Arjohuntleigh Flowtron ACS900 Instructions For Use Manual

Arjohuntleigh Flowtron ACS900 Instructions For Use Manual

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INSTRUCTIONS FOR USE
Flowtron ACS900
526933EN_G • 06/2019

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  • Page 1 INSTRUCTIONS FOR USE Flowtron ACS900 526933EN_G • 06/2019...
  • Page 2 WARNING To avoid injury, always read this Instructions for Use and accompanied documents before using the product. Mandatory to read the Instructions for Use Design Policy and Copyright ® and ™ are trademarks belonging to the Arjo group of companies. ©...
  • Page 3: Table Of Contents

    About the Flowtron ACS900 System ........
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  • Page 5: General Safety

    GENERAL SAFETY Before you connect the system pump to a mains socket, read carefully all the installation instructions contained within this manual. The system has been designed to comply with regulatory safety standards including: • EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 • ANSI/AAMI ES 60601-1(2005)+AMD(2012) and CAN/CSA C22.2 No.60601-1 (2008)+(2014).
  • Page 6 Electromagnetic Compatibility (EMC) This product complies with the requirements of applicable EMC Standards. Medical electrical equipment needs special precautions regarding EMC and needs to be installed in accordance with the following instructions: • The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance.
  • Page 7: Introduction

    1. Introduction Flowtron About this Manual Flowtron Intended Use Flowtron About the Flowtron ACS900 System Flowtron Flowtron...
  • Page 8: Pump: Front View

    Flowtron Flowtron Pump: Front View Garment Tubeset Connector 1 LED Indicators Connectors (Blue Button) Control Buttons Power Button LCD Screen Tubeset Connector 2 (Orange Button) Tubeset Retention Clips Swing-out Bed-Hooks Mains Power Cord Mains Power Cord Retention Clip Pump: Rear View Integral Carry Handle USB Port (refer to Service...
  • Page 9: Clinical Applications

    2. Clinical Applications Indications Flowtron The type of garment used on an individual patient must be specified by a physician. Contraindications Uniform & Sequential Calf and Calf & Thigh Garments Foot Garments...
  • Page 10: Cautions

    If you are unsure of any contraindications refer to the patient’s physician before using the device. Cautions Many patients are at risk for pressure ulcers on the heel. Use of the foot garments does not negate the necessity for heel protection and appropriate skin care.
  • Page 11: Guidelines And Recommendations

    These are guidelines only and should not replace clinical judgement and experience. Guidelines and Recommendations General Recommendations...
  • 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 Power Button and Mains Indicator...
  • Page 13: Lcd Screen Icons

    Middle Control Button Left Control Button Only certain alarms can be muted. Refer to “Troubleshooting” on page 22 for details of the various alarm conditions and possible corrective actions to rectify the faults. Right Control Button LCD Screen Icons Garment Low Pressure/ Kinked/ Mains Power...
  • Page 14 Garment Type and 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. Connected and Connected and Garment Not Inflated Inflated Foot Uniform (DVT) Calf (or Calf &...
  • Page 15 Mains Power Indication The pump is connected to the mains power supply. The pump is NOT connected to the mains power supply. Battery Indication Battery Empty Battery ¼ Full Battery ½ Full Battery ¾ Full Battery Full If the pump is not connected to the mains power supply and the battery is fully charged and in good condition, the pump will continue to operate normally for approximately 12 hours for calf and...
  • Page 16: Led Indicators On The Pump Case

    Audible Alarm Status Audible Alarm Muted Warning and Alarm Indications Alarm detected which may cause an interruption in therapy. Low pressure or garment leak. Kinked or blocked tubeset. High temperature. Hardware fault detected or periodic service required. LED Indicators on the Pump Case LED Colours Pump Status...
  • Page 17: Operation

    4. Operation General If the operation or performance of the pump changes during use, refer to “Troubleshooting” on page 22 of this IFU before calling a service engineer or contacting your local Arjo sales office. Installing the Pump Start Up Mains Power Connected Mains Power Disconnected...
  • Page 18: Standby Screens

    Major Revision Minor Revision Standby Screens The Start Therapy icon does not appear until at least one garment is connected to a tubeset connector. Do not re-use the garments. Do not use the garments on multiple patients.
  • Page 19: Starting Therapy

    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. The same garment outline is used for both calf and calf & thigh garments. Tubeset No garment connected Connector 1...
  • Page 20 If the pump is switched on and one or more garments are connected to the pump, but therapy is not started within 15 minutes, an alarm will occur. If no action is taken to start therapy or silence the alarm, then 15 minutes after the alarm starts, the pump will go into an “Off”...
  • Page 22: Stopping Therapy

