ACKERMANN 16-2041N 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 reserved.
This manual should not be photo-copied, duplicated or otherwise copied or distributed, completely or in part,
without the approval of the manufacturer. The manufacturer will appreciate any errors or anything unclear in
this operating manual being pointed out to us by users of our products.
Due to the continuing progress and development of our products, we reserve all rights for technical
alterations.
Rev. 07/2016
SERVICE ADDRESS: Ackermann Instrumente GmbH
Eisenbahnstrasse 65-67
78604 Rietheim-Weilheim
Germany
Tel:
Fax:
E-Mail:
Web:
0086
+49 (0)7461 96617 0
+49 (0)7461 96617 70
[email protected]
www.ackermanninstrumente.de
USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
CONTENTS
PAGE
1. SAFETY INSTRUCTIONS
1.1 INTENDED USE
1.2 CONTRAINDICATION
1.3 WARNING
4
4
4
5
2. STATUTORY RECOMMENDATIONS
2.1 COMPLIANCE
2.2 ELECTROMAGNETIC COMPATIBILITY
2.3 MEDICAL DEVICE VIGILANCE
2.4 END OF LIFE
5
5
5
6
6
3. DESCRIPTION OF THE FRONT AND BACK PANELS
6
4. SPECIAL FEATURES
4.1 GREATER SAFETY OF USE
4.2 LOW FLOW
4.3 HIGH FLOW
4.4 AUTOMATIC LOW/HIGH FLOW SWITCHING
4.5 EXTERNAL PRESSURE RELIEF VALVE
4.6 MONITORING OF THE CYLINDER PRESSURE
4.7 LCD DISPLAY
4.8 FILTER
7
7
7
7
8
8
8
8
8
5. INSPECTION AND INSTALLATION IN THE OPERATING THEATRE
5.1 CHECKING THE DEVICE
5.2 SCOPE OF SUPPLY
5.3 RECOMMENDED ACCESSORIES (OPTIONAL)
5.4 ELECTRICAL CONNECTION
5.5 EQUIPOTENTIAL BONDING
5.6 CONNECTING THE GAS CYLINDER
5.7 DISCONNECTING THE GAS CYLINDER
9
9
9
9
9
9
10
10
6. CREATING AND MAINTAINING PNEUMOPERITONEUM
6.1 STARTING THE INSUFFLATOR
6.2 CONNECTING – DISCONNECTING THE PATIENT TUBING
6.3 MODIFYING PARAMETERS VIA THE MENU
6.4 PRESSURE INITIAL SETTING
6.5 STARTING INSUFFLATION
5.6 CONTROL
6.7 OVER-PRESSURIZATION
6.8 MONITORING THE FLOW
6.9 MONITORING THE VOLUME OF GAS USED
6.10 MONITORING THE VOLUME OF GAS AVAILABLE
6.11 END OF OPERATION
10
10
11
12
12
12
13
13
14
14
15
15
7. FAULTS AND WARNING SIGNALS
16
8. CLEANING / SERVICING / MAINTENANCE
8.1 CLEANING / DECONTAMINATION
8.2 SERVICING / MAINTENANCE
16
16
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 read this manual carefully before using the device, pay particular attention to the sections detailing the
safety and environmental conditions related to the device.
1.1 INTENDED USE
This device is designed to create and maintain a pneumoperitoneum (distension of the abdomen with CO2
gas) as part of a diagnostic and/or laparoscopic operative procedure.
Please refer to your laparoscope user manual for information on specific use.
This manual is only designed to assist the user with proper installation, set up and operation of the insufflaor.
FEDERAL LAW:
Federal Law in the United States restricts the use of this device solely to, or under the supervision of, a
surgeon.
1.2 CONTRAINDICATION
The device should only be used for an endoscopic procedure when insufflation of the abdomen is necessary
to faciliate navigation of the endoscope. Please refer to your laparoscope user manual for absolute and
relative contraindications.
