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Medical Vcare a Series User Manual

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Summary of Contents for Medical Vcare a Series

  • Page 1: User Manual

    User Manual...
  • Page 2 Introduction Regulated Negative Pressure Wound Therapy (RNPT) has revolutionized and enhanced  ® wound care during the last two decades. Vcare 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.

  • Page 3: Important Safety Warnings

    IVT Medical Ltd. service personnel to ensure continued safe use of equipment   ® Assembly, adjustments, modifications, maintenance and/or repair of the Vcare system must be carried out by a qualified personnel authorized by IVT Medical Ltd.   ® To avoid risk of electric shock, the Vcare unit must only be connected to a supply mains with protective earth.
  • Page 4 Medical or local authorized distributer. Disposal  ® o The Vcare unit must be returned to IVT Medical at the end of its operational life, i.e. following 5,000 hours of the internal pump operation.  ® o All disposables (Vcare...
  • Page 5 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 system  ® The Vcare system is indicated for wound management via application of a ...
  • Page 6   ® A meticulous homeostasis should be established prior to the application of Vcare system. The care provider should ensure that no exposed blood vessels, nerves, areas with fresh vascular anastomosis and internal organs are in direct contact with the vacuum system.
  • Page 7   ® Vacuum levels in Vcare 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 ...
  • Page 8 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 & 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.
  • Page 9  Treatment of long standing unhealed wounds should be evaluated for possible malignancy by biopsy of ulcers.  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.
  • Page 10 Operation Rate of Dressing Intended use Pressure mode change (every- x days) – type of range frequency Remarks* wound (mmHg) range (on/off min) Trauma Stop active bleeding before starting vacuum Acute treatment. Watch for active bleeding. Do not 04-024 2-2- 3/1 infection apply on blood vessels or internal organs.
  • Page 11 The above guidelines should be regarded as general recommendations only! The treating physician should amend and adjust treatment to each individual clinical condition.  ® Vcare Unit Components  ® Vcare Unit Unit Main Components • An Internal Suction Pump •...
  • Page 12 The following image illustrates the Vcare  ® system External Fuse External Vacuum Source inlet Gripping (On the back side) (On the back side) Handle External Power adapter inlet (On the back side) Pump Power LED Tubing Alarm LED Buzzer Hose LCD Screen adapter...
  • Page 13 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.
  • Page 14 Displays information and messages regarding working 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 symbols description. First text line Second text line Symbol Symbol Description...
  • Page 15 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.
  • Page 16 An automatic charging facility switches to battery power when main power is off.  ® The Vcare unit shall be connected to an approved medical grade AC/DC adapter (UL, TUV or CSA certification is required).  ® Note: When connected to the external power adapter, the Vcare apparatus is considered as ME SYSTEM (refer to IEC 60601-1).
  • Page 17 Warning: the external power adapter must comply with the specifications listed in the specifications chapter in this manual. 1.11. A Gripping Handle. 1.12. External vacuum source tube. 2. Disposables 2.1. A wound discharge Collection Canister 2.2. Tubing 2.2.1. Distal Connecting Tube, a tube adapter attached to its distal end and an Attachment drape.
  • Page 18 Primary Unit Functions Setting  ® Positioning of the Vcare 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.
  • Page 19 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.
  • Page 20  It is 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.
  • Page 21 Wound Dressing Removal Warning: 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.
  • Page 22 (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 IVT Medical Ltd. and the second line displays Vcare Alpha.
  • Page 23 3.2. 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.
  • Page 24 For continuous mode of operation use an 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. 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.
  • Page 25 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. 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. This function determines the evaluated risk of bleeding from the wound.
  • Page 26 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: • Working neg. Pressure. • Upper / Lower Limit. • Max. Flow. • Work / Pause Time (displayed only if the previous Mode of Operation is Intermittent).
  • Page 27 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: Cyclic – Cont. Baseline Pressure Risk of Bleeding Displayed Optional Baseline Levels Default [mmHg] [mmHg] High 40, 50 Moderate 40, 50 or 75...
