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Warning: the external power adapter must comply with the

specifications listed in the specifications chapter in this manual.

1.11. A Gripping Handle.

1.12. External vacuum source tube.

2. Disposables

2.1. A wound discharge Collection Canister

2.2. Tubing

2.2.1. Distal Connecting Tube, a tube adapter attached to its distal end and an

Attachment drape.

2.2.2. Proximal Canister Tube.

2.3. Sponge.

The Sponge consists of a basal porous layer and a covering air-tight layer

(drape).

2.4. Drape Stripes.

Note: all items in the Vcare



system are suitable for use within the patient

environment.

Vacuum Operation Modes

The Vcare



system can be used to apply negative pressure in the following modes:

Cyclic-Continuous mode

– basic mode of operation. The neg. pressure oscillates

around a pre-determined value to a range of



20% of the baseline neg. pressure.

Intermittent mode

– advanced mode of operation, allows setting and adjusting

different system parameters. When using this mode of operation, it is highly

recommended to follow the clinical guidelines for recommended vacuum pressures

and wound dressing changes provided earlier in this manual.

Continuous mode - advanced mode of operation, allows setting and adjusting

different system parameters. Typically used following skin transplant applications.

When using this mode of operation, it is highly recommended to follow the clinical

guidelines for recommended vacuum pressures and wound dressing changes

provided earlier in this manual.

Содержание Vcare a Series

Страница 1: ...1 User Manual ...

Страница 2: ...ures enhances patient safety by regulating pressure at the wound site and warning possibility of uncontrolled bleeding Additionally the Vcare helps direct drainage to a specially designed canister that reduces the risk of exposure to exudates fluids and infectious materials Intended Use The Vcare is indicated for wound management via application of a pre set level of continuous or intermittent neg...

Страница 3: ...t and may result in serious injury For safe and proper operation of the Vcare system the safeguards below must be followed The operation of this product must be according to this manual No modification of the Vcare system is allowed without prior authorization of IVT Medical Ltd If this equipment is modified appropriate inspection and testing must be conducted by IVT Medical Ltd service personnel ...

Страница 4: ...ipe using an absorbent cloth Before reconnecting the unit make sure that the power connector is dry If the Vcare is not working properly contact IVT Medical or local authorized distributer Disposal o The Vcare unit must be returned to IVT Medical at the end of its operational life i e following 5 000 hours of the internal pump operation o All disposables Vcare wound dressing drapes collection cani...

Страница 5: ...ssure flaps and grafts Specifically the Vcare system is indicated to be used with the following wounds Chronic wounds o Wounds in diabetic and PVD affected limbs o Decubitus ulcers o Trophic ulcers o Venostatic arterial diabetic neuropathic post irradiation and pressure sores Dehisced and infected surgical wounds and complications of failed sternal closures Traumatic Wounds Deep and partial thickn...

Страница 6: ...its extensions and content should precede Vcare application The use of Vcare system is contraindicated in apparent anaerobic infection Vcare system is restricted to small and medium size burns as treatment of wide partial thickness and deep burns may lead to extensive extra cellular fluid loss and electrolyte imbalance by the applied suction Vcare system may be ineffective or contraindicated in ca...

Страница 7: ...quite environment with background noise of no more than 45 50dB A portable modality of utilization enables via a mobile stand IV intravenous medication administration by IV pump can be integrated with Vcare treatment The pump shall be hanged on IV pole that structured in the mobile stand or being placed on a flat surface that is higher than the Vcare unit Warnings regarding clinical application of...

Страница 8: ... wound Constant efficient negative pressure should be applied to the wound in order to avoid bacterial overgrowth and super infection If vacuum is ineffective for over 30 min aeration of the wound by removal of occlusive dressing or other form of ventilation should be considered The Vcare system should not be used in cases with apparent or suspected anaerobic infection Negative pressure may exacer...

Страница 9: ...values applied in an intermittent mode Dot not place the mold or apply vacuum over a healthy tissue Applying vacuum on healthy tissue may cause irritation and damage the skin Clinical Guidelines of the Vcare system The clinically based range of recommended vacuum pressure level range span frequency of operation mode and exchange of dressing in Vcare system for various conditions is presented in th...

