NIMBUS PAEDIATRIC SYSTEM

Transcription

1 NIMBUS PAEDIATRIC SYSTEM Instructions For Use Product Photo

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3 Contents General Safety iii Introduction About this Manual About the Nimbus Paediatric System Clinical Applications Indications Contraindications Cautions Product Description Mattress Pump Installation Preparing the Pump and Mattress Replacement Connecting the Tubeset Disconnecting the Tubeset Inflating the Mattress Testing the Power Fail Alarm Deflating the Mattress Operation System Optimisation Modes of Operation Mode Selection CPR Control To Reset CPR Patient Transport Controls, Indicators and Alarms Decontamination Routine Maintenance Nimbus Paediatric System Pump Mattress Replacement Troubleshooting Technical Description Pump Mattress Size Information Cleaning Symbols (i)

4 (ii)

5 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: EN :1990/A13:1996 and IEC :1988/A2:1995 UL , UL and CAN/CSA C22.2 No 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. (iii)

6 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. 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 (iv)

7 1. Introduction About this Manual This manual is your introduction to the Nimbus Paediatric Mattress Replacement System. Use it initially to set up the system and keep it handy as a reference for day-to-day routines and as a guide to maintenance. About the Nimbus Paediatric System The complete system consists of a mattress replacement, top cover, and pump unit. The system is used for the prevention and management of pressure ulcers. The Nimbus Paediatric System incorporates the unique Auto-Matt sensor pad which ensures that the patient is automatically supported at optimum pressures regardless of size, height, position or weight distribution. The mattress replacement is designed for use with the ArjoHuntleigh ChildMinder or Hi-Lo Cot. Users are able to employ established practises for moving and handling patients. A water resistant, vapour permeable cover is supplied which enhances patient comfort by preventing heat build-up whilst protecting the mattress replacement interior from contamination. It is simple to clean in situ but can be easily removed for laundering. In the event of cardiac arrest, the mattress can be quickly deflated in approximately 10 seconds to allow cardiac resuscitation procedures to be performed. The Nimbus Paediatric System is designed to operate in 3 modes: Dynamic mode continuously changes the tissue pressure points, providing a high degree of pressure relief. Static mode provides constant low pressure reduction and is used when a moving surface is contraindicated. Autofirm mode provides a stable surface for nursing procedures, patient transfer and physiotherapy. 1

8 2. Clinical Applications Indications Contraindications Cautions The Nimbus Paediatric systems are indicated for the prevention and management of all categories 1 of pressure ulcer when combined with an individualised monitoring, repositioning and wound care programme. The Nimbus Paediatric mattress is designed for patients weighing between 6-25 kg (13-55 lb). Do not use Nimbus Paediatric systems for patients with unstable spinal fractures. 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 Paediatric 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. The above are guidelines only and should not replace clinical judgement. The Nimbus Paediatric 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,

9 3. Product Description Mattress The Nimbus Paediatric mattress replacement is comprised of a series of 18 individual cells, all of which inflate alternately. The best way of describing cell arrangement is that, if all cells were numbered 1 to 18, the odd number cells inflate simultaneously whilst the even number cells are deflated and then vice versa. The sequence of dynamic pressure relief is: Phase 1 odd numbered cells inflated for approximately 4 minutes. Phase 2 total support period where all cells are inflated (cross-over) for approximately one minute. Phase 3 even numbered cells inflated for approximately 4 minutes. Phase 4 as phase 2 (one minute) 3

