Instructions for Use en

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Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures
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P31693 Rev. K
 This instructions for use contains information that is subject
en to copyright. All rights reserved. This instructions for use
should not be photocopied, duplicated on microfilm or other-
wise copied or distributed, completely or in part, without the
approval of W.O.M. WORLD OF MEDICINE GmbH.
We reserve the right to technical changes without prior notification due to
the continuous further development of our products. Function or design
may partially differ from the description in the instructions for use. Please
contact us for additional information about this or any of our other
products.
Some of the parts and equipment referred to in this instructions for use
bear registered trademarks but are not identified as such. It should there-
fore not be assumed that the absence of the trademark symbol indicates
that any given designation is not subject to trademark protection.
Users of this product should not hesitate to point out to us any errors or
unclarities in this instructions for use.
Copyright © W.O.M. WORLD OF MEDICINE GmbH
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Manufacturer:

W.O.M. WORLD OF MEDICINE GmbH

CE marking according to Directive 93/42/EEC
Salzufer 8
10587 Berlin, Germany
Phone:   +49 30 39981-550
Fax:        +49 30 39981-545
E-mail:   [email protected]
Distributed by:

Stryker Endoscopy
5900 Optical Court, San Jose
CA 95138 (USA)
(408) 754-2000 (800) 624-4422
www.stryker.com
Type: FM300 / 1201459 / 10000018417 08 / 2020-09
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Table of Contents
1 Important User Notes ...............................................................................................................................................................................................  7
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2 Safety Information .....................................................................................................................................................................................................  8

3 General Information ..................................................................................................................................................................................................  9

3.1 Device Description........................................................................................................................................................................................... 9
3.2 Intended Use and Contraindications ......................................................................................................................................................... 9
3.2.1 Intended Use ................................................................................................................................................................................................  9
3.2.2 Contraindications ..................................................................................................................................................................................... 10
3.3 Warnings.........................................................................................................................................................................................................  10
3.3.1 General Warnings CO2 Insufflation .................................................................................................................................................... 10
3.3.2 Warnings Standard and High Flow/Bariatric Operating Mode................................................................................................... 14
3.3.3 Warnings Pediatric Operating Mode .................................................................................................................................................. 16
3.3.4 Warnings Vessel Harvest Operating Mode ....................................................................................................................................... 17
3.3.5 Warnings TAMIS Operation Mode ....................................................................................................................................................... 18
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3.4 General Precautions.....................................................................................................................................................................................  19

4 Initial Device Setup .................................................................................................................................................................................................. 21

4.1 Device Setup and Connection ...................................................................................................................................................................  21
4.2 Front of the Device .......................................................................................................................................................................................  22
4.3 Rear of the Device.........................................................................................................................................................................................  23
4.4 Gas Connection .............................................................................................................................................................................................  23
4.4.1 Connecting a Gas Bottle.......................................................................................................................................................................... 24
4.4.2 Connecting to Central Gas Supply ....................................................................................................................................................... 25
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4.5 Gas Supply ......................................................................................................................................................................................................  25
4.6 Switching Device On ....................................................................................................................................................................................  26
4.7 Switching Device Off ...................................................................................................................................................................................  26

5 Operating the Device - General ............................................................................................................................................................................ 28

5.1 Monitor with Touch Screen .......................................................................................................................................................................  28
5.2 Insufflation Tube Sets..................................................................................................................................................................................  28
5.3 Connecting an Insufflation Tube Set ......................................................................................................................................................  29
5.4 Using Gas Heating........................................................................................................................................................................................  30
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5.5 Using the Smoke Evacuation Function...................................................................................................................................................  31
5.6 Use of Insufflation Gas Humidification Function................................................................................................................................  33
5.7 Using Device Control ...................................................................................................................................................................................  35
5.8 Unlocking Operating Modes......................................................................................................................................................................  36
5.9 Displaying/Selecting Insufflation Operating Mode............................................................................................................................  36
5.10 Setting the Nominal Pressure - All Operating Modes ........................................................................................................................  36
5.11 Setting the Nominal Flow - All Operating Modes ...............................................................................................................................  37
5.12 Running Function Tests before Device Use...........................................................................................................................................  37
5.13 Gas Consumption Display ..........................................................................................................................................................................  39
5.14 Starting/Stopping Insufflation .................................................................................................................................................................  39
5.15 Desufflation....................................................................................................................................................................................................  40

6 Operating Modes of the PNEUMOCLEAR™ Insufflator .................................................................................................................................. 41

6.1 Standard Operating Mode .........................................................................................................................................................................  41
6.2 High Flow/Bariatric Operating Mode .....................................................................................................................................................  43
6.3 Pediatric Operating Mode ..........................................................................................................................................................................  46
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6.4 Advanced Flow Operating Mode..............................................................................................................................................................  48
6.5 Vessel Harvest Operating Mode...............................................................................................................................................................  48
6.6 TAMIS Operating Mode...............................................................................................................................................................................  50

7 Menu (Overview) ...................................................................................................................................................................................................... 51

8 Safety Functions........................................................................................................................................................................................................ 53
8.1 Automatic Venting System........................................................................................................................................................................  53
8.2 Occlusion.........................................................................................................................................................................................................  53
8.3 Contamination ..............................................................................................................................................................................................  54
8.4 Leakage Detection ........................................................................................................................................................................................  54

9 Care and Maintenance............................................................................................................................................................................................ 55

9.1 Cleaning the Device .....................................................................................................................................................................................  55
9.2 Maintenance Intervals ................................................................................................................................................................................  55
9.3 Maintenance by Authorized Service Technician..................................................................................................................................  55
9.4 Replacing the Fuse........................................................................................................................................................................................  56

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 10 Annual Inspection..................................................................................................................................................................................................... 58
en 10.1 Electrical Safety Test ....................................................................................................................................................................................  58
10.2 Basic Function Test (in Standard Operating Mode) ............................................................................................................................  58
10.3 Pressure Sensor Test (Standard Operating Mode) ..............................................................................................................................  59
10.4 Pressure Monitoring Test (in Standard Operating Mode) ................................................................................................................  60
10.5 Venting Valve Test........................................................................................................................................................................................  60
10.6 Maximum Device Pressure Test ...............................................................................................................................................................  60
10.7 Gas Flow Rate Test........................................................................................................................................................................................  61

11 Electromagnetic compatibility ............................................................................................................................................................................. 62

11.1 Electrical Connections .................................................................................................................................................................................  62
11.2 Guidance and Manufacturer's Declaration - Electromagnetic Emissions....................................................................................  62
11.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity...........................................................  63

12 Error and Warning Messages................................................................................................................................................................................ 65

13 Technical Data ........................................................................................................................................................................................................... 67

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14 Accessories ................................................................................................................................................................................................................. 69

15 Warranty and Service .............................................................................................................................................................................................. 71

16 Glossary ....................................................................................................................................................................................................................... 72

17 Appendix ..................................................................................................................................................................................................................... 73

Index............................................................................................................................................................................................................................. 75
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 Important User Notes

1 Important User Notes

Read the instructions for use carefully and become familiar with the operation and en
function of the device and the accessories before use during surgical procedures.
Non-observance of the instructions listed in this manual can lead
• to life-threatening injuries of the patient,
• to severe injuries of the surgical team, nursing or service personnel, or
• damages or malfunction of device and/or accessories.
The manufacturer reserves the right to modify the appearance, graphics, and tech- Subject to technical changes
nical data of the product through continued development of its products.
Paragraphs marked with the words WARNING, CAUTION, and NOTE carry special Please note
meanings. Sections marked with these words must be given special attention.

WARNING!
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The safety and/or health of the patient, user, or a third party are at risk. Comply
with this warning to avoid injury to the patient, user, or third party.

CAUTION!
These paragraphs include information provided to the operator concerning the in-
tended and proper use of the device or accessories.
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NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.
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 Safety Information

2 Safety Information
en Federal Law (only for U.S. market) CAUTION!  Federal law restricts this device to sale by or on the order of a
physician.
Exclusion of liability The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
• the device and/or the accessories are improperly used, transported, stored,
prepared, or maintained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the
device or accessories;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedules are not adhered to.
The handing over of technical documents does not constitute authorization to
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make repairs or alterations to the device or accessories.
WARNING! Modification of the devices PNEUMOCLEAR™ is not permitted.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or altera-
tions on the device or accessories and use the service menu. Any violation will void
the manufacturer's warranty. Authorized service technicians are only trained and
certified by the manufacturer.
Care and maintenance The service and maintenance of the device and its accessories has to be carried out
as per instructions to ensure the safe operation of the device. For the protection of
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the patient and the operating team, check that the device is complete and func-
tional before each use. Maintenance of the device may not be performed during
the operation.
NOTE! Service or maintenance work may not be carried out during surgery.
Contamination Before shipping, decontaminate device and accessories in order to protect the ser-
vice personnel. Follow the instructions listed in these instructions for use. If this is
not possible,
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• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Waste management This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected separately. For
disposal of the device and its accessories, please consult the manufacturer or an
authorized disposal company, in compliance with legal or national regulations.
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 General Information

3 General Information
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3.1 Device Description
The device PNEUMOCLEAR™ is an insufflator and serves to create a cavity through
the insufflation of CO2 with a preset flow rate and pressure. The gas will be trans-
ported to the patient via a tube connected with a trocar. The insufflator limits the
pressure to a maximum of 30 mmHg and the flow rate to a maximum of 50 l/min.
The device can be operated in different operating modes which are intended to suit
different surgical procedures and/or different patient’s physical characteristics.
The following table describes the different operating modes.
Operating mode Description Patients Population
designed for laparoscopies per-
used to distend the peritoneal
formed on normal weight and
Standard operating mode cavity during laparoscopic pro-
slightly obese (BMI  <  30  kg/m2)
cedures by insufflating CO2.
patients over the age of 14.
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designed for laparoscopies per-
used to distend the peritoneal
High Flow/Bariatric operating formed on normal weight and
cavity during laparoscopic pro-
mode obese patients (BMI > 30 kg/m2)
cedures by insufflating CO2.
over the age of 14.
used to distend the peritoneal designed specifically for use on
Pediatric operating mode cavity during laparoscopic pro- newborns, infants, and children
cedures by insufflating CO2. under the age of 14.
used to distend the peritoneal
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designed for laparoscopies per-
cavity during laparoscopic pro-
formed on normal weight and
Advanced Flow operating mode cedures, including but not lim-
obese patients over the age of
ited to robotic-assisted laparo-
14.
scopies by insufflating CO2.
used to distend the cavity along
the vena saphena magna and ra- designed for patients over the
Vessel Harvest operating mode
dial artery during an endoscopic age of 14.
vessel harvesting procedure.
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used to dilate and fill the rectum
and colon by insufflating CO2 designed for patients over the
TAMIS operating mode
during transanal minimally in- age of 14.
vasive surgery.
The device measures the actual pressure in the cavity and compares it to the set Essential performance
nominal pressure. The function of this device is to maintain the nominal pressure.
Overpressure within the cavity is lowered to the preset nominal pressure by the
automatic venting system.
Additional optional features are available to increase user and patient comfort:
1. Integrated gas heater to heat the insufflation gas.
2. Suction function to evacuate surgical smoke from the cavity.
3. Humidification of the insufflation gas.
These features become available by use of the appropriate tube sets, see Chapter
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Insufflation Tube Sets [} 28].
The insufflator is a pneumatic device that works through the port on the back, with
central gas as well as bottled gas. It is operated via buttons and indicators or dis-
plays on the front of the device. Optionally, the device can be operated via remote
access and a central device control, either by voice control or a remote touch panel.

3.2 Intended Use and Contraindications

3.2.1 Intended Use

The device PNEUMOCLEAR™ is a CO2- insufflator intended for use during diagnostic
and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2
gas. The operating modes Standard, High Flow/Bariatric, Pediatric and Advanced
Flow of the device are indicated to fill and distend a peritoneal cavity with gas dur-
ing a laparoscopic procedure. The Pediatric operating mode is indicated for pediat-
ric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use

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 General Information

during endoscopic vessel harvesting procedures to create a cavity along the

en saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and
distend the rectum and colon using CO2 gas during transanal minimally invasive
surgery.

3.2.2 Contraindications
The device should not be used to fill a cavity with CO2 if an endoscopy is contrain-
dicated. Please consult the manual of your endoscope for absolute and relative
contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it
may not be used to distend the uterus.
The gas flow may not exceed 14  l/min when performing a laparoscopy on new-
borns or patients weighing less than 25 kg.
The device may not be used for the endoscopic harvesting of vessels if this surgical
application is contraindicated. Please consult the manual of the instrument for ab-
solute and relative contraindications.
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3.3 Warnings

3.3.1 General Warnings CO2 Insufflation

WARNING!
Condensation / Water penetration
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Protect device from moisture. Do not use if moisture has penetrated the device.

WARNING!
Check all factory settings
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.
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WARNING!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient and
determine if the use of this device is indicated. The physician must determine the
specific technique and procedure that will accomplish the desired clinical effect.

WARNING!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environments.
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WARNING!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Notify the authorized service technicians of any required repairs.

WARNING!
Risk of electrical shock
To avoid the risk of electrical shock, only use this device when connected to a prop-
erly grounded power supply network.

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 General Information

WARNING! en
Replace the fuse
Replace the fuse only with a fuse provided by the manufacturer (see Chapter Ac-
cessories [} 69]).

WARNING!
Professional qualification
The instructions for use do not include descriptions or instructions for surgical pro-
cedures/techniques. It is not suitable for training physicians in the use of surgical
techniques. Medical peripherals and devices may be used only by physicians or
medical assistants with the appropriate technical/medical qualifications working
under the direction and supervision of a physician.
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WARNING!
Automatic device self-test
The device self-test must be performed prior to each surgery. Because the device
self-test is performed during initial start up, the unit must be power cycled (off/on)
prior to each surgery.
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WARNING!
Sterile media and accessories
Always work exclusively with sterile substances and media, sterile fluids, and
sterile accessories if so indicated.

WARNING!
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Replacement device and accessories
In case the device or any of the accessories fail during surgery, a replacement
device and replacement accessories should be kept within close proximity to be
able to finish the operation with the replacement components.

CAUTION!
Cleaning the Device
Do not sterilize the device.

WARNING!
Obvious defects
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Never use the device if it has suspected or confirmed defects, especially if these in-
volve the power plugs or the mains power supply connection cables. In this case
have the device repaired by authorized service personnel.

WARNING!
Positioning the patient
Positioning the patient lower than the device can prevent body fluids from leaking
into the tube set. Actual pressure may increase and fluid may penetrate the insuf-
flation tube if the patient is repositioned during surgery. If this occurs, immediately
disconnect the insufflation tube. When the patient is repositioned onto his or her
side, internal tissue may block the insufflation channel. Always insufflate through
the elevated side of the patient.

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 General Information

en WARNING!
Removing the insufflation tube
Always disconnect the insufflation tube after ending surgery and before switching
off the device to prevent backflow of bodily fluids. Fluid may penetrate the insuffla-
tion tube whenever you change the gas bottle and/or when you stop the gas flow
during the operation. If this happens, you must immediately disconnect the insuf-
flation tube from the trocar or from the device.

