ARJOHUNTLEIGH FLOWTRON ACS800 + TRI PULSE Instructions for Use April 2014

Contents General Safety... iii Introduction... 1 About this Manual... 1 Intended Use... 1 About Flowtron ACS800 + Tri Pulse... 1 Pump: Front View... 2 Pump: Rear View... 2 Clinical Applications... 3 Indications... 3 Contraindications... 3 Cautions... 4 Guidelines and Recommendations... 5 Controls, Alarms and Indicators... 6 Control Panel With Typical LCD Screen View in Run Mode... 6 LED Indicators on the Front Case... 9 Operation... 10 General... 10 Start Up... 10 Standby Screens... 11 Starting Therapy... 13 Stopping Therapy... 15 Switching Off the Pump... 16 Alarms... 16 Changing Options... 16 Settings Adjustment... 20 Decontamination... 21 Routine Maintenance... 22 Flowtron ACS800 + Tri Pulse System... 22 Pump... 22 Serial Labels... 22 Troubleshooting... 23 Accessories... 29 Technical Specification... 30

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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 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. • The Flowtron® ACS800 + Tri Pulse system is NOT intended for use in the Home Healthcare Environment (e.g. private dwellings or nursing homes). 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 open 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.

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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 pump 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 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 2014

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1. Introduction About this Manual

This manual is your introduction to the Flowtron® ACS800 + Tri Pulse system, which is a Flowtron ACS800 pump enabled for use with both Tri Pulse and uniform DVT garments. Refer to “Accessories” on page 29 for a list of the garments which can be used. 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 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). The garments are single patient use only. It is not for use in the home healthcare environment. The Flowtron ACS800 + Tri Pulse system should be used as part of a prescribed plan of care (refer to “Indications” on page 3).

About Flowtron ACS800 + Tri Pulse

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 ArjoHuntleigh inflatable garments, including foot, calf and calf & thigh versions. The pump automatically adjusts to the correct therapy profile depending upon which garment type (foot, uniform DVT calf or calf & thigh, or Tri Pulse calf or calf & thigh) is connected. The tubeset is integral to the system and cannot be disconnected from the pump. The mains power supply is the primary power source for the pump. The pump incorporates an internal battery pack, which is a secondary power source to back up the pump in the event of failure or disconnection (accidentally or deliberately) from the mains power supply. 1

The system is intended for use ONLY in Professional Healthcare Facilities (e.g. hospitals or physicians’ offices). A full technical description of the Flowtron ACS800 + Tri Pulse system can be found in the Service Manual, part number SER0020, available from your local ArjoHuntleigh sales office. Pump: Front View LCD Screen and Controls

Integral Carry Handle Integral Tubesets

LED Indicator Tubeset 1 (Blue Button)

Garment Connectors

Tubeset 2 (Orange Button)

Pump: Rear View

Swing-out Bed-Hooks

Tubeset 1

Integral Tubesets Mains Power Cord Tubeset 2

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2. Clinical Applications Indications

The intended use of the Flowtron ACS800 + Tri Pulse system is to help prevent Deep Vein Thrombosis (DVT). The system should be combined with an individualised monitoring programme. These systems represent one aspect of a DVT 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. 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.

Contraindications Uniform DVT Calf/Calf & Thigh and Tri Pulse Calf/Calf & Thigh Garments

Foot Garments

The system, when used with the uniform DVT calf/calf & thigh and Tri Pulse calf/calf & thigh garments, should not be used in the following conditions: 1. Severe arteriosclerosis or other ischemic vascular diseases. 2. Severe congestive cardiac failure or any condition where an increase of fluid to the heart may be detrimental. 3. Known or suspected acute deep vein thrombosis, thrombophlebitis or pulmonary embolism. 4. Any local condition in which the garments would interfere, including: • Gangrene • Recent skin graft • Dermatitis • On untreated, infected leg wounds. The system, when used with the foot garments, should not be used in the following conditions: 1. Severe congestive cardiac failure or any condition where an increase of fluid to the heart may be detrimental. 2. Known or suspected acute deep vein thrombosis, thrombophlebitis or pulmonary embolism.

