AVA Activity Analytics Anti-Decubitus Air Alternating Pressure Mattress Replacement System Instructions for Use
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics About This Document Congratulations and thank you for purchasing this high quality antidecubitus system. Please read these Instructions for Use carefully before use and observe the safety instructions and the requirements for the operation and maintenance of the device.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics About This Document Information on the Manufacturer's Representative Carilex Medical, Inc. No. 77, Keji 1st Rd., Guishan District, Taoyuan City(33383), Taiwan(R.O.C) EU Representative: Carilex Medical B.V Zekeringstraat 41D, 1014BV Amsterdam Tel:+31 (0) 208905788 Email: nl@carilexmedical.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics Table of Contents 1 Important Notes for Safe Use 5-11 1.1 Designation of the Groups of Individuals 1.2 Notes for the Users 1.2.1 Instruction 1.2.2 Handing Over the Device 1.2.3 Maintenance and Installation 1.2.4 Information and Test Obligation of the User 1.2.5 Rechargeable Coin Cell Replacement Notice 1.3 Procedures for Accident Prevention 1.3.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics Table of Contents 5 Features 18-21 5.1 Control Panel 5.2 Side Panel 5.3 Rear Panel 18 21 21 6 System Installation, Operation, Transfer and Transport of Patient 6.1 System Installation 6.2 Operation 6.3 Transfer and Transport of Patient 7 Application 22 22 23 24 7.1 Preparing the Application 7.1.1 Inflating the Mattress 7.1.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use Named groups of persons 1.1 Designation of the Groups of Individuals The named groups of persons in these Instructions for Use are as follows. Operators An operator (surgical supplier, health insurance, clinic, etc.) is any legal person, who owns AVA Activity Analytics System and uses it, or on whose behalf the device is in use.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use 1.2 Notes for the Users Note that the AVA Activity Analytics System should only be used by persons who have been trained in the operation and the intended use of the device. Training on the device 1.2.1 Instruction The training of users on how to use the device must be carried out by the qualified personnel of the operator using the device.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use 1.3 Procedures for Accident Prevention The AVA Activity Analytics System is made according to the current state of the art technology and is reliable. However, hazards may arise during the use of this device if it is operated by untrained personnel or it is not operated as described in these Instructions for Use. 1.3.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use 1.4 Intended use Purpose of the Device To ensure the security of patients and users, the device may only be used for its intended use. 1.4.1 Intended Use The therapeutic air alternating mattress / cushion system is designed for patients who endure pressure ulcer and potential patients who wish to reduce the likelihood of pressure ulcer.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use • EMC and RF notices For leaning & disinfection Processes of ME equipment being performed by a Lay Operator shall be investigated by the Usability Engineering Process. 1.4.3 EMC and RF Compliance Statement Use of accessories and/or cables other than those specified or provided by the manufacturer of the SR396 may negatively affect EMC performance.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use 1.6 Safety Information and Symbols of These Instructions for Use The safety instructions in this Instructions for Use are marked with symbols and key words. Signal words like WARNING, CAUTION or ATTENTION designate the classification of the risk. 1.6.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 1 Important Notes for Safe Use 1.6.4 Additional Symbols to the Safety Information Additional symbols to the safety information are those listed below Machine Wash Warm : Max. 60°C Machine Wash Warm : Max.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 2 Security Norms 2.1 Correct Use of the System (1) In order to guarantee the correct operation, ensure that the system is perfectly assembled and securely fasten the mattress with the specific straps to the bedframe. Make sure that the straps do not interfere with the bed movements.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 2 Security Norms 2.2 CAUTION: Ensure no points, springs protruding from mattress which may pierce the air cells. Advice (1) Use the mattress within the bed side rails and assure that the space between the sides of the bedframe and the mattress is not big enough to insert the patient’s head and neck. Neglecting this could cause serious injuries to the patient.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 3 Delivery and Storage 3.1 Packaging 3.2 Delivery Control AVA Activity Analytics System is supplied in sturdy cardboard packaging. All packaging materials are recyclable and can be separated. Following actions could be unsafe as applicable: Use of accessories, detachable parts, and materials not described in the instructions for use.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 4 Device and Functional Description 4.1 Device Description Power unit The power unit is used as the housing for the air source as well as control features: • A control panel with buttons and lights to adjust the air system. • Two hooks on the back to hang the power unit to a bedframe. • A receptacle for an air filter on the rear panel. • Two air outlets for quick coupling.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 4 Device and Functional Description 4.2 Operation and Functional Test To perform a functional test and at the initial start-up of the power unit take the following actions: • Fully lay out the replacement mattress. Both air hoses must be able to move easily without any kinks or pressure points. • Make sure that the CPR valve is closed.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 5 Features 5.1 Control Panel Power Press power button to power on or off the power unit. Please make sure that the power cord is securely inserted into the proper wall socket and the black cable of the mattress is inserted into the power unit. The system will automatically start the initial inflating and calculating the mattress, ring light of knob will be spinning in green.