Arjo Caylis Pro Instructions For Use Manual
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Arjo Caylis Pro Instructions For Use Manual

Arjo Caylis Pro Instructions For Use Manual

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INSTRUCTIONS FOR USE
Caylis Pro
Reactive system with low air loss
04.CY.00EN_01 • 2024-10

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Summary of Contents for Arjo Caylis Pro

  • Page 1 INSTRUCTIONS FOR USE Caylis Pro Reactive system with low air loss 04.CY.00EN_01 • 2024-10...
  • Page 2 © Arjo 2024. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. The content of this publication may not be copied either whole or in part without the consent of Arjo.

  • Page 3: Table Of Contents

    Contents Foreword...............................5 Pre-sale information............................ 6 Intended use..............................7 Safety instructions............................8 Preparations..............................9 Parts designation - Pro mattress......................10 Parts designation - Pump.......................... 11 Parts designation - Touchscreen......................12 Icon explanation............................13 Product description - Pro mattress......................15 Mattress connector with tube-set......................15 Top cover (detachable)..........................15 Cell-holding sheet with loop straps......................15 Cells................................
  • Page 4 Audio pause icon............................20 Audio ON/OFF............................20 Settings..............................21 Assemble the system..........................22 Assemble the mattress..........................22 Assemble the pump...........................23 Assemble mattress extension........................24 The reactive system with low air loss...................... 25 Caregiver position............................. 25 Start-up..............................25 Cell valves - Supine/Semi-recumbent position..................25 Comfort control............................25 Continuous Low Pressure.........................

  • Page 5: Foreword

    Foreword Definitions in this IFU ® Thank you for choosing the Caylis Pro reactive system with low air loss. WARNING Customer contact information For questions regarding this product or other Warning means: Safety warning. Failure to Arjo products and services, contact Arjo, an Arjo understand and obey this warning may result in authorised representative or visit www.arjo.com.

  • Page 6: Pre-Sale Information

    Pre-sale information GENERAL Intended use, the intended user See Intended use on page 7 group and the intended environment; including any contraindications. Maintenance requirements See Care and preventive maintenance on page 41 Cleaning requirements See Cleaning and disinfection on page 36 Disinfection requirements See Cleaning and disinfection on page 36 Operator controls...

  • Page 7: Intended Use

    The system also benefits the microclimate of the Expected service life patient. By definition this is climate of a small The expected service life of the Caylis Pro pump or restricted area that differs from the climate of is 7 years.

  • Page 8: Safety Instructions

    Safety instructions WARNING WARNING To prevent injury, always read this To prevent pressure injury, make sure Instructions for use before using the that the system is assembled correctly. product. WARNING WARNING To prevent pressure injury, do not To prevent injury, side rails should let the patient wear clothing with be used when the patient is left creases, seams etc that may cause...

  • Page 9: Preparations

    The mattress range is designed to be used on Arjo bed frames. See Measurements and Place the patient on the mattress making sure compatibility on page 50. their head is placed on the head section.

  • Page 10: Parts Designation - Pro Mattress

    Parts designation - Pro mattress Cell types 1. Mattress and CPR connector with tube-set 8. Securing straps (four on each side) and (Mattress connector) Anchor points (five on each side) 2. Top cover with valve cover panel 9. Mattress extension (accessory) 3.

  • Page 11: Parts Designation - Pump

    Parts designation - Pump 1. Light sensor 6. Electrical port (on bottom of pump) 2. Touchscreen 7. Pump cable management 3. Run/Standby button 8. Power cable 4. Handles 9. Bed hooks 5. Repeater lights (underneath the handles) 10. Air inlet (on bottom of pump) PARTS DESIGNATION - PUMP...

  • Page 12: Parts Designation - Touchscreen

    Parts designation - Touchscreen Caylis Pro The touchscreen is divided into four different information areas. 1. Status bar: Shows active therapy mode, alarms and audio status. 2. Secondary mode bar: Shows Settings icon, Locked/Unlocked icon and any active alarm conditions.

  • Page 13: Icon Explanation

    Icon explanation ICON DESCRIPTION ICON DESCRIPTION ICON DESCRIPTION Continuous Low Confirm prompt Bed exit alarm Pressure Pulsation Refer to Service settings Instructions for Patient turn Back General prompt Autofirm Locked Safety prompt Proning Unlocked Low pressure alarm Comfort control Locked, insert Low pressure alarm - Patient turn...
  • Page 14 ICON DESCRIPTION ICON DESCRIPTION ICON DESCRIPTION Pause Service alarm ICON EXPLANATION...

