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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-MI391-002.001 Revision Date: 2023-02-15...
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Page 2: 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...............20 Maintenance and Cleaning..................22 Warranty Information.....................23 Electromagnetic Compatibility Tables..............24 Contact Infomation....................27 CLINICIAN... -
Page 3: 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 Bandage Dressings and the extriCARE®... -
Page 4: Indications For Use
• partial-thickness burns • ulcers (such as diabetic or pressure) • flaps and grafts The extriCARE 3000 Negative Pressure Wound Therapy System is suitable for use in healthcare facilities. 3. Contraindications for Use The extriCARE® 3000 NPWT Pump should NOT be used in the following conditions: •... -
Page 5: Package Content
4. Package Content MODE: 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 with US Plug. 5. Accessories The following accessories are available for purchase with the extriCARE® 3000 NPWT pump. -
Page 6: 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 7: User Interface
7. User Interface 9. Mute Symbol 10. Play/Pause Symbol 8. Battery Level 11. Lock /Unlock Indicator Symbol IN OPERATION: 7. Therapy Time Display 1. Target Vacuum Pressure 3. Actual Vacuum 12. Air pump status Pressure Indicator indicator mmHg 2. +/- Pressure Adjustment buttons MODE: 4. - Page 8 7. User Interface (continued) 4. Mode button: Pressing this area will change the mode from continuous to intermittent or vice versa. The line below indicates the current mode – a continuous line denotes continuous mode, whereas a dashed line denotes intermittent mode.
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Page 9: 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 10 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...
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Page 11: 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, 7.4V, 2600mAh BATTERY TYPE: (rechargeable) Model Number: SAW30B-120-2000U 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 12: Warnings
10. 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 13: 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 14 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.
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Page 15: 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 apply the dressing. 12.1 Canister Installation The extriCARE®... - Page 16 12. Operating Instructions (continued) IN OPERATION: Increases the target pressure Decreases the target pressure in 5mmHg increment. in 5mmHg increment. mmHg MODE: OPTIONS 400cc The extriCARE® 3000 pump can either deliver a continuous or an intermittent vacuum pattern. In the intermittent vacuum mode, each cycle consists of a continuous vacuum at the target pressure for 5 minutes, and then followed by a vacuum at 20mmHg for 2 minutes.
- Page 17 12. Operating Instructions (continued) 12.4 Running a Treatment Once the treatment settings are set, treatment can begin by pressing the Play/Pause Button. When treatment begins, the blue backlight will light for the duration of the treatment. Pressure sensing technology in the pump will ramp up pumping power depending on the amount of air leaks in the dressing and vacuum level.
- Page 18 12. Operating Instructions (continued) 12.5 Automatic Screen Shut-Off To maximize battery life, extriCARE® 3000 has an automatic screen shut-off feature. If the screen is not touched for 5 minutes, it will automatically shut off. One of the following scenarios would re-activate the screen: •...
- Page 19 12. Operating Instructions (continued) 12.6 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 20 12. Operating Instructions (continued) 12.7 Alarm Sound and Lock Mode Toggles (continued) IN OPERATION: Alarm sound toggle Lock Mode toggle mmHg Alarm sound toggle: the display window shows the current state (mute, in the above MODE OPTIONS example). Pressing the sound symbol will toggle the alarm sound on or off: 400cc Alarm sound is turned on.
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Page 21: Error Messages / Troubleshooting
12. Operating Instructions (continued) 12.8 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 22 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 3 beeps with Stop treatment immediately and restart SYSTEM HIGH PRESSURE High 1 red flash every device.
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Page 23: 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 24: 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 25: 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 inches) to any part of the extriCARE®... - Page 26 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 27 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...
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Page 28: 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...
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Questions and answers
How do you get the device out of locked mode
To unlock the Alleva extriCARE 3000 device, use the Device Options button to access the Lock Mode toggle. In the Lock Mode, treatment parameters cannot be changed. Pressing the Lock Mode toggle will disable Lock Mode and unlock the device.
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