Flowtron Universal AC 600 User Manual

Contents Description and Operating Principle...1 Clinical Applications...2 Cautions & Contraindications...3 Cautions... 3 Contraindications... 3 System Set up...4 Garment Application... 4 General Guidelines and Recommendations... 4 System Operation... 5 To Use One Garment... 7 To Use Different Garments on Each Limb... 8 Settings Adjustment...9 Troubleshooting...10 Options...11 Battery Operation...12 Connecting the Battery Pack... 12 Battery Pack in Use... 13 Battery Power Saving Features... 13 Checking the Status of the Battery... 14 Recharging the Battery Pack... 15 Alternative Method of Charging... 16 Warranty and Service...17 Cleaning Instructions...18 Ordering Information...19 Technical Data...20

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General Safety Before you connect the system pump to a mains socket, read carefully all the installation instructions in Section 4 - System Set Up. The system has been designed to comply with regulatory safety standards including EN60601-1:1990/A13:1996. Safety Warnings • Electrical equipment may be hazardous if misused. The pump's case back should only be removed by authorised technical personnel. • Do not use the pump in the presence of flammable gases such as anaesthetic agents. Caution Electromagnetic compatibility (EMC). This product complies with the requirements of applicable EMC Standards. The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance. Precautions For your own safety and the safety of the equipment, always take the following precautions: • Regularly check the system when in use, for pump operation and garment fit. • Keep the pump away from sources of liquids and do not immerse in water. • Do not expose the system, especially the garments, to naked flames, such as cigarettes etc. • Do not store the system in direct sunlight. • Switch off the electrical supply to the pump by disconnecting the pump from the mains socket before cleaning and inspection. • Do not use hypercarbonate or phenolic based cleaning solutions. • Ensure the system is clean and dry prior to storage. • Only the pump and garment combination as indicated by Huntleigh Healthcare should be used. The correct function of the product cannot be guaranteed if the incorrect pump/garment combinations are used.

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1. Description and Operating Principle The Flowtron® Universal system is a non-invasive external intermittent pneumatic compression system for reducing the incidence of Deep Vein Thrombosis (DVT). The application of external pneumatic compression has two effects; • Augments venous blood flow velocity, thereby reducing stasis. • Enhances fibrinolytic activity to reduce the risk of early clot formation. The system comprises a pump that can be used in conjunction with an extensive range of Huntleigh Healthcare inflatable garments, including foot, calf and thigh length versions. The system is designed to be simple and easy to operate. The pump automatically adjusts to the correct therapy profile depending upon which garment type (foot, calf or thigh length) is connected. An optional battery pack is available which allows the pump to be used independently of an AC power outlet.

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2. Clinical Applications The primary application of the Flowtron Universal system is for the prevention of DVT. Depending on the garment type used, other clinical applications are also appropriate. The FG foot garment, in particular, has a wide range of clinical applications. Full details for clinical applications are included in the packaging of every garment. The type of garment used on an individual patient must be specified by a physician.

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3. Cautions & Contraindications Cautions

• Garments should be removed immediately if the patient experiences tingling, numbness or pain. • When used for DVT prophylaxis, continuous use is recommended and any interruption of therapy for a substantial length of time should be at the discretion of the physician. • Patients should be instructed not to stand or walk with foot garments on.



These are guidelines only and should not replace clinical judgement and experience.

Contraindications

The Flowtron Universal system should not be used in the following conditions: 1. Severe arteriosclerosis or other ischaemic vascular diseases. 2. Known or suspected acute DVT. 3. Severe congestive cardiac failure or any condition where an increase of fluid to the heart may be detrimental. 4. Any local condition in which the garments would interfere, including gangrene, recent skin graft, dermatitis or untreated, infected leg wounds.



If you are unsure of any contraindications refer to the patient’s physician before using the device.

