ARJOHUNTLEIGH NIMBUS 4 AND NIMBUS PROFESSIONAL Instructions for Use Oct 2009

Contents General Safety... iii Introduction... 1 About this Manual... 1 About Nimbus 4 and Nimbus Professional... 1 Nimbus Pump... 2 Nimbus 4 Mattress... 2 Nimbus Professional Mattress... 3 Mattress CPR and Transport Controls... 3 Clinical Applications... 4 Indications... 4 Contraindications... 4 Cautions... 4 Care of the patient when sitting... 4 Installation... 5 Preparing the System for Use... 5 Installing the Nimbus 4 or Nimbus Professional Mattress... 5 Installing the Pump... 6 Testing the Power Fail Alarm... 7 Connecting the Tubeset... 8 Disconnecting the Tubeset... 8 System Operation... 8 Controls, Alarms and Indicators... 9 Pump Controls... 9 Pump Indicators... 10 Operation... 12 Installing the System... 12 Inflating the Mattress... 12 Comfort Control... 12 Operating Modes... 12 Mattress Vent Valves... 13 Guidelines for Selecting Vent Valves to Open... 13 Transport Control... 14 Deflating the Mattress... 14 CPR Control... 15 Nimbus Professional Mattress: Patient Positioning Guide... General... Supine Position... Prone Position...

16 16 17 18

Decontamination... 19

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Routine Maintenance... 21 Nimbus 4 and Nimbus Professional Systems... 21 Nimbus Pump... 21 Nimbus 4 and Nimbus Professional Mattresses... 21 Serial Number Labels... 21 Troubleshooting... 22 Technical Description... 23 Pump... 23 Accessories... 24 Mattress... 24 Cleaning Symbols... 25 Cover Options and Features... 26 Cover Specification... 26

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GENERAL SAFETY Before you connect the system pump to a mains socket, read carefully all the installation instructions contained within this manual. The system has been designed to comply with regulatory safety standards including: • EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995 • UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90

Safety Warnings • It is the responsibility of the care giver to ensure that the user can use this product safely. • Whilst the patient is unattended, safety sides should be used based on clinical assessment and in line with local policy. • Alignment of the bed frame, safety sides and the mattress should leave no gap wide enough to entrap a patient's head or body, or to allow egress to occur in a hazardous manner where entanglement with the mains power cable and tubeset or air hoses may result. Care should be exercised to prevent occurrence of gaps by compression or movement of the mattress. Death or serious injury may occur. • Make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas. Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable. • Electrical equipment may be hazardous if misused. There are no user-serviceable parts inside the pump. The pump's case must only be removed by authorised technical personnel. No modification of this equipment is allowed. • The mains power socket/plug must be accessible at all times. To disconnect the pump completely from the electricity supply, remove the plug from the mains power socket. • The CPR control and/or the CPR indicator tag must be visible and accessible at all times. • Disconnect the pump from the mains power socket before cleaning and inspecting. • Keep the pump away from sources of liquids and do not immerse in water. • Do not use the pump in the presence of uncontained flammable liquids or gasses. • The cover of this product is vapour permeable but not air permeable and may present a suffocation risk. • Only the pump and mattress combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and mattress combinations are used. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Due to the inherently lower flame retardancy of the high performance eVENT®1 fabric, it is NOT suitable for use in the homecare environment. Precautions For your own safety and the safety of the equipment, always take the following precautions: 1. eVENT® is a registered trademark of BHA Technologies Inc.

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• Placing extra layers between the patient and the mattress potentially reduces the benefits provided by the mattress and should be avoided or kept to a minimum. As part of sensible pressure area care, it is advisable to avoid wearing clothing which may cause areas of localised high pressure due to creases, seams, etc. Placing objects in pockets should be avoided for the same reason. • Do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc. • In the event of a fire, a leak in the seat or mattress could propagate the fire. • Do not store the system in direct sunlight. • Do not use phenol-based solutions to clean the system. • Make sure the system is clean and dry prior to use or 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.

