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1. VJ Medical Ltd Vcare X e Treatment of long standing unhealed wounds should be evaluated for possible malignancy by biopsy of ulcers e Treatment of Diabetic Foot Diabetic foot patients with an ankle brachial ratio less than 0 5 should be treated with the lowest effective negative pressure and should be closely monitored for distal perfusion impairment mainly when having circumferential vacuum wound dressing e Treatment of Contaminated Wounds High levels of negative pressure deeper vacuum may be needed for the initial treatment of heavily contaminated wounds e Treatment of Tissue Ischemia Tissue ischemia can be managed and avoided by short term higher negative pressure values applied in an intermittent mode e 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 a system The clinically based range of recommended vacuum pressure level range span frequency of operation mode and exchange of dressing in Vcare a system for various conditions is presented in the following table The practicing physician should recognize the need for specific settings for vacuum work pause ratio and the frequency of dressing changes adjusted to the varying clinical conditions for each individual wound Guidelines for clinical application of Vcare a system O The presented guidelines should be regarded as general recommendations o
2. vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz 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 Field strengths from fixed transmitters such as base station for radio a cellular cordless telephones and mobile radios amateur radio AM and FM radio 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 a device is used exceeds the applicable RF compliance level above the Vcare a device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Vcare a device Over the frequency range 150 kHz to 80 MHz field strengths should be less than Vi V m Recommended separation distances between portable and mobile RF communication equipment and the Vcare a device The Vcare a device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Vcare a device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile R
3. X W 6 7 cm Operation time 1 hour Charging time from critical to fully charged condition 16 hours O To avoid battery malfunction connect the Vcare a unit to an external power adapter when the device is turned off Battery voltage continues dropping when the device is off OQ Battery warrantee is provided by IVT Medical Ltd for one year from Vcare a purchasing Internal suction pum Max Vacuum 650 mmHg 80 KPa Rated current 3 1A Ambient temperature 0 40 C Max operation hours 5 000 0 The Vcare af unit must be returned to IVT Medical at the end of its operational life i e following 5 000 pump operation hours Therapy Adjustment Options Negative Pressure Range 30 200 mmHg Modes of Operation Cyclic Continuous Continuous or Intermittent External fuse Quick blow glass fuse 4A 250V External Wall Suction Tube 49 R VJ Medical Ltd Voare X Length 1 7 meters The external vacuum source connector can tolerate vacuum of up to 760 mmHg however the recommended input vacuum is max 200 mmHg Internal fuse Quick blow fuse 5A 250V Buzzer Manufacturer Mallory Sonalerts products INC Sound pressure range 10 cm 88 dB 1 m 70 qB High priority alarms Specifications Beep Pause 100 ms Beep Pause 100 ms Beep Pause 300 ms Beep Pause 100 ms Beep Pause 500 ms Beep Pause 100 ms Beep Pause 100 ms Beep Pause 300 ms Beep Pause 100 ms Beep Repeat
4. above the upper limit 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 above upper limit where 1 and 2 are presented one after the other for 5 seconds each To resolve this alert e Stop the vacuum operation Turn the Vcare aL unit off e If connected to an external vacuum source reduce the pressure from it 44 UV ST mecca Ltd e Restart the device In case this alarm is repeated after following these instructions contact your service provider O In order to confirm that the preset vacuum is actually applied to the wound it is recommended that together with the treatment operational setting the care provider should inspect the sponge to be evenly condensed squeezed wanina failure to respond to this alert may lead to High Vacuum alarm condition 2 2 Low Vacuum alert Description the applied neg pressure is below the lower limit Note as vacuum operation is initiated the low vacuum alert will be displayed on the screen until the working negative pressure stabilizes on the desired level unless it cannot be stabilized due to leakage 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 al
5. alarm e Inspect the sponge drape strips tubing and collection canister for possible leakage e Make sure that the canister is positioned properly in the canister socket e If connected to an external vacuum source make sure that the pressure from the external vacuum source is above the working pressure e Incase 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 wanina 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 Low Battery alarm Description this alarm is initiated when battery voltage is low and approximately 10 minutes of operation are left 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 Additional signals general warning status symbol no 7 low battery status symbol no 8 with 1 black bar from screen symbols description table Information sentences First line Low battery Second line connect to main source 42 Vcare q UVa Medical Ltd To resolve this alarm connect the Vcare a unit to the wall outlet using a suitable external power adapter se
6. and wound status should be monitored regularly according to the clinical condition of the wound 9 When the device is operated by the internal battery operation of approximately 1 hour is expected Alarms and Alerts Vcare a Alarm system The Vcare af system has two kinds of alarm signals o Visual alarm consists of an indication LED red yellow and of the following alarm condition symbol Alarm sumbol no 1 from the symbols description table 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 9 In order to hear the auditory alarm the device must be operated in a quite environment with background noise of no more than 45 500B For further information see buzzer specification in the specifications section The user is able to choose between a visual alarm and a visual amp auditory alarm signals 1 Alarm conditions 1 1 Critical battery alarm Description this alarm is initiated when battery voltage is too low to support operation of the system In this case vacuum operation is shut down and alarms are set Priority High en Vcare q R VJ Medical Ltd Vcare X Visual alarm signal flickering red indication LED alarm signal no 1 general alarm signal
7. bleeding determine the alarm limits 54 R VJ Medical Ltd Vcare X Alarm inactivation states The Vcare o system has two alarm indications audio and visual while the user can adjust the alarm indication to audio amp visual or visual e When the auditory alarm is off i e the user chose only Visual alarm signal the Audio off alarm signal alarm signal no 2 from screen symbols description table is constantly displayed on the screen during treatment In case that an alarm condition requiring alarm signal is generated the audio off signal will switch with the alarm condition signal alarm signal no 1 repetitively High priority alarms will generate both audio and visual alarms regardless to the user alarm setting Alarm system security The suction apparatus of the Vcare a is controlled by a firmware pre installed on the device s microcontroller The firmware cannot be modified or replaced by the user following its primary manufacturer installation Electromagnetic Compatibilit O The Vcare a 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 af unit is 1 8 m dd 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 A Warning Connecting the unit to power adapter and or cabl
8. description 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 Q To resolve this alert Contact IVT Medical Ltd for a certified technical personnel inspection of Internal and external fuses inspection N Battery voltage measurement of maximal voltage and inspection for possible leakage and corrosion Replacing the internal pump Inner hydro gel filter replacement Fluid trapped replacement Clear PVC tubes inspection and replacement if indicated Fan cleaning po Ta p RO Tightening of loose screws 9 Alarm Buzzer and LEDs inspection 10 Pressure sensors validation 11 Screws on the outer shell should be inspected for fatigue and replaced if necessary For further guidance and maintenance instructions refer to Maintenance chapter in this manual 46 m R VJ Medical Ltd Voare X Error alerts 3 2 Err01 Extreme High Vacuum Description this alert is initiated In case Extreme High Vacuum alarm is repeated more than 3 times is 24 hours Alarm signals none Additional signals general warning status symbol no 7 from screen symbols description table Information sentences First line Error Alert Err01 Postpone Done Second line Refer to user manual for details Q To resolve this alert e If connected to external suction make sure that
9. dry soft cloth to wipe the outer device surface 8 Do not use plastic solvents or abrasives wanina 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 a unit proper and safe operation routine maintenance and system components inspection is required The maintenance procedures should be done only by trained and authorized technical personnel Prior to operation Responsibility operator 1 Make sure that the external wall suction tube is not damaged and properly connected to the unit Inspect the unit for any signs of contamination If there is any sign of contamination clean the unit according to cleaning the unit section in this manual wanina do not connect the Vcare al unit to a damaged external power adapter Alarm appendix 53 R VJ Medical Ltd Vcare X Generation of alarm signal for two or more alarm conditions e When there are several conditions that require alarm signals the alarm system generates the signals of the highest priority alarm condition The text lines on the screen display information regarding the higher priority condition and the information symbols and measured value of each condition will be displayed on the screen e Ifthe alarm conditions are of the same priority the symbols and measured values of al
