Huntleigh Hydroven 12 LymphAssist Homecare Instructions For Use Manual
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Huntleigh Hydroven 12 LymphAssist Homecare Instructions For Use Manual

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Hydroven 12
LymphAssist
Homecare
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Summary of Contents for Huntleigh Hydroven 12 LymphAssist Homecare

  • Page 1 Hydroven 12 LymphAssist Homecare ™...

  • Page 2: Table Of Contents

    4.2 Contraindications ................12 5. Preliminary Checks ............ 13 6. Garment and Insert Information ........ 14 6.1 Garment Dimensions ................15 7. Hydroven 12 LymphAssist Homecare System ... 17 7.1 Garment Connections ................17 7.2 Operating Modes.................18 7.2.1 Standby ........................18 7.2.2 Sleep Mode .......................18 7.2.3 Run Mode .........................18...
  • Page 3 10. Decontamination ............27 10.1 Cleaning ....................27 10.2 Chemical Disinfection ................27 10.3 Cleaning and Sterilising Garments ...........27 11. Routine Maintenance ..........28 11.1 Hydroven 12 System................28 11.1.1 Maintenance......................28 11.1.2 Servicing .........................28 11.1.3 Service Period ......................28 11.2 General Care, Maintenance and Inspection ........28 11.2.1 Pump ........................28 11.2.2 Garments ........................28 11.3 Serial Number Labels .................28...

  • Page 4: Safety

    Safety Before using this equipment, please study this manual carefully and familiarise yourself with the controls, display features and operation. Ensure that each user fully understands the safety and operation of the unit, as misuse may cause harm to the user or patient, or damage to the product.
  • Page 5 WARNING: Disconnect the pump from the mains power socket before cleaning and inspecting. WARNING: Only the pump and garment/insert combination as indicated by Huntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and garment combinations are used.

  • Page 6: Electromagnetic Compatibility

    Electromagnetic Compatibility Make sure the environment in which Hydroven 12 is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer’s instructions, it may cause or be subject to interference. Type-tested in a fully configured system, complies with EN60601-1-2, the standard intended to provide reasonable protection against such interference.
  • Page 7 Guidance and Manufacturer’s declaration - electromagnetic immunity The Hydroven 12 is intended for use in the electromagnetic environment specified below. The customer or the user of the Hydroven 12 should assure that it is used in such an environment. IEC 60601 test Compliance Electromagnetic Environment Immunity Test level level - guidance Electrostatic ± 6 kV contact ±...
  • Page 8 Guidance and Manufacturer’s declaration - electromagnetic immunity The Hydroven 12 is intended for use in the electromagnetic environment specified below. The customer or the user of the Hydroven 12 should assure that it is used in such an environment. IEC 60601 test Compliance Immunity Test Electromagnetic Environment - guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the Hydroven 12, including cables, than the recommended separation distance...
  • Page 9 Recommended separation distances between portable and mobile RF communications equipment and the Hydroven 12 The Hydroven 12 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Hydroven 12 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Hydroven 12 as recommended below, according to the maximum output power of the communications equipment.

  • Page 10: Introduction

    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 LymphAssist system, contact your local Huntleigh sales representative, 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”...

  • Page 11: Use Environment

    Use Environment Hydroven 12 LymphAssist Homecare is suitable for use in hospital, primary care, community settings and in the home. It must not be used outdoors, or in any environment where it may come into contact with water. 3.5 Intended User Profile...

  • Page 12: Clinical Applications

    Clinical Applications Indications Intermittent Pneumatic Compression (IPC) is effective in the treatment of the following clinical conditions, when combined with an individualised monitoring programme: • Lymphoedema. • Primary and secondary (including post surgery, radio or chemotherapy). Selection should be based upon a holistic assessment of the patients’ individual care needs.

  • Page 13: Contraindications

    Contraindications IPC should NOT be used in the following circumstances: • Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis and acute infections of the skin, such as cellulitis. • Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema or any condition where an increase of fluid to the heart may be detrimental. • Severe arteriosclerosis or other ischaemic vascular disease. •...

  • Page 14: Preliminary Checks

    1 x Instructions for Use Homecare Delivery Inspection Huntleigh Healthcare Ltd takes every precaution to ensure that goods reach you in perfect condition. However, accidental damage can occur in transit and storage. For this reason we recommend that a thorough visual inspection is made immediately the unit is received.

