ARJO HUNTLEIGH Flowtron Excel User manual

FLOWTRON EXCEL
Instructions for Use
...with people in mind
0086

(i)
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
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
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Garment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Garments and Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

(ii)

(iii)
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:
• EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995
• UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90
Safety Warnings
• It is the responsibility of the care giver to ensure that the user can use this product
safely.
• Make sure that the mains power cable and tubeset or air hoses are positioned to
avoid causing a trip or other hazard, and are clear of moving bed mechanisms or
other possible entrapment areas.
• Electrical equipment may be hazardous if misused. There are no user-serviceable
parts inside the pump. The pump's case must only be removed by authorised
technical personnel. No modification of this equipment is allowed.
• The mains power socket/plug must be accessible at all times. To disconnect the
pump completely from the electricity supply, remove the plug from the mains
power socket.
• Disconnect the pump from the mains power socket before cleaning and inspecting.
• 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.
Precautions
For your own safety and the safety of the equipment, always take the following precautions:
• Do not expose the system to naked flames, such as cigarettes, etc.
• Do not store the system in direct sunlight.
• Do not use phenol-based solutions to clean the system.
• Make sure the system is clean and dry prior to use or storage.
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.
• Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell
phones) can affect medical electrical equipment.
• If this equipment needs to be used adjacent to other electrical equipment, normal
operation must be checked before use.
• For detailed EMC information contact ArjoHuntleigh service personnel.
Service Information
ArjoHuntleigh recommend that this system should be serviced every 12 calendar months or,
where applicable, when the service indicator is illuminated.

(iv)
Environmental Protection
Incorrect disposal of this equipment and its component parts, particularly batteries or other
electrical components, may produce substances that are hazardous to the environment. To
minimise these hazards, contact 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.
© ArjoHuntleigh 2009.

1
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.
Caution
Federal law restricts this device to sale by or on the order of a
physician.

2
Flowtron Excel Pump Front View

3
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.

4
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
illuminates. If the Single Leg button is pressed by
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 (or the
pressure prescribed by the physician)
• 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.

5
• 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.

6
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.

7
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.
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.
Display Problem Corrective Action
1. Hose disconnected at garment.
2. Garment leak.
3. Low pressure.
1. Check the hose connection at
garment end.
2. Check garment and replace if
faulty.
3. Call service engineer.
1. Hose kinked causing a blocked tube.
2. Hose disconnected at pump.
3. Single garment attached without
pressing ‘single leg’ button.
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.
Pump failure. DO NOT USE PUMP.
Call service engineer.
No display,
no operation
1. Power failure.
2. Fuse blown.
1. Check power supply.
Check power cable.
2. Call service engineer.

8
6. 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.
The Flowtron Excel system should be routinely decontaminated between patients
and at regular intervals while in use; as is good practice for all reusable medical
devices.
To clean Clean all exposed surfaces and remove any organic
debris by wiping with a cloth moistened with a simple
(neutral) detergent and water.
Chemical Disinfection We recommend 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).
Wipe all cleaned surfaces with the solution, rinse and
dry thoroughly.
Alcohol based disinfectants (maximum strength 70%)
may be used as an alternative.
Ensure the product is dry before storage.
If an alternative disinfectant is selected from the wide
variety available we recommend that suitability for use
is confirmed with the chemical supplier prior to use.
WARNING
Remove the electrical supply to the pump by disconnecting the mains power
cord 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. Avoid
immersing electrical parts in water during the cleaning process. Do not spray
cleaning solutions directly onto the pump. Do not immerse the tubeset in
water.
Caution
Garments are single patient use and hence cannot be cleaned or reused.

9
7. Garment Information
GARMENTS AND TUBING
Dimensions
Description Garment
Part No. Size
Standard Calf Garment DVT10 Circumference up to 43cm (17”)
Large Calf Garment DVT20 Circumference up to 58cm (23”)
Extra Large Calf Garment DVT60 Circumference up to 71cm (28”)
Standard Thigh Garment DVT30 Circumference up to 71cm (28”)
Large Thigh Garment DVT40 Circumference up to 89cm (35”)
Connector Tubing L550 Length 150cm (60”)

10
8. Technical Description
PUMP
Model: Flowtron Excel
Part Numbers: 247001-P
Supply Voltage: 120V
Supply Frequency: 60 Hz
Power Input: 26 VA MAX
Size: 5.25 x 6.00 x 10.75” (133 x 152 x 275 mm)
Weight: 5.1 lb (2.3 kg)
Case Material: ABS Plastic
Pump Fuse Rating: F500 mAH 250 V
Degree of protection
against electric shock:
Class II, Double Insulated with Functional Earth
Type BF
Degree of protection
against liquid ingress: IPX0
Mode of operation: Continuous
Cycle or Therapy Modes: 60 seconds total
12 seconds inflation
48 seconds deflation
Pressure Range: 30 - 60 mmHg (± 4 mmHg)
SYMBOLS
O
(Off)
Power
Disconnects from
the mains supply
Do not dispose of in
domestic refuse Alternating Current Double Insulated
I
(On)
Power
Connects to the
mains supply
Refer to
accompanying
documents
Type BF Refer to the User
Manual
Fuse Dangerous voltage SN: Serial Number Ref: Model number
With respect to electric
shock, fire and
mechanical hazards
only in accordance
with UL60601-1 and
CAN/CSA C22.2 No.
601.1 MEDICAL
EQUIPMENT
i

