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Alleva extriCARE 3600, Руководство по эксплуатации

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3

4

Warning/Caution:

 See instructions for use for additional 

guidance

Single Use Only

Date Of Manufacture

Type BF applied part

Keep Dry

Serial Number

Power Switch

Manufacture Lot Number

2

SN

LOT

Class II Equipment

2. Symbol List (continued)

Authorized Representative in the European Community

Use By

Содержание extriCARE 3600

Страница 1: ...v C 20150317 EN US Suite M Q 12th Floor Kings Wing Plaza 2 1 On Kwan St Shek Mun Shatin N T Hong Kong Tel 852 3166 7200 Fax 852 2355 7663 www allevamedical com MEDICAL CO 2018 United States Contact Toll free line at 1 877 312 NPWT 4709 Distribution Ct 2 Orlando FL 32822 info allevamedical com ...

Страница 2: ...raumatic subacute and dehisced wounds partial thickness burns diabetic ulcers neuropathic ulcers pressure ulcers flaps and grafts may benefit from this system The extriCARE 3600 Negative Pressure Wound Therapy pump and extriCARE wound dressings are able to produce a negative pressure environment in either intermittent or continuous mode This allows the user to program the specific pressure ranging...

Страница 3: ...ontinuous mode The solid line indicates Continuous mode In Continuous mode the device will always maintain the set pressure Intermittent mode The dashed line indicates Intermittent mode In Intermittent mode the device will run for 5 minutes at the set pressure and then increase pressure to negative 20 mmHg for 2 minutes The device will continuously repeat this cycle while in Intermittent mode To c...

Страница 4: ... additional guidance Single Use Only Date Of Manufacture Type BF applied part Keep Dry Serial Number Power Switch Manufacture Lot Number 2 SN LOT Class II Equipment 2 Symbol List continued Authorized Representative in the European Community Use By ...

Страница 5: ...ified to CSA STD C22 2 No 60601 1 60601 1 11 Manufacturer 4005914 C Catalog Model Number Sterilized Using Ethylene Oxide Refer to instruction manual Protected against foreign objects equal to or greater than 12 5mm and against falling drops of water when enclosure tilted up to 15 IP22 ...

Страница 6: ...tput 15V 4A 60W VACUUM MODES Continuous or Intermittent OPERATING CONDITIONS Temperature 5 C to 40 C 41 F to 104 F Humidity 15 93 PRESSURE OPTIONS 40mmHg 200mmHg 5mmHg in increments of 5mmHg CHARGING TIME 5h BAROMETRIC PRESSURE 800hPa 1060hPa STORAGE TRANSPORTATION Temperature 25 C to 70 C CONDITIONS Humidity 93 non condensing ALTITUDE RANGE 2000m INGRESS PROTECTION IP22 PROTECTION AGAINST ELECTRI...

Страница 7: ...or Use The extriCARE 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate infectious materials and tissue debris from the wound bed The extriCARE 3600 Negative Pressure Wound Therapy System is indicated for the following wound types chronic acute traumatic subacute and dehisced wounds par...

Страница 8: ... Larger canister sizes 400cc or larger should only be used in a facility where drainage can be closely monitored due to the increased risk of injury to the patient due to bleeding when using the 400cc canister Precautionary measures should be taken for patients who have an increased risk of bleeding Please see Section 8 1 1 when using larger canisters Negative Pressure Wound Therapy has not been c...

Страница 9: ...s ligaments or tendons are exposed Additionally sharp edges due to bone fragments require special attention these areas should be covered and smoothed wherever possible These conditions should be factored into the therapy prescription as the attending clinician sees fit 3 ENVIRONMENT The extriCARE system should not be used in an magnetic resonance im aging MRI environment in hyperbaric chamber env...

Страница 10: ...with acute enteric fistulae 8 ENTERIC FISTULAS Wounds with enteric fistulas require special consideration to be effective in negative pressure wound therapy If enteric fistula effluent management or containment is the only goal of such therapy extriCARE is not recommended 9 CIRCUMFERENTIAL DRESSING Do not use circumferential dressings 10 BRADYCARDIA Avoid placement of the extriCARE 3600 Negative P...

Страница 11: ...wound dressings materials must be removed from the wound prior to further treatment Clean and debride the wound as necessary Any bleeding should be controlled Follow facility protocol for wound prep and infection control The type of extriCARE wound dressings chosen for use is dependent on the wound type size and location extriCARE wound dressings size and type is labeled on each package Care shoul...

Страница 12: ...wer Switch Used to turn the system power on and off Located on the back panel of the device 5 Mode Button Allows user to set the pump to either continuous or intermittent mode 11 Set Pressure 10 Canister Error Symbol 3 Actual Pressure 8 Start Stop Button 5 Mode Button 18 Charging Symbol 17 Pump Symbol 16 Audio Symbol 7 Down Button 6 Up Button 14 Tubing Input 15 Canister Clip 13 Lock Symbol 12 Mode...

