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Summary of Contents for Arjo Huntleigh WoundExpress
- Page 1 INSTRUCTIONS FOR USE ™ WoundExpress WoundExpress Therapy Device 785344EN-2...
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Page 2: Table Of Contents
Contents 1. Safety ................3 1.1 Warnings ....................3 2. Introduction ..............5 2.1 Intended Use ..................5 2.2 About the WoundExpress Therapy Device ........5 2.3 Use Environment ................5 3. Clinical Applications ............6 3.1 Indications ................... 6 3.2 Contraindications ................ - Page 3 9. Routine Maintenance ............18 9.1 WoundExpress Therapy Device ............18 9.1.1 Maintenance ......................18 9.1.2 Servicing ........................18 9.1.3 Service Period ......................18 9.2 WoundExpress Therapy Device Pump ..........18 9.2.1 General Care, Maintenance and Inspection .............18 9.2.2 Serial Labels ......................18 10. Trouble Shooting ............19 11.
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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 Electrical equipment may be The mains power socket/ hazardous if misused. There plug must be accessible at all are no user-serviceable parts times. To disconnect the pump inside the pump. The pump’s completely from the electricity case must only be removed supply, remove the plug from by authorised technical the mains power socket.
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Page 6: Introduction
Introduction The WoundExpress Therapy Device is a system consisting of a pump and garment which operates by using low pressure air to deliver a compression therapy. 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. -
Page 7: Clinical Applications
Clinical Applications Indications Intermittent Pneumatic Compression (IPC) is effective in the treatment of the following clinical condition when combined with an individualised monitoring programme: • Chronic wounds including leg ulcers (venous leg ulcers and mixed aetiology leg ulcers). IPC may also be benefi cial in the management of: •... -
Page 8: 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 signifi cant limb oedema or any condition where an increase of fl... -
Page 9: Preliminary Checks
Preliminary Checks Contents (supplied with each system) Item Item 1 x WoundExpress Therapy Device 1 x Instructions for Use 1 x Quick Reference Guide 1 x WoundExpress Diary Delivery Inspection Huntleigh takes every precaution to ensure that goods reach you in perfect condition. However, accidental damage can occur in transit and storage. -
Page 10: Clinical Treatment Guide
Clinical Treatment Guide The WoundExpress Therapy Device has a preset pressure of 60mmHg. The recommended therapy time is 2 continuous hours per day. A diary is included with the pump for the patient to complete, to monitor concordance with the therapy. Note Loss of mains power will halt therapy. -
Page 11: Pump Description
Pump Description Item Description Function On/Off Switch Operation of this switch Starts or Stops the system Status Indicator Indicates the pressure in the garment Tube connectors For garment attachment (3A and 3B) Carry Handle For easy handling of the pump Power status LED Indicates the power status of the pump Note... -
Page 12: Status Indicator Description
Status Indicator Description Normal Operating Range Rest and Off Error Refer to Service Status Indicator 1. The sand timer symbol indicates that the device is not currently delivering a compression cycle. This can be during the 2 minute rest phase, or when the device is turned off. -
Page 13: Operation
Operation Garment Description The garment Inner and Outer panels are made from a laminate of brushed polyester and Polyurethane foam. The outer edges of the garment are ‘fi nished’ with a sewn nylon binding with a nylon thread. The garment has a hook and loop fastener to enable adjustable fi tting. Air is delivered to the 3 bladder chambers through PU tubing connector via grommets in the bladders. - Page 14 Fit the garment to the thigh (left or right) of the limb affected by the chronic wound. Ensure it is a snug fi t and fasten using the velcro strip. WoundExpress WE100G 05051968040374 Designed in the UK Assembled in China Tubing Connector to the Pump Attach the garment tubing to the pump.
