ACKERMANN 16-2040N User manual

USER MANUAL
16-2040N / 16-2041N / 16-2042N
INSUFFLATOR 20L / 30L / 45L

USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
These operating instructions contain information that is subject to copyright.
All rights are reserve .
This manual shoul not be photo-copie , uplicate or otherwise copie or istribute , completely or in part,
without the approval of the manufacturer. The manufacturer will appreciate any errors or anything unclear in
this operating manual being pointe out to us by users of our pro ucts.
Due to the continuing progress an evelopment of our pro ucts, we reserve all rights for technical
alterations.
Rev. 07/2016
SERVICE ADDRESS: Ackermann Instrumente GmbH
Eisenbahnstrasse 65-67
78604 Rietheim-Weilheim
Germany
Tel: [phone]
Fax: [phone]
E-Mail: info@ackermanninstrumente. e
Web: www.ackermanninstrumente. e
0086

USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
CONTENTS AGE
1. SAFETY INSTRUCTIONS 4
1. 1 INTENDED USE 4
1. 2 CONTRAINDICATION 4
1. 3 WARNING 5
2. STATUTORY RECOMMENDATIONS 5
2.1 COMPLIANCE 5
2.2 ELECTROMAGNETIC COMPATIBILITY 5
2.3 MEDICAL DEVICE VIGILANCE 6
2.4 END OF LIFE 6
3. DESCRIPTION OF THE FRONT AND BACK PANELS 6
4. SPECIAL FEATURES 7
4.1 GREATER SAFETY OF USE 7
4.2 LOW FLOW 7
4.3 HIGH FLOW 7
4.4 AUTOMATIC LOW/HIGH FLOW SWITCHING 8
4.5 EXTERNAL PRESSURE RELIEF VALVE 8
4.6 MONITORING OF THE CYLINDER PRESSURE 8
4.7 LCD DISPLAY 8
4.8 FILTER 8
5. INSPECTION AND INSTALLATION IN THE OPERATING THEATRE 9
5.1 CHECKING THE DEVICE 9
5.2 SCOPE OF SUPPLY 9
5.3 RECOMMENDED ACCESSORIES (OPTIONAL) 9
5.4 ELECTRICAL CONNECTION 9
5.5 EQUIPOTENTIAL BONDING 9
5.6 CONNECTING THE GAS CYLINDER 10
5.7 DISCONNECTING THE GAS CYLINDER 10
6. CREATING AND MAINTAINING PNEUMOPERITONEUM 10
6. 1 STARTING THE INSUFFLATOR 10
6. 2 CONNECTING – DISCONNECTING THE PATIENT TUBING 11
6. 3 MODIFYING PARAMETERS VIA THE MENU 12
6. 4 PRESSURE INITIAL SETTING 12
6. 5 STARTING INSUFFLATION 12
5. 6 CONTROL 13
6. 7 OVER-PRESSURIZATION 13
6. 8 MONITORING THE FLOW 14
6. 9 MONITORING THE VOLUME OF GAS USED 14
6. 10 MONITORING THE VOLUME OF GAS AVAILABLE 15
6. 11 END OF OPERATION 15
7. FAULTS AND WARNING SIGNALS 16
8. CLEANING / SERVICING / MAINTENANCE 16
8. 1 CLEANING / DECONTAMINATION 16
8. 2 SERVICING / MAINTENANCE 16
9. SYMBOLS USED 17
10. TECHNICAL SPECIFICATIONS 17
11. ELECTROMAGNETIC COMPATIBILITY 19
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
1. SAFETY INSTRUCTIONS
Please rea this manual carefully before using the evice, pay particular attention to the sections etailing the
safety an environmental con itions relate to the evice.
1.1 INTENDED USE
This evice is esigne to create an maintain a pneumoperitoneum ( istension of the ab omen with CO2
gas) as part of a iagnostic an /or laparoscopic operative proce ure.
Please refer to your laparoscope user manual for information on specific use.
This manual is only esigne to assist the user with proper installation, set up an operation of the insufflaor.
FEDERAL LAW:
Fe eral Law in the Unite States restricts the use of this evice solely to, or un er the supervision of, a
surgeon.
