Ethicon Endo-Surgery ECHELON FLEX 45 Mode D'emploi page 8

• Since the motor may stop if it stalls, it is important to do a visual check to ensure that the knife blade indicator, on the underside of the
cartridge jaw, has reached the end of the transection.
• If the instrument locks out, the motor will stop. Release the fi ring trigger and slide the knife reverse switch forward to return the knife to
the home position. In this position, the instrument should be removed, opened, and reloaded in order to continue.
• After the manual override system is used, the instrument is disabled and cannot be used for any subsequent fi rings.
• Incomplete fi ring may result in malformed staples, incomplete cut line, bleeding, and/or diffi culty removing the device.
• If the fi ring mechanism becomes inoperative, do not continue to use the instrument
• If the jaws do not automatically open after the anvil release switch is pressed, fi rst ensure that the knife is in the home position. The
position of the knife can be determined by observing the knife blade indicator under the cartridge jaw. If the knife blade indicator is not
in the home position or the position of the knife cannot be determined, slide the knife return switch to activate the motor and return the
knife to home position. Try opening the jaws again using the anvil release switch. If the jaws do not open at this point, then gently pull the
closing trigger (1) upward (away from the handle) until both fi ring and closing triggers return to their original positions.
• Examine the staple lines for pneumostasis/hemostasis and proper staple closure. Minor bleeding can be controlled with manual sutures or
other appropriate techniques.
• Prior to reloading the instrument, hold the instrument in a vertical position, with anvil and cartridge jaw completely submerged in sterile
solution. Swish vigorously and then wipe the inside and outside surfaces of the anvil and cartridge jaw to clean any unused staples from
the instrument. Do not use the instrument until it has been visually inspected to confi rm there are no staples on the anvil and cartridge jaw.
• Before removing the instrument, be sure tissue is cleared from the jaws and then close the jaws.
• When selecting the cartridge, careful consideration should be given to existing pathologic conditions as well as any pre-surgical treatment,
such as radiotherapy, that the patient may have undergone. Certain conditions or preoperative treatments may cause change in tissue
thickness that would exceed the indicated range of tissue thickness for the standard choice of cartridge.
• When dividing major vascular structures, be sure to adhere to the basic surgical principle of proximal and distal control.
• Do not use hospital autoclaves to sterilize or disinfect battery pack.
• Use of any other type of battery other than the battery supplied with the device may result in increased EMISSIONS or decreased
IMMUNITY of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter.
• Portable radio and mobile RF communications equipment can effect medical devices. Follow the directions of the following tables when
using the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter.
• Avoid use of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, monitor the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter and the other
equipment to assure normal operation.
• Instruments or devices which come into contact with bodily fl uids may require special disposal handling to prevent biological
contamination.
• This device is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness or
death. Also, reprocessing or resterilization of single use devices may create a risk of contamination and/or cause patient infection or cross-
infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device
may lead to injury, illness, or death of the patient.
Specifi cations
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter has a power rating of 40 W.
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is resistant to water ingress and is classifi ed per IEC 60601-1 as IPXO.
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in this document. Portable and mobile RF communications equipment can effect
Medical Electrical Equipment.
WARNING: Use of any other type of battery other than the battery supplied with the device may result in increased EMISSIONS or decreased
IMMUNITY of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter.
WARNING: Portable radio and mobile RF communications equipment can effect Medical Electrical Equipment. Follow the directions of the
following tables when using the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter.
WARNING: Avoid use of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, monitor the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter and the other equipment to
assure normal operation.
A88091P00 AMP IFU_1_18_12.indd 14-15 A88091P00 AMP IFU_1_18_12.indd 14-15
14
Electromagnetic Emissions Guidance
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter should assure that it is used in such
an environment.
Emissions test Compliance
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fl uctuations/
fl icker emissions Not applicable
IEC 61000-3-3
RF emissions Complies The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is not
CISPR 14-1 suitable for interconnection with other equipment.
Electromagnetic Immunity Guidance
For electromagnetic immunity, essential performance is: no knife movement without activation of the fi ring trigger.
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter should assure that it is used in such
an environment.
Immunity test IEC 60601 Compliance level
Test level
Electrostatic ± 6 kV contact ± 6 kV contact
Discharge (ESD)
± 8 kV air ± 8 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for power
Transient/burst supply lines Not applicable
IEC 61000-4-4 ± 1 kV for input/output
lines
Surge ± 1 kV line(s) to line(s)
Not applicable
IEC 61000-4-11 ± 2 kV line(s) to earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
Voltage fl uctuations/ (60 % dip in UT) Not applicable
fl icker emissions for 5 cycles
70 % UT
IEC 61000-3-3 (30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
NOTE UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic environment - guidance
Electromagnetic environment –
guidance
Floors should be wood, concrete or ceramic tile. If
fl oors are covered with synthetic material, the relative
humidity should be at least 30 %.
15
1/18/12 9:29 AM 1/18/12 9:29 AM