The Novacare® ASX semi-digital alternating pressure system is a medical device designed for the treatment and prevention of pressure ulcers (decubitus). It is primarily intended for use by medical experts or professional users in clinical, nursing, and homecare settings. The system is suitable for standard beds, preferably hospital or nursing beds.
Function Description:
The system consists of a control unit with a digital sensor-controlled membrane pump and a mattress with 18 horizontally arranged air cells. Three of these cells in the head area are static, providing a pillow function. The cell unit is equipped with a bi-elastic, watertight, and steam-permeable protective cover made of skin-friendly PU. The system operates in two modes: alternating pressure mode and static mode. In alternating pressure mode, every second cell is alternately inflated and vented, reducing pressure on the skin and stimulating blood circulation. In static mode, all cells are filled with the same pressure, and the variable inflation and deflation stops. The system is equipped with an alarm system that reacts to low pressure and cycle errors with visual (LED display "LOW" flashes) and acoustic signals. A delay function is incorporated into the low pressure alarm for the ventilation time during system start-up, activating automatically after approximately 45 minutes. Short-term low pressure (e.g., due to patient movement or cycle change) is not indicated unless it persists for longer than five minutes. Malfunctions of the alternating pressure function are also signaled visually and acoustically. The system includes a CPR emergency valve on the right side of the head part, allowing for rapid deflation in case of resuscitation.
Important Technical Specifications:
- Control Unit (all variations):
- Weight: 2.7 kg
- Dimensions: 30 x 19 x 12 cm
- Electric ratings: AC 220-240 V, 50-60 Hz / max. 0.1 A
- Protection class: Typ BF, Class II
- Fuses: T1AH 250 VAC 1A
- Length power cord: 4.6 m
- Max. inflation pressure (unloaded): 65 mm Hg
- Min. inflation pressure (unloaded): 20 mm Hg
- Cycle: approx. 10 min
- Mattress (Product variations 997008S 88 / 998008S 88):
- Treatable Decubitus Grade: I-III (997008S 88) / I-II (998008S 88)
- Suitable as mattress replacement system: Yes, with Novacare® base mattress (997008S 88) / No (998008S 88)
- Cell Dimensions: 88 x 13 cm Ø
- Cell Material: Nylon / PU coated
- Recommended patient weight: 20-140 kg (997008S 88) / 20-130 kg (998008S 88)
- Note: 18 cells, 10 microperforated (vented) and 3 static head cells (pillow function).
- Weight: 5.4 kg
- Measurements: 200 x 88 x 13 cm
- Material (cover): 100% PE, PU coated
- Environmental Conditions:
- Storage Temperature: +5 to +50 °C
- Operation Temperature: +5 to +40 °C
- Transport Temperature: -20 to +50 °C
- Relative Humidity (non-condensing): 30-75% (Storage and Operation)
- Air Pressure: 700-1060 hPa (Storage and Operation)
- Regulatory Requirements:
- Regulation (EU) 2017/745 about Medical Devices
- Testing of medical electrical devices according to DIN EN 60601-1 and -11
- Test for flammability according to BS EN 597-1 and -2 (cells)
- Testing for biocompatibility according to DIN EN ISO 10993
- Oeko-Tex® Standard 100
- CPR emergency valve
- Optical and acoustic low pressure alarm
Usage Features:
- Installation: The control unit is attached to the foot end of the bed using mounting brackets. The mattress is placed on an existing foam base or an optional integrated mattress base. The connection hose from the mattress to the control unit must be securely engaged and free of kinks. The CPR emergency valve should be in the "close" position. After connecting the power cord and switching on the unit, the overlay inflates, which takes about 40-45 minutes. The system is ready for use when the "LOW" display goes out.
- Operating Modes: Users can select between alternating pressure mode ("ALTER" LED lights up) and static mode ("STATIC" LED lights up) by pressing the mode button.
- Weight Adjustment: After inflation, the regulator on the control panel should be adjusted according to the patient's weight. A practical test involves sliding a flat hand between the vented cells and the patient with slight resistance to ensure correct pressure settings.
- Profiling Beds: The system can be used on profiling beds. When the bed head is raised, the mattress pressure should be increased by one or two levels, and a practical test performed. Avoid adjusting the backrest by more than 30°.
- Power Interruption/Transport: If a power interruption is necessary, the system should be switched to static mode beforehand. Without power supply, the pressure in the system drops slowly, so patients should not lie on the system. For transport, the cap on the connection adapter of the main connection hose should be used to prevent dirt ingress.
- Safety: The system should not be used in an uninflated state, near heat sources, flammable gases, or in potentially explosive areas. It should be protected from pointed objects, humidity, direct fluid exposure, falling, or damage. The power cord should be laid under the bed to avoid injuries. Only original spare and consumable parts should be used, and repairs should only be carried out by the manufacturer or an authorized specialist dealer. Children should be kept away from the product due to the risk of injury from small parts, strangling, and squeezing limbs.
Maintenance Features:
- Reprocessing: The product is suitable for repeated use. National regulatory requirements for hygienic reprocessing must be observed to ensure error-free function.
- Home Use (without changing patient): The cover should be wiped regularly with commercially available cleaning agents or disinfectants and a soft cloth. Abrasive agents containing phenols or diethylene glycol monoethyl ether should not be used. The cover can be removed and washed in a washing machine at up to 70 °C with commercially available detergents, then gently dried at low temperatures.
- Nursing Area (change of patient): Reprocessing should comply with national regulatory requirements and recommendations from the German Robert Koch Institute. The system cover can be chemo-thermally cleaned up to 70° C if necessary. Cells should be disinfected by wiping; chemo-thermal disinfection is only necessary if required. Cells should not be cleaned in a washing machine.
- Disinfection: Disinfection measures must only be carried out with suitable, tested disinfectants. Disinfectants that can damage the materials should be avoided. The instructions for use provided by the disinfectant manufacturer must be observed. Using unsuitable or untested preparations invalidates the warranty.
- Regular Maintenance: To maintain functionality, regular maintenance or safety checks by qualified personnel are required at least every two years. An annual safety check and maintenance interval are recommended for continuous use. Maintenance or inspection is carried out by the manufacturer or an authorized company and is subject to a charge. The last inspection date is found on the seal on the device.
- Repairs: All service, repair, and testing measures must only be carried out by competent and trained personnel. Only original spare and consumable parts may be used. The system should not be repaired by the user. In case of damage, the power plug must be pulled, and a damaged product should not be used.
- Disposal: The mattress can be disposed of with household waste. The control unit is electrical waste and must be delivered to an appropriate disposal point. The system's batteries are registered. No special types of packaging are used, and applicable disposal guidelines must be observed.
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