Related Manuals for Hartmann Vivano Tec Pro
Summary of Contents for Hartmann Vivano Tec Pro
- Page 1 Vivano ® Negative pressure unit IFU_4095080_0302884_190824_EN.indd 1 IFU_4095080_0302884_190824_EN.indd 1 19.08.24 12:31 19.08.24 12:31...
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Page 2: Table Of Contents
Table of Contents Important safety instructions Contraindications ..................5 Warnings . - Page 3 Table of Contents Negative pressure therapy Setting the negative pressure ............... . . 26 7�1�1 Continuous mode �...
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Page 4: Important Safety Instructions
CAUTION! 1. Important safety instructions The VivanoTec Pro negative pressure unit is designed in accordance with IEC 60601-1 / EN 60601-1� The negative pressure unit and the supplied power supply constitute a medical electrical system with Class II protection� Please note the environmental conditions as stated in the technical data (see chapter Technical data)�... -
Page 5: Contraindications
IMPORTANT: The VivanoTec Pro negative pressure unit may only be used together with components of Vivano System by PAUL HARTMANN AG� 1.1 Contraindications Contraindications for the use of the Vivano System: • Malignant tumour wounds • Non-enteric/unexplored fistulas • Untreated osteomyelitis • Necrotic tissue NOTE: For more information on a particular contraindication, please refer to the Warnings and Precautions sections of this document�... -
Page 6: Special Precautions
Non-enteric/unexplored fistulas Application of the wound dressing on non-enteric or unexplored fistulas is contraindicated, as it may damage the intestinal structures and/or organs� Untreated osteomyelitis Application of the wound dressing in wounds with untreated osteomyelitis is contraindicated, as it may result in the spreading of the infection�... -
Page 7: Electrical Safety
potential contact of intestinal content with the wound, enteric fistula needs to be surgically separated, following local guidelines or established surgical practices� Spinal cord injuries with the development of autonomic hyperreflexia Discontinue the negative pressure wound therapy if the patient has spinal cord injuries with the development of autonomic hyperreflexia�... -
Page 8: Patient Population
Resterilization Components of the Vivano System that are provided sterile are meant for single use� Do not resterilize any of these components as it may cause overall decline in the therapeutic efficiency of the kit and potentially lead to wound contamination and/or infection�... - Page 9 NOTE: For more information related to bleeding in the context of negative pressure wound therapy, please refer to the Bleeding section of this document� Disconnection from the VivanoTec Pro unit The decision on how long the patient can be disconnected from the VivanoTec Pro unit is a clinical assessment that has to be made by the attending physician�...
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Page 10: Incident Reporting
Reprinting, even of excerpts, is permitted only with the written consent of PAUL HARTMANN AG� The operating instructions must always be kept in the vicinity of the device� Cleaning, care and inspection as well as correct operation ensure the operational safety and capability of the VivanoTec Pro negative pressure unit and are... -
Page 11: Intended Use
� 3, 4 VivanoTec Pro is only intended for use in conjunction with the Vivano System by PAUL HARTMANN AG� NOTE: To establish a functional negative pressure wound therapy dressing, at least the following further components are required: •... -
Page 12: Indications
3.3 Indications The Vivano System is used in wounds with injured tissue to support healing by secondary intention� VivanoMed Foam may be used on intact skin and wounds healing by primary intention when direct contact with the underlying structure is prevented by a suitable wound contact layer� VivanoTec Pro is used to establish controlled negative pressure at the site of an acute or chronic wound�... -
Page 13: Transport And Storage
3.5 Transport and storage The negative pressure unit must only be transported and stored in the VivanoTec Pro carry case� Transport damage must be immediately documented and reported� > Before shipping the negative pressure unit, package it in the supplied plastic bag with transparent closure�... -
Page 14: Symbols On The Vivanotec Pro Negative Pressure Unit And Power Supply
Symbols on the VivanoTec Pro negative pressure unit and power supply Follow instructions for use Temperature limit Medical device Humidity limitation Manufacturer Atmospheric pressure limitation Date of manufacture Type BF applied part Protected against solid objects with a diameter of 12,5 mm and IP22 Catalogue number against vertically falling drops of... -