10 Pump At the foot end of the mattress replacement a tube-set serves to inflate and deflate the Nimbus Paediatric mattress replacement. To deflate the mattress replacement quickly in the event of cardiac arrest pull the CPR Tag firmly to remove the CPR plugs. To reinflate the Nimbus Paediatric mattress replacement, replace the CPR plugs securely. Alarm Indicator On/Off Switch Wait Indicator Power Indicator Autofirm Static Dynamic Mute Button / Indicator Mode Select The pump comprises a rugged moulded case with nonslip feet on the base and rear and an integral carry handle. The unit has been designed to maintain sustained operation and to withstand prolonged use in the hospital environment. Weight has been minimised and is evenly distributed throughout the case with the centre of gravity beneath the carry handle. The On/Off switch is situated on the side panel. Other controls and indicators (lights) are located on the front panel which is recessed to prevent accidental operation. New pumps have different icons on the control panel compared to old pumps. Refer to Controls, Indicators and Alarms on page 14 for the different icons. The pump incorporates a sophisticated alarm system that differentiates between normal operation and genuine system faults. If an alarm situation is detected a 4

11 flashing indicator will illuminate and an audible warning will sound. Bed Bracket Tube-Set The pump can be fixed to the foot end of the ArjoHuntleigh ChildMinder or Hi-Lo Cot by the separate cot bracket which has been designed for simplicity and ease of use. It features a simple self adjusting mechanism that clips onto most common cot frames (18-50 mm wide) and a hook that fits into the pump handle. The pump can also be stood on the floor, either vertically or horizontally. The tube-set incorporates a flexible, compact anti-kink tube that is resistant to crushing and the obstruction of air flow. Incorporated into the tube-set is the facility to set the mattress to Normal or Transport mode. There is a quick connect system for connecting the tubeset of the mattress replacement to the pump. The other end the tube-set is permanently connected to the mattress. 5

12 4. Installation These instructions cover initial set up and operation of the Nimbus Paediatric System. More detailed information regarding controls, alarms and indicators is in Section 5. Preparing the Pump and Mattress Replacement Installing the Nimbus Paediatric Pump 1. Remove the pump from the carton together with the mattress replacement and cover. You should have the following items: Mattress replacement with cover & tube-set Pump and bed bracket 2. The pump can be suspended from the cot foot rail by means of the hanging device or alternatively stood upright or on its back on any convenient horizontal surface. 3. Check there are no protruding springs or similar sharp objects on the cot base. 4. Place the Nimbus Paediatric mattress replacement on the cot base with the air feed tubes located near the pump at the foot of the cot, ensuring that the Auto-Matt sensor pad is flat. 6

13 5. Ensure individual cells of the Nimbus Paediatric mattress replacement are uppermost. 6. Secure the Nimbus Paediatric mattress replacement by fixing the six straps (three at each end) to the moveable part of the cot base. 7. Place the protective cover on the mattress replacement and fix into position with the zips and velcro provided. 8. Ensure the transport facility on the tubeset is in the normal mode. Make sure the CPR tag is not tucked under the mattress and it is routed out of the cot in an accessible position. Fixing Straps 7

14 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

15 Inflating the Mattress 1. Insert the mains power plug into the power socket. 2. Switch the pump ON/OFF switch to ON; the ON light on the front panel should illuminate. 3. The pump will now run a self test for approximately 3 seconds when all lights will be illuminated. 4. If the pump detects low pressure it will enter an inflation sequence with the WAIT message illuminated. Once normal operating pressure has been reached, the WAIT light will switch off. It may take up to 20 minutes to fully inflate the paediatric mattress replacement. 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. In use, it may have become discharged or reached the end of its life. It is therefore recommended that the alarm be tested before use. 1. Connect the pump to the mains, switch on and allow to run for seconds. 2. Remove the mains power at the wall socket without switching the pump off. 3. The alarm should operate within 10 seconds. Caution If the power fail alarm does not operate after this test, only use the pump under supervision to ensure that the power-on status is checked at regular intervals. Route the power cable so that it cannot be damaged or be hazardous to the carer or visitor. 4. If the alarm does not operate, run the pump for 4 hours to recharge the battery. 9

