ExtriCARE™ 2400 Negative Pressure Wound Therapy (NPWT) System

Product Overview
Operational Instructions
Downloads
Technical Specifications

extriCARE™ 2400 Negative Pressure
Wound Therapy (NPWT) System
The FDA-cleared extriCARE™ 2400 Negative Pressure Wound Therapy pump is portable and battery-powered. The device generates negative pressure (suction) to remove wound exudates, infectious material, and tissue debris from the wound bed, which may promote wound healing.

NOTE: FOR PRESCRIPTION USE ONLY

The extriCARE™ 2400 Pump is used with Devon Medical Products’ proprietary extriCARE™ bandages. These bandages have a wound pad enclosed in mesh under a sticky film that can be applied directly onto the wound bed. There is a drainage tube that connects to a canister adjacent to the pump that collects exudates and bodily fluid. The bandages come in oval shapes as well as other designs.

Key Product Features
Quick & Easy Application: Wound preparation time is approximately 15 minutes (competitors as long as 45 minutes). This allows wound care nurses and caregivers to see additional patients more quickly. Lightweight & Portable: Only 8.6 oz. (competitors as high as 20 lbs. or more). A carrying pouch is available, promoting an active wound healing lifestyle. Anatomically Fitted Bandages: Create tighter seals for all parts of the body, including various sizes and specialty bandages for the foot, and sacrum, etc. Rechargeable Battery: 24 hours of continuous battery life, and the battery is rechargeable. U.S. patent-pending Able to handle multiple wound sites with use of Y Bridging Kit. Medicare Reimbursement Code: E2402

Precautions & Warnings Extra precaution and care should be taken when using Negative Pressure Wound Therapy in the following conditions: Bleeding and hemorrhage Hemostasis, anticoagulants, and platelet aggregation inhibitors Friable vessels and infected blood vessels Vascular anastomosis Infected wounds Osteomyelitis Exposed organs, vessels, nerves, tendons, and ligaments Sharp edges (bone fragments) Dressing being retained in wound Use in MRI environment Use in hyperbaric chamber environment Use with defibrillation Patient size and weight Use near vagus nerve (bradycardia) Patients with spinal cord injury Enteric fistulas Protection of periwound skin Circumferential dressing application Intermittent versus continuous pressure Transmission of infectious agents		Contraindications The use of the extriCARE 2400™ pump is contraindicated in the presence of: Necrotic tissue with eschar present Untreated osteomyelitis Non-enteric and unexplored fistulas Malignancy in the wound Exposed vasculature Exposed nerves Exposed anastomotic site Exposed bone or tendons

Instructions for Use

1. LCD SCREEN: Indicates the pump operating pressure and displays symbols (also features a blue backlight).

2. CONNECTION TUBING:
Tubing which connects canister to drainage tubing.

3. BATTERY POWER: Indicates how
much battery power is left. Icon has 1-4 bars representing 25%, 50%, 75%, and 100% battery power.

4. CANISTER CLIP: Clip that connects
the canister to the NPWT device.

5. MODE SYMBOL: Indicates
pump operating mode
(continuous or intermittent).

6. MODE BUTTON: Allows user to set the pump to either continuous or intermittent mode.

7. POWER PLUG: Enables user to charge device.

8. PUMP BUTTON: Used to turn pump on or off. Also can be used to exit a setting.

9. SET BUTTON: Used to program desired pressure.

10. POWER SWITCH: Used to turn the system power on and off.



Operating the Device
1.	POWER ON/OFF: To Power on the device, push the POWER SWITCH on the right side of the device downward. The device should then turn on. Push the POWER SWITCH upward to turn device off.	LED DISPLAY
2.	CONTROL PRESSURE: Holding down the SET key for two seconds will initiate the procedure for setting the pressure. The screen will display a flashing pressure reading at this time. Press SET once to increase pressure by 20mmHg. In order to obtain a lower pressure, scroll through by pressing SET button. The pressure will increase until 140mmHg, and then will start at 40mmHg again. When desired pressure is reached, press the PUMP button to confirm and exit pressure settings.
3.	SET MODE: Hold down MODE button for two seconds to select the mode (continuous or intermittent). A dotted line at the top right of the LCD Screen indicates intermittent treatment while a straight line indicates a continuous treatment. To change current mode, press the MODE button. To exit Mode Settings, press the PUMP button.
4.	START/STOP TREATMENT: To start treatment, hold the PUMP button for two seconds. Do the same to stop treatment.
5.	LOCK: The locking feature prevents the settings from being changed. If no buttons on the device are pressed for more than 60 seconds, the lock will automatically turn on. If the Lock is on and buttons are accidentally pressed, nothing will be changed. Press the SET and MODE button simultaneously for 2 seconds to turn the lock on manually. Repeat for 3 seconds in order to unlock. The backlight should turn off when the device is locked and turn back on when it is unlocked.

