Flowtron Excel User Manual

Contents Description and Operating Principle...1 Cautions and Contraindications...3 Cautions... 3 Contraindications... 3 System Set Up...4 Garment Application... 4 To Use Only One Garment... 4 Pre-Use Check... 4 Operation... 5 Pressure Adjustment...6 Pressure Output Check... 6 Resetting the Output Pressure... 6 System Calibration Check... 6 Troubleshooting...7 Alarm Cancel... 7 Corrective Action Check (when using On/Off Reset)... 7 Fuse Replacement... 7 Cleaning Instructions...9 Garment Information...10 Warranty and Service...11 Warranty... 11 Service... 11 Technical Data...12

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Safety Before you connect the system pump to a mains socket, read carefully all the installation instructions in Section 3 - System Set Up and Section 4 - Pressure Adjustment. Take the following precautions: • Regularly check the system when in use, for pump operation and garment fit. • Keep the pump away from sources of liquid • Do not expose the system, especially the garments, to naked flames, such as cigarettes, etc. • Do not store the system in direct sunlight • Do not use hypercarbonate or phenolic based cleaning solutions on the pump.

WARNING Electrical equipment may be hazardous if misused. The pump cover should only be removed by authorised technical personnel. Do not use the Flowtron® Excel pump in the presence of flammable gases such as anaesthetic agents.

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1. Description and Operating Principle The Flowtron Excel system is a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis (DVT). The application of intermittent pneumatic compression has two effects: 1. Augments venous blood flow velocity, thereby reducing stasis. 2. Enhances fibrinolytic activity to reduce the risk of early clot formation. The Flowtron Excel system consists of a pump and a pair of calf or thigh length, single patient use garments. The pump provides intermittent cycles of compressed air which alternately inflate the single-chambered air garments. The compression applied on the extremity augments venous blood flow velocity and stimulates fibrinolysis. The pump operates on a 60-second automatically timed cycle consisting of approximately 12 seconds of inflation followed by approximately 48 seconds of deflation. The Flowtron Excel system may be used on patients at risk of developing deep vein thrombosis and in conjunction with systemic interventions (e.g. anticoagulation drugs) for the high risk patient.

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2. Cautions and Contraindications Cautions

1. Garments should be removed immediately if the patient experiences tingling, numbness or pain. 2. 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.

Contraindications

Flowtron Excel system should not be used in the following conditions:

1. Severe arteriosclerosis or other ischaemic vascular diseases. 2. Known or suspected acute Deep Vein Thrombosis (DVT) or phlebitis. 3. Severe congestive cardiac failure or any condition where an increase of fluid to the heart may be detrimental. 4. Pulmonary embolism. 5. 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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3. System Set Up Garment Application

1. Check that the power switch on the pump is off. Remove the garments from the packaging and unfold. 2. Place the back of the patient’s leg in the centre section of the garment with the connector tubing pointing downwards towards the foot. 3. Starting with the side that does not have the Velcro1 tabs, wrap securely against the leg. While holding the garment snugly against the leg, wrap the taps over the top. Ensure that the garments are fitted snugly and are not ‘wrinkled’ or ‘tucked’. The connector tubing should be pointing towards the patient’s heel. 4. Snap-lock the garment connector to the tubing assembly. Ensure that a sharp ‘click’ is heard. Pull lightly to confirm proper connection. 5. To disconnect the garments from the tubing, press the snap-lock connector and pull apart.

To Use Only One Garment

To use only one garment, connect a single tube to either connector. The snap-lock connectors on the pump are self-sealing and, unlike other systems, do not require the unused garment to be attached. Press the Single Leg button to prevent the alarm system incorrectly indicating a fault. The system responds with a ‘beep’ and the LED on the button is pressed by illuminates. If the Single Leg button mistake with two garments connected, the system will reset itself to normal after two cycles.

Pre-Use Check

Before using the Flowtron Excel system on the patient, ensure that: • The pump has been set at 40 mmHg pressure prescribed by the physician)

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• Garments have been applied to patient’s legs correctly, snugly and without wrinkles • There are no kinks in the tubing 1. Velcro® is a registered trademark of VELCRO USA Inc.

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• The pump is connected to an electrical outlet • All tubing connections are secure Operation

Turn the power switch on which will illuminate green. The pump performs a two-second self test cycle where the display, LED’s and alarm are tested. The compressor then proceeds directly to the inflation cycle. The garments will inflate alternately. The first garment inflates for approximately 12 seconds and is deflated for approximately 48 seconds. The second garment inflates 30 seconds after the inflation of the first garment and follows the same inflation/deflation cycle. Verify that the display is indicating the desired output pressure. Refer to section 4 - Pressure Adjustment for specific pressure setting instructions.

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4. Pressure Adjustment The pressure control mechanism is located on the front of the pump and ranges from 30-60mmHg. The pressure exerted by the garments on the leg can be adjusted by turning this knob. Turning the knob clockwise increases the pressure; counterclockwise decreases the pressure.