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4. System Set up The Flowtron Universal system is simple to set up and operate. The pump does not require any setting or adjustment of controls. It automatically senses the type of garment connected and adjusts the therapy cycle and pressure profile accordingly. Garment Application Use the correct garment type as ordered by the patient’s physician. For detailed instructions on correct fitting and use, carefully read and follow the instruction provided with every garment set. General Guidelines and Recommendations General recommendations:

• Garments should be removed regularly to inspect the skin. • Where appropriate patients should be instructed in the proper use of the system, the purpose of therapy and that any problems should be reported to the nursing staff. DVT prophylaxis

• The Flowtron Universal system should be applied to the patient preoperatively, prior to the induction of anaesthesia. • The system should be used continuously for no less than 72 hours postoperatively or until the patient becomes fully ambulatory. • If the garment cannot be applied to the operative limb during surgery, it may be applied to the limb once the patient reaches the recovery unit. • In the non-surgical patient, the system should be initiated immediately the risk of DVT formation is identified.

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System Operation Run/Standby Button LCD Display and Function Buttons

Hose Set Connectors

Power/Alarm Indicators

Plug the pump into an electrical outlet. The pump will first go through a self-test routine and then remain in until required for use.

Apply the prescribed Huntleigh Healthcare garment to the patient by carefully following the instructions included in the garment packaging. Connect the garments to the pump hose set connectors and ensure the connectors click into place.

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Check that the connection and garment type are confirmed correctly on the display.

Typical garment options and therapy parameters Garment Type/ LCD Display

Inflation Pressure (mmHg)

Inflation Hold (seconds)

Cycle (seconds)

130

3

30

40

12½

60

Foot garments e.g., FG100-200

Single chamber garments e.g., DVT10-40,60

TO START, press and hold the green RUN button on the pump. The green power indicators will illuminate and therapy will begin.

(this example shows the pump running and the left garment inflated to 40 mmHg) TO STOP press and hold the green RUN button a second time. The green power indicators will go out and therapy will stop.

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Recommended Checks:

• Check display symbols to confirm that the correct type of garment has been connected. • During garment inflation, check the display to confirm that the correct pressure is being applied and that there are no fault messages appearing. • Check that there are no kinks in the pump hoses and garment tubing. • Check that the pump hoses and connectors do not cause the patient any discomfort. • Regularly check that the garments remain correctly fitted to the patient. To Use One Garment When the pump is in standby (page 5 system operation) connect one garment to either pump hose connector. The display will confirm that only one garment is connected.



If a garment is disconnected while the pump is running, the system will alarm Lo. If the single garment option is still required, simply press the RUN button to reset the system and press RUN again to restart therapy. If, at any time, a second garment is connected while the pump is running, the pump will automatically change to two garment operation.

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To Use Different Garments on Each Limb It is possible to use different garment types on each limb (if prescribed by the patient’s physician). Simply connect the garments to either tubing outlet and the correct therapy cycle will be administered. Check on the display panel to confirm the garment types connected.



The system is not designed to be used with different garment types (e.g. foot and calf/thigh) on the same limb.

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5. Settings Adjustment The pump is configured to give the recommended therapy for each garment type and does not require any setting by the clinician or nurse. If the physician requires different therapy settings, limited changes can be made through a service link. Contact your local Huntleigh Healthcare Sales Representative for details.

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6. Troubleshooting The Flowtron Universal pump features an audible and visual alarm. If a problem occurs, the system will sense the fault and briefly flash a message on the display. If the same fault continues for 10 successive inflations (up to 10 minutes), the audible alarm will sound, the red alarm lights flash and a message will appear on the display until corrective action is completed. (The exception to this is an “F” fault, which will alarm immediately.) Pump LCD Display

Problem

Corrective Action

Lo

Garment leak

Garment Leak

Check garment and replace if faulty.

Lo

Garment unplugged

Garment disconnected

Check and reconnect.

Lo

Garment loosened

Foot garment has come off patient during use

Reapply foot garment to patient.

HI

Tube kinked

Pump hose kinked causing a blocked tube

Check pump hoses for kinks and obstructions.

F

Pump fault

Pump failure

Do not use pump, refer to service.

Alarm Cancel:

After a fault has been corrected, the alarm can be cancelled by two methods: Press the RUN pump is running.

button twice, or until the green power indicators are lit and the

With the exception of a pump failure ( F ), correct the fault and allow the pump to run until it senses a normal inflation; it will then reset itself. Recommended Checks:

To confirm that the fault has corrected, watch the display for approximately one minute. If the fault has not been corrected, a fault message will flash during that time. In addition, the pump will refuse to start if it does not recognize the attached garment. Pump Display “None”

Problem

Corrective Action

Pump will not start due to no garments connected or a nonHuntleigh Healthcare authorized garment connected.

