ARJOHUNTLEIGH FLOWTRON HYDROVEN 3 Instructions for Use Rev 1 Sept 2012

Contents General Safety... iii Introduction... 1 About this Manual... 1 Intended Use... 1 About Flowtron Hydroven 3... 1 Clinical Application... 2 Indications... 2 Contraindications... 2 Cautions... 3 Warning... 3 Clinical Treatment Guide... 4 Garment and Insert Information... 5 Garment Description... 5 Selecting the correct Garment... 5 Applying the Garment... 6 Operation... 8 Pump Description... 8 Operation... 9 Shut Down... 9 Decontamination... 10 Routine Maintenance... 12 Flowtron Hydroven 3 System... 12 Flowtron Hydroven 3 Pump... 12 Serial Labels... 12 Troubleshooting... 13 Service Returns... 13 Accessories... 14 Garments... 14 Inserts... 15 Technical Specification... 16 Pump... 16 Cleaning Symbols... 17

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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 • EN60601-1:2006 and IEC 60601-1:2005 • AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008)

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. Caution (applicable to the USA market only) • US Federal law restricts this device to sale by or on the order of a physician. 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. • Pets and children must be supervised in the vicinity of the system. 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.

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• 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.

Expected Service Life The Flowtron® Hydroven 3 has an expected service life of seven years. To maintain the condition of the pump have the pump serviced regularly according to the schedule recommended by your ArjoHuntleigh distributor. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Flowtron Hydroven 3 system. Failure to observe this caution could result in injury, or in extreme cases, death. 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. The content of this publication may not be copied either whole or in part without the consent of ArjoHuntleigh. © ArjoHuntleigh 2012

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1. Introduction About this Manual

This manual is your introduction to the Flowtron® Hydroven 3 system. You must read and fully understand this manual before using the system. Use this manual to initially set up the system, and keep it as a reference for day-to-day routines and as a guide to maintenance. If you have any difficulties in setting-up or using the Flowtron Hydroven 3 system, contact your local ArjoHuntleigh sales office, listed at the end of this manual.

Intended Use

The intended use of this product is to manage the list of clinical conditions detailed in the “Indications” (refer to page 2). The Flowtron Hydroven 3 system should be used as part of a prescribed plan of care detailed in the “Indications” (refer to page 2).

About Flowtron

The pump supplies air via connecting tubes to an inflatable garment allowing the application of controlled pressure to gently compress the limb. This action assists in increasing the return of blood, excess fluids, improves venous stasis and encourages the reabsorption of waste products. The pump operates on an automatically timed cycle of 3 minutes, 90 seconds inflation followed by 90 seconds deflation. Variable pressure output ranges from 30-100 mmHg. The garments are inflated alternately. The Flowtron Hydroven 3 system operates two types of garments: • Hydroven 1 garments have a single chamber and provide uniform compression. • Hydroven 3 garments have three chambers providing graduated segmental compression, inflating distally to proximally. Optional garment inserts can be used to increase the circumference of the standard arm and leg garments. A full technical description of the Flowtron Hydroven 3 system can be found in the Service Manual, part No. SER0014, available from your local ArjoHuntleigh sales office.

Hydroven 3

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2. Clinical Application Indications

Intermittent Pneumatic Compression (IPC) is effective in the treatment of the following clinical conditions, when combined with an individualised monitoring programme: • Edema. • Dependent (including secondary to cerebrovascular incident, pregnancy or paralysis). • Traumatic (post-surgical or injury). • Lymphedema. • Primary and secondary (including post surgery, radio or chemotherapy). • Chronic venous insufficiency. • Post phlebotic syndrome. • Acute and chronic wounds including venous leg ulcers and post-surgical wounds. IPC may also be beneficial in the management of: • Fixed flexion deformity. • Arthritic conditions. • Lower limb pain due to trauma or surgery. • Lipedema. Selection should be based upon a holistic assessment of the patients' individual care needs.

