxflow LED illuminated.

Dwelling in centre (check turn time).

Check status of LED display.

If LED display is illuminated with ’d’ mattress is dwelling.

Therapy is set for left or right turn only.

Ensure bilateral therapy setting has been set.

Enter Bi-lateral therapy settings.

Both setting may not be illuminated.

For bilateral turn ensure

Maxflow

LED display showing ‘F’.

Mattress inflates but appears to be noisy as if a leak has appeared in the tube-set connection with the pump.

Mattress inflates but doesn't appear to turn.

Mattress inflates but only appears to turn to one side.

Mattress turns but then suddenly stops mid cycle.

Replace if neccesary. Check integrity of plug.

is activated (LED illuminated).

activated.

Dwelling in centre (check turn time).

If the LED display is blank, check integrity of power supply at the wall socket.

Check status of LED display.

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Set Turn angles.

Press the button to deactivate, and enter required therapy settings.

If not, press

to select

and ensure the LED illuminates. Press the button to deactivate, and set turn angles. If LED display is illuminated with ’d’ mattress is dwelling.

Symptom

Possible Cause

Mattress appears to be bottoming out.

Comfort Control Settings too soft.

Assess comfort control settings.

Adjust as necessary.

Patient Weight.

Check patient weight is within limit for system.

Refer to User Manual. Page 4 Indications.

Air leak from manifold.

Check connections.

Remove connection, and reconnect.

Loose hose connector.

Check connections in tubeset connector.

Reconnect if possible, otherwise call Service Engineer.

Torn or damaged cell.

Check.

Call service engineer to replace damaged cell.

Blower motor inside pump sounds excessively noisy during continuous use.

The blower inside the pump unit may be approaching the end of its life.

Check to ensure the mattress is fully inflated.

Call service engineer to request a replacement pump unit (if rental system).

Mattress appears to ignore therapy settings

Pump is not responding to therapy settings.

Check.

Reset Pump and re-enter therapy settings.

Blower Unit Sounds noisier than usual.

Check

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Action