Arjohuntleigh Flowtron ACS900 Instructions For Use Manual

Arjohuntleigh Flowtron ACS900 Instructions For Use Manual

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Flowtron ACS900
Instructions For Use
526933EN Rev B - 09/2015
...with people in mind

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  • Page 1 Flowtron ACS900 Instructions For Use 526933EN Rev B - 09/2015 ...with people in mind...
  • Page 3: Table Of Contents

    About the Flowtron ACS900 System ........
  • Page 4 (ii)
  • Page 5: General Safety

    • Do not use the pump in the presence of uncontained flammable liquids or gasses. • Only the pump and garment combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and garment combinations are used.
  • Page 6 ArjoHuntleigh for information on correct disposal. Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.
  • Page 7: Introduction

    Vein Thrombosis (DVT). The garments are single patient use only. It is not for use in the home healthcare environment. The Flowtron ACS900 system should be used as part of a prescribed plan of care (refer to “Indications” on page 3).
  • Page 8: Pump: Front View

    (for example private dwellings). A full technical description of the Flowtron ACS900 system can be found in the Flowtron ACS900 Service Manual, part number SER0026, available from your local ArjoHuntleigh sales office.
  • Page 9: Clinical Applications

    2. Clinical Applications Indications The intended use of the Flowtron ACS900 system is to help prevent Deep Vein Thrombosis (DVT). The system should be combined with an individualised monitoring programme. This system represents one aspect of a DVT strategy; if the patient's condition changes, the overall therapy regimen should be reviewed by the prescribing clinician.
  • Page 10: Cautions

    3. Any local condition in which the garments would interfere, including: • Gangrene • Recent skin graft • Dermatitis • On untreated, infected leg wounds  If you are unsure of any contraindications refer to the patient’s physician before using the device. Cautions 1.
  • Page 11: Guidelines And Recommendations

    7. When used for DVT prevention, continuous external pneumatic compression is recommended until the patient is fully ambulatory. Uninterrupted use of the system is encouraged. 8. The system should be USED WITH CAUTION on patients with: • Insensitive extremities. • Diabetes. •...
  • Page 12: Controls, Alarms And Indicators

    3. Controls, Alarms and Indicators Control Panel with Typical LCD Screen View in Run Mode Mains Indicator LCD Screen Power Button Left Control Button Middle Control Button Right Control Button To switch the pump on: Power Button and Mains Indicator •...
  • Page 13: Lcd Screen Icons

    When the pump is in Standby and one or two garments Middle Control Button are connected, press this button to put the pump into the Run mode and start therapy; the LED indicators on the front and underside of the case will be illuminated green. To stop the therapy and put the pump into Standby, press and hold this button for approximately 2 seconds until the Standby screen is displayed and then release the...
  • Page 14 These show which garment type is connected to each Garment Type and tubeset and when each garment is being inflated. Inflation Indication  A garment connected but not inflated is shown as an outline on the leg icon. When it is inflated, the garment outline is filled in black.
  • Page 15 Mains Power Indication The pump is connected to the mains power supply. The pump is NOT connected to the mains power supply. When the pump is connected to the mains power supply: Battery Indication • If the battery is fully charged, the indicator will be static and show “full”.
  • Page 16: Led Indicators On The Pump Case

    When an alarm which is able to be muted is shown on Audible Alarm Status the LCD screen, this icon is shown to indicate that the alarm can now be muted. When the pump is in Standby, this icon indicates that the alarm volume can be changed (refer to “To Change the Audible Alarm Volume Setting”...
  • Page 17: Operation

    If the operation or performance of the pump changes during use, refer to “Troubleshooting” on page 21 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office. Start Up 1. To switch on the pump, do one of the following: •...
  • Page 18: Standby Screens

     The Start Therapy icon does not appear until at least one garment is connected to a tubeset connector. Apply the prescribed ArjoHuntleigh garment(s) to the patient by following the instructions included in the garment packaging. ...
  • Page 19: Starting Therapy

    Tubeset No garment connected Connector 1 Tubeset Foot garment Connector 2 Tubeset Sequential (Tri Pulse) calf or Connector 1 calf & thigh garment Tubeset No garment connected Connector 2 Tubeset Uniform (DVT) calf or calf & Connector 1 thigh garment Tubeset Uniform (DVT) calf or calf &...
  • Page 20 It is recommended that the following checks are carried out at the start of, and throughout, the therapy: • Check the LCD screen icons to confirm that the correct type of garment(s) have been connected. • During garment inflation, check the LCD screen to confirm that there are no fault indicators displayed and that the correct pressure is being supplied.
  • Page 21 3. The foot garment is deflated to zero. Both garment icons are outlines. 4. Foot garment 2 is then inflated to the target pressure, with an inflate time of 3 seconds and a deflate time of 27 seconds. The foot garment icon is black while it is inflated.
  • Page 22: Stopping Therapy

    6. Deflate the calf (or calf & thigh) garment. 7. This cycle of garment inflations repeats from step 1 until the therapy is stopped. Stopping Therapy To stop the therapy and put the pump into Standby, press and hold the Middle Control button for approximately 2 seconds until the Standby screen is displayed (refer to “Standby Screens”...
  • Page 23: Warnings/Alarms

