Surgiquest AirSeal iFS Скачать руководство пользователя

Страница: 18 / 60

Initial Device Startup

nection or connect to centralized CO

gas supply.

4.2.1

Connecting a Gas Cylinder

CAUTION!
Always use a high-pressure hose to connect gas cylinder and device.

The gas cylinder must be in a vertical position. The gas bottle pressure may not
exceed 80 bar/1160 psi. For the device start, the gas cylinder pressure must be at
least 25 bar/363 psi.

CAUTION!
Gas cylinders with riser pipes can release dirt and oily fluids into the device. Do
not use gas cylinders with riser pipes.

High pressure hoses

The following high pressure hoses are available:

Installation

High Pressure Hoses with PIN Connector

• Connect or loosen to the device using the open-end wrench SW 14.
• Connect or loosen to the gas bottle with your hand.

High Pressure Hoses with DIN Connector

• Connect or loosen to the device using the open-end wrench SW 14.
• Connect or loosen to the gas bottle using the open-end wrench SW 30.

High Pressure Hoses with ISO Connector

• Connect or loosen to the device using the open-end wrench SW 14.
• Connect or loosen to the gas bottle using the open-end wrench SW 32.

4.2.2

Connecting to Central Gas Supply

Use the following device connectors and high-pressure hoses available as addi-
tional equipment to connect to a central gas supply (house supply):

• Connector and hose for house gas supply NIST or
• Connector and hose for house gas supply DISS

Designation

High Pressure Hose Device US / Bottle DIN
High Pressure Hose Device US / Bottle ISO
High Pressure Hose Device US / Bottle PIN Index

Содержание AirSeal iFS

Страница 1: ...EN Instructions for use...

Страница 2: ...ts reserved This manual should not be photocopied du plicated on microfilm or otherwise copied or distributed com pletely or in part without the approval of SURGIQUEST Some of the parts and equipment...

Страница 3: ...quipotentiality Decrease House gas supply full Degrees of protec tion provided by enclosures IPCode Keep dry House gas supply low Alternating cur rent Top Bottom Gas bottle full 40 bar Service Fragile...

Страница 4: ......

Страница 5: ...First Nominal Pressure 34 8 2 Gas Flow Rates 34 8 3 Setting Smoke Evacuation Level 34 8 4 Setting General Volume 34 8 5 Setting Brightness 34 8 6 Setting Audible Occlusion Signal 35 8 7 Setting Gas S...

Страница 6: ...2 EN 15 AirSeal iFS Warranty 52 16 Test Log 53 16 1 Test Log 53 16 2 Return Form 54 Index 55...

Страница 7: ...manufacturer reserves the right to modify the appearance graphics and technical data of the product through continued development of its products Please note The words WARNING CAUTION and NOTE carry s...

Страница 8: ...ments by filling the abdominal cavity with gas to distend it by creating and maintaining a gas sealed obstruction free instrument path and by evacuating surgical smoke This instrument is used to insuf...

Страница 9: ...G 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 environ ments WARNING Risk o...

Страница 10: ...Dan gers WARNING Risk of electrical shock To avoid the risk of electrical shock only use this device when connected to a properly grounded power supply network WARNING Reprocessing of sterile disposa...

Страница 11: ...Please consult the manual of your laparoscope for absolute and rela tive contraindications The device is not suitable for hysteroscopic insufflations i e it may not be used to distend the uterus 3 1 D...

Страница 12: ...dered gas flow WARNING Connecting the tube Always use the proper tube set for the device The tube outlet may only be con nected to instruments which are intended for intra abdominal CO2 insufflation W...

Страница 13: ...O2 High pres sure 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 intravasa tion Never exceed the max cavity pres...

Страница 14: ...rst insufflation and ensure that the insufflation instru ment is correctly positioned Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal p...

Страница 15: ...for electrical safety and electromechanical compatibility However if you detect or suspect such interference please follow these sugges tions Move this the other or both devices to a different locati...

Страница 16: ...Do not operate the device in the vicinity of ex plosive anesthetic gases and not in the vicinity of oxygen enriched environ ments 4 1 Device Setup and Connection Setting up Place the device on a flat...

Страница 17: ...located in rear of device type plate to determine the operating voltage of the device Grounding contact The power connection must be equipped with a grounding contact Use the orig inal power cable if...