Connect an authorized Huntleigh Healthcare garment.

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7. Options Pressing the option button will bring up a multi-choice menu of options. The option can be set using a combination of the three function buttons on the display.

To return to the previous menu at any time, highlight Back using the arrow buttons and press the  button to confirm. To exit the options menu at any time, highlight Exit using the arrow buttons and press the  button to confirm. Audio Alarm Volume

• Press the function button adjacent to

. to highlight Audio Alarm Volume.

• Use the arrow buttons

• Press the  button to display the volume setting controls. • Use buttons to select either high or low volume setting. • Press the  button to confirm. • The selected volume setting will remain in place, during subsequent uses of the pump. Patient Hours Meter

• Press the function button adjacent to

. to highlight Patient Hours Meter.

• Use the arrow buttons

• Press the  button to display the total hours run. To Clear the Patient Hours Meter

• In the Patient Hours Meter menu use the arrow buttons select Clear Patient Hours. • Press the  button to clear the hours to 0.

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8. Battery Operation When used with the optional battery pack, the system can be run independently of AC power. Typically, 8 hours of operation can be expected from a fully charged battery pack. Connecting the Battery Pack From the front of the pump, engage the pack on the runners and slide into place until a click is heard. To remove the pack, depress the latch at the rear of the unit and slide pack forward and out.

Reset/Status Latch

Battery Pack

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Battery Pack in Use The battery pack will automatically take over powering the pump whenever the AC cord is removed from the wall outlet. When running under battery power, a battery symbol appears in the top right hand corner of the display.

Battery Power Saving Features In order to save battery power when the pump is left in standby, it will automatically switch off after 10 minutes. The display screen will go blank and the pump is fully switched off. Press the RUN therapy.

button to return to standby and press RUN

again to start

The amount of charge remaining in the battery pack is indicated by the black block inside the battery symbol.

When the battery has only 10% of the charge remaining, the symbol will flash and the remaining charge will be displayed as a percentage. Recharge the battery as soon as possible. Then, when the battery has 0% charge, the audible alarm will sound and the pump will stop running. Recharge the battery.

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Checking the Status of the Battery Battery Label LED 1

Jack Socket Polarity

LED 2

80-100% Charge Battery Pack OK Battery Pack needs recycling

30-80% Charge

Battery Pack Fault

<30% Charge

Press Reset / Status Latch

To Check the Battery Status:

1. Remove the battery from the pump unit. 2. Press the Reset/Status Latch which will activate the 2 LEDs on the top of the battery. If the battery pack is not on charge, the LEDs will display one of the following conditions: LED 1

LED 2

Green

Green

Green

Green

Red Red

The Battery Pack is OK. It has > 80% charge. The Battery Pack is OK. It has between 30-80% charge. The Battery Pack is OK. It has < 30% charge.

Green Red

Battery Status

Green

The Battery Pack needs recycling*. It has between 30-80% charge. The Battery Pack needs recycling*. It has < 30% charge. The Battery Pack has an error. Press Reset/Status Latch. The Battery Pack has an error. Try recharging.

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If the battery pack is on charge via the optional battery charger, the LEDs will display one of the following conditions: LED 1 Green

LED 2 Green Green

Red Red

Green

Battery Status The Battery Pack is OK. It is fully charged. The Battery Pack is charging. The Battery Pack needs recycling*. The Battery is charging. The Battery has a fault. The Battery has a fault.

* Once the Battery Pack has entered the ‘recycling’ mode, it will never show that the battery is fully charged (Note: This does not indicate a fault condition). Recharging the Battery Pack The battery pack is automatically recharged whenever the pump is connected to an AC outlet. On the display, the arrow confirms the pump is connected to AC power and the battery is charging.

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Alternative Method of Charging Alternatively, the battery pack can be recharged away from the pump by plugging it into the battery charger as shown below.



Avoid charging the battery near source of heat or in direct sunlight.

Caution Only Huntleigh-approved battery chargers must be used. Use of a non-approved charger may result in damage to the battery pack or ineffective charging and therefore voids the warranty.

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