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Alleva extriCARE 3000 Operating Manual

Negative pressure wound therapy system
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Operating Manual
extriCARE
3000
®
Negative Pressure Wound
Therapy System
For Clinicians Use
Online Reference for Clinicians
ENGLISH VERSION - US
www.allevamedical.com
IFU1-MI391-002.003
Revision Date: 2024-08-16

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Summary of Contents for Alleva extriCARE 3000

  • Page 1 Operating Manual extriCARE 3000 ® Negative Pressure Wound Therapy System For Clinicians Use Online Reference for Clinicians ENGLISH VERSION - US www.allevamedical.com IFU1-MI391-002.003 Revision Date: 2024-08-16...

  • Page 3: Table Of Contents

    CONTENTS FOR CLINICIAN USE Introduction......................2 Indications for Use....................3 Contraindications for Use..................3 Package Content.....................4 Accessories......................4 Features........................5 User Interface......................6 Symbol........................8 Device Specifications....................10 Warnings........................11 Precautions......................12 Operating Instructions....................14 Error Messages / Troubleshooting...............23 Maintenance and Cleaning..................25 Warranty Information.....................26 Electromagnetic Compatibility Tables..............27 Contact Infomation....................30 CLINICIAN...

  • Page 4: Introduction

    For wounds with larger drainage needs, a 400cc collection canister is also available. Alleva Medical provides two main type of wound filler dressings to be used in conjunction to an extriCARE pump unit – the extriCARE Negative Pressure Wound Therapy ®...

  • Page 5: Indications For Use

    2. Indications for Use The extriCARE 3000 Negative Pressure Wound Therapy System is intended to generate ® negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. It is indicated for the following wound types: •...

  • Page 6: Package Content

    4. Package Content 999 59 Each box contains: 1. An extriCARE 3000 Negative Pressure Wound Therapy Pump unit. ® 2. An extriCARE 100cc collection canister with solidifying agents. ® 3. A 12V/2A AC/DC Adapter. 4. An electric plug (of either US, UK, EU variant) for the adapter. 5.

  • Page 7: Features

    6. Features 3. Canister Release Button 6. Tubing Input 1. Power Button 2. Adapter Cover/Port 4. Play/Pause Button 5. Collection canister with backlight 1. Power Button: to turn the device on or off. 2. Adapter Cover/Port: the soft adapter cover protects the adapter port from dust and debris.

  • Page 8: User Interface

    7. User Interface 7. Lock/Unlock Symbol 8. Play/Pause Symbol 1. Product Name 9. Battery Level 999 59 2. Time in Operation Indicator 3. Target Vacuum Pressure 10. Air Pump Status Indicator 4. Vacuum Mode Indicator 5. Exudate Level 11. Actual Vacuum Indicator Pressure 6.
  • Page 9 7. User Interface (continued) 4. Vacuum Mode Indicator: indicates the selected vacuum mode. A straight line denotes continuous mode, and a dashed line denotes intermittent mode 5. Exudate Level Indicator: indicates the approximate level of the collection canister and the size of the canister. Pressing this area will generate a log with collection time and level (See Section 12.7) 6.

  • Page 10: Symbol

    8. Symbol List Battery Level Indicator: In 5 states (1 to 4 bars, or empty) Indicates that the device is charging normally. The battery levels would also alternate. Therapy in session Therapy Symbol: Indicates whether the device is in therapy or in pause. Therapy in pause Sound On Alarm Indicator: Indicates if the device alarm is muted...
  • Page 11 8. Symbol List (continued) Keep Dry Serial Number Power Switch Class II Equipment CONFORMS TO AAMI STD ES 60601-1, IEC STD 60601-1-6, AAMI STD HA 60601-1-11. Catalog / Model Number Consult Instructions For Use Protection against solid objects of >12.5mm and modest vertical liquid ingress Operation temperature Limit (low left number denotes the lower temperature limit and upper right...

  • Page 12: Device Specifications

    9. Device Specifications Length: 4.0” (10.2cm) DIMENSIONS: Depth: 3.1” (7.9cm) Height: 5.0” (12.7cm) WEIGHT: 1.21 lbs (0.55 kg) Lithium Battery, 7.3V, 2450mAh BATTERY TYPE: (rechargeable) Model Number: UES24LCP1-120200SPA AC/DC ADAPTER: AC Input: 100-240Vac, 50/60Hz, 0.8A DC output: 12V 2A VACUUM MODES: Continuous or Intermittent Temperature: +5°C to 40°C (41°F to 104°F) OPERATING CONDITIONS:...

  • Page 13: Warnings

    • Review this manual prior to using the extriCARE 3000 NPWT Pump. If clarification is ® needed, contact technical personnel or Alleva Medical Devices at 1-877-312-NPWT prior to use. Additional questions can be immediately addressed as well. • Do not use the extriCARE 3000 NPWT Pump around explosive or flammable material.

  • Page 14: Precautions

    11. Precautions 11.1 Be aware for any of the following conditions: There are additional conditions to take into account before using Negative Pressure Wound Therapy, such as: 1. BLEEDING: There is a risk of bleeding/hemorrhaging with negative pressure wound therapy. If hemostasis cannot be achieved, if the patient is on anticoagulants or platelet aggregation factors, or if the patient has friable blood vessels or infected vascular anastomosis, he or she may have an increased risk of bleeding;...
  • Page 15 11. Precautions (continued) 11.1 Be aware for any of the following conditions (continued): NOTE: If any of this information is not understood, contact the manufacturer before using the device. 6. SPINAL CORD INJURY: If a patient experiences autonomic dysreflexia (sudden changes in blood pressure or heart rate because of sympathetic nervous system stimulation), discontinue the therapy to minimize sensory stimulation and give immediate medical assistance.