The recommended pressure setting is 40 mmHg, or the pressure prescribed by the physician. The Flowtron Excel pump pressure monitoring system is independent of the pressure control and delivery system, providing added reliability and safety. The digital display indicates the actual pressure that is delivered to the garments, and furnishes immediate and continuous feedback regarding pump performance. The pressure display is used for the following functions: Pressure Output Check

After turning the pump on, check that the pressure display is showing the desired output pressure when the garments are inflated. Visually recheck the display at regular intervals.

Resetting the Output Pressure

Rotate the pressure control knob during the active inflation period until the required pressure is displayed.

System Calibration Check

To confirm the calibration accuracy of the pressure control and display, perform the following check each time the pump is turned on. During normal operation when the display reads , the pointer on the pressure control knob should be located somewhere within the 40 mmHg arc on the front panel. If the pointer falls outside of this arc, the pump should not be used and referred to service for recalibration.

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5. Troubleshooting The Flowtron Excel system 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, the audible alarm will sound and a flashing message will remain on the display until corrective action is completed. The exception to this is an

fault which will alarm immediately.

Display

Problem

Corrective Action

1. Hose disconnected at garment. 2. Garment leak. 3. Low pressure. 1. Hose kinked causing a blocked tube. 2. Hose disconnected at pump. 3. Single garment attached without pressing ‘single leg’ button. Pump failure.

1. Check the hose connection at garment end. 2. Check garment and replace if faulty. 3. Refer to service. 1. Check hoses for kinks or obstructions. 2. Check the hose connection at pump outlet. 3. Press ‘single leg’ button, if only one garment to be used. DO NOT USE PUMP. Refer to service.

In the unlikely event of a display electronics failure, the red LED on the top panel will rapidly flash (approximately four times a second). Do not use the pump : refer to service. Alarm Cancel

After a fault has been corrected, the alarm can be cancelled by two methods: 1. Switch the pump off, then on again, using the on/off switch. 2. Allow the pump to run until it senses a normal inflation; it will then reset itself.

Corrective Action Check (when using On/Off Reset)

To confirm that the fault has corrected, watch the display for about one minute. If everything is normal, there will be no or message flashing during that time.

Fuse Replacement

If the system fails to operate when plugged in and switched on, the fuse on the underside of the pump 7

should be checked. To do this, disconnect the pump from the main power supply and remove fuse holder cap using a suitable screwdriver. IMPORTANT To protect against fire hazard, replace blown fuse with identical type and rating - F500mA. If the fuse blows again, refer the pump for service.

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6. Cleaning Instructions The outside pump casing is made from ABS plastic and should be cleaned using a soft cloth dampened with a mild detergent. Hypocarbonate and phenolic based cleaning solutions should never be used as they cause this plastic to deteriorate. This can be followed by wiping down with a sodium hypochlorite or sodium chloroisocyanurate (NaDCC) solution to a dilution of 1000ppm. WARNING Do not spray any disinfectant or detergent directly onto the pump. The pump cannot be sterilised. The garments are single patient use and hence cannot be cleaned or reused.

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7. Garment Information The Flowtron Excel pump should only be used with the following garments: Code

Description

DVT10/E

Standard Calf Garment - up to 43cm (17") calf circumference

DVT20/E

Large Calf Garment - up to 58cm (23") calf circumference

DVT60/E

Extra Large Calf Garment - Up to 71cm (28”) calf circumference

DVT30/E

Standard Thigh Garment - up to 71cm (28") thigh circumference

DVT40/E

Large Thigh Garment - up to 89cm (35") thigh circumference

L550

Connector Tubing - 150cm (60") length

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8. Warranty and Service Warranty Huntleigh’s standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service The Flowtron Excel pump should be routinely inspected (not less than once a year) by a qualified biomedical service technician to assure proper operation of the pump and garment system. Inspection should verify that pressure output and timing cycle are within listed specifications and that the audible and visual alarms function. The Flowtron Excel pump should receive annual preventative maintenance. All required servicing should be performed by Huntleigh Healthcare service personnel. For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare product, please contact: Huntleigh Healthcare 310-312 Dallow Road Luton Beds LU1 1TD UK. Tel : 01582 413104 Fax: 01582 459100 or your local distributor.

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9. Technical Data Pump Model No.:

AC550/UK

Size:

133 x 152 x 275 mm

Weight:

2.7 kg

Pressure Range:

30-60 mmHg

Cycle:

60 seconds total 12 seconds inflation 48 seconds deflation

Rated Voltage:

220-240 V

Rated Frequency:

50 Hz

Rated Input Power:

26 V A

Protection Class:

Class II (double insulated), Type BF. Not protected against ingress of water.

Equipment Symbols:

Refer to user manual SN:

Serial number

Ref:

Model number Alternating Current

O

(Off) Power disconnected from mains supply.

I

(On) Power connected to mains supply. Fuse rated F 500 mA.

Rated for:

Continuous consumption

Tested to:

EN60601-1, IEC601-1 and IEC601-1-2

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Environmental Conditions Operating Temperature Range:

+10°C to +40°C

Relative humidity:

30% to 75%

Atmospheric pressure

700hPa to 1060 hPa

Storage Storage temperature range:

-40°C to +70°C

Relative humidity:

10% to 100% (non-condensing)

Atmospheric pressure:

500 hPa to 1060 hPa

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247903_05 © Huntleigh Technology PLC 2002