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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. Proper garment application and connection to the pump is essential. 2. Garments should be positioned in such a way that there is no potential for sustained pressure points on the skin and underlying tissues. Lower limb positioning in relation to the garment and tubing should also be considered particularly in a patient that is unconscious, cannot feel or has reduced sensation and/or ability to move their leg(s). 3. While using the system, the patient's skin should be inspected frequently and regularly, paying particular attention to bony prominences such as the malleolus and heel. It is recommended that these checks should be performed not less than every hour if the patient cannot feel or has reduced sensation and/or ability to move their leg(s); in all other patients, perform these checks not less than every 6 hours. 4. Clinical judgement is required to determine if the patient's skin condition requires additional protective measures, or if the therapy should be discontinued and an alternative modality used. 5. Garments should be removed immediately if the patient experiences tingling, numbness, or pain, and the physician notified. 6. When used for DVT prevention, continuous external pneumatic compression is recommended until the patient is fully ambulatory. Uninterrupted use of the system is encouraged. 7. The system should be USED WITH CAUTION on patients with: • Insensitive extremities. • Diabetes. • Impaired circulation. • Fragile or impaired skin.

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

Guidelines and Recommendations General • While using the system, the patient’s limbs should be checked not less than every six hours, and more often Recommendations if the patient has known circulatory or skin problems, or is diabetic. • Note: Many patients are at risk for pressure ulcers on the heel. Use of the foot garments does not negate the necessity for heel protection and proper skin care. • Clinical judgment should be used to determine if the patient’s skin condition requires additional measures, or if the treatment should be discontinued and alternative modalities used. • 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. Any compression stocking used should be routinely checked to ensure continued proper fit and application, in addition to assessing the condition of 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 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 post-operatively 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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3. Controls, Alarms and Indicators Control Panel With Typical LCD Screen View in Run Mode Garment Type and Therapy Indicator (the possible garment types are detailed in “LCD Screen” section below) Mains/Power Indicator

Battery Indicator LED Indicator

Pressure Indicator

On/Off Button Stop

2h

LCD Screen

Patient Hours Meter Start/Stop Therapy

“Down” Select Button

On/Off Button and LED Indicator

Start/Stop Button

“Up” Select Button

Press the On/Off button to power up the pump from its unpowered state and put it into Standby (refer to “Standby Screens” on page 11).  Connecting the pump to the mains power supply will automatically power up the pump from its unpowered state and put it into Standby, without having to press the On/Off button. Make sure the system has been arranged so that the power cable and garment hoses do not pose a trip or strangulation hazard. The adjacent LED indicator shows the pump status:

LED Colour

Mains Power

Pump Status

Extinguished

Disconnected

Off

Amber

Connected

Off

Amber

Connected or disconnected

Standby

Green

Connected or disconnected

Run

To switch off the pump, press and hold the On/Off button for approximately 2 seconds until the LCD screen goes blank, and then release. If you switch off the pump and then press the On/Off button to power it back up: 6

Start/Stop Button

“Up” and “Down” Select Buttons

LCD Screen

• 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 or icon displayed above the button: • To start or stop therapy. • To confirm the option selected in the Options menu. When the pump is in Standby, press the Start/Stop button to put the pump into the Run mode and start therapy; the LED indicator adjacent to the On/Off button will change to green and the LEDs on the front case will be illuminated green. To stop the therapy and put the pump into Standby, press and hold the Start/Stop button for approximately 2 seconds until the Standby screen is displayed and then release the button. The LED indicator adjacent to the On/Off button changes to amber and the LEDs on the front case are extinguished. These have the following functions depending on the text or icon displayed above the buttons: • To select the Options menu. • To move up and down the Options menu. • To mute certain audible alarm conditions. This displays the pump operating mode and status: 1. Foot, uniform DVT calf (or calf & thigh) or Tri Pulse calf (or calf & thigh) therapy indications. These show what garment type is connected to each tubeset and when each garment is being inflated: Uniform DVT Calf or Calf & Thigh Garment