 These systems represent one aspect of a treatment strategy; if the patient's condition changes the overall therapy regimen should be reviewed by the prescribing clinician.

 The above are guidelines only and should not replace clinical judgement. Contraindications

IPC should NOT be used in the following circumstances: • Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis. • Acute infections of the skin such as cellulitis.

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• Decompensated / severe congestive cardiac failure, pulmonary edema associated with significant limb edema or any condition where an increase of fluid to the heart may be detrimental. • Severe arteriosclerosis or other ischaemic vascular disease. • Active metastatic disease affecting the limb.  If you are uncertain whether you have any of the above conditions please consult a physician before use. Cautions

IPC should be used with care in patients with the following symptoms or conditions: • Peripheral neuropathy, pain or numbness in the limb. • Undiagnosed, untreated or infected wounds, fragile skin, grafts or dermatological conditions that may be aggravated by the garment. • Extreme limb deformity which may practically impede the correct application of the garment.

Warning

• Therapy should be interrupted if pain, tingling or numbness of the limb occurs during, or as a result of therapy. • In the event of a power failure, or fault whereby the garment remains inflated, remove the garment. • Patients must not walk or stand when wearing leg garments.

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3. Clinical Treatment Guide An initial pressure setting of 40 mmHg is suggested at the commencement of treatment. It may be necessary to start at a lower level of pressure dependant on the patient’s tolerance. The pressure can be gradually increased over time, until the required pressure is reached. The upper treatment pressure range is generally 60-70 mmHg. A single treatment session is usually 20-30 minutes.

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The above settings and timings are guidelines, and should not be used as a substitute for clinical judgement and experience.

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Loss of mains power will halt therapy.

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4. Garment and Insert Information Garment Description Zip Ring Pull

Zip Ring Pull Quick Air Release Bung Tubing Connector (To Pump)

Tubing Connector (To Pump) Garment

Garment Bung/Connector For Insert Tubing

Bung/Connector For Insert Tubing Hydroven 3 Garment

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Hydroven 1 Garment

For Hydroven 1 garments, when an insert is not in use, the bung can be used as a quick air release.

Selecting the correct Garment 1. Select the type of garment depending on treatment type: • Hydroven 1 garments have a single chamber and provide uniform compression. • Hydroven 3 garments have three chambers providing graduated segmental compression, inflating distally to proximally. 2. Measure the circumference of the largest part of the limb, and the length in cm/inch from the heel to the upper thigh for a full leg garment, heel to knee for half leg garment, from shoulder to finger tips for full arm garment, and from elbow to finger tips for half arm garment. Refer to “Accessories” on page 14 to order the correct size garment. Shoulder Circumference Knee Circumference

Half Leg Garment

Full Arm Garment

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Hand Circumference

Applying the Garment Quick air release bung

Tubing to pump

Tubing to pump

Arm Garment

Leg Garment

 Before fitting the garment ensure all quick air release bungs are closed, as this will effect the efficiency of the garment. 1. If a larger circumference is required, fit a matching length insert piece before applying to the limb. If appropriate, a primary dressing or stockinette may be used underneath the garments. 2. Undo the zip on the garment. 3. If a garment insert is fitted to the garment, fully fasten one of the zips between the garment and insert, leaving the other unfastened. 4. Before applying the garment (and insert, if fitted) to the limb, zip up the first 150 mm (6”) of the unfastened garment zip. Put the garment (and insert) onto the limb and fully fasten the zip. Make sure that the quick air release bung is secured. 5. Make sure the patient is in a comfortable position with the limb supported or elevated as necessary. 6. Check that the insert piece connecting tube is not kinked and is attached to the garment using the lower outlet bung as shown below.

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Leg Garment With Insert Fitted

Arm Garment With Insert Fitted

7. Attach the garment tubing to the pump ensuring a “click” is heard from each snap-lock connector. 8. If only one garment is to be used, attach the garment to either port on the pump. The system will automatically identify that only one garment is to be used.  Ensure that the all zips are fully done up on the garment before switching the pump on. 9. Switch on the pump and adjust the pressure control accordingly. Caution Do not apply the garment to the limb unless it is partially zipped, as you may damage the garment zip. Do not apply or remove the garment while it is attached to the pump and the pump is in operation, as you may damage the garment zip. Do not stand or walk while leg garments are fitted.