16 5. Retest the alarm after at least 4 hours. Allow the alarm to operate for 2 minutes to ensure that it has been adequately recharged. 6. If the alarm does not operate for 2 minutes, call the service engineer. Continue to use the pump only under supervision to ensure that the power-on status is checked at regular intervals. All other alarms will continue to function as normal. Deflating the Mattress To deflate and store the mattress, switch off the pump and remove the tube-set at the pump end. Ensure the transport facility on the tube-set is set to normal mode and roll up the mattress, starting at the end furthest from the tube-set. 10

17 5. Operation System Optimisation 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. The Nimbus Paediatric System automatically compensates for patient weight distribution and position, optimising the pressure relieving performance. To ensure that the pressure relieving properties are not impaired, the cover must not be pulled tight and any covering sheets not fitted too tightly. Similarly, any covering sheets should not be too loose to cause rucking. Always use the Nimbus Paediatric mattress with the protective top cover. Placing extra layers and catheter tubes between the patient and the mattress potentially reduces the benefits provided by the mattress and should be avoided or kept to minimum. Modes of Operation The system provides 3 modes of operation: Dynamic Static Autofirm The pump defaults to Dynamic mode when switched on. Dynamic Mode Static Mode Autofirm Mode Provides the optimum pressure relieving properties and should be used in most cases. The support surface beneath the patient will cycle every 10 minutes. Provides a non-moving support surface for instances where a dynamic support system is contra-indicated. All cells are equally inflated and remain constant. Provides a non-moving support surface with increased firmness to assist in the application of certain nursing procedures (physiotherapy, etc). All cells are equally inflated at an increased pressure for 30 minutes before reverting to dynamic mode. 11

18 Mode Selection Silencing Audible Alarms CPR Control Press the Mode Select button to cycle through the different modes. An audible tone will sound and a visual indicator will illuminate to show the selected mode. Audible alarms can be silenced using the Mute button. To silence an alarm simply push the Mute button once. To perform CPR, pull the CPR tag firmly up and away from the mattress. This will disconnect 2 CPR plugs and rapidly deflate the Nimbus Paediatric System. On disconnection, the mattress replacement will rapidly deflate, sufficient for CPR procedures to commence. 12

19 To Reset CPR Patient Transport To reset the Nimbus Paediatric System after the CPR has been activated: 1. Push the CPR plugs fully into the holes in the side of the mattress. 2. Close the CPR cover flap using the Velcro provided. 3. Ensure that the CPR Tag hangs freely from the CPR cover flap. The patient may be transported on the Nimbus Paediatric System as follows: 1. Turn the transport facility on the tube-set to transport. The pressure in the two sets of cells will be maintained and the patient will continue to be supported for up to 12 hours with the patient in the supine position. 2. Turn the pump off and disconnect the tubeset from the pump. To resume normal operation, re-connect the tube-set to the pump, switch the pump on and turn the transport knob to normal. If the tube-set remains connected to the pump when the transport control is set to transport, the pump will indicate a low pressure fault. To obtain the maximum use of the transport facility ensure that the patient remains in the supine position and the mattress is put in transport mode when all cells are inflated. 13

20 Controls, Indicators and Alarms On/Off Switch (And Alarm Reset) Control Panel Situated on the side panel of the pump, this switches the mains power on and off. It is combined with an internal battery circuit that will activate the alarm system if the power supply is interrupted prior to switching off. Examples are accidental mains lead removal or mains power failure. New pumps have different icons on the control panel compared to old pumps. For a detailed description of the controls and indicators, you must refer to the correct control panel section: Old control panel icons for pumps which have a nine digit serial number starting with a 631 prefix, e.g , refer to Old Control Panel Icons on page 14. New control panel icons for pumps which have a ten digit serial number starting with a 09 prefix, e.g , refer to New Control Panel Icons on page 16. Old Control Panel Icons Power Indicator A green light on the front panel indicates that the power is ON. Wait Indicator If the pump detects low pressure in the mattress replacement, the WAIT indicator is illuminated and the pump performs a start up procedure to inflate the mattress replacement. Once correct operating pressures have been reached the WAIT indicator goes out. 14

