ARJOHUNTLEIGH FLOWTRON ACS900 DVT System Instructions For Use Rev C Dec 2017

Contents General Safety... iii Introduction... 1 About this Manual... 1 Intended Use... 1 About the Flowtron ACS900 System... 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 LCD Screen Icons... 7 LED Indicators on the Pump Case... 10 Operation... 11 General... 11 Start Up... 11 Standby Screens... 12 Starting Therapy... 13 Stopping Therapy... 16 Switching Off the Pump... 16 Warnings/Alarms... 17 Settings Adjustment... 18 Cleaning and Disinfection... 19 Routine Maintenance... 20 Flowtron ACS900 System... 20 Serial Labels... 20 Troubleshooting... 21 General... 21 Troubleshooting Table... 21 Accessories... 27 Technical Specification... 28 Pump Specification... 28 Electromagnetic Compatibility... 30 Symbols... 33

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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: • EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 • ANSI/AAMI ES 60601-1(2005)+AMD(2012) and CAN/CSA C22.2 No.60601-1 (2008)+(2014).

Safety Warnings • It is the responsibility of the caregiver 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 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® ACS900 system is NOT intended for use in the home healthcare environment (for example private dwellings). 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 (for example 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.

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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 2017

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1. Introduction About this Manual

This manual is your introduction to the Flowtron ACS900 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 ACS900 system, contact your local ArjoHuntleigh sales office, listed at the end of this manual.

Intended Use

The intended use of this product is to help prevent Deep Vein Thrombosis (DVT). The garments are single patient use only. It is not for use in the home healthcare environment. The Flowtron ACS900 system should be used as part of a prescribed plan of care (refer to “Indications” on page 3).

About the Flowtron ACS900 System

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 is comprised of a pump that can be used in conjunction with an extensive range of ArjoHuntleigh inflatable uniform (DVT), sequential (Tri Pulse) and foot garments. Refer to “Accessories” on page 27 for a complete list of the calf, calf & thigh and foot garments which can be used with the Flowtron ACS900 pump. The pump automatically adjusts to the correct therapy profile depending upon which garment type 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, which is a secondary power source to back up the pump in the event of failure of or disconnection from (accidental or deliberate) the mains power supply.

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The Flowtron ACS900 system is intended for use ONLY in professional healthcare facilities. It is not intended for use in the home healthcare environment (for example private dwellings). A full technical description of the Flowtron ACS900 system can be found in the Flowtron ACS900 Service Manual, part number SER0026, available from your local ArjoHuntleigh sales office. Pump: Front View Garment Connectors

Tubeset Connector 1 (Blue Button)

LED Indicators

Control Buttons Power Button LCD Screen Tubeset Connector 2 (Orange Button) Tubeset Retention Clips Swing-out Bed-Hooks

Mains Power Cord

Mains Power Cord Retention Clip

Pump: Rear View Integral Carry Handle USB Port (refer to Service Manual SER0026)

Integral Tube and Cable Management System

Mains Power Cord

Swing-out Bed-Hooks

LED Indicator (on underside)

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2. Clinical Applications Indications

The intended use of the Flowtron ACS900 system is to help prevent Deep Vein Thrombosis (DVT). The system should be combined with an individualised monitoring programme. This system represents 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 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 & Sequential Calf and Calf & Thigh Garments

Foot Garments

The system, when used with calf or 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 they do not create any potential for constant pressure points on the patient's limb. If using apparatus with straps or securing devices, for example lithotomy stirrups, make sure that the tubing is not placed inside the strap next to the patient’s skin, and regularly check the patient's skin for signs of redness or pressure points. The garment is most effective in preventing venous stasis when the garment air bladders are located in the posterior position. If the air bladders cannot be placed at the posterior, the garment can be rotated around the calf to alternative positions all of which will still help to prevent venous stasis. 3. 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). 4. The patient’s skin should be inspected frequently during every shift.  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 appropriate skin care. 5. 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. 6. Garments should be removed immediately if the patient experiences tingling, numbness, or pain, and the physician notified.

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7. When used for DVT prevention, continuous external pneumatic compression is recommended until the patient is fully ambulatory. Uninterrupted use of the system is encouraged. 8. The system should be USED WITH CAUTION on patients with: • Insensitive extremities. • Diabetes. • Impaired circulation. • Fragile or impaired skin.  These are guidelines only and should not replace clinical judgement and experience. Guidelines and Recommendations General • The system should be initiated immediately once the risk of DVT formation is identified and the plan of Recommendations care has been prescribed. • If compression stockings 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. • For surgical patients, 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.

