ACKERMANN 16-2040N Скачать руководство пользователя страница 19

USER MANUAL 16-2040N / 16-2041N / 16-2042N

 Rev. 07/2016

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

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.

Harmonic emissions
EN 61000-3-2

Conform

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

N.A.

The quality of the main power supply should be that of
a typical commercial or hospital environment.

Brown-outs, brief 
power
failures and 
voltage
variations
EN 61000-4-11

• <5% U

– for 10 ms

• 40% U

– for 100 ms

• 70% U

– for 500 ms

• <5% U

– for 5 s

<5% U

T

10 ms
<40% U

T

100 ms
<70% U

T

500 ms
<5% U

T

5 s

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

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.

Note: U

is the nominal value of the power voltage applied during the test.

PAGE 19

 OF 21

Содержание 16-2040N

Страница 1: ...USER MANUAL 16 2040N 16 2041N 16 2042N INSUFFLATOR 20L 30L 45L ...

Страница 2: ...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 49 0 7461 96617 0 Fax 49...

Страница 3: ... 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 ...

Страница 4: ...NING 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 abd...

Страница 5: ... 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 de...

Страница 6: ... 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 ...

Страница 7: ...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 f...

Страница 8: ... 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 warnin...

Страница 9: ... 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...

Страница 10: ...de 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 b...

Страница 11: ...ing 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...

Страница 12: ...lected 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 pressur...

Страница 13: ...nto 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 OVER PRESSURIZATION is then displayed on the screen There ...

Страница 14: ...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 PAGE 14 OF 21 ...

Страница 15: ...ed 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 ap...

Страница 16: ...un Remove the tubing for 2 seconds then replace Fault in tubing detection Send device for servicing CO2 NOT DETECTED 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 For any other pro...

Страница 17: ...re 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 CO...

Страница 18: ...nment 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 s...

Страница 19: ... 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 b...

Страница 20: ...romagnetic 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...

Страница 21: ...16 P d 2 33 P 0 01 0 1 1 10 100 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...

Отзывы: