Care of Sweden CuroCell iA Automatic Instructions For Use Manual

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Instructions for use
2025-04-16
CuroCell® iA Automatic and CuroCell® iA Manual
Air mattress system
Instructions for use item number: 95-001456-EN0000
Read the instructions carefully before use.
All user instructions and safety instructions must be followed.
EN

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  • Page 1 Instructions for use 2025-04-16 CuroCell® iA Automatic and CuroCell® iA Manual Air mattress system Instructions for use item number: 95-001456-EN0000 Read the instructions carefully before use. All user instructions and safety instructions must be followed.
  • Page 2: Table Of Contents

    Table of content Maximum pressure (caring mode) 15 Symbol key ........3 6.10 Maximum pressure notification ..15 Warnings- and safety precautions .. 5 6.11 Comfort settings ......15 Introduction ........6 6.12 Notifications ........16 General information ....... 6 6.13 Table of notifications ....
  • Page 3 10.3 Replacing air filter ......31 14.1 Technical lifetime ......33 Troubleshooting ......31 14.2 Warranty ........33 Technical specification ....32 14.3 Disassembly and recycling .... 33 12.1 Standards ........33 14.4 Return ........... 34 Storage ......... 33 14.5 Technical assistance requests ..
  • 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: Introduction

    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: Intended Purpose

    Intended purpose The mattress systems 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). Indications Suitable for a wide range of patients with increased risk for pressure ulcers/injuries, including those with superficial ulcers, up to category IV in association with an individualized plan of care.
  • 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: 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 11 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 12: 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 When shutting down the system, follow the steps below: 1.
  • Page 13: Operation Curocell® Ia Automatic

    Operation CuroCell® iA Automatic The following instructions are only applicable to CuroCell® iA Automatic, 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 14 Button Function Mute the information signal Panel lock Gentle Alternating Low Pressure (GALP) 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). The diodes are also used for error notifications.
  • Page 15: Function (Automatic)

    Function (Automatic) The mattress system independently and without manual adjustment controls the inner pressure of the mattress according to the weight, height, 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 height of the patient.
  • Page 16: 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 17: Notifications

    6.12 Notifications Different notifications exist based on how serious the warning is. With a malfunction or an error, a notification will be given by 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 18 Notification (sound) Description and troubleshooting High temperature. Valves and compressors are turned off. If the control unit is in direct sunlight, relocate it. If problem persists, contact an authorized service technician. Default settings are not completed. Contact an authorized service technician. Incorrect input voltage.
  • Page 19: Operation Curocell® Ia Manual

    Operation CuroCell® iA Manual The following instructions are only applicable to CuroCell® iA Manual, 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 20 Button Function Mute the information signal Panel lock Gentle Alternating Low Pressure (GALP) 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). The diodes are also used for error notifications.
  • Page 21: Function

    Function 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 22: Function Control - Hand Check

    Function control – Hand check Perform a hand check to ensure that the mattress system works properly. Hand check should be performed regularly; for CuroCell® iA Manual we recommend once every eight hours as well as after installation of the system. Ensure that the air mattress is filled with air before performing a hand check.
  • Page 23: Notifications

    7.12 Notifications Different notifications exist based on how serious the warning is. With a malfunction or an error, a notification will be given by 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 24 Notification (sound) Description and troubleshooting High temperature. Valves and compressors are turned off. If the control unit is in direct sunlight, relocate it. If problem persists, contact an authorized service technician. Default settings are not completed. Contact an authorized service technician. Incorrect input voltage.
  • Page 25: Product Description

    Product description Read the label of your products carefully to understand which products you are using. Product combinations The products in this instruction for use are combinations of the product groups below. Product configuration – Individualised airflow configuration (PCON002) Product group, Individualised airflow- Product group, CuroCell individualized air controlled control unit (CE030) mattresses (CE040)
  • Page 26: Control Unit

    Control unit Materials the user comes in contact with: CuroCell® iA Automatic • Polycarbonate/acrylonitrile-butadiene-styrene • Silicone • High impact plastic, 94V0 polycarbonate Control panel Tube/CPR connection Power switch On/Off Connection power cable Air filter Hangers CuroCell® iA Manual Power supply 25(34)
  • Page 27: Mattresses

    Mattresses Materials the user comes in contact with: • Polycarbonate/acrylonitrile-butadiene-styrene • Polyester with polyurethane coating (Cover Olivia, Cover Olivia Grip-lock, Cover Top part Olivia, • Cover bottom part CuroCell) • Polyamide with polyurethane coating (Cover Stone, Cover Stone Grip-lock, Cover Top part Stone) CuroCell®...
  • Page 28 CuroCell® Ci20 PRO 1. Mattress 2. Hygiene cover – top part 3. Main cells 4. Heel cells 5. Press studs for inner cover 6. Cell holder (integrated in inner cover) 7. Tubing set 8. CPR (quick deflation) 9. Safety mattress 10.
  • Page 29: 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 30: Reconditioning

    Reconditioning CONTROL UNIT Clean the control unit according to section 9.1 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 9.1 Cleaning and disinfection - Inner cover and Mattress cover.
  • Page 31: 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 32: Replacing Air Filter

    The patient is bottoming to re-start the control unit (see section 5.3). Wait until the diodes stop flashing. If the issue remains, contact Care of Sweden or your distributor. Ensure that the mattress is secured to the underlying base mattress...
  • Page 33: Technical Specification

    IP classification IP42 Degree of safety in presence The device is not intended for use of inflammable anesthetics with flammable anaesthetic gases Applied part Mattress Note: Care of Sweden reserves the right to modify the product specification at any time. 32(34)
  • Page 34: 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 35: Return

    14.4 Return Contact Care of Sweden or your distributor before the product is returned. 14.5 Technical assistance requests If technical assistance is required, contact the 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 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, 2025 35(34)

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