Flowtron Excel DVT System Instructions For Use Rev 24 April 2019

Contents General Safety... iii Introduction...1 About this Manual... 1 Intended Use... 1 About Flowtron Excel... 1 Clinical Applications...3 Indications... 3 Contraindications... 3 Cautions... 3 Guidelines and Recommendations... 4 System Set Up...5 Installing the Pump... 5 Garment Application... 5 Garment Removal... 5 To Use Only One Garment... 5 Pre-Use Check...6 Operation...7 Start Up... 7 Shut Down... 7 Pressure Adjustment...8 Pressure Output Check... 8 Adjusting the Output Pressure... 8 System Calibration Check... 8 Decontamination...9 Routine Maintenance...10 Flowtron Excel System... 10 Flowtron Excel Pump... 10 Serial Labels... 10 Troubleshooting - Alarm Condition...11 Alarm Condition...11 Alarm Cancel... 11 Troubleshooting...12 Accessories...13 Garments and Tubing... 13 Technical Specification...14 Electromagnetic Compatibility (EMC)...16

(i)

Intentionally left blank

(ii)

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 • IEC60601-1:2005/A1:2012 and IEC60601-1-8:2012 • ANSI/AAMI ES60601-1(2005)+AMD(2012) and CAN/CSA-C22.2 No.60601-1(2008)+(2014)

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 gases. • Only the pump and garment/insert combination as indicated by Arjo should be used. The correct function of the product cannot be guaranteed if incorrect pump and garment combinations are used. • The Flowtron® Excel system is NOT intended for use in the Home Healthcare Environment (e.g. private dwellings or nursing homes).

WARNING - Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 in) to any part of the Flowtron Excel (ACS550), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Caution (applicable to the USA market only) • US Federal law restricts this device to sale by or on the order of a physician.

(iii)

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. • When the pump is in use the operator should remain in area in case the system alarms. • If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or patient should report the serious incident to the medical device manufacturer or the distributor. In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located. 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 Arjo service personnel. Expected Service Life The Flowtron Excel 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 Arjo. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Flowtron Excel system. Failure to observe this caution could result in injury, or in extreme cases, death. End of Life Disposal • Garment material or any other textiles, polymers or plastic materials etc. should be sorted as combustible waste. • Pump units have electrical and electronic components should be disassembled and recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with local or national regulation. 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 Arjo for information on correct disposal.

(iv)

1. Introduction About this Manual

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Intended Use

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About Flowtron Excel

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1

Carry Handle

Pressure Display

Single Leg Mode Button and Indicator Garment Connectors

Mains Power Switch

Pressure Control

Flowtron Excel Pump - Front View

2

2. Clinical Applications Indications

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Contraindications

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Cautions

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Guidelines and Recommendations General Recommendations

DVT Prophylaxis

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4

3. System Set Up Installing the Pump

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Garment Application

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To Use Only One Garment

7RXVHRQORQHJDUPHQWFRQQHFWDVLQJOHJDUPHQWWR HLWKHUFRQQHFWRU NOTE The snap-lock connectors on the pump are self-sealing and do not require unused garments to be attached.

5

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6

5. Operation Start Up

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Shut Down

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'LVFRQQHFWDQGUHPRYHWKHJDUPHQW V DVUHTXLUHG NOTE Garments are for single patient use only. Do not use the garments on a different patient after treatment.

7

6. Pressure Adjustment 7KHSUHVVXUHFRQWUROPHFKDQLVPLVORFDWHGRQWKHIURQW RIWKHSXPSDQGUDQJHVIURPPP+J7KHSUHVVXUH H[HUWHGEWKHJDUPHQWVRQWKHOHJFDQEHDGMXVWHGE WXUQLQJWKLVNQRE7XUQLQJWKHNQREFORFNZLVHLQFUHDVHV WKHSUHVVXUHFRXQWHUFORFNZLVHGHFUHDVHVWKHSUHVVXUH NOTE The recommended pressure setting is 40 mmHg. Alternatively, use the pressure prescribed by the treating physician.

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Adjusting the Output Pressure

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System Calibration Check

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8

7. Decontamination 7KHIROORZLQJSURFHVVHVDUHUHFRPPHQGHGEXWVKRXOGEHDGDSWHGWRFRPSOZLWK WKHORFDORUQDWLRQDOJXLGHOLQHV 'HFRQWDPLQDWLRQRI0HGLFDO'HYLFHV ZKLFKPD DSSOZLWKLQWKH+HDOWKFDUH)DFLOLWRUWKHFRXQWURIXVH,IRXDUHXQFHUWDLQRX VKRXOGVHHNDGYLFHIURPRXUORFDO,QIHFWLRQ&RQWURO6SHFLDOLVW 7KHFlowtron([FHOSXPSVKRXOGEHURXWLQHOGHFRQWDPLQDWHGEHWZHHQSDWLHQWVDQG DWUHJXODULQWHUYDOVZKLOHLQXVHDVLVJRRGSUDFWLFHIRUDOOUHXVDEOHPHGLFDOGHYLFHV WARNING Remove the electrical supply to the pump by disconnecting the mains power cable 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

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Chemical Disinfection

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Garments are single patient use and hence cannot be cleaned or reused.