  • Page 15: Product Description - Pro Mattress

    Product description - Pro mattress Mattress connector with tube-set The cover is clipped around the Mattress connector using two fasteners. WARNING To prevent serious injury or death, the Mattress and CPR connector must be visible and accessible at all times. The Mattress connector attaches the mattress to the pump.
  • Page 16 3-way valves 2-way valves The head and torso cells have individual valves The foot cells have individual valves that can that can fully or partially deflate. fully deflate. The foot cells are used for heel offloading. The torso cells are used to optimise patient support and comfort when in prone position.

  • Page 17: Cable Management Loops

    Cable management loops Securing straps and anchor points The mattress has eight securing straps. These can be used in any of the ten anchor points on WARNING the base of the mattress. This allows the mattress To prevent tripping or strangulation, to be attached to different types of bed frames.

  • Page 18: Cpr Rapid Deflation

    CPR rapid deflation In the event of the patient suffering a cardiac Deactivate the CPR rapid deflation arrest, the mattress can be rapidly deflated using Reconnect the Mattress connector to the pump. the Mattress connector. The mattress begins to inflate based on the active therapy mode.

  • Page 19: Product Description - Pump

    Product description - Pump Light sensor Repeater lights The light sensor automatically adjusts the The repeater lights are located underneath the brightness of the touchscreen and repeater lights handles. dependent on ambient light level. • The repeater lights are green during normal mode.

  • Page 20: Product Description - Touchscreen

    Product description - Touchscreen General description Locked/Unlocked icon To operate the touchscreen tap the desired icon The lock button icon is used to activate / with one finger to make a choice. deactivate the lock. The icon also indicates the lock status.

  • Page 21: Settings

    (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Arjo AB could void the user's authority to operate this equipment. When the pump is first switched on, the Bed exit alarm is disabled.

  • Page 22: Assemble The System

    Assemble the system Assemble the mattress 1. Remove any existing mattress from the bed WARNING frame. To prevent injury by displacement of the mattress from the bed frame, 2. Check that there are no protruding sharp secure the mattress to the bed frame objects on the bed frame surface.

  • Page 23: Assemble The Pump

    8. Clip the cover around the Mattress connector, use the two fasteners. The Mattress WARNING connector must be accessible at all times. To prevent tripping or strangulation, make sure that the tube-set is positioned along side the bed. Connect the Mattress connector to the pump. Assemble the pump 1.

  • Page 24: Assemble Mattress Extension

    2. Make sure that the mattress extension is fitted with its cover. WARNING To prevent tripping, keep cables 3. Check that there are no protruding sharp away from moving bed parts or other objects on the bed frame surface. possible entrapment areas. 4.

  • Page 25: The Reactive System With Low Air Loss

    The reactive system with low air loss Caregiver position Cell valves - Supine/Semi- The caregiver should be positioned in front of the recumbent position pump during operation. • For long term off-loading/pressure relief: NOTE Do not deflate any more cells in each section or it may affect the support of the patient, especially in profiled positions.

  • Page 26: Continuous Low Pressure

    Low Pressure. the mattress softer. Pulsation NOTE Autofirm and Patient turn does not have Caylis Pro comfort control. Comfort control can be selected in any other therapy mode. 5 10 Continuous Low Pressure Caylis Pro Pulsation is a therapy mode where the air cells inflate and deflate sequentially.

  • Page 27: Patient Turn

    Deactivate Pulsation tubes/lines/drains are safely positioned Activate another mode to deactivate Pulsation. during turning or repositioning. Patient turn Caylis Pro WARNING To prevent injury make sure the backrest is positioned between flat and 15:00 30 degrees prior to activating patient turn.
  • Page 28 The head of bed angle is between 30° and restraints are in use. flat. The maximum turn is achieved when the bed is flat. Activate Patient turn Caylis Pro 1. Tap >30° 14:59 (± 05:00) 2. Choose left or right.

  • Page 29: Autofirm

    This can only be activated in the last minute of therapy mode within 2 minutes. Autofirm. Until this point the option is unavailable. Autofirm 00:57 Caylis Pro +5:00 15:00 It is possible to extend Autofirm up to 3 times. The number of time extensions already used is shown by plus symbols underneath the timer.