WARNING!
Backflow
Body secretions or contaminated gas can flow counter to the insufflation direction
and block the insufflation filter, if
• the actual pressure is higher than the nominal pressure or
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• the automatic venting valve is activated.

WARNING!
Gas flow
A high gas flow can occur due to large leaks within the surgical system or instru-
ment. This can result in a false actual pressure reading, which in turn may en-
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danger the patient. In case of a disrupted gas flow, you should therefore inspect
device, tube, and instruments immediately. Surgical procedures should be per-
formed with a gas flow of 4 to 10 l/min. An even lower gas flow is recommended
for diagnostic purposes.

WARNING!
Keep filled CO2 bottle on hand
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Always keep a filled CO2 bottle on hand ready for replacement. This avoids having
to interrupt surgery due to a lack of insufflation gas (see Chapter Gas Connection
[} 23]).

WARNING!
Gas supply
Maintain adequate gas supply at all times.

WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected. Make
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sure the device or/and accessories can no longer be operated until a qualified ser-
vice technician conducts the appropriate tests and repairs.

WARNING!
Fatigue symptoms
When there is a high level of CO2 consumption, you should make sure to supply the
operating area with enough fresh air, since an increasing CO2 level in the air can
cause the medical personnel to suffer fatigue symptoms, an inability to concen-
trate, unconsciousness, or even death.

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 General Information

WARNING! en
Insufflation of CO2
The insufflation of CO2 should be done carefully and while monitoring the patient's
response. The user, particularly the anesthetist, should be informed about possible
cardiovascular and respiratory problems of the patient and monitor these intra-op-
eratively.

WARNING!
Medically pure CO2
Make sure to use only medically pure CO2. Other gases (e.g., helium, N2O, argon),
mixtures of gases, gases with entrapped liquids, or polluted gases must not be
used with this device.
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WARNING!
Fill the tube set with CO2
For the safety of the patient please fill the tube set with CO2 gas prior to beginning
the insufflation by activating the insufflation for a few seconds and then turning it
off again before introducing the insufflation instrument to the cavity and begin-
ning the surgery.
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WARNING!
Lowest gas flow and pressure
Depending on age and health condition of the patient, the smallest possible gas
flow and pressure for establishing the pneumoperitoneum should be selected. It is
not recommended to exceed insufflation pressures of 15 mmHg in colo-rectal pro-
cedures.
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WARNING!
Limited venting system
The venting rate of the automatic venting system is limited. Always monitor the
actual pressure when using additional insufflation sources.

WARNING!
Connecting the tube
Always use the proper tube set for the device. The tube outlet may only be connec-
ted to instruments which are intended for intra-abdominal CO2 insufflation.
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WARNING!
Electronic device control
Do not close the valve at the cannula sleeve during surgery. The electronic control
unit of the device adjusts the actual pressure as desired.

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 General Information

3.3.2 Warnings Standard and High Flow/Bariatric Operating Mode

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WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk
of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reac-
tion).

WARNING!
CO2 absorption
CO2 is absorbed during insufflation (intravasation). This means the body absorbs a
part the CO2 gas used for insufflation. CO2 concentrations in the blood or respirat-
ory system that are too high can lead to death of the patient in extreme cases. To
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lower this risk, always carefully and closely monitor the patient's vital signs during
the entire insufflation process and make sure patient is breathing well. Sufficient
respiration can help avoid or limit problems with CO2. High pressure or a high gas
flow promotes CO2 absorption. The abdomen is sufficiently distended using a pres-
sure between 10 to 15  mmHg. Pressure values above 15  mmHg are required for
only a few cases but do increase the risk of intravasation. Never exceed the max-
imum intra-abdominal pressure of 30 mmHg.
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WARNING!
Metabolic and cardiac reactions
Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregular-
ities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
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• Reduction of venous reflux
• Reduced cardiac output
• Metabolic acidosis

WARNING!
Hypothermia/monitoring body temperature
The gas flow can lead to a lowering of the patient's body temperature during insuf-
flation. Hypothermia during insufflation can cause heart and cardiovascular prob-
lems. The risk for hypothermia can be significantly reduced with the use of gas that
is pre-warmed to body temperature. Therefore, you must always monitor the pa-
tient's body temperature during the entire insufflation process. Make especially
sure that the following, hypothermia-fostering, surgical conditions are avoided as
best as possible:
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• High gas flow due to large leaks
• Long surgeries
• Use of irrigation and infusion solutions that are not preheated to body temperat-
ure.

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 General Information

WARNING! en
Dehydration
Insufflation can lead to dehydration of the tissue, especially if the surgery time is
prolonged. This can lead to damage of peritoneal cell structures within the tissue.
Insufflation, especially with unconditioned gas, is associated with post-operative
pain. Long surgeries and large leaks increase the risk of dehydration especially at
the insertion points of the trocars.
The use of humidified and prewarmed gas can reduce risks associated with tissue
dehydration.

WARNING!
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating a
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vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk,
use a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument im-
mediately if the actual pressure rapidly reaches the nominal pressure value. CO2
embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pres-
sure settings and close damaged blood vessels at once.
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WARNING!
Subcutaneous emphysema
Incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to
emphysema. To reduce the risk, use a low gas flow rate for the initial insufflation
and ensure that the insufflation instrument is correctly positioned. Long surgeries,
the use of many access points, duration and size of leaks at these points may also
contribute to emphysema. Be sure to close leakages in trocar accesses immediately.
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WARNING!
Subcutaneous emphysema
When puncturing the thicker abdominal wall of morbidly obese patients with the
Veress cannula or the trocar, carefully monitor the correct position of the instru-
ment in the abdomen.

WARNING!
Additional insufflation sources/automatic venting system
Make sure the automatic venting system is activated (see Chapter Menu (Over-
view) [}  51]). The use of additional insufflation sources increases the intra-ab-
dominal pressure. Continuously monitor intra-abdominal pressure over the course
of the entire insufflation if additional sources are used.
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WARNING!
Altered Respiratory Physiology
Always monitor the patient's respiratory functions during the entire surgery. The
larger body mass supported by the thoracic cage and the larger amount of fat in
the abdominal cavity may reduce the elasticity of the thoracic wall. In addition, the
increased intra-abdominal pressure secondary to insufflation may alter the normal
physiological lung parameters thus resulting in a reduction of the functional lung
volume. Shallow, rapid breathing is symptomatic of this condition. Even modest
physical stress causes a tremendous increased demand for oxygen, which stands in
contrast to the ineffective respiratory musculature that requires more oxygen be-
cause it must overcome the reduced elasticity of the thoracic cage. The functional
capacity of the lungs is small and even moderate stress can lead to respiratory fail-
ure.

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 General Information

en WARNING!
CO2 supersaturation
To avoid generating CO2 supersaturation, an increased level of respiratory activity
is required. An overweight patient's oxygen demand and carbon dioxide produc-
tion are greater and increase faster under physical stress than do those of patients
with normal body weight.

WARNING!
Heart and cardiovascular insufficiency
Constantly monitor all heart and cardiovascular parameters during surgery since
morbidly obese patients have an increased risk of heart and cardiovascular insuffi-
ciencies.
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3.3.3 Warnings Pediatric Operating Mode

WARNING!
Gas flow limit
The gas flow may not exceed 14  l/min when performing a laparoscopy on new-
borns or patients weighing less than 25 kg (approximately 55 US pounds).
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WARNING!
Recommended work settings
The flow values listed for laparoscopic procedures performed on newborns, infants,
and children are only suggested values. The selection of the suitable flow and pres-
sure values is solely the responsibility of the attending physician.
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WARNING!
Pneumolabium/pneumoscrotum
Children are at risk of a pneumolabium or pneumoscrotum.

WARNING!
Procedures with children
Only those who are specially trained and qualified for procedures with children or
endoscopic vessel harvesting procedures may use this device for these purposes.

WARNING!
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Increased airway pressure
When laparoscopic procedures are performed on children, the increased intra-ab-
dominal pressure also increases the risk for higher airway pressures. Always strictly
monitor respiration and airway function when performing laparoscopic procedures
on children younger than 12 years of age.

WARNING!
Compression of the vena cava
When insufflating the abdomen of a child with medical CO2, an increased risk of
compressing the vena cava exists. This risk can be reduced by monitoring the
systolic and diastolic blood pressure during the entire surgery.

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 General Information

WARNING! en
Haemodynamic stability
A laparoscopy performed on children younger than 12  years of age may result in
problems of the haemodynamic system due to the CO2 content in the blood. It is re-
commended to increase the breathing rate of the patient and to work with low
flow values and pressure values not exceeding 12 mmHg. The patient's circulatory
system should be monitored at all times.

WARNING!
Hypothermia
The insufflation gas flow usually drops significantly after the target pressure has
been reached and it is then only required to maintain the abdominal pressure.
However, leaks within the abdomen or the instrument can lead to a constant gas
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flow of above 1 l/min. When operating on children younger than 12, a gas flow of
more than 1 l/min poses an increased risk of hypothermia for the patient. Corres-
ponding measures to prevent hypothermia include the use of blankets or pre-
warmed gas. The patient's body temperature has to be monitored at all times dur-
ing surgery.

WARNING!
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Children with cardiovascular problems
Laparoscopy with CO2 should not be performed on children with cardiovascular
problems.

WARNING!
Hypercapnia
Because pediatric patients are especially susceptible to hypercapnia, it is recom-
AF
mended to establish an end-tidal CO2 monitoring routine.

3.3.4 Warnings Vessel Harvest Operating Mode

WARNING!
CO2 absorption
Due to the special surgical procedures - start of the heart bypass operation, and the
endoscopic removal of the vessel - special care has to be taken as CO2 is always ab-
sorbed through the tissue of the patient during insufflation (intravasation). This
means the body absorbs part of the CO2 gas used for insufflation. CO2 concentra-
tions in the blood or respiratory system that are too high can lead to death of the
patient in extreme cases. To lower this risk, always carefully and closely monitor
the patient's vital signs during the entire insufflation process and make sure pa-
T
tient is breathing well. Sufficient respiration can help avoid or limit problems with
CO2. High pressure or a high gas flow promotes CO2 absorption.

WARNING!
Metabolic and cardiac reactions
Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregular-
ities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
• Reduced cardiac output
• Metabolic acidosis

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 General Information

en WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue, especially if the surgery time is
prolonged. This can lead to damage of peritoneal cell structures within the tissue.
Insufflation, especially with unconditioned gas, is associated with post-operative
pain. Long surgeries and large leaks increase the risk of dehydration especially at
the insertion points of the trocars.
The use of humidified and prewarmed gas can reduce risks associated with tissue
dehydration.

WARNING!
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating a
D
vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk,
use a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument im-
mediately if the actual pressure rapidly reaches the nominal pressure value. CO2
embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pres-
sure settings and close damaged blood vessels at once.
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WARNING!
Procedures with children
Only those who are specially trained and qualified for procedures with children or
endoscopic vessel harvesting procedures may use this device for these purposes.

WARNING!
Instrument used for CO2 insufflation
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Before using the insufflator to endoscopically harvest vessels, please check
whether the instrument used is intended for CO2 insufflation.

WARNING!
Pneumoperitoneum
When a vessel is harvested from the leg of a patient with a perforated groin, it is
possible for CO2 to reach the abdomen and cause a pneumoperitoneum. Make sure
the abdomen does not fill with CO2 during surgery.

3.3.5 Warnings TAMIS Operation Mode

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WARNING!
CO2 absorption
CO2 is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO2 gas used for insufflation. CO2 concentrations in the blood or respir-
atory system that are too high can lead to death of the patient in extreme cases. To
lower this risk, always carefully and closely monitor the patient's vital signs during
the entire insufflation process and make sure patient is breathing well. Sufficient
respiration can help avoid or limit problems with CO2. High pressure or a high gas
flow promotes CO2 absorption. Pressure values above 15  mmHg are required for
only a few cases but do increase the risk of intravasation. It is recommended not to
exceed insufflation pressures of 15mmHg during transanal minimally invasive sur-
gery.

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 General Information

WARNING! en
Lowest gas flow and pressure
Depending on age and health condition of the patient, the smallest possible gas
flow and pressure for establishing the cavity should be selected. It is not recom-
mended to exceed insufflation pressures of 15 mmHg in transanal minimally invas-
ive surgery procedures.

3.4 General Precautions

CAUTION!
Continuous operation
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After 24 hours of continuous operation, a device self-test must be carried out.
Switch device off and on again.

CAUTION!
Endoscope
The device may only be connected with endoscopes designed for and featuring the
technical specification permitting such a combined use. Any utilized endoscopes
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must comply with the most recent versions of EC 60601-2-18 and ISO 8600. Com-
bining/connecting with other devices generates a medical electrical system (MES).
The system configurator is responsible for compliance with the standard
IEC 60601-1 / EN 60601-1 in its latest version.

CAUTION!
Electrical interference
AF
(See Chapter Electromagnetic compatibility [} 62]). Care was taken during the de-
velopment and testing of this device that electrical interference of or from other
devices or instruments was practically eliminated. However, if you still detect or
suspect such interference, please follow these suggestions:
• Move this, the other, or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert

CAUTION!
Use of other accessories, other transducers and cables
The use of accessories, transducers, and cables other than those specified, with the
exception of transducers and cables sold by the MANUFACTURER of the ME EQUIP-
T
MENT or ME SYSTEM (see Chapter Glossary) as replacement parts for internal com-
ponents, may result in increased EMISSIONS or decreased IMMUNITY of the ME
EQUIPMENT or ME SYSTEM.

CAUTION!
ME Device in Rack
The ME device may not be used when stacked or stored directly adjacent to or with
other devices. If it should be necessary to operate the device close to stacked with
other devices, the ME device or ME system should be monitored to ensure it works
properly as configured.

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 General Information

en CAUTION!
Service connection
Service connection is reserved for service tasks . The connected equipment must
comply with the standard EN 60950 in the currently valid version. Do not connect a
device to the service connection during surgery.

CAUTION!
Peripheral Devices
Additional peripheral equipment connected to interfaces of the medical monitor
has to meet the requirements of the following specifications in the respective cur-
rent valid version: IEC  60601-2-18 / EN  60601-2-18 for endoscopic devices and
IEC 60601-1 / EN 60601-1 for electrical medical devices. All configurations have to
comply with IEC 60601-1 / EN 60601-1 specifications. Whoever connects additional
D
equipment to signal output or signal input is considered the system configurator
and as such is responsible for complying with requirements of the standard
IEC 60601-1 / EN 60601-1.

CAUTION!
Mains Power Cable
Any power cables employed by the user that are not provided by the manufacturer
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must meet the safety requirements of the national standards in the respective cur-
rent valid version.
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 Initial Device Setup

4 Initial Device Setup

The operation of the device PNEUMOCLEAR™ is reserved for medical staff with the en
relevant professional qualifications trained to use the device.

NOTE!
Locations
The device may be used only in the hospital or operating rooms.