21 Alarm Indicator The pump unit incorporates a sophisticated alarm detection system to differentiate between patient movement and genuine alarm conditions. Whenever an alarm occurs, the flashing red indicator is illuminated. Additionally, an audible warning will sound unless cancelled by the MUTE button as described earlier. Once an alarm has been initiated, it can only be cancelled by switching the pump unit off and then switching back on. Alarm Mute Button and Indicator Under some circumstances the low pressure alarm may be activated after the patient is removed from the mattress. If this occurs the alarm may be cancelled by switching the pump off and then switching back on. For possible causes for the alarm, see the table in Section 8. An audible alarm mute is provided to cancel audible warning sounds during an alarm condition. The yellow light is illuminated when the alarm has been silenced. Mode Select Button Dynamic Mode Indicator Selects the operating mode, switching between Dynamic, Static and Autofirm. Indicates that the pump is in Dynamic mode. Static Mode Indicator Indicates that the pump is in Static mode. Autofirm Mode Indicator Indicates that the pump is in Autofirm mode. When Autofirm mode is selected it remains operational for 30 minutes before returning to Dynamic mode. After 29 minutes an alarm sounds to warn of the imminent return to Dynamic operation. 15

22 New Control Panel Icons Power Indicator A green light on the front panel indicates that the power is ON. Wait Indicator If the pump detects low pressure in the mattress replacement, the WAIT indicator is illuminated and the pump performs a start up procedure to inflate the mattress replacement. Once correct operating pressures have been reached the WAIT indicator goes out. Alarm Indicator The pump unit incorporates a sophisticated alarm detection system to differentiate between patient movement and genuine alarm conditions. Whenever an alarm occurs, the flashing red indicator is illuminated. Additionally, an audible warning will sound unless cancelled by the MUTE button as described earlier. Once an alarm has been initiated, it can only be cancelled by switching the pump unit off and then switching back on. Under some circumstances the low pressure alarm may be activated after the patient is removed from the mattress. If this occurs the alarm may be cancelled by switching the pump off and then switching back on. For possible causes for the alarm, see the table in Section 8. 16

23 Alarm Mute Button and Indicator An audible alarm mute is provided to cancel audible warning sounds during an alarm condition. The yellow light is illuminated when the alarm has been silenced. Mode Select Button Dynamic Mode Indicator Selects the operating mode, switching between Dynamic, Static and Autofirm. Indicates that the pump is in Dynamic mode. Static Mode Indicator Indicates that the pump is in Static mode. Autofirm Mode Indicator Indicates that the pump is in Autofirm mode. When Autofirm mode is selected it remains operational for 30 minutes before returning to Dynamic mode. After 29 minutes an alarm sounds to warn of the imminent return to Dynamic operation. 17

24 6. 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 Nimbus Paediatric 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 electrical supply to the pump by disconnecting the mains power cord from the mains power supply before cleaning. Protective clothing should always be worn when carrying out decontamination procedures. 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. Do not spray cleaning solutions directly onto the pump. To clean Chemical Disinfection Clean all exposed surfaces and remove any organic debris by wiping with a cloth moistened with a simple (neutral) detergent and water. Dry thoroughly. To protect the integrity of the cover we recommend a chlorine-releasing agent, such as sodium hypochlorite, at a strength of 1,000ppm available chlorine (this may vary from 250ppm to 10,000ppm depending on local policy and contamination status). Wipe all cleaned surfaces with the solution, rinse and dry thoroughly. Alcohol based disinfectants (maximum strength 70%) may be used as an alternative. Ensure the product is dry before storage. If an alternative disinfectant is selected from the wide variety available we recommend that suitability for use is confirmed with the chemical supplier prior to use. 18

25 DO NOT WRING/MANGLE, AUTOCLAVE OR USE PHENOLIC BASED SOLUTIONS. Thermal Disinfection For information for the mattress top cover, including laundering guidelines, refer to Cleaning Symbols table on page

