WORLD OF MEDICINE Stryker Pneumoclear User manual

Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures
P31693 Rev. K
Instructions for Use en
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Manufacturer:
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
10587 Berlin, Germany
Phone:[phone]
Fax:[phone]
E-mail:[email protected]
CE marking according to Directive 93/42/EEC
Distributed by:
Stryker Endoscopy
5900 Optical Court, San Jose
CA 95138 (USA)
[phone] [phone]
www.stryker.com
Type: FM300 / 1201459 / 10000018417 08 / 2020-09
en This instructions for use contains information that is subject
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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Authorized for Sale or use by
Physician only
Stryker European Represent-
ative
Non-ionizing electomagnetic
radiation
Complies with Australian
regulatory requirements
Complies to IEC 60601-1 in-
cluding US and Canadian de-
viations in their respective
valid version
Data transmission port (see
Using Device Control in-
structions for detail)
Only for service
Caution: Hot Air Out
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indicates the product has
not been tampered with or
serviced.
Due date of next service
Only to be used with med-
ical-grade CO2
Maximum supply pressure
of medical-grade CO2
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Table of Contents
1 Important User Notes ...............................................................................................................................................................................................7
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
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
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
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
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
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
14 Accessories .................................................................................................................................................................................................................69
15 Warranty and Service..............................................................................................................................................................................................71
16 Glossary.......................................................................................................................................................................................................................72
17 Appendix.....................................................................................................................................................................................................................73
Index.............................................................................................................................................................................................................................75
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Important User Notes
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1 Important User Notes
Read the instructions for use carefully and become familiar with the operation and
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.
Subject to technical changes
The manufacturer reserves the right to modify the appearance, graphics, and tech-
nical data of the product through continued development of its products.
Please note
Paragraphs marked with the words WARNING, CAUTION, and NOTE carry special
meanings. Sections marked with these words must be given special attention.
WARNING!
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.
NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.
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Safety Information
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2 Safety Information
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
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
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,
• 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
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3 General Information
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
Standard operating mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures by insufflating CO2.
designed for laparoscopies per-
formed on normal weight and
slightly obese (BMI < 30 kg/m2)
patients over the age of 14.
High Flow/Bariatric operating
mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures by insufflating CO2.
designed for laparoscopies per-
formed on normal weight and
obese patients (BMI>30kg/m2)
over the age of 14.
Pediatric operating mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures by insufflating CO2.
designed specifically for use on
newborns, infants, and children
under the age of 14.
Advanced Flow operating mode
used to distend the peritoneal
cavity during laparoscopic pro-
cedures, including but not lim-
ited to robotic-assisted laparo-
scopies by insufflating CO2.
designed for laparoscopies per-
formed on normal weight and
obese patients over the age of
14.
Vessel Harvest operating mode
used to distend the cavity along
the vena saphena magna and ra-
dial artery during an endoscopic
vessel harvesting procedure.
designed for patients over the
age of 14.
TAMIS operating mode
used to dilate and fill the rectum
and colon by insufflating CO2
during transanal minimally in-
vasive surgery.
designed for patients over the
age of 14.
Essential performanceThe device measures the actual pressure in the cavity and compares it to the set
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
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
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during endoscopic vessel harvesting procedures to create a cavity along the
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.
3.3 Warnings
3.3.1 General Warnings CO2 Insufflation
WARNING!
Condensation / Water penetration
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.
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.
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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WARNING!
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.
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.
WARNING!
Sterile media and accessories
Always work exclusively with sterile substances and media, sterile fluids, and
sterile accessories if so indicated.
WARNING!
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
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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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
• 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-
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
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
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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WARNING!
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.
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!
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.
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.
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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3.3.2 Warnings Standard and High Flow/Bariatric Operating Mode
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
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!
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!
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:
• 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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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
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!
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.
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.
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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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.
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).
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.
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!
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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WARNING!
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
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.
WARNING!
Hypercapnia
Because pediatric patients are especially susceptible to hypercapnia, it is recom-
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-
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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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
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!
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
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
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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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.
3.4 General Precautions
CAUTION!
Continuous operation
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
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
(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-
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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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
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
must meet the safety requirements of the national standards in the respective cur-
rent valid version.
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