WORLD OF MEDICINE Stryker Pneumoclear User manual

SHORT INSTRUCTION
1
Front and graphical user interface of the device
Before you start: Device and tube set testing
1. Make sure the gas supply is connected and open and device is switched on.
2. Select the operating mode (e.g. Pediatric).
3. Under consideration of sterile/non sterile aspects open the package of the insufflation tube set that will be used for the pro-
cedure. Connect the tube set to the device.
4. Attach the insufflation tube to the cannula and close the stopcock.
5. Reset the volume display to 0 L and select a pressure of 8 mmHg and a gas flow of 2 l/min.
6. Start insufflation and insufflate approximately 30 s. The status line should depict Occlusion after maximum 4 seconds.
7. Stop insufflation
If the actual gas consumption is higher than 0.4 l and Occlusion was not detected, there is a leak in the system.
Do not continue to use this tube set. Repeat the test with a new one or refer to chapter 5.12 of the IFU for further testing.
Fig. 1-1 Screen displays
(1) Actual pressure display
(2) Gas heating status
(3) Operating mode display
(4) Gas supply display
(5) Gas humidification icon
(6) Reduce nominal gas flow
(7) Actual gas flow display
(8) Increase nominal gas flow
(9) Nominal gas flow display
(10) Increase smoke evacuation levels
(11) Set smoke evacuation level/ON/OFF/
PAUSE
(12) Reduce smoke evacuation level
(13) Message display
(14) Gas consumption display with reset
button
(15) START/STOP button
(16) Menu button/speaker volume
(17) Back button (selection of operating
mode)
(18) Increase pressure
(19) Reduce pressure
(20) Nominal pressure display
(4)
(2)(3) (6)
(12)
(14)(15)(16)(17)
(18)
(19)
(1) (5) (7) (8)
(11)
(10)
(13)
(20) (9)

2
Available Insufflation Tube Sets
Mode description
HIGH-FLOW TUBE SET
(0620050100/blue) Disposable tube set with:
• Filter
HEATED HIGH-FLOW TUBE
SET (0620050200/green) Disposable tube set with:
• Filter
• Gas heating
SMOKE EVACUATION HIGH-
FLOW TUBE SET
(0620050250/black)
Disposable tube set with:
• Filter
• Lumen for smoke evacuation with filter
HEATED HUMIDIFIED TUBE
SET (0620050300/red) Disposable tube set with:
• Filter
• Gas heating
• Gas humidification
HEATED HUMIDIFIED SMOKE
EVACUATION TUBE SET
(0620050350/orange)
Disposable tube set with:
• Filter
• Gas heating
• Gas humidification
• Lumen for smoke evacuation with filter
Standard For laparoscopies performed on normal weight and slightly obese (BMI < 30 kg/m2)
patients over the age of 14.
Maximum nominal pressure 30 mmHg and maximum gas flow 40 l/min.
High Flow/Bariatric For laparoscopies performed on normal weight and obese patients (BMI > 30 kg/m2) over
the age of 14.
Maximum nominal pressure 30 mmHg and maximum gas flow 45 l/min.
Pediatric Designed specifically for use on newborns, infants, and children under the age of 14.
Maximum nominal pressure 20 mmHg and maximum gas flow 20 l/min.
Advanced Flow Especially supports the compensation of large leaks that may occur during laparoscopic
procedures, including but not limited to robotic-assisted laparoscopies. For normal
weight and obese patients over the age of 14.
Maximum nominal pressure 30 mmHg and maximum gas flow 50 l/min.
Vessel Harvest Designed to distend the cavity along the vena saphena magna and radial artery during an
endoscopic vessel harvesting procedure. For patients over the age of 14.
Maximum nominal pressure 20 mmHg and maximum gas flow 10 l/min.
TAMIS Designed to dilate and fill the rectum and colon by insufflating CO2 during transanal min-
imally invasive surgery. For patients over the age of 14.
Maximum nominal pressure 20 mmHg and maximum gas flow 40 l/min.

3
Icon description
Humidification
The humidification tube set provides approximately 200 liters of humidified gas when filled with water or saline. After 200 liters
of gas has been consumed, the tube set can still be used, however, in order to maintain a high level of humidity, the tube set
should be refilled every 200 to 300 liters of consumed gas. To refill the tube set, press the humidification icon and follow the in-
structions.
NOTE: Do not refill the tube set if the absorber is still soaked with water.
Gas heating
Smoke evacuation function
Icon Description Explanation/Troubleshooting
Humidification tube set connected, push icon to
start refill work flow. None
Humidification tube set is not connected or function
defective and therefore deactivated None
Icon Description Explanation/Troubleshooting
Gas Heater OK Gas heating function is available.
Gas heating defective Insufflation can be continued but the heating function is not avail-
able.
Restart the device if you want to use the heating function. If the
gas heating is still defective, have an authorized service technician
check or repair the device.
Overheating of the heating tube
(>43°C / 109°F)
Safety Feature Warning
Insufflation paused due to gas exceed-
ing 43 °C/109 °F. Insufflation will
resume shortly.
Insufflation is automatically paused and the heating function is
deactivated. There are three options to continue insufflation:
• Wait until the temperature has decreased below 43°C, insuffla-
tion and heating will resume automatically shortly.
• Disconnect and reconnect tube set. If temperature is below 43°C
insufflation with heating can be resumed (manual start).
• Exchange tube set with a new one.
The heating temperature is low. Insufflation can be continued. The heating tube has not yet
reached the optimum heating temperature.
Inactive gas heating Gas heating function is not available.
Icon Description Explanation/Troubleshooting
Smoke evacuation function is turned
off. Smoke evacuation function is turned off. To activate this function, press this symbol.
Smoke evacuation function is turned
on. Smoke evacuation function is turned on. To switch off this func- tion, press this symbol.
Smoke evacuation function is paused. Smoke evacuation function is paused. To switch off this function,
press this symbol.
Smoke evacuation is automatically paused if:
• the abdominal pressure is too low,
• the insufflation line is plugged or closed,
• or the smoke evacuation line is plugged or closed.

4
Smoke evacuation tube set connection
Leakage warning
Not able to achieve set pressure. Leakages can occur at port sites, port sealings or due to excessive use of a suction device.
Occlusion warning
Tube, Veress cannula, or trocar is blocked. Intra-cavity pressure can not be measured and actual pressure display depicts 0 mmHg.
Contamination warning
Fluid has penetrated the device via the insufflation tube connection. It is possible to conclude any currently ongoing surgery with
this device.
If insufflation is stopped subsequently, it can be restarted within 20 minutes and the surgery can be continued. A change of op-
erating mode is no longer possible. If insufflation is not restarted within 20 minutes or if the device is turned off and on again,
further use of the device is not possible. This is to prevent cross-contamination.
Contact technical service after surgery.
This short instruction is just an extract. For detailed device description please refer to the
PNEUMOCLEAR™ Instruction for Use.
Stryker Endoscopy
5900 Optical Court, San Jose
CA 95138 (USA)
[phone] [phone]
www.stryker.com
CE marking according to directive 93/42/EEC
Type: FM300
1201492/10000019270 01/2018-09
Distributed by
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
10587 Berlin, Germany
Phone: [phone]
Fax: [phone]
E-mail:info.ber[email protected]
Manufacturer
P31699 Rev. B