  • Page 15: Garment And Insert Information

    Garment and Insert Information WARNING: Bags supplied with this equipment can present a suffocation risk; to avoid the risk of suffocation, keep the bags away from babies and small children. The LymphAssist pump is designed to be used with Hydroven™ 12 garments, which are available in two sizes for arms and four sizes for legs.

  • Page 16: Garment Dimensions

    Garment Dimensions Limbs should be measured and the correct garment(s) chosen using the following measuring guides and tables of dimensions. When determining the correct garment size: • Remove any bandages, stockings and/or any bulky dressings. • Measure the circumference of the limb where stated. •...
  • Page 17 Width of Insert (at top of thigh) 19 cm 19 cm 19 cm 19 cm Note: The Hydroven 12 leg garment insert piece adds 19 cm to the top-of-thigh circumference of the garment. For further information about garment sizing, please contact Huntleigh.

  • Page 18: Hydroven 12 Lymphassist Homecare System

    Hydroven 12 LymphAssist Homecare System The Hydroven 12 pump is designed for table-top use, with the controls situated at the front of the pump. It comprises a moulded case with non-slip feet on the base and rear cover, and an integral carry handle. Carry Handle Upper 12-Way connector...

  • Page 19: Operating Modes

    Operating Modes Refer to “Pump Controls and Indicators” for a description of the controls and indicators on the pump. The pump has the following three operating modes: 7.2.1 Standby After the mains power supply has been switched on to the pump, the pump will perform a short self-test and then go into Standby.

  • Page 20: Inflation Modes

    7.3 Inflation Modes 7.3.1 LymphAssist Inflation Refer to the diagram below for the LymphAssist cycle. Note: Chamber 1 is at the distal (foot/hand) end and chamber 12 is at the proximal (thigh/shoulder) end. 1. On initial application, the LymphAssist therapy starts with a single peristaltic Wave inflation from chamber 1 to chamber 12. 2. A LymphAssist cycle is comprised of the following sequence of inflations/ deflations, starting at chamber 12, then 11, 10, etc., down to chamber 1: • There are 5 pulses where the chamber is inflated and deflated. These are referred to as LymphAssist pulses. • This is followed by a single “partial”-peristaltic Wave inflation of part of the garment - between the next chamber and chamber 12. For example, at chamber 5, the 5 LymphAssist pulses are followed by a partial-peristaltic Wave inflation from chamber 6 to chamber 12.

  • Page 21: Lymphassist System

    Note: The maximum pump pressure that can be set in LymphAssist mode is 40 mmHg. 7.3.2 LymphAssist System The LymphAssist system is factory set to deliver two LymphAssist cycles lasting approximately 35 minutes. The inflation time is preset to 80 seconds and the deflation time preset is 50 seconds.

  • Page 22: Controls, Indicators And Alarms

    Controls, Indicators and Alarms Typical Control Panel in Run mode Run mode Pressure Sleep mode indicator Display indicator Run/Standby button Pressure setting buttons Therapy time display Pump Controls and Indicators The pump control panel has the following controls and indicators: Note: When a button on the pump control panel is pressed, the sounder will “beep” to confirm a valid selection.

  • Page 23: Run/Standby Button, And Run And Sleep Mode Indicators

    8.2.1 Run/Standby Button, and Run and Sleep Mode Indicators • When the pump is in Standby, both the Run and Sleep mode indicators are extinguished. • Press and hold the Run/Standby button for 3 seconds to start the patient therapy. The Run mode indicator (the left one of the two indicators) is illuminated to show that the pump is in Run mode.

  • Page 24: Therapy Setting Display

    8.2.3 Therapy Setting Display Treatment duration (in minutes) • When the therapy starts, the Treatment duration shown on the Therapy Setting display will count down, indicating the time remaining (to the nearest full minute). • At the end of the therapy, as set by the Treatment duration, the pump will stop.