Always check all parts and optional accessories of the device immediately after re- Delivery inspection
ceiving the shipment. The manufacturer only considers replacement claims that
have been immediately submitted or reported to a sales representative or an au-
thorized service company.
If it becomes necessary to return the device, always use the original packaging. The Returning the device
manufacturer does not take responsibility for damage that has occurred during
transportation if the damage was caused by inadequate transport packaging.
D
Please keep the original packaging.
Please make sure that all required information has been supplied:
• Name of owner
• Address of owner
• Device type and model
• Serial number of the equipment (see identification plate)
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• Detailed description of defect

4.1 Device Setup and Connection

Place the device on a flat surface free of vibration located in a dry environment. The Setting up
ambient conditions must meet the requirements mentioned in Chapter Technical
Data [} 67].
AF
CAUTION!
ME systems
The medical electrical (ME) device is suitable for integration in ME equipment sys-
tems (see Chapter  Glossary). Operation of the ME device in vicinity of non-ME
devices may result in voiding the intended use of the ME device.

CAUTION!
Device setup
Device should be positioned outside of the sterile area in such a way that
• it can be easily disconnected,
• it is easy to use and switch off and on,
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• it allows an easy monitoring of the display values, device functions, and access
to the control elements.

CAUTION!
Ventilation of the device
• Avoid device overheating.
• Ensure free air circulation especially to the bottom and rear of the device (rear
panel distance of at least 10 cm).

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 Initial Device Setup

en CAUTION!
Position of the user
To ensure safe operations of the device, the user must be positioned correctly to-
wards the device
• within a display viewing angle of ±50° to operate the device,
• up to 2 m/6.5 ft from the device front for monitoring the actual values.

NOTE!
Device Control
The device may be optionally controlled via Stryker's central device control in the
operating room.
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Mains connection

CAUTION!
Mains connection
• Make sure the available mains voltage matches the data listed on the type la-
bel attached to the back of the device. Incorrect voltage can cause errors and
malfunctions and may destroy the device.
• Make sure the connection data and technical specifications of the power sup-
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ply comply with DIN VDE or national requirements. The mains connection
cable may be plugged only into a properly installed, grounded safety wall
socket (shockproof socket) (see DIN VDE 0100-710).
• Read the device label located in rear of device (type plate) to determine the op-
erating voltage of the device.

Grounding contact The power connection must be equipped with ground contact (protective contact).
Use the original power cable (if included in scope of delivery) to establish a connec-
tion between the mains wall socket and the non-heating device plug located in the
AF
rear of the device.
Only for U.S. operators Only use a certified (UL-listed), removable mains connection cable, type SJT, min-
imal 18  AWG, 3 leads. The plug connectors must comply with NEMA 5-15 and
IEC 60320-C13. Grounding will only be reliable if the equipment is connected to a
corresponding hospital grade socket.
Potential equalization The equipotential bonding is used as a protective measure against the failure of
the protective conductor according to requirements of IEC 60601-1 in the respect-
ively valid version. The installation must be according to the relevant local safety
regulations.

4.2 Front of the Device

Fig. 4–1  Device front
(1) ON/OFF switch
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(2) Monitor with touch screen
(3) Tube connection
(4) Eject button

(1) (2) (3) (4)

Familiarize yourself with the control and function elements at the front of the
device.

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 Initial Device Setup

4.3 Rear of the Device

Fig. 4–2  Device rear en
(5) Type plate
(5) (6) (7) (8) (9) (10) (6) Device data plate
(7) USB port (only for authorized
service technician)
(8) Device Control Interface
(9) Data input/output (only for au-
thorized service technician)
(10) Gas outlet
(11) Fuse holder
(12) Device mains socket
(13) Connection for potential
equalization
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(14) (13) (12) (11) (14) Gas supply connection

Familiarize yourself with the connection elements at the rear of the device.

4.4 Gas Connection

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WARNING!
Medically pure CO2
Make sure to use only medically pure CO2. Other gases (e.g., helium, N2O, argon),
mixtures of gases, gases with entrapped liquids, or polluted gases must not be
used with this device.
AF
WARNING!
Gas supply
Maintain adequate gas supply at all times.

Use a high-pressure tube to connect a CO2 gas bottle to the rear gas inlet connec-
tion or connect to centralized CO2 gas supply.
The device is equipped with a universal gas connector that can be configured with
different adapters to support both central gas and bottle gas supply.
It supports gas supply pressures from 3.4 bar (50 psi) to 80 bar (1160 psi).
The gas connector has an exchangeable sinter filter to protect the insufflator from Exchangable sinter filter
dirt particles. This filter has to be checked during the annual test and be replaced at
least every two years. During the maintenance the sinter filter has to be ex-
changed. The sinter filter is available as a spare part (see Chapter 14 Accessories
T
[} 69]). The sinter filter may be blocked or soiled due to unclean gas or gas supply
residues. Heavy soiling is especially noticeable during higher flow rates. As a result, (1)

the actual gas flow is falling short of the nominal gas flow during active insuffla-
tion or the device is showing gas supply warnings although gas supply is sufficient.
In this case the sinter filter needs to be exchanged.
(2)
1. Remove the connector (1) using two open-end wrenches size 17  mm and
19 mm.
2. Unscrew the sinter filter (2) using a screwdriver if necessary.
3. Screw the new sinter filter finger-tight and fasten the connector to the device.

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 Initial Device Setup

Angled gas connector An angled connector is available to reduce the depth needed for the installation of
en the device. This connector includes the exchangeable sinter filter and allows the
use of the different gas supply adapters described below as well.
Fig. 4–3  Connecting the gas supply to
the angled gas connector
D
4.4.1 Connecting a Gas Bottle

WARNING!
Keep filled CO2 bottle on hand
Always keep a filled CO2 bottle on hand ready for replacement. This avoids having
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to interrupt surgery due to a lack of insufflation gas (see Chapter Gas Connection
[} 23]).

CAUTION!
High-pressure hose
Always use a high-pressure hose to connect gas bottle and device.
AF
The gas bottle must be in a vertical position. The gas bottle pressure may not ex-
ceed 80 bar/1160.3 psi or be less than 15 bar/217.5 psi.

CAUTION!
Gas bottles with riser pipe
Gas bottles with riser pipe can release dirt and oily fluids into the device. Do not
use a gas bottle with riser pipe.

High-pressure hoses The following high-pressure hoses are available:

Designation
High-Pressure Hose Device US/Bottle DIN
High-Pressure Hose Device US/Bottle ISO
High-Pressure Hose Device US/Bottle PIN Index
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Installation High-Pressure Hoses with PIN Connector
• Connect or loosen to the device using the open-end wrench size 14 mm.
• Connect or loosen to the gas bottle with your hand.
High-Pressure Hoses with DIN Connector
• Connect or loosen to the device using the open-end wrench size 14 mm.
• Connect or loosen to the gas bottle using the open-end wrench size 30 mm.
High-Pressure Hoses with ISO Connector
• Connect or loosen to the device using the open-end wrench size 14 mm.
• Connect or loosen to the gas bottle using the open-end wrench size 32 mm.

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 Initial Device Setup

Switching valve
There is a switching valve available that allows the connection of two gas bottles to en
the insufflator. This ensures uninterrupted insufflation particularly during the
change of the gas bottle.

4.4.2 Connecting to Central Gas Supply

The following low-pressure hoses are available for connecting to the central gas Low-pressure hoses
supply:
Designation
Hose for CO2 central gas supply DISS-DISS, 0.9 m/3 ft
Hose for CO2 central gas supply DIN-US, 3 m/10 ft
Hose for CO2 central gas supply DIN-US, 5 m/16.5 ft
Hose for CO2 central gas supply AGA-US, 3 m/10 ft
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Hose for CO2 central gas supply AGA-US, 5 m/16.5 ft
Hose for CO2 central gas supply NF-US, 3 m/10 ft
Hose for CO2 central gas supply NF-US, 5 m/16.5 ft
Hose for CO2 central gas supply UNI-US, 3 m/10 ft
Hose for CO2 central gas supply UNI-US, 5 m/16.5 ft
• Connect or loosen to the device using the open-end wrench size 14 mm. Installation
• Connect or loosen to the central gas supply receptacle on the wall pulling the
R
plug in or out.
An adapter and a low-pressure tube are required for connecting to the central gas
supply with DISS connection:
• DISS Adapter for gas connection
• DISS Hose for central gas supply
1. Remove the connector (1) using two open-end wrenches size 17  mm and Exchange of the gas supply adapter
19 mm.
AF
2. Check if the sinter filter (3) needs a change (residues or blocked pores).
3. Exchange the sinter filter using a screwdriver.
4. Install the new connector (2) using the open-end wrenches. (1)

For older NIST central gas supply hoses there is a NIST adapter available:
• NIST Adapter for gas connection
Set in the user menu the type of gas supply: central gas or bottle gas supply (see
Chapter Menu (Overview) [} 51]). (2) (3)

4.5 Gas Supply

The status of the gas supply is monitored by the device and indicated with icons
and acoustic signals.
The following gas bottle pressures are displayed: Gas supply with gas bottle
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Icon Description

≥ 40 bar/580.1 psi
(green)

< 40 bar/580.1 psi - 20 bar/290 psi

(green)

< 20 bar/290 psi - 10 bar/145 psi. Acoustic signals can be heard and a message is dis-
played. User is advised to prepare for changing the gas bottle.
(yellow)

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 Initial Device Setup

Icon Description
en
< 10 bar /145 psi - 4 bar /58 psi. Acoustic signals can be heard and a message is dis-
played. Replace the gas bottle.
(red)

< 4 bar /58 psi - 0 bar / 0 psi. Acoustic signals can be heard and a message is displayed.
Immediately replace the gas bottle.
(red)

Central gas supply The following central gas supply icons are displayed:
Icon Description

Central gas supply pressure OK

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(green)

Central gas supply pressure too low

(red)

4.6 Switching Device On

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Fig. 4–4  Setting up the device

(1)
(3) (2)
AF
1. Connect the device with the mains power.
2. Connect the gas supply to the gas connection port and open the gas supply.
3. Press the ON/OFF switch. The power LED lights up green when the device is
turned on.
4. The device performs an automatic self-test after being switched on. If the self-
test is not successful, the corresponding error message will be displayed (see
Chapter Error and Warning Messages [} 65]).
5. The language selection is displayed when starting the device for the first time.
Select the desired language and confirm with the Continue button on the bot-
tom left.
6. The display depicts an overview of the insufflation operating modes. Unavail-
able operating modes are depicted in gray and cannot be selected. Press the re-
spective button to select the desired operating mode (e.g. Standard).
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Unavailable insufflation operation modes can be unlocked. For this, contact your
customer service.

4.7 Switching Device Off

In order to safely terminate the operation of the system, press the ON/OFF switch.

Disconnect device from power supply Disconnect the device from the mains power supply (pull cable out off the groun-
ded safety wall socket) if the device is not being used for several days or longer.

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 Initial Device Setup

WARNING! en
Never pull on the cable
Always hold on to the power plug when disconnecting the device from the power
supply. Never pull on the cable itself.

WARNING!
Power supply
Disconnection from the power supply is only guaranteed if the mains plug is pulled
from the mains wall socket.
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 Operating the Device - General

5 Operating the Device - General

en
5.1 Monitor with Touch Screen
Fig. 5–1  Screen displays
(1) Actual pressure display
(2) Gas heating status (1) (2) (3) (4) (5) (6) (7) (8)
(3) Operating mode display
(4) Gas supply display
(5) Gas humidification status
(6) Reduce nominal gas flow
(7) Actual gas flow display
(8) Increase nominal gas flow (20)
(9) Nominal gas flow display (9)
(19) (10)
(10)
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Increase smoke evacuation
level (11)
(18) (12)
(11) Setting smoke evacuation
level and display of smoke (13)
evacuation state ON/OFF/
PAUSE
(12) Reduce smoke evacuation
level
(17) (16) (15) (14)
(13) Message display
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(14) Gas consumption display with
reset button The touch screen depicted above shows all buttons when the insufflator is stopped.
(15) START/STOP button Additional explanations for individual elements are listed in the subsequent con-
trol element descriptions.
(16) Menu button/speaker volume
(during insufflation)
(17) Back button (selection of op- 5.2 Insufflation Tube Sets
erating mode) Different insufflation tube set types can be connected to the insufflation tube con-
AF
(18) Increase pressure nection at the front of the device.
(19) Reduce pressure
(20) Nominal pressure display
Icon Description Information

Disposable tube set with:

• Filter

HIGH-FLOW TUBE SET

To be used with the following operating
(0620050100/blue) modes:
Standard, - Pediatric, - HighFlow/Bariat-
ric, - Advanced Flow, -Vessel Harvest, -
TAMIS
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Disposable tube set with:
• Filter
• Gas heating
HEATED HIGH-FLOW TUBE SET
To be used with the following operating
(0620050200/green) modes:
Standard, - Pediatric, - HighFlow/Bariat-
ric, - Advanced Flow, -Vessel Harvest, -
TAMIS

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 Operating the Device - General

Disposable tube set with:

• Filter en
SMOKE EVACUATION HIGH-FLOW TUBE • Lumen for smoke evacuation with
SET filter
(0620050250/black) To be used with the following operating
modes:
Standard, - Pediatric, - HighFlow/Bariat-
ric, - Advanced Flow, - TAMIS

Disposable tube set with:

• Filter
• Gas heating
HEATED HUMIDIFIED TUBE SET • Gas humidification
D
(0620050300/red) To be used with the following operating
modes:
Standard, - Pediatric, - HighFlow/Bariat-
ric, - Advanced Flow, -Vessel Harvest, -
TAMIS

Disposable tube set with:

• Filter
R
• Gas heating
HEATED HUMIDIFIED SMOKE EVACU- • Gas humidification
ATION TUBE SET • Lumen for smoke evacuation with
(0620050350/orange) filter
To be used with the following operating
modes:
Standard, - Pediatric, - HighFlow/Bariat-
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ric, - Advanced Flow, -TAMIS
All tube sets are intended for single use.
The tube sets have been sterilized with ethylene oxide according to procedures val-
idated by ISO 11135-1 and ISO 10993-7.
Transponder technology (RFID) automatically detects the tube type, the validity, as RFID technology/Invalidating a tube set
well as the reliability of a tube set.
After insertion of the tube set and starting insufflation, the tube set is marked as
used after 10  minutes and thereafter can only be used with the same insufflator
and will not be valid for use with another insufflator. The tube set then can be used
for maximal 12 hours before it is invalidated. However, for each patient, a new and
sterile tube set must be used. Insufflation can be stopped and restarted (start-stop-
button) during the use, this will not invalidate the tube set. The device may be
switched off and on for a limited time without invalidating the tube set. But if the
device is switched off for more than 2 hours the tube set will be invalid and cannot
T
be used after restart.
If an invalidated tube set is connected to the device, the message Invalid Tube Set
appears. If this is the case, insufflation is not possible unless a valid tube set is in-
serted.

5.3 Connecting an Insufflation Tube Set

WARNING!
Visual inspection of the tube set
Before the operation, perform a visual inspection of the tube set and its packaging.
Damaged tube sets or tube sets from damaged packagings may not be used.

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 Operating the Device - General

en WARNING!
Air in the insufflation tube set
Air in the insufflation tube set can cause an embolism.
Start the insufflation before the tube set is connected to the patient to push the air
out of the insufflation tube set. Stop the insufflation when at least 1 liter of CO2
has been insufflated.