This device is contraindicated for hysteroscopic insufflation; under no circumstances must it be used in cases
of intrauterine distension.
Note: the distension pressure of an insufflator for laparoscopy must not exceed 24 mmHg
1.3 WARNING
• Metabolic acidosis and resulting cardiac irregularity
Avoid prolonged intra-abdominal pressures above 20 mm of mercury. This would cause one of the following
risks:
• Reduction of respiration with compromised diaphragmatic movement
• Reduction of venous return
• Reduction of cardiac output
• Acidosis
Excessive absorption of CO2 is due to either a too high flow rate or excessive pressure, or both. The
abdomen can be sufficiently distended by a pressure between 10 and 15 mm of mercury. It is rarely
necessary to select an abdominal pressure higher than 15 mm of mercury. At these levels, the extent of
intravascular penetration should be low. Pressures higher than 20 mm of mercury are hardly ever necessary;
they will increase the quantity and the speed of intravascular penetration. Adequate respiration helps to
prevent problems associated with CO2.
• Idiosyncratic reactions
For patients suffering from microdrepanocytic diseases or pulmonary insufficiency, the use of these devices
can present an increased risk of metabolic imbalance related to the excessive absorption of CO2.
• Hypothermia
High-flow insufflation allows for a potential risk of hypothermia; therefore we recommend using a heating
system to keep the patient’s temperature stable.
• Gas flow
Surgical procedures must be carried out with insufflators able to reach flows between 4 to 10 l/min.
Insufflators providing lower flow must only be used for diagnostics procedures.
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
• Gas coagulation system
Some medical devices delivering gas to the interior of the peritoneal cavity during surgical laparoscopies (gas
lasers, for example) may lead to abdominal overpressurization. If venous sinuses are formed, triggering an
embolism, the use of a secondary gas source that is far less soluble in the blood than CO2 can cause a rapid
rise in intra-abdominal pressure. We recommend avoiding the use of these coagulation systems during
laparoscopic procedures, as we, the manufacturer could not be held responsible for any incident associated
with their use.
• Bacterial filter
The use of a hydrophobic bacterial filter is essential for preventing cross-contamination with the patient
• Please 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 device was designed and manufactured by Ackermann in a certified quality system.
It complies with the requirements of European directive 93/42/EEC on medical devices.
Consequently it complies in particular with the specific standards relating to electrical safety (IEC) and
electromagnetic compatibility (EMC).
2.2 ELECTROMAGNETIC COMPATIBILITY
Although this product complies with the electromagnetic compatibility standards (Appendix XII) it is possible
that, in very particular circumstances, it could interfere with other devices, or that other devices or an adverse
electromagnetic environment could interfere with it.
To prevent probability of these situations, we recommend to:
• check the quality of the electrical network (and in particular the earthing of all the devices and trolleys)
• keep the device 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 medical device, this unit is subject to the provisions related to medical device vigilance; therefore
any serious malfunction must be promptly reported to the proper authority and to us, giving as much detailed
information as possible. Please refer to the second page for our contact details.
2.4 END OF LIFE
This device carries the recycling symbol in accordance with European directive 2002/96/CE on Waste
Electrical and Electronic Equipment (DEEE or WEEE).
By following the correct procedures for disposing of this device you will be contributing to the prevention of
any consequences that could be harmful to the environment or human health.
The symbol
to be found on the device and/or in the accompanying documentation indicates that this
product may on no account be treated as household waste. It must therefore be delivered to a waste
collection point for the recycling of electrical and electronic equipment. For disposing of the device, please
observe the standards applied in the country of installation. To obtain complete details about the treatment,
recovery and recycling of this appliance, please contact your closest dealer to know how to proceed.
