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Flowtron ACS800

Instructions for Use

...with people in mind
513933EN_03 • 05/2016

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Summary of Contents for Arjohuntleigh Flowtron ACS800

  • Page 1: Instructions For Use

    Flowtron ACS800 Instructions for Use ...with people in mind 513933EN_03 • 05/2016...
  • Page 3: Table Of Contents

    Contents General Safety ............iii Introduction .
  • Page 4 (ii)
  • Page 5: General Safety

    • Keep the pump away from sources of liquids and do not immerse in water. • Do not use the pump in the presence of uncontained flammable liquids or gasses. • Only the pump and garment/insert 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

    If you have any difficulties in setting-up or using the Flowtron ACS 800 system, contact your local ArjoHuntleigh sales office, listed at the end of this manual. Intended Use The intended use of this product is to prevent Deep Vein Thrombosis (DVT).
  • Page 8: Pump: Front View

    A full technical description of the Flowtron ACS 800 system can be found in the Service Manual, part number SER0020, available from your local ArjoHuntleigh sales office. Pump: Front View LCD Screen Integral Carry Handle and Controls Integral Tubesets LED Indicator...
  • Page 9: Clinical Applications

    2. Clinical Applications Indications The primary application of the Flowtron ACS 800 system is for the prevention of Deep Vein Thrombosis (DVT) when 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 • ArjoHuntleigh does not recommend the use of compression stockings with its system. If these are ordered by the physician, the clinician should ensure that the compression stockings are properly measured, applied and worn by the patient.
  • Page 12: Controls, Alarms And Indicators

    3. Controls, Alarms and Indicators Control Panel With Typical LCD Screen View in Run Mode Calf (or Calf & Thigh) Therapy Indicator Foot Therapy Indicator Mains/Power Indicator Battery Indicator LED Indicator Pressure Indicator On/Off Button Patient Stop Hours Meter LCD Screen Start/Stop Therapy “Up”...
  • Page 13 • If the mains power is disconnected, the pump runs the diagnostic tests and then goes into Standby. • If the mains power remains connected, the pump goes into Standby and does not run diagnostic tests. This has the following functions depending on the text Start/Stop Button or icon displayed above the button: •...
  • Page 14 Where the tubesets enter the side of the pump, the top tubeset is marked “1”. 2. Pressure indication: this is the inflation pressure applied to the garment, as follows: • Foot Garment: 130 mmHg. • Calf and Calf & Thigh Garments: 40 mmHg. 3.
  • Page 15: Led Indicators On The Front Case

    LED Indicators on the There are two sets of LED indicators on the front case of Front Case the pump. Their status is as follows: LED Colours Pump Status Warnings/Alarms Extinguished Off or Standby • No fault detected. Green (Static) •...
  • Page 16: Operation

    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 ArjoHuntleigh sales office. To switch on the pump, do one of the following: Start Up •...
  • Page 17: Standby Screens

     There is no text above the Start/Stop button until at least one garment is connected to a tubeset. Apply the prescribed ArjoHuntleigh garment(s) to the patient by following the instructions included in the garment packaging.
  • Page 18: Starting Therapy

     Garments are for single patient use only. Do not use the garments on a different patient after treatment. Connect the garment(s) to the pump by pushing the garment connector firmly into the pump tubeset connector until it “clicks”. The pump LCD screen will show which garments are connected to each tubeset connector: the garment connector with the blue push button is “1”...
  • Page 19 Press the button below “Start” to start the therapy. The LEDs on the front case change to static green. 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.
  • Page 20 2. Foot garment 1 is inflated to 130 mmHg, with a ramp up and hold time of 3 seconds. The foot garment indicator is black while it is inflated: Stop 3. The foot garment is deflated to zero. Both garment indicators are grey: Stop 4.
  • Page 21: Stopping Therapy

    times for a foot garment are shorter than for a calf (or calf & thigh) garment, there is a modified inflation sequence: the foot garment is always inflated twice in succession and then the calf (or calf and thigh) garment is inflated, as follows.
  • Page 22: Changing Options

    1. The visual-only warning is a fault message on the LCD screen. The LED indications remain unchanged and there is no audible alarm. 2. If the fault is not cleared then the warning is replaced by an audible and visual alarm, which consists of: •...
  • Page 23 • On the “Options” menu, select and confirm “Audio Alarm Volume” and the “Audio Alarm Volume” screen is displayed: Set Volume High Set Volume Low Back Exit • The “tick” on the left side of the screen shows that the alarm is currently set to High Volume. •...
  • Page 24 option is selected, and then press the “tick” button to toggle the option on or off. • The text “Hours Run 00001” indicates the current value of the Patient Hours Meter. • To clear the elapsed time showing in the Patient Hours Meter (for example, when therapy is started on a new patient), use the “up”...
  • Page 25: Settings Adjustment

