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Care of Sweden CuroCell A4 CX15 Instructions For Use Manual

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Instructions for use
2025-04-16
CuroCell® IQ, CuroCell® A4, CuroCell® M4
Air mattress systems
Instructions for use item number: 95-001436-EN0000
Read the instructions carefully before use.
All user instructions and safety instructions must be followed.
EN

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Summary of Contents for Care of Sweden CuroCell A4 CX15

  • Page 1 Instructions for use 2025-04-16 CuroCell® IQ, CuroCell® A4, CuroCell® M4 Air mattress systems Instructions for use item number: 95-001436-EN0000 Read the instructions carefully before use. All user instructions and safety instructions must be followed.

  • Page 2: Table Of Contents

    Table of content Operation CuroCell® IQ ..16 Symbol key ....... 3 Function (Automatic) ..... 18 Warnings- and safety Program ......... 18 precautions ......5 Cardiopulmonary resuscitation - Introduction ......7 CPR ......... 18 General information ....7 Function control ..... 18 Intended purpose .....
  • Page 3 7.11 Product combinations .... 35 Transport function ....26 Control unit ......36 7.12 Sitting positioning ....26 Mattresses ......37 7.13 Comfort settings ....26 Reuse and cleaning ....39 7.14 Notifications ......27 10.1 Cleaning and disinfection ..39 7.15 Table of notifications .....

  • 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...

  • 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 •...

  • 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 is intended to be used as an aid in the prevention and treatment of pressure ulcers/pressure injuries (PU/PI).

  • Page 9: Intended Patient Population

    Intended patient population The mattresses are intended for use by patients with a recommended minimum length of 120 cm. Patients who, due to amputated legs, do not reach 120 cm can use the air mattress system. The specifications for weight are listed in the table below. Mattress Recommended patient weight CuroCell®...

  • Page 10: User Qualification

    User qualification Training is not mandatory to use the system. Lay persons are qualified to operate the air mattress systems. 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 11: 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 There are no known contraindications.

  • Page 12: 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 13 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.

  • Page 14: 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 15: Common Operations

    Common operations The following operations apply to all products included in this instruction for use. Cardiopulmonary resuscitation – CPR 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 to empty the mattress of air quickly. Shut down (Pack&Go) The product may be packed as follows: 1.

  • Page 16: 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 17: Operation Curocell® Iq

    Operation CuroCell® IQ The following instructions are only applicable to CuroCell® IQ, regardless of which mattress that is used. Read the label of the control unit carefully to know which product you have. 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.
  • Page 18 Button Function Mute the information signal Pack & Go®. Function for deflating the system Maximum pressure (caring mode) Information signal Incorrect connection of the air connector (CPR) Check-symbol. System is ready to use Notification diodes...

  • Page 19: Function (Automatic)

    Function (Automatic) The mattress system independently and without manual adjustment controls the inner pressure of the mattress according to the weight, length, and position of the patient. No manual action needs to be performed to adjust the inner pressure of the mattress. This function works as follows: At start-up, automatic setting of the inner pressure of the mattress is always carried out according to the weight and length of the patient.

  • Page 20: Maximum Pressure (Caring Mode)

    Maximum pressure (caring mode) With this function, the entire mattress is inflated and provides firmed support. This function reverts to the previous setting after 20 minutes. Use this function during caring, shifting the patient’s position, or during bed entry and bed exit. Maximum pressure notification See section 5.5.
  • Page 21 Notification (sound) Description and troubleshooting High temperature. Valves and compressors are turned off. If the control unit is in direct sunlight, relocate it. Otherwise, contact the technical support. Default settings are not completed. Contact the technical support. Incorrect input voltage. Make sure that the correct power supply is used, otherwise contact the technical support.
  • Page 22 Notification (light) Description and troubleshooting Leakage in one of the sections. Secure the CPR, mattress, and connection tubes. Information to service technicians: this notification shows a leakage in the blue cell section. More information in the service manual for CuroCell® IQ. Leakage in one of the sections.

  • Page 23: Operation Curocell® A4

    Operation CuroCell® A4 The following instructions are only applicable to CuroCell® A4, regardless of which mattress is used. Read the label of the control unit carefully to know which product you have. 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.
  • Page 24 Button Function Mute the information signal Panel lock Pack & Go®. Function for deflating the system Maximum pressure (caring mode) Information signal Incorrect connection of the air connector (CPR) Comfort settings Cycle time settings (10, 15, 20, 25 minutes). The diodes are also used for error notifications.

  • Page 25: Function (Automatic)

    The new version of display has the following buttons for program modes Manufactured from 2025-03-27 Gentle Alternating Low Pressure Mode (GALP) Pulsating mode Constant low pressure (CLP) Function (Automatic) The mattress system adjusts the inner pressure of the mattress according to the weight, height, and position of the patient.

  • Page 26: Program

    Program Choose program by pressing the button on the control unit. Choose between three programs: Program Symbol Explanation Old version of display for program modes Constant Low Air pressure is distributed evenly in all air cells. The control unit Pressure (CLP) adapts the pressure according to the patient’s weight and length.