3. DESCRIPTION OF THE FRONT AND BACK PANEL
FRONT
Description
BACK
Description
A
5.7-inch LCD screen
1
CO2 Input
B
Warning light
2
On/Off switch
C
Tubing connector for patient
insufflation
3
Fuse housing
D
Tubing connector for external
desufflation
4
Mains socket
E
Low/high flow selector button
5
Equipotential socket
F
Start/stop insufflation
6
Labeling
G
Selection and validation thumbwheel
H
Start/standby button
I
Start/standby LED
FRONT PANEL
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
BACK PANEL
4. SPECIAL FEATURE
4.1 GREATER SAFETY USE
• Autotest
The device performs an autotest in less than 1 sec. where it calibrates itself automatically and check for basic
components.
• Detection of tubing
The device will only start if a sterile tube is connected to the outlet and 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 abdominal pressure equal to the pressure
setting.
• An additional pressure sensor
If the measurement circuit fails, consistency of the measurements is continuously monitored; this means that
the insufflation cycles can be interrupted if there is the slightest cause of doubt.
• 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 mode, the insufflation flow is limited 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 default, the insufflator starts in low-flow manual mode. The surgeon can choose the automatic or the
manual mode to activate the high flow.
4.3 HIGH FLOW
When the pneumoperitoneum is created, activating the high flow mode permits a maximum flow of between
20 and 45l, depending on the model. 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 selected from the menu, the device starts insufflating in low-flow mode, then switches
to the high-flow position once blow-off pressure is reached.
4.5 EXTERNAL PRESSURE RELIEF VALVE
Our insufflators have a valve that allows CO2 overpressure outside the device in order to avoid:
• over-pressurization in the pneumoperitoneum (if the pressure is more than 5mmHg greater than the blow-off
pressure for more than 3 seconds)
• any return of fluid to the device’s interior, thus preventing any risk of deterioration or contamination.
4.6 MONITORING OF THE CYLINDER PRESSURE
This last generation of insufflators is equipped with a system for measuring the cylinder pressure which is
continuously displayed. Moreover, when the cylinder pressure reaches 40 bars, a cylinder icon is displayed
on the LCD and “cylinder empty” blinks. As soon as the cylinder pressure reaches 20 bars, the insufflator
informs the user via:
• The display of the cylinder pressure in the alarm area
• A red light on the display
Below 10 bars the insufflator is not allowed to be used.
4.7 LCD DISPLAY
In order to communicate better with the user and to improve the ease of use, we have equipped our latest
generation of insufflators with a 5.7-inch LCD display.
This allows the following to be displayed in 5 different languages:
• warnings and error messages in full
• interactive menu allowing the device to be personalized
• indication of empty cylinder
• indication of blow-off pressure in mm Hg
• indication of intracavitary pressure in mm Hg
• indication of flow in l/min
• indication of volume of CO2 used in liters
• indication of status: in start/stop and “high flow”/“low flow”
• moving around in the menu by means of a selection thumbwheel
4.8 FILTER
• CO2 cylinder
A particle filter is inserted in the CO2 inlet to prevent contamintaion arising from particles or impurities which
may be present in the CO2 from entering cylinders.
• 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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5. INSPECTION AND INSTALLATION IN THE OPERATING THEATRE
5.1 CHECKING THE DEVICE
Any deterioration, malfunction or missing ancillary equipment must be immediately reported or confirmed by
us and/or distrubutor by registered letter so that it can be covered by insurance if necessary.
Please keep the original device packaging for its yearly maintenance return. When doing so, please enclose
a document to include your name, address and the reason for returning the device (problem encountered).
Place 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 delivered with the following ancillary equipment:
Description
Quantity
User manual
1x
Main power cable 2.50 m long
1x
Open-ended spanner for the high-pressure hose connector
1x
Set of 1 sterile disposable Y-tubes equipped with a viral filter, packed 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 feed 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 safeguards against discharge of static electricity (ESD) are as follows:
• application of equipotential bonding on all devices is to be connected; connect the voltage compensator
cable to the connector [5] on the rear panel.
• exclusive use of the ancillary equipment mentioned
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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 cylinder in an upright position to avoid possible movement (cylinder head facing upwards),
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 cylinder side is present (DIN only)
Use the open-ended spanner to tighten the connector linked to the cylinder outlet, then the one linked 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 PNEUMOPERITONEUM
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 RESPONSE
Press the on/off switch [2] on the rear panel to [I].
