F102 Insufflator User Guide July 2014

Important User Notes 1

Important User Notes

EN

Read the manual 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 staff or service personnel, or • to damage or malfunction of device and/or accessories. The manufacturer reserves the right to modify the appearance, graphics, and technical data of the supplied product through continued product development.

Subject to technical changes

The words WARNING, CAUTION, and NOTE carry special meanings. Sections marked with these words must be read especially attentively.

Please note

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 parties.

CAUTION! These paragraphs include information provided to the operator concerning the intended and proper use of the device or accessories.

NOTE! Here you will read information about the maintenance of the device or the accessories.

3

Safety Information

EN

2

Safety Information

Federal Law (only for U.S. market)

U.S. federal law restricts use of this device to use by or on the order of a physician.

Exclusion of liability

The manufacturer is not liable for direct or consequential damage and the warranty is null and void if: • the device and/or the accessories are improperly used, prepared, or maintained, • the instructions and rules in the manual are not adhered to, • non-authorized persons perform repairs, adjustments, or alterations on or to the device or accessories, • non-authorized persons open the device, • the prescribed inspection and maintenance schedules are not adhered to. Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations on or to the device or accessories.

Authorized service technician

Only an authorized service technician may perform repairs, adjustments, or alterations 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 functional before each use.

Contamination

Before shipping, decontaminate device and accessories in order to protect the service personnel. Follow the instructions listed in this manual. 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 of as unsorted municipal waste and must be collected separately instead. Please contact the manufacturer or an accordingly authorized disposal or waste management company for further information.

2.1

Hazards

WARNING! Condensation / Water penetration Protect device from moisture. Do not use if moisture has penetrated the device.

WARNING! Original accessories For your own safety and that of your patient, use only original accessories.

WARNING! Check all factory settings. Factory settings are not mandatory settings for the physician. The physician is responsible for all settings affecting the surgical procedure.

4

Safety Information 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.

EN

CAUTION! Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device.

WARNING! Not explosion-proof The device is not explosion-proof. Do not use in an area where flammable anesthetic gases are present.

WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Refer servicing to qualified service personnel.

WARNING! Disconnect device from power supply Pressing the ON/OFF key does not disconnect the device from the power supply. This requires pulling the plug located in the rear of the device.

WARNING! Replacing fuse Replace the fuse only with a fuse of the same type and rating.

WARNING! Professional qualification This manual does not include descriptions or instructions for surgical procedures/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! Functional test The functional test must be performed prior to each surgery.

WARNING! Sterile mediums and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated.

5

Safety Information WARNING! Cleaning the device Do not sterilize the device.

EN

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.

WARNING! Device-inherent dangers Read the warnings specific to this device in chapter 3.1 "Device-Inherent Dangers".

WARNING! Device defect If a device defect is suspected or confirmed, do not use it. Make sure the device can no longer be used until a qualified service technician conducts the appropriate tests and repairs.

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 IEC 60601-2-18 and ISO 8600.

6

Purpose 3

Purpose

The device serves to insufflate CO2 into the abdomen during a diagnostic or therapeutic laparoscopy. Please consult the instructional manual of your laparoscope for additional information and special application indications. The insufflator limits the pressure to max. 30 mm Hg (mm mercury column) and the gas flow to max. 20 l/min. The device measures the pressure within the abdomen in short intervals and continuously compares the nominal with the actual abdominal pressure. The function of this device is to maintain the nominal pressure. Any overpressure within the abdomen is lowered to the preset nominal pressure by the automatic venting system. If the nominal flow is set too low, the nominal pressure cannot be reached.

EN

Intended Use

Check for possible leaks. The device may not be used to fill an abdomen with CO2 if a laparoscopy is contraindicated. Please consult the manual of your laparoscope for absolute and relative contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it may not be used to distend the uterus.

Contraindications

The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos.

3.1

Device-Inherent Dangers

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 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 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 pressure 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. intra-abdominal pressure of 30 mmHg.

WARNING! Metabolic and cardiac reactions Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irregularities expressed with the following symptoms: • Reduced respiration with restricted diaphram function • Hypercapnia • Reduction of venous reflux • Reduced cardiac output • Metabolic acidosis

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 reaction).