    If the physician requires different therapy settings for calf and calf & thigh garments, then limited changes can be made to the pump pressure by accessing a Service screen on the pump. Contact your local ArjoHuntleigh sales office for details. ...
  • Page 26: Decontamination

    5. Decontamination The following processes are recommended, but should be adapted to comply with the local or national guidelines (Decontamination of Medical Devices) which may apply within the Healthcare Facility or the country of use. If you are uncertain, you should seek advice from your local Infection Control Specialist.
  • Page 27: Routine Maintenance

    Flowtron ACS 800 System The equipment has been designed to be maintenance- Maintenance free between service periods. will make available on request service Servicing ArjoHuntleigh manuals, component parts lists and other information necessary for trained personnel to repair ArjoHuntleigh the system.
  • Page 28: Troubleshooting

    7. Troubleshooting On detection of a fault condition, the Flowtron ACS 800 pump provides a visual- only warning followed by an audible and visual alarm if the fault is not cleared. Warning Conditions The visual-only warning is a fault message on the LCD screen. The LED indications remain unchanged and there is no audible alarm.
  • Page 29 Condition Description and Corrective Action Blocked Garment/Kinked Tube The warning is activated after 3 inflation cycles and shows a blocked garment 1 or Stop kinked tube. Screens A and B alternate with the “standard” Run screen. The warning changes to an alarm after 10 inflation cycles and shows a blocked garment 1 or kinked tube.
  • Page 30 Condition Description and Corrective Action Battery Low These Battery Low warning and alarm will only be activated when the pump is operating Connect power from just 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 Mute...
  • Page 31 Condition Description and Corrective Action Hardware Fail This alarm is activated if the pump detects an internal fault. The “spanner” symbol is permanently displayed. Therapy is suspended. Switch off the pump. Call the service engineer. Faulty Tubeset The Faulty Tubeset warning and alarm are activated if the pump detects a fault in the tubeset.
  • Page 32 Condition Description and Corrective Action Setup Required The Setup Required warning and alarm are activated if the pump detects a fault in the Setup required tubeset. For both conditions: • Switch off the pump. • Call the service engineer. If the pump is in Standby when the faulty Setup required tubeset is detected: •...
  • Page 33 Condition Description and Corrective Action This alarm is activated when the temperature Pump Too Hot inside the pump exceeds 55°C. “Pump too hot!” is displayed at the top of the Pump too hot! “standard” Run screen (screen A) and an audible alarm sounds.
  • Page 34: Accessories

    8. Accessories The Flowtron ACS 800 pump should only be used with the following garments: CALF GARMENTS Order Code Type Calf Circumference DVT10 DVT10 Standard Calf Garment Up to 43 cm (17") DVT10S DVT10S Standard Calf Garment (Sterile) Up to 43 cm (17") L501-M L501-M Standard Calf Garment Up to 43 cm (17")
  • Page 35: Technical Specification

    9. Technical Specification PUMP Model: Flowtron ACS 800 Part Numbers: 513001 - Flowtron ACS 800 UK 513003 - Flowtron ACS 800 US 513004 - Flowtron ACS 800 EUR 513009AU - Flowtron ACS 800 Australia 513001OR - Flowtron ACS 800 UK, Operating Room 513003OR - Flowtron ACS 800 US, Operating Room 513009KSA - Flowtron ACS 800 KSA Pressure Range:...
  • Page 36: Environmental Information

    ENVIRONMENTAL INFORMATION Condition Temperature Range Relative Humidity Atmospheric Pressure Operating +10 °C to +40 °C 30% to 75% 700 hPa to 1060 hPa (+50 °F to +104 °F) (non-condensing) Storage and Transport +10 °C to +40 °C 20% to 95% 700 hPa to 1060 hPa (Long Term) (+50 °F to +104 °F)
  • 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 IEC 60601 Test Compliance Electromagnetic environment - guidance Test...
  • Page 38 Recommended separation distances between portable and mobile RF communications equipment and the pump The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the pump as recommended below, according to the maximum output power of the communications equipment.
  • Page 39 Free: +1 800 072 040 Fax: +33 (0) 3 20 28 13 14 Fax: + 61 89337 9077 E-mail: info.france@arjohuntleigh.com POLSKA ArjoHuntleigh Polska Sp. z o.o. BELGIQUE / BELGIË HONG KONG ul. Ks Piotra Wawrzyniaka 2 ArjoHuntleigh NV/SA ArjoHuntleigh (Hong Kong) Ltd...
  • Page 40 Getinge Group is a leading global provider of products and systems that contribute to quality the three brands of ArjoHuntleigh, Getinge and Maquet Getinge provides solutions for Maquet specializes in solutions, therapies and products for surgical interventions, interventional ArjoHuntleigh focuses on patient handling and hygiene, disinfection, DVT prevention,...

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