ARJOHUNTLEIGH NIMBUS 4 and NIMBUS PROFESSIONAL Instructions for Use Rev 3 Sept 2015

WARNING To avoid injury, always read this Instructions for Use and accompanied documents before using the product. Mandatory to read the Instructions for Use

Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © ArjoHuntleigh AB 2015. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.The content of this publication may not be copied either whole or in part without the consent of ArjoHuntleigh AB.

Contents General Safety... iii Introduction... 1 About this Manual... 1 Intended use... 1 About Nimbus 4 and Nimbus Professional... 1 Nimbus Pump... 2 Nimbus 4 Mattress... 3 Mattress CPR and Transport Controls... 3 Nimbus Professional Mattress... 4 Clinical Applications... 5 Indications... 5 Contraindications... 5 Cautions... 5 Care of the patient when sitting... 5 Installation... 6 Preparing the System for Use... 6 Installing the Mattress... 6 Installing the Pump... 7 Testing the Power Fail Alarm... 8 Connecting the Tubeset... 9 Disconnecting the Tubeset... 9 System Operation... 9 Controls, Alarms and Indicators... 10 Pump Controls... 10 Pump Indicators... 11 Operation... 13 Installing the System... 13 Inflating the Mattress... 13 Comfort Control... 14 Operating Modes... 14 Shut Down... 14 Mattress Vent Valves... 14 Guidelines for Selecting Mattress Vent Valves to Open... 15 Transport Control... 16 Deflating the Mattress... 16 CPR Control... 17 Nimbus Professional Mattress: Patient Positioning Guide... 18 General... 19 Supine Position (face up)... 19 Prone Position (face down) - Not for Homecare Environment... 20 Decontamination... 21

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Routine Maintenance... 23 Nimbus 4 and Nimbus Professional Systems... 23 Nimbus Pump... 23 Nimbus 4 and Nimbus Professional Mattresses... 23 Serial Number Labels... 23 Troubleshooting... 24 Technical 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. • EN60601-1:2006, EN60601-1-11:2010 and IEC 60601-1:2005. • AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008).

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, the decision to use safety sides should be 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. The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual. • 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. • Do not use the mattress without a cover, it provides a protective barrier. • Bags supplied with this equipment may present a suffocation risk; to avoid the risk of suffocation keep the bags away from babies and small children. • When not fitted to a bed, the bed hooks on the pump may present a hazard to small children. Store the pump in a safe place. • Only the pump and mattress or seat combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and mattress or seat combinations are used.

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Precautions For your own safety and the safety of the equipment, always take the following precautions: • 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. Creases in the top cover and 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 use or 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. • Pets and children must be supervised in the vicinity of the system. • Always make sure the drag handles are fastened to the base cover, when the patient is NOT being transported. 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. Expected Service Life The Nimbus® pump has an expected service life of seven years. To maintain the condition of the pump, have the pump serviced regularly according to the schedule recommended by ArjoHuntleigh. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Nimbus 4 and Nimbus Professional system. Failure to observe this caution could result in injury, or in extreme cases, death. 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. The content of this publication may not be copied either whole or in part without the consent of ArjoHuntleigh. © ArjoHuntleigh 2015

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1. Introduction About this Manual

This manual is your introduction to the Nimbus 4 and Nimbus Professional systems. You must read and fully understand this manual before using the system. Use this manual to initially set up the system, and keep it as a reference for day-to-day routines and as a guide to maintenance. If you have any difficulties in setting-up or using the Nimbus 4 and Nimbus Professional systems, contact your local ArjoHuntleigh sales office, listed at the end of this manual.

Intended use

The intended use of this product is to prevent and/or manage pressure ulcers for patients up to 250 kg (550 lb). The Nimbus 4 and Nimbus Professional systems should be used as part of a prescribed plan of care (refer to “Indications” on page 5).