Electromagnetic Compatibility (EMC) This product complies with the requirements of applicable EMC Standards. Medical electrical equipment needs special precautions regarding EMC and needs to be installed in accordance with the following instructions: • The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance. • Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell phones) can affect medical electrical equipment. • If this equipment needs to be used adjacent to other electrical equipment, normal operation must be checked before use. • For detailed EMC information contact ArjoHuntleigh service personnel. Environmental Protection Incorrect disposal of this equipment and its component parts, particularly batteries or other electrical components, may produce substances that are hazardous to the environment. To minimise these hazards, contact ArjoHuntleigh for information on correct disposal. Service Information ArjoHuntleigh recommend that this system should be serviced every 12 calendar months or, where applicable, when the service indicator is illuminated. Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. © ArjoHuntleigh 2009.

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1. Introduction About this Manual

This manual is your introduction to the Nimbus® 4 and Nimbus Professional systems. Use it to initially set up the system, and keep it as a reference for day-to-day routines and as a guide to maintenance.

About Nimbus 4 and Nimbus Professional

Nimbus 4 and Nimbus Professional are highly effective

Dynamic Flotation Systems providing active therapy for the prevention, treatment and management of pressure ulcers. The systems comprise a pump and mattress replacement which can be used on standard hospital and normal domestic beds. Beds with divided sections for independent elevation of a patient's head and/or knees can be adjusted with these mattresses in position. Both systems use the same Nimbus pump, which has two operating modes: • Dynamic mode that cycles the support surface beneath the patient every 10 minutes providing periods of pressure relief for the whole body. • Static mode where the support surface remains constant (all cells equally inflated). The Nimbus Professional mattress combines all the qualities of the Nimbus range of mattresses with the added benefit of optional head cell deflate; this will assist the clinician with a range of nursing procedures including prone nursing, intubation, neck cannulation and hygiene, while the body of the mattress continues to provide optimal alternating pressure redistribution. Both mattresses have been designed with specialised Vent Valves, so that some of the cells (including the three head cells on the Nimbus Professional mattress) can be selectively deflated to assist with pressure area care and patient management. The mattresses incorporate an advanced AutoMatt® sensor pad which ensures the patient is automatically supported at optimum pressures regardless of size, height, position or weight distribution. Both mattresses incorporate the five Heelguard® cells at the foot end of the mattress which ensure that the patient’s heels are provided with the maximum pressure relief. If cardiac arrest occurs, the mattresses can be rapidly deflated using the CPR (Cardio-Pulmonary Resuscitation) Control to allow cardiac resuscitation procedures to be performed.

Caution Federal law restricts this device to sale by or on the order of a physician.

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Nimbus Pump Mains Power Switch

Carry Handle Alarm Indicators Comfort Control

Mains Power Cable

Tubeset Connector

Front Panel Static Control

Mute Control

Nimbus 4 Mattress 5 Heelguard Cells 8 Torso Cells

4 Thigh Cells CPR/Transport Control

3 Head Section Cells (Constant Pressure)

FOOT END

HEAD END

5 Vent Valves Carry Handle Drag Handle Detachable Cover

Securing Strap Cable Management Flap

2

CLOSED

OPEN

Nimbus Professional Mattress Shoulder Support (4th) Cell (Alternating, No Vent Valve) 3 Head Section Cells (Alternating Pressure)

5 Heelguard Cells 3 Thigh Cells CPR/Transport Control

8 Torso Cells

FOOT END

HEAD END

19 Vent Valves Carry Handle Drag Handle Detachable Cover

Securing Strap Cable Management Flap

CLOSED

OPEN

Mattress CPR and Transport Controls CPR Control

Transport Control

FAST DEFLATE

CP

NORMAL

NORMAL

TRANSPORT

TRANSPORT

R 1 2

3

Tubeset Connector

Pump Tubeset

 This is common to both Nimbus 4 and Nimbus Professional mattresses, and is at the foot end of the mattress on the opposite side to the Vent Valves.

