ARJOHUNTLEIGH NIMBUS 3 AND NIMBUS 3 PROFESSIONAL Instructions for Use Oct 2009

Contents General Safety... iii Introduction... 1 About this Manual... 1 About Nimbus 3 and Nimbus 3 Professional... 1 Nimbus 3 Pump... 2 Nimbus 3 Mattress... 3 Nimbus 3 Professional Mattress... 4 Clinical Applications... 6 Indications... 6 Contraindications... 6 Cautions... 6 Care of the patient when sitting... 6 Installation... 7 Preparing the Nimbus 3 and Nimbus 3 Professional Systems for Use... 7 Installing the Nimbus 3 or Nimbus 3 Professional Mattress... 7 Installing the Pump... 9 Connecting the Tubeset... 10 Disconnecting the Tubeset... 10 System Operation... 10 Controls, Alarms and Indicators... Pump Controls... Pump Indicators... Mattress Controls... Additional Controls on the Nimbus 3 Professional Mattress...

11 11 12 14 14

Operation... 16 Installing the System... 16 Inflating the Mattress... 16 Testing the Power Fail Alarm... 16 Deflating the Mattress... 17 System Optimisation... 18 Selecting the Operating Mode... 18 Silencing Audible Alarms... 19 Comfort Control... 19 Transport Control... 19 CPR Control... 20 Patient Positioning Guidance for the Nimbus 3 Professional Mattress... 21 Decontamination... 23 Routine Maintenance... Nimbus 3 and Nimbus 3 Professional Systems... Nimbus 3 Pump... Nimbus 3 and Nimbus 3 Professional Mattresses...

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25 25 25 25

Serial Number Labels... 26 Troubleshooting... 27 Technical Description... 28 Pump... 28 Accessories... 29 Mattress... 29 Cover Specification... 30 Cleaning Symbols... 31

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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® 3 and Nimbus 3 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 3 and Nimbus 3 Professional Nimbus 3 and Nimbus 3 Professional are Dynamic

Flotation Systems for the prevention, treatment and management of pressure ulcers. Nimbus 3 and Nimbus 3 Professional systems comprise

a pump and mattress replacement which can be used on standard hospital and normal domestic beds. Beds can be adjusted or profiled with the mattress in position. The Nimbus 3 Professional mattress has the following additional features to enable the patient to be proned, and to assist with pressure area and patient care management: • A Head Section Deflate Control to allow the three head cells to be fully deflated. • Individual Vent Valves to allow 16 of the 20 cells to be independently deflated. The Nimbus 3 and Nimbus 3 Professional mattresses incorporate an advanced AutoMatt® sensor pad which makes sure that the patient is automatically supported at optimum pressures regardless of size, height, position or weight distribution. If cardiac arrest occurs, the Nimbus 3 and Nimbus 3 Professional mattresses can be deflated in less than 10 seconds to allow cardiac resuscitation procedures to be performed.

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Nimbus 3 Pump

The same pump is used on the Nimbus 3 and Nimbus 3 Professional systems. The pump comprises a moulded case with non-slip feet on the base and rear, and an integral carry handle. Carry Handle

Mains Power Switch

Alarm Indicators

mmHg Hi mmHg

mmHg

-

+

Lo

Mains Power Cord

Tubeset

Front Panel

The pump has two modes of operation: • 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 controls and indicators are located on the front panel, and a sophisticated alarm system differentiates between normal operation and genuine system faults. If an alarm situation is detected a flashing indicator will illuminate, together with an indication of the cause of alarm, and an audible warning will sound. The pump can be fixed to the foot end of a hospital bed by the separate bed bracket. The bed bracket fits in the pump handle and then clips onto most common bed frames. The pump can also be stood on the floor, either upright or on its rear cover.

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Nimbus 3 Mattress

The Nimbus 3 mattress comprises the following components:

Detachable Cover 3 Head Cells 4 Thigh Cells Head End

5 “Heelguard” Cells

Drag Handle

8 Torso Cells L MA NOR

FAST

CPR

DE

FLAT

E

TRA

NSP

ORT

1 2

3

Securing Strap

Foot End

Carry Handle

CPR Control Pump Tubeset

Transport Control

Detachable Cover

The standard protective cover comprises a 2-way stretch cover zipped to a durable anti-slip base. The zips are protected by flaps to prevent ingress of contaminants, and allow easy removal of the cover for cleaning. Alternative covers with advanced properties, such as Advantex® and eVENT®, are also available (Refer to “Cover Specification” on page 30).