Foot Garment

Tri Pulse Calf or Calf & Thigh Garment

• All therapy indications are initially shown as grey to indicate they are deflated. • A therapy indication changes to black to show it is inflating. • The therapy indication reverts to grey when it starts to deflate. • The garment connector on the end of each tubeset has a push button which is colour-coded 7

and has a number marked on it: blue “1” or orange “2”. The numbers corresponds with the “1” and “2” on the right side of the LCD screen. 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. • Uniform DVT calf and calf & thigh. The pressure is adjustable between 35 - 65 mmHg. To be adjusted only by authorised personnel. The pump will default to the last pressure set. • Tri Pulse calf and calf & thigh garments: 45 mmHg. 3. Mains power indications: The pump is connected to the mains power supply. The pump is not connected to the mains power supply, but is powered by the internal battery only.

4. Battery indication: • When the pump is connected to the mains power supply, then: •• If the battery is fully charged, the indicator will be static and show “full”. •• If the battery is not fully charged, the indicator will “scroll” from “empty” to “full” to indicate that the pump is being charged. • When the pump is NOT connected to the mains power supply, then the indicator is static and shows the charge remaining in the battery: Battery Empty

Battery 1/3 Full

Battery 2/3 Full

Battery Full

 The battery has a service life of 5 years (600 charge cycles). It is not user replaceable and must be replaced as part of the service procedure. 5. Patient Hours Meter: if this is selected, the total therapy time is shown (in hours). Refer to “Changing Options” on page 16 to select and/or clear the Patient Hours Meter.

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• This is the pump run time since the Patient Hours Meter was last cleared. • The factory default is to NOT show the Patient Hours Meter on the LCD screen. 6. Warning and alarm indications (refer to “Troubleshooting” on page 23). LED Indicators on the Front Case

There are two sets of LED indicators on the front case of the pump. Their status is as follows:

LED Colours

Pump Status

Warnings/Alarms

Extinguished

Off or Standby

--

Green (Static)

Run

• No fault detected. • Warning only detected.

Red (Flashing)

Run

Fault detected with full audible and visual alarm

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4. Operation These instructions cover the day-to-day operation of the system. Other operations, such as maintenance and repair, should only be carried out by suitably qualified personnel. Refer to “Controls, Alarms and Indicators” on page 6 for a description of the controls, indicators and LCD screen.  If the operation or performance of the pump changes during use, refer to “Troubleshooting” on page 23 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office. Start Up To switch on the pump, do one of the following: • Connect the pump to the mains power supply using the power cable provided. The pump will power up automatically and start running a diagnostic test, and display the following screen: General

Progress Bar

• If operating from just the battery (disconnected from the mains power supply), press the On/Off button. The pump will power up and start running the diagnostic test, and display the following screen. Note the “Checking Battery” text and the “Mains power not connected” icon at the top of the screen: Checking Battery

“Mains power not connected” icon

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After a few seconds, the following screen is displayed, showing “Battery OK”: Battery OK

 If the text at the top of the screen says “Low

Battery” then you must connect mains power before you can start therapy. • At the end of the diagnostic test, the following screen is displayed, showing the “Hours Run” at the top, the software version of the pump at the bottom and “ACS800 Tri Pulse” below “Flowtron”: Hours Run: 145

ACS800 Tri Pulse XX.XXXX-XXX

 The “Hours Run” value displayed on this screen is

for service use only, and is different to the “Patient Hours Meter” displayed during therapy. Refer to “Controls, Alarms and Indicators” on page 6 for the “Patient Hours Meter”.