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2. Clinical Applications Indications

The Nimbus 4 and Nimbus Professional systems are indicated for the prevention and management of all categories1 of pressure ulcer when combined with an individualised monitoring, repositioning and wound care programme. The Nimbus 4 and Nimbus Professional mattress is designed for patients weighing up to 250 kg (550 lb).

Contraindications

Do not use Nimbus 4 and Nimbus Professional systems for patients with unstable spinal fractures.

Cautions

If patients have other unstable fractures, or conditions which may be complicated by a soft or moving surface, advice should be sought from an appropriate clinician before use. While the Nimbus 4 and Nimbus Professional systems have been designed to manage patients up to the weight limits indicated above, those approaching this upper limit are likely to have additional care and mobility needs and may be better suited to a specialist bariatric system. Active therapy (alternating) cushions may be unsuitable for patients with poor sitting posture or pelvic deformity; advice from a seating specialist should be sought.

Care of the patient when sitting



Seated patients are at increased risk of pressure ulcers particularly if they are immobile or have wounds over the seating area. For optimal outcome, provide a pressure redistributing seat cushion in a chair which promotes a good sitting posture and has a level base seat to support the cushion, in addition to an individualised repositioning programme.

The above are guidelines only and should not replace clinical judgement. The Nimbus 4 and Nimbus Professional systems represent one aspect of a pressure ulcer management strategy; if existing wounds do not improve or the patients condition changes the overall therapy regimen should be reviewed by the prescribing clinician. Mattress and cushion combinations may have different upper weight limits. Cushions should be used in combination with pressure-redistributing mattresses to provide 24-hour therapy.

1. NPUAP/EPUAP International Pressure Ulcer Guideline, 2009.

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3. Installation The Nimbus 4 and Nimbus Professional systems are very simple to install using the following guidelines.

 Refer to Section 4, Page 9 “Controls, Alarms and Indicators” for a comprehensive description of the controls and indicators on the pump. Preparing the System for Use

1. Remove the system from the packaging. You should have the following items: • Nimbus pump, with integral mains power cable and bed bracket. • Nimbus 4 mattress replacement or Nimbus Professional mattress replacement. • Tubeset.

Installing the Nimbus 4 or Nimbus Professional Mattress 1. Remove the conventional mattress from the bed frame and check that there are no protruding bed springs or sharp objects on the bed frame surface.

 Heavily ridged bed baseboards may require special considerations for correct system operation consult your ArjoHuntleigh representative. 2. Unroll the mattress onto the bed base and make sure that the CPR is at the foot end, and the CPR label is hanging freely. 3. Attach the mattress to the bed frame using the new fastener straps, as shown. These 8 fastener straps can be moved to any of the 10 anchor points on the base of the mattress, to allow for attaching the mattress to different types of bed frame.

 If the bed has divided sections for independent elevation of a patient's head and/or knees, attach the mattress to the movable parts of the bed frame only. 4. To make sure that the pressure relieving properties are not impaired, the mattress cover must not be pulled tight and covering sheets should fit loosely. 5. Make sure that ALL the Vent Valves are closed:

Closed

5

Open

6. Make sure the CPR control is closed and locked in position and the Transport control is set to NORMAL. FAST DEFLATE

CP

NORMAL

NORMAL

R 1

TRANSPORT

TRANSPORT

2

3

CPR Control

Installing the Pump

Transport Control

1. If the pump is to be hung from the end of the bed, make sure that the bed bracket is securely attached to the pump, and then attach the pump and bed bracket to the bed frame.

2. Alternatively the pump can be placed underneath the bed, either upright or lying on its back.

Cable Management

3. Insert the connector on the end of the mains power cable into a suitable mains power outlet. The mains power cable should be put through one of the cable management flaps which are on each side of the mattress base cover, as follows: 1. Locate one of the cable management flaps. 2. If necessary, open the press studs along the flap. 3. Run the mains power cable along the side of the mattress securing the flap round the cable using the press studs.