  • Page 27: Cardiopulmonary Resuscitation - Cpr

    Cardiopulmonary resuscitation - CPR See section 5.1. Function control A function control shall be performed regularly to ensure that the product is working correctly. Ensure that the air mattress is filled with air before performing function control. This is indicated by a green light above the chosen program. The function control is performed by verifying that a green light is illuminated on the control panel for the selected program.

  • Page 28: Notifications

    7.14 Notifications Different notifications exist based on how serious the warning is. With a malfunction or an error, a notification will be given by way of a flashing warning triangle. To mute the warning signal, press the mute button. When a notification occurs, the current cycle time diode will turn off and a notification code is shown on the four different cycle time diodes (10, 15, 20, 25).
  • Page 29 Notification (sound) Description and troubleshooting High temperature. Valves and compressors are turned off. If the control unit is in direct sunlight, relocate it. Default settings are not completed. Incorrect input voltage. Make sure that the correct power supply is used, otherwise contact the technical support. Low pressure.

  • Page 30: Operation Curocell® M4

    Operation CuroCell® M4 The following instructions are only applicable to CuroCell® M4, regardless of which mattress is used. Read the label of the control unit carefully to know which product you have. 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.
  • Page 31 Button Function Mute the information signal Panel lock Pack & Go®. Function for deflating the system Gentle Alternating Low Pressure (GALP) Pulsating mode Constant low pressure (CLP) Maximum pressure (caring mode) Patient weight settings Information signal Incorrect connection of the air connector (CPR) Seating function Cycle time settings (10, 15, 20, 25 minutes).

  • Page 32: Function (Manual)

    Function (Manual) At start-up, the inner pressure of the mattress must be set manually based on the weight and height of the patient. The mattress system maintains the pre-set inner pressure regardless of movement and position changes. This means that when the patient changes position, for example, the mattress’s inner pressure must be adjusted manually.

  • Page 33: Function Control (Hand Check)

    Function control (hand check) Hand check is performed to ensure that the mattress system works properly and to ensure that the weight setting is correct. Recommendation on when to perform a hand check: • Once per work shift • After installation of the product •...

  • Page 34: Sitting Positioning

    8.12 Sitting positioning Press the button for “Seating function” if the patient is sitting in bed. A visible and audible notification is generated when the seating function has been active for two consecutive hours, notifying that repositioning of the individual may be necessary. The control unit will also notify if an attempt is made to switch on the system while seating function is active.
  • Page 35 Notification (sound) Description and troubleshooting High temperature. Valves and compressors are turned off. If the control unit is in direct sunlight, relocate it. Default settings are not completed. Incorrect input voltage. Make sure that the correct power supply is used. Low pressure.

  • Page 36: Product Description

    Product description Read the label of your products carefully to identify which products you are using. Product combinations The products in this instruction for use are combinations of the product groups below. Product configuration – Active airflow configuration (PCON001) Product group, Active airflow-controlled Product group, CuroCell active air mattresses control unit (CE010) (CE020)

  • Page 37: Control Unit

    Control unit Materials the user comes in contact with: • Polycarbonate/acrylonitrile-butadiene-styrene • Silicone • High impact plastic, 94V0 polycarbonate CuroCell® IQ 1. Control panel 2. Tube/CPR connection 3. Power switch, On/Off 4. 3,5 mm plug input 5. Connection power cable 6.

  • Page 38: Mattresses

    Mattresses Materials the user comes in contact with: • Polycarbonate/acrylonitrile-butadiene-styrene • Polyester with polyurethane coating • Polyamide with polyurethane coating CuroCell® CX10 1. Mattress 2. Hygiene cover 3. Main cells 4. Cell holder (integrated in inner cover) 5. Heel cells 6.
  • Page 39 CuroCell® CX16 1. Mattress 2. Hygiene cover 3. Main cells 4. Cell holder (integrated in inner cover) 5. Press studs for inner cover 6. Safety mattress 7. Tubing set 8. CPR (quick deflation) 9. Bottom part CuroCell® CX20 1. Mattress 2.

  • Page 40: 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, air cells and hoses each time the product is cleaned. Also, check the control unit, tube connectors and power cable during cleaning.

  • Page 41: Reconditioning

    10.2 Reconditioning CONTROL UNIT Clean the control unit according to section 10.1 Cleaning and disinfection – CONTROL UNIT. MATTRESS Disconnect the tube connector from the control unit and remove the air from the mattress. Cleaning of mattress Primarily Clean all external surfaces of the mattress according to section 10.1 Cleaning and disinfection - Inner cover, hygiene cover and comfort cover.

  • Page 42: Maintenance

    We recommend that the control unit is 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 43: Service- And Maintenance Schedule

    11.3 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 44: Replacing Air Filter

    11.4 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 45: Technical Specification

    14 Technical specification CONTROL UNIT SPECIFICATION Model CuroCell® IQ, CuroCell® A4, CuroCell® M4 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 46: Standards

    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 47: Return

    15.4 Return Contact Care of Sweden or your distributor before the product is returned. 15.5 Technical assistance requests If technical assistance is required, contact the name supplier at the address indicated on the invoice at the time of delivery of the unit; otherwise contact the local Engineer or Technician suggested by the Supplier.
  • Page 50 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, 2025...

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