Open the gas cylinder.
Press the button [H] on the front panel.
The indicator light [I] on the front panel flashes, to
show the device is running.
The device performs an AUTO TEST.
The indicator light [I] on the front lights up.
The welcome page appears indicating the type of
insufflator.Followed by the menu
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USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
The AUTOMATIC TEST will only run if tubing is not connected. It only takes a second.
You may now connect the tubing as described
in the following chapter
The device is waiting for the blow-off
pressure and will not start until it receives
this information.
6.2 CONNECTING-DISCONNECTING THE PATIENT TUBING
We cannot be held liable for any failure or malfunctions arising from the use of damaged or
unsuitable tubing.
Do not use tubing if the packaging is damaged.
Sterile tubes are disposable; do not re-sterilize.
Use of a hydrophobic bacterial filter is essential for the prevention of cross-contamination with the
patient.
Open the first set of packaging film around the tubing. Hand the second set to sterile personnel.
Keep the patient’s sterile tube in the operating theatre.
Open the second sterile pouch and connect the tubing to the insufflator’s gas outlet.
Insert the other part of tubing into the external desufflation actuator
The tube needs to be straight, inserted with ease and must not be obstructed. Do not switch the two
tubes, as they have different diameters.
• Connect the Luer lock to the trocar port on the patient side.
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6.3 MODIFYING PARAMETERS VIA THE MENU
USER ACTION
DEVICE RESPONSE
• The menu is displayed at the start of the procedure
• Use the thumbwheel to select and modify a parameter
• The default language is English. This can be changed to
French, German, Italian or Spanish.
• Automatic or manual low/high flow switching
• Intra-cavity blow-off pressure
• Reset the volume of CO2 used to zero.
• Contrast control
• Reset the chronometer to zero
The parameter is highlighted in the display
Turn the thumbwheel to change the values and press on it
to validate.
To exit, select “return” and validate.
Automatic switching must be selected by order of the surgeon.
6.4 PRESSURE INITIAL SETTING
This operation must be carried out by or under the control of an experienced surgeon.
Use the thumbwheel to help you select the required intra-abdominal pressure between 0 and 24 mmHg. The
pressure that is commonly used is 12 mmHg, which is sufficient for most operations. You will be asked as a
safety precaution to confirm if blow off pressure is above 15 mmHg.
6.5 STARTING INSUFFLATION
Insufflation will start once the button [F] on the front panel is pressed. An icon on the screen shows the RUN
mode.
The MENU cannot be accessed while the device is operational; to access it, insufflation has to be stopped by
pressing the button [F].
Insufflation start in low-flow mode, 2 l/min, so that pneumoperitoneum is created under the safest possible
conditions. The low-flow icon is activated.
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High-flow mode is initiated manually by pressing the button [E] on the front panel, or automatically if this
mode is activated.
6.6 CONTROL
Once the required cavity is created, the insufflator keeps pneumoperitoneum at the pressure selected and
corrects CO2 leakage immediately.
The insufflation flow will very often be limited when passing into the trocar (and the instrumentation) than by
the performance of the insufflator.
Once blow-off pressure is reached, the insufflator stops insufflating. Insufflation restarts as soon as
intracavitary pressure drops below blow-off pressure.
6.7 OVER-PRESSURIZATION
As soon as intracavitary pressure exceeds blow-off pressure by 5mmHg. The message “OVERPRESSURIZATION” is then displayed on the screen.
There is a visual warning light [B] and an audible warning signal (beep) as well.
After 3 seconds the device will discharge the surplus gas by opening the external pressure relief valve.
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6.8 MONITORING THE FLOW
The immediate flow is indicated on the LCD screen in liters/minute.
6.9 MONITORING THE VOLUME OF GAS USED
The volume of gas used is shown in litres on the LCD display to the nearest deciliter.