Page 15: Set-Up And Initial Operation
4. Set-up and initial operation 4.1 Overview of the device Front side Touchscreen (touch-sensitive display) On/Off switch Exudate canister (not part of scope of delivery) Exudate canister unlock key Connector Side view Hanger bar Charging socket USB port Rear side Exudate canister unlock key Exudate canister connections Type plate... -
Page 16: Keys And Symbols
4.2 Keys and symbols The VivanoTec Pro negative pressure unit is equipped with a touchscreen� The device is operated by tapping and touching the keys on the touchscreen� Keys Designation Function Press the switch for 2 seconds� Switches the negative pressure unit on On/Off switch or off�... -
Page 17: Symbols
Symbols Symbol Definition Displays the battery charge level� Battery charging Key lock enabled Key lock disabled Leakage indicator� This symbol is only visible when the pump is running� Slowly pulsating green symbol -> no leaks in system Quickly pulsating green symbol ->... -
Page 18: Installation Site And Position Of The Negative Pressure Unit
IMPORTANT! • Unpack the negative pressure unit carefully� • Hold the negative pressure unit securely and do not allow it to fall� • Only operate the negative pressure unit using the original power supply supplied� • Time required from minimum or maximum storage temperature to usage temperature is at least 2 hours�... -
Page 19: Hanger Bar
INFORMATION The negative pressure unit signals when the battery charge is low� A warning message appears on the touchscreen (see chapter Warning messages)� If the battery is too low, the negative pressure unit switches off automatically� Hanger bar Attaching the negative pressure unit using the hanger bar VivanoTec Pro can be easily attached using the hanger bar�... -
Page 20: Carry Bag
Attaching the negative pressure unit to the patient’s bed > Unhook the strap clip and hook in the clip � > Place the loop around the bed rail and close it� Carry bag > Insert the negative pressure unit with the installed 300 ml exudate canister into the carry bag�... -
Page 21: Removing The Exudate Canister
Removing the exudate canister Connecting/removing > Removing the exudate canister (see chapter the negative pressure unit to/from the wound dressing)� > Press the blue unlock key on the negative pressure unit� > Slightly tilt the exudate canister and remove it� >... -
Page 22: Basic Functions
Disposal > Before disposal, break off the stopper from the connector and plug it onto the exudate lumen � This ensures that no exudate can escape from the canister. 5. Basic functions The activities in this chapter may be carried out only by a physician or a qualified person� 5.1 Switching the negative pressure unit on and off Switching the negative pressure unit on >... -
Page 23: Checking For Correct Function Of The Display
5.3 Checking for correct function of the display > Start the therapy without an exudate canister� > Manually cover the left opening on the rear side of the device� The warning message “Exudate canister full” appears after a few seconds. 5.4 Key lock Automatic key lock The VivanoTec Pro negative pressure unit has an automatic key lock�... -
Page 24: Language
6.1 Language > Tap on Language in the settings menu Language selection menu appears. > Tap on the required language� The language is marked with a checkmark. > Using the keys, scroll to the next page with more languages� >... -
Page 25: Filtering The Event History
The factory settings are not restored. The main menu is displayed again. 6.5 USB port The USB port may be used only by the staff of PAUL HARTMANN AG for data transfer� No other USB device may be connected to the VivanoTec Pro negative pressure unit�... -
Page 26: Negative Pressure Therapy
7. Negative pressure therapy The activities in this chapter may be carried out only by a physician or a qualified person� Two therapy modes are available: > Continuous mode > Intermittent mode Continuous mode The factory setting is 125 mmHg in continuous mode� Generally the most recent settings are always stored�... -
Page 27: Starting The Therapy
IMPORTANT! Tapping on the key closes the intermittent menu and saves the values� If the new values are not to be saved, wait without touching the touchscreen until the display switches to the main menu� Setting the values 7.2 Starting the therapy CAUTION! To achieve the correct negative pressure in the system as set, before starting the therapy ensure that all connections are correctly made and that all therapy parameters have been set�... -
Page 28: Automatic Switch-Off