Страница 10: ...n 60 120 intermittent use only 2 310 2 1 2 Correlate vacuum treatment with measured Ankle brachial pressure ratio Use lowest pressure possible in range Extremely greater negative pressure 140 100 mmHg may be applied for a few days for treating heavily infected wounds applying a 2 1 ratio of intermittent mode and frequent dressing changes Reduce pressure as soon as the wound becomes cleaner Evaluat...

Страница 11: ...Suction Pump Display Screen and Controls Internal Battery Disposables A disposable wound dressing kit includes o Wound dressing Sponge o Drape stripes o Distal connecting tube and hose adapter connecting between the attachment drape and the proximal canister tube Proximal canister tube connecting between the distal connecting tube and the collection canister Wound discharge collection canister inc...

Страница 12: ... the bottom of the Vcare unit there is a control panel that includes six buttons for controlling the software and adjusting the device and treatment settings EXT INT FUNC OP SET Attachment Drape Pump Tubing External Vacuum Source inlet On the back side Collecting Canister Control Keypad Power LED Alarm LED LCD Screen Power Switch on the left side Gripping Handle External Power adapter inlet On the...

Страница 13: ...tton has the following functions Set a flickering value While browsing throughout the menus the default value of each function is flickering on the screen By pressing OP SET the user sets the flickering value This will cause the value to stop flickering When the Stand by screen is displayed pressing the OP SET button will start or stop the vacuum operation The user can than choose to start working...

Страница 14: ...bols description Symbol Symbol Number Description 1 Standby displayed when no vacuum operation mode is applied Flickering when vacuum is paused in intermittent mode 2 Work Status displayed when one of the vacuum operation modes is operating cyclic continuous intermittent or continuous 3 Continuous Operation Status displayed when continuous vacuum is applied 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 11 b a...

Страница 15: ...2V 11 8V 2 bars 11 8V 11 37V 1 bar 11 37 10 96V 0 bars 10 96 10 8 9 Full Canister Status displayed when the canister is full and must be replaced 10 Canister Fill Status indicates the canister fill level Flickering eight full bars when high flow alarm is set a Primary numerical display In Set Up menu displays the adjustable value of the current function During vacuum operation displays the actual ...

Страница 16: ...n battery life An automatic charging facility switches to battery power when main power is off The Vcare unit shall be connected to an approved medical grade AC DC adapter UL TUV or CSA certification is required Note When connected to the external power adapter the Vcare apparatus is considered as ME SYSTEM refer to IEC 60601 1 The power adapter must comply with the specifications described below ...

Страница 17: ...pply negative pressure in the following modes 1 Cyclic Continuous mode basic mode of operation The neg pressure oscillates around a pre determined value to a range of 20 of the baseline neg pressure 2 Intermittent mode advanced mode of operation allows setting and adjusting different system parameters When using this mode of operation it is highly recommended to follow the clinical guidelines for ...

Страница 18: ...it are not covered or blocked If the device is connected to mobile stand there is a need to make sure that it is securely connected to the mobile stand and that the lock pin is closed The Vcare unit and tubing should be placed in a visible location in order to enable direct eye contact with the system and enable early detection of bleeding and or effective vacuum application to the treated area Co...

Страница 19: ...off the device using the main power switch 2 Disconnect the proximal tube from the distal tube 3 Press the canister release button hold the canister gently and pull it upwards in order to take it off its socket 4 Seal the canister through the proximal connecting tube using the tube lid 5 Discard the canister and tubing according to the hospital and bio hazard protocols Insert a new collection cani...

Страница 20: ...wound edges for better sponge and drape stripes attachment 6 Remove the taping from the drape stripes and use them to attach the sponge edges to the wound surrounding tissue It is recommended to cover 3 5 cm of surrounding intact skin Make sure that the drawing on the top of the drape is visualized visual regulation 7 Choose the location to apply the distal tube and attachment drape The location s...

Страница 21: ...sitioning of the Vcare unit on the mobile stand 1 Hold the Vcare with one hand by its carrying handle when its LCD screen faced toward the front of the mobile stand 2 Slide the Vcare by its external plate on the shelf track that placed on the upper side of the mobile stand 3 Pull the pin lock until the external plate is properly inserted into the shelf track 4 In order to complete its positioning ...

