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Summary of Contents for Huntleigh Hydroven 3
- Page 1 INSTRUCTIONS FOR USE Hydroven 3 779344EN-4 04/20222...
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Page 2: Table Of Contents
2. Electromagnetic Compatibility ............5 3. Introduction ..................8 3.1 About this Manual ..................8 3.2 Intended Use .................... 8 3.3 About the Hydroven 3 system ..............8 3.4 Use Environment ..................8 4. Clinical Applications ................9 4.1 Indications ....................9 4.2 Contraindications ..................10 5. - Page 3 10.1 Hydroven 3 System.................. 20 10.1.1 Maintenance ......................... 20 10.1.2 Servicing ........................20 10.1.3 Service Period ....................... 20 10.2 Hydroven 3 Pump ..................20 10.2.1 General Care, Maintenance and Inspection..............20 10.2.2 Serial Labels ......................... 20 11. Trouble Shooting .................21 12.
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Page 4: Safety
Warnings Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Hydroven 3 system. Failure to observe this caution could result in injury, or in extreme cases, death. WARNING: A possible explosion hazard exists if used in the presence of flammable anaesthetics. - Page 5 This has been defined as the minimum time period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device has been defined as 7 years. Instructions For Use...
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Page 6: Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic emissions The Hydroven 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the Hydroven 3 should assure that it is used in such an environment. - Page 7 Guidance and Manufacturer’s declaration - electromagnetic immunity The Hydroven 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the Hydroven 3 should assure that it is used in such an environment. IEC 60601 test...
- Page 8 Recommended separation distances between portable and mobile RF communications equipment and the Hydroven 3 The Hydroven 3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Hydroven 3 can help prevent electromagnetic interference by...
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Page 9: Introduction
The intended use of this product is to manage the list of clinical conditions detailed in the “Indications” section. The Hydroven 3 system should be used as part of a prescribed plan of care detailed in the “Indications” section. About the Hydroven 3 system The pump supplies air via connecting tubes to an inflatable garment allowing the application of controlled pressure to gently compress the limb. -
Page 10: 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: • Oedema. • Dependent (including secondary to cerebrovascular incident, pregnancy or paralysis). • Traumatic (post-surgical or injury). •... -
Page 11: 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. -
Page 12: Preliminary Checks
1 x Instructions for Use 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 13: Clinical Treatment Guide
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, dependent on the patient’s tolerance. The pressure can be gradually increased over time, until the required pressure is reached. -
Page 14: Garment And Insert Information
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/... -
Page 15: Applying The Garment
Applying the Garment 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. Quick air release bung Tubing to pump Tubing to pump Leg Garment Arm Garment Note: 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. - Page 16 CAUTION: Do not apply the garment to the limb unless it is partially zipped, as you may damage the garment zip. 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. CAUTION: Do not stand or walk while leg garments are fitted.
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Page 17: Operation
If the operation of performance of the pump changes during use, refer to “Trouble Shooting” section of this IFU before calling a service engineer or contacting your local Huntleigh sales office. 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. -
Page 18: Operation
Operation It is the responsibility of the care giver to ensure that the user can use this product safely. The pump should be placed securely on a flat surface. Before starting the pump ensure that the garments are properly applied, the zippers are secured and the garment connecting tubes are attached to the pump outlet ports via the snap-lock connectors (3). -
Page 19: To Set The Garment Pressure
8.2.3 To Set the Garment Pressure While the garment is inflating, rotate the pressure control 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. -
Page 20: Decontamination
Healthcare Facility or the country of use. If you are uncertain, you should seek advice from your local Infection Control Specialist. The 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. -
Page 21: Routine Maintenance
Huntleigh will make available on request service manuals, component parts lists and other information necessary for Huntleigh trained personnel to repair the system. 10.1.3 Service Period Huntleigh recommend that the Hydroven 3 pump is serviced every 12 months by a Huntleigh authorised service agent. 10.2 Hydroven 3 Pump 10.2.1... -
Page 22: Trouble Shooting
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” . Instructions For Use... -
Page 23: Accessories
56 cm 5101A68 Full Arm 68 cm 44 cm 62 cm 5101A78 Full Arm 78 cm 44 cm 62 cm Hydroven 3 Leg Garment Order Code Type Length (L) Circumference 5103L50 Half Leg 50 cm 61 cm 5103L66 Full Leg... - Page 24 Inserts Hydroven Garment Insert Pieces (to fit Hydroven 1 and 3 Garments) Order Code Type Length (L) Circumference Circumference Wide End Narrow End 510LI50 Half Leg 50 cm 19 cm 14 cm 510LI66 Full Leg 66 cm 19 cm 14 cm 510LI71 Full Leg 71 cm 19 cm 14 cm 510LI76...
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Page 25: Specifications
Equipment not suitable for use in the presence of application in the presence a FLAMMABLE ANAESTHETIC MIXTURE WITH of a flammable anaesthetic AIR, OXYGEN OR NITROUS OXIDE 13.2 General Model Hydroven 3 Part Numbers 510001 510009AU Australia & New Zealand 510009ZA South Africa & India Pressure Range 30 - 100 mmHg ±... -
Page 26: Environmental
13.3 Environmental Condition Temperature range Relative Humidity Atmospheric Pressure Operating 5°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 27: Product Labelling
14. Product Labelling Symbols Hydroven 3 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). - Page 28 Medical Device Cardboard packaging can be recycled. Cleaning Symbols Wipe surface with damp Use solution diluted to 1000 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 Instructions For Use...
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Page 29: End Of Life Disposal
15. 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. Instructions For Use... -
Page 30: 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 31 This section is only applicable to United Kingdom (UK) market when UK marking is applied to the Arjo medical device labelling. UK Symbol: UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approval Body supervision. UK Responsible Person &...
- Page 32 In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located. Manufactured for Huntleigh Healthcare Ltd on behalf of; ArjoHuntleigh AB Hans Michelsensgatan 10 www.huntleigh-diagnostics.com/...
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