1.2 CONTRAINDICATION
The evice shoul only be use for an en oscopic proce ure when insufflation of the ab omen is necessary
to faciliate navigation of the en oscope. Please refer to your laparoscope user manual for absolute an
relative contrain ications.
This evice is contrain icate for hysteroscopic insufflation; un er no circumstances must it be use in cases
of intrauterine istension.
Note: the istension pressure of an insufflator for laparoscopy must not excee 24 mmHg
1.3 WARNING
• Metabolic acidosis and resulting cardiac irregularity
Avoi prolonge intra-ab ominal pressures above 20 mm of mercury. This woul cause one of the following
risks:
• Re uction of respiration with compromise iaphragmatic movement
• Re uction of venous return
• Re uction of car iac output
• Aci osis
Excessive absorption of CO2 is ue to either a too high flow rate or excessive pressure, or both. The
ab omen can be sufficiently isten e by a pressure between 10 an 15 mm of mercury. It is rarely
necessary to select an ab ominal pressure higher than 15 mm of mercury. At these levels, the extent of
intravascular penetration shoul be low. Pressures higher than 20 mm of mercury are har ly ever necessary;
they will increase the quantity an the spee of intravascular penetration. A equate respiration helps to
prevent problems associate with CO2.
• Idiosyncratic reactions
For patients suffering from micro repanocytic iseases or pulmonary insufficiency, the use of these evices
can present an increase risk of metabolic imbalance relate to the excessive absorption of CO2.
• Hypothermia
High-flow insufflation allows for a potential risk of hypothermia; therefore we recommen using a heating
system to keep the patient’s temperature stable.
• Gas flow
Surgical proce ures must be carrie out with insufflators able to reach flows between 4 to 10 l/min.
Insufflators provi ing lower flow must only be use for iagnostics proce ures.
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
• Gas coagulation system
Some me ical evices elivering gas to the interior of the peritoneal cavity uring surgical laparoscopies (gas
lasers, for example) may lea to ab ominal overpressurization. If venous sinuses are forme , triggering an
embolism, the use of a secon ary gas source that is far less soluble in the bloo than CO2 can cause a rapi
rise in intra-ab ominal pressure. We recommen avoi ing the use of these coagulation systems uring
laparoscopic proce ures, as we, the manufacturer coul not be hel responsible for any inci ent associate
with their use.
• Bacterial filter
The use of a hy rophobic bacterial filter is essential for preventing cross-contamination with the patient
• lease follow the conditions of use and storage.
• Keep the device in a dry and clear environment.
• This device must only be opened by a technician approved by us, the manufacturer.
• In order to prevent any danger of electrocution, fire, short circuits or dangerous emissions, do not
insert metal objects into the device.
• Do not expose the device to water spray or splashes, and do not install it in a very humid area.
• Use only the ancillary equipment delivered with the device or suggested by the manufacturer as an
option.
• Do not connect this device to any other device.
• This insufflator must not be used in the presence of flammable anesthetics.
• This device has not been designed for use in an ionizing environment.
2. SATUTORY RECOMMENDATIONS
2.1 COMPLIANCE
This evice was esigne an manufacture by Ackermann in a certifie quality system.
It complies with the requirements of European irective 93/42/EEC on me ical evices.
Consequently it complies in particular with the specific stan ar s relating to electrical safety (IEC) an
electromagnetic compatibility (EMC).
2.2 ELECTROMAGNETIC COMPATIBILITY
Although this pro uct complies with the electromagnetic compatibility stan ar s (Appen ix XII) it is possible
that, in very particular circumstances, it coul interfere with other evices, or that other evices or an a verse
electromagnetic environment coul interfere with it.
To prevent probability of these situations, we recommen to:
• check the quality of the electrical network (an in particular the earthing of all the evices an trolleys)
• keep the evice away from electromagnetic sources (for example mobile phones, compressors, motors,
transformers, HF generators, etc.)
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
2.3 MEDICAL DEVICE VIGILANCE
Like any me ical evice, this unit is subject to the provisions relate to me ical evice vigilance; therefore
any serious malfunction must be promptly reporte to the proper authority an to us, giving as much etaile
information as possible. Please refer to the secon page for our contact etails.
2.4 END OF LIFE
This evice carries the recycling symbol in accor ance with European irective 2002/96/CE on Waste
Electrical an Electronic Equipment (DEEE or WEEE).