10. flickering value Press OP SET button to finalize your selection The displayed value stops flickering Press Func shortly to enter advanced settings in order to select one of the additional baseline pressures 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 e tis 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 e Following the determination of the Cyclic Continuous base line working neg pressure pressing will switch to the last function in this menu Start Working Pressing the OP SET button will transfer the user to the stand by screen see Main screens chapter Dl 9 2 Intermittent Continuous Mode 5 1 3 2 1 Working Negative Pressure Determination When entering the Working neg Pressure determination function the following screen is displayed Insert printout Common working neg pressure values are displayed in the first lime and the displayed default neg pressure value is flickering 21 UV ST mecca Ltd Risk for Bleeding High Vcare The available working neg pressure and default value are determined according to the Risk of Bleeding see the table below for detailed default working neg pressure and displayed valu
11. from screen symbols description table Auditory alarm signal high frequency repetitive beeping sound Additional signals general warning status symbol no 7 low battery status symbol no 8 with no black bars from screen symbols description table Information sentences First line Critical Battery Condition Second line Connect to main source To resolve this alarm connect the Vcare a unit to the wall outlet using a suitable external power adapter see specifications section and press OP SET to resume treatment Battery malfunction is expected if the system is not connected to an external power adapter immediately In case this 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 i High flow stops the vacuum operation OG lt will not be possible to re activate the device by pressing the OP SET button For re operation the device will have to be re started 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
12. 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 stripes are available in the following dimensions Sponge Size W L Drape Size W Drape Size L 100 x 100 mm 150x55 mm 150x55 mm 100 x 200 mm 150x55 mm 250x65 mm 150 x 200 mm 200x55 mm 250x65 mm 300 x 200 mm 350x65 mm 250x65 mm 400 x 450 mm 450x65 mm 500x65 mm A Y shaped connector is provided with the two large wound dressing sets Disposables storage conditions Store away from direct sunlight in a cool dry place Maintenance and routine inspections Cleaning the unit 52 m R VJ Medical Ltd Voare X D Cleaning and disinfection of the device between different patients is necessary and should be done in accordance with the guidelines below 1 Unplug the device from the external power adapter and external vacuum source 2 Inspect the unit for any signs of contamination 3 Gently wipe the LCD screen using a soft cloth and a designated LCD detergent The cloth should be damp but not dripping Using a soft cloth and 70 alcohol gently wipe down the outer surface of the device Use a low level cleaning agent or disinfectant and ensure its compatibility with plastics Follow manufacturer s guidelines for use of cleaning agents 6 Use another fiber free damp cloth to remove any remaining solution from the device surface 7 Usea clean and
13. symbol no 7 from screen symbols description table Information sentences First line Watch for possible bleeding Second line Turn off for reactivation 38 R VJ Medical Ltd Vcare X To resolve this alarm Turn the Vcare a unit off A physician must inspect the patient to find if there is active bleeding from the wound Therapy should not be re activated before an extensive physician inspection and re evaluation of active bleeding and the risk of bleeding from the wound If there are still signs for bleeding apply compressive pressure on the wound and evaluate the need for further intervention In case this alarm is repeated after following these instructions contact your service provider 1 3 Extreme High Vacuum alarm Description this alarm is initiated when the applied neg pressure is e 20 mmHg above upper limit for 30 seconds or e Above the upper limit but below upper limit 20 mmHg for 1 more minute meaning 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 table Information sentences First line Hazardous operation level S
14. the canister socket according to replacing the collection canister section in this manual o Turn onthe device and check if this error alert is repeated check for errors in the leds sensors 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 o Turn off the device e Insert anew empty canister into the canister socket e 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 a system specifications Technical Specifications Classification Medical Electrical system Vcare af unit Specifications e Operation mode Continuous e Applied part type BF sponge surrounding drape and drape stripes IPXO Not protected against harmful effects of water External power adapter e ULor TUV or CSA medical grade Power Adapter Vcare af unit Dimensions L 37 cm x H 22 8 cm x W 22 cm Weight 5 9 kg Input 15V DC MAX 3 3A Max Power consumption 75W Max Inlet vacuum 200 mmHg 26 7 KPa 48 R VJ Medical Ltd Voare X Internal battery Type Sealed lead acid battery Nominal Voltage approximately 12V Maximal voltage fully charged battery 14 9 V Rated Current 3 2A Dimensions L 13 4 cm X H 6 1 cm
15. the proximal canister tube e Proximal canister tube connecting between the distal connecting tube and the collection canister e Wound discharge collection canister includes means of protection and control 11 R VJ M eoical Ltd Vcare X The following image illustrates the Vcare a system External Fuse On the back side External Power adapter inlet Gripping External Vacuum Source inlet Handle On the back side On the back side Pump Power LED ee Alarm LED TT oe Tubing Buzzer Vearea Hose LCD ra cone adapter Attachment Power Switch Drape on the left Collecting Canister side i Control Keypad Sponge Vcare a Device Technical Operation Introduction Vcare a system components and functions 1 Vcare a Unit 1 1 Main Power Switch turn the Vcare a on off 0 1 1 2 An Internal Software controlled Suction Pump 1 3 Control Panel On the bottom of the Vcare a unit there is a control panel that includes six buttons for controlling the software and adjusting the device and treatment settings FUNC OP SET 12 UV ST mecca Ltd Vcare q 1 3 1 EXT defines the vacuum source to be external 1 3 2 INT defines the vacuum source to be the internal pump 1 3 3 FUNC this button has the following functions Long press in Menu Selection Screen entering System Set Up Menus screen Short press while setting parameters in treatment menu disp
16. value stops flickering Press to continue to the next parameter A rna do not set high values of upper limit in order for the system to detect improper vacuum applied to the wound O In case the vacuum applied by the device will 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 buttons in the control panel to change the flickering value and determine the required working time Press OP SET button to finalize your selection The value stops flickering For advanced work time setting press the FUNC button shortly The work time value will be displayed in a Use the up and down scroll arrow buttons in the control panel to change the displayed value and determine the required working 30 R VJ Medical Ltd Vcare X time The working time can be linearly adjusted in the range of 1 15 min Press OP SET button to finalize your selection The displayed value stops flickering Press to continue to the next parameter e See the Clinical guidelines for recommended intermittent treatment parameters e For an intermittent therapy the determined value is the lengt
17. F communications equipment transmitters and the Vcare a device as recommended below according to the maximum output power of the 58 Vcare q R VJ Medical Ltd Vcare X communications equipment Rated maximum Separation distance according to frequency of the output power of transmitter transmitter m 150 kHz to 80 80 MHz to 800 800 MHz to 2 5 GHz MHz 0 23 S 07 146 J233 O 3 6900 11 66 2333 For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter in watts w according to the transmitter manufacturer N OTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies N OTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection form structures objects and people D efinitions of symbols used Warning for possible hazard to Manaen system patient or operator Important Operational Information SN Serial Number Follow Instructions For Use REF Model Name Not for General Waste Direct Current Fuse Do not reuse Authorized Representative in the European Community Do not re sterilize This side up Batch lot number 59 Medical Equipment classified with respect to Electrical Shock Fire and Mechanical Hazards Steril