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Page 15: Switching On
Note Ensure that the garment is applied correctly before switching the pump on. 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. WARNING Patients must not walk or stand when wearing leg garments. -
Page 16: Therapy
Therapy During therapy the user should lie down or sit with the leg elevated. Check that the garment remains snugly in place and does not move down the leg, reposition as necessary. Check occasionally to ensure the pump is running its normal cycle and is reaching a pressure in the green zone on the gauge on top of the pump. -
Page 17: Switching Off
Switching Off Turn the power switch (1) to the off (O) position. Turning the power off will stop the patient therapy. Note If it is required to completely isolate the pump from the mains power, remove the plug from the mains power socket. Removing the Garment Make sure the pump power switch (1) is in the off (O) position and disconnect the tubing from the pump by removing the tube connectors (3). -
Page 18: Decontamination
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 19: Routine Maintenance
Routine Maintenance WoundExpress Therapy Device 9.1.1 Maintenance The equipment has been designed to be maintenance-free between service periods. 9.1.2 Servicing Huntleigh will make available on request service manuals, component parts lists and other information necessary for Huntleigh trained personnel to repair the system. 9.1.3 Service Period Huntleigh recommend that the WoundExpress Therapy Device pump is serviced every... -
Page 20: Trouble Shooting
10. Trouble Shooting If you should encounter a problem, please follow the fault fi nding guide below. If the fault cannot be rectifi ed, please refer to Service. Fault Check Remedy Pump does not Is power switch on? Check switch. operate. -
Page 21: Accessories
11. Accessories WARNING: Use only recommended accessories listed in this manual. Accessory Order Code WoundExpress Therapy Device Garment WE100G... -
Page 22: Specifi Cations
12. Specifi cations 12.1 Equipment Classifi cation Class II, Double Insulated Type of protection against electric shock Type BF Degree of protection against electric shock Continuous Mode of operation Degree of protection against IP21 - Protection against ingress of solid objects more solid and liquid ingress than 12.5mm diameter and water droplets falling vertically. -
Page 23: Environmental
12.3 Environmental Condition Temperature range Relative Humidity Atmospheric Pressure Operating 10°C to 40°C 30% to 75% 700 to 1060 hPa (41°F to 104°F) (non condensing) 10°C to 40°C 20% to 95% 700 to 1060 hPa Storage and transport (50°F to 104°F) (non condensing) (Long term) Storage and... -
Page 24: Product Labelling
13. Product Labelling Symbols WoundExpress Therapy Device is Class II, double insulated according to the defi nitions in BS EN 60601-1:1990 Applied parts are type BF according to the defi nitions in BS EN 60601- 1:1990 Refer to this document (Instructions for Use) for a description of the product classifi... -
Page 25: Electromagnetic Compatibility
14. Electromagnetic Compatibility Make sure the environment in which WoundExpress Therapy Device 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. - Page 26 Guidance and Manufacturer’s declaration - electromagnetic immunity The WoundExpress Therapy Device is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the WoundExpress Therapy Device should assure that it is used in such an environment.
- Page 27 Recommended separation distances between portable and mobile RF communications equipment and the WoundExpress Therapy Device The WoundExpress Therapy Device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the WoundExpress Therapy Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the WoundExpress Therapy Device as recommended below, according to the maximum output power of the communications equipment.
- Page 28 Guidance and Manufacturer’s declaration - electromagnetic immunity The WoundExpress Therapy Device is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the WoundExpress Therapy Device should assure that it is used in such an environment.
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Page 29: End Of Life Disposal
15. End of Life Disposal This symbol signifi es 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 30: Warranty & Service
16. Warranty & Service Huntleigh Healthcare Diagnostic Products Division standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service Returns If for any reason the WoundExpress Therapy Device has to be returned, please: •... - Page 32 As a proud member of the Arjo family, we have been committed to supporting healthcare professionals in improving outcomes and enhancing patient wellbeing since 1979. We do this through our proven solutions for Vascular Assessment & Treatment and Fetal & Patient Monitoring. With innovation and customer satisfaction as our guiding principles, we strive for clinical excellence and improved performance, for life.
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