14
15
•
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 dif
fi
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 con
fi
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 classi
fi
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.
Electromagnetic Emissions Guidance
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment speci
fi
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
Electromagnetic environment - guidance
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage
fl
uctuations/
fl
icker emissions
IEC 61000-3-3
Not applicable
RF emissions
CISPR 14-1
Complies
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is not
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 speci
fi
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
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
fl
oors 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
± 1 kV for input/output
lines
Not applicable
Surge
IEC 61000-4-11
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Not applicable
Voltage
fl
uctuations/
fl
icker emissions
IEC 61000-3-3
<5 %
U
T
(>95 % dip in
U
T)
for 0,5 cycle
40 %
U
T
(60 % dip in
U
T)
for 5 cycles
70 %
U
T
(30 % dip in
U
T)
for 25 cycles
<5 %
U
T
(>95 % dip in
U
T)
for 5 s
Not applicable
NOTE
U
T is the a.c. mains voltage prior to application of the test level.
A88091P00 AMP IFU_1_18_12.indd 14-15
A88091P00 AMP IFU_1_18_12.indd 14-15
1/18/12 9:29 AM
1/18/12 9:29 AM