18. PT When bleeding risk is anticipated to be high early following trauma or surgery working negative pressure levels should be set as low as possible and should not exceed a maximum of 80 mmHg While working on stiff surfaces as in clinical cases of low perfused tissues like PVD diabetic traumatic wounds low vacuum is essential in order to prevent tissue ischemia Maximal Flow Rate Setting Maximal flow rate from the wound through the tubing to the collection canister is pre set as default to be up to 100 ml hr In case that the flow exceeds this limit an alarm is activated and the suction apparatus shuts Vcare q UVa Medical Ltd down It is obligatory to maintain this default setting Increasing the maximal flow rate allowed from the wound may eliminate control of acute bleeding Alarms Setting Alarms are pre set as default to audio amp visual alarms Any alarm condition will be indicated by audio a repetitive beeping sound and visual A flickering triangle symbol in the middle of the display screen and an indication LED alarms Changing this pre setting should be considered carefully Change of alarms settings may prevent from the care giver the detection of critical indications regarding the vacuum treatment Never leave a wound covered for an extended time without effective negative pressure As the Vcare a system is operating fluids are discharged and constantly evacuates from the wound Once the vacuum is halt
19. 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 Pump Operation Time Display The total working hours of the engine are displayed on the screen Press Down Scroll arrow in order to continue to the next function 5 2 6 F6 Software Version Display The current version of the system software is displayed on the screen Press the Down Scroll button in order to continue to the next function 5 2 7 F7 Back Screen 5 2 1 Incase reaching from treatment menu First line To Treatment menu press OP SET returning to the last screen we had been in the 35 R VJ Medical Ltd Vcare X treatment menu before reaching the set up menu Second line To start over press FUNC start over the set up menu 5 2 7 2 Incase reaching from Stand By screen after setting all parameters in the treatment menu First line To start treatment press OP SET returning to the stand by screen Second line To start over press FUNC start over the set up menu 5 2 7 3 Incase reaching from Stand By screen after yes was chosen at use previous setting screen First line To Treatment menu press OP SET returning to the risk of bleeding screen Second line To start over press FUNC start over the set up menu Note as vacuum operation is in
20. Veare oC Voare User Manual UV ST mecca Ltd Introduction Regulated Negative Pressure Wound Therapy RNPT has revolutionized and enhanced wound care during the last two decades Veare a utilizes RNPT by multiple mechanisms of action to remove fluids and infectious materials help protect the wound environment aid promote perfusion and provide moist healing environment help draw together wound edges and promotes granulation RNPT is the controlled application of sub atmospheric pressure to a wound using a therapy unit to intermittently or continuously apply negative pressure to a specialized wound dressing to help promote wound healing The wound dressing is a resilient open cell polyurethane foam surface dressing and is sealed with an adhesive drape that contains the sub atmospheric pressure at the wound site Important safety features enhances patient safety by regulating pressure at the wound site and warning possibility of uncontrolled bleeding Additionally the Vcare a helps direct drainage to a specially designed canister that reduces the risk of exposure to exudates fluids and infectious materials Intended Use The Vcare a is indicated for wound management via application of a pre set level of continuous or intermittent negative pressure to the wound for removal of fluids including wound exudates irrigation fluids and infectious materials It is intended for management of chronic acute traumatic sub acute a
21. 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 second line change according to the selected mode Press OP SET to finalize your selection The value stops flickering Press to continue to the next parameter a See Clinical guidelines and Vacuum Operation Modes sections before choosing the Mode of Operation 5 1 3 1 Cyclic Continuous Working Negative Pressure The following screen is displayed Insert printout The default value of cyclic continuous working neg pressure is flickering 26 R VJ Medical Ltd Vcare X The default baseline pressure in cyclic continuous mode and available baseline pressure values according to the risk of bleeding are detailed in the table below Risk of Bleeding Cyclic Cont Baseline Pressure Displayed Optional Baseline Levels Default mmHg mmHg igh o o 40 50 Modera 5 door 40 50 75 100 or 125 40 and 125 The baseline working neg pressure in cyclic continuous mode oscillates within the range of approximately 20 from the baseline neg pressure Use the up and down scroll arrow buttons in the control panel to change the
22. at battery malfunction is suspected during warrantee period contact IVT Medical Ltd The Power indication LED is lit Turn the Vcare a unit on using its power switch button located on the left side of the unit e When turning the device on the operator should face the power switch on the left side of the device e During treatment parameter settings and vacuum operation the operator should face the front side of the Vcare a unit in front of the screen and control panel 3 Main screens 3 1 Opening screen As the unit is turned on an opening screen is displayed for approximately 10 seconds The first line displays the caption VT Medical Ltd and the second line displays Vcare Alpha 22 UVa Medical Ltd 3 2 3 9 3 4 3 0 Self test screen Following the Opening screen the LCD screen is being self tested for a few seconds this self test is performed every time the unit is turned on During the self testing phase the display shows TEST LCD symbols 1 10 are displayed on the screen digits in a and b vary from 0 through 9 bars in symbol no 10 fill gradually and the buzzer produces a short beeping sound Menu selection screen After the LCD self test screen is displayed the user will have two options for setting the treatment s parameters pressing for treatment menu in which basic treatment parameters are set or pressing FUNC for approximately 5 seconds in order to enter the advanced s
23. care a is operating fluids are discharged and constantly evacuated from the wound Once the vacuum is halted the system is at risk of becoming occlusive which might lead to infection 5 1 4 Max Flow Rate Determination When entering the Max Flow function the following screen is displayed Insert printout The default or pre set in treatment menu value of maximal allowed flow ml hr is flickering This function enables the determination of maximal flow rate of fluids ml hr allowed from the patient s wound to the Vcare a 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 ml hour or 300 ml hour It is highly recommended to keep the default value of up to 100 ml hr of flow Higher flow values may limit the detection of acute bleeding Use the up and down scroll arrow buttons to change the flickering value and determine the maximal allowed flow from the wound to the canister Press OP SET to finalize your selection The value stops flickering Press FUNC to continue to the next function O For the safety of the patient if you have previously evaluated the Risk of Bleeding as High or Moderate you will not be able t
24. conjunction with the Vcare a system UV ST mecca Ltd Vacuum levels in Vcare a system should be tailored to each specific wound and adjusted according to patient s clinical condition General guidelines and recommended vacuum levels are shown in the table below Inexperienced personnel is advised to always use the cyclic continuous mode or consult a trained physician regarding the treatment settings before using the Vcare a system When applying external vacuum make sure that the vacuum level supplied from the external vacuum source is 50 mmHg above the desired working pressure but should not exceed 200 mmHg It is recommended to connect the unit to an external vacuum source by a pressure regulator The external vacuum tube must be disconnected from the unit when external vacuum is not in use When working with the unit s internal pump make sure that the external vacuum tube is not connected to the unit The device must be operated in a 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 a 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 o unit A Warnings regarding clinical application of the Vcare a system Bleeding and infection should be anticipated during the use of RN
25. d characteristics of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Guidance and Manufacturer Declaration Electromagnetic Immunity The Vcare a device is intended for use in the electromagnetic environment specified below The customer or the user of the Vcare a device should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electronic Environment test level Level guidance Portable and mobile RF communications equipment should be used no closer to any part of Vcare a device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 5 IEC 61000 4 6 150 kHz to 80 a i 33 NP 1164P MHz V a NP 1164P Di UVa Medical Ltd Radiated RF 3 V m E 3V m _ 80 MHZ to 800 MHz IEC 61000 4 3 80 MHZ to 2 5 GHz d hr 2 334 P 1 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strength from fixed RF transmitter as determined by an electromagnetic site Survey should be less than the compliance level in each frequency range Interference may occur in the
