Table of Contents
Related Manuals for Care of Sweden CuroCell A4 Plus
Summary of Contents for Care of Sweden CuroCell A4 Plus
- Page 1 Instructions for use 2024-12-19 CuroCell A4 Plus Air mattress system Instructions for use item number: 95-001453-EN0000 Read the instructions carefully before use. All user instructions and safety instructions must be followed.
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Page 2: Table Of Contents
Table of content Symbol key ........................3 Warnings- and safety precautions ................5 Introduction ........................7 General information ...................... 7 Intended purpose ......................7 Indications........................7 Intended patient population ..................7 Intended user ......................... 7 User qualification ......................8 Intended use environment .................... 9 3.7.1 Optimum environmental conditions ................ - Page 3 Product combinations ....................21 Control unit ........................22 Mattress ........................23 Reuse and cleaning ..................... 24 Cleaning and disinfection ..................... 25 Reconditioning ......................26 Maintenance ....................... 27 General ........................27 Between patients ......................27 Service- and maintenance schedule ................28 Replacing air filter ......................
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Page 4: Symbol Key
Symbol key Symbols to convey medical device information CE-marked in accordance with Medical Device Manufacturer Regulation (EU) 2017/745 Medical device Distributor Unique device identifier Date of manufacture Warning Caution Catalogue number Batch code Read the instructions for Serial number Consult instructions for use Symbols for product information –... - Page 5 Symbols for product information - Mattress Year-Month-Day Foot placement XXXX-XX-XX Patient information – Recommended patient pressure ulcer category weight Counteracts shear Do not rotate Heel function Do not turn around Place on top of existing Place on top of the bed mattress Do not place on top of Do not place directly on bed...
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Page 6: Warnings- And Safety Precautions
• The product must not be combined, assembled or repaired with parts (e.g. control unit and mattress), accessories or spare parts other than those described in this manual or other documentation from Care of Sweden. The product must not be modified in any way as this might result in hazards. - Page 7 Contact an authorized service technician for examination and repair. • Never connect anything other than the Care of Sweden supplied power supply to the control unit power cable connector.
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Page 8: Introduction
All information involving accidents or incidents relating to our products, shall be reported immediately to Care of Sweden. Intended purpose The mattress system consists of a control unit and a mattress and are intended to be used as an aid in the prevention and treatment of pressure ulcers/pressure injuries (PU/PI). -
Page 9: User Qualification
User qualification Training is not mandatory to use the system. The table below describes common user scenarios and what type of user that shall perform each activity. Healthcare professionals shall inform lay persons on which activities the lay person is allowed to perform according to the table below. -
Page 10: Intended Use Environment
Intended use environment The mattress system is intended to be used during hospital care, long term care and home care. Avoid direct sunshine and extensive noise in the room. 3.7.1 Optimum environmental conditions The product is intended to be used indoors in room temperature. Contraindications The mattress system is not intended to be used by patients weighing <160 kg. -
Page 11: Assembly And Installation
Assembly and installation When the product is unpacked, check that no parts are damaged. If damage is found, contact Care of Sweden or your local distributor before using the product. Do not use sharp objects when unpacking as it might damage the product. The operator should follow and check the below information before use. - Page 12 Do not hold the 12V plug on the power supply while touching the patient. Never use a power supply that is not provided by Care of Sweden. The power supply is a potential risk. Never use the 3,5 mm outlet, this shall only be used by authorized technicians or Care of Sweden.
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Page 13: Install The Mattress With A 3 Meter Tubing Set
Install the mattress with a 3 meter tubing set Read the entire instruction before installation is executed. 1. Ensure that the power cable is not plugged into the control unit. This is to avoid the power cable getting caught and causing potential damage. 2. -
Page 14: Assemble Comfort Cover
Assemble Comfort cover The Comfort cover shall be used together with a hygiene cover. When using a Comfort cover, the pressure relieving properties may be slightly reduced. It is therefore important to always make a clinical assessment of the needs of each individual whether to use a Comfort cover or not. -
Page 15: Operation Curocell® A4 Plus
Operation CuroCell® A4 Plus If the control unit has been stored in its minimum or maximum storage temperature (- 25°C or 70°C), wait at least one (1) hour before starting the control unit. This time is based on an ambient temperature of 20°C. How to start the system: 1. - Page 16 Button Function Mute the information signal Panel lock Pack & Go®-function for deflating the system Gentle Alternating Low Pressure Mode (GALP) Pulsating mode Constant Low Pressure (CLP) Maximum pressure (caring mode) Information signal Incorrect connection of the air connector (CPR) Cycle time settings (10, 15, 20, 25 minutes).