This meter is started by pressing on the button [F] and only resets to zero once the device is no longer in use.
If necessary set it to zero via the menu.
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6.10 MONITORING THE VOLUME OF GAS AVAILABLE
As soon as the cylinder pressure reaches 40 bars a flickering cylinder icon is displayed.
At 20 bars a red light alarm light [B] and an alarm message “CYLINDER PRESSURE 20 bar” is
displayed.
The cylinder status in the display is updated continuously.
Below 10 bars it is not possible to start the device (RUN/STOP key disabled); the cylinder must be
changed immediately.
No operation may proceed using a cylinder below a level which would not last the duration of the
surgery.
6.11 END OF OPERATION
Stop insufflation by pressing [F]; the STOP icon appears.
Disconnect the tubing from the trocar and the insufflator immediately to prevent any liquid or gas from flowing
back to the device.
The used tubing must be disposed of in an appropriate container after use.
The total volume of gas insufflated during the operation appears; reset the gas meter to zero if another
operation is planned (see chapter VII – C). Close the CO2 gas cylinder
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7. FAULTS AND WARNING SIGNALS
WARNING MESSAGE
POSSIBLE CAUSE
ACTION TO BE TAKEN
CYLINDER LOW
Cylinder pressure at 40 bar
Prepare a replacement cylinder
Cylinder pressure at 20 bar
Change the cylinder immediately
Gas cylinder valve closed
Open the valve
Insufflator high-pressure hose connector
disconnected
Turn off the device, check CO2 intake
and restart the device
Sporadic action on pneumoperitoneum
None (if pressure is 5 mmHg greater
than blow-off pressure for more that 3
seconds the device performs an
external desufflation)
Tubing kinked
Stretch the tubing
The tubing is missing
Connect the tubing
The tubing is wrongly connected
(desufflation actuator)
Connect the tubing correctly
CALIBRATION ERROR
The tubing is connected
Disconnect
the
tubing
from
insufflator’s outlet connector for 2
seconds only
REMOVE TUBING
AUTOMATIC TEST not run
Remove the tubing for 2 seconds,
then replace
Fault in tubing detection
Send device for servicing
Gas cylinder valve closed
Open the valve
Insufflator high-pressure hose
disconnected
Connect the hose correctly to the
insufflator
SERVICE
Maintenance action essential
Send device for servicing
No power
Fuses damaged
Check and replace the 2.5A UR fuses
if necessary
OVER-PRESSURIZATION
TUBING NOT THERE
CO2 NOT DETECTED
For any other problem, please contact your nearest after-sales service team or our HQ in Germany.
8. CLEANING / SERVICE / MAINTANCE
8.1 CLEANING / DECONTAMINATION
Only instructions created by the personnel responsible for sterilization in each hospital or health
centre must be followed; these instructions will take precedence over the information contained in
this manual, which is provided for guidance only.
Always disconnect the device’s electrical plug before cleaning it.
After each use:
• discard disposable sterile tubing; do not try to sterilize it
• clean up any possible splashes of liquid on the insufflator by wiping them with a slightly dampened cloth.
The device MUST be decontaminated before it is sent to the after-sales service team.
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8.2 SERVICING / MAINTANCE
• If a problem persits, and it is necessary to send the insufflator back to us, please ensure it is returned in its
original packaging to us. Please also include a detailed explanation about the malfunction.
• Upon receipt of your equipment, please inspect its condition. If there are any reservations or concerns about
the condition on delivery, we recommend you address these concerns immediately. A window of 48 hours is
allowed for these concerns to be raised. If the delivered equipment suffers any damages while in transit,
please notify us and the courier immediately. In case charges need to be implemented, we would require all
relevant information to establish liability, before we can proceed.
• Immediately check functionality of the delivered equipment.
• All repairs on the equipment will be performed by us and we reserve the right to withhold any technical
data.