Press Stud Cable Management Flap

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Testing the Power Fail Alarm

The Power Fail Alarm is powered by a rechargeable battery. The duration of the alarm will depend on the level of charge in the battery. The battery may have become discharged or reached the end of its life. It is therefore recommended that the alarm is tested when the pump is installed, as follows:

 Refer to Section 4, Page 9 “Controls, Alarms and Indicators” for a comprehensive description of the controls and indicators on the pump. 1. Connect the pump to the mains power supply, switch on the pump and allow it to run for 10-15 seconds. 2. Remove the mains power at the wall socket without switching the pump off. 3. The power fail alarm should operate within 10 seconds, as follows: • The red Alarm triangle will flash. • The Power indicator will flash. • An audible warning will sound. 4. The alarm will continue until the mains power is resumed or the pump is switched off using the Power switch on the pump control panel. 5. If the alarm does not operate, run the pump for approximately four hours to recharge the battery. 6. Retest the alarm after the battery has been recharged. Allow the alarm to operate for approximately two minutes to ensure that it has been adequately recharged. 7. If the alarm does not operate for two minutes, call the service engineer.

 If the Power Fail Alarm does not operate after this test and a service engineer has been called, the pump can continue to be used with regular checks of the Power-On status. All other alarms will continue to function as normal.

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Connecting the Tubeset

To connect the tubeset to the mattress and pump: 1. Locate the bottom of the tubeset connector onto the bottom of the pump/mattress connector. 2. Pull the top of the tubeset connector up and over the top of the pump/mattress connector, until the tubeset connector “clicks” into position. 3. Make sure both connections are secure. 2

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Disconnecting the Tubeset

To disconnect the tubeset from the mattress and pump: 1. Move the tubeset connector down by pulling the tubeset extrusion downwards, and then pull the bottom of the tubeset connector away from the bottom of the pump/mattress connector. 2. Lift the top of the tubeset connector off the top of the pump/mattress connector.

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System Operation

The system is now ready for use. Refer to Section 4, Page 9 “Controls, Alarms and Indicators” and Section 5, Page 12 “Operation” for day-to-day operating instructions.

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4. Controls, Alarms and Indicators Power Switch & Reset Alarm

Mute Control & Indicator

On/Reset Alarm Indicator Static Control & Indicator

Pump Controls Power Switch (and Reset Alarm)

Alarm Indicator

High Pressure Indicator

Low Pressure Indicator

Wait Indicator

Service Indicator

Comfort Control

Power Fail Indicator

Pump Fault Indicator

The pump front panel has the following controls: Switches the mains power to the pump on and off. The green indicator is illuminated when the mains power is connected and the pump switched on. The switch is also used to reset the pump after an alarm condition has been detected.

Static Mode

Alarm Mute

Comfort Control

Selects the operating mode, either Static or Dynamic. Static mode is confirmed when the yellow indicator on the button is illuminated. When Dynamic mode (default) is selected the yellow indicator will be extinguished. An Alarm Mute button is provided to cancel warning sounds during an alarm condition.

The Nimbus 4 and Nimbus Professional systems automatically compensate for patient weight distribution and position, to optimise the pressure relieving performance. However, the mattress cell pressure can be manually adjusted for patient comfort using the rotary Comfort Control. Turn the Comfort Control clockwise for a firmer setting and counterclockwise for a softer setting.

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Pump Indicators On / Reset Alarm

Static Mode Alarm Mute

The pump front panel has the following indicators: The green On / Reset Alarm indicator below the Power switch is illuminated when the mains power is connected and the pump switched on. The indicator on the Static button is illuminated when Static mode has been selected for operation. The indicator on the Mute button is illuminated when an audible alarm has been silenced.