  • Page 25: Operation

    If the operation or performance of the pump changes during use, refer to “Routine Maintenance” before calling a service engineer or contacting your local Huntleigh sales office. WARNING: Bags supplied with this equipment may present a suffocation risk; to avoid the risk of suffocation, keep the bags away from babies and small children.
  • Page 26 7. Connect the garment(s) to the two 12-way connectors on the pump, as follows: • If two garments are used (either two arm garments, two leg garments, or one arm/leg garment and one garment insert), one will be connected to the upper connector and the other connected to the lower connector.

  • Page 27: Starting Therapy

    Starting Therapy 1. Make sure the pump is in Standby. Note: Make sure that all garment zips are completely and securely fastened before starting the therapy. 2. Press and hold the Run/Standby button for 3 seconds to start the patient therapy.

  • Page 28: Decontamination

    10. 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.

  • Page 29: Routine Maintenance

    This equipment has been designed to be virtually maintenance free between service periods. 11.1.2 Servicing Huntleigh will make available on request service manuals, component parts lists and other information necessary for Huntleigh trained personnel to repair the system. 11.1.3 Service Period Huntleigh recommend that the LymphAssist pump is serviced every 24 months by a Huntleigh approved service agent.

  • Page 30: Trouble Shooting

    Note: If the trouble shooting procedures do not return the system to normal performance, stop using the system immediately and call the service engineer or return the unit to Huntleigh for service. Refer to “Warranty & Service” .

  • Page 31: Accessories

    13. Accessories Garments and Garment Inserts Arm Garment Dimensions Garment Part No. 316A68 316A78 Length (shoulder to fingertips) 68 cm (26.8”) 78 cm (30.7”) Circumference (at shoulder) Arm Garment 62 cm (24.4”) 62 cm (24.4”) with Garment Insert 79 cm (31.1”) 79 cm (31.1”) Corresponding Insert piece part No.

  • Page 32: Specifications

    14. Specifications 14.1 Equipment Classification Type of protection Class II, Double Insulated against electric shock. Degree of protection Type BF against electric shock Mode of operation. Continuous Degree of protection IP21 - Protection against ingress of solid objects against solid and liquid more than 12.5mm diameter and water droplets ingress falling vertically.

  • Page 33: Environmental

    14.3 Environmental Condition Temperature Relative Atmospheric range Humidity Pressure Operating 10°C to 40°C 30% to 75% 700 to 1060 hPa (41°F to 104°F) (non condensing) Storage and 10°C to 40°C 20% to 95% 700 to 1060 hPa transport (50°F to 104°F) (non condensing) (Long term) Storage and...

  • Page 34: Product Labelling

    15. Product Labelling Symbols Hydroven 12 is Class II, double insulated according to the definitions in BS EN 60601-1:1990 Applied parts are type BF according to the definitions in BS EN 60601-1:1990 Refer to this document (Instructions for Use) for a description of the product classification (3rd Edition). Standby. Note: Unit is not isolated from mains supply. With respect to electric shock, fire and mechanical hazards only in accordance with CAN/CSA-C22.2 No. 60601.1 (2008). MEDICAL EQUIPMENT This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and...
  • Page 35 Cleaning Symbols Wipe surface with Use solution diluted to 1000 damp cloth ppm of Available Chlorine 1000ppm NaOCl NaDCC Do not iron Do Not Use Phenol-based cleaning Solutions Do not dry clean Do not tumble dry...

  • Page 36: End Of Life Disposal

    16. End of Life Disposal This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of responsibly in accordance with local procedures.

  • Page 37: Warranty & Service

    • Mark the package ‘Service Department ‘ For further details, refer to NHS document HSG(93)26. Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certificate. Service Department. Huntleigh Healthcare, Diagnostic Products Division, 35, Portmanmoor Rd.,...
  • Page 39 Tel: +49 (0) 2152 551110 CA-MISSISSAUGA, ON, L5R 3R3 Fax: +49 (0) 2152 551120 Tel/Tél: +1 905 238 7880 E-mail: verkauf@huntleigh.de Free: +1 800 665 4831 Institutional Free: +1 800 868 0441 Home Care Fax: +1 905 238 7881 SVERIGE E-mail: info.canada@arjohuntleigh.com...
  • Page 40 Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 F: +44 (0)29 20492520 sales@huntleigh-diagnostics.co.uk www.huntleigh-diagnostics.com Registered No: 942245 England & Wales. Registered Office: ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF ©Huntleigh Healthcare Limited 2014...

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