26. d to make sure that it is securely connected to the mobile stand and that the lock pin is closed The Vcare af 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 Collection Canister installation 1 Insert the collection canister into the canister socket in the Vcare a unit by pressing it inwards When properly inserted a clicking sound is heard Make sure that the canister is placed secured and sealed in the canister socket for effective operation of the vacuum 2 Connect the Proximal Canister tube to the Canister tubing outlet Replacing the Collection Canister The Collection Canister may be replaced during normal operation alarm condition or routine maintenance 18 Vcare q R VJ Medical Ltd Vcare X The canister must be replaced when the liquid level exceeds 650 ml In this case an alarm will be activated The vacuum operation will stop when the fluids level in the Canister reaches 700 ml When fluids in the canister reach approximately 650 ml solidification process of the fluids by the hydro gel at the top of the canister will start and will be completed within 60 minutes A worn The collection canister and tubing are intended for single use only and must be disposed off after usage according to hospital and bio hazard protocols and according t
27. direct contact with the vacuum system e Ulcerated malignant wounds are contraindicated for treatment by Vcare a system as vacuum treatment may accelerate tumor growth within the wound cavity with exception of palliative care to enhance quality of life Note Treatment of long standing unhealed wounds should be evaluated for possible malignancy by biopsy of ulcers prior to RNPT e Vcare a system is contraindicated for treatment of non enteric unexplored fistulas Exploration of a fistula and determinations of its extensions and content should precede Vcare a application e The use of Vcare a system is contraindicated in apparent anaerobic infection e Vcare af 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 a system may be ineffective or contraindicated in case of e Necrotic tissue with eschar e Areas where adhesive tape application is limited dense hairy areas mucus membranes and joints thatcannot be fixated Q General Guidelines e Always use the lowest effective negative pressure e Safety measures regarding the use of Vcare a system should always be considered and implemented e Conservatively debride necrotic tissue prior to the use of vacuum treatment with the Vcare a system e Evaluate the need for initiation and cessation of systemic antibiotic treatment in
28. e in the pre set available range Use the up and down scroll arrow buttons in the control panel to change the displayed value and determine the required lower limit Press OP SET button to finalize your selection The displayed value stops flickering Press 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 Insert printout The default upper limit value is flickering The default value of the upper limit is pre set to be 15 mmHg above the working neg pressure and the range of the allowed upper limit is pre set according to the Risk of Bleeding and Working neg Pressure WP selection as follows Risk of Bleeding Upper Limit Range High WP 15 to 80 29 UV ST mecca Ltd Vcare q For advanced Upper Limit settings press FUNC shortly This allows the user to change the Upper Limit to a different value in the pre set available range The upper limit is displayed in a Use the up and down scroll arrow buttons in the control panel to change the displayed value and determine the required upper limit Press OP SET button to finalize your selection The displayed
29. e specifications section 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 To avoid battery malfunction connect the system to an external power adapter immediately Waring this device should be operated with a power adapter which complies with the specifications detailed in the external power adapter specifications section warning The internal battery is not accessible for users In case that battery malfunction is suspected Contact IVT Medical Ltd for a certified technical personnel If not 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 Additional signals general warning status symbol no 7 and canister fill status indicates the canister fill level symbol no 10 from screen symbols description table Information sentences First line Canister near full capacity 1 9 Full Canister alarm Description As the liquid volume reaches 700 ml vacuum operation is automatically shut down Priority Low Visual alarm signal cons
30. e that don t meet the requirements listed above may result in increased emissions or decreased Immunity of the Vcare af unit Guidance and Manufacturer Declaration Electromagnetic Emissions The Vcare a device is intended for use in the electromagnetic environment specified below The customer or the user of the Vcare a device should assure that it is used in such an environment RF emission Group 1 The Vcare af uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic 55 UVa Medical Ltd equipment RF emission Class B The Vcare a Device is suitable for use in CISPR 11 all establishments including domestic establishments and those directly Harmonic Emissions Class A connected to the public low voltage power IEC 61000 3 2 supply network that supplies buildings used for domestic purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 A wanina the Vcare o unit should not be used adjacent to or stacked with other equipment In case such use is necessary the device should be observed to verify normal operation in the configuration in which it will be used Guidance and Manufacturer Declaration Electromagnetic Immunity The Vcare a device is intended for use in the electromagnetic environment specified below The customer or the user of the Vcare af device should assure tha
31. e unless the package is damaged or open Expiration date Vcare a Sterilized using irradiation O m Fragile Marks portable and mobile RF MIZ communications equipment that may Keep away from sunlight interfere in the vicinity of the device Certifies that a product has met European Union consumer safety health or environmental requirements IVT Medical Ltd 16 Hatidhar St Ra anana 43665 Israel Phone 972 9 7463737 Fax 972 9 7604506 ec ree Obelis s a Bd G n ral Wahis 53 1030 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net Oct 2013 Rev 0 3 D SW Ver 0 1 Biohazard 60
32. econd line 1 Caution 2 Extreme high op zone 3 Turn off for re activation where 1 2 and 3 are presented one after the other for 5 seconds each To resolve this alarm Turn the Vcare o unit off e Incase an external vacuum source is connected reduce the pressure from the external vacuum source to 10 mmHg above the working negative pressure level If not e Restart the device In case this alarm is repeated after following these instructions contact your service provider 39 UV ST mecca Ltd In order to confirm that the preset vacuum Is actually applied to the wound it is recommended that together with the treatment operational setting the care provider should inspect the sponge to be evenly condensed squeezed 1 4 High Vacuum alarm Description The applied neg pressure is above the upper limit but does not exceed upper limit 20 mmHg for continuously 30 seconds 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 Additional signals general warning status symbol no 7 from screen symbols description table Information sentences First line Caution High level vacuum If connected to external suction the Second line displays 1 Reduce external suction 2 to Working Pressure where 1 and 2 are prese
33. ed the system is at risk of becoming occlusive which might lead to infection Wound dressing must be replaced according to the clinical guidelines or physician s judgment in order to prevent super infection to the 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 a system should not be used in cases with apparent or suspected anaerobic infection Negative pressure may exacerbate uncontrolled bleeding All precautions should be taken in order to avoid uncontrolled bleeding and the immediate cessation of RNPT in case of excessive bleeding should be executed Avoid high negative pressure during the early stage of trauma treatment Severe life threatening bleeding may result from the application of vacuum in treatment of acute trauma immediately after surgery at early stages following debridement of wounds in patients treated with anticoagulants or suffering from hematological disorders Setting high values of negative pressures may induce ischemia and may aggravate clinical ischemic conditions such as in peripheral vascular disease diabetic leg and traumatized tissue Excessive topical pressure may lead to compromised blood circulation and impairment of wound healing Vcare q R
34. ed by the pin lock a clicking sound needed to be heard Vcare af termination of operation 1 Turn the vacuum operation off using the OP SET button in the control panel 2 Turn the Vcare af system off using the power switch Vcare a Operation Before operating the Vcare af verify that e The Vcare afis placed on a suitable surface according to Positioning the Vcare a unit section in this manual 21 R VJ Medical Ltd Vcare X The collection canister is properly installed according to Disposable canister installation section in this manual The wound dressing is properly applied according to Setup for wound dressing application section in this manual When connecting the Vcare a to its mobile stand make sure it is properly connected according a clicking sound is heard Use a suitable external power adapter to connect the Vcare a unit via the electric receptacle to the wall electrical outlet When connecting the unit to the external power adapter the operator should be facing the back of the device in front of the power electrical outlet A worn The External power adapter must follow the specifications detailed in the External power adapter specifications section in this manual A rna 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 A rna The internal battery is not accessible for users In case th