 The indicator will NOT be illuminated when a Power Fail alarm is muted.

Wait

High Pressure

Low Pressure

The Wait indicator is illuminated when the mattress is being inflated. The indicator will remain illuminated until the mattress has been fully inflated. This may take up to 15 minutes. The High Pressure indicator is illuminated whenever the pump detects high pressure within the mattress. If this condition occurs, the air supply from the pump is switched off until normal pressure is detected. After 2 seconds of normal pressure being detected the indicator is switched off and the air supply restarted. The Low Pressure indicator is illuminated whenever the pump detects low pressure within the mattress. This may indicate that there is insufficient pressure to support a patient or that the Transport control is turned to the Transport position whilst the pump is on and connected to the mattress.

Alarm

The Low Pressure indicator will be switched off once normal pressure is reached. The pump unit incorporates a sophisticated alarm detection system that differentiates between patient movement and genuine alarm conditions. Whenever an alarm condition is detected the red Alarm triangle starts flashing together with an indicator of the cause of the alarm. Additionally, an audible warning will sound, which can be cancelled by pressing the Alarm Mute button (Refer to “Alarm Mute” on page 9). The triangular Alarm symbol is displayed with one or more of the following indicators: • Low Pressure (refer to “Low Pressure” on page 10). • High Pressure (refer to “High Pressure” on page 10). • Pump Fault (refer to “Pump Fault” on page 11). 10

• Power (refer to “Power Fail” on page 11).  For all alarm conditions except Power Fail, once the alarm condition has been detected and displayed, it can only be cancelled by switching the pump unit off and then back on.

Pump Fault

Power Fail

Refer to Section 9, Page 22 “Troubleshooting” for possible causes of the above alarm conditions. The Pump Fault indicator is illuminated when an internal pump malfunction is detected. The fault can only be rectified by carrying out a service on the pump. The Power indicator will flash when a mains power failure has been detected. The alarm will continue until the mains power is resumed or the pump is switched off using the Power switch on the pump control panel. The Power Fail Alarm is powered by a rechargeable battery. The duration of the alarm will depend on the level of charge in the battery. The battery may have become discharged or reached the end of its life; it is therefore recommended that the alarm is tested before the pump is used (refer to “Testing the Power Fail Alarm” on page 7).

 If the Power Fail Alarm does not operate after this

Service Indicator

test and a service engineer has been called, the pump can continue to be used with regular checks of the Power-On status. All other alarms will continue to function as normal. The Service Indicator symbol will be illuminated after a set number of running hours to indicate that the pump is ready for a service. This service period is set to 12 months run time.

 The pump will continue to operate normally even when the Service Indicator symbol is illuminated.

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5. Operation These instructions cover day-to-day operation of the system. Other operations, such as maintenance and repair, should only be carried out by suitably qualified personnel.

 Refer to Section 4, Page 9 “Controls, Alarms and Indicators” for a comprehensive description of the controls and indicators on the pump. Installing the System

Before using the Nimbus 4 or Nimbus Professional system make sure that it has been installed correctly in accordance with Section 3, Page 5 “Installation”. • The CPR unit on the mattress is closed and locked in position. • The Transport control on the mattress is set to Normal.

• ALL Vent Valves on the mattress are closed. Inflating the Mattress

1. Connect the pump to the mains power supply and switch on the pump. 2. The pump will now run a self test for approximately 3 seconds when all the indicators on the front panel will be illuminated. 3. Once normal operating pressure has been reached both the Low Pressure and Wait lights will extinguish.

 It may take up to 15 minutes to inflate the mattress. Comfort Control

Adjust the Comfort Control to the patient’s requirements.

Operating Modes

The system has two operating modes: • Dynamic mode provides the optimum pressure relieving performance and should be used in most cases. In Dynamic mode the support surface beneath the patient is cycled every 10 minutes. • Static mode provides a stable, non-moving support surface (all cells are equally inflated). • The pump defaults to the Dynamic operating mode when switched on. Select the required operating mode.