WARNING! Hypothermia/monitoring body temperature The gas flow can lead to a lowering of the patient's body temperature during insufflation. Hypothermia during insufflation can cause heart and cardiovascular

7

Purpose problems. The risk for hypothermia can be significantly reduced with the use of gas that is pre-warmed to body temperature. Always monitor the patient's body temperature during the entire insufflation. Make especially sure that the following, hypothermia promoting, surgical conditions are avoided as best as possible: • High gas flow due to large leaks • Long surgeries • Use of cold (not preheated) irrigation and infusion solutions

EN

WARNING! Dehydration Insufflation can lead to dehydration of the tissue. This can result in organ tissue damage and cardiovascular reactions of the patient. Long surgeries and large leaks increase the risk of dehydration (especially at the insertion points of the trocars or when changing instruments).

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 instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value. CO2 embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pressure settings and close damaged blood vessels at once.

WARNING! Gas flow A high gas flow can occur due to large leaks within the surgical system or instrument. This can result in a false actual pressure reading, which in turn may endanger the patient. In case of a disrupted gas flow, you should therefore inspect device, tube, and instruments immediately. Surgical applications should be carried out with a gas flow of 4-10 l/min. An even lower gas flow is recommended for diagnostic purposes. It is recommended to perform endoscopies with the lowest gas flow possible.

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 4.2 "Connecting a Gas Cylinder").

WARNING! The venting rate of the automatic venting system is limited. Always monitor the actual pressure when using additional insufflation sources.

WARNING! Additional insufflation sources The use of additional insufflation sources increases the intra-abdominal pressure. Continuously monitor intra-abdominal pressure over the course of the entire insufflation if additional sources are used.

8

Purpose 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 service technician conducts the appropriate tests and repairs.

EN

WARNING! Filter Use a new/sterile filter for each patient. You must work with a 0.2 μm two-way (retention rate 99.99 %) hydrophobic filter between patient and device. This should prevent bodily fluids from entering the device and also prevents impurities from possibly entering into the patient’s body. Reduced flow capacity should be considered when using a hydrophobic filter.

WARNING! Contaminated filter Replace a contaminated filter immediately during surgery to ensure unhindered gas flow.

WARNING! Connecting the tube Always use the proper tube set for the device. The tube outlet may only be connected to instruments which are intended for intra-abdominal CO2 insufflation.

WARNING! Positioning the patient Always position the patient lower than the device to prevent body fluids from leaking into the insufflation tube. Actual pressure may increase and fluid may penetrate the insufflation 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.

WARNING! 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 automatic venting valve is activated.

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 insufflation 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 insufflation tube from the trocar or from the device.

9

Purpose WARNING! Electronic device control Do not close the valve at the trocar sleeve during surgery. The electronic control unit of the device adjusts the actual pressure as desired.

EN

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 concentrate, unconsciousness, or even death.

WARNING! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (i.e., helium, N2O, argon), mixtures of gases, high pressure compressed gases, gases with entrapped liquids, or polluted gases must not be used with this device.

WARNING! Service connection Connected devices have to comply with the EN 60950 standard. Do not connect a device to the service connection during surgery.

CAUTION! Electrical Interference (See chapter 12 "Electromagnetic Compatibility"). Electrical interference with other devices or instruments was practically eliminated when developing this devices and none was detected during testing. 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

WARNING! Peripheral devices Additional peripheral equipment connected to interfaces of the medical monitor has to meet the requirements of the following specifications: 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.

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Initial Device Startup 4

Initial Device Startup

Always check all parts and accessories of the device immediately after receiving the shipment. The manufacturer considers only replacement claims that have been immediately submitted or reported to a sales representative or an authorized service company.

Delivery inspection

If it becomes necessary to return the device, always use the original packaging. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging.

Returning the device

EN

Please fill out the return form enclosed at the end of the instructions. Enclose the manual with the device. Please make sure that all required information has been supplied: • Name of owner • Address of owner • Device type and model • Serial number (see identification plate) • Description of defect Place the device on a level surface and install in a dry environment. The ambient temperature and humidity must meet the requirements mentioned in chapter 13 Technical Data, page 40.

Setting up the device

WARNING! Not explosion-proof The device is not explosion-proof. Do not use in an area where flammable anesthetic gases are present. Mains connection CAUTION! Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device.

Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The mains connection cable may be plugged only into a properly installed, grounded safety wall socket (shockproof socket) (see DIN VDE 0100-710). Read the device label located in rear of device (type plate) to determine the operating voltage of the device. The power connection must be equipped with a grounding contact. Use the original power cable (if included in scope of delivery) to establish a connection between the mains wall socket and the non-heating device plug located in the rear of the device.

Grounding contact

Only use a certified (UL-listed), removable mains connection cable, type SJT, minimal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 or IEC 60320. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.

Only for U.S. operators

Integrate the device into the potential equalization system as specified by local safety rules and regulations.