  • Page 30: Proning

    Proning WARNING Caylis Pro To prevent serious injury monitor the patient frequently to make sure there is no build of pressure on areas such as: • Head and face including eyes • Top of the shoulders • Sternum • Breasts and genitals •...
  • Page 31 Cell levels - Prone position The decision to initiate prone positioning must be authorised by the physician responsible for the patients care. WARNING Turning a patient prone carries a degree of To prevent airway disruption, risk from a moving and handling perspective asphyxiation, and/or strangulation for both patient and clinical staff.
  • Page 32 9. Check that the shoulders are still in line with appropriate must be made by the caregiver, as the fourth cell. the pump is not capable of measuring patient size Caylis Pro or distribution. Activate Proning 1. Optional - Tap and then tap to activate Autofirm.

  • Page 33: Transport Mode

    ET tube is Caylis Pro adequately supported. Conscious proning Prone position for conscious patients can be considered on the Caylis Pro mattress. The decision to initiate conscious prone positioning must be authorised by the physician responsible for the patients care. NOTE...
  • Page 34 NOTE The sub-mattress remains inflated for up to 12 hours, if the mattress remains connected to the pump. Activate Transport mode WARNING To prevent injury, do not use the mattress as a patient transfer device. 1. Touch and hold the button on the pump for 2 seconds to place it in standby mode.

  • Page 35: Turn-Off And Store The System

    Turn-off and store the system Turn off the pump 3. Place the tube-set over the mattress parallel to the foot end. 1. Unlock the pump if locked. 2. Touch and hold the button on the pump for 2 seconds to place it in standby mode. 3.

  • Page 36: Cleaning And Disinfection

    The product should be cleaned and disinfected at CAUTION regular intervals and between patients. To prevent product damage: Contact Arjo Customer Service for any questions • Do not use Phenol-based solutions regarding the cleaning and disinfection of the or abrasive compounds or pads product.
  • Page 37 ALLOWED DISINFECTANTS Disinfectant Pump Tube-set Internal Top cover Bottom cover mattress cover system Isopropyl alcohol solution ● ● ● ● ● ≤ 70 % Chlorine solution ≤ 1 % ● ● ● ● ● (10 000 ppm) Quaternary ammonium solution 1.92 % ●...

  • Page 38: Clean And Disinfect

    Clean and disinfect CAUTION (33 steps) Never clean the pump by pouring water on it. Prepare the pump 1. Switch off the pump unit. Disconnect the Use a clean dry cloth to remove any excess pump from the power source. moisture from the pump.
  • Page 39 Disinfect the mattress 13. To remove any visible dirt on the mattress use a clean cloth with warm water and neutral 22. Add disinfectant solution onto a dry clean detergent (cleaning solution) to wipe down cloth. Spread the solution onto all external all areas.

  • Page 40: Launder

    33. If required, disinfect the securing straps and base of the mattress using the same method as above. The straps should be unclipped before cleaning for ease of access. Launder Launder the mattress top cover 1. Unfasten and remove the top cover from the mattress.

  • Page 41: Care And Preventive Maintenance

    Care and preventive maintenance Under normal use the product is subject to wear and tear. Perform the following actions when specified to make sure that the product remains within its original manufacturing specifications. WARNING To prevent electric shock, do not service or maintain the pump while it is in use. WARNING To prevent malfunction resulting in injury, inspect your product regularly.

  • Page 42: After Each Patient

    Check that the touchscreen is firmly affixed, section Labels on pump on page 51 and Labels undamaged and legible. on mattress on page 53. If any label is missing, contact Arjo customer service. Visually check all electrical connections and power cable Visually check the cell fasteners •...
  • Page 43 Visually check the securing straps Check that the securing straps are secure and undamaged. Visually check cell-holding sheet with loop straps • Check that all loop straps are correctly connected to the cell-holding sheet. • Check that no loop straps are loose or damaged.

  • Page 44: Troubleshooting And Alarms

    Audio Pause button in the bottom right corner. With some alarm conditions it is possible to return to the normal therapy screens by pressing the back arrow in the top left hand corner. All alarm conditions are low priority. Caylis Pro Caylis Pro 05:42 To bring up the full alarm screen again, press the small alarm condition icons.
  • Page 45 PROBLEM POSSIBLE CAUSE ACTION Low pressure - Patient There is a leak in the 1. Tap Audio pause if required. turn patient turning cells. 2. CLP, Pulsation, Autofirm modes will still function as normal. 3. Contact qualified service personnel. Alarm activation delay: 2 minutes Low pressure - There is a leak in the...
  • Page 46 PROBLEM POSSIBLE CAUSE ACTION High temperature The pump is operating 1. Tap Audio pause if required. outside its internal 2. Turn off the pump. temperature range 3. Disconnect the power cable. (40 °C, 104 °F). 4. Check the position of the pump: •...
  • Page 47 PROBLEM POSSIBLE CAUSE ACTION Cell is deflated Cell valve is set to 1. Check that the cell valves are turned to the deflated position. correct position. Alarm activation delay: Not applicable. 2. Re-inflate valve if not set to desired position. 3.