  • Page 28 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 values). 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.
  • Page 29 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 value in the pre-set available range.
  • Page 30 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.
  • Page 31 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.  See the Clinical guidelines for recommended intermittent treatment parameters.
  • Page 32 Press ↓ to continue to the next parameter. 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.
  • Page 33 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.
  • Page 34 5.2.1. 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 unit. Press the Down Scroll button in order to continue to the next function. 5.2.2.
  • Page 35 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 & 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.
  • Page 36 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".
  • Page 37 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 and wound status should be monitored regularly according to the clinical condition of the wound.
  • Page 38 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), 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”.
  • Page 39 To resolve this alarm Turn the Vcare  ® • 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.
  • Page 40 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.
  • Page 41 1.5. 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.
  • Page 42 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).
  • Page 43 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.
  • Page 44 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).
  • Page 45 • 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.
  • Page 46 Information sentences: First line: “Postpone Done”, Second line: (1) “Maintenance required”, (2) “Refer to user manual”: To resolve this alert: Contact IVT Medical Ltd. for a certified technical personnel inspection of: Internal and external fuses inspection Battery voltage measurement of maximal voltage and inspection for possible leakage...
  • Page 47 ?‫האם בבית חולים יש אופציה לקבוע לחץ חיצוני‬ • • If the 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.
  • Page 48 Applied part: type BF (sponge, surrounding drape and drape stripes) • IPX0 Not protected against harmful effects of water External power adapter: • UL or TUV or CSA medical grade Power Adapter  ® Vcare unit Dimensions: L 37 cm x H 22.8 cm x W 22 cm Weight: 5.9 kg...
  • Page 49 Max. operation hours: 5,000.  ® The Vcare unit must be returned to IVT Medical at the end of its operational life, i.e following 5,000 pump operation hours. Therapy Adjustment Options Negative Pressure Range: 30-200 mmHg Modes of Operation: Cyclic-Continuous, Continuous or Intermittent.
  • Page 50 Input Voltage: 100-240 V Max. Power Consumption: approximately 50 W Max. input current: 1.5A UL / TUV / CSA medical grade certified. Operation Temperature: ~0-65 C Output Voltage: approximately 15V DC Max. output current: 3.3 A Operation relative humidity: ~20%-90% Storage Temperature: ~(-20)-85 C...
  • Page 51 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...
  • Page 52 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.
  • Page 53 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.
  • Page 54 Generation of alarm signal for two or more alarm conditions • 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.
  • Page 55 Alarm inactivation states  ® The Vcare system has two alarm indications: audio and visual, while the user can adjust the alarm indication to audio & visual or visual. • When the auditory alarm is off (i.e. the user chose only Visual alarm signal), the Audio off alarm signal (alarm signal no.
  • Page 56 equipment. “The Vcare  ® RF emission Class B Device is suitable for use in CISPR 11 all establishments, including domestic establishments and those directly connected to the public low-voltage power Harmonic Emissions Class A supply network that supplies buildings IEC 61000-3-2 used for domestic purposes”...
  • Page 57 of the Vcare  ® on power supply For 0,5 cycles requires input lines continued operation during IEC 61000-4-11 40% UT power mains interruptions, it is recommended that the Vcare  ® (60% dip in be powered from an For 5 cycles uninterruptable power supply or a battery.
  • Page 58  Radiated RF 3 V/m 80 MHz to 800 MHz   IEC 61000-4-3 80 MHz to 2.5       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 d is the recommended separation...
  • Page 59 communications equipment. Rated maximum Separation distance according to frequency of the output power of transmitter transmitter 150 kHz to 80 80 MHz to 800 800 MHz to 2,5 GHz 0.01 0.17 0.17 0.23 0.37 0.37 0.07 1.16 1.16 2.33 3.69 3.69 7.38 11.66...
  • Page 60 Medical Equipment classified with respect to Electrical Shock, Fire and Model name Mechanical Hazards Sterile unless the package is damaged or open Caution Sterilized using Expiration date irradiation Fragile Recycle Marks portable and mobile RF communications equipment that may Keep away from sunlight...