Cells

The Nimbus 3 mattress comprises 20 polyurethane (PU) cells providing support to the user in either Alternating or Static modes. The cells are grouped in four sections, each of which has a specific function: • The three Head cells remain at a constant pressure for pillow stability and patient comfort. • The eight Torso cells combine alternating and static pressure characteristics to support patients fully in both lying and sitting positions without the risk of ‘bottoming’. • The four Thigh cells cycle dynamically to maximise pressure relief. • The five Heelguard® cells are specially powered to maximise the pressure relief under the heels. 3

AutoMatt

The advanced AutoMatt sensor pad is under the cells, and makes sure that the patient is automatically supported at optimum pressures regardless of size, height, position or weight distribution.

CPR Control

The CPR (Cardio-Pulmonary Resuscitation) Control is at the foot end of the mattress, and allows the air to be evacuated in under 10 seconds.

Transport Control

The Transport Control is next to the CPR Control. When operated, it seals the mattress so that air is not exhausted when the tubeset is disconnected and also creates an even pressure in all the cells.

Tubeset

The tubeset incorporates a flexible, compact anti-kink tube that is resistant to crushing and any subsequent obstruction of air flow. Each end has a quick-lock system for easily connecting and disconnecting the air supply at the pump and mattress.

Nimbus 3 Professional Mattress The Nimbus 3 Professional mattress is of similar construction to the Nimbus 3 mattress, with the addition of a Head Section Deflate Control, individual Vent Valves on 16 of the 20 cells and a Shoulder Support Cell. Detachable Cover

5 “Heelguard” Cells

CPR/Transport Control

7 Torso Cells Shoulder Support Cell (with Central Cutout)

Foot End

Drag Handle 4 Thigh Cells 16 Vent Valves Head End 3 Head Section Cells (“Power-Down” Cells)

Carry Handle Securing Strap

4

Head Section Deflate Control

Head Section Deflate Control

This is a two-position rotary-action control at the head end of the mattress: • Dynamic (Normal) Mode. The three cells in the Head Section are inflated at a constant pressure and the remaining 17 cells alternate. • TriCell Head Section Deflate. The three cells in the Head Section are fully deflated to assist with patient care management, and the Shoulder Support Cell (the fourth cell, next to the Head Section) is inflated to a constant pressure to support the patient’s shoulders. The remaining 16 cells alternate.

Cells

The Nimbus 3 Professional mattress has the same number of cells as the Nimbus 3 mattress (20 cells). The function of the first four cells at the head end of the mattress is different on the Nimbus 3 Professional: • The three cells in the Head Section are either fully inflated or fully deflated, depending on the position of the Head Deflate Control, to assist with patient care management. The cells are specially powered to enable them to be fully deflated. • The single Shoulder Support Cell (the fourth cell, next to the Head Section) has a shallow cutout in the mid-section of the cell. This is to allow access to the neck area for clinical procedures and to ensure the smooth, uniform extension of the neck during deflation. Its operation is controlled by the Head Section Deflate Control: the cell is either fully inflated to support the patient’s shoulders or alternates (together with the remaining 16 cells). • The remaining 16 cells (seven Torso cells, four Thigh cells and five Heelguard cells) have the same basic function as on the Nimbus 3 mattress.

Vent Valves

The seven Torso cells, four Thigh cells and five Heelguard cells have individual Vent Valves to allow each cell to be independently deflated, to assist with pressure area and patient care management.

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2. Clinical Applications Indications

The Nimbus 3 and Nimbus 3 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 3 and Nimbus 3 Professional mattress is designed for patients weighing up to 250 kg (550 lb). The Nimbus 3 and Nimbus 3 Professional cushion is designed for patients weighing up to 250 kg (550 lb).

Contraindications

Do not use Nimbus 3 and Nimbus 3 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 3 and Nimbus 3 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 3 and Nimbus 3 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 3 and Nimbus 3 Professional systems are very simple to install using the following guidelines.



Refer to Section 4, Page 11 “Controls, Alarms and Indicators” for a comprehensive description of the controls and indicators on the pump and mattress.

Preparing the Nimbus 3 and Nimbus 3 Professional Systems for Use 1. Remove the system from the packaging. You should have the following items: • Nimbus 3 pump, with integral mains power cord. • Nimbus 3 mattress replacement or the Nimbus 3 Professional mattress replacement. • Bed bracket. • Tubeset. Installing the Nimbus 3 or Nimbus 3 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 hook and loop securing straps.



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.