    Warnings/Alarms On detection of a fault condition, the pump provides a visual-only warning followed by an audible and visual alarm if the fault is not cleared. 1. The visual-only warning is a fault icon on the LCD screen. The LED indicators remain unchanged and there is no audible alarm.
  • Page 24: Settings Adjustment

    These changes, and returning the pump to the default settings, can only be made either: • By contacting service personnel through your local ArjoHuntleigh sales office, or • By trained authorised technical personnel at the facility. ...
  • Page 25: Cleaning And Disinfection

    Do not use anything abrasive to clean the LCD window on the pump. Chemical Disinfection ArjoHuntleigh recommends a chlorine-releasing agent, such as sodium hypochlorite, at a strength of 1,000ppm available chlorine (this may vary from 250ppm to 10,000ppm depending on local policy and contamination status).
  • Page 26: Routine Maintenance

    Servicing manuals, component parts lists and other information necessary for ArjoHuntleigh trained personnel to repair the system. The Flowtron ACS900 Service Manual, part number Service Manual SER0026, is available from your local ArjoHuntleigh sales office. ArjoHuntleigh recommend that the pump is serviced...
  • Page 27: Troubleshooting

    Where reference is made in the following Troubleshooting table to the Flowtron ACS900 Service Manual, this is part number SER0026 and is available from your local ArjoHuntleigh sales office. Troubleshooting Table The following table provides typical warning and alarm conditions shown on the LCD screen.
  • Page 28 Condition Description and Corrective Action The warning is activated after 4 minutes and shows Low Pressure/Leak a leak in garment 1 or its tubing. The warning changes to an alarm after an additional 6 minutes (10 minutes total). Examine the garment and tubing for leaks. The warning or alarm will be cleared if the leak is repaired.
  • Page 29 Condition Description and Corrective Action The Battery Low warning and alarm will only be Battery Low activated when the pump is operating from the battery (the mains power is disconnected). When any of these Battery Low warning or alarm screens are activated, connect the pump to the mains power supply to recharge the battery and continue therapy.
  • Page 30 Condition Description and Corrective Action The Faulty Tubeset warning and alarm are activated Faulty Tubeset if the pump detects a fault in the tubeset. For both conditions: • Switch off the pump. • Call the service engineer. If the pump is in Standby when the faulty tubeset is detected: •...
  • Page 31 Therapy is suspended. Switch off the pump. Call the service engineer. The fault codes and their descriptions can be found in the Flowtron ACS900 Service Manual, part number SER0026. The Tubeset Disconnected alarm is activated if the Tubeset Disconnected/ pump detects that the tubeset has been...
  • Page 32 Condition Description and Corrective Action The Battery Fault alarm is activated if the pump Battery Fault detects a fault in the internal battery. If the pump is in Standby, on battery power: • An alarm is activated which can be muted. •...
  • Page 33: Accessories

    8. Accessories The Flowtron ACS900 pump should only be used with the following garments: CALF GARMENTS Order Type Calf Therapy Code Circumference DVT10 DVT10 Standard Calf Garment Up to 43 cm (17”) Uniform DVT10S Standard Calf Garment (Sterile) Up to 43 cm (17")
  • Page 34: Technical Specification

    9. Technical Specification Pump Specification PUMP Model Flowtron ACS900 Supply Supply Part Number Country Voltage Frequency Configuration (Hz) 526000-01 US, Canada, Venezuela, Mexico, Ecuador, Colombia, Peru 526000-02 526000-03 United Kingdom, Singapore, Hong Kong 526000-04 526000-05 Australia, New Zealand, Argentina 526000-06...
  • Page 35: Environmental Information

    PUMP (continued) Case Material Flame Retardant ABS Plastic Mains Power Plug 5A to BS1362 (UK ONLY) Fuse Rating Degree of protection Class II, Double Insulated against electric Type BF shock Degree of protection against liquid IPX3 - Protected against spraying water ingress Mode of operation Continuous...
  • Page 36: Electromagnetic Compatibility

    Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic emissions The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions...
  • Page 37 Guidance and manufacturer’s declaration - electromagnetic immunity The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic environment - guidance Level...
  • Page 38 Guidance and manufacturer’s declaration - electromagnetic immunity The pump is intended for use in the electromagnetic environment specified below. The customer or the user of the pump should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic environment - Level...
  • Page 39: Symbols

    Symbols With respect to electric shock, fire and Conforms to the Medical mechanical hazards Device Directive (93/42/ only in accordance with Serial EEC). CAN/CSA-C22.2 No. Number Supervised by Notified 0086 60601.1 (2008). Body BSI. MEDICAL EQUIPMENT The operator must read Refer to this document this document (Instructions (Instructions for Use)
  • Page 43 AUSTRALIA FRANCE POLSKA ArjoHuntleigh Pty Ltd ArjoHuntleigh SAS ArjoHuntleigh Polska Sp. z o.o. 78, Forsyth Street 2 Avenue Alcide de Gasperi ul. Ks Piotra Wawrzyniaka 2 O’Connor CS 70133 PL-62-052 KOMORNIKI (Poznan) AU-6163 Western Australia FR-59436 RONCQ CEDEX Tel: +48 61 662 15 50 Tel: +61 89337 4111 Tél: +33 (0) 3 20 28 13 13...
  • Page 44 Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, Getinge and Maquet. Getinge provides solutions for infection control within healthcare and contamination prevention within life sciences.

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