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Mattress Vent Valves

On the Nimbus 4 and Nimbus Professional mattresses, the Vent Valves along the side of the mattress offer further operating modes to assist with pressure area care and patient management: 1. Nimbus 4 mattress has only 5 Vent Valves in the Heelguard section at the foot end of the mattress. 2. Nimbus Professional mattress: • The 3 Head Section cells have Vent Valves. • The 8 Torso cells, 3 Thigh cells and 5 Heelguard cells have Vent Valves. • The single Shoulder Support (4th) cell has no Vent Valve and cannot be deflated. 3. During system operation, open individual Vent Valves on the Torso, Thigh and/or Heelguard cells to deflate the cell and assist with pressure area care and patient management, including everyday interventions such as CXR imaging.

Nimbus Professional Mattress - Vent Valves Head End

Foot End Head Cells

Torso Cells

Thigh Cells

Heelguard Cells

Shoulder Support Cell

Guidelines for Selecting Vent Valves to Open The following guidelines should be adhered to when selecting Vent Valves to open on the Nimbus 4 and Nimbus Professional mattresses: 1. For permanent off-loading/pressure relief:



• Select no more than one cell directly under the area you want to relieve (head, torso, calf or heel section). • Open the Vent Valve to deflate the cell. This single cell can be left permanently deflated.

2. For temporary nursing procedures: • Select one or more adjacent cells. • Open the Vent Valve(s) to deflate the cell(s). • Once the nursing/clinical procedure is complete re-inflate the cell(s) by closing the Vent Valve(s). 13

 Deflating more than one adjacent cell may affect the support of the patient during the normal alternating cycle, so should only be used for temporary procedures. 3. For complex patient needs, you can off-load more than one area on the patient for longer periods, but with the following restrictions:

 Transport Control

• Deflate only one cell in the torso section. • Deflate only one cell in the calf/heel section. • Deflate only one cell in the Head Section when the patient is in the supine position, or all three cells in the Head Section when the patient is in the Prone position. Do not deflate any more cells in each area or it may affect the support of the patient during the normal alternating cycle.

This sets the mattress into Transport mode where the mattress is sealed and the support surface is equally pressurised; the pump and/or tubeset can then be removed. In this mode the mattress will support the patient for up to 12 hours. To set Transport mode: 1. Turn the Transport control knob clockwise to Transport. 2. Turn the pump off and disconnect the tubeset.

 If the Transport control is set to Transport with the tubeset connected and the pump switched on, the pump will indicate a Low Pressure fault alarm. To resume normal operation: 1. Re-connect the pump and tubeset to the mattress. 2. Turn the Transport control knob counterclockwise to Normal. Deflating the Mattress

To deflate and store the mattress, do the following: 1. Switch off the pump, and disconnect the pump from the mains power supply. 2. Remove the tubeset from the pump and mattress. 3. Activate the CPR control. 4. Make sure the Transport control is set to Normal. 5. Roll up the mattress, starting at the foot end.

 Make sure the mattress is dry before rolling it up. 14

CPR Control IMPORTANT IN THE EVENT OF CARDIAC ARREST.

To Activate the CPR

In the event of a patient suffering cardiac arrest and CPR needing to be administered: 1. Lift the red CPR handle at the foot end of the mattress. FAST DEFLATE

CP

NORMAL

R 1

TRANSPORT

2

3

2. Turn the handle counterclockwise. FAST DEFLATE

CP

NORMAL

R 1

TRANSPORT

2

3

3. Pull the handle away from panel. FAST DEFLATE

R CP

NORMAL

1

TRANSPORT

2

3

To Reset the CPR

4. The grey triangular seal will rotate and the air will rapidly exhaust from the mattress. 1. Turn the grey triangular seal clockwise and push onto the connectors. 2. Turn the red handle clockwise. 3. Fold the handle flat to lock in position.

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