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4. For Nimbus 3 mattresses only, check the AutoMatt sensor pad, as follows: • Unzip the cover on one side of the mattress only. • Pull the side of the mattress away from the cells. • The AutoMatt sensor pad is situated under the cells between the soft and hard foam sheets. • Make sure that the AutoMatt sensor pad is lying flat and is not “kinked”. • Zip the cover back onto the mattress, taking care not to trap any cell material in the zip. Cells

Cover

Head End

Foot End AL NORM

E

LAT

TRAN

T DEF

T SPOR

FAS

CPR

1 2

3

Soft Foam Sheet AutoMatt Sensor Pad

Hard Foam Sheet Hard Foam Sheet

AutoMatt Sensor Pad



For Nimbus 3 Professional mattresses, the AutoMatt is encapsulated and does not need to be checked. 5. Leave the ends of the mattress cover free when profiling the bed. 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

8

Transport Control

Additional Checks on the Nimbus 3 Professional Mattress

1. Make sure that all 16 Vent Valves are closed.

Closed

Open

2. Make sure that the Head Section Deflate Control is set to Dynamic (Normal) Mode. TriCell Head Section Deflate

Dynamic (Normal) Mode

Installing the Pump

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 the connector on the end of the mains power cord into a suitable mains power outlet.

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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

1

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.

2 1

System Operation

The system is now ready for use. Refer to Section 4, Page 11 “Controls, Alarms and Indicators” and Section 5, Page 16 “Operation” for day-to-day operating instructions.

WARNING Make sure the mains power cord and tubeset are positioned to avoid causing a hazard. Caution Make sure the mains power cord and tubeset are clear of moving bed mechanisms or other possible entrapment areas. 10

4. Controls, Alarms and Indicators

Power Switch & Alarm Reset

Mute Control & Indicator

Alarm Indicator

High Pressure Indicator

Low Pressure Indicator

mmHg

N

R

Hi mmHg

Wait Indicator

On/Reset Alarm Indicator Static Control & Indicator

Power Fail Indicator

-

+

mmHg Lo

Service Indicator

Comfort Control Pump Fault Indicator

Pump Controls

The pump front panel has the following controls:

POWER Switch (and RESET ALARM)

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

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.

Alarm MUTE

COMFORT CONTROL mmHg

+

An audible alarm mute is provided to cancel warning sounds during an alarm condition.

This is a rotary action control to set the relative firmness/ softness of the mattress for patient comfort.

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Pump Indicators

The pump front panel has the following indicators:

ON / RESET ALARM

The green ON / RESET ALARM indicator below the POWER switch is illuminated when the mains power is connected and the pump switched on.

STATIC Mode

The indicator on the STATIC button is illuminated when Static mode has been selected for operation.

Alarm MUTE

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

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.

HIGH PRESSURE

The HIGH PRESSURE indicator is illuminated whenever the pump detects high pressure within the mattress.

Hi mmHg

LOW PRESSURE mmHg Lo

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. The LOW PRESSURE indicator will be switched off once normal pressure is reached.

Alarm

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 11). The triangular Alarm symbol is displayed with one or more of the following indicators:

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• LOW PRESSURE (Refer to “LOW PRESSURE” on

page 12). • HIGH PRESSURE (Refer to “HIGH PRESSURE” on

page 12). • PUMP FAULT (Refer to “PUMP FAULT” on



page 13). • POWER (Refer to “POWER Fail” on page 13). 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. Refer to Section 8, Page 27 “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 the pump is switched off using the POWER switch on the pump control panel.

Service Indicator

The 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.



The pump will continue to operate normally even when the illuminated.

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symbol is

Mattress Controls

All Nimbus 3 and Nimbus 3 Professional mattresses have the following two controls, situated at the foot end of the mattress: FAST DEFLATE

CP

NORMAL

NORMAL

R 1

TRANSPORT

TRANSPORT

2

3

CPR Control



Transport Control

Transport Control

This sets the mattress into TRANSPORT mode where the support surface is equally pressurised and the pump and tubeset can be removed. In this mode the mattress will support the patient for up to 12 hours.

CPR Control

The CPR (Cardio-Pulmonary Resuscitation) Control provides a means of rapidly deflating the mattress to allow normal resuscitation procedures to be carried out.

The CPR control is used to deflate the mattress for packing and storage.

Additional Controls on the Nimbus 3 Professional Mattress The following two controls are on the opposite side of the mattress to the CPR/Transport Control: Head Section Deflate Control

This is a two-position rotary-action control at the head end of the mattress: • Dynamic (Normal) Mode. The three cells in the Head Section are inflated at a constant pressure and the remaining 17 cells alternate. • TriCell Head Section Deflate. The three cells in the Head Section are fully deflated to assist with patient care management, and the Shoulder Support Cell (next to the Head Section) is inflated to a constant

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pressure to support the patient’s shoulders. The remaining 16 cells alternate. TriCell Head Section Deflate

Dynamic (Normal) Mode 16 Vent Valves

The seven Torso cells, four Thigh cells and five Heelguard cells have individual Vent Valves to allow each cell to be independently deflated, to assist with pressure area and patient care management.

Closed

15

Open