Prioritisation of the warning messages is in accordance with the following table, in decreasing priority� Automatic switch-off If no power supply was connected despite repeated “Battery discharged!” warning messages, the negative pressure unit switches itself off Automatic switch-off automatically 1 minute after the warning message� The device will automatically switch off in a few minutes. -
Page 29: Leakage
The negative pressure unit is no longer functioning correctly and is possibly damaged� Technical defect > The negative pressure unit is no longer in an operational condition� Return it to your specialist dealer or to PAUL HARTMANN AG for checking and repair� Please send back for service. Exudate canister full The delay until this warning message condition is determined is 2 - 47 seconds (+/-1 second)�... -
Page 30: Battery Discharged
The negative pressure unit is no longer functioning correctly and is possibly damaged� Impact > The negative pressure unit is no longer in an operational condition� Return it to your specialist dealer or to PAUL HARTMANN AG for checking and repair� Please send back for service. > Tap on the key�... -
Page 31: Battery Service Life Exceeded
Battery service life exceeded When the useful life of the rechargeable battery has been reached, a warning message appears each time the negative pressure unit is Battery Service Life Exceeded switched on� Have the battery replaced by the manufacturer as soon as possible to avoid a loss of function�... -
Page 32: Leakage
Leakage This warning message is displayed if the system detects a leak which cannot be compensated for by the negative pressure unit� Leakage > Notify your attending physician or nursing staff immediately� > Tap on the key� The warning message is suppressed for 5 minutes 1. -
Page 33: Device Inactive
Device Inactive This warning message appears if the therapy has not been started within the previous 30 minutes� Device Inactive > Notify your attending physician or nursing staff immediately� No therapy has been running for 30 minutes Battery service life exceeded This warning message will be displayed if the average lifetime of the storage battery is reached�... -
Page 34: Cleaning And Care Instructions
10. Cleaning and care instructions 10.1 Basic information IMPORTANT! • Some disinfection solutions can cause discolouration of the plastic surfaces� Avoid the ingress of fluids� • Please use disposable gloves at all times when carrying out all work� • All surface disinfectants listed in Chapter 10�3 “Recommended disinfectants”, are suitable for disinfection�... -
Page 35: Cleaning And Disinfecting
10.2 Cleaning and disinfecting IMPORTANT! • Fluids in the internal parts of the device can damage the negative pressure unit and the power supply� > The device and the power supply must never be autoclaved, rinsed under running water or immersed in liquids�... -
Page 36: Hygiene Plan
10.4 Hygiene plan What Type When VivanoTec Pro Manual cleaning by wiping Manual disinfection by wiping VivanoTec Exudate Canister Single-use product, not suitable for reprocessing� Replace after use VivanoTec Shoulder Strap Single-use product, not suitable for reprocessing� Replace after use VivanoTec Bag Single-use product, not suitable for reprocessing�... -
Page 37: Handling Of Rechargeable Batteries
CAUTION! Service is not intended during therapy� Operational and functional faults which cannot be rectified by the measures set out in the chapter “Rectifying malfunctions”� Measures to be taken when sending in the negative pressure unit If the negative pressure unit needs to be sent in after consultation with the manufacturer or an authorised service partner, the following points must be observed: >... -
Page 38: Rectifying Malfunctions
Change unit and the exudate canister� the exudate canister if necessary� Battery service life exceeded The battery must be replaced� Please contact HARTMANN Customer Service� IFU_4095080_0302884_190824_EN.indd 38 IFU_4095080_0302884_190824_EN.indd 38 19.08.24 12:31 19.08.24 12:31... -
Page 39: Technical Data
14. Technical data VivanoTec Pro The essential performance characteristic of the negative pressure unit is the Essential performance generation and maintenance of the set negative pressure (+ 7 %) or the generation of a warning message conforming with EN 60601-1-8 (for further information refer to Technical Data Sheet)�... - Page 40 Warning message signal 3 pulses of 200 ms and 150 ms pause, with 2�5 seconds separation sound pressure level: min� 47 dB (A) (measured in a hemisphere with a radius of 1 m) Transport and storage Temperature: -25 to +60 °C conditions Relative Humidity: 15 to 90 %, non-condensing Pressure: 700 hPa to 1060 hPa Ambient conditions in Temperature: +5 to +40 °C...