Connecting the tube set 1. Align the bottom of the tube set connector with the bottom of the receptacle
on the front of the insufflator,
2. then push the top of the tube set connector until the tube set audibly snaps
into place.
2. A short acoustic signal is emitted.
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1.

Removing the tube set Press the eject button to remove the tube set. Hold the tube set to prevent it from
falling to the floor when being ejected.
If the tube set has been removed the device will return to the operating mode se-
R
lection screen after 10 minutes of idle time.

5.4 Using Gas Heating

It is possible to insufflate gas with a body temperature (approximately 37 °C/99 °F)
with the help of tubes with heating function (see Chapter Insufflation Tube Sets
[} 28]).
AF
NOTE!
Slow moving gas
If the actual flow is < 5 l/min, the gas temperature might be below 37 °C when en-
tering the trocar. Slow moving gas cools down quickly.

CAUTION!
Direct heat
Do not subject the heating tube to direct heat (e.g., endoscope connected with
light source) or high room temperatures.

The device automatically determines whether a tube set with or without gas heat-
ing is connected. After the corresponding tube set has been correctly identified,
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Gas Heater OK is displayed.
The insufflator automatically controls the gas heater at the start and stop of the in-
sufflation.
The following table describes all possible gas heater states, the corresponding
icons as well as additional information.
Icon Description Information

Inactive gas heating Gas heating function is not available.

(grey)

Insufflation can be continued. The heating tube has not yet reached the
Gas temperature is low
optimum heating temperature.
(blue)

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 Operating the Device - General

Icon Description Information

en
Gas heater OK Gas heating function is available.
(green)
Insufflation is automatically stopped and the heating function is deac-
tivated. There are three options to continue insufflation:
Safety Feature Warning
• Wait until the temperature has decreased below 43 °C, insufflation
Insufflation paused due to gas and heating will resume automatically.
exceeding 43 °C/109 °F. Insuf-
(red) • Disconnect and reconnect tube set. If temperature is below 43  °C
flation will resume shortly.
insufflation with heating can be resumed (manual start).
• Exchange tube set with a new one.
Insufflation can be continued in this case but the heating function is
not available.
Gas heater defective Restart the device if you want to use the heating function. If the gas
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(red) heating is still defective, have an authorized service technician check or
repair the device.

5.5 Using the Smoke Evacuation Function

WARNING!
Surgical smoke in operating room
R
Do not vent surgical smoke to the operating room. Use the provided smoke evacu-
ation function with integrated filter if possible.

WARNING!
Increased concentration of CO2 in the operating room
Smoke evacuation function may increase the CO2 concentration in the operating
AF
room.
Ensure sufficient supply of fresh air and use the smoke extraction function only if it
is necessary.
Fig. 5–2  Smoke evacuation indicator
(10) Increase smoke evacuation
level
(11) Set smoke evacuation level/
ON/OFF/PAUSE
(12) Reduce smoke evacuation level

(10)
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(11)
(12)

An additional function of the device is the extraction of smoke from the cavity. Use
tubes with an additional lumen for smoke evacuation (see Chapter Insufflation
Tube Sets [} 28]) to extract the smoke.

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 Operating the Device - General

To enable this function, insert a valid tube set and then press the Smoke evacu-
en ation button (11). Use the +/- buttons (see Fig. Smoke evacuation indicator [} 31]
(10)/(12)) to increase or reduce the extraction intensity. The smoke evacuation
rate can be manually set to the following rates: 1, 2, 3, and 4.
Not all rates are available in all operating modes.
Nominal flow setting must be higher than smoke evacuation flow rate otherwise
actual evacuation performance will be limited.
Fig. 5–3  Connections of the tube set
with smoke evacuation
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water trap
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at insufflation trocar

at second trocar
Suggested minimum flow settings to ensure proper smoke evacuation:
Smoke evacuation rate Approximate evacuation Minimum nominal flow (l/
flow (l/min) min)
1 3 8
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2 6 11
3 9 14
4 12 17
Smoke evacuation is not available for Vessel Harvest mode.

CAUTION!
Do not lift the water trap.
If the water trap hangs horizontally or upside down, smoke evacuation filter can be
clogged.

Smoke evacuation icons Description Information

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Smoke evacuation function is This icon means that the smoke evacuation function is
turned off. turned off. To activate this function, press this icon.

(white)

Smoke evacuation function is This icon means that the smoke evacuation function is
turned on. turned on. To switch off this function, press this icon.

(green)

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 Operating the Device - General

Smoke evacuation icons Description Information

This icon means that the smoke evacuation function is en
paused. To switch off this function, press this icon.
Smoke evacuation is automatically paused if:
Smoke evacuation function is • the abdominal pressure is too low,
paused. • the insufflation line is plugged or closed,
(yellow) • or the smoke evacuation line is plugged or closed.
Smoke evacuation will automatically resume once the
preconditions are restored again.

This icon means that the smoke evacuation function is

Smoke evacuation function not not available in the selected operating mode or the con-
available. nected tube set is not suitable or the vacuum pump is de-
fective.
(greyed out)
D
5.6 Use of Insufflation Gas Humidification Function
An additional function of the device is the humidification of the insufflation gas.
Use tubes with a humidification function (see Chapter Insufflation Tube Sets
[} 28]) to warm up the insufflation gas to approximately 37 °C/99 °F and to humid-
ify the gas. If a suitable tube set is connected, a corresponding message is shown
on the display.
R
For filling and refilling the humidification tube set with sterile water or saline the Filling and refilling the humidification
insufflation needs to be stopped. In the sterile field: tube set
• fill syringe with 10 ml of sterile water or saline by means of a syringe as shown
in Fig. Filling the gas humidification tube [} 33].
Lift up the distal end of the tube set, connect the syringe to the Luer Lock connector
and gently empty it into the tube set.
Fig. 5–4  Filling the gas humidification
tube
AF
After filling the tube set and confirming the humidification dialog the blue humidi-
fication icon is displayed (5).
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 Operating the Device - General

Fig. 5–5  Insufflation gas humidification

en indicator
(5) Humidification icon (blue)

(5)
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Refilling
R
NOTE!
To refill the tube set
The humidification tube set provides approximately 200 l of humidified gas when
filled with water or saline. After 200 l of gas have 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 l of consumed gas. To refill the tube set, press
the humidification icon and follow the instructions.
AF
Press the humidification icon to start the refilling process. Pressing the humidifica-
tion icon will give the user the option to pause the running insufflation for refilling
purpose. While insufflation is not running tube set refilled question appears on the
display.

CAUTION!
Filling the tube set
Filling the tube set with more than 10 ml of water can lead to formation of water
drops. Do not refill the tube set if the absorber is still soaked with water.

Humidification icons Description Information

T
Humidification tube set connected, push icon Indicates that a tube set with humidification
to start refill work flow. ability is connected.

(blue)

Humidification tube set is not connected or

Humidification not available.
function defective and therefore deactivated.

(grey)

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 Operating the Device - General

5.7 Using Device Control

Please consult the additional documentation of SDC3 HD Information Manage- Documentation en
ment System for information about settings, use, and troubleshooting before con-
necting the insufflator to it. Physicians and medical or care and support personnel
must be thoroughly familiar with the setup and operation of the Stryker Device
Control.
The insufflator is prepared for the Stryker Device Control which can be used option- Purpose
ally. The connection of the insufflator to the Device Control system allows the re-
mote control and the remote display of the following insufflation parameters:
• Device Status (e.g. gas supply, gas heater)
• Messages
• Procedure modes
• Flow and pressure parameters
• Smoke evacuation function
D
There are several ways to control the device once connected to Stryker Device Con-
trol:
• Using the touchscreen on Device Control
• Using the remote to control the Device Control menu on the surgical display
• Using the Stryker Camera Head
• Using the Voice Control feature
R
If Device Control is connected and active, the functions and settings of the insuf-
flator may be adjusted using the buttons on the insufflator as well as the device
control system.
A communication of the insufflator through the Device Control interface is only Required characteristics
possible with a Stryker SDC3 device. This is ensured by a device identification
mechanism. The insufflator is compatible with the SDC3 when the Device Driver
Package is installed on the SDC3.
Required configuration
Fig. 5–6  Connecting the PneumoClear
AF
to the Device Control
Device Control PneumoClear

Interface: USB-B connector Technical specification

Protocol: Sidne Serial Device Protocol
The SIDNE interface cable is a standard four conductor USB-A male to USB-B male
cable. The configuration of the connection is preset and cannot be changed. No
manual configuration by the user is required.
T
The Device Control connection to the insufflator is a master/slave connection to re- Intended information flow
motely control the insufflator and remotely display insufflator parameters.
Device Control as the communication master initiates the communication by send-
ing requests. The insufflator as communication slave responds to the requests.
Basic safety and essential performance are not influenced by this remote control
feature because Device Control is only optional to the insufflator user interface
control and not required to operate the insufflator. The insufflator only executes
requests which are within the limits of the allowed insufflator settings.
A failure of connection between insufflator and Device Control will cause List of hazardous situations potentially
• no reaction of insufflator if controlled by Device Control, resulting from a failure of the
connection to Device Control
• Device Control will not show actual values of insufflator.
The insufflator can always be controlled by its touch screen. Unexpected discon-
nection to the Device Control will not affect this.

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 Operating the Device - General

5.8 Unlocking Operating Modes

en The device can be equipped with up to 6 procedure modes.
Device Standard Version Device Plus Version
High Flow/Bariatric Operating Mode High Flow/Bariatric Operating Mode
Standard Operating Mode Standard Operating Mode
Pediatric Operating Mode Pediatric Operating Mode
Vessel Harvest Operating Mode Vessel Harvest Operating Mode
TAMIS Operating Mode
Advanced Flow Operating Mode
TAMIS and Advanced Flow operating modes can be purchased separately. Contact
your sales representative for more information on how to purchase them and how
to get your device upgraded.
D
5.9 Displaying/Selecting Insufflation Operating Mode
The display depicts an overview of the insufflation operating modes. Unavailable
operating modes are depicted in gray and cannot be selected. Press the respective
button to select the desired operating mode (e.g. Standard).
The displayed parameters correspond with the factory settings or the values set in
the user menu (see Chapter Menu (Overview) [} 51]).
R
5.10 Setting the Nominal Pressure - All Operating Modes
To set the nominal pressure, press the + or - button Screen displays [} 28] on the
display below the actual pressure display.
• The nominal pressure can be increased or decreased during insufflation or
while insufflation is stopped.
• With every touch of the + or - button the nominal pressure is increased/re-
duced in steps of 1  mmHg. When pressing the pressure button longer,
scrolling is activated but only up to the respective, operating mode-dependent
AF
safety threshold (see below).
• An operating mode-dependent safety threshold (12 or 15 mmHg) applies when
setting the nominal pressure. If the pressure is to be increased above these val-
ues, the depicted query on the operating screen of the insufflator must be con-
firmed accordingly.

WARNING!
Exceeding the safety limit
Exceeding this safety limit is to be decided by and the responsibility of the user/op-
erator.
T
Operating Mode Safety threshold
High Flow/Bariatric Operating Mode 15 mmHg
Standard Operating Mode 15 mmHg
Pediatric Operating Mode 12 mmHg/15 mmHg
Vessel Harvest Operating Mode 12 mmHg/15 mmHg
TAMIS Operating Mode 15 mmHg
Advanced Flow Operating Mode 15 mmHg

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 Operating the Device - General

5.11 Setting the Nominal Flow - All Operating Modes

To set the nominal flow, press the + or - buttons (see Fig. Screen displays [}  28] en
(10)/(12)) on the display below the actual gas flow display.
• With every touch of the + or - button the nominal flow is increased/reduced in
steps of 1 l/min. When working within the range of 0.1 to 2 l/min in Pediatric
Operating Mode, the value is increased/reduced by 0.1  l/min. When pressing
the flow button longer, scrolling through the flow levels is activated but only
up to the respective, operating mode-dependent safety threshold (see below).
• When setting the nominal flow rate, Pediatric operating mode has a safety
threshold at 5  l/min, Vessel Harvest at 6  l/min. If the flow is to be increased
above these values, the depicted query must be confirmed accordingly.

WARNING!
Exceeding the safety limit
D
Exceeding this safety limit is to be decided by and the responsibility of the user/op-
erator.

Operating Mode Safety threshold

High Flow/Bariatric Operating Mode n.a
Standard Operating Mode n.a
R
Pediatric Operating Mode 5 l/min
Vessel Harvest Operating Mode 6 l/min
TAMIS Operating Mode n.a
Advanced Flow Operating Mode n.a

CAUTION!
Safety threshold
AF
The safety threshold of the nominal flow is deactivated per default.

The safety threshold of the nominal flow can be activated/deactivated in the User
Menu.
Veress insufflation is a gentle type of insufflation that prevents exceeding the pre- Veress insufflation
set nominal pressure by the actual pressure even in case of small volumes. To min-
imize the risks in case of a faulty incision, the manufacturer recommends using
Veress insufflation to start a procedure (filling abdomen with CO2).

CAUTION!
Venting system
Please note that the automatic venting system is not active during Veress insuffla-
tion.
T
The activation of the Veress insufflation depends on the chosen mode. How to activate Veress Insufflation
Pediatric Mode: With a nominal flow setting of ≤ 1 l/min, Veress Insufflation is dis-
played after pressing the START/STOP button.
High Flow/Bariatric, Standard, Advanced Flow Mode: With a nominal flow setting
of ≤ 5 l/min, Veress Insufflation is displayed after pressing the START/STOP button.
Vessel Harvest, TAMIS: Veress insufflation is not available.

5.12 Running Function Tests before Device Use

Check all the sterile disposable items before removing them from the package to Preparation
ensure that the packaging is intact and that the expiration date is still valid.
For your own safety and that of your patient, use only original accessories (see
Chapter Accessories [} 69]).

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 Operating the Device - General

en WARNING!
Functional test
The functional test must be successfully completed prior to each surgery.

WARNING!
Fill the tube set with CO2
For the safety of the patient please fill the tube set with CO2 gas prior to beginning
the insufflation by activating the insufflation for a few seconds and then turning it
off again before introducing the insufflation instrument to the cavity and begin-
ning the surgery.

WARNING!
D
Cannula
Do not attach any cannula with tube set to patient during the function test.

Checking the device

NOTE!
Checking the device
R
This test can be conducted with the tube set and cannula that will be used for the
procedure. Consider sterile/non-sterile aspects during handling.

1. The device is switched off, no tube set is connected.

2. Make sure the gas supply is connected and open.
3. Use the ON/OFF switch to turn the device on. The device now conducts an
automatic self-test.
4. Select the operating mode (e.g. Pediatric).
AF
5. Under consideration of sterile/non-sterile aspects open the package of the in-
sufflation tube set that will be used for the procedure. Connect the tube set to
the device.
6. Attach the insufflation tube to the cannula and close the stopcock.
7. If the gas consumption display field (see Chapter Gas Consumption Display
[} 39]) depicts a value, press the button to reset the display to zero 0 L.
8. Select a nominal pressure of 8 mmHg and a gas flow of 2 l/min.
9. Start insufflation: Press the START button.
10. Insufflate approximately 30 seconds. The display status line depicts Occlusion
after maximum 4 seconds.
11. Stop insufflation: Press the STOP button.
T
WARNING!
Leak in system
If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If
this is the case, use steps 12 to 14 outlined below to locate the leak.