Potential equalization

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Initial Device Startup 4.1

EN

Gas Connection

WARNING! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (i.e., helium, N2O, argon), mixtures of gases, high pressure compressed gases, gases with entrapped liquids, or polluted gases must not be used with this device.

Use a high-pressure tube to connect a CO2 gas cylinder to the rear gas inlet connection or connect to centralized CO2 gas supply.

4.2

Connecting a Gas Cylinder

CAUTION! The total length with a directly connected gas bottle may not exceed 35.5 cm (incl. valve) with a max. diameter of 8.5 cm.

The gas bottle pressure may not exceed 80 bar. The bottom of the gas bottle has to be at the same height as the baseline of the device (see Fig. 4-1 "Min. angle of tilt for gas bottle").

Abb. 4-1

Min. angle of tilt for gas bottle

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

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Operating the Device 5

Operating the Device

5.1

Front of the Device

(18)(17) (16) (15)

(1) (2) (3)

(14)

(13)

EN (12)

(4) (5) (6) (7)

(11) (10)

(8) (9)

Familiarize yourself with the control and function elements at the front of the device.

5.2

Abb. 5-1

Device Front

(1)

On/Standby key

(2)

LED for On/Standby key (green/ yellow)

(3)

Nominal pressure setting

(4)

Nominal pressure display

(5)

Menu key

(6)

Reset key

(7)

Nominal Flow Setting

(8)

LED VERESS mode

(9)

LED INSUFFLATION mode

(10)

Connection for insufflation tube

(11)

Nominal gas flow display

(12)

Actual gas flow display

(13)

Volume display

(14)

Actual pressure display

(15)

Start/stop LED

(16)

Start/stop key

(17)

LED > 25 bar (green)*

(18)

LED < 25 bar (orange)*

Rear of the Device Abb. 5-2 (25)

(19) (20) (21)

Device Rear

(19)

Device plug

(20)

Fuse holder

(21)

Cover (optional data interface)

(22)

Potential Equalization Plug

(23)

Type plate

(24)

Device data plate

(25)

Gas connection

(22) (23)(24)

Familiarize yourself with the connection elements at the rear of the device.

13

Operating the Device 5.3

EN

Switching Device On

(See Abb. 5-1 "Device Front") 1. Connect gas supply to gas connection port. 2. Open the gas supply line. 3. Connect the power cable. The LED (2) is illuminated in green; the device is automatically switched on and conducts a self-test. Press the On/Standby key if the device is already connected to the power supply and in Standby mode (1). The device conducts a self-test. Self-test displays

1. All LEDs and segment displays are briefly illuminated. 2. Three warning signals can be heard.

Displays after self-test has concluded

The displays and indicators depend on the preset/set values in the user menu. The following information is based on factory settings. Actual pressure (PRESSURE) (14)

0

Actual gas flow (FLOW) (12)

---

Nominal pressure (SET mm Hg) (4)

10

Nominal flow (SET l/min) (11)

3

Volume (13)

0.0

Start/stop LED (15)

Off

LED VERESS (8)

ON

LED INSUFFLATION (9)

Off

LED On/Standby (2)

On (green)

The device test concluded successfully. The device is operational.

5.4

Preselecting the Nominal Pressure

First nominal pressure

The nominal pressure indicator (4) already displays a nominal pressure (4) value after the device self-test has concluded. This "first nominal pressure" can range from 1 to 15 mm Hg (factory setting = 10 mm Hg) depending on the user menu settings.

Setting

The nominal pressure can be set while in standby mode as well as during the started insufflation. The desired nominal pressure can be preset to range of 1-30 mm Hg. Reduce the nominal pressure with the minus key (3) (in one-step increments down to 1 mm Hg). This set value is a "volatile value". The initially set "first nominal" value entered into the user menu is restored after stopping the insufflation, turning the device off and back on or starting the device. Increase the nominal pressure with the plus key (3) (in one-step increments from 1 to 15 mm Hg and from 15 to 30 mm Hg). This set value is a "volatile value". The initially set "first nominal" value entered into the user menu is restored after stopping the insufflation, turning the device off and back on or starting the device.

Threshold value

The nominal pressure value "15 mm Hg" is a threshold value. This is where the recommended range for the intra-abdominal pressure ends (starting to flash at 15 mm Hg). Exceeding this safety limit is to be decided by and the responsibility of the user/operator. Release the plus key for at least 1 second to adjust to a higher setting. The display switches from flashing to being continuously illuminated. Now you can set a value up to 30 mm Hg. This set value is a "volatile value". The initially set "first nominal" value entered into the user menu is restored after

14

Operating the Device stopping the insufflation, turning the device off and back on or starting the device.

