Related Manuals for Devon extriCARE 2400
Summary of Contents for Devon extriCARE 2400
- Page 1 Negative Pressure Wound Therapy System extriCARE 2400 ® Operating Manual ENGLISH www.devonmedicalproducts.com 1.866.446.0092 IFU30.0003 Rev H 20150403...
- Page 2 1. Introduction extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, ® battery-powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing. The extriCARE 2400 System consists of one AC power...
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Page 3: Symbol List
2. Symbol List Warning/Caution: See instructions for use Single Use Only Date Of Manufacture Type B. Applied Part. Internally powered electrical device Keep Dry Serial Number Prescription Use Only Power Switch Manufacture Lot Number Biohazard Class II Equipment Waste Electrical Goods Recycled... - Page 4 2. Symbol List (continued) Authorized Representative in the European Community Conforms with the Medical Device Directive (93/42/EEC) and has been subject to the conformity procedures laid down in 0123 the council directive ETL Listed, Conforms to UL Std. 60601-1 Manufacturer Catalog / Model Number Sterilized Using Ethylene Oxide Use By...
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Page 5: Device Specifications
3. Device Specifications DIMENSIONS: Length: 3.35” (8.5cm) Height: 5.67” (14.4cm) Width: 1.46” (3.7cm) WEIGHT: 8.6 oz. MOBILITY: Portable. Carrying case available. BATTERY TYPE: Lithium (rechargeable), 3.7V AC/DC ADAPTER: Input: 100-240 V, 50/60 Hz, 0.4A; Output: 5V, 1.5A VACUUM MODES: Continuous or Intermittent OPERATING CONDITIONS: Temperature: +5°C to 40°C (41°F to 104°F) Humidity: 15% to 85% non-condensing... -
Page 6: Contraindications For Use
4. Accessories AC/DC Adapter: Input: 100 – 240V, 50/60Hz, 0.4A. Output: 5.0V, 1.5A. Tubing set: 1.55m tubing with a luer-lock connector on one end preattached. A clamp is also attached to the tubing. Canister: Available in 100 and 400cc configurations. Dressings: Please reference extriCARE 2400 Negative Pressure Wound Therapy... - Page 7 2400 Negative Pressure Wound ® Therapy Pump System. If clarification is needed, contact technical personnel or Devon Medical Products at 1-866-446-0092 prior to use. Additional questions can be immediately addressed as well. • Do not use the extriCARE 2400 Negative Pressure Wound Therapy Pump around ®...
- Page 8 8. Precautions 8.1) Be aware for any of the following conditions: There are additional conditions to take into account before using Negative Pressure Wound Therapy, such as: 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 9 8.1) Be aware for any of the following conditions (continued): INFECTION: Infected wounds and osteomyelitis pose significant risks for Negative Pressure Wound Therapy. If untreated osteomyelitis is present, therapy should not be initiated. Negative Pressure Wound Therapy should not be used to treat infections, and all infections should be treated and addressed prior to using the extriCARE Negative Pressure Wound Therapy...
- Page 10 8.2) Prior to Therapy • Patient should be assessed and measures should be taken to optimize and stabilize their medical condition. Nutrition, medication, blood glucose, blood pressure, and circulation as well as other medical issues should be addressed. • The wound should be recently debrided by whatever measure is appropriate and the amount of necrotic tissue should be minimized.
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Page 11: Battery Power
9. Features 9.1) Defined Features 4.) Canister Clip 3.) Battery Power 5.) Mode Symbol 10.) Power Switch 1.) LCD Screen 7.) Power Plug 9.) SET Button 6.) Mode Button 2.) Connection Tubing 8.) Pump Button LCD SCREEN: Indicates the pump operating pressure and displays symbols (also features a blue backlight). - Page 12 9.2) Alarm Features/Troubleshooting In order to assure proper patient compliance, the extriCARE 2400 system is ® equipped with both audio and visual alarms for all the errors listed in the chart below. To disengage the alarms: 1. Audio alarms can be muted by pressing any button on the device front plate. 2.
- Page 13 9.2) Alarm Features/Troubleshooting (continued) Error Audio Alarm Visual Alarm System Suggested Error Type Cause Code Features Features Status Mitigation Alarm symbol and Pump will Properly Canister The canister is not de- 3 beeps “E06” flashing on not run install the Installation tected or is installed every 20...
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Page 14: Instructions For Use
10. Instructions for Use 10.1) Dressing and Canister Application The clinician may loosely place extra non occlusive dressing material into areas of undermining and tunneling. The decision type of non occlusive material used is based on clinician preference. Document the amount of additional packing material used. extriCARE wound dressings should be changed as needed. - Page 15 10.1) Dressing and Canister Application (continued) When using on a venous or other leg ulcer: • Edema control must continue during wound treatment. • Consider lower pressures when applied over fragile skin. When applying the wound dressings over toes: extriCARE ®...
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Page 16: Operating The Device
10.2) Operating the Device LCD Display 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. CONTROL PRESSURE: Holding down the SET key for two seconds will initiate the procedure for setting the pressure. -
Page 17: Maintenance And Replacement Parts
Use only a Devon Medical Products approved battery. If the device will not be in use for an extended period of time, the battery should be maintained by recharging regularly. - Page 18 10.6) Pump Operation Tips 1. Fluid Stagnation in Tubing (aka, “Vapor Lock”): This rare condition may occur when an exceptionally tight seal of the wound dressing facilitates a situation which interferes with fluid flow, preventing the proper removal of exudates from the wound site. This phenomenon is caused by a loss of differential pressure between the wound site and pump, which drives the motion of fluid removal.
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Page 19: Warranty Information
Operation Manual. THERE ARE NO OTHER WARRANTIES THAN THOSE EXPRESSLY STATED HEREIN. TO THE EXTENT PERMITTED BY LAW, DEVON MEDICAL PRODUCTS DOES NOT MAKE ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO ANY PRODUCT OR DEVICE, WHETHER OR NOT THAT PRODUCT OR DEVICE IS COVERED BY ANY EXPRESS WARRANTY CONTAINED HEREIN. -
Page 20: Product Classification
12. Contact Information (continued) Obelis s.a Bd. Général Wahis 53 1030 Brussels, BELGIUM Tel: +32.2. 732.59.54 Appendix 1 Product Classification: • According to the type of protection against electrical shock, this device is classified as a Class II Equipment, and Type B Equipment that is powered by an external electrical power source. -
Page 21: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Appendix 2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 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... - Page 22 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...
- Page 23 Recommended separation distances between portable and mobile RF communications equipment and the model extriCARE 2400. ® model extriCARE 2400 is intended for use in an electromagnetic environment ® in which radiated RF disturbances are controlled. The customer or the user of model extriCARE 2400 can help prevent electromagnetic interference by...
- Page 24 www.devonmedicalproducts.com 1.866.446.0092...
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