9. SYMBOLS USED
DESCRIPTON
CORRESPONDING
Class 1 device
Class 1
Type BF device
UR time-lag fuse (conforms to UL standard)
Record of equipotential
Connector for CO2 port
Date of manufacture MM/YYYY
Manufacturer
Complies with European directive 93/42/CEE
Electric or electronic device launched on the
market after 08/01/05
10. TECHNICAL SPECIFICATIONS
Pneumatics:
• CO2 gas supply system:
- DIN 477-1 no. 6 or US 7/16” connector
- Maximum permitted pressure of 70 bar
• Maximum flow without loss of head (to the nearest decilitre):
- 20 to 45 l/min in high flow (depending on the model)
- 2 l/min in low flow
• Blow-off pressure: 0 to 24 mmHg to an accuracy of 1mmHg
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• External desufflation valve
• Option of automatic low/high flow switching
Interface:
• 5.7-inch LCD screen showing: immediate flow, intra-cavity pressure, blow-off pressure, total volume of CO2
used and low levels in the cylinder
• Thumbwheel navigation and validation system
• Internal warning data memory
Power supplies:
• Types of power supply: 100-230 V AC 50-60 Hz
• Protection by fuses: 2 x 2.5 AT – 250V time-lag fuses - UR
• Power used: 40VA
Mechanics:
• Dimensions: L=300mm, D=340mm, H=145mm
• Weight: 5 kg
Operating – transportation and Storage Environment:
• Operating temperature range: +10°C / +40°C
• Operating relative humidity range: 30 to 75 %
• Transport and storage temperature range: +10°C / +40°C
• Transport and storage relative humidity range: 20% to 85%
• Operating, transport and storage atmospheric pressure range: 700hPa to 1060hPa
Standards:
• Electrical protection: class 1 type BF
• Conforms to European directive 93/42/CEE on medical devices: class IIa
• Conforms to standard IEC 60 601–1; UL 60601-1 ; CSA 60601-1
• Not protected against water (IPX0)
• Not adapted for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide
Ancillary equipment:
• Main power cable
• Open-ended spanner intended for CO2 high-pressure feed hose connector.
• 4 sterile, disposable external desufflation tubes fitted with a viral filter.
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11. ELECTROMAGNETIC COMPATIBILITY
Guide and declaration by manufacturer – electromagnetic emissions
This insufflator is designed to be used within the electromagnetic environment specified below. The user should ensure
that it is indeed used within this environment
EMISSIONS TEST
COMPLIANCE ELECTROMAGNETIC ENVIRONMENT-GUIDE
RF emissions
CISPR 11
Group 1
This insufflator only uses radioelectrical energy for its internal
subsystems. Therefore, it emits very low RF energy and is not likely to
interfere with nearby electronic devices.
RF emissions
CISPR 11
Class A
Harmonic emissions
EN 61000-3-2
Conform
This insufflator must be used in all premises other than residential
premises and premises connected directly to the public low-voltage power
distribution network used for powering residential buildings.
Voltage fluctuations /
flicker EN 61000-3-3
Conform
Guide and declaration by manufacturer – electromagnetic immunity
This insufflator is intended to be used within the electromagnetic environment specified below. The user should ensure
that it is indeed used within this environment
IMMUNITY
TEST
CEI 60601
SEVERITY LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT-GUIDE
Electrostatic
discharges
EN 61000-4-2
± 6 kV via contact
± 8 kV via air
± 6 kV
± 8 kV
The floor should be in timber, concrete or tiling. If the
floor is covered with a synthetic material, the relative
humidity should be at least 30%.
Quick transients
in bursts
EN 61000-4-4
± 2 kV for power lines
± 1 kV for
input/output lines
± 2 kV
± 1 kV
The quality of the main power supply should be that of
a typical commercial or hospital environment.
Voltage shocks
EN 61000-4-5
Differential mode
± 1 kV
Common mode ± 2 kV
± 1 kV
The quality of the main power supply should be that of
a typical commercial or hospital environment.
N.A.