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3. Controls, Alarms and Indicators Control Panel with Typical LCD Screen View in Run Mode Mains Indicator LCD Screen

Power Button

Left Control Button

Power Button and Mains Indicator

Middle Control Button

Right Control Button

To switch the pump on: • Connect the pump to mains power and the pump will run its internal diagnostic tests and go to Standby (refer to “Standby Screens” on page 12). • If the pump is already connected to mains power, press and hold the Power button for approximately 2 seconds, and the pump will go directly to Standby. • If the pump is not connected to mains power, press and hold the Power button for approximately 2 seconds, and the pump will run its internal diagnostic tests and go to Standby. The Mains indicator above the Power button shows the mains power status of the pump: • Extinguished: mains power is disconnected. • Illuminated green: mains power is connected to the pump. To switch off the pump, press and hold the Power button for approximately 2 seconds. Then, • If the pump is connected to mains power, the LCD screen backlight will be extinguished and only the mains power and battery indication icons will be displayed. Release the button. • If the pump is not connected to mains power, the pump will power down and the LCD screen will be blank. Release the button.

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When the pump is in Standby and one or two garments are connected, press this button to put the pump into the Run mode and start therapy; the LED indicators on the front and underside of the case will be illuminated green. To stop the therapy and put the pump into Standby, press and hold this button for approximately 2 seconds until the Standby screen is displayed and then release the button. The LED indicators on the front case will be extinguished. Left Control Button If an audible alarm sounds during therapy, press this button to mute the audible alarm.  Only certain alarms can be muted.  Refer to “Troubleshooting” on page 21 for details of the various alarm conditions and possible corrective actions to rectify the faults. When the pump is in Standby, press this button to change the alarm volume (refer to “To Change the Audible Alarm Volume Setting” on page 17). Right Control Button Press this button to reset the patient run hours. This can be done either at power up, after the pump has initialised or if the therapy is stopped and the pump is in Standby (refer to “Resetting the Patient Run Hours” on page 18).

Middle Control Button

LCD Screen Icons

Garment Pressure Indication

This screen shows the position and description of all possible icons which can be displayed. The actual icons which will be displayed will depend on the pump status, patient therapy and whether a fault has been detected.

Low Pressure/ Leak

Kinked/ Blocked Tube

Mains Power Not Connected

Battery Level Indication

Garment Type and Inflation Indication

Warning/Alarm Indication

Tubeset Connector Number

Hardware Fault/ Service Required

Audible Alarm Muted Audible Alarm Status

Mains Power Connected

Patient Run Hours Audible Alarm Volume

Start/Stop Therapy

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Wait/ Initialising

High Temperature Alarm

Garment Type and Inflation Indication

These show which garment type is connected to each tubeset and when each garment is being inflated.  A garment connected but not inflated is shown as an outline on the leg icon. When it is inflated, the garment outline is filled in black. Connected and Not Inflated

Garment

Connected and Inflated

Foot

Uniform (DVT) Calf (or Calf & Thigh) Sequential (Tri Pulse) Calf (or Calf & Thigh)

Tubeset Connector Number

Start/Stop Therapy

The garment connector on the end of each tubeset has a push button which is colour-coded and has a number marked on it: blue “1” or orange “2”. The numbers correspond with the “1” and “2” on the left side of the LCD screen adjacent to the leg icons. The icon above the Middle Control button changes between Run and Standby modes, as follows. Start Therapy icon. In normal operation, this icon is displayed when the pump is in Standby and at least one garment is connected. Press the button to start therapy. Stop Therapy icon. In normal operation, this icon is displayed when the pump is in Run mode. Press the button to stop therapy.

Garment Pressure Indication

The default target inflation pressure for each garment is as follows: • Foot: 130 mmHg. • Uniform calf and calf & thigh: 40 mmHg. • Sequential calf and calf & thigh: 45 mmHg.

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Mains Power Indication

The pump is connected to the mains power supply. The pump is NOT connected to the mains power supply.

Battery Indication

When the pump is connected to the mains power supply: • 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 “Battery Empty” to the current battery capacity for example “Battery ½ Full”, to indicate that the pump is being charged. When the pump is NOT connected to the mains power supply, the indicator is static and shows the approximate charge remaining in the battery. Battery Empty

Battery ¼ Full

Battery ½ Full

Battery ¾ Full

Battery Full

 If the pump is not connected to the mains power

supply and the battery is fully charged and in good condition, the pump will continue to operate normally for approximately 12 hours for calf and calf and thigh garments, and for approximately 6 hours for foot garments.  The battery has a service life of 5 years (approximately 600 charge cycles). It is not user replaceable and must be replaced as part of the service procedure. Wait/Initialising This is a rotating 6-segment circular icon, which indicates that the pump is initialising after power up. Patient Run Hours This shows the total pump run time in hours. Refer to “Resetting the Patient Run Hours” on page 18 to clear the patient run hours.  This is the pump run time since the patient run hours was last reset.

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Audible Alarm Status

Audible Alarm Muted Warning and Alarm Indications

When an alarm which is able to be muted is shown on the LCD screen, this icon is shown to indicate that the alarm can now be muted. When the pump is in Standby, this icon indicates that the alarm volume can be changed (refer to “To Change the Audible Alarm Volume Setting” on page 17). This icon indicates that the audible alarm has been muted. The following five icons indicate that a fault has been detected in the system. Refer to “Troubleshooting” on page 21) for a list of fault conditions, the corresponding warning and alarm indications, and possible corrective actions to rectify the faults. Alarm detected which may cause an interruption in therapy. Low pressure or garment leak. Kinked or blocked tubeset. High temperature. Hardware fault detected or periodic service required.