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 consist of a pump and mattress replacement which can be used on top of 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)

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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. A full technical description of the Nimbus 4 and Nimbus Professional system can be found in the Service Manual, part No. SER0007, available from ArjoHuntleigh. Nimbus Pump Run/Standby Button

Carry Handle (recess) Alarm Indicators Comfort Control

Mains Power Cable

Tubeset Connector

Front Panel Static Control

Mute Control

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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

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

 These controls are common to both Nimbus 4 and Nimbus Professional

mattresses, and are located at the foot end of the mattress on the opposite side to the Vent Valves.

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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

 The drag handles enable transportation of a patient in case of emergency. This is the only situation the drag handles can be unfastened. In any other situation the drag handles must be fastened to the base cover in order to remove the risk of tripping.

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2. Clinical Applications The Nimbus 4 and Nimbus Professional systems are indicated for the prevention and/or management of all categories1 of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care. Selection should be based upon a holistic assessment of the patient’s individual care needs. These systems represent one aspect of a pressure ulcer management protocol; all other aspects of care should be considered by the prescribing clinician. If existing wounds do not improve or the patient's condition changes the overall therapy regimen should be reviewed by the prescribing clinician. The above are guidelines only and should not replace clinical judgement. 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 Seated patients are at increased risk of pressure ulcers when sitting 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 individual repositioning programme.  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. Indications

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

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

 Refer to Section 4, Page 10 “Controls, Alarms and Indicators” for a

comprehensive description of the controls and indicators on the pump. Preparing the System for Use

Remove the system from the packaging. You should have the following items: • Nimbus pump, with integral bed bracket. • Mains power cable (pump). • Nimbus 4 mattress replacement or Nimbus Professional mattress replacement with covers. Do not use the mattress without a cover. • Tubeset.

Installing the 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 sales office. 2. Unroll the mattress onto the bed base and make sure that the CPR control 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 eight 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.

 Secure drag handles by fastening them to the base

cover. 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

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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

TRANSPORT

TRANSPORT

R 1 2

3

CPR Control

Installing the Pump

Cable Management

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. 3. Insert one end of the mains power cable into the receptacle on the pump. 4. Connect the other end of the mains power cable into a suitable mains power outlet. In order to prevent a trip hazard, 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.

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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

Testing the Power Fail Alarm

The Power Fail Alarm is powered by an internal rechargeable battery. The duration of the alarm will depend on the level of charge in the battery, which also depends on the age and condition of the battery. • The battery has a service life of between five to seven years. It is not user replaceable and must be replaced as part of the service procedure. It is recommended that the alarm is tested when the pump is installed, as follows:  Refer to Section 4, Page 10 “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, and press the Run/Standby button on the pump to put the pump in the Run mode. Allow it to run for 10-15 seconds. 2. Remove the mains power at the wall socket without putting the pump into Standby first. 3. The power fail alarm operates within 10 seconds, as follows: • The red Alarm triangle flashes. • The Power indicator flashes. • An audible warning sounds. 4. The alarm continues until: • The mains power is resumed. • You press and hold the Run/Standby button to put the pump into Standby. 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

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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 continue to function as normal.

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 from 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 10 “Controls, Alarms and Indicators” and Section 5, Page 13 “Operation” for day-to-day operating instructions.

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4. Controls, Alarms and Indicators Run/Standby Button

Mute Control & Indicator

Run Mode Indicator Static Mode Control & Indicator

Alarm Indicator

High Pressure Indicator

Low Pressure Indicator

Wait Indicator

Service Indicator

Comfort Control

Power Fail Indicator

Pump Controls

Pump Fault Indicator

The pump front panel has the following controls: Run/Standby Button Press the Run/Standby button to put the pump into the Run mode; the Run indicator will change to green. To put the pump into Standby, press and hold the Run/ Standby button for approximately 3 seconds; this prevents accidental operation. The Run indicator will be extinguished. Static Mode Selects the operating mode, either Static or Dynamic. When the pump is first powered up, its default setting is Dynamic mode. To switch to Static mode, press and hold the Static Mode button for a minimum of 3 seconds. Static mode is confirmed by the illumination of the button’s yellow indicator. To return to Dynamic mode, press and hold the button for a minimum of 3 seconds. Dynamic mode is confirmed by the extinguishing of the button’s yellow indicator. Alarm Mute An Alarm Mute button is provided to silence warning sounds during an alarm condition. Press and hold the Alarm Mute button for a minimum of 3 seconds to mute any alarms. Alarm Mute is confirmed by the illumination of the button’s yellow indicator.  The Alarm Mute button does not operate in a Power Fail condition.