Страница 18: ...evice using the open end wrench SW 14 Connect or loosen to the gas bottle with your hand High Pressure Hoses with DIN Connector Connect or loosen to the device using the open end wrench SW 14 Connect...

Страница 19: ...ssures are displayed House gas supply The following house gas supply pressures are displayed 40 bar 580 psi 30 40 bar 435 580 psi 15 30 bar 218 435 psi 5 15 bar 73 218 psi warning screen Gas level low...

Страница 20: ...16 Initial Device Startup EN House gas supply pressure OK House gas supply pressure too low...

Страница 21: ...f they come in proximity Keep ventilation slots free of obstructions or soiling to ensure optimal cooling of the device Fig 5 1 Front of the Device 1 ON OFF switch 2 Touch screen display 3 Receptacle...

Страница 22: ...sages 5 The message Device ready is shown after the successful initial self test An acoustic signal is emitted and the display depicts Mode Selection NOTE After the successful initial self test factor...

Страница 23: ...g modes Smoke Evacuation and AirSeal are connected to the filter recep tacle see Fig 5 1 Front of the Device 3 Single Lumen Filtered Tube Set hereafter referred to as single lumen tube Disposable conv...

Страница 24: ...tion The Initial Insufflation phase remains in operation until the set nominal pressure has been reached through the insuf flation for the first time CAUTION For the safety of the patient please fill...

Страница 25: ...ing the Device 21 EN 5 5 4 Power Device Off Use the ON OFF button to turn the device off CAUTION Disconnection from the power supply is only guaranteed if the mains plug is pulled from the mains wall...

Страница 26: ...ingle Lumen Fil tered Tube Set and conventional cannula 6 1 AirSeal Mode The AirSeal Mode is intended to establish and maintain a pathway of entry for laparoendoscopic instruments to the field of surg...

Страница 27: ...itor see manufacturer s instructions Insert the endoscope into the opening at the proximal end of the obturator until it reaches the distal tip of the obturator 6 1 2 Initial Insufflation When working...

Страница 28: ...b Initial insufflation with AirSeal Access Port Connect the Tri Lumen Filtered Tube Set with the AirSeal Access Port see 6 1 1 AirSeal Access Port To be carried out by non sterile technician Insert t...

Страница 29: ...eedle in the AirSeal Mode The status line depicts Initial In sufflation Initial Insufflation ends when the AirSeal Cannula is attached to the Tri Lumen tube set Once the set pressure is achieved messa...

Страница 30: ...ng placement should be checked to make sure no more fluid enters the fluid trap At this point insert AirSeal obturator and change the filtered tube set Insufflation can be continued with full func tio...

Страница 31: ...l 2 20 l min Level 3 40 l min To set the flow rate press the key 1 3 or 4 Setting the nominal pressure Press the key or 5 or 8 to set the nominal pressure Values may range from 5 to max 20 mmHg and ca...

Страница 32: ...insufflation is still active If the Smoke Evacuation Mode has been stopped because the fluid level HIGH was reached the iFS should be inspected to assess any possible damage Call for service 6 3 Stan...

Страница 33: ...CAUTION Exceeding this safety limit is to be decided by and the responsibility of the user operator 5 Start insufflation with the START key The status line depicts Initial Insufflation The initial ins...

Страница 34: ...NING Backflow Body secretions or contaminated gas may backflow into the device through the insufflation tube if a filter is not used the actual pressure is higher than the nominal pressure or the auto...

Страница 35: ...itted The actual pressure display de picts 0 The warning tone can be deactivated in the user menu see chapter 8 User Menu Remove the occlusion if this is not done intentionally e g with a closed stopc...

Страница 36: ...ds may be flushed from the surgical field through the evacuation line and into the filter housing In order to prevent contamination of the device bodily fluid is retained by the fluid trap of the hous...

Страница 37: ...g A to open the user menu Fig B Device parameters can be changed in the user menu The following pages pro vide an overview as well as a detail description Access to the service menu Access to the serv...

Страница 38: ...or the warning signals as well as the info and alert signals all in the form of acoustic signals The selection setting ap plies to all insufflation operating modes Press the or key to set the desired...

Страница 39: ...the desired gas supply In this menu item press the or key to select the desired volume for No Gas Alarm 8 8 Setting the Language In the user menu tap the Language key to access the language selection...

Страница 40: ...assist in early detection of possible malfunctions This helps preserve the device and increases its safety and service life NOTE Service or maintenance work may not be carried out during surgery 9 3 M...