12. Repeat steps 7 to 11 without cannula and with closed tube end. The previously
connected cannula has a leak if gas consumption is now below 0.4 l.
13. Repeat steps 8 to 12 with a new tube if another leak becomes apparent. If the
gas consumption is now below 0.4 l, the previously used tube set has a leak.
14. If another leak is detected, this leak is then directly within the device. Make
sure the device can no longer be operated until an authorized service techni-
cian conducts the appropriate checks.

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 Operating the Device - General

WARNING! en
Leaky insufflation tube
Never work with a leaky insufflation tube, accessory, and/or device. This can lead to
an incorrect measurement of the actual pressure values, which can cause an un-
controlled pressure increase in the abdomen.

Choose desired operating mode, pressure and flow settings and continue with pro-
cedure.

5.13 Gas Consumption Display

The gas consumption display indicates the insufflated volume of CO2 in liters since
the last resetting of the display.
The gas consumption display can be reset to 0.0 during running or stopped insuf- Resetting the display
flation.
D
(1) Press the button to reset the gas consumption display.

5.14 Starting/Stopping Insufflation

Either the START or STOP button is displayed depending on insufflation status.

(1)
R
Start insufflation:
The START button is displayed when insufflation is stopped.
(2) Press this button to start insufflation.
AF
(2)

Stop insufflation:
The STOP button is displayed while insufflation is active.
(3) Stop insufflation by pressing the STOP button.

(3)
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 Operating the Device - General

5.15 Desufflation
en The Desufflation function allows for the remaining CO2 in the cavity to be removed
to a pressure of approximately 3 mmHg after insufflation has been stopped. Desuf-
flation is available after the insufflation when a smoke evacuation tube is connec-
ted. After stopping, a query is displayed asking whether the desufflation function
should be started.
Fig. 5–7  Confirming or denying desuf-
flation
D
The display shows Desufflation active. Desufflation can be stopped at any time
with the Cancel button.
R
Desufflation ends automatically once the actual pressure in the cavity is
≤ 3 mmHg. The display shows Desufflation finished.
Mode Desufflation
High Flow/Bariatric Mode available
Standard Mode available
Pediatric Mode not available
Vessel Harvest Mode not available
AF
TAMIS Mode not available
Advanced Flow Mode available
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 Operating Modes of the PNEUMOCLEAR™ Insufflator

6 Operating Modes of the PNEUMOCLEAR™ Insufflator

en
CAUTION!
Deviation between cavity pressure and pressure display
The insufflator measures the pressure via the tube set. Using a tight trocar/instru-
ment combination limits the equalization of pressure between cavity and tube set.
Consequently, the device potentially displays a pressure that is higher than the
pressure in the cavity. This can lead to a decrease of the distention performance.
For a good equalization of pressure, it is suggested to ensure there is adequate
clearance for flow between trocar and the instrument.

NOTE!
D
Maximum gas flow
The actual maximum gas flow into the cavity is limited by the Luer lock connection,
the trocar and the inserted endoscope or instrument. It is suggested to ensure
there is adequate clearance for flow between the trocar and the instrument.

Modes Overview
Standard Pediatric High Flow / Advanced Flow Vessel Harvest TAMIS
Bariatric
R
Nominal flow (l/min) 1 - 40 0.1 - 20 1 - 45 1 - 50 1 - 10 0.5 - 40
Level 1: 3 Level 1: 0,1 Level 1: 5 Level 1: 5 Level 1: 1 Level 1: 3
Flow levels (l/min) Level 2: 20 Level 2: 2 Level 2: 25 Level 2: 25 Level 2: 4 Level 2: 10
Level 3: 40 Level 3: 20 Level 3: 45 Level 3: 50 Level 3: 10 Level 3: 40
Safety threshold flow (l/min) n.a. 5 n.a. n.a. 6 n.a.
Starting pressure 15 8 15 15 10 12
AF
Set pressure (mmHg) 1 - 30 1 - 20 1 - 30 1 - 30 1 - 20 1 - 20
Pressure increments (mmHg) 1 1 1 1 1 1
Safety threshold pressure
15 12/15 15 15 12/15 15
(mmHg)

6.1 Standard Operating Mode

The Standard operating mode is used to distend the peritoneal cavity during lap-
aroscopic procedures by insufflating CO2.
The Standard operating mode is designed for laparoscopies performed on normal Patients
weight and slightly obese (BMI < 30 kg/m2) patients over the age of 14.
The maximum nominal pressure can be set to 30  mmHg and the maximum gas Insufflation parameters
flow to 40 l/min.
T
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk
of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reaction).

41 / 77
 Operating Modes of the PNEUMOCLEAR™ Insufflator

en WARNING!
CO2 absorption
CO2 is absorbed during insufflation (intravasation). This means the body absorbs a
part the CO2 gas used for insufflation. CO2 concentrations in the blood or respirat-
ory system that are too high can lead to death of the patient in extreme cases. To
lower this risk, always carefully and closely monitor the patient's vital signs during
the entire insufflation process and make sure patient is breathing well. Sufficient
respiration can help avoid or limit problems with CO2. High pressure or a high gas
flow promotes CO2 absorption. The abdomen is sufficiently distended using a pres-
sure between 10 to 15  mmHg. Pressure values above 15  mmHg are required for
only a few cases but do increase the risk of intravasation. Never exceed the max-
imum intra-abdominal pressure of 30 mmHg.

WARNING!
D
Metabolic and cardiac reactions
Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregular-
ities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
R
• Reduced cardiac output
• Metabolic acidosis

WARNING!
Hypothermia/monitoring body temperature
The gas flow can lead to a lowering of the patient's body temperature during insuf-
flation. Hypothermia during insufflation can cause heart and cardiovascular prob-
AF
lems. The risk for hypothermia can be significantly reduced with the use of gas that
is pre-warmed to body temperature. Therefore, you must always monitor the pa-
tient's body temperature during the entire insufflation process. Make especially
sure that the following, hypothermia-fostering, surgical conditions are avoided as
best as possible:
• High gas flow due to large leaks
• Long surgeries
• Use of irrigation and infusion solution not pre-heated to body temperature.

WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue, especially if the surgery time is
T
prolonged. This can lead to damage of peritoneal cell structures within the tissue.
Insufflation, especially with unconditioned gas, is associated with post-operative
pain. Long surgeries and large leaks increase the risk of dehydration especially at
the insertion points of the trocars.
The use of humidified and prewarmed gas can reduce risks associated with tissue
dehydration.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

WARNING! en
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating a
vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk,
use a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument im-
mediately if the actual pressure rapidly reaches the nominal pressure value. CO2
embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pres-
sure settings and close damaged blood vessels at once.

WARNING!
Emphysema
Incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to
D
emphysema. To reduce the risk, use a low gas flow rate for the first insufflation and
ensure that the insufflation instrument is correctly positioned. Long surgeries
(>  200 min.), the use of many access points, duration and size of leaks at these
points may also contribute to emphysema. Be sure to close leakages in trocar ac-
cesses immediately.

WARNING!
R
Additional insufflation sources / automatic venting system
Make sure the automatic venting system is activated (see Chapter Menu (Over-
view) [}  51]). The use of additional insufflation sources increases the intra-ab-
dominal pressure. Continuously monitor intra-abdominal pressure over the course
of the entire insufflation if additional sources are used.

6.2 High Flow/Bariatric Operating Mode

AF
The High Flow/Bariatric operating mode is used to distend the peritoneal cavity
during laparoscopic procedures by insufflating CO2. It features a constantly in-
creased performance to compensate port side leakages and continuing smoke
evacuation over the time of the procedure.
The High Flow/Bariatric operating mode is designed for laparoscopies performed Patients
on normal weight and obese patients (BMI > 30 kg/m2) over the age of 14.
The High Flow/Bariatric operating mode may be used for a number of different
procedures, including but not limited to:
• weight loss surgery
• bowel resection
• colorectal surgery
The maximum nominal pressure can be set to 30  mmHg and the maximum gas Insufflation parameters
T
flow to 45 l/min.

WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk
of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reaction).

43 / 77
 Operating Modes of the PNEUMOCLEAR™ Insufflator

en WARNING!
CO2 absorption
CO2 is absorbed during insufflation (intravasation). This means the body absorbs a
part the CO2 gas used for insufflation. CO2 concentrations in the blood or respirat-
ory system that are too high can lead to death of the patient in extreme cases. To
lower this risk, always carefully and closely monitor the patient's vital signs during
the entire insufflation process and make sure patient is breathing well. Sufficient
respiration can help avoid or limit problems with CO2. High pressure or a high gas
flow promotes CO2 absorption. The abdomen is sufficiently distended using a pres-
sure between 10 to 15  mmHg. Pressure values above 15  mmHg are required for
only a few cases but do increase the risk of intravasation. Never exceed the max-
imum intra-abdominal pressure of 30 mmHg.

WARNING!
D
Metabolic and cardiac reactions
Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregular-
ities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
R
• Reduced cardiac output
• Metabolic acidosis

WARNING!
Hypothermia/monitoring body temperature
The gas flow can lead to a lowering of the patient's body temperature during insuf-
flation. Hypothermia during insufflation can cause heart and cardiovascular prob-
AF
lems. The risk for hypothermia can be significantly reduced with the use of gas that
is pre-warmed to body temperature. Therefore, you must always monitor the pa-
tient's body temperature during the entire insufflation process. Make especially
sure that the following, hypothermia-fostering, surgical conditions are avoided as
best as possible:
• High gas flow due to large leaks
• Long surgeries
• Use of irrigation and infusion solution not pre-heated to body temperature.

WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue, especially if the surgery time is
T
prolonged. This can lead to damage of peritoneal cell structures within the tissue.
Insufflation, especially with unconditioned gas, is associated with post-operative
pain. Long surgeries and large leaks increase the risk of dehydration especially at
the insertion points of the trocars.
The use of humidified and prewarmed gas can reduce risks associated with tissue
dehydration.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

WARNING! en
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating a
vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk,
use a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument im-
mediately if the actual pressure rapidly reaches the nominal pressure value. CO2
embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pres-
sure settings and close damaged blood vessels at once.

WARNING!
Emphysema
Incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to
D
emphysema. To reduce the risk, use a low gas flow rate for the first insufflation and
ensure that the insufflation instrument is correctly positioned. Long surgeries
(>  200 min.), the use of many access points, duration and size of leaks at these
points may also contribute to emphysema. Be sure to close leakages in trocar ac-
cesses immediately.
R
WARNING!
Additional insufflation sources / automatic venting system
Make sure the automatic venting system is activated (see Chapter Menu (Over-
view) [}  51]). The use of additional insufflation sources increases the intra-ab-
dominal pressure. Continuously monitor intra-abdominal pressure over the course
of the entire insufflation if additional sources are used.
AF
WARNING!
Altered Respiratory Physiology
Always monitor the patient's respiratory functions during the entire surgery. The
larger body mass supported by the thoracic cage and the larger amount of fat in
the abdominal cavity may reduce the elasticity of the thoracic wall. In addition, the
increased intra-abdominal pressure secondary to insufflation may alter the normal
physiological lung parameters thus resulting in a reduction of the functional lung
volume. Shallow, rapid breathing is symptomatic of this condition. Even modest
physical stress causes a tremendous increased demand for oxygen, which stands in
contrast to the ineffective respiratory musculature that requires more oxygen be-
cause it must overcome the reduced elasticity of the thoracic cage. The functional
capacity of the lungs is small and even moderate stress can lead to respiratory fail-
ure.
T
WARNING!
Subcutaneous emphysema
When puncturing the thicker abdominal wall of morbidly obese patients with the
Veress cannula or the trocar, carefully monitor the correct position of the instru-
ment in the abdomen.

WARNING!
CO2 supersaturation
To avoid generating CO2 supersaturation, an increased level of respiratory activity
is required. An overweight patient's oxygen demand and carbon dioxide produc-
tion are greater and increase faster under physical stress than do those of patients
with normal body weight.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

en WARNING!
Heart and cardiovascular insufficiency
Constantly monitor all heart and cardiovascular parameters during surgery since
morbidly obese patients have an increased risk of heart and cardiovascular insuffi-
ciencies.

6.3 Pediatric Operating Mode

The Pediatric operating mode is used to distend the peritoneal cavity during lap-
aroscopic procedures by insufflating CO2.
Patients The Pediatric operating mode is designed specifically for use on newborns, infants,
and children under the age of 14.
Insufflation parameters The maximum nominal pressure can be set to 20  mmHg and the maximum gas
D
flow to 20 l/min.
For use with children, the control of the device - depending on nominal flow selec-
tion - is optimized and recommended based on age and weight as per the follow-
ing:
Age group Weight Flow range
Children younger than 1 year approximately 1 - 9 kg 0.1 – 0.5 l/min
Children between 1-3 years approximately 10 - 15 kg 0.5 – 1.0 l/min
R
Children between 3-4 years approximately 16 - 19 kg 1.0 – 2.0 l/min
Children between 4-14 years > 20 kg > 2.0 l/min und < 14 l/min
All children < 25 kg ≤ 14 l/min

WARNING!
Recommended work settings
AF
The flow values listed for laparoscopic procedures performed on newborns, infants,
and children are only suggested values. The selection of the suitable flow and pres-
sure values is solely the responsibility of the attending physician.

NOTE!
Limited smoke evacuation function
The smoke evacuation function is limited to rate 1 and 2. The use of the smoke
evacuation function requires a minimal flow setting, for further information refer
to the table given in Chapter Using the Smoke Evacuation Function [} 31]. Do not
exceed the recommended flow settings, especially for newborns, infants, and small
children.
T
WARNING!
Gas flow limit
The gas flow may not exceed 14  l/min when performing a laparoscopy on new-
borns or patients weighing less than 25 kg (approximately 55 US pounds).

WARNING!
Pneumolabium/pneumoscrotum
Children are at risk of a pneumolabium or pneumoscrotum.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

CAUTION! en
Low nominal flow setting
The nominal pressure cannot be reached in case of leaks if the nominal flow is set
too low.

WARNING!
Procedures with children
Only those who are specially trained and qualified for procedures with children or
endoscopic vessel harvesting procedures may use this device for these purposes.
D
WARNING!
Increased airway pressure
When laparoscopic procedures are performed on children, the increased intra-ab-
dominal pressure also increases the risk for higher airway pressures. Always strictly
monitor respiration and airway function when performing laparoscopic procedures
on children younger than 12 years of age.
R
WARNING!
Compression of the vena cava
When insufflating the abdomen of a child with medical CO2, an increased risk of
compressing the vena cava exists. This risk can be reduced by monitoring the
systolic and diastolic blood pressure during the entire surgery.

WARNING!
AF
Haemodynamic stability
A laparoscopy performed on children younger than 12  years of age may result in
problems of the haemodynamic system due to the CO2 content in the blood. It is re-
commended to increase the breathing rate of the patient and to work with low
flow values and pressure values not exceeding 12 mmHg. The patient's circulatory
system should be monitored at all times.