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 5 Features Multiple Cycle Time This button is used to select cycle time in dynamic mode. The number indicators correspond to the time for 1 complete cycle.Three cycle times can be selected: 10, 15 and 20 minutes. Static Mode Static Mode or Continuous Low Pressure mode is the therapy in which all air cells maintain a constant low pressure support.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 5 Features Mute User may press this button to turn off the audible indicator. After mute, the audible indicator will not re-start again and only have LED flashing to visually notify the caregivers until the problem is solved. Panel Unlock When there is no operation after 2 minutes, system will automatically lock the control panel. The white LED will light to indicate the panel is locked.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 5 Features 5.2 Side Panel 1 3 2 4 Air Outlet (1) Quick coupling enables a rapid and firm connection between the mattress and the power unit. Power Receptacle (2) Two pin IEC 60320 C18 AC inlet to accept power cord set with 2 Pin_ IEC 60320_Type C17 IEC connector. Power Unit Outlet (3) Provide the power to sensors of mattress and collect the sensors’ data from the mattress to power unit.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 6 System Installation,Operation,Transfer and Transport of Patient Specification ID Label (3) This label includes all the information for medical device and safety requirements. Air Filter (4) We recommend inspecting and cleaning this filter monthly or more often, depending on the environment the unit is being used.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 6 System Installation,Operation,Transfer and Transport of Patient (4) WARNING! Use the mattress within the boundaries of the bedframe and assure that the space between the sides of the bedframe and the mattress is not big enough to insert the patient’s head and neck. Neglecting this could cause serious lesions to the patient. (5) Always turn off the power unit by using the power button.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 7 Application Fix the mattress 7.1 (1) (2) (3) (4) Preparing the Application Place the bedframe in the supine (flat) position. Fix the mattress with the straps onto the bedframe. Make sure that the CPR valve is closed. Hang the power unit with the two hooks on to the footboard of the bedframe and check that the fixing is stable.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 8 Cleaning and Disinfection In order to prevent cross-contamination, the cleaning and disinfection of the entire the AVA Activity Analytics System must be carried out between uses with different patients. Check electrical components WARNING Electric shock! Water has a high electrical conductivity. Contact with liquid under voltage can lead to a fatal electric shock.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 8 Cleaning and Disinfection 8.1 Cleaning When using the AVA Activity Analytics System in non-clinical areas the users or appropriately trained cleaning personnel can carry out the cleaning of the device. WARNING Remove the power cord set from the wall socket before cleaning of the power unit. Do not spray any cleaning liquid directly onto the power unit.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 8 Cleaning and Disinfection If the coverlet is soiled or loses its water-resistant properties, it must be replaced. Any resulting damage of the mattress caused by a spoiled coverlet will be not covered by the warranty. Please follow the hygiene control regulations of your local authority.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 9 Care and Maintenance 9.1 Inspection 9.2 Maintenance The safe operating condition of the AVA Activity Analytics System has to be checked at each use by the operator or during use by the patients and at least once in a year in particular with regards to the following: • Function of the keys of the power unit. • Function of the emergency CPR. • Condition of the air hoses and quick coupling.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 10 Troubleshooting Problem Control Procedure 1.) The power unit is 1.1) Verify that air flows liberally working but the mattress across the tubes and the mattress is not inflating. manifold. Check if there are any cuts, blockage or breakages. Possible Solution 1.1) It may be necessary to move the tubes or the manifold if they are kinked or twisted.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 10 Troubleshooting Problem Control Procedure Possible Solution 4.2) Check if the mattress is insufficient pressure. 4.2) Check if there is any air loss from air cell. 4.3) Check if the mattress is excessive pressure. 4.3) Check if the mattress is too hard. 4.4) Check if the power cord is loose. 4.4) Check the power cord is firmly connect with power unit and wall socket. 4.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 10 Troubleshooting Sensor Pad Assembly Configuration Drawing (Back View): Right side Head 27 25 18 24 19 26 23 20 22 21 10 9 17 11 8 2 16 12 7 3 15 13 6 4 14 5 Left side 31 1 Foot
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 11 Technical Data The AVA Activity Analytics System is suitable for continuous operation. Power unit System Name.................................................AVA Activity Analytics Model .........................................................................................SR396 Dimensions(W x H x D).............................339 x 266 x 130mm (±5mm) Weight............................
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 12 EMC Declaration Declaration of Conformity For EN 60601-1-2 (4th Ed.) Company Name: Carilex Medical, Inc. Product Name: No. 77, Keji 1st Road, Guishan District, Taoyuan City 33383, Taiwan, R.O.C. AVA Activity Analytics System Model No.: SR396 Report Number: ETC 21-01-RBO-054-01 Power Supply: 100-240Vac 50/60Hz 0.5-0.
Instructions for Use | Anti-Decubitus Air Alternating Pressure Mattress Replacement System AVA Activity Analytics 12 EMC Declaration Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are use in the professional healthcare facility environment or in the home healthcare environment The AVA Activity Analytics System declaration – electromagnetic immunity The AVA Activity Analytics System system is intended for use in the electromagnetic environment specified below.
U-2S2006-30171-G V1.