By following the correct proce ures for isposing of this evice you will be contributing to the prevention of
any consequences that coul be harmful to the environment or human health.
The symbol to be foun on the evice an /or in the accompanying ocumentation in icates that this
pro uct may on no account be treate as househol waste. It must therefore be elivere to a waste
collection point for the recycling of electrical an electronic equipment. For isposing of the evice, please
observe the stan ar s applie in the country of installation. To obtain complete etails about the treatment,
recovery an recycling of this appliance, please contact your closest ealer to know how to procee .
3. DESCRI TION OF THE FRONT AND BACK ANEL
FRONT Description BACK Description
A5.7-inch LCD screen 1CO2 Input
BWarning light 2On/Off switch
CTubing connector for patient
insufflation
3Fuse housing
DTubing connector for external
esufflation
4Mains socket
ELow/high flow selector button 5Equipotential socket
FStart/stop insufflation 6Labeling
GSelection an vali ation thumbwheel
HStart/stan by button
IStart/stan by LED
FRONT ANEL
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
BACK ANEL
4. S ECIAL FEATURE
4.1 GREATER SAFETY USE
• Autotest
The evice performs an autotest in less than 1 sec. where it calibrates itself automatically an check for basic
components.
• Detection of tubing
The evice will only start if a sterile tube is connecte to the outlet an external pressure relief valve (for
safety reasons it is impossible to connect a single tube)
• Automatic regulation of the flow rate
This insufflator automatically regulates the flow rate to maintain an ab ominal pressure equal to the pressure
setting.
• An additional pressure sensor
If the measurement circuit fails, consistency of the measurements is continuously monitore ; this means that
the insufflation cycles can be interrupte if there is the slightest cause of oubt.
• A high-pressure relief valve
If over-pressurization occurs at the level of the high pressure regulator, a safety valve is available to limit any
risk.
4.2 LOW FLOW
In this mo e, the insufflation flow is limite to 2 l/min to create a pneumoperitoneum. This flow is not sufficient
to regulate intracavitary pressure in the event of a major leakage.
By efault, the insufflator starts in low-flow manual mo e. The surgeon can choose the automatic or the
manual mo e to activate the high flow.
4.3 HIGH FLOW
When the pneumoperitoneum is create , activating the high flow mo e permits a maximum flow of between
20 an 45l, epen ing on the mo el. This flow rate allows for the compensation for any type of leakage.
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
4.4 AUTOMATIC LOW/ HIGH FLOW SWITCHING
If automatic switching is selecte from the menu, the evice starts insufflating in low-flow mo e, then switches
to the high-flow position once blow-off pressure is reache .
4.5 EXTERNAL PRESSURE RELIEF VALVE
Our insufflators have a valve that allows CO2 overpressure outsi e the evice in or er to avoi :
• over-pressurization in the pneumoperitoneum (if the pressure is more than 5mmHg greater than the blow-off
pressure for more than 3 secon s)
• any return of flui to the evice’s interior, thus preventing any risk of eterioration or contamination.
4.6 MONITORING OF THE CYLINDER PRESSURE
This last generation of insufflators is equippe with a system for measuring the cylin er pressure which is
continuously isplaye . Moreover, when the cylin er pressure reaches 40 bars, a cylin er icon is isplaye
on the LCD an “cylin er empty” blinks. As soon as the cylin er pressure reaches 20 bars, the insufflator
informs the user via:
• The isplay of the cylin er pressure in the alarm area
• A re light on the isplay
Below 10 bars the insufflator is not allowed to be used.
4.7 LCD DISPLAY
In or er to communicate better with the user an to improve the ease of use, we have equippe our latest
generation of insufflators with a 5.7-inch LCD isplay.
This allows the following to be isplaye in 5 ifferent languages:
• warnings an error messages in full
• interactive menu allowing the evice to be personalize
• in ication of empty cylin er
• in ication of blow-off pressure in mm Hg
• in ication of intracavitary pressure in mm Hg
• in ication of flow in l/min
• in ication of volume of CO2 use in liters
• in ication of status: in start/stop an “high flow”/“low flow”
• moving aroun in the menu by means of a selection thumbwheel
4.8 FILTER
• CO2 cylin er
A particle filter is inserte in the CO2 inlet to prevent contamintaion arising from particles or impurities which
may be present in the CO2 from entering cylin ers.