    Stopping Therapy The Mains indicator above the Power button will remain green if the pump is connected to the mains power and extinguished if the mains power is disconnected.
  • Page 23: Switching Off The Pump

    Switching Off the Pump The Mains indicator above the Power button will remain green if the pump is connected to the mains power and extinguished if the mains power is disconnected.
  • Page 24: Warnings/Alarms

    Warnings/Alarms To Change the Audible Alarm Volume Setting Audible Alarm Audible Alarm Volume Status If the Left Control button is not pressed for more than 2 minutes, the selected setting will be stored, the Volume and Audible icons will be removed and the pump will exit the Audible Alarm Volume Setting mode.
  • Page 25: Settings Adjustment

    Resetting the Patient Run Hours This is the pump run time since the patient run hours was last reset. Settings Adjustment The pump pressures for foot garments and sequential calf and calf & thigh garments are fixed and cannot be changed. The pressure range and factory default pressure for the uniform calf and calf &...
  • Page 26: Cleaning And Disinfection

    5. Cleaning and Disinfection WARNING Remove the electrical supply to the pump by disconnecting the mains power cable from the mains power supply before cleaning. Protective clothing should always be worn when carrying out decontamination procedures. Caution Do not use Phenol-based solutions or abrasive compounds or pads during the decontamination process as these will damage the surface coating.
  • Page 27: Routine Maintenance

    6. Routine Maintenance Flowtron ACS900 System Maintenance Servicing Flowtron Service Manual Service Period General Care, Maintenance and Inspection Serial Labels...
  • Page 28: Troubleshooting

    7. Troubleshooting General Warning Conditions Alarm Conditions For simplicity, the following screens (except Battery Low, Hardware Fail and High Temperature) show a fault detected on garment 1; similar fault messages are displayed if the fault is detected on garment 2 (or both garments). If the trouble shooting procedures do not return the system to normal performance, stop using the system immediately and call the service engineer.
  • Page 29 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 30 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 31 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 32 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 33 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 34: Accessories

    8. Accessories Flowtron CALF GARMENTS Order Type Calf Therapy Code Circumference DVT5 DVT5 Small Calf Garment Up to 36 cm (14") Uniform DVT10 DVT10 Standard Calf Garment Up to 43 cm (17”) Uniform DVT10S Standard Calf Garment (Sterile) Up to 43 cm (17") Uniform DVT10S L501-M...
  • Page 35: Technical Specification

    9. Technical Specification Pump Specification PUMP Part numbers 526000-XX 526000-17/18 (KSA) Supply Voltage (V) 100 - 230V 230V (KSA) Supply Frequency (Hz) 50 - 60Hz 60Hz (KSA) Power Input 10 - 40 VA Size 230 x 228 x 190 mm (9.1 x 9.0 x 7.5 in.) Weight 4.1 kg (9.0 lb) a.
  • Page 36: Electromagnetic Compatibility

    Electromagnetic Compatibility WARNING Wireless communications equipment such as wireless computer network devices, mobile phones, cordless telephones and their base stations, walkie-talkies, etc. can affect this equipment and should be kept at least 1.5m away from the equipment. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
  • Page 37 Guidance and manufacturer’s declaration - electromagnetic immunity Immunity Test IEC 60601-1-2 Compliance Electromagnetic environment - guidance Test Level Level Electrostatic ±2kV, ±4kV, ±8kV, ±2kV, ±4kV, Floors should be wood, concrete or ceramic discharge ±15kV air ±8kV, ±15kV tile. If floors are covered with synthetic (ESD) material the relative humidity level should be at least 30%...
  • Page 38 Guidance and manufacturer’s declaration - electromagnetic immunity Surge ±0,5kV ±1kV; ±2 kV, ±0,5kV ±1kV; Mains power quality should be that of AC Mains, Line to ±2 kV, AC a typical commercial or hospital Ground Mains, Line environment. to Ground ±0,5kV ±1kV, ±0,5kV ±1kV, AC IEC 61000-4-5 AC Mains,...
  • Page 39: Symbols

    Symbols With respect to electric CE marking indicating shock, fire and conformity with European mechanical hazards only Community harmonised in accordance with CAN/ legislation Serial CSA-C22.2 No. 60601.1 E348583 Number Figures indicate Notified (2008) + (2014). ANSI/AAMI ES 60601-1 Body supervision. (2008) + (2014) (2005) +AMD (2012) ANSI/AAMI ES 60601-1...
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  • Page 43 AUSTRALIA FRANCE POLSKA Arjo Australia Pty Ltd Arjo SAS Arjo 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 (Pozna ) 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 With products and solutions that ensure ergonomic patient handling, personal hygiene, disinfection, diagnostics, and the effective prevention of pressure ulcers and venous thromboembolism, we help professionals across care environments to continually raise ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden www.arjo.com...

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