WARNING!
Hypothermia
The insufflation gas flow usually drops significantly after the target pressure has
been reached and it is then only required to maintain the abdominal pressure.
However, leaks within the abdomen or the instrument can lead to a constant gas
flow of above 1 l/min. When operating on children younger than 12, a gas flow of
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more than 1 l/min poses an increased risk of hypothermia for the patient. Corres-
ponding measures to prevent hypothermia include the use of blankets or pre-
warmed gas. The patient's body temperature has to be monitored at all times dur-
ing surgery.

WARNING!
Children with cardiovascular problems
Laparoscopy with CO2 should not be performed on children with cardiovascular
problems.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

en WARNING!
Hypercapnia
Because pediatric patients are especially susceptible to hypercapnia, it is recom-
mended to establish an end-tidal CO2 monitoring routine.

6.4 Advanced Flow Operating Mode

The Advanced Flow operating mode is used to distend the peritoneal cavity during
laparoscopic procedures, including but not limited to robotic-assisted laparoscop-
ies by insufflating CO2. The Advanced Flow operating mode is designed to com-
pensate for large leaks e.g. due to the use of suction instruments.
Patients The Advanced Flow operating mode is designed for laparoscopies performed on
normal weight and obese patients over the age of 14.
The Advanced Flow operating mode may be used for a number of different proced-
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ures, including but not limited to:
• Prostatectomy
• Hysterectomy
• Gastrectomy
• Colectomy
• Nephrectomy
Insufflation parameters The maximum nominal pressure can be set to 30  mmHg and the maximum gas
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flow to 50 l/min.

6.5 Vessel Harvest Operating Mode

The Vessel Harvest operating mode is used to distend the cavity along the vena
saphena magna and radial artery during an endoscopic vessel harvesting proced-
ure.
Patients The Vessel Harvest operating mode is designed for patients over the age of 14.
AF
Insufflation parameters The maximum nominal pressure can be set to 20  mmHg and the maximum gas
flow to 10 l/min.

WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk
of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reac-
tion).

WARNING!
CO2 absorption
Due to the special surgical procedures - start of the heart bypass operation, and the
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endoscopic removal of the vessel - special care has to be taken as CO2 is always ab-
sorbed through the tissue of the patient during insufflation (intravasation). This
means the body absorbs part of the CO2 gas used for insufflation. CO2 concentra-
tions in the blood or respiratory system that are too high can lead to death of the
patient in extreme cases. To lower this risk, always carefully and closely monitor
the patient's vital signs during the entire insufflation process and make sure pa-
tient is breathing well. Sufficient respiration can help avoid or limit problems with
CO2. High pressure or a high gas flow promotes CO2 absorption.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

WARNING! en
Metabolic and cardiac reactions
Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregular-
ities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
• Reduced cardiac output
• Metabolic acidosis

WARNING!
Dehydration
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Insufflation can lead to dehydration of the tissue, especially if the surgery time is
prolonged. This can lead to damage of peritoneal cell structures within the tissue.
Insufflation, especially with unconditioned gas, is associated with post-operative
pain. Long surgeries and large leaks increase the risk of dehydration especially at
the insertion points of the trocars.
The use of humidified and prewarmed gas can reduce risks associated with tissue
dehydration.
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WARNING!
Embolism/insufflation of internal organs
Improper placement of the insufflation instrument could cause gas penetrating a
vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk,
use a low flow rate for the first insufflation and ensure that the insufflation instru-
ment is correctly positioned. Check the position of the insufflation instrument im-
AF
mediately if the actual pressure rapidly reaches the nominal pressure value. CO2
embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pres-
sure settings and close damaged blood vessels at once.

WARNING!
Procedures with children
Only those who are specially trained and qualified for procedures with children or
endoscopic vessel harvesting procedures may use this device for these purposes.

WARNING!
Instrument used for CO2 insufflation
Before using the insufflator to endoscopically harvest vessels, please check
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whether the instrument used is intended for CO2 insufflation.

WARNING!
Pneumoperitoneum
When a vessel is harvested from the leg of a patient with a perforated groin, it is
possible for CO2 to reach the abdomen and cause a pneumoperitoneum. Make sure
the abdomen does not fill with CO2 during surgery.

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 Operating Modes of the PNEUMOCLEAR™ Insufflator

6.6 TAMIS Operating Mode

en The TAMIS operating mode is used to dilate and fill the rectum and colon by insuf-
flating CO2 during transanal minimally invasive surgery.
Patients The TAMIS operating mode is designed for patients over the age of 14.
Insufflation parameters The maximum nominal pressure can be set to 20  mmHg and the maximum gas
flow to 40 l/min.

WARNING!
Lowest gas flow and pressure
Depending on age and health condition of the patient, the smallest possible gas
flow and pressure for establishing the cavity should be selected. It is not recom-
mended to exceed insufflation pressures of 15 mmHg in transanal minimally invas-
ive surgery procedures.
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WARNING!
CO2 absorption
CO2 is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO2 gas used for insufflation. CO2 concentrations in the blood or respir-
atory system that are too high can lead to death of the patient in extreme cases. To
lower this risk, always carefully and closely monitor the patient's vital signs during
the entire insufflation process and make sure patient is breathing well. Sufficient
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respiration can help avoid or limit problems with CO2. High pressure or a high gas
flow promotes CO2 absorption. Pressure values above 15  mmHg are required for
only a few cases but do increase the risk of intravasation. It is recommended not to
exceed insufflation pressures of 15mmHg during transanal minimally invasive sur-
gery.

CAUTION!
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Different indication to taTME
The TAMIS indication is different than the taTME (trans anal total mesorectal ex-
cision) procedure.
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 Menu (Overview)

7 Menu (Overview)
Mode and user-dependent device settings can be changed in the menu. en
User Menu Operating Mode Options Default
Standard 1 - 15 mmHg 15 mmHg
Starting pressure (Operat- High Flow/Bariatric 1 - 15 mmHg 15 mmHg
ing mode dependent)
Advanced Flow 1 - 15 mmHg 15 mmHg
Sets the initial nominal
Pediatric 1 - 12 mmHg 8 mmHg
pressure value for each
mode Vessel Harvest 1 - 15 mmHg 10 mmHg
TAMIS 1 - 15 mmHg 12 mmHg

Rate 1: 1 - 5 l/min Rate 1: 3 l/min

Standard Rate 2: Rate 1+1 - 39 l/min Rate 2: 20 l/min
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Rate 3: Rate 2+1 - 40 l/min Rate 3: 40 l/min
Rate 1: Rate 1 - 5 l/min Rate 1: 5 l/min
High Flow/Bariatric Rate 2: Rate 1+1 - 44 l/min Rate 2: 25 l/min
Gas Flow Rates (Operating Rate 3: Rate 2+1 - 45 l/min Rate 3: 45 l/min
mode dependent)
Rate 1: 1 - 5 l/min Rate 1: 5 l/min
Sets the flow rates for each
mode Advanced Flow Rate 2: Rate 1+1 - 49 l/min Rate 2: 25 l/min
Rate 3: Rate 2+1 - 50 l/min Rate 3: 50 l/min
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Rate 1 0.1 - 2 l/min Rate 1: 0.1 l/min
Flow rate 1 will be loaded
per default in operating Pediatric Rate 2: Rate 1+1 - 19 l/min Rate 2: 2 l/min
screen, holding the flow Rate 3: Rate 2+1 - 20 l/min Rate 3: 20 l/min
button will allow scrolling
through the rates Rate 1: 1 - 5 l/min Rate 1: 1 l/min
Vessel Harvest Rate 2: Rate 1+1 - 9 l/min Rate 2: 4 l/min
Rate 3: Rate 2+1 - 10 l/min Rate 3: 10 l/min
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Rate 1: 0.5 - 5 l/min Rate 1: 3 l/min
TAMIS Rate 2: Rate 1+1 - 39 l/min Rate 2: 10 l/min
Rate 3: Rate 2+1 - 40 l/min Rate 3: 40 l/min

- Always ON
Standard In Veress mode OFF
- In Veress mode OFF
- Always ON
High Flow/Bariatric In Veress mode OFF
- In Veress mode OFF
- Always ON
Advanced Flow In Veress mode OFF
Venting valve (Operating - In Veress mode OFF
mode dependent) - Always ON
Pediatric Always ON
- In Veress mode OFF
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- Always ON
Vessel Harvest Always OFF
- Always OFF
- Always ON
TAMIS Always ON
- Always OFF

Standard Evacuation level 1-4 Level 1

Smoke Evacuation Level High Flow/Bariatric Evacuation level 1-4 Level 1
(Operating mode depend-
Advanced Flow Evacuation level 1-4 Level 1
ent)
Pediatric Evacuation level 1-2 Level 1
Sets the default starting
suction rate for each mode Vessel Harvest Not available
TAMIS Evacuation level 1-4 Level 1

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 Menu (Overview)

User Menu Operating Mode Options Default

en Brightness
Display Audio All modes 3
Level 1-4
General Volume
3
Level 1-4
Audible Occlusion Signal
- ON ON
- OFF
Audible Smoke Evacuation
paused Signal
OFF
- ON
- OFF
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- House gas
Gas Supply All modes House gas
- Bottle gas

- English
- Français - Suomi
- Deutsch - Greek
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- Español - Svenska
- Português - Dansk
Languages All modes English
- Italiano - Polski
- Nederlands - Românã
- Norsk - Korean
- Simplified - Japanese
Chinese
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Software version All modes Displays the installed software version xx.xx

Allows the user to reset all setting done in the user

Factory reset All modes
menu to factory default after confirmation.

Unlock new procedures via an upgrade code

Procedure upgrade All modes
Pass code entry
Authorized access only
Service menu All modes
Passcode entry
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 Safety Functions

8 Safety Functions
en
8.1 Automatic Venting System
The device is equipped with an automatic venting system. Automatic venting system
When the insufflator detects an overpressure it automatically activates the venting
system. The venting system releases gas from the cavity until the set nominal pres-
sure has been reached again.
The automatic venting system can be configured in the user menu individually for
each operating mode.
When the venting system is active, the venting threshold is 3  mmHg above set
pressure with a delay of 3  seconds. There is instant venting if actual pressure is
6 mmHg above set pressure.
If the venting valve is deactivated, the message Venting valve deactivated is shown
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when the mode is activated and an acoustic signal is emitted.
The venting function will always be automatically activated without delay if the
abdominal pressure exceeds 45 mmHg, even if the venting system is deactivated.
The manufacturer advises against using additional, non-pressure-controlled insuf- Insufflation source
flation sources during minimally invasive surgical procedures.
The use of CO2-cooled lasers and argon beamers can lead to values exceeding the
recommended and safe pressure rating.
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WARNING!
Additional insufflation sources / automatic venting system
Make sure the automatic venting system is activated (see Chapter Menu (Over-
view) [} 51]). The use of additional insufflation sources increases the intra-abdom-
inal pressure. Continuously monitor intra-abdominal pressure over the course of
the entire insufflation if additional sources are used.
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WARNING!
Limited venting system
The venting rate of the automatic venting system is limited. Always monitor the
actual pressure when using additional insufflation sources.

If the overpressure cannot be reduced by the automatic venting system within Overpressure
5 seconds, the display depicts Overpressure. An acoustic signal is emitted.
Once the nominal pressure limit of the used operating mode has been reached/ex-
ceeded the display depicts the message Maximum pressure reached! A warning
signal is emitted at the same time.
If the actual pressure exceeds 45 mmHg for more than 10 seconds the display de-
picts the message Excessive Overpressure along with an acoustic signal.
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8.2 Occlusion
When the tube, Veress cannula, or trocar experiences a blockage, the display de- Warning display "Occlusion"
picts Occlusion and gives an acoustic signal. The actual pressure displays 0 mmHg.
The acoustic signal can be activated/deactivated in the user menu.

CAUTION!
Measurement in the body cavity
The pressure in the body cavity cannot be measured during an occlusion!

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 Safety Functions

8.3 Contamination
en
WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected. Make
sure the device or/and accessories can no longer be operated until a qualified ser-
vice technician conducts the appropriate tests and repairs.

Error message "Contamination" When fluid has penetrated the device via the insufflation tube connection, the dis-
play depicts Contamination and gives an acoustic signal. 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 operating mode is no longer possible. If
insufflation is not restarted during 20 minutes or if the device is turned off and on
D
again, further use of the device is not possible. This is to prevent cross-contamina-
tion.
Contamination When you turn on an already contaminated device, a corresponding message ap-
pears on the display. The device can no longer be used. The contaminated device
has to be clearly marked as contaminated and sealed in two separate protective
layers of safety foil. Make sure the device cannot be used until a qualified service
technician conducts the appropriate tests and repairs.
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8.4 Leakage Detection
If the device is not able to achieve the set pressure, a leakage notification is dis-
played.
Leakages can occur at port sides, port sealings or due to excessive use of a suction
device.
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 Care and Maintenance

9 Care and Maintenance

Special care is necessary when servicing, maintaining, and storing the device and en
its accessories to maintain the functionality of the device and its accessories.

NOTE!
Service or maintenance work
Service or maintenance work may not be carried out during surgery.

9.1 Cleaning the Device

The manufacturer recommends that the device is cleaned after every procedure as Manufacturer’s specifications
follows:
1. Use the ON/OFF button (push-push) to turn the device off.
2. Remove the power cable.
D
3. Wipe the surface of the device with a soft lint-free cloth moistened with the
surface disinfectant (for example Meliseptol® rapid). The concentration and
the time the disinfectant must be applied, depends on the information
provided by the manufacturer of the disinfectant. Make sure moisture does
not enter the device.

CAUTION!
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Cleaning the Device
Do not sterilize the device.

9.2 Maintenance Intervals

The manufacturer stipulates that qualified personnel or hospital technicians must Manufacturer's specifications
regularly test the device to assess its functionality and technical safety. This inspec-
AF
tion has to be carried out once a year. The tests are described in Chapter Annual In-
spection [} 58].
Regular inspections will assist in early detection of possible malfunctions. This
helps to preserve the device and increases its safety and service life.

9.3 Maintenance by Authorized Service Technician

An authorized service technician has to inspect and service the device at appropri- Two-year maintenance interval
ate intervals to ensure its safety and functionality. The minimum service interval is
two years, depending on frequency and duration of use. If the service interval is not
maintained, the manufacturer does not assume any liability for the functional
safety of the device.
A sticker located on the rear panel of the device states the latest date for the next
service or maintenance check.
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Authorized service technicians are only trained and certified by the manufacturer. Authorized trained personnel
All of the service tasks, such as changes, modifications, repairs, calibrations, etc.
may be carried out only by the manufacturer or manufacturer-approved trained
and skilled technicians.
The manufacturer is not liable for the operational safety of the device if unauthor- Unauthorized personnel
ized persons conduct this maintenance or any other service tasks.
Unauthorized opening of the device and repairs performed by unauthorized per- Liability
sonnel or third parties and/or changes or modifications release the manufacturer
of any liability concerning the operational safety of the device.
Receiving technical documentation from the manufacturer does not authorize indi- Technical documents
viduals to perform repairs, adjustments, or alterations on the device or accessories/
peripherals.

55 / 77
 Care and Maintenance

Certification Ask the service technician for a certificate after he or she has inspected the unit or
en performed any service tasks. This certificate lists the type and scope of the service
as well as the date and name of the servicing company together with the signature
of the service technician.