35. ermittent 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 3 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 17 UV ST mecca Ltd Primary Unit Functions Setting Positioning of the Vcare o unit The Vcare unit should be placed close to the patient bed in proximity to the external vacuum and electricity sources The unit should be preferably operated by direct connection to a grounded electrical source and external vacuum source The unit can be placed on a stable flat dry surface or can be attached and secured to a designated mobile stand to enable patient ambulation The device must be operated in a quite environment with background noise of no more than 45 500B e Makesurethatthe external power adapter and its connecting cables are not creating a tripping hazard e Makesurethatthe ventilation holes at the back of the unit are not covered or blocked e lf the device is connected to mobile stand there is a nee
36. ert e Inspect the sponge drape stripes tubing and collection canister for possible leakage e Make sure that the canister is positioned properly in the canister socket e Make sure that the pressure from the external vacuum source is above the working pressure In case this alarm is repeated after following these instructions contact your service provider wanina failure to respond to this alert may lead to Low pressure alarm condition 3 Maintenance and Error alerts The maintenance and error alerts are displayed when necessary following the self test screen The user can choose to postpone the alert to a later stage Postpone or to resolve it immediately Done by using the scroll arrow buttons and finalizing 45 Vcare q R VJ Medical Ltd Voare X the selection by pressing the OP SET button The user needs to follow the instruction in user manual section 3 1 3 3 Only after conducting all the required procedures the user need to press the Done botton The default selection of this alert is Postpone 3 1 Device Service and Maintenance Description in order to maintain the device performance and effective operation the Vcare a unit should go through routine maintenance inspection Routine maintenance is required after 5000 hours or following one year of engine operation whichever comes first Alarm signals none Additional signals general warning status symbol no 7 from screen symbols
37. ertification is required Note When connected to the external power adapter the Vcare a apparatus is considered as ME SYSTEM refer to IEC 60601 1 The power adapter must comply with the specifications described below in the specifications section However the unit can also operate using its internal rechargeable battery when not connected to the power supply It is advised to connect the unit to the main power supply through the power adapter whenever possible in order to keep long battery life and to keep the battery fully charged 16 R VJ Medical Ltd Vcare X A rna 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 af system are suitable for use within the patient environment Vacuum Operation Modes The Vcare a system can be used to apply 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 Int
38. es In addition the working neg pressure can be linearly adjusted within the range of 30 200 mmHg and is limited in accordance to the Risk of Bleeding evaluation as described in the table below Default Working Displayed Pressure Working Pressure Pressure Values mmHg Range mmHg o 4050 60 0 90 60 30 65 65 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 change the displayed value and determine the required Working neg Pressure Press OP SET to finalize your selection The displayed value stops flickering Press to continue to the next parameter 5 1 3 2 2 Lower Limit When entering the Lower Limit function the following screen is displayed Insert printout The default lower limit value is flickering 28 R VJ Medical Ltd Vcare X The default value of the lower limit is pre set to be 10 mmHg below the working neg pressure and the range of the lower limit can be linearly adjusted within the range of 30 mmHg to the default value For advanced Lower Limit settings press FUNC shortly This allows the user to change the Lower Limit to a different valu
39. et up menu for detailed information about the menus go to the menus chapter Stand by screen This screen is displayed after setting the treatment parameters and before starting the vacuum operation The caption Stand 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 Working mode screen As the user starts the vacuum operation the working mode screen is displayed during treatment The working mode screen displays the pre set working neg pressure in b the actual pressure applied to the wound in a the pressure units in c the vacuum source in d along with symbol no 2 As the vacuum pauses when working in intermittent or cyclic continuous mode symbol no 1 is flickering on the screen as an indication 4 Vacuum Applying Mode Determination 4 1 The button INT EXT allows the user to choose the desired vacuum source Internal Suction Mode Pump In order to work with the device s internal suction apparatus press INT button 4 2 External Suction Mode Press EXT button in order to work with external vacuum source This requires connection to the external source using the external vacuum source tube 23 Vcare q R VJ Medical Ltd Vcare X OQ For continuous mode of operation use an
40. every 2 5 sec s Beep 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 a unit can be connected to the main power supply through a power adapter The power adapter is not part of the Vcare a device but it is mandatory to use it The power adapter must comply with the specifications described below Input Voltage 100 240 V Max Power Consumption approximately 50 W Max input current 1 5A UL TUV CSA medical grade certified Output Voltage approximately 15V DC Operation Temperature 0 65 C Max output current 3 3 A Operation relative humidity 20 90 Leakage current 0 5mA 240VAC Storage Temperature 20 85 C 50 R VJ Medical Ltd Vcare X Frequency 50 60 Hz Storage relative humidity 10 95 Accuracy of displayed values Max Error of pressure sensor 2 5 Pressure Display error 0 01 mmHg KPa Canister Fill level Display error 50 ml Battery Voltage Display error 0 01 V Storage and environmental conditions Storage and Transportation Temperature Range 15 80 C Storage and Transportation Relative Humidity Range 0 50 Storage and Transportation Atmospheric Pressure 700 1060 hPa Operational Temperature Range 0 40 C Operational Relative Humidity Range 0 50 Operational Atmospheric Pressure 700 1060 hPa Q Prior to
41. external vacuum is 50 mmHg above the working neg pressure which were determined and check if this error alert is repeated e Reduce the external vacuum level to 10 mmHg above the working neg pressure 2aiyin YNY VIAR N YIIN W D IN N22 DRA e Ifthe alarm 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 in one or more of the LEDs in two sequential operations an error alert will be displayed Alarm signals none Additional signals none Information sentences First line Error Alert Err02 Postpone Done Second line Refer to user manual for details Q To resolve this alert e Check for correlation between the canister fill level bars on the screen display and the actual liquid volume inside the canister each bar represents 100 ml of liquid In case the display and the actual liquid volume are correlated the 47 R VJ Medical Ltd Vcare X sensors are not damaged and you may proceed with the vacuum operation In case they are not correlated turn the unit off and proceed all to the next steps Turn off the deviceEject the current canister out of
42. external vacuum source The device cannot operate in continuous mode and will not allow choosing 0 minutes pause time when operating under internal suction mode 9 For cyclic continuous mode it is recommended to use external vacuum source When using the internal pump in cyclic continuous mode the pump will pause for 1 minute every 10 minutes of operation All other settings will operate in the same way for both external and internal suction modes 5 Menus 5 1 Treatment Setting Menu In menu selection screen press in order to enter Treatment Setting Mode in order to change system parameters press FUNC for approximately 5 seconds and see the Set Up Menu section for guidelines While setting treatment parameters symbol no 6 appears on the screen as an indication Using the control panel in treatment setting mode While browsing through 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 control panel OP SET button shortly to select the displayed value for the current treatment parameter or use the up and down scroll arrow buttons to scroll between available values for the current paramete
43. f 100 ml hr and Audio amp 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 button to finalize your selection The value stops flickering Press to continue to the next parameter AA warring Consider carefully any change from the default settings Use Previous Settings The user may choose to use the previous treatment settings if the Risk of Bleeding is identical to that of the previous treatment The default value of this function is NO Use the up and down scroll arrow buttons in the control panel to change the displayed value and determine whether or not to use the previous settings 25 R VJ Medical Ltd Vcare X If the chosen value is YES the previous set values of the following parameters will be displayed one after the other on the second text line e Working neg Pressure e Upper Lower Limit e Max Flow e Work Pause Time displayed only if the previous Mode of Operation is Intermittent After viewing the previous settings the following options are available e Press to go to Stand by screen e Press FUNC to adjust treatment settings Pressing FUNC will transfer the user to the next function in the menu In this case the flickering values will be the values chosen in the previous treatment and the user will be able to change them 5 1 3 Mode of Operation