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Page 41: Disposal
15. Disposal Used in compliance with the operating instructions, the expected service life of the device is 5 years� It is assumed that regular thorough cleaning and disinfection of the negative pressure unit and its application components or the operation of the device are carried out in accordance with the operating instructions�... -
Page 42: Information Relating To Emc (Electromagnetic Compatibility)
16. Information relating to EMC (electromagnetic compatibility) • Medical electrical devices are subject to special precautionary measures with regard to EMC and must be installed in accordance with the EMC information described in the following� • Portable and mobile HF communication systems can influence medical electrical devices� •... -
Page 43: Guidelines And Manufacturer's Declaration - Electromagnetic Interference Immunity
16.2 Guidelines and manufacturer’s declaration – electromagnetic interference immunity Electromagnetic IEC 60601- Test Level Compliance Level Electromagnetic interference immunity Environment - Guidelines tests Electrostatic discharge ± 8 kV contact as test level Floors should be made of wood or (ESD) in accordance discharge concrete or covered with ceramic with IEC 61000-4-2... - Page 44 Electromagnetic IEC 60601- Test Compliance Electromagnetic interference immunity Level Level Environment - Guidelines tests Conducted = 3 V 3 V Portable and mobile radio devices should not interference in 150 kHz to be used closer to the VivanoTec Pro negative accordance with 80 MHz pressure unit, including the cables, than IEC 61000-4-6 = 6 V 6 V...
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Page 45: Recommended Protective Distances
Recommended protective distances Between portable and mobile RF telecommunications devices and the VivanoTec Pro negative pressure unit The VivanoTec Pro negative pressure unit is designed for operation in an electromagnetic environment in which the RF interference parameters are controlled� The user of the VivanoTec Pro negative pressure unit can help to avoid electromagnetic interference by adhering to the minimum prescribed distance between portable and mobile RF telecommunications devices (transmitters) and the VivanoTec Pro negative pressure unit –... - Page 46 IFU_4095080_0302884_190824_EN.indd 46 IFU_4095080_0302884_190824_EN.indd 46 19.08.24 12:31 19.08.24 12:31...
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Page 49: Warranty Certificate
17. Warranty certificate Warranty certificate 2-year warranty Vivano ® Serial no�: Purchase date: Dealer’s stamp / Signature Name: Address: Phone / Fax: Service If you need technical support, please contact: Distributor: Address: Phone / Fax: URL /E-Mail: IFU_4095080_0302884_190824_EN.indd 49 IFU_4095080_0302884_190824_EN.indd 49 19.08.24 12:31 19.08.24 12:31... - Page 50 IFU_4095080_0302884_190824_EN.indd 50 IFU_4095080_0302884_190824_EN.indd 50 19.08.24 12:31 19.08.24 12:31...
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- Page 52 PAUL HARTMANN AG Paul-Hartmann-Straße 12 89522 HEIDENHEIM, GERMANY www�hartmann�info www.vivanosystem.info IFU_4095080_0302884_190824_EN.indd 52 IFU_4095080_0302884_190824_EN.indd 52 19.08.24 12:31 19.08.24 12:31...
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