Страница 22: ...cifications section in this manual Warning Do not connect the unit to a damaged external power adapter Note In order to work in Battery mode make sure that power adapter is not connected Warning The internal battery is not accessible for users In case that battery malfunction is suspected during warrantee period contact IVT Medical Ltd The Power indication LED is lit 2 Turn the Vcare unit on using...

Страница 23: ...tand by is displayed in the first line Pre set neg working pressure is displayed in b pressure units are displayed in c vacuum source is displayed in d and symbol no 1 is displayed on the screen The user is instructed to press OP SET to start the vacuum operation 3 5 Working mode screen As the user starts the vacuum operation the working mode screen is displayed during treatment The working mode s...

Страница 24: ...rough the treatment setting mode default values of the treatment parameters will flicker in the first text line The other displayed values are recommended treatment values except for the risk of bleeding parameter The second line displays guiding messages to help the user in choosing the appropriate treatment settings At any stage of treatment setting when a flickering value is displayed press the...

Страница 25: ... Cyclic Cont Operation Mode 50 40 50 75 40 50 75 100 125 As the Risk of Bleeding is set to High or Moderate for the safety of the treatment Max Flow and Alarms will be limited to the default values of 100 ml hr and Audio Visual respectively Use the up and down scroll arrow buttons in the control panel to change the flickering value and determine the evaluated Risk of Bleeding Press the OP SET butt...

Страница 26: ...peration When entering the Mode of Operation function the following screen is displayed Insert printout The default mode of operation Cyclic Continuous mode is flickering There are two optional modes of operation Intermittent or Cyclic Continuous Use the up and down scroll arrow buttons in the control panel to change the flickering mode to the required mode of operation The guiding messages in the...

Страница 27: ...The pressure will be displayed on the screen Use the UP and Down scroll arrow buttons in the control panel to change the displayed value Press OP SET button to finalize your selection The value stops flickering It is recommended to use external vacuum source as possible When using the internal pump in cyclic continuous mode the pump will pause for 1 minute every 10 minutes of operation Following t...

Страница 28: ... 80 100 No limit 30 200 Use the up and down scroll arrow buttons in the control panel to change the flickering value and determine the required Working neg Pressure Press OP SET to finalize your selection The value stops flickering For advanced pressure setting press FUNC shortly The working neg pressure value will be displayed in a Use the up and down scroll arrow buttons in the control panel to ...

Страница 29: ...s to continue to the next parameter Warning do not set low values of lower limit in order for the system to detect improper vacuum applied to the wound In case the pressure applied by the device will be lower than the lower limit value an alert will be generated see the Alarms chapter for more details 5 1 3 2 3 Upper Limit When entering the Upper Limit function the following screen is displayed In...

Страница 30: ...ill be higher than the upper limit value an alert will be generated see Alarms chapter for more details 5 1 3 2 4 Working Time Determination When entering the Working Time determination function the following screen is displayed Insert printout Common working time values are displayed in the first line 1 5 minutes The default working time value 3 min is flickering Use the up and down scroll arrow ...

Страница 31: ...n entering the Pause Length determination function the following screen is displayed Insert printout Common pause time values are displayed in the first text row 0 3 minutes The default pause time value 1 min is flickering Use the up and down scroll arrow buttons in the control panel to change the flickering value and determine the required pause time Press OP SET button to finalize your selection...

Страница 32: ...wed from the patient s wound to the Vcare canister In order to respond immediately in case of bleeding the default and recommended value for maximal flow is up to 100 ml hour If a patient s wound is treated using liquids which need to be collected to the canister as part of the treatment procedure and there is no risk of bleeding Low according to the physician a higher value can be determined 200 ...

Страница 33: ...tion screen press FUNC for approximately 5 seconds in order to enter System Set Up Screen While setting treatment parameters symbol no 6 appears on the screen as an indication Using the control panel in system set up menu At any stage of system set up when a flickering value is displayed press shortly on the control panel OP SET button in order to select the displayed value for the current treatme...

Страница 34: ...rms indication will be only visual flickering indication light and general alarm symbol A relevant message will be displayed on the screen 5 2 2 2 A V Audio and Visual alarms In any case which necessitates alarm generation the indication will be both auditory A repetitive beeping sound and visual flickering indication light and general alarm symbol along with a relevant message In order to monitor...