  • Page 16: Operating Instructions

    12. Operating Instructions Please consult Section 10 Warnings and Section 11 Precautions before reading this section. extriCARE 3000 Wound Dressings (sold separately) include bandages and foam kits. ® Follow detailed instructions that come with your extriCARE 3000 Wound Dressing to ®...
  • Page 17 12. Operating Instructions (continued) 2. Setting up the Month 1. Setting up the Year 3. Setting up the Day 4. Setting up the Time 5. A confirmation page will appear once all the time and date are set. Pressing the “Confirm” button will enter into the Main Page. CLINICIAN...
  • Page 18 12. Operating Instructions (continued) 12.3.1 Resetting the Date / Time It is possible to reset the date and time (for example, when the pump is being used in a different time zone). To reset the date and time on the extriCARE ®...
  • Page 19 12. Operating Instructions (continued) mode name. The mode will toggle between Continuous and Intermittent Mode. (Intermittent mode cycles through the target vacuum for 5 minutes, and then at 20mmHg vacuum for 2 minutes.) 12.4.2 Changing the Target Vacuum Pressure To change the target vacuum pressure, simply press on the green “+” or red “-“ button on the screen.

  • Page 20: Normal Mode

    12. Operating Instructions (continued) 12.5.2 Blockage Alarm extriCARE 3000 NPWT pump allows for two blockage modes. Under the normal ® default mode, blockage alarm will be triggered only after 120 minutes in continuous mode and 140 minutes under intermittent mode. Under sensitive mode, a blockage alarm can be triggered within 20 minutes.
  • Page 21 12. Operating Instructions (continued) • Plugging the device to the external charger • An alarm is generated Note: When the screen is shut-off, a green light will be flashing if treatment is in process, or a greenlight light will be flashing if the device is charging normally. 12.7 Tracking Exudate Level in Collection Canister 3000 has a proprietary technology to not only monitor exudate level in the extriCARE...
  • Page 22 12. Operating Instructions (continued) 12.7 Tracking Exudate Level in Collection Canister (continued) Pressing the Canister & Fluid Level Indicator would display a new window that list out the cumulative collection time to reach each level. The cumulative drain time allow user to determine whether exudate level collection is accelerating (possible bleeding) or decelerating (increased wound healing).

  • Page 23: Device Options

    12. Operating Instructions (continued) 12.8 Alarm Sound and Lock Mode Toggles (continued) Device Options Alarm sound toggle Lock Mode toggle Alarm sound toggle: the display window shows the current state (mute, in the above example). Pressing the sound symbol will toggle the alarm sound on or off: Alarm sound is turned on.
  • Page 24 12. Operating Instructions (continued) 12.9 Usage Log extriCARE® 3000 NPWT pump has the ability to record events encountered during the therapy, including all alarms, the time when the therapy was paused/resumed, exudate level changes, and any therapy settings changes. The Usage Log can be accessed through the Device Options button.

  • Page 25: Error Messages / Troubleshooting

    12. Operating Instructions (continued) 12.10 End of Therapy To shut down the device, locate the Power Button on the side of the device and press down for 2 seconds. A shutdown page will appear, with a dwindling white bar. Press down on the Power Button until the white bar completely disappears.
  • Page 26 13. Error Messages / Troubleshooting (continued) The following are the list of error messages (in descending priorities) and their mitigative actions: Error Message Priority Alarm Signal Action to Remove Alarm 4 beeps every 5 Stop treatment immediately and restart SYSTEM HIGH PRESSURE High seconds with 1 red device.

  • Page 27: Maintenance And Cleaning

    In the event the extriCARE® device requires repairs, it should be returned to your durable medical equipment company (DME) or local distributor, or to Alleva Medical Devices directly. No modification of the device is allowed.

  • Page 28: Warranty Information

    In addition, this Limited Warranty does not cover any Device which may have been damaged in transit or has been subject to misuse, neglect, or accident; or has been used in violation of Alleva Medical Devices’ instructions, including, without limitation, the instructions contained in the Operation Manual.

  • Page 29: Electromagnetic Compatibility Tables

    WARNING: Use of accessories and cables other than those specified or provided by Alleva Medical may negatively affect EMC performance. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12...
  • Page 30 16. Electromagnetic Compatibility Tables – RF Emissions Class B (continued) Guidance and manufacturer’s declaration – electromagnetic immunity extriCARE® 3000 NPWT Pump is in compliance for each IMMUNITY test specified by the standard, e.g. IMMUNITY test level. Immunity test IEC 60601-1-2 test level Compliance level Electrostatic ±8 kV contact...
  • Page 31 16. Electromagnetic Compatibility Tables – RF Emissions Class B (continued) Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Modulation Max. Distance Test Level Compliance Frequency (MHz) Power (V/m) level (MHz) 380-390 TETRA 400 Pulse Modulation 18 Hz 430-470...

  • Page 32: Contact Infomation

    NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 17. Contact Infomation Manufactured for: Alleva Medical Devices 1050 W. Central Avenue, Unit B Brea, CA 92821 www.allevamedical.com...