Standby Screens “Mains power connected” icon

The “No Garments” Standby screen is then displayed: Attach garments

Battery Indication

Options

There are two “leg” icons with no garments attached and the text “Attach garments” at the top of the screen; this indicates that no garments are currently connected to either tubeset.  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. 11

 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” and the one with the orange push button is “2”. If any pump options (Audio Alarm Volume, Patient Hours Meter or Language) need to be changed, they must be changed before the patient therapy is started. Refer to “Changing Options” on page 16. The following six screens show typical Standby screens with different garment configurations:

Start

Start

Options

Foot Garment Connected to Tubeset 1

Start

Uniform DVT Calf (or Calf & Thigh) Garment Connected to Tubeset 1

Options

Start

Two Uniform DVT Calf (or Calf & Thigh) Garments Connected

Start

Options

Options

Foot and Uniform DVT Calf (or Calf & Thigh) Garments Connected

Start

Options

Options

Foot and Tri Pulse Calf (or Calf & Thigh) Garments Connected

Tri Pulse Calf (or Calf & Thigh) Garment Connected to Tubeset 1

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Starting Therapy

Make sure the garment(s) are fitted correctly to the patient and the pump. Make sure any pump options have been changed if necessary.  If the pump is to be positioned under a bed, make sure it is placed horizontally (with the bed-hooks underneath) to prevent damage to the pump. While the pump is in Standby, the LEDs on the front case remain extinguished. 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. • During garment inflation, check the LCD screen to confirm that there are no fault messages displayed and that the correct pressure is being supplied. The supplied inflation pressures for the different garments are: • Foot garment: 130 mmHg. • Uniform DVT calf and calf & thigh garments: 40 mmHg. • Tri Pulse calf and calf & thigh garments: 45 mmHg.  Initial inflation cycles (up to 10) may not show the correct inflation pressure. This is to be expected. • Check that there are no kinks in the pump tubesets. • Check that the pump tubesets and connectors do not cause the patient any discomfort. • Regularly check that the garments remain correctly fitted to the patient. The pump will inflate and deflate each garment in turn, as follows, starting with garment 1:  The following example shows two foot garments fitted to the pump. 1. Both garments are initially deflated. The garment pressure is displayed on the left side of the screen. If the Patient Hours Meter is selected in the “Options” menu (refer to “Changing Options” on

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page 16), the total elapsed time (in hours) is shown in the bottom right of the screen:

Stop

2h

Patient Hours Meter

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

2h

3. The foot garment is deflated to zero. Both garment indicators are grey:

Stop

2h

4. Foot garment 2 is then 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

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2h

5. The foot garment is deflated to zero. Both garment indicators are grey:

Stop

2h

6. This cycle of alternate garment inflations repeats from step 2 (above) until the therapy is stopped. If calf (or calf & thigh) garments are attached to the pump, then each of these garments is inflated to 40 mmHg (uniform DVT) or 45 mmHg (Tri Pulse), with a ramp up and hold time of 12 seconds. If a foot garment, uniform DVT calf (or calf & thigh) or Tri Pulse calf (or calf & thigh) garment are attached to the pump, then since the inflate and hold 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 uniform DVT calf (or calf & thigh) or Tri Pulse calf (or calf & thigh) garment is inflated, as follows.  The first garment to be inflated is always garment 1. 1. Inflate the foot garment to 130 mmHg. 2. Deflate the foot garment. 3. Repeat the inflation of the foot garment to 130 mmHg. 4. Deflate the foot garment. 5. Inflate the uniform DVT calf (or calf & thigh) garment to 40 mmHg or the Tri Pulse calf (or calf & thigh) garment to 45 mmHg. 6. Deflate the uniform DVT calf (or calf & thigh) garment or Tri Pulse calf (or calf & thigh) garment. 7. This cycle of garment inflations repeats from step 1 (above) until the therapy is stopped. Stopping Therapy

To stop the therapy and put the pump into Standby, press and hold the Start/Stop button for approximately 2 seconds until the Standby screen is displayed (refer to “Standby Screens” on page 11) and then release it. The LED indicator by the On/Off button changes to amber and the LEDs on the front case are extinguished.

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