Страница 35: ...control panel to change the flickering value and determine the systems pressure units mmHg or KPa Press OP SET to finalize your selection The value stops flickering Press Down Scroll arrow to continue to the next function 5 2 4 F4 Battery Voltage Display The current battery voltage in volts is displayed on the screen Press Down Scroll arrow in order to continue to the next function 5 2 5 F5 Total ...

Страница 36: ...structions guide 1 Verify that the wound doesn t actively bleed 2 Insert the collection canister into the canister socket sound 3 Connect the proximal canister tube to the collection canister 4 When using mobile stand make sure the Vcare unit is securely connected to the mobile stand and that the lock pin is closed 5 Connect the Vcare unit using a suitable power adapter see specifications chapter ...

Страница 37: ...ble o Auditory alarm repetitive beeping sound produced by a buzzer The beeping frequencies and inter burst intervals change according to alarm condition priority High and Low in order for the care giver to identify the priority of the alarm condition from distance and act accordingly In order to hear the auditory alarm the device must be operated in a quite environment with background noise of no ...

Страница 38: ...alarm is repeated after following these instructions contact your service provider 1 2 High flow alarm Description this alarm is initiated when the system detects that the accumulated liquids volume in the collection canister exceeds the pre defined maximal volume per hour In this case vacuum operation is automatically shut down and alarms are set High flow stops the vacuum operation It will not b...

Страница 39: ...ning 1 5 minutes from the high vacuum alert activation In this case vacuum operation is automatically shut down Priority High Visual alarm signal flickering red indication LED alarm signal no 1 general alarm signal from screen symbols description table Auditory alarm signal high frequency repetitive beeping sound Additional signals general warning status symbol no 7 from screen symbols description...

Страница 40: ...el vacuum If connected to external suction the Second line displays 1 Reduce external suction 2 to Working Pressure where 1 and 2 are presented one after the other for 5 seconds each To resolve this alarm Stop the vacuum operation Turn the Vcare unit off In case an external vacuum source is connected reduce the pressure from the external vacuum source to 10 mmHg above the working negative pressure...

Страница 41: ...f connected to an external vacuum source make sure that the pressure from the external vacuum source is above the working pressure In case the applied vacuum is 0 mmHg but the pump is working contact your service provider for hydro gel filter inspection In case this alarm is repeated after following these instructions contact your service provider Warning Do not leave a wound covered without effec...

Страница 42: ... the pump is working contact your service provider for hydro gel filter inspection In case this alarm is repeated after following these instructions contact your service provider Warning Do not leave a wound covered without effective vacuum for long time periods Warning failure to respond to this alarm may exacerbate wound infection 1 7 Low Battery alarm Description this alarm is initiated when ba...

Страница 43: ...resolved immediately low battery condition would eventually turn to Critical battery condition 1 8 Near Full Canister alarm Description The liquid volume in the collection canister is 650 ml Priority Low Visual alarm signal constant yellow indication LED alarm signal no 1 general alarm signal from screen symbols description table Auditory alarm signal low frequency repetitive beeping sound Additio...

Страница 44: ...t your service provider Vacuum operation stops automatically when the fluids level in the canister is 700 ml In case this alarm is repeated contact your service provider For further information regarding the alarm system please refer to the alarm appendix In case of mechanical or electronic failure of the device and for any query or improvement suggestion contact your service provider 2 Alert cond...

Страница 45: ... Alarm signals none Additional signals general warning status symbol no 7 from screen symbols description table Information sentences Second line 1 Caution Pressure is 2 below lower limit To resolve this alert Inspect the sponge drape stripes tubing and collection canister for possible leakage Make sure that the canister is positioned properly in the canister socket Make sure that the pressure fro...

Страница 46: ...on table the signals will appear only after 4500 hours of operation Information sentences First line Postpone Done Second line 1 Maintenance required 2 Refer to user manual To resolve this alert Contact IVT Medical Ltd for a certified technical personnel inspection of 1 Internal and external fuses inspection 2 Battery voltage measurement of maximal voltage and inspection for possible leakage and c...