5.5

EN

Preselecting Nominal Flow

The nominal gas flow indicator (11) already displays a nominal flow value after the device self-test has concluded. This value can range from 1 to 5 l/min depending on the "Gas flow rate 1" user menu settings. (Factory setting 3 l/min)

Nominal gas flow start value

The nominal gas flow can be set while in standby mode as well as during operation of the device. The desired nominal gas flow can be preset to range of 1-20 l/ min.

Setting

Reduce the nominal gas flow with the minus key (7) (in one-step increments down to 1 l/min). This set value is a "volatile value". The initially set "Gas flow rate 1" value entered into the user menu is restored after stopping the insufflation, turning the device off and back on or starting the device. Increase the nominal gas flow with the plus key (7) (in one-step increments up to max. 20 l/min). Keep the plus key or the minus key depressed to scroll to gas flow rate 1, 2, 3 after a delay of 1.5 seconds (values depend on preset selections in user menu). The device monitors the gas flow in two different operating modes:

"Veress Operating Mode"

• Veress (1-5 l/min) operating mode • "Insufflation Operating Mode“ (6-20 l/min) The operating mode "Veress" is intended for gentle insufflation since the actual pressure does not exceed the preset nominal pressure even in case of small volumes (e.g., abdomen of a child). To minimize the risks of a faulty incision, the manufacturer recommends using the "Veress" operating mode to start off a procedure (filling abdomen with CO2). Please note that the automatic venting system is not active during the Veress operating mode. Reduce the nominal gas flow with the minus key (7) until the following is displayed: • Nominal gas flow value less or equal to 3 l/min • LED VERESS -> On • LED INSUFFLATION -> Off Pressure drops due to leaks are quickly equalized during the "Insufflation Operating Mode". APC technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. In case of large volumes, the actual pressure does not exceed the nominal pressure (cf. 6 "Safety Functions"). Tube, filter, and instrument can reduce the gas flow.

"Insufflation Operating Mode"

Increase the nominal gas flow with the plus key (7) until the following is displayed: • Nominal gas flow value > 5 l/min • LED VERESS -> Off • LED INSUFFLATION -> On

5.6

Starting Insufflation

Press the Start/Stop key (16). Actual gas flow display (12) -> depicts actual flow value

Display after pressing Start/Stop key

LED Start/Stop (15) -> On

15

Operating the Device

EN

Resetting the gas consumption display

The gas consumption display can be reset (volume indicator) when insufflation has been stopped or during insufflation. The display depicts 3 ranges: • 0.0-9.9 l • 10.0-99.9 l • 100-999 l Press the reset key (5). The gas consumption display (13) is reset to "0.0".

5.7

Stopping Insufflation

Press the Start/Stop key (16). Display after pressing Start/Stop key

The values for pressure and flow are reset to the starting values preselected in the user menu. • Displayed volume value -> is not automatically reset to 0. • LED INSUFFLATION -> off • LED VERESS -> On • Nominal flow -> 3 l/min, or preselected value • Nominal pressure -> 10 mm Hg, or preselected value

5.8

Switching Device Off

Press the On/Standby key (1) for longer than 1 second. The device is now in Standby mode. Display after pressing On/Standby key

Standby LED (2) -> continuous yellow LED. CAUTION! Pressing the On/Standby key does not disconnect the device from the power supply. This requires pulling the plug located in the rear of the device.

Pull the power plug if you wish to turn off the device completely.

16

Safety Functions 6

Safety Functions

The device is equipped with an automatic venting system.

EN

Automatic Venting System

• The venting system is always deactivated while using Veress mode. • The venting system can be activated/deactivated in the user menu when using the Insufflation mode. • The threshold values for the venting pressure and the venting response time are adjustable in the user menu. The relief or venting system is triggered if the actual pressure exceeds the venting pressure set in the user menu. The activation is triggered after the time delay set in the user menu. The venting system releases gas until the set nominal value has been reached again. CAUTION! The venting system is only active in the operating mode “Insufflation” and not the “Veress” mode.

WARNING! The venting rate of the automatic venting system is limited. Always monitor the intra-abdominal pressure when using additional insufflation sources.