Страница 13: ...r 11 Set Pressure This displays the pressure that the extriCARE 3600 is set for 12 Mode Symbol Indicates pump operating mode continuous or intermittent 13 Lock Symbol Indicates if the device is locked or not 14 T ubing Input This is the connection port used for the extriCARE 3600 dressings to attach to the pump 15 Canister Clip Clip that connects the canister to the extriCARE 3600 device 16 Audio ...

Страница 14: ...f exudates or a false fullness is caused by incorrect use of the system 3 beeps every 20 seconds 3 beeps every 20 seconds 3 beeps every 20 seconds 3 beeps every 20 seconds Yellow LED flashing every 2 seconds Yellow LED flashing every 2 seconds Yellow LED flashing every 2 seconds Yellow LED flashes every 2 seconds Pump remains on Fuse may blowout Pump remains function ing until the battery depletes...

Страница 15: ... minutes of continu ous alarm and with out any operation Pump remains on Inspect for possible air leaks between the wound and extriCARE dressing the extriCARE dressing and canister the canister and pump if necessary power off and back on to restart the system after adjustment Replace with new dressing and tubing set There are many potential sources of leaks incomplete seal between extriCARE 3600 d...

Страница 16: ...ARE wound dressings sticks to the wound moisten with saline or water during removal Adhesive remover may be used Dispose of soiled extriCARE wound dressings according to facility protocol Avoid outside sources wetting the extriCARE wound dressings The extriCARE wound dressings should be protected from moisture during bathing or changed prior to reconnecting to the pump Do not use the extriCARE 360...

Страница 17: ...enestrated silicone contact layer be applied atop the wound between the graft and the NPWT dressing Heavy petrolatum or similar products cannot be used as negative pressure will not have an impact on the wound surface Additional care should be used during dressing change to prevent dislodging graft 10 2 Operating the Device 1 POWER ON OFF To power on the device flip the POWER SWITCH located on the...

Страница 18: ...K UNLOCK DEVICE The extriCARE 3600 will lock automatically if there is no button input for 3 minutes At this time any button press will illuminate the display with the current settings but the buttons will not take any input and the backlight to the screen will turn off If there is no additional button presses the backlight will turn off after 6 seconds To unlock the device press and hold the MODE...

Страница 19: ...the socket located at the back of the device Release the screw on the clamp to make space for the hanging media Snap the clamp onto the hanging medium with the socket opening facing the ground Tighten the screw make sure there is a secure clamp Figure 2 Note Do not use the device as a hanger and hang objects on the device i e clothes Figure 1 Figure 2 ...

Страница 20: ...t company or to Alleva Medical Products directly No modification of the device is allowed Power adapter The extriCARE device should only be recharged using the AC DC adapter provided or an equivalent IEC 60601 1 compliant adapter with a DC 15V 4A output Battery Do not attempt to open disassemble or service the battery pack Do not crush puncture short external contacts or dispose of in fire or wate...

Страница 21: ...d in transit or has been subject to misuse neglect or accident or has been used in violation of Alleva Medical Products instructions including without limitation the instructions contained in the Operation Manual THERE ARE NO OTHER WARRANTIES THAN THOSE EXPRESSLY STATED HEREIN TO THE EXTENT PERMITTED BY LAW ALLEVA MEDICAL PRODUCTS DOES NOT MAKE ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FO...

Страница 22: ...are environment high levels of interference may induce an abnormal stoppage or other disruption of this device This device may also cause adverse effects in other nearby equipment It is strongly recommended that this device be isolated from other electromagnetic equipment when in use This system is classified as Equipment not Suitable for use in the presence of a Flammable Anesthetic Mixture with ...

Страница 23: ... as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the MODEL 3600 4 Warning that the MODEL 3600 should not be used adjacent to or stacked with other equipment 5 Guidance and manufacturer s declaration electromagnetic emissions The MODEL 3600 is intended for use in the electromagnetic environment specified below The customer or the user of the M...

Страница 24: ... 3 A m 6 kV contact 8 kV air 2 kV for power supply lines 1 kV line s and neutral 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 3A m Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commerc...

Страница 25: ...ked with the following symbol NOTE 1 At 80 MHz the higher the frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radi...

Страница 26: ...ency of transmitter m output power of transmitter W 0 01 0 1 1 10 100 150 kHz to 80 MHz d 1 2 P 0 12 0 38 1 2 3 8 12 80 MHz to 800 MHz d 1 2 P 0 12 0 38 1 2 3 8 12 800 MHz to 2 5 GHz d 2 3 P 0 23 0 73 2 3 7 3 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the t...

Страница 27: ...References References available upon request 26 ...

Страница 28: ...a 2 1 On Kwan St Shek Mun Shatin N T Hong Kong Tel 852 3166 7200 Fax 852 2355 7663 www allevamedical com MEDICAL CO 2018 United States Contact Toll free line at 1 877 312 NPWT 4709 Distribution Ct 2 Orlando FL 32822 info allevamedical com ...

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