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Comfort Control

The Nimbus 4 and Nimbus Professional systems automatically compensate for patient weight distribution and position, to optimise the mattress 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.

Pump Indicators

The pump front panel has the following indicators: Run Mode The green Run indicator below the Run/Standby button is illuminated to confirm the pump is in Run mode. Static Mode The yellow indicator on the Static button is illuminated when Static mode has been selected for operation. Alarm Mute The yellow indicator on the Mute button is illuminated when an audible alarm has been silenced.  The Alarm Mute button does not operate in a Power Fail condition. Wait The Wait indicator is illuminated when the mattress is being inflated.

 The indicator will remain illuminated until the High Pressure

Low Pressure

Alarm

mattress has been fully inflated. 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 two 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. 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 temporarily silenced by

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pressing the Alarm Mute button for a minimum of 3 seconds (Refer to “Alarm Mute” on page 10). The triangular Alarm symbol is displayed with one or more of the following indicators: • Low Pressure (refer to “Low Pressure” on page 11). • High Pressure (refer to “High Pressure” on page 11). • Pump Fault (refer to “Pump Fault” on page 12). • Power (refer to “Power Fail” on page 12).  For all alarm conditions except Power Fail, once the alarm condition has been detected and displayed, it can only be cancelled by pressing and holding the Run/Standby button to put the pump into Standby. Refer to Section 9, Page 24 “Troubleshooting” for possible causes of the above alarm conditions. Pump Fault 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. Power Fail The Power indicator will flash when a mains power failure has been detected. The alarm will continue until: • The mains power is resumed, or • You press and hold the Run/Standby button to put the pump into Standby. 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 8).  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. Service Indicator 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 10 “Controls, Alarms and Indicators” for a

comprehensive description of the controls and indicators on the pump.

WARNING DO NOT PLACE THE PATIENT ON THE MATTRESS UNTIL IT IS FULLY INFLATED AND NORMAL OPERATING PRESSURE HAS BEEN REACHED. 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 6 “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 using the supplied cable and press the Run/Standby button to put the pump into the Run mode; the Run indicator will change to green. 2. The pump runs a self test for approximately three seconds then all the indicators on the front panel are illuminated. 3. When 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.

However, at the lower end of the operating temperature range, it may take longer to inflate. Always wait until both the Low Pressure and Wait indicators have been extinguished. 4. Place the patient on the mattress in the supine (face up) position. Refer to Section 6, Page 18 “Nimbus Professional Mattress: Patient Positioning Guide”.

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 If the operation of the pump changes during use,

refer to Section 9, Page 24 “Troubleshooting” before calling a service engineer or contacting your local ArjoHuntleigh sales office.

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 first powered up. Select the required operating mode.  When changing between operating modes, the patient’s monitoring and repositioning program should be reviewed.

Shut Down

Put the pump into Standby, by pressing and holding the Run/Standby button for a minimum of 3 seconds; the Run indicator will be extinguished. • If the pump needs to be completely isolated from the mains power supply, remove the plug from the mains power socket.

Mattress Vent Valves

On the Nimbus 4 and Nimbus Professional mattresses, the Vent Valves along the side of the mattress enable individual cells to be deflated: 1. Nimbus 4 mattress has only five Vent Valves in the Heelguard section at the foot end of the mattress. 2. Nimbus Professional mattress: • The three Head Section cells have Vent Valves. • The eight Torso cells, three Thigh cells and five 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 chest x-rays.

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