CAUTION! The manufacturer advises against using additional, non-pressure controlled insufflation sources during minimally invasive surgical procedures. The self-inflating property of lasers cooled with CO2 and argon beamers can lead to values exceeding the nominal pressure. (See Abb. 5-1 "Device Front")

Overpressure within Insufflation System

• If pressure exceeds the nominal pressure by 3 to 5 mm Hg for a duration of 3 to 5 seconds, • as well as with pressure > 29 mm Hg the actual pressure display (14) flashes and 3 warning beeps are emitted after 3 seconds. If the tube, Veress cannula, or the trocar has a blockage:

In Case of Occlusion

• “0” in display and flashing actual flow display (12) • and 3 warning beeps. If the device is malfunctioning, can no longer be operated safely, and requires service:

In Case of Malfunction

• Exx (xx=error code) display and flashing of the actual flow display (12) according to error list and warning signal. The device has deactivated itself. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. • Green LED (17) is on. • Orange LED (18) is off.

Gas bottle pressure > 25 bar

• Green LED (17) is off. • Orange LED (18) is flashing.

Gas bottle pressure < 25 bar

If gas bottle pressure continues to drop during insufflation:

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Safety Functions • Orange LED flashes and 3 warning beeps are heard. • Gas flow is deactivated after a volume of 10 l has been supplied; warning beeps are emitted (repeated after 1 minute). • Actual flow display “0.”

EN House Gas Supply OK

If the central or house gas supply is functioning properly: • orange LED is illuminated and • green LED is off.

House Gas Supply Malfunction

If the central or house gas supply is malfunctioning or insufficient: • gas flow is deactivated, • orange LED is flashing, • green LED is off. • 3 warning beeps are emitted (repeated after 1 minute).

Error Message "Contamination"

Three beeps and the display E21 for 5 s warn the user that fluid has penetrated into the device via the insufflation tube. It is possible to conclude any currently ongoing surgery with this device. Insufflation is not possible after turning the device off and back on using the On/Off key. This is to prevent cross-contamination. The display E21 is depicted if the device is already contaminated and you turn the device back on. The device can no longer be used. The contaminated device has to be clearly marked as contaminated and sealed in two separate protective layers of safety foil. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

Power failure

18

If the power fails for less than 1 second, all settings are retained. If the power fails for an extended time period, the device will function as it does when it is being restarted.

User Menu 7

User Menu

The device features an option-dependent user menu as well as a service menu. Device parameters can be changed before surgery in the user menu. The following pages list a user menu overview. The service menu is protected from unauthorized access by a numeric code only known to the service technician.

Abb. 7-1 (12)

(14)

P

(1) (5) (6)

EN

Menu control

Menu control elements

(1)

On/Standby key

(5)

Menu key

(6)

Reset key

(7)

Nominal gas flow minus key

(12)

Display field for the actual gas flow

(14)

Display field for the actual pressure

(7)

1. Initial Status: The device is turned off. Keep the menu key (5) depressed while briefly pressing the On/Standby key (1) as well. 2. Continue pressing the menu key until the LED test is finished. 3. Increasingly louder beeps are emitted after the end of the LED test and P is displayed in the display field for the actual pressure (14). The device is now in the first menu level of the user menu. 4. Switch between user and service menu with the +/- keys (7). 5. Confirm the user menu selection with the menu key (5). 6. The values to be set are depicted in the actual gas flow (12) display field. The factory default values are initially displayed - then the last saved value. 7. Use the nominal gas flow Plus or nominal gas flow Minus keys (7) to select the desired menu level. 8. Press the Menu key to access the selected menu level. Scroll with the nominal gas flow Plus or Minus key (7) to change settings. 9. Save settings with menu key (5). You are then automatically switched to the next higher menu level. 10. Press the reset key (6) to exit menu level without saving. 11. Turn the device off and wait 10 seconds before turning back on to enter normal mode. 12. The following page lists an overview over the setting options.

How do I use the user menu?

19

User Menu

EN

20

Functional Test 8

Functional Test

EN

WARNING! Functional test The functional test must be performed prior to each surgery.

WARNING! Sterilize reusable instruments and tubing before surgery to prevent infections. Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

WARNING! Original accessories For your own safety and that of your patient, use only original accessories.

8.1

Testing the Device (1)

(2) (3)

(4)

(5)

(6)

--10

0.0

3

1. The device is turned off. 2. Connect and open the gas supply. 3. Use the On/Standby key to turn the device on. The device now conducts a self-test. 4. Connect the device with a hydrophobic filter, an insufflation tube, and a Veress cannula. 5. Attach the stopcock (valve) to the Veress cannula. 6. Select a nominal pressure of 10 mm Hg (2) and a nominal gas flow of 3 l/min (5). 7. Press the reset key (4) (display (3) has to show 0.0 l). 8. Start insufflation: Press the Start/Stop key (1). Insufflate for approx. 30 s. After max. 4 s the actual gas flow display (6) flashes. 9. Stop insufflation: Press the Start/Stop key (1). WARNING! If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If

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