WARNING!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Notify the authorized service technicians of any required repairs.

WARNING!
Modification of the device
This device may not be modified without the permission of the manufacturer.
D
WARNING!
Modified device
If the device is modified, suitable examinations and tests must be carried out to en-
sure further safe use of the device.
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9.4 Replacing the Fuse

CAUTION!
Replace the fuse
Before replacing the fuse, check the values for the fuse to be inserted in accordance
with Chapter Technical Data [} 67].
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The fuse may be defective and is in need of replacement if:
• displays and LEDs (if available on your equipment) do not light up,
• the device does not function.
Check to make sure
• the main power supply cable is properly connected to the power supply input
and to a safety socket,
• the house power supply fuse is functioning.

WARNING!
Checking the fuse
Unplug the power cable from the device before checking the fuse.
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 Care and Maintenance

The device does not have to be opened to replace the fuse.

Fig. 9–1  Opening the fuse holder en

A
D
B

1. Switch device off.

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2. Disconnect device from power supply by pulling the mains plug from the
mains socket.
3. Remove power connection cable from mains socket.
4. The fuse holder is located next to the mains socket.
5. Remove fuse holder as depicted in Fig. Opening the fuse holder [} 57].
6. A Undo the latch of the fuse holder with two fingers.
7. B Remove the fuse holder.
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8. C Check fuse.
9. Insert a new fuse. Use only the specified type of fuse (see Chapter  Technical
Data [} 67]).
10. Insert the fuse holder until it can be heard snapping into place.
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 Annual Inspection

10 Annual Inspection
en Measured values and tolerances Each test conducted must be documented with date and signature on the test log.
The following measuring tools and resources are required to determine the listed
measurements and tolerances:
Manometer Range 0-100 mmHg, error class 1 (± 1 % of span)
Syringe 60 ml
PNEUMOCLEAR™ HIGH-FLOW TUBE SET
Silicone tube 4 mm x 40 cm
T-adapter 6/4/6
Veress cannula length 100 mm
opening diameter 1.4 mm,
inner cannula diameter 1.6 mm
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An authorized service technician must check the device if the specified parameters
and tolerances are exceeded.

10.1 Electrical Safety Test

1. Perform a visual inspection. Make sure that
– the fuse corresponds with the specifications indicated by the manufac-
turer,
– labels and stickers on device are legible,
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– the mechanical condition of the device allows for its safe use,
– the device is clean to ensure proper and safe functionality.
2. Carry out the measurements for the ground leakage current, short-circuit cur-
rent/housing leakage current, and the protective conductor resistance as per
IEC 62353 in the current version or according to the applicable national stand-
ard.
AF
10.2 Basic Function Test (in Standard Operating Mode)
1. Remove insufflation tube from the device.
2. Use the On/Off switch to turn the device on. The device now conducts a device
check. An audible signal can be heard. Set the Standard operating mode.
3. A nominal pressure of 15 mmHg and a nominal flow of 3 l/min are set at the
factory.
4. The following values are displayed:
Nominal pressure 15* (mmHg)
Nominal gas flow 3* (l/min)
Actual pressure 0 (mmHg)
Gas consumption 0.0 (l)
*These values correspond with the factory setting. If values in the user menu
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were changed, these changed values are displayed. Insert an PNEUMOCLEAR™
HIGH-FLOW TUBE SET.
5. Start insufflation: Press the START button. The following values are displayed:
Actual pressure 0 (mmHg)
Veress Insufflation is displayed. Streaming gas can be heard at the insufflation
tube.
6. Select a nominal gas flow of 20 l/min. The following value is displayed:
Nominal gas flow 20 l/min
Actual pressure 0 (mmHg)
Insufflation Active is displayed. Streaming gas can be heard at the insufflation
tube.

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 Annual Inspection

7. Stop insufflation: Press the STOP button.

The following values are displayed: en
Actual pressure 0.0 (mmHg)
Gas consumption > 0.0 (l)
8. Press the gas volume button.
Gas consumption 0.0 (l)
The basic function check of the device is complete.

10.3 Pressure Sensor Test (Standard Operating Mode)

Fig. 10–1  Pressure sensor test setup
(1) Manometer
(2) Syringe
(3) PNEUMOCLEAR™ HIGH-FLOW
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TUBE SET
(4) Silicone tube
(5) T adapter

(1)
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(4)

(3)

(3) (5)
(2)
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CAUTION!
Gas extraction
Never use the syringe to extract gas from the device.

1. Set the Standard operating mode.

2. Select a nominal gas flow rate of 1.0 l/min.
Do not press the START/STOP button.
3. Connect a manometer and an air-filled syringe to the insufflation tube connec-
tion.
4. Use the syringe to generate a pressure of 10 mmHg, which is indicated on the
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manometer.
Actual pressure display: 10 (mmHg)
5. Use the syringe to generate a pressure of 20 mmHg, which is indicated on the
manometer.
Actual pressure display: 20 (mmHg)
6. Use the syringe to generate a pressure of 30 mmHg, which is indicated on the
manometer.
Actual pressure display: 30 (mmHg)

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 Annual Inspection

10.4 Pressure Monitoring Test (in Standard Operating Mode)

en See also Chapter Technical Data [} 67].
1. In the user menu activate the Venting Valve.
2. Go to the OP Screen.
3. Set the Standard operating mode.
4. Select a nominal pressure of 15 mmHg and a nominal gas flow of 3 l/min.
5. Use the syringe to create pressure between 27 mmHg and 30 mmHg, indicated
on the manometer. Start insufflation: Press the START button. An acoustic sig-
nal is emitted (for 5  seconds) and the display depicts Overpressure while the
pressure exceeds 18 mmHg (measured with external manometer).
6. Reduce the pressure. The warning ends when the pressure falls below
19 mmHg (nominal pressure plus 4 mmHg). Stop insufflation: Press the STOP
button.
7. Select a nominal pressure of 29 mmHg.
D
8. Use the syringe to generate a pressure of at least 31 mmHg, which is indicated
on the display. Start insufflation: Press the START button. An acoustic signal is
emitted with a pressure of more than 30 mmHg and the display depicts Max-
imum Insufflation Pressure Reached.
9. Reduce the pressure. The warning ends when the pressure falls below
30 mmHg. Stop insufflation: Press the STOP button.
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10.5 Venting Valve Test
See also chapter Pressure Sensor Test (Standard Operating Mode) [} 59].
1. In the user menu Venting System, switch the venting system on (if setting
Veress Insufflation OFF).
2. Select a nominal pressure of 15 mmHg and a nominal gas flow of 10 l/min.
3. Use the syringe to generate a pressure of at least 18 mmHg, which is indicated
on the manometer. Start insufflation. The venting valve is activated with a
AF
pressure of more than 18 mmHg (for 3 seconds).

10.6 Maximum Device Pressure Test

Fig. 10–2  Connections for maximum
device pressure test
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(1)

(2)
(3)

1. Select Standard operating mode.

2. Select the maximum nominal gas flow.

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 Annual Inspection

3. Connect a manometer (1) and an open Veress cannula (3) to the insufflation
tube connection (2). en
4. Start insufflation:
Press the START button. The manometer registers a pulsing pressure increase.
When the pressure stabilizes, the manometer registers a pressure between 55
and 65 mmHg
5. Stop insufflation:
Press the STOP button.

10.7 Gas Flow Rate Test

Test setup with open connection, without connected insufflation tube.
• Select a nominal gas flow rate of 15 l/min.
• Start insufflation:
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Press the START button.
• Press the gas volume button (0.0 l must be displayed).
• Now start measuring for one minute.
• Stop the insufflation after one minute: Press the STOP button.
The gas consumption should be at least 11-12 l.
Each successfully conducted test must be documented with the test log.
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 Electromagnetic compatibility

11 Electromagnetic compatibility
en
CAUTION!
Accessories
To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-
sion, the device PNEUMOCLEAR™ must be used only with the accessories listed in
Chapter Accessories [} 69].

Precautionary measures
Medical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
The device is to be used only for the purposes described in the Instructions for Use
and is intended for use in environments in Professional Healthcare Facility Environ-
ment. This applies even if individual requirements meet the conditions for deviat-
ing electromagnetic environments. During installation and commissioning as well
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as during operation of the device, the compliance with the notes and instructions
for EMC must be strictly observed.
To ensure the basic safety and essential functionality in relation to electromagnetic
interference over the life of the device, the device must be restarted after 24 hours
so that a diagnostic self-test can be performed. The maintenance intervals indic-
ated in Chapter Maintenance Intervals [} 55] must also be observed.
This device complies with the electromagnetic compatibility (EMC) requirements
for medical electrical devices as defined by IEC 60601-1-2. The limits used in testing
R
provide a basic level of safety against typical electromagnetic interference likely to
occur in professional health care facilities. Nevertheless, it can happen that indi-
vidual performance features are no longer available or only to a limited extent due
to the presence of EM interference.
In the presence of EM interference, it may happen that the heating function is af-
fected. If the heating function is influenced by EM interference, it will be switched
off for safety reasons. After the EM interference has faded, the heating function is
reactivated.
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11.1 Electrical Connections
ESD (Electrostatic Discharge) The following are ESD precautionary measures:
precautionary measures • Apply potential equalization (PE), if available on your equipment, to all devices
to be connected.
• Use only the listed equipment and accessories.
Hospital employees should be informed about and trained in ESD precautionary
measures.

11.2 Guidance and Manufacturer's Declaration - Electromagnetic

Emissions
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The device PNEUMOCLEAR™ is intended for use in an environment as described be-
low. The user/operator of the device PNEUMOCLEAR™ should make sure the device
is operated within such an environment.

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 Electromagnetic compatibility

Emissions test Compliance Electromagnetic environment - guidance

The device PNEUMOCLEAR™ uses RF energy solely for its en
internal function. Therefore, its RF emissions are very low
RF emissions CISPR 11 Group 1
and are not likely to cause any interference in nearby elec-
tronic equipment.
The device PNEUMOCLEAR™ is suitable for use in all estab-
lishments, other than public establishments and those
RF emissions CISPR 11 Class B
directly connected to the public mains network that sup-
plies buildings used for public purposes.
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/ flicker
Complies
emissions IEC 61000-3-3

11.3 Guidelines and Manufacturer's Statement - Electromagnetic

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Interference Immunity
The device PNEUMOCLEAR™ is intended for use in an electromagnetic environment
as described below. The user/operator of the device PNEUMOCLEAR™ should make
sure the device is operated within such an environment.
Electromagnetic inter- IEC 60601 test level Compliance levels Electromagnetic environment guidelines
ference immunity tests
Floors should be made from wood or concrete or
Electrostatic discharges ± 8 kV contact ± 8 kV contact
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covered with ceramic tiles. If the floor covering
(ESD) IEC 61000-4-2 ± 2, ± 4, ± 8, ± 15 kV air ± 2, ± 4, ± 8, ± 15 kV air consists of synthetic material, the relative humid-
ity should be at least 30 %.
Electrical fast transi- ± 2 kV for power lines ± 2 kV for power lines The quality of the supply voltage should be the
ents/bursts according to same as the voltage of a typical business or hos-
IEC 61000-4-4 Modulation 100 kHz Modulation 100 kHz pital environment.
The quality of the supply voltage should be the
Surges according to ±1 kV line(s) to line(s) ±1 kV line(s) to line(s)
same as the voltage of a typical business or hos-
IEC 61000-4-5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth pital environment.
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0 % UT; 0.5 cycle 0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°,
Blackouts, brownouts, 180°, 225°, 270° and 180°, 225°, 270° and
and fluctuations of the 315° 315°
power supply according 0 % UT; 1 cycle and 0 % UT; 1 cycle and
to IEC 61000-4-11 70  %  UT; 25/30 cycles 70  %  UT; 25/30 cycles
Single phase: at 0° Single phase: at 0°
0 % UT; 250/300 cycles 0 % UT; 250/300 cycles
Supply frequency Magnetic fields of the mains power frequency
(50/60  Hz) magnetic 30 A/m 30 A/m should comply with the typical values of business
field IEC 61000-4-8 and hospital environments.
3 Vrms 3 Vrms
0.15 MHz to 80 MHz 0.15 MHz to 80 MHz
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Conducted RF 6  Vrms in ISM bands 6  Vrms in ISM bands
IEC 61000-4-6 between 0.15  MHz and between 0.15  MHz and
80 MHz 80 MHz
80 % AM at 1 kHz 80 % AM at 1 kHz
3 V/m 0.15  MHz to 3  V/m 0.15  MHz to
Transients RF
80 MHz 80 MHz
IEC 61000-4-3
80 % AM by 1 kHz 80 % AM by 1 kHz

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 Electromagnetic compatibility

IMMUNITY to proximity fields from RF wireless communications equipment

en Test method IEC 61000-4-3
Test frequency Band Service Modulation Maximum power Distance IMMUNITY TEST LEVEL (V/m)
(MHz) (MHz) (W) (m)
Pulse modu-
385 380-390 TETRA 400 lation 1.8 0.3 27
18 Hz
FM
GMRS 460, FRS ±5 kHz devi-
450 430-470 2 0.3 28
460 ation
1 kHz sinus
710 Pulse modu-
745 704-787 LTE Band 13, 17 lation 0.2 0.3 9
780 217 Hz
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810 800-960
GSM 800/900, Pulse modu-
870 TETRA 800, IDEN lation
2 0.3 28
820, CDMA 850,
930 LTE Band 5 18 Hz

1720 GSM 1800;

1845 CDMA 1900; Pulse modu-
1700-1990 GSM 1900; DECT; lation 2 0.3 28
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1970 LTE Band 1, 3, 4, 217 Hz
25; UMTS
Bluetooth, WLAN
Pulse modu-
2450 2400-2570 802.11 b/g/n, lation 2 0.3 28
RFID 2450, LTE 217 Hz
Band 7
5240 Pulse modu-
WLAN
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5500 5100-5800 lation 0.2 0.3 9
WLAN 802.11 a/n
5785 217 Hz

WARNING!
Portable HF communication equipment
Portable HF communication equipment can affect the performance characteristics
of the device PNEUMOCLEAR™. Such equipment must therefore comply with a min-
imum distance of 30  cm (regardless of all calculations) from the device
PNEUMOCLEAR™, its components and cables.
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 Error and Warning Messages