Brown-outs, brief • <5% UT – for 10 ms
power
failures and
• 40% UT – for 100 ms
voltage
variations
• 70% UT – for 500 ms
EN 61000-4-11
• <5% UT – for 5 s
<5% UT
10 ms
<40% UT
100 ms
<70% UT
500 ms
<5% UT
5s
The quality of the main power supply should be
that of a typical commercial or
hospital environment.
If the user of this insufflator requires being able to
continue to work during interruptions in the main
power supply, it is recommended that this insufflator
be powered via a UPS or battery.
Magnetic field at
network
frequency
(50/60 Hz)
3 A/m
The magnetic field at the network frequency should be
at a level characteristic of a location within a typical
commercial or hospital environment.
3 A/m
Note: UT is the nominal value of the power voltage applied during the test.
PAGE 19 OF 21
USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
Guide and declaration by manufacturer – electromagnetic immunity
This insufflator is designed to be used within the electromagnetic environment specified below. The user should ensure
that it is indeed used within this environment
IMMUNITY
TEST
CEI 60601
SEVERITY LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT-GUIDE
Conducted RF
EN 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Radiated RF
EN 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3V/m
Portable and mobile RF communication equipment
should be used no closer to any part of the camera
including cables, than the recommended seperation
distance calculated from the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power of the
transmitter, in Watts (W), assigned by the
manufacturer of the transmitter and the recommended
separation distance (d) in meters (m).
The field levels emitted by immobile RF transmitters –
which are to be established by an electromagnetic
measurement at the site – must be lower than the
compliance level in each frequency band.
Interference can occur nearby devices bearing the
following symbol:
Note 1 At 80 MHz and 800 MHz, the higher frequency band applies.
Note 2 These recommendations may not apply in all situations. The propagation of electromagnetic waves is modified
by absorption and reflection due to structures, objects and people.
a The field level of immobile transmitters, such as radio telephone base stations (cellular and cordless) and mobile
terrestrial radio systems, amateur radio systems, AM/FM radio communication systems, and TV systems cannot be
evaluated theoretically with precision. To ascertain the electromagnetic environment due to immobile RF transmitters, a
site measurement must be performed. If a field level measured within the environment in which this insufflator is used
exceeds the above applicable compliance levels, check that this insufflator operates in a satisfactory manner. If
abnormal operation is observed, additional measurements should be taken, such as reorientation or relocation of the
reference system.
b Outside the frequency band of 150 kHz to 80 MHz, the field level should be less than 3 V/m
PAGE 20 OF 21
USER MANUAL 16-2040N / 16-2041N / 16-2042N Rev. 07/2016
Separation distances recommended between portable and mobile RF communications systems and this
insufflator
This insufflator is designed to be used within an electromagnetic environment in which radiated RF interference is
controlled. The user of this insufflator can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communication systems (transmitters) and this insufflator, such as recommended
below, as a function of the maximum output power of the communications system.
Maximum assigned output Separation distance as a function of the transmitter’s frequency M
power of the transmitter W
150 kHz to 80 MHz 80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.1
1
10
100
d = 1,16 P
d = 1,16 P
d = 2,33 P
0.116
0.366
1.16
3.66
11.6
0.116
0.366
1.16
3.66
11.6
0.233
0.736
2.33
7.36
23.3
Note 1 At 80 MHz and 800 MHz, the higher frequency band applies.
Note 2 These recommendations may not apply in all situations. The propagation of electromagnetic waves is modified
by absorption and reflection due to structures, objects and people.
For transmitters of which the maximum output power is not listed above, the recommended separation distance d in
meters (m) can be established by using the equation applicable for the transmitter frequency, in which is the
transmitter’s maximum output power in Watts (W) assigned by the transmitter’s manufacturer.
Note 1 At 80 MHz and 800 MHz, the separation distance stated for the higher frequency range should be applied.
Note 2 These recommendations may not apply in all situations. The propagation of electromagnetic waves is modified
by absorption and reflection due to structures, objects and people.
PAGE 21 OF 21
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