U S E R M A N U A L Contents Page 1. Explanation of Labels Symbols and Statements ..............2 2. Introduction ........................3 3. Important Information ......................3 Intended Use ........................3 Intended Environments ....................3 Contraindications for Use ....................3 List of Components ......................
V E N T U R I M I N O ® 1. Explanation of Label Symbols and Statements YYYYMMDD Warning 12345 1234567890 Example of a UDI label 0 5060178 XXXXX X Refer to instruction manual YYMMDD / booklet 1234567890 Medical Devices Directive 93/42/EEC This is a statement that alerts the Medical Device Regulation 2017/745...
2. Introduction Thank you for choosing to use the VENTURI MINO Negative Pressure Wound Therapy (NPWT) system from Direct Healthcare Group. The VENTURI MINO NPWT system is indicated for use in a wide range of patients with acute or chronic wounds.
• The VENTURI MINO TG600/14 vacuum power unit must only be used with the approved power adapter supplied by Direct Healthcare Group (see Specification on page 12) • The VENTURI MINO NPWT system (Vacuum power unit and power adapter) is not used in the presence of flammable anesthetics or in an oxygen enriched environment.
4.1 Getting Started NB. A Wound Care Set must be used with the VENTURI MINO system to carry out NPWT (see page 4 for available options). Please refer to the ‘Wound Care Set Instructions for Use’ leaflet (supplied with Wound Care Set) for dressing application and setup.
Pressing the RUN/STOP/UNLOCK button will also illuminate the display screen for 10 seconds. The VENTURI MINO power unit is suitable for ambulatory use at the advice of a Physician and is supplied with a carry bag which can be worn on the shoulder, across the body or around the waist. When placing the power unit in the carry bag, make sure that it is oriented so that the tubing exits the top of the bag without kinking, bending or straining against the connector port to ensure correct operation.
• Charge status is shown on the display of the power unit when it is in operation. • The power adapter will display a green light when delivering a charge to the VENTURI MINO power unit. • The battery is not serviceable and cannot be removed, changed or replaced.
6. Care and Maintenance 6.1 Power Unit Always disconnect the VENTURI MINO power unit from the power adapter and the power adapter from the power source before carrying out cleaning. Check all electrical connections and power cord for signs of excessive wear. The power unit / power adapter can be wiped down with detergent or disinfectant solution or wipe*.
U S E R M A N U A L 7. Fault Finding The VENTURI MINO power unit features audible and graphic indicators to alert when user intervention is required. Once corrective action has been taken the alert will self-cancel and normal operation will resume.
10246 The above mains adapter is considered part of the ME equipment. The VENTURI MINO power unit must only be used with the specific external power adapter as supplied by Direct Healthcare Group. EXPECTED SERVICE LIFE: The expected service life of the medical device and its ACCESSORIES is two years.
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U S E R M A N U A L 8.5 EMI/EMC Statement and Manufacturer’s Declaration This equipment has been tested and found to comply with the limits of EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in both a medical and residential environment.
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V E N T U R I M I N O ® Declaration – Electromagnetic Emissions Guidance and Manufacturer’s Declaration: Electromagnetic Emissions (IEC 60601-1-2) Emissions Test Compliance Electromagnetic Environment - Guidance RF emissions Class B CISPR 11 The VENTURI systems are suitable for use in all establishments, including domestic establishments Harmonics emissions Class A...
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U S E R M A N U A L Declaration – Electromagnetic Immunity Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2) IEC 60601 Test Electromagnetic Immunity Test Compliance Level Level Environment - Guidance 3 V rms 3 V rms Field strengths from fixed RF 150 kHz ~ 80 MHz transmitters as determined by...
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PRESSURE ULCER PREVENTION SAFE MOVING & HANDLING SPECIALIST THERAPIES BATHROOM SAFETY RENTAL & SERVICE SOLUTIONS Direct Healthcare Group Ltd Withey Court, Western Industrial Estate Caerphilly, United Kingdom CF83 1BF T: +44 (0) 800 043 0881 F: +44 (0) 845 459 9832 E: info@directhealthcaregroup.com Talley Group Ltd Premier Way...
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