12 Error and Warning Messages

Error and warning messages Cause Troubleshooting
en
Electronic error! Restart the
device. If the error occurs again Malfunctions in the electronic Restart the device. If the error occurs again, contact
switch off device and call ser- system. technical service.
vice!
Calibration error! The device
The device is not calibrated The device must be re-calibrated. Contact technical
must be re-calibrated. Call ser-
properly. service.
vice!
Serious fault. Do not use device. Contact technical ser-
Device temperature error! Turn Temperature in device is too low vice.
device off! or too high. Make sure the device has been acclimatized to its en-
vironment before turning on.
The device must be checked by an authorized service
Device contaminated! Fluid has
The device is contaminated with technician. It is to be clearly marked and wrapped
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penetrated the device. Contact
fluid. twice in safety foil before sending to the service de-
technical service!
partment for repairs.
Continued use of the device is possible. However, the
Device service is almost due!
Maintenance is due in 4 weeks. device must be serviced by an authorized service tech-
Contact Stryker for service.
nician soon.
Last maintenance is more than
Device service is due! Please
24  months ago. Flow rate and The device must be serviced by an authorized service
send to Stryker for service. Con-
pressure might not be accurate technician.
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tinue?
anymore.
Determine the cause for exceeding the nominal pres-
Excessive overpressure! The actual pressure > 45 mmHg. sure. If the venting valve is disabled, the overpressure
must be reduced manually by opening the trocar.
Nominal pressure limit
Reduce the abdominal pressure by reducing the set
Maximum pressure reached! 20/30 mmHg has been reached/
pressure or opening a stop cock.
exceeded.
Abdominal pressure exceeds set
AF
Determine the cause for exceeding the set pressure. If
pressure and cannot be reduced
Overpressure! the venting valve is disabled, the overpressure must
by the automatic venting system
be reduced manually by opening the trocar.
within 5 seconds.
Gas heating - Over temperature! There are three options to continue insufflation:
Insufflation paused. • Wait until the temperature has decreased below
43 °C, insufflation and heating will resume automatic-
The temperature of the gas ex- ally shortly.
Safety Feature Warning ceeds 43  °C/109  °F. The device • Disconnect and reconnect tube set if temperature is
Insufflation paused due to gas pauses gas heating and insuffla- below 43 °C insufflation with heating can be resumed
exceeding 43 °C/109 °F. Insuffla- tion. (manual start).
tion will resume shortly. • Exchange tube set with a new one. If this error mes-
sage is displayed again, have the gas heating checked
by a qualified service technician.
Actual pressure > 12/15 mmHg.
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Confirm the query to further increase the pressure. Ex-
Actual flow > 5 l/min (Pediatric).
Exceed Safety Threshold? ceeding this safety limit is to be decided by and the re-
Actual flow >  6  l/min (Vessel sponsibility of the user/operator.
Harvest).
Change gas tank! Low insufflation gas supply. Check gas supply.
Gas level low. Prepare to change
Gas supply < 20 bar/290.1 psi. Prepare for changing the gas bottle.
gas tank.
Insufficient insufflation gas sup-
Check gas supply! Insufflation Insufflation starts automatically after restoring the
ply (bottle or central gas supply)
paused! gas supply.
during insufflation.
Tube set invalid The tube set is not valid. Insert a valid tube set.

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 Error and Warning Messages

Error and warning messages Cause Troubleshooting

en Insufflation can be continued in this case, but the
heating function is not available.
Restart the device if you want to use the heating func-
Gas heating defective! Gas heater malfunction.
tion.
If the gas heating is still defective, have an authorized
service technician check or repair the device.
The venting system has been de- The user can activate the venting valve in the user
Reminder: Venting valve off!
activated menu.
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 Technical Data

13 Technical Data
Type or model designation: FM300
en
Production location: W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8, 10587 Berlin
Software version: See display during the automatic device self-test
Mains voltage range: AC 100 to 240 V~
Supply frequency range: 50/60 Hz
Fuse designation: 2x T 4 A H, 250 V
Power consumption: Current (A) Power consumption (VA)
Normal operation 100 V AC/60 Hz: 1.05 105
Normal operation 240 V AC/50 Hz: 0.50 120
Maximum Power consumption: - 120
Protection class (I, II, III): I
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Application part type (B, BF, CF): CF
Protection type (IP Code): IP40
Classification (I, IIa, IIb, III): IIa
Operating conditions: 10 to 30 °C/50 to 86 °F
30 to 75 % rel. humidity
700 to 1060 hPa air pressure
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3000 m/9843 ft maximum altitude above sea level for device use
Storage and transportation conditions: -20 to +60 °C /-4 to +140 °F
10 to 85 % rel. humidity
700 to 1060 hPa air pressure
(maximum 6 weeks)
Inlet pressure range:
Maximum inlet pressure: 80 bar/1160.3 psi
AF
Minimum inlet pressure for bottled gas: 15 bar/217.5 psi
Minimum inlet pressure for central gas: 3.4 bar/49.3 psi
Maximum output pressure: 75 mmHg (1 mmHg = 1.33 mbar = 133 Pa)
Maximum gas flow: 50 l/min
Adjustable pressure range: 1 to 30 mmHg
Pressure display resolution: 1 mmHg
Dimensions: Width x Height x Depth
Without gas connector: 318 mm x 149 mm x 429 mm
With US gas connector: 318 mm x 149 mm x 480 mm
With DISS gas connector: 318 mm x 149 mm x 480 mm
With angled gas connector: 318 mm x 149 mm x 467 mm
Weight: 10 kg
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Interfaces/ports/connections: USB service interface (type Mini-B), only for authorized service
technician
USB service interface (type A), only for authorized service techni-
cian
Device Control interface (USB type B)
Mains power connection (IEC-60320-1 C14)
Transponder technology (RFID): Transmit/Receive Frequency Range: 13.56 MHz ± 0.424 MHz
Transceiver class: Class I
RF Output Power: -10.83 dBµA/m at 10 m/ 32.8 ft
Type of Antenna: Inductive Loop Antenna
Antenna loop area: 0.00032 m²
Modulation: Amplitude-shift keying (ASK)
Mode of Operation (Simplex / Duplex): Duplex

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 Technical Data

Essential performance: The function of this device is to maintain pressure in the cavity at
en the nominal pressure.
(Limits, fully functional: 1 to 30 mmHg)

Limit, total loss of the identified performance (Normal Condition):

Pressure of > 45 mmHg can cause injury to patient and is identi-
fied as unacceptable risk.
Pressure of <  0  mmHg in abdomen can cause injury to patient
(due to instruments perforating tissue) and is identified as unac-
ceptable risk.
Limit, total loss of the identified performance (Single fault condi-
tion):
Pressure of > 80 mmHg can cause injury to patient and is identi-
fied as unacceptable risk.
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Pressure < -112.5 mmHg in abdomen can cause injury to patient
(due to instruments perforating tissue) and is identified as unac-
ceptable risk.
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 Accessories

14 Accessories
Article
en
0620050800 Premium Upgrade for Advanced Flow and TAMIS Modes
User Manual
P31693 PNEUMOCLEAR™ User Manual (Americas Version)
Language: EN, ES, FR, PT
P31694 PNEUMOCLEAR™ User Manual (EU Version 1)
Language: EN, DE, FR, NL, PL
P31695 PNEUMOCLEAR™ User Manual (EU Version 2)
Language: NO, SV, DA, FI
P31696 PNEUMOCLEAR™ User Manual (EU Version 3)
Language: ES, IT, PT, EL, RO
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P31697 PNEUMOCLEAR™ User Manual (Asia version),
Language: JA, KO, RU, TR, ZH
P31698 PNEUMOCLEAR™ Service Manual, language: EN, DE
Tube sets
0620050100 PNEUMOCLEAR™ HIGH-FLOW TUBE SET
0620050200 PNEUMOCLEAR™ HEATED HIGH-FLOW TUBE SET
0620050250 PNEUMOCLEAR™ SMOKE EVACUATION HIGH-FLOW TUBE SET
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0620050300 PNEUMOCLEAR™ HEATED HUMIDIFIED TUBE SET
0620050350 PNEUMOCLEAR™ HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET
Gas supply hoses
0620050900 High pressure hose bottle DIN/device US, 1.5 m/5 ft
0620050901 High pressure hose bottle ISO/device US, 1.5 m/5 ft
0620010103 CO2 tank yoke
0620010104 CO2 tank hose
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0620040003 Hose for CO2 central gas supply DISS-DISS, 0.9 m/3 ft
0620050904 Hose for CO2 central gas supply DIN-US, 3 m/10 ft
0620050905 Hose for CO2 central gas supply DIN-US, 5 m/16.5 ft
0620050906 Hose for CO2 central gas supply AGA-US, 3 m/10 ft
0620050907 Hose for CO2 central gas supply AGA-US, 5 m/16.5 ft
0620050908 Hose for CO2 central gas supply NF-US, 3 m/10 ft
0620050909 Hose for CO2 central gas supply NF-US, 5 m/16.5 ft
0620050910 Hose for CO2 central gas supply UNI-US, 3 m/10 ft
0620050911 Hose for CO2 central gas supply UNI-US, 5 m/16.5 ft
Gas connections
0620050912 NIST Adapter for universal gas connection
0620050913 DISS Adapter for universal gas connection
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0620050914 US Adapter for universal gas connection
0620050915 Universal gas connector, angled
0620050916 Sinter filter for universal gas connection
Miscellaneous
0620030503 CO2 Switching valve for insufflators
0620050917 Power supply cord US, 2.5 m/8.2 ft
0620050918 Power supply cord Euro, 2 m/6.5 ft
0620050919 Power supply cord UK, 1.8 m/5.9 ft
0620050920 Power supply cord CN, 2 m/6.5 ft
0620050921 Micro fuse T 4 A H, 250 V AC

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 Accessories

en WARNING!
Original accessories
For your own safety and that of your patient, use only original accessories.
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 Warranty and Service

15 Warranty and Service

Warranty: en
Stryker Endoscopy warrants this product against defects in both materials and
workmanship to the registered owner at the time of purchase. All components are
covered by the warranty for a period of one year from the date of purchase.
This warranty does not apply to any unit which has been subject to misuse, neglect,
improper installation or that which has been altered, adjusted, or tampered with
by any person other than Stryker Endoscopy authorized personnel.
If upon examination by authorized service personnel, it is determined that the mal-
function is due to misuse or abuse, warranty provisions will not apply. An estimate
of the cost of repair work will be given to the customer prior to servicing and re-
pairing the unit.
The customer is responsible for returning the defective equipment to the factory at
his or her own expense. Stryker Endoscopy or its representative will service the
unit, repair or replace any defective parts thereof, and return the unit.
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If, upon examination, it is determined that the fault has been caused by misuse or
abnormal conditions of operation, the repairs will be billed to the customer as out-
of-warranty repairs.
Instruments repaired under Stryker Endoscopy’s standard repair program will be is-
sued a thirty-day warranty against defects in both materials and workmanship,
provided the original warranty period has passed. Instruments submitted due to
defects in materials and workmanship during the warranty period will be repaired
at no charge to the customer.
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The warranty as set forth herein is exclusive and in lieu of all other warranties,
remedies, obligations and liabilities of Stryker Endoscopy Inc., expressed or implied,
including the implied warranties of merchantability and fitness for use and of con-
sequential damages. These products are being sold only for the purpose described
herein, and such warranty only runs to the purchaser. In no event shall Stryker En-
doscopy be liable for any breach of warranty in any amount exceeding the pur-
chase price of the product.
No agent, employee or representative of Stryker Endoscopy has the authority to
AF
bind the Company to any other warranty, affirmation, or representation concern-
ing this instrument.
This warranty is valid only to the original purchaser of Stryker Endoscopy products
directly from Stryker Endoscopy or from a Stryker Endoscopy authorized agent. The
warranty cannot be transferred or assigned by the original purchaser.
Service and Claims:

CAUTION!
Superfluous service
Do not attempt any service not outlined in this intructions for use.

If service is needed either during or after the warranty period:

• Contact Stryker Endoscopy at 1-800-624-4422 or phone your local Stryker Endo-
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scopy sales representative.
• Package all the components carefully in the original shipping container if pos-
sible.
• Ship the device, prepaid and insured to:
Stryker Endoscopy Customer Service
Attention: Repair Department
5900 Optical Court
San Jose, CA 95138
For service outside of the United States, visit our website at www.stryker.com for
the appropriate service address.

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 Glossary

16 Glossary
en
EMC
The electromagnetic compatibility describes the ability of a
device to function satisfactorily within an electromagnetic
environment without adding unacceptable electromag-
netic interferences/disturbances to the environment that
may cause problems for other devices or equipment located
nearby.

ME Device
Medical electrical device used for therapy, monitoring or
diagnosis of patients, equipped with no more than one con-
nection to a supply network and which necessarily comes
into physical or electrical contact with the patient or which
transfers energy to or from the patient or which records or
D
captures such energy transfer to or from the patient.

ME System
Medical electrical system consisting of a combination of
devices, of which at least one is classified as a medical elec-
trical device and specified by the manufacturer as such and
which are joined together by a functional connection or by
using a power strip.
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 Appendix

17 Appendix
en
Test log

Date Result Comment Signature

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 List of Figures

List of Figures
en Fig. 4–1 Device front............................................................................................................................................................................................ 22
Fig. 4–2 Device rear.............................................................................................................................................................................................. 23
Fig. 4–3 Connecting the gas supply to the angled gas connector.......................................................................................................... 24
Fig. 4–4 Setting up the device........................................................................................................................................................................... 26
Fig. 5–1 Screen displays ...................................................................................................................................................................................... 28
Fig. 5–2 Smoke evacuation indicator.............................................................................................................................................................. 31
Fig. 5–3 Connections of the tube set with smoke evacuation ................................................................................................................ 32
Fig. 5–4 Filling the gas humidification tube ................................................................................................................................................. 33
Fig. 5–5 Insufflation gas humidification indicator ..................................................................................................................................... 34
Fig. 5–6 Connecting the PneumoClear to the Device Control ................................................................................................................. 35
Fig. 5–7 Confirming or denying desufflation ............................................................................................................................................... 40
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Fig. 9–1 Opening the fuse holder..................................................................................................................................................................... 57
Fig. 10–1 Pressure sensor test setup ................................................................................................................................................................. 59
Fig. 10–2 Connections for maximum device pressure test ........................................................................................................................ 60
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 Index

Index
en
A Measured values and tolerances  58

Angled gas connector  24

Authorized service technician  8 O
Authorized trained personnel  55 Only for U.S. operators  22
Automatic venting system  53 Overpressure  53

C P
Care and maintenance  8 Patients  41, 43, 46, 48 , 50
Central gas supply  26 Potential equalization  22
Certification  56 Preparation  37
Checking the device  38 Purpose  35
Connecting the tube set  30
Contamination  8, 54
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D Refilling  34
Removing the tube set  30
Delivery inspection  21 Required characteristics  35
Disconnect device from power supply  26 Required configuration  35
Documentation  35 Returning the device  21
RFID technology/ Invalidating a tube set  29
E
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Error message Contamination  54 S
Essential performance  9, 68 Setting up  21
Exchangable sinter filter  23 Subject to technical changes  7
Exchange of the gas supply adapter  25
Exclusion of liability  8
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F Technical documents  55
Technical specification  35
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Federal Law (only for U.S. market)  8 Two-year maintenance interval  55
Filling and refilling the humidification tube set  33

G U
Unauthorized personnel  55
Gas supply with gas bottle  25
Grounding contact  22
V
H Veress insufflation  37
High-pressure hoses  24
How to activate Veress Insufflation  37 W
Warning display Occlusion  53
I Waste management  8
T
Installation  24, 25
Insufflation parameters  41, 43, 46, 48 , 50
Insufflation source  53
Intended information flow  35

L
Liability  55
List of hazardous situations potentially resulting from a
failure of the connection to Device Control  35
Low-pressure hoses  25

M
Mains connection  22
Manufacturer’s specifications  55
Manufacturer's specifications  55

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