44. h of therapy s time segments e For continuous therapy choose the intermittent operation mode and make sure that the device is connected to an external vacuum source This will enable the user to set the pause time value to zero 5 1 3 2 5 Pause Length Determination When 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 The value stops flickering For advanced pause time setting press FUNC shortly The pause time value will be displayed in a Use the up and down scroll arrow buttons in the control panel to change the displayed value and determine the required pause time The pause time can be linearly adjusted within the range of 0 10 min Press OP SET button to finalize your selection The displayed value stops flickering 31 UV ST mecca Ltd Press to continue to the next parameter 9 For continuous therapy make sure that the device is connected to an external vacuum source This will enable the user to set the pause time value to zero The device cannot operate on continuous mode when using the internal pump A wanina Avoid long pause of the vacuum As the V
45. hen the canister is full and must be replaced Canister Fill Status indicates the canister fill level Flickering eight full bars when high flow alarm is set Primary numerical display In Set Up menu displays the adjustable value of the current function j j During vacuum operation displays the actual pressure applied by the system Secondary numerical display displays the O H H Li pre set Working Negative Pressure selected et by the user during vacuum operation ee Vacuum units displays the units of applied vacuum Cc Vacuum source indicates the applied vacuum source Suction indicates External vacuum Pump indicates internal pump 15 R VJ Medical Ltd Voare X General alarm signal indicates that an alarm condition is present Alarm symbol 1 Audio off signal indicates that the auditory alarm signal is off when the user chooses Alarm symbol only visual alarm 2 1 5 Indication LEDs 1 5 1 Power LED green LED 1 5 2 Alarm LED red yellow LED 1 6 Canister Socket 1 6 1 Flow PCB 1 6 2 Canister Release button 1 6 3 Phototube holder 1 7 Electric Outlet 1 8 External vacuum source inlet 1 9 External Fuse 1 10 Integrated Battery Integrated charger provides up to 1 hour of operation battery life An automatic charging facility switches to battery power when main power is off The Vcare ol unit shall be connected to an approved medical grade AC DC adapter UL TUV or CSA c
46. ion canister for possible leakage e Make sure that the canister is positioned properly in the canister socket e If connected to an external vacuum source make sure that the pressure from the external vacuum source is above the working pressure e Incase 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 effective vacuum for long time periods A warning failure to respond to this alarm may exacerbate wound infection If not resolved immediately low pressure condition may eventually turn to Extreme low pressure condition 1 6 Extreme Low Vacuum alarm Description the applied neg pressure is less than 20 mmHg for continuously 30 seconds Priority Low Visual alarm signal constant yellow indication LED alarm signal no 1 general alarm signal from screen symbols description table 41 Vcare q UVa Medical Ltd Auditory alarm signal low frequency repetitive beeping sound Additional signals general warning status symbol no 7 from screen symbols description table Information sentences First line Ineffective vacuum level Second line 1 Check for leakage 2 and tubing connectivity where 1 and 2 are presented one after the other for 5 seconds each To resolve this
47. itiated the low vacuum alert will be displayed on the screen until the working negative pressure stabilizes on the desired level unless it cannot be stabilized due to leakage Vcare a quick instructions guide Verify that the wound doesn t actively bleed Insert the collection canister into the canister socket sound Connect the proximal canister tube to the collection canister O Ns When using mobile stand make sure the Vcare o unit is securely connected to the mobile stand and that the lock pin is closed 5 Connect the Vcare a unit using a suitable power adapter see specifications chapter to the wall electrical outlet Turn the Vcare a unit on 7 Select External Internal vacuum source it is advised to use external vacuum source as possible to avoid burnout of the internal pump Set the treatment parameters using the Treatment Setting Menu section Apply wound dressing to the wound see Setup for dressing application for detailed instructions 10 Connect the proximal canister tube to the distal connecting tube via the two way tube connector 11 Activate vacuum using the OP SET button on the control panel 12 Verify that the wound dressing is sealed inspect the sponge to be evenly condensed squeezed 36 UV ST mecca Ltd 13 Check the display and verify that the neg pressure applied is according to the pre set value a minor fluctuation of 5 mmHg in actual pressure should be expected 14 Patient
48. l alarm symbol along with a relevant message Q In order to monitor the wound healing and treatment process it is important for the care giver to be aware to all alarms and indications regarding the suction apparatus and treatment Therefore it is advised to keep the default alarm setting which is an audio and visual alarm Any change of alarms setting may prevent from the care giver the detection of critical indications regarding the vacuum treatment and may lead to misuse of the suction apparatus 34 R VJ Medical Ltd Voare X O For the safety of the patient if you have previously evaluated the Risk for Bleeding as High or Moderate you will not be able to change the Alarms from the default setting Audio amp Alarms Press OP SET button to finalize your selection The value stops flickering Press Down Scroll arrow in order to continue to the next function 9 For more information regarding alarms types and operation see the alarms chapter 5 2 3 F3 Negative Pressure Units Determination When entering the Pressure Units determination function the following screen is displayed Insert printout The default pressure units setting mmHg is flickering in the first text line Use the up and down scroll arrow buttons in the 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
49. l conditions will be displayed on the screen The text lines will display the information sentences according to the following internal ranking o For high priority alarms 1 Extreme high vacuum High flow whichever is initiated first 2 Critical battery o For low priority alarms 1 High Low vacuum 2 Full canister 3 Low battery Alarm preset The Vcare a treatment parameters are affected by the operator 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 chosen carefully while taking into consideration possible harms and hazards to the patient Therefore even if the operator sets the parameters to extreme values these values are still in the allowed range for the current treatment Alarm limits are limited by the Risk of bleeding as well Alarm limits Prior to each treatment the operator sets the treatment parameters within a possible pre programmed range according to the Risk of bleeding which defines the limits of alarm triggering events The operator sets the maximal desired flow the working pressure and its upper and lower limits These parameters along with the chosen Risk of
50. lays the value of the current function in a primary numerical display and allows manual setting of the value Long press while setting parameters in treatment menu switches to System Set Up Menu screen Short press in Stand by mode entering Treatment menu Short press while vacuum is operating displays treatment settings on the screen Work Pause time Upper Lower limit and Max Flow 1 3 4 OP SET this button 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 go to the main screen by pressing shortly on the OP SET button 1 3 5 f up scroll arrow 1 3 6 down scroll arrow The scroll arrows are used in the menus and have the following functions When a function value is flickering the user can use the arrows to switch between values Long press on the arrow buttons will faster the scrolling of the available values When a function value is not flickering the user can use the arrows to switch between functions go up and down in the menu 1 4 LCD Screen Display 13 R VJ Medical Ltd Vcare X Displays information and messages regarding working
51. may be applied to the wound if necessary Irrigation system is not part of the Vcare af system VANN Do not place the sponge or apply vacuum over a healthy tissue Applying vacuum on healthy tissue may cause irritation and damage the skin A rna Avoid cutting the dressing directly over the wound in order to prevent particles from entering the wound bed Choose a suitable sponge according to the wound dimensions Choose drape stripes in a suitable length for a safe attachment of the Sponge to the surrounding skin the length should be determined in compliance with the Sponge size Dry the wound edges for better sponge and drape stripes attachment 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 should be at the most dependent area of the wound to prevent from accumulation of fluids in the wound bed 8 At this location cut a hole through the covering layer of the sponge the drape layer approximately 1 2 cm in diameter leaving the foam layer of the mold mostly intact Make sure that the size of the hole is sufficient to allow fluid passage through the drape It is very important to cut a complete hole rather than a slit since a slit may no