26 7. Routine Maintenance Nimbus Paediatric System Maintenance Servicing Pump General Care, Maintenance and Inspection Mattress Replacement General Care The equipment has been designed to be virtually maintenance-free between service periods. It is recommended that the pump is serviced annually by a ArjoHuntleigh authorised service agent. ArjoHuntleigh will make available on request service manuals, component parts lists, and other information necessary for ArjoHuntleigh trained personnel to repair the system. Check all electrical connections and power cord for signs of excessive wear. Test power fail alarm system before use. For procedure, see Installation section. In the event of the pump being subjected to abnormal treatment, e.g. immersed in water or dropped, the unit must be returned to an authorised service depot. Remove the top cover and inspect for signs of wear or any tears. Check all cover fasteners are secure. Check integrity of all connectors, including cell to manifold and sensor pad to the air inlet plate. Ensure all cell fasteners are snapped to the base sheet and are not loose or damaged. 20

27 8. Troubleshooting The following table provides a troubleshooting guide for the Nimbus Paediatric system in the event of malfunction. Indicator Possible Problem Possible Cause Remedy The pump is inflating the mattress replacement. This indicator will go out when operating pressure is reached. CONTINUOUS FLASHING LOW PRESSURE HIGH PRESSURE POWER FAIL 1. Patient removed from mattress. 2. The tube-set is not connected properly. 3. There is a leak in the system. 1. There is a block in the pneumatic circuit. 2. Tube-set blocked. 1. No mains power. 2. Fuse blown. 1. Reset pump. 2. Check connections and re-secure. 3. Call service engineer. 1. Check in bottom layer of mattress replacement that the Auto-Matt is flat and not kinked. 2. Check for kinked tube. 1. Check plug and socket. Check for power cut. 2. Call service engineer. PUMP FAULT Dynamic valve fault. Call service engineer. - Control board fault. Call service engineer. CONTINUOUS 21

28 9. Technical Description PUMP Model: Nimbus Paediatric Part Numbers: Supply Voltage: Supply Frequency: Power Input: 220V - 240V 50 Hz 30 VA Size: 336 x 210 x 100 mm (13.2 x 8.3 x 4.0 ) Weight: 3.5 kg (7.7 lb) Case Material: Plug Fuse Rating: Pump Fuse Rating: Degree of protection against electric shock: Degree of protection against liquid ingress: Mode of operation: ABS Plastic 5A to BS1362 F500 mah 250 V Mains Connected - Class I Type BF IPX0 Continuous SYMBOLS O (Off) Power Disconnects from the mains supply Do not dispose of in domestic refuse Alternating Current Dangerous voltage I (On) Power Connects to the mains supply i Refer to accompanying documents Type BF Refer to the User Manual With respect to electric shock, fire and mechanical hazards only in accordance with UL and CAN/CSA C22.2 No MEDICAL EQUIPENT Fuse Ref: Model number SN: Serial Number ENVIRONMENTAL INFORMATION Condition Temperature Range Relative Humidity Atmospheric Pressure Operating +10 C to +40 C (+50 F to +104 F) 30% to 75% 700hPa to 1060 hpa Storage and Transport -40 C to +70 C (-40F to +158 F) 10% to 95% (non-condensing) 500 hpa to 1060 hpa 22

29 MATTRESS SIZE INFORMATION Part No. Material Weight kg Length mm Width mm Height mm Cover: Polyurethane coated knitted fabric Base: Polyurethane coated woven fabric 5.8 (13 lb) 1300 (51 ) 660 (26 ) 150 (6 ) Cell: 0.3mm (0.012 ) Polyurethane flexible sheeting CLEANING SYMBOLS Wash at 80 C (176 F) Do Not Tumble Dry Do not iron Wipe surface with damp cloth Do Not Use Phenol-based cleaning Solutions Use solution diluted to 1000 ppm of Available Chlorine 23

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