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5. Operation Pump Description

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4

1 3

2

Flowtron Hydroven 3 Pump

Control Number

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Description

Function

1

On/Off Switch

Operation of this switch starts or stops the system

2

Pressure Control Knob

Rotates clockwise to increase and counterclockwise to decrease pressure (user range 30 - 100 mmHg)

3

Tube Connectors

For garment attachment (snap-lock)

4

Pressure Gauge

Indicates delivery pressure to garment (mmHg)

5

Carry Handle

For easy handling of pump

If the operation or performance of the pump changes during use, refer to “Troubleshooting” on page 13 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office.

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Caution Do not apply or remove the garment while it is attached to the pump and the pump is in operation, as you may damage the garment zip. Operation

The pump should be placed securely on a flat surface. Before starting the pump ensure that the garments are properly applied, the zips are secured and the garment connecting tubes are attached to the pump outlet ports via snap-lock connectors.  Make sure the system has been arranged so that the power cable and garment hoses do not pose a trip or strangulation hazard. Ensure that the pressure level is set at minimum i.e. the knob (2) is fully rotated in a counterclockwise direction.

Connect the pump to the mains power supply using the power cable provided. Turn the mains power switch (1) to the on (I) position. To Set the Garment While the garment is inflating, rotate the pressure control Pressure knob (2) slowly clockwise until the required pressure is displayed on the gauge (4). The garments will take approximately three cycles to fully inflate. Check and adjust as necessary after three inflation cycles.  It might be necessary to start at a lower pressure level dependant on the patient’s tolerance. Compression should not cause any discomfort or pain to the patient. Switch On

Shut Down

Turn the power switch (1) to the off (O) position. Turning the power off will stop the patient therapy.

 If it is required to completely isolate the pump from the mains power, remove the plug from the mains power socket. To Remove the Garment

Make sure the pump power switch is in the off (O) position, disconnect the tubes from the pump by releasing the snap-lock connectors (3), and release the quick air release bung on the garment. Only open the zip after the garment is completely deflated.

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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 Hydroven 3 system should be routinely decontaminated between patients and at regular intervals while in use; as is good practice for all reusable medical devices. 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. To clean

Clean all exposed surfaces and remove any organic debris by wiping with a cloth moistened with a simple (neutral) detergent and water. Do not allow water or cleaning solutions to collect on the surface of the pump.

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, then wipe using a cloth moistened with water and dry thoroughly. Alcohol based disinfectants (strength 70%) may be used as an alternative. Ensure the product is dry before storage.

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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. To Clean and Sterilise Garments

Wipe down garments using a neutral detergent or soap powder at 40°C (104°F). Dry thoroughly. After cleaning gas sterilisation is possible, however: • Do not exceed 51°C (120°F). • Do not autoclave.

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7. Routine Maintenance Flowtron Hydroven 3 System Maintenance The equipment has been designed to be maintenancefree between service periods. Servicing ArjoHuntleigh will make available on request service manuals, component parts lists and other information necessary for ArjoHuntleigh trained personnel to repair the system. Service Period ArjoHuntleigh recommend that the Flowtron Hydroven 3 pump is serviced every 12 months by an ArjoHuntleigh authorised service agent. Flowtron Hydroven 3 Pump General Care, Check all electrical connections and power cable for Maintenance and signs of excessive wear. Inspection Check the tubeset and connectors for any damage. In the event of the pump being subjected to abnormal treatment, e.g. immersed in water or dropped, the unit must be returned to an authorised service centre. Serial Labels

The serial number for the pump is on the label on the back of the pump case. Quote this serial number when requesting service.