9

8. Routine Maintenance Flowtron Excel System Maintenance Servicing

Service Period

Flowtron Excel Pump General Care, Maintenance and Inspection

Serial Labels

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10

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Problem

Corrective Action

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

Alarm Cancel

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

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11

Troubleshooting Display

Problem

No displays, no indications, no operation

1. Power failure.

Yellow LED on the top panel flashes (approximately 4 times per second)

Internal electronic fault

Corrective Action 1. Check mains power supply. Check power cable. 2. Call the service engineer.

2. Fuse blown.

DO NOT USE PUMP. Call the service engineer.

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

12

10. Accessories GARMENTS AND TUBING Description

Garment Part No.

Size

Standard Calf Garment

DVT10

Circumference

up to 43cm (17”)

Calf Garment (Sterile)

DVT10S

Circumference

up to 43cm (17”)

Large Calf Garment

DVT20

Circumference

up to 58cm (23”)

Standard Thigh Garment

DVT30

Circumference

up to 71cm (28”)

Thigh Garment (Sterile)

DVT30S

Circumference

up to 71cm (28”)

Large Thigh Garment

DVT40

Circumference

up to 89cm (35”)

Extra Large Calf Garment

DVT60L

Circumference

up to 81cm (32”)

Calf Garment

L501-M

Circumference

up to 43cm (17”)

Thigh Garment

L503-M

Circumference

up to 71cm (28”)

Connector Tubing

L550 (SP057)

Length

150 cm (60”)

Connector Tubing

L552 (SP061)

Length

300 cm (118”)

Small Calf Garment

DVT5

Circumference

up to 36 cm (14”)

13

11. Technical Specification 7DEOH Pump Supply Voltage and Frequency:

230V / 50 Hz, 230V / 60 Hz, 220V / 60 Hz, 120V / 60 Hz, 100V / 50 Hz 100V / 60 Hz

Power Input:

35 VA MAX

Size:

133 x 152 x 275 mm

Weight:

2.7 kg

Case Material:

Fire Retardant ABS Plastic

Plug Fuse Rating:

5A BS1362 (UK ONLY)

Pump Fuse Rating:

T1AL 250 V

Degree of protection against electric shock:

Class II, Double Insulated with Functional Earth Type BF

Degree of protection against liquid ingress:

IPX0 - No protection

Mode of operation:

Continuous

Cycle or Therapy Modes:

60 seconds total 12 seconds inflation 48 seconds deflation

Pressure Range:

30 - 60 mmHg (±10 mmHg)

ENVIRONMENTAL INFORMATION Condition

Temperature Range

Relative Humidity

Atmospheric Pressure

Operating

+10 °C to +40 °C (+50 °F to +104 °F)

30% to 75% (non-condensing)

700 hPa to 1060 hPa

Storage and Transport (Long Term)

+10 °C to +40 °C (+50 °F to +104 °F)

20% to 95% (non-condensing)

700 hPa to 1060 hPa

Storage and Transport (Short Term)

-20 °C to +50 °C (-4 °F to +122 °F)

20% to 95% (non-condensing)

500 hPa to 1060 hPa

Products should be well packaged and stored in a well-ventilated, dry and non-corrosive environment.

NOTE If this pump unit is subjected to extreme cold during transit or storage, initial performance may be impaired. Connect to power supply and leave running for approx. 30 minutes before use.

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Symbols The operator must read this document (Instructions for Use) before use. Note: This symbol is blue on the product label.

E348583

CAN/CSA-C22.2 No 60601-1 (2008)+(2014) and ANSI/AAMI ES 60601-1(2005) +AMD(2012)

i

With respect to electric shock, fire and mechanical hazards only in accordance with CAN/CSA-C22.2 No. 60601-1 (2008) + (2014) and ANSI/AAMI ES 60601-1 (2005) + AMD (2012) MEDICAL EQUIPMENT

O (Off)

I

Power: Disconnects from the mains supply

(On)

Power: Connects to the mains supply

Refer to this document (Instructions for Use) for a description of the product classification (3rd Edition).

SN

Serial Number

Refer to this document (Instructions for Use) for a description of the product classification (2nd Edition).

REF

Model number

Manufacturer: This symbol is accompanied by the name and the address of the manufacturer.

Type BF

CE marking indicating conformity with European Community harmonised legislation Figures indicate Notified Body supervision.

Fuse

Indicates the product is a Medical Device according to EU Medical Device Regulation 2017/745

Double Insulated

Do not dispose of in domestic refuse

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