Dressing and Canister Application

1.	The clinician may loosely place extra gauze dressing material into areas of undermining and tunneling. The decision type of gauze material used is based on clinician preference. Document the amount of additional packing material used.
2.	Dressings should be changed as needed. • The initial dressing should be changed in 24 - 48 hours or when leaking, whichever comes first. Dressings should not be left in place longer than 72 hours. • If the dressing sticks to the wound, moisten with saline or water during removal. Adhesive remover may be used. • Dispose of soiled dressings according to facility protocol.
3.	Avoid outside sources wetting the dressing. The dressing should be protected from moisture during bathing or changed prior to reconnecting to the pump. Do not use the extriCARE™ 2400 Negative Pressure Wound Therapy Pump while showering or bathing. Always disconnect and remove pump from areas of moisture (bathing area or tub). Clamp the tubing when pump is disconnected.
4.	To remove a canister, pull up on the canister clip on the top of the device and pull the canister away. To reinstall a canister, line up the notch on the bottom of the canister with the hole for it on the extriCARE™ pump, and then press the canister clip into place. The clip should click into place and the canister should feel snug.
5.	The extriCARE™ 2400 Negative Pressure Wound Therapy System is capable of accommodating more than one dressing set for multiple wounds on a single patient. A Y Bridging Kit is available to connect the dressings to enable the use of one pump.

extriCARE™ Negative Pressure Wound Therapy Instructional Video

extriCARE™ Pump Operation

extriCARE™ Dressing Application

AVAILABLE LITERATURE
	extriCARE™ 2400 One Page Slick	CLICK HERE
	extriCARE™ Brochure	CLICK HERE
	extriCARE™ 2400 User Manual (663 kb)	CLICK HERE

Click here to download Adobe Acrobat Reader.

Device Specifications:
Weight: 8.6 oz.
Mobility: Portable, Carrying pouch included
Battery Type: Lithium (rechargeable)
Vacuum Modes: Continuous or intermittent
Dimensions: Length: 3.35” (8.5 cm) Height: 5.67” (14.4 cm) Width: 1.46” (3.7 cm)
Input: 100-240 V 50/60 Hz 0.4 A


Operating Conditions:
Temperature: +5° C – 40° C
Humidity: 15% – 85% non-condensing
Pressure Options: 60mmHg – 140mmHg
Fuse: 1.5 A
Charging Time: < 3.5 hours
Barometric Pressure Range: 800 hPA – 1060 hPA
Storage Temperature: -10°C – +45°C
Altitude Range: < 2000 m
Ingress Protection: IPX0
Protection Against Electric Shock: CLASS II
Patient Protection: Type B


Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The model extriCARE™ 2400 is intended for use in the electromagnetic environment specified below. The customer or the user of the model extriCARE™ 2400 should assure that it is used in such an environment.
Immunity Test	IEC 60601 Test Level	Compliance Level	Electromagnetic Environment Guidance

Electrostatic discharge (ESD) IEC 61000-4-2	6 kV contact 8 kV air	6 kV contact 8 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4	2 kV for power supply lines	2 kV for power supply lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	1 kV line(s) and neutral	1 kV line(s) and neutral	Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11	<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5s	<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5s	Mains power quality should be that of a typical commercial or hospital environment. If a dip or an interruption of mains power occurs, the current of the model extriCARE™ 2400 may be dropped off from normal level, it may be necessary to use uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	3 A/m	Not applicable	Not applicable
NOTE: UT is the a.c. mains voltage prior to application if the test level.