LED Indicators on the Pump Case

There are additional LED indicators on the pump to show pump status and alarms: • Two sets on the front of the pump. • One set on the underside of the pump. Their status is as follows:

LED Colours

Pump Status

Warnings/Alarms

Extinguished

Off or Standby

--

Green

Run

• No fault detected. • Warning only detected.

Yellow

Run

Fault detected with full audible and visual alarm.

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4. Operation These instructions cover the routine 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 21 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office. Start Up 1. To switch on the pump, do one of the following: • Connect the pump to the mains power supply using the power cable provided. • If operating on battery (the pump is disconnected from the mains power supply), press the Power button. 2. The pump will power up automatically and start running a diagnostic test and initialising the pump. One of the following screens will be displayed, with a rotating 6-segment circular icon: General

Mains Power Connected

Mains Power Disconnected

3. During the last part of the initialisation process, the software version will be displayed, comprised of: • Major revision in top left. • Minor revision in bottom right. This screen shows software version “V1.047”. Major Revision

Minor Revision

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4. At the end of the successful diagnostic test, the “No Garments” Standby screen is displayed.

5. The Patient Run Hours value can now be reset by pressing the Right Control button (refer to “Resetting the Patient Run Hours” on page 18). 6. The alarm volume can also be set by pressing the Left Control button (refer to “To Change the Audible Alarm Volume Setting” on page 17). Standby Screens

The “No Garments” Standby screen (above) shows two leg icons on the left side of the LCD screen with no garment outlines on them, indicating that no garments are currently connected to either tubeset.  The Start Therapy icon does not appear until at least one garment is connected to a tubeset connector. Apply the prescribed ArjoHuntleigh garment(s) to the patient by following the instructions included in the garment packaging.  Garments are for single patient use only. Do not use the garments on multiple patients. 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” (refer to “Garment Type and Inflation Indication” on page 8). The following four screens show typical Standby screens with different garment configurations.  A garment connected but not inflated is shown as an outline on the leg icon. When it is inflated, the garment outline is filled in black.  The same garment outline is used for both calf and calf & thigh garments.

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Starting Therapy

Tubeset Connector 1

No garment connected

Tubeset Connector 2

Foot garment

Tubeset Connector 1

Sequential (Tri Pulse) calf or calf & thigh garment

Tubeset Connector 2

No garment connected

Tubeset Connector 1

Uniform (DVT) calf or calf & thigh garment

Tubeset Connector 2

Uniform (DVT) calf or calf & thigh garment

Tubeset Connector 1

Foot garment

Tubeset Connector 2

Uniform (DVT) calf or calf & thigh garment

Make sure the garment(s) are fitted correctly to the patient and the pump. While the pump is in Standby, the LED indicators on the front and underside of the pump remain extinguished. Press the Middle Control button below the Start Therapy icon to start the therapy. The LEDs on the front and underside of the pump change to green.  If the pump is switched on and one or more garments are connected to the pump, but therapy is not started within 15 minutes, an alarm will occur. If no action is taken to start therapy or silence the alarm, then 15 minutes after the alarm starts, the pump will go into an “Off” state (refer to “Troubleshooting” on page 21). 13

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 indicators displayed and that the correct pressure is being supplied. The default target inflation pressures for the different garments are: • Foot garment: 130 mmHg. • Uniform calf and calf & thigh garments: 40 mmHg. • Sequential calf and calf & thigh garments: 45 mmHg. • Check that there are no kinks in the tubeset. • Check that the tubeset 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 the garment connected to tubeset connector 1. The garment pressure is displayed in the top left side of the screen. The Patient Run Hours are displayed in the bottom right of the screen.  The following example shows two foot garments fitted to the pump. 1. Both garments are initially deflated, and the garment icons are shown as outlines.

2. Foot garment 1 is inflated to the target pressure, with an inflate time of 3 seconds and a deflate time of 27 seconds. The foot garment icon is black while it is inflated.

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3. The foot garment is deflated to zero. Both garment icons are outlines.

4. Foot garment 2 is then inflated to the target pressure, with an inflate time of 3 seconds and a deflate time of 27 seconds. The foot garment icon is black while it is inflated.

5. The foot garment is deflated to zero. Both garment icons are outlines.

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 the target pressure, with an inflate time of 12 seconds and a deflate time of 48 seconds. If a foot garment and a 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 calf (or calf & thigh) garment is inflated, as follows. 1. Inflate the foot garment. 2. Deflate the foot garment. 3. Repeat the inflation of the foot garment. 4. Deflate the foot garment. 5. Inflate the calf (or calf & thigh) garment. 15