  • Page 48: Technical Specifications

    Total power consumption 24 hrs 1.02 kWh Analysis of electricity consumption based on Arjo laboratory data. A standard work sequence consists of a 3 minute pre-inflation cycle, then operation in Constant Low Pressure (CLP) or Pulsation mode under a load of 140 kg for a total of 24 hours.
  • Page 49 • Pump units that have electrical and electronic components should be disassembled and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with national or local regulations. ALLOWED COMBINATIONS Caylis Pro mattress Mattress extension TECHNICAL SPECIFICATIONS...
  • Page 50 When the Patient turn mode is activated the max mattress height is 260 mm (10 in). For the dimension and weight specifications in this IFU, there could be some tolerance, not explicitly listed. Arjo is entitled to have the final explanation on these specifications. TOP COVER SPECIFICATION...

  • Page 51: Labels On Pump

    Labels on pump 1. Product label - States technical performance 2. Serial number label - States the item and requirements, e.g. input power and input identification voltage. States storage requirements. SYMBOL EXPLANATION Refer to instruction manual/ booklet - Instructions for use should be read CE marking indicating conformity with European Community harmonised legislation.
  • Page 52 UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approved Body supervision. UK Responsible Person & UK Importer: Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF For Northern Ireland (NI) CE marking will still apply until further amendment to applicable regulations.

  • Page 53: Labels On Mattress

    Labels on mattress 1, 2, 3 6, 7, 8 4, 5 1. Mattress ID label (inside the bottom cover) - 5. Cleaning label States the product identification and product 6. US law tag (inside the mattress extension) - weight States certification of flammability test 2.
  • Page 54 UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) UK Responsible Person & UK Importer: Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF For Northern Ireland (NI) CE marking will still apply until further amendment to applicable regulations.

  • Page 55: Electromagnetic Compatibility

    If this product needs to be used adjacent to other electrical equipment, normal operation must be checked before use. For detailed EMC information contact Arjo service personnel. WARNING Stacking or placing other electrical equipment next to this equipment is not recommended, it can interfere with the equipment’s operation and safety.
  • Page 56 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY Immunity test IEC 60601 test Compliance Electromagnetic environment - level level guidance Conducted RF IEC 3Vrms 6Vrms ISM, 10Vrms Portable and mobile RF communications 61000-4-6 150 kHz- 80MHz equipment should be used no closer to 150 kHz- 2300 MHz any part of the pump, including cables, 80 % AM 1 kHz...
  • Page 57 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT AND THE PUMP Rated maximum output Separation distance according to frequency of transmitter - m power of transmitter - W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz d = 1.2√P d = 1.2√P...
  • Page 58 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY Immunity test IEC 60601 test Compliance Electromagnetic environment – level level guidance Power frequency 30 A/m 30 A/m Power frequency magnetic fields should (50/60 Hz) be at levels characteristic of a typical location in a typical domestic commercial Magnetic field or hospital environment.

  • Page 59: Regulatory Compliances

    Regulatory compliances REGULATORY COMPLIANCES FCC Conformity section FCC ID: 2BBKF675003 IC: 30708-675003 Also contains radio module with the following approvals: FCC ID: SQG-EWB1 IC: 3147A-EWB1 US FCC compliance statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 60 ArjoHuntleigh AB as the manufacturer of this medical device, takes sole responsibility and declares conformity with the applicable provisions of EU Directive 2014/53/EU and the UK Radio Equipment Regulations 2017. Full Declarations can be found at: www.arjo.com This device is intended for indoor use only.

  • Page 61: Parts And Accessories

    Parts and accessories Mattress extension 636615 PARTS AND ACCESSORIES...
  • Page 62 Intentionally left blank...
  • Page 63 AUSTRALIA FRANCE POLSKA Arjo Australia Arjo SAS Arjo Polska Sp. z o.o. Building B, Level 3 2 Avenue Alcide de Gasperi ul. Ks Piotra Wawrzyniaka 2 11 Talavera Road CS 70133 PL-62-052 KOMORNIKI (Poznań) Macquarie Park, NSW, 2113, Australia FR-59436 RONCQ CEDEX...
  • Page 64 At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.

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