52. mode settings alarm current pressure liquid level scale suction and power source internal or external The following figure illustrates the screen display with all symbols Screen svmbols descriotion Messages line 32 letters or signs First text line T line 32 letters or signs Second text line dh ULY Pumpr JBI AE ggge C illl Symbol Symbol Description Number Standby displayed when no vacuum 1 operation mode is applied Flickering when vacuum is paused in intermittent mode Work Status displayed when one of the y D vacuum operation modes is operating cyclic g continuous intermittent or continuous Continuous Operation Status displayed fun 3 when continuous vacuum is applied 14 R VJ Medical Ltd Vcare X Intermittent Operation Status displayed when intermittent vacuum is applied Cyclic Continuous Operation Status displayed when cyclic continuous vacuum Is applied Setting Mode displayed when setting the treatment parameters in Treatment System Set Up menu General Warning Status displayed when one of the alarms or alerts is activated Battery Status displayed when the device is not connected to a power source This symbol indicates the battery voltage 4 bars indicate full battery 12 2V or more 3 bars 12 2V 11 8V 2 bars 11 8V 11 37V 1 bar 11 37 10 96V 0 bars 10 96 10 8 Full Canister Status displayed w
53. nd dehisced wounds partial thickness burns ulcers i e diabetic or pressure flaps and grafts This user manual includes important information and instructions for correct and safe operation of the Vcare a device It is provided for training of personnel and as a reference for users Caution When applying Vcare a wound treatment products be sure to apply the product according to manufacturer s instructions for use Vcare q R VJ Medical Ltd Voare X A Important Safety Warnings In order to reduce potential risk for serious or fatal injury prior to use read and follow the instructions for use This user manual is part of the Vcare a system All safety information and warnings must be read prior to use The Vcare a is intended to be operated by licensed and specifically trained medical staff Treatment mode and parameters must be set only by physicians or dedicatedly trained nurses A Important Do not use the Vcare a system without consulting and supervision of a physician Read through and follow the user instructions and safety information before using the Vcare a system Using the system without physician supervision or without following the clinical guidelines on this manual may risk the patient and may result in serious injury A For safe and proper operation of the Vcare a system the safeguards below must be followed e The operation of this product must be according
54. negative pressure The Vcare a system may promote wound healing by either removal of excess exudate or irrigation fluids and infectious materials It is intended for management of chronic acute traumatic sub acute and dehisced wounds partial thickness burns ulcers i e diabetic or pressure flaps and grafts Specifically the Vcare af system is indicated to be used with the following wounds e 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 e Dehisced and infected surgical wounds and complications of failed sternal closures e Traumatic Wounds e Deep and partial thickness small to medium size burns e Treatment of skin grafts and flaps e Extensive tissue losses e Treatment of open fractures e Crush injuries e Compartment syndromes Contraindications Vcare a system is contraindicated in case of e Uncontrolled bleeding o Following trauma o Following surgery o Patients with hematological disorders o Vcare a system should be restricted in patients with open wounds who are treated with anticoagulants or suffer hematological disorders R VJ Medical Ltd Vcare X e Ameticulous homeostasis should be established prior to the application of Vcare a system The care provider should ensure that no exposed blood vessels nerves areas with fresh vascular anastomosis and internal organs are in
55. nly The treating physician should amend and adjust treatment to each individual clinical condition R VJ Medical Ltd Voare X Operation Rate of Dressing Intended use Pressure mode change every x days type of range frequency wound mmHg range on off min 40 120 2 2 3 1 1 3 Chronic 40 80 2 5 1 2 2 4 40 120 2 2 3 1 1 3 Chronic 40 80 2 5 1 2 2 4 Stop active bleeding before starting vacuum treatment Watch for active bleeding Do not apply on blood vessels or internal organs Apply lowest pressure possible in range Increase pressure and frequency of dressing change for treatment of infected traumatic wounds Apply non adhesive antimicrobial dressing to the wound below the sponge Intermittent mode is preferable Acute infection Conservatively debride necrotic tissue prior to application of Vcare a system Start treatment with greater vacuum in intermittent mode when wounds are heavily infected Reduce pressure as the wound becomes cleaner Consider combined systemic antibiotic treatment Acute infection 60 120 Correlate vacuum treatment with measured _ Acute intermittent 2 3 1 2 1 2 Ankle brachial pressure ratio Use lowest MIZGuOK use only 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
56. nted one after the other for 5 seconds each To resolve this alarm e Stop the vacuum operation Turn the Vcare o unit off e Incase an external vacuum source is connected reduce the pressure from the external vacuum source to 10 mmHg above the working negative pressure level If not e Restart the device In case this alarm is repeated after following these instructions contact your service provider In order to confirm that the preset vacuum Is actually applied to the wound it is recommended that together with the treatment operational setting the care provider should inspect the sponge to be evenly condensed squeezed wanina failure to respond to this alarm may lead to tissue damage If not resolved immediately high vacuum condition would eventually turn to Extreme High Vacuum condition 40 Vcare q UVa Medical Ltd 1 9 Low Vacuum alarm Description The applied neg pressure is less than 30 mmHg from the lower limit for continuously 30 seconds 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 Additional signals general warning status symbol no 7 from screen symbols description table Information sentences First line Ineffective vacuum level To resolve this alarm e Inspect the sponge drape stripes tubing and collect
57. o change the Max Flow to be higher than 100 ml hr 32 Vcare q UV ST mecca Ltd O In case the accumulated fluid volume in the canister exceeds the maximal volume allowed during operation an alarm will be activated and the vacuum operation will be shut down see the Alarms and Alerts chapter for more details 5 1 5 Start Working When entering the Start Working Screen the following screen is displayed Insert printout Press OP SET to go to the Stand by screen Press to return to the first function in the treatment menu Press FUNC for approximately 5 seconds in order to go to the set up menu Note as vacuum operation is initiated the low vacuum alert will be displayed on the screen until the working negative pressure stabilizes on the desired level unless it cannot be stabilized due to leakage 5 2 System Set Up Menu In menu selection 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 treatment parameter or use the up and down scroll arrow buttons to brows between available values for the current parameter and then press OP SET button to select the required value After
58. o institutional procedures and local state and federal environmental regulations Once the fluids have solidified and reached 650 ml follow the steps below to replace the canister 1 Turn 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 Seal the canister through the proximal connecting tube using the tube lid Discard the canister and tubing according to the hospital and bio hazard protocols Insert a new collection canister to the socket A clicking sound will indicate that the canister is properly inserted 6 Connect the new proximal canister tube to the distal tube connected to the dressing Turn the device on using the main power switch Activate Vacuum using the OP SET button Verify that the applied pressure displayed on the screen matches your pre defined setting Setup for Wound Dressing Application 1 Perform adequate conservative debridement of the wound to minimize bleeding prior to dressing application 2 Make sure that the wound area is clean 19 m R VJ Medical Ltd Voare X e Itis possible to apply spacer in the interface between the sponge and the wound The spacer should serve specific conditions in RNPT treatment To prevent adherent of the sponge to the underlying tissue or skin graft a non adherent gauze should be used Wound irrigation
59. of intermittent mode and frequent dressing changes Reduce pressure as soon as the wound becomes cleaner Evaluate distal perfusion Chronic 60 80 2 5 1 2 5 2 3 5 1 2 Sub acute 60 120 3 5 1 2 1 3 Infected burn 60 140 2 5 1 2 1 2 Skin Graft 50 80 Limit application to small to medium sized deep burns Restrict surface area to be treated according to the amount of fluid discharge from the wound Stop treatment If excessive fluid is drained Watch for acute bleeding Determine and correct electrolyte imbalance evaluate need for replacement therapy and systemic antibiotic treatment Conservatively debride eschar Stop active bleeding before starting treatment Use lowest pressure possible in range Apply non adherent antimicrobial dressing Spacer to cover the skin graft below sponge Mesh skin graft Continuous for 3 4 days followed by intermittent mode 6 4 1 2 4 7 10 m R VJ Medical Ltd Voare X Q The above guidelines should be regarded as general recommendations only The treating physician should amend and adjust treatment to each individual clinical condition Vcare a Unit Components Vcare o Unit Unit Main Components e An Internal Suction Pump e Display Screen and Controls Internal Battery Disposables e 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