Страница 41: ...s not have to be opened to reset the fuse 1 Switch device off 2 Disconnect device from power supply 3 Remove power connection cable from mains socket 4 The fuse switch is located next to the mains soc...

Страница 42: ...5 Remove the fuse holder as shown in Fig 9 2 Opening the fuse holder 6 Undo the latch of the fuse holder with two fingers 7 Remove the fuse holder 8 Check fuse 9 Insert a new fuse Use only the specifi...

Страница 43: ...tion Test 1 Conduct this test without the Single Lumen Filtered Tube Set connected to the AirSeal iFS 2 Use the ON OFF switch to turn the device on The device now conducts a self test A short acoustic...

Страница 44: ...inge to generate a pressure of at least 10 mmHg which is indicat ed on the manometer Actual pressure display 10 2 mmHg 5 Use the syringe to generate a pressure of at least 20 mmHg which is indicat ed...

Страница 45: ...flow 5 Start insufflation Press the START key The manometer registers a pulsing pressure increase When the pressure sta bilizes the manometer indicates a maximum pressure between 50 and 75 mmHg 6 Stop...

Страница 46: ...be restarted after 24 hours to allow the self test to be repeated Further more the service interval described in chapter 9 2 Maintenance Intervals must also be adhered to CAUTION Continuous operation...

Страница 47: ...5 270 and 315 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 The quality of the supply voltage should be the same as the voltage of a typical business or hospital environment If the user opera tor...

Страница 48: ...re orient ing or relocating the insufflator b The field strength should be less than 3 V m for the frequency range of 150 kHz to 80 MHz IMMUNITY TEST Transients HF IEC 61000 4 3 WARNING Portable HF co...

Страница 49: ...ce RF emissions CISPR 11 Group 1 The AirSeal iFS uses RF energy solely for its internal function There fore its RF emissions are very low and are not likely to cause any inter ference in nearby electr...

Страница 50: ...tain Pres sure Change Tube Set to Protect iFS Unit and Continue with AirSeal Function Low fluid level of the fluid trap in the filter housing during AirSeal mode Please insert a new tube set Smoke Eva...

Страница 51: ...lockage Determine the cause for the occlusion Check the positioning of the cannula Filter contaminated Insert new tube set High fluid level of the fluid trap in the filter housing Please insert a new...

Страница 52: ...e for exceeding the nominal pressure Check the electronic displays of the device if overpressure exists for a longer period of time Overpressure Venting active The actual pressure is above the nomi na...

Страница 53: ...ng standards in the respective currently valid version DIN EN 60601 1 IEC 60601 1 EN 60601 1 2 IEC 60601 1 2 Operating conditions 10 to 30 C 50 to 86 F 30 to 75 rel humidity 700 to 1060 hPa air pressu...

Страница 54: ...value from the table below Example Rated current 5 A Enviroment temperature 50 C Correction factor 1 04 Resulting current 5 2 A Fount to next higher rated current 6 A 2 See DIN EN 60 3 Acc to 93 42 E...

Страница 55: ...art w bottle racks 6 160 mm Valve1 Connectors iFS BC1 Bottle Gas Connector iFS WC1 DISS Wall Connector iFS WC2 NIST Wall Connector Tube Sets Tri Lumen Filtered Tube Set AirSeal Mode Bifurcated Smoke E...

Страница 56: ...determined that the fault is not covered by this war ranty the repairs will be billed to the customer as out of warranty repairs Devic es repaired under the Company s standard repair program will be...

Страница 57: ...Test Log 53 EN 16 Test Log 16 1 Test Log Date Results Comment Signature...

Страница 58: ...this form when returning the device Name of owner Sales partner Address of person returning unit IMPORTANT Street ZIP Postal code City Country Serial number see identification plate Device REF Descri...

Страница 59: ...use gas supply 15 I Informational warning and error messages 46 Intended use 7 7 L Leakage warning 32 Liability 36 M Mains connection 13 Manufacturer s specifications 36 Measured values and tolerances...

Страница 60: ...W55 186 EN AA...

Результаты поиска

Содержание AirSeal iFS

Отзывы:

Похожие инструкции для AirSeal iFS

Бренды по названию

Популярные бренды

Surgiquest AirSeal iFS, Инструкция по эксплуатации

Результаты поиска

Содержание AirSeal iFS

Отзывы:

Похожие инструкции для AirSeal iFS

Бренды по названию

Популярные бренды