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8. Troubleshooting If you should encounter a problem, please follow the fault finding guide below. If the fault cannot be rectified, please refer to Service. Fault

Pump does not power up

Pump operates but garment will not inflate.

Check

Remedy

Is power switch on?

Check switch.

Is power cord plugged in correctly?

Check connections.

Fuse Blown

Call Service Engineer

Blockage in garment supply tube.

Ensure that the tube airway is clear.

Garment not correctly fitted to pump.

Check connections.

Pressure control set too low.

Increase pressure control.

Air leak in garment.

Check garment. Replace if defective.

Service Returns

If for any reason your Flowtron Hydroven 3 is being returned, please: 1. Clean the product following the instructions in section “Decontamination” on page 10. 2. Enclose a covering letter explaining the reasons for the return, with documentation (including an appropriate decontamination certificate if possible). 3. To prevent damage in transport please pack the pump in a suitably robust box.

 If the trouble shooting procedures do not return the system to normal performance, stop using the system immediately and call the service engineer.

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9. Accessories To order garments, please contact your distributor quoting the appropriate codes as shown below:

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Refer to diagrams on page 5 of this manual.

Garments HYDROVEN 1 LEG GARMENTS Order Code

Type

Length (L)

Circumference (W)

5101L50

Half Leg

19.7" (50cm)

24" (61cm)

5101L66

Full Leg

26" (66cm)

25.2" (64cm)

5101L71

Full Leg

28" (71cm)

26" (66cm)

5101L76

Full Leg

29.9" (76cm)

28” (72cm)

5101L84

Full Leg

33.1" (84cm)

28" (72cm)

5101L92

Full Leg

36.2" (92cm)

28" (72cm)

HYDROVEN 1 ARM GARMENTS Order Code

Type

Length (L)

Circumference Hand (H)

Circumference Shoulder (S)

5101A51

Half Arm

20.1" (51cm)

17.3" (44cm)

22" (56cm)

5101A68

Full Arm

26.8" (68cm)

17.3" (44cm)

24.4" (62cm)

5101A78

Full Arm

30.7" (78cm)

17.3" (44cm)

24.4" (62cm)

HYDROVEN 3 LEG GARMENTS Order Code

Type

Length (L)

Circumference (W)

5103L50

Half Leg

19.7" (50cm)

24" (61cm)

5103L66

Full Leg

26" (66cm)

25.2" (64cm)

5103L71

Full Leg

28" (71cm)

26" (66cm)

5103L76

Full Leg

29.9" (76cm)

28" (72cm)

5103L84

Full Leg

33.1" (84cm)

28" (72cm)

5103L92

Full Leg

36.2" (92cm)

28" (72cm)

HYDROVEN 3 ARM GARMENTS Order Code

Type

Length (L)

Circumference Hand (H)

Circumference Shoulder (S)

5103A68

Full Arm

26.8" (68cm)

17.3" (44cm)

24.4" (62cm)

5103A78

Full Arm

30.7" (78cm)

17.3" (44cm)

24.4" (62cm)

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Inserts HYDROVEN INSERT PIECES (To Fit Hydroven 1 and Hydroven 3 Garments) Order Code

Type

Length (L)

Added Circumference Wide End

Added Circumference Narrow End

510LI50

Half Leg

19.7" (50cm)

7.5" (19cm)

5.5" (14cm)

510LI66

Full Leg

26" (66cm)

7.5" (19cm)

5.5" (14cm)

510LI71

Full Leg

28" (71cm)

7.5" (19cm)

5.5" (14cm)

510LI76

Full Leg

29.9" (76cm)

7.5" (19cm)

5.5" (14cm)

510LI84

Full Leg

33.1" (84cm)

7.5" (19cm)

5.5" (14cm)

510LI92

Full Leg

36.2" (92cm)

7.5" (19cm)

5.5" (14cm)

510AI68

Full Arm

26.8" (68cm)

6.7" (17cm)

4.7" (12cm)

510AI78

Full Arm

30.7" (78cm)

6.7" (17cm)

4.7" (12cm)

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