11
ENVIRONMENTAL INFORMATION
Condition Temperature Range Relative Humidity Atmospheric Pressure
Operating +50°F to +104°F
(+10°C to +40°C)
30% to 75% 700hPa to 1060 hPa
Storage and Transport -40°F to +158°F
(-40°C to +70°C)
10% to 95%
(non-condensing)
500 hPa to 1060 hPa

12

AUSTRALIA
ArjoHuntleigh Pty Ltd
78, Forsyth street
O’Connor
AU-6163 Western Australia
Tel: [phone]
Free: [phone]
Fax: + 61 89337 9077
BELGIQUE / BELGIË
ArjoHuntleigh NV/SA
Evenbroekveld 16
B-9420 ERPE-MERE
Tél/Tel: [phone]
Fax: [phone]
E-mail: [email protected]
CANADA
ArjoHuntleigh Canada Inc.
1575 South Gateway Road
Unit "C"
MISSISSAUGA, ON, L4W 5J1
Tel/Tél: [phone]
Free: [phone] Institutional
Free: [phone] Home Care
Fax: [phone]
E-mail: [email protected]
ČESKÁ REPUBLIKA
ARJO Hospital Equipment s.r.o.
Hlinky 118
CZ- 603 00 BRNO
Tel: [phone]
Fax: [phone]
DANMARK
ArjoHuntleigh A/S
Vassingerødvej 52
DK-3540 LYNGE
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
DEUTSCHLAND
ArjoHuntleigh GmbH
Peter-Sander-Strasse 10
D-55252 MAINZ-KASTEL
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
ΕΛΛΑΔΑ
C. Psimitis Co Ltd
Dimitriou Andr. 59
GR-16121 KAISARIANI ATTIKIS
Τηλ: 21 0724 36 68
Φάξ: 21 0721 55 53
ESPAÑA
ArjoHuntleigh Ibérica S.L.
Ctra. de Rubí, 88 1ª planta - A1
08173 Sant Cugat del Vallés
ES- BARCELONA 08173
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
FAR EAST
ARJO Far East Limited
Unit 3A, 4/F., Block B Hoi Luen
Industrial Centre
55 Hoi Yuen Road,
Kwun Tong, Kowloon
HONG KONG
Tel: [phone]
Fax: [phone]
FRANCE
ArjoHuntleigh SAS
2 Avenue Alcide de Gasperi
BP 133
59436 RONCQ CEDEX
Tél: [phone]
Fax: [phone]
E-mail : [email protected]
INTERNATIONAL
ArjoHuntleigh International Ltd.
ArjoHuntleigh House
Houghton Hall Park
Houghton Regis
UK-DUNSTABLE LU5 5XF
Tel: [phone]
Fax: [phone]
E-mail:
[email protected]
ITALIA
ArjoHuntleigh S.p.A.
Via di Tor Vergata 432
00133 ROMA - ITALIA
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NEDERLAND
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Biezenwei 21
4004 MB TIEL
Postbus 6116
4000 HC TIEL
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NORGE
ArjoHuntleigh Norway AS
Ryenstubben 2
NO-0679 OSLO
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Faks: [phone]
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POLSKA
ArjoHuntleigh Polska Sp. z o.o.
ul. Ks Piotra Wawrzyniaka 2
PL 62-052 KOMORNIKI (Poznan)
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PORTUGAL
ArjoHuntleigh em Portugal:
MAQUET Portugal, Lda.
(Distribudor Exclusivo)
Rua Poeta Bocage n.º 2 - 2G
1600-233 Lisboa, Portugal
Tel: [phone]
Fax: [phone]
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SUISSE / SCHWEIZ
ArjoHuntleigh AG
Fabrikstrasse 8
Postfach
4614 Hägendorf,
Tél/Tel: [phone]
Fax: [phone]
SUOMI
ArjoHuntleigh OY
Vanha Porvoontie 229
FI-01380 VANTAA
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Faksi: [phone]
SVERIGE
ARJO Scandinavia AB
Verkstadsvägen 5
Box 61
SE-241 21 ESLÖV
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Fax: [phone]
E-mail: [email protected]
UNITED KINGDOM
ArjoHuntleigh UK
ArjoHuntleigh House
Houghton Hall Park
Houghton Regis
UK-DUNSTABLE LU5 5XF
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
USA
ArjoHuntleigh Inc.
2349 W Lake Street Suite 250
Addison, IL 60101
Tel: [phone]
Free: [phone] Institutional
Free: [phone] Home Care
Fax: [phone]
E-mail: [email protected]
ÖSTERREICH
ArjoHuntleigh GmbH
Dörrstrasse 85
AT-6020 INNSBRUCK
Tel: [phone]
Fax: [phone]
www.arjohuntleigh.com

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. ArjoHuntleigh
focuses on patient mobility and wound management solutions.
GETINGE provides solutions for infection control within healthcare
and contamination prevention within life sciences. MAQUET
specializes in solutions, therapies and products for surgical
interventions and intensive care.
www.arjohuntleigh.com
ArjoHuntleigh AB
Verkstadsvägen 5
241 38 Eslöv
SWEDEN 247900-P_01: 04/2012