• Patient
In order to guarantee patient safety, it is essential to use disposable sterile tubing sets with a
moisture-repellent viral filter supplied with the insufflator and to replace it for each patient.
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
5. INS ECTION AND INSTALLATION IN THE O ERATING THEATRE
5.1 CHECKING THE DEVICE
Any eterioration, malfunction or missing ancillary equipment must be imme iately reporte or confirme by
us an /or istrubutor by registere letter so that it can be covere by insurance if necessary.
Please keep the original evice packaging for its yearly maintenance return. When oing so, please enclose
a ocument to inclu e your name, a ress an the reason for returning the evice (problem encountere ).
lace the insufflator on a flat and dry surface. This insufflator must be placed on a flat surface and
must be higher than the patient to prevent any liquid from flowing backwards through the tubes.
5.2 SCOPE OF SUPPLY
Your insufflator is elivere with the following ancillary equipment:
Description Quantity
User manual 1x
Main power cable 2.50 m long 1x
Open-en e spanner for the high-pressure hose connector 1x
Set of 1 sterile isposable Y-tubes equippe with a viral filter, packe in a separate box 1x
5.3 RECOMMENDED ACCESSORIES (OPTIONAL)
• Pin connector, type DIN 477-1 no. 6 or US 7/16”
• High-pressure CO2 fee hose (Pmax: 200 bar), 1m long.
5.4 ELECTRICAL CONNECTION
Check that the specifications of the main power supply include 100 to 230VAC and 50 Hz – 60 Hz with
a required power of 40VA.
Connect the power cable on the rear panel in [4].
Connect the power cable to the main power supply.
In the United States and Canada a “Hospital Grade” power cable supplied should be used, and it
must, be connected to the “Hospital Grade” mains connection, without fail.
This insufflator is protected by two 2.5 amp time-lag supply fuses (UR), on the rear panel in [3]; do not
use UR fuses of different sizes that are not certified.
5.5 EQUIPOTENTIAL BONDING
The safeguar s against ischarge of static electricity (ESD) are as follows:
• application of equipotential bon ing on all evices is to be connecte ; connect the voltage compensator
cable to the connector [5] on the rear panel.
• exclusive use of the ancillary equipment mentione
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5.6 CONNECTING THE GAS CYLINDER
Maximum permitted operating pressure (70 bar).
Never begin a surgical operation without being sure that there is a spare CO2 CYLINDER available.
Use medical grade CO2 only.
Keep the CO2 gas cylin er in an upright position to avoi possible movement (cylin er hea facing upwar s),
if possible on the same trolley as the insufflator.
Never use the insufflator if it is connected to a cylinder placed horizontally or upside down (cylinder
head facing downwards).
Ensure that a seal on the high pressure cable on the cylin er si e is present (DIN only)
Use the open-en e spanner to tighten the connector linke to the cylin er outlet, then the one linke to the
insufflator inlet port [1].
5.7 DISCONNECTING THE GAS CYLINDER
Before unscrewing the high-pressure hose, check that the cylinder valve is closed, and then lower the
pressure inside the system by gently loosening it.
6. CREATING AND MAINTAINING NEUMO ERITONEUM
This insufflator is intended only for diagnostic or operative laparoscopy. Any use outside this area
constitutes misuse of the product for which the user will be responsible and for which the
manufacturer declines all responsibility.
This device must be used only by qualified staff. The surgeon and the anesthetist will be responsible
for the device, with the anesthetist guaranteeing particular supervision of blood gases. The safety
features which this device is equipped with will not in any way relieve the medical staff of their
responsibility for the constant monitoring and supervision of the patient.
6.1 STARTING THE INSUFFLATOR
USER ACTION DEVICE RES ONSE
Press the on/off switch [2] on the rear panel to [I].
Open the gas cylin er.
Press the button [H] on the front panel.
The in icator light [I] on the front panel flashes, to
show the evice is running.
The evice performs an AUTO TEST.
The in icator light [I] on the front lights up.
The welcome page appears in icating the type of
insufflator.Followe by the menu
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