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Page 17: Function
Function The mattress system adjusts the inner pressure of the mattress according to the weight, height, and position of the patient. No manual action is needed to adjust the inner pressure of the mattress. This works as follows: At start-up, an automatic setting of the inner pressure of the mattress is carried out according to weight and height of the patient. -
Page 18: Cpr - Cardiopulmonary Resuscitation
CPR – Cardiopulmonary resuscitation In case of an emergency where CPR (Cardiopulmonary resuscitation) is necessary, remove the connection (marked ‘CPR’) from the control unit and leave the lid open in order to empty the mattress of air quickly. Function control A function control shall be performed regularly to ensure that the product is working correctly. -
Page 19: Restart
Restart If a restart is required: 1. Set the On/Off switch on the side of the control unit to ‘0’ (off). 2. Wait for approximately ten (10) seconds. 3. Set the On/Off switch on the side of the control unit to ‘1’ (on). Power failure In the event of a power failure, unplug the CPR connection, close the lid, and place the CPR connection at the end of the bed. -
Page 20: Table Of Notifications
5.13 Table of notifications Information about each notification is shown in the notification table on the next page. Notifications that are described under ‘Notification (sound)’ are shown by both light and sound. The error code will be displayed until the error has been rectified. If the mute button is pressed the audible warning will crease for a period of 5 minutes and will return until the error has been rectified. - Page 21 Notification (light) Description and troubleshooting Notification 10+15; 10+15+25; 10+15+20 - Leakage in cell section Leakage in one of the cell sections. Control the CPR connection, mattress and tubes. Information to technicians: More information regarding leakage in cell sections are found in the Service- and repair manual for CuroCell®...
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Page 22: Product Description
Product description CuroCell® A4 Plus is an automatic air mattress system used as an aid to prevent and treat pressure ulcers/pressure injuries. The automation means that the control unit’s built-in sensors use software to adjust the inner pressure of the mattress according to the patient’s weight, height, position, and change in position. -
Page 23: Control Unit
Control unit Materials the user comes in contact with: Polycarbonate/acrylonitrile-butadiene-styrene (Control unit casing) • • Silicone (Control panel) • High impact plastic, 94V0 polycarbonate (Power supply) CuroCell ® A4 Plus Control panel Tube/CPR connection Power switch, On/Off 3,5 mm plug input (only for use by manufacturer) Connection power cable Air filter... -
Page 24: Mattress
Mattress Materials the user comes in contact with: Polycarbonate/acrylonitrile-butadiene-styrene (CPR Connector) • • Polyester with polyurethane coating (Cover Top part Olivia, Cover Bottom part CuroCell) Polyamide with polyurethane coating (Cover Top part Stone) • CuroCell® CX20 Plus 1. Mattress 2. Cover (Hygiene Cover or with Comfort Cover) 3. -
Page 25: Reuse And Cleaning
Always follow local instructions and the instructions for use of the cleaning and disinfecting agent. Consult your hygiene manager or Care of Sweden for help and instructions in case of uncertainty. Check the Hygiene cover and Comfort cover, air cells and hoses each time the product is cleaned. -
Page 26: Cleaning And Disinfection
Cleaning and disinfection CONTROL UNIT Wipe off using a damp cloth. Information on detergent If other agents are used, choose one that does not harm the exterior of the control unit. Primarily Solvent-free soap with a neutral pH-value. If necessary Disinfectant, such as alcohol with or without surfactants or oxidizing solutions. -
Page 27: Reconditioning
Reconditioning CONTROL UNIT Clean the control unit according to section 7.1 Cleaning and disinfection – CONTROL UNIT. MATTRESS Disconnect the tube connector from the control unit and remove the air from the mattress. Cleaning of mattress Clean all external surfaces of the mattress according to section 7.1 Cleaning and Primarily disinfection - Inner cover, hygiene cover and comfort cover. -
Page 28: Maintenance
We recommend that the control unit shall be regularly serviced and inspected to maintain functionality and performance. Service and maintenance must always be performed by Care of Sweden or one of its authorized technicians. Only use spare parts approved by Care of Sweden. Only perform service and maintenance when the system is not in use. -
Page 29: Service- And Maintenance Schedule
Service- and maintenance schedule Service in the right column shall always be performed by an authorized service technician. Always ensure that the control unit is shut off before any maintenance or service is performed. Maintenance and/or service shall never be performed while the product is in use. -
Page 30: Replacing Air Filter
Replacing air filter Replacing the air filter can be done by a lay person. Always ensure that the control unit is shut off before any maintenance or service is performed. Maintenance and/or service shall never be performed while the product is in use. -
Page 31: Storage
10 Storage It is advisable to store the mattress and control unit in the product bag (accessory), original package or equivalent for protective storage. Handle the packaged product with caution. Do not place any heavy objects on top of it. For additional information about storage temperature, see section 11. -
Page 32: Technical Specification
11 Technical specification CONTROL UNIT SPECIFICATION Model CuroCell® A4 Plus Input voltage 100-240 V / 50-60 Hz / 0,6 A Output voltage 12 V DC Power supply Ungrounded AC outlet, Use only power supply with P/N electrical safety class II WR9QE1500LRPCIMG3138 Power consumption Max 18 W... -
Page 33: Standards
11.1 Standards The system is tested and approved according to the following European standards, where applicable requirements are met. IEC 60601-1 EN ISO 10993 ISO 3746 IEC60601-1-2 EN 597-1 ISO 11201 IEC 60601-1-11 EN 597-2 IEC60601-1-6 EN ISO 14971 IEC 62304... -
Page 34: Other Information
The product warranty covers manufacturing defects and is valid from the date the product is shipped with intent of usage, either directly from Care of Sweden or through one of Care of Sweden’s designated distributors. The product warranty does not cover normal wear and tear, issues resulting from improper use, or damage caused by non-compliance with usage instructions. -
Page 35: Own Notes
Own notes... - Page 36 SE-514 23 Tranemo SWEDEN Visit address: Fabriksgatan 5A SE-514 33 Tranemo SWEDEN Cargo address: Byns väg 4A SE-514 33 Tranemo SWEDEN Distributed by: Care of Sweden and CuroCell are trademarks of Care of Sweden AB © Care of Sweden AB, 2024...
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