Страница 47: ...rm is repeated contact IVT Medical Ltd certified technical personnel for inspection of the pressure regulation valves 3 3 Err02 Flow LEDs error Description the canister fill level bars display is based on the internal canister fill LEDs detection The device automatically tests each one of the 16 flow LEDs sensors functionality every time it is turned on In case the LEDs self test detects a failure...

Страница 48: ...vice provider o Turn off the device Insert a new empty canister into the canister socket Turn the device on o If error alert 02 is not displayed the sensors are not damaged and you may proceed with the vacuum operation o If error alert 02 is displayed turn the unit off and contact your service provider Vcare system specifications Technical Specifications Classification Medical Electrical system Vc...

Страница 49: ...ff Battery voltage continues dropping when the device is off Battery warrantee is provided by IVT Medical Ltd for one year from Vcare purchasing Internal suction pump Max Vacuum 650 mmHg 80 KPa Rated current 3 1A Ambient temperature 0 40 C Max operation hours 5 000 The Vcare unit must be returned to IVT Medical at the end of its operational life i e following 5 000 pump operation hours Therapy Adj...

Страница 50: ...p on time is 100 ms Low priority alarms Specifications Beep Pause 200 ms Beep Repeat every 5 minutes Beep on time is 200 ms Designed to Meet IEC 60601 1 8 External power adapter The Vcare unit can be connected to the main power supply through a power adapter The power adapter is not part of the Vcare device but it is mandatory to use it The power adapter must comply with the specifications describ...

Страница 51: ...Pressure 700 1060 hPa Operational Temperature Range 0 40 C Operational Relative Humidity Range 0 50 Operational Atmospheric Pressure 700 1060 hPa Prior to storage of the device make sure the battery is fully charged 14 9 Volt For short time periods the device can be stored in temperatures of 5 to 50 degrees Celsius In case the device has been stored in temperatures below freezing bring the system ...

Страница 52: ... for liquids and air transformation from one side of the sponge to the other The upper layer of the sponge is a non permeable polyurethane sealing drape that seals the wound together with the drape strips Drape stripes The Drape stripes are made of 3 layers the upper layer is made of LDPE Low Density polyethylene the middle layer is PU polyurethane and the bottom layer is glue The Sponge and Drape...

Страница 53: ...e 7 Use a clean and dry soft cloth to wipe the outer device surface 8 Do not use plastic solvents or abrasives Warning Fluids should not be allowed to enter into the device Do not use unnecessary liquids to clean the device If any liquids penetrate the device contact your local authorized provider Maintenance Procedures In order for the Vcare unit proper and safe operation routine maintenance and ...

Страница 54: ...tor s evaluation of the patient s Risk of Bleeding There are three possible such risks High Moderate and Low As the user chooses the appropriate Risk of bleeding based on his experience and judgment other treatment parameters are limited accordingly The user can set the parameters to default values or to a different value within a pre programmed range The parameters ranges and default values were ...

Страница 55: ...ation Electromagnetic Compatibility The Vcare must be connected to an external power adapter which meets the specifications listed in the specifications section of this manual The maximal cable length between the adapter and the Vcare unit is 1 8 m The power adapter must be connected to a 3 pin certified power cable according to institute regulation The maximal cable length should be 1 5 m Warning...

Страница 56: ... below The customer or the user of the Vcare device should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance Level Electronic Environment guidance Electromagnetic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air compliance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least ...

Страница 57: ... c mains voltage prior to application of the test level Guidance and Manufacturer Declaration Electromagnetic Immunity The Vcare device is intended for use in the electromagnetic environment specified below The customer or the user of the Vcare device should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance Level Electronic Environment guidance Portable an...

Страница 58: ... broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electronic site survey should be considered If the measured field strength in the location in which the Vcare device is used exceeds the applicable RF compliance level above the Vcare device should be observed to verify normal operation If abnormal p...

Страница 59: ... the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection form structures objects and people Definitions of symbols used Warning for possible hazard to system patient or operator Manufacturer Important Operation...

Страница 60: ...mmunications equipment that may interfere in the vicinity of the device Keep away from sunlight Certifies that a product has met European Union consumer safety health or environmental requirements Latex free Biohazard IVT Medical Ltd 16 Hatidhar St Ra anana 43665 Israel Phone 972 9 7463737 Fax 972 9 7604506 Obelis s a Bd Général Wahis 53 1030 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 ...

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