60. pressing OP SET the displayed value will stop flickering When the value is not flickering press the Down Scroll arrow button shortly in order to continue to the next function At any stage of the system set up menu pressing the FUNC button for approximately 5 seconds will switch to the Stand By screen The user can then choose to start the vacuum operation by pressing OP SET 33 Vcare q R VJ Medical Ltd Vcare X 2 1 322 F1 Language When entering the Language function the following screen is displayed Insert printout The language function displays the current language used for user interface in the Vcare af unit Press the Down Scroll button in order to continue to the next function F2 Alarm Mode Determination When entering the Alarms function the following screen is displayed Insert printout The displayed default alarm mode Audio and Visual alarms A amp V is flickering Use the up and down scroll arrow buttons in the control panel to change the flickering value and select the desired alarm mode 5 2 2 1 Visual Visual alarm only The alarms indication will be only visual flickering indication light and general alarm symbol A relevant message will be displayed on the screen 9 2 2 2 A amp 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 genera
61. r and then press OP SET to select the required value After pressing OP SET the displayed value will stop flickering When the value is not flickering use the up and down scroll arrow buttons to scroll between treatment parameters At certain treatment setting functions pressing FUNC shortly allows advanced treatment settings In this mode the default value is displayed in a and by using the up and down scroll arrow buttons the value can be changed in a pre set range 24 R VJ Medical Ltd Voare X At any stage of the treatment setting mode holding the FUNC button for approximately 5 seconds allows switching to Set Up Menu 5 1 1 Working Risk of Bleeding Evaluation When entering the treatment setting menu the following screen is displayed Insert printout The default risk of bleeding value is flickering T This function determines the evaluated risk of bleeding from the wound The following risk evaluations are available High Moderate or Low risk of bleeding As a default for the safety of the patient the risk is pre set to be High For each option the working neg pressure will be limited as follows Risk of Bleeding High Moderate Neg Pressure mmHg Intermittent Operation Mode 30 65 30 90 90 30 200 200 Cyclic Cont Operation Mode a ii 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 o
62. s e If any liquid is spilled on the system disconnect the unit from its external power adapter and wipe 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 A Disposal o The Vcare a 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 a wound dressing drapes collection canister tubing connectors and filters should be handled and discarded according to institutional procedures and local state and federal regulations o If not disposed properly contact with the disposables may lead to contamination or super infection A Safety Information Disposables QD the disposables of the Vcare a system are intended for single use only Do not re use or re sterile the disposables as this may cause infection to the wound AA Waring Do not use non sterile disposables R VJ Medical Ltd Vcare X Always dispose the wound dressing collection canister drapes and tubing according to hospital and bio hazard protocols and according to institutional procedures and local state and federal environmental regulations Indications for use of Vcare a system The Vcare a system is indicated for wound management via application of a pre set level of continuous or intermittent
63. 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 OQ In case the device has been stored in temperatures below freezing bring the system to room temperature prior using Disposables Specifications Collection Canister Volume 800 ml Fluid trapped Volume 33ml Proximal canister tube The Proximal canister tube is made of PVC Poly Vinyl Chloride Length 1 7 m SI R VJ Medical Ltd Vcare X Distal connecting tube Tube adapter and attachment drape The Distal connecting tube is made of PVC Poly Vinyl Chloride Tube length 500 mm 15 mm A Tube adapter is attached to the bottom end of the tube The Tube adapter has an inlet which enables tube washing during vacuum operation in case of tube blockage The Attachment drape is 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 Attachment drape is attached to the Hose adapter Sponge The bottom layer of the sponge in contact with the wound surface is open cell multi channel polyurethane foam that allows 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
64. t allow fluid passage through the drape 9 Remove the taping from the end of the distal tube and attach it to the soonge above the hole 10 Connect the distal tube to the proximal canister tube via the two way tube connector 20 R VJ Medical Ltd Voare X Wound Dressing Removal A rna The wound dressing sponge proximal and distal connecting tubes and attachment drape are intended for single use only and must be disposed off after usage according to hospital and bio hazard protocols and according to institutional procedures and local state and federal environmental regulations Turn the vacuum operation off using the OP SET button in the control panel Turn the Vcare a system off using the power switch Disconnect the distal tube from the proximal tube Remove the drape stripes from the surrounding of the wound Remove the sponge from the wound bed D 1 Aa oO Make sure that the entire sponge has been removed Positioning of the Vcare a unit on the mobile stand 1 Holdthe Vcare a with one hand by its carrying handle when its LCD screen faced toward the front of the mobile stand 2 Slide the Vcarea by its external plate on the shelf track that placed on the upper side of the mobile stand Pull the pin lock until the external plate is properly inserted into the shelf track In order to complete its positioning release the pin lock and continue sliding the external plate until the external plate is lock
65. t it is used in such an environment Immunity Test IEC 60601 test Compliance Electronic Environment guidance level Level Electromagnetic 6 kV contact compliance Floors should be wood concrete discharge ESD 8 kV air or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 Electrical fast 2kV for compliance Mains power quality should be transient burst power supply that of a typical commercial or IEC 61000 4 4 lines hospital environment 1kV for input output lines Surge 1kV line s to compliance Mains power quality should be IEC 61000 4 5 line s that of a typical commercial or 2kV line s to hospital environment earth Voltage dip short lt 5 UT compliance Mains power quality should be interruptions and gt 95 dip in that of a typical commercial or voltage variations hospital environment If the user 56 Vcare q R VJ Medical Ltd Vcare X on power supply For 0 5 cycles of the Vcare a requires input lines continued operation during IEC 61000 4 11 40 UT power mains interruptions it is 60 dip in recommended that the Vcare a UT be powered from an For 5 cycles uninterruptable power supply or a battery 70 UT 30 dip in UT For 25 cycles lt 5 UT gt 95 dip in UT For 5 cycles Power frequency compliance Power frequency magnetic fields 50 60 Hz should be at levels Magnetic fiel
66. tant yellow indication LED alarm signal no 1 general alarm signal from screen symbols description table Auditory alarm signal low frequency repetitive beeping sound 43 Vcare q R VJ Medical Ltd Vcare X Additional signals general warning status symbol no 7 and canister fill status indicates the canister fill level symbol no 10 from screen symbols description table Information sentences First line Full canister Second line 1 Turn system off 2 replace canister and 3 Re activate treatment where 1 2 and 3 are presented one after the other for 5 seconds each Additional signal symbol number 9 appears on the screen To resolve this alarm Stop the vacuum operation Turn the Vcare o unit off e Replace the collection canister as instructed in replacing the collection canister section in this manual e Restart the device In case this alarm is repeated after following these instructions contact 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 conditions 2 1 High Vacuum alert Description the applied neg pressure is
67. to this manual e No modification of the Vcare a system is allowed without prior authorization of IVT Medical Ltd e lf this equipment is modified appropriate inspection and testing must be conducted by IVT Medical Ltd service personnel to ensure continued safe use of equipment e Assembly adjustments modifications maintenance and or repair of the Vcare a system must be carried out by a qualified personnel authorized by IVT Medical Ltd e To avoid risk of electric shock the Vcare af unit must only be connected to a supply mains with protective earth e Do not connect this product to damaged external power supply e Do not insert any object into any opening or tubing of the Vcare a unit e The Vcare a disposables are intended to be used only with the Vcare af unit e Do not shake or rock the Vcare o unit R VJ Medical Ltd Vcare X e The Vcare a unit should not be placed over heated surfaces e Special precautions regarding EMC must be taken when installing and preparing the Vcare a unit for operation according to the EMC section in this manual e Portable and mobile RF communication equipments may produce Electromagnetic interference If interference is suspected separate the equipment and contact your service provider For further details see EMC section in this manual e Do not touch the external fuse or fuse holder and the patient simultaneously e Do not spill any fluids on the Vcare a unit or any of its part

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