FM134 Instructions for Use April 2015

Table of contents 1

Important User Notes ... 3

2

General Safety Notes ... 4

3

General Information ... 5 3.1 Device Description ... 5 3.2 Intended Use and Contraindications ... 5 3.2.1 Intended Use... 5 3.2.2 Contraindications ... 5 3.3 General Warnings and Precautions ... 5 3.3.1 General Warnings ... 5 3.4 Precautions... 11

4

Initial Device Startup ... 12 4.1 Scope of Delivery ... 12 4.2 Preparing the Device ... 12 4.3 Gas Connection... 13 4.3.1 Connecting a Gas Bottle... 13 4.3.2 Connecting to Central Gas Supply... 13 4.3.3 Switching Device Off ... 14

5

Operating the Device - General ... 15 5.1 Front of the Device... 15 5.2 Rear of the Device ... 15 5.3 Touch Screen Display... 16 5.4 Switching the Device On ... 17 5.4.1 Insufflation Tube Connection ... 17 5.4.2 Gas Heater... 18

6

Device Use and Control with High Flow Operating Mode ... 20 6.1 Device-Specific Risks Associated With Use of the Device in High Flow Operating Mode ... 20 6.2 Selecting High Flow Insufflation Mode... 21 6.3 Presetting Nominal Pressure in High Flow Operating Mode... 22 6.4 Presetting Nominal Flow in High Flow Operating Mode... 22 6.5 Performing the Function Test in High Flow Operating Mode... 23 6.5.1 Filling Tube System with CO2 ... 24 6.6 Using the Device during Surgery ... 25 6.6.1 Insufflating with Veress Cannula... 25 6.6.2 Insufflating with the Trocar... 25 6.6.3 Stopping Insufflation ... 26

7

Device Use and Control with Bariatric Operating Mode ... 27 7.1 Device-Specific Risks Associated With Use of the Device in Bariatric Operating Mode ... 27 7.2 Selecting Bariatric Operating Mode... 29 7.3 Presetting Nominal Pressure in Bariatric Operating Mode... 29 7.4 Presetting Nominal Flow in Bariatric Operating Mode... 30 7.5 Performing the Function Test in Bariatric Operating Mode before Using the Device during Surgery ... 31 7.5.1 Filling Tube System with CO2 ... 32 7.6 Using the Device during Surgery ... 32 7.6.1 Insufflating with the Veress Cannula ... 32 7.6.2 Insufflating with the Trocar... 33 7.7 Stopping Insufflation ... 33

8

Configuration Menu (Overview)... 34 8.1 Configuration Menu I... 36 8.1.1 Setting First Nominal Pressure... 36 8.1.2 Setting the Venting Valve... 36 8.1.3 Setting the Gas Supply Type... 38 8.1.4 Setting the Alarm Volume ... 38 8.2 Configuration Menu II... 39 8.2.1 Setting the Gas Flow Rate... 39 8.2.2 Setting the Maximum Nominal Pressure... 39 8.2.3 Setting the Occlusion Warning Signal ... 40 8.3 Utility Menu... 40 8.3.1 Brightness... 40 8.3.2 Select Language... 41 8.3.3 Checking Software Version... 41 8.3.4 Service Menu ... 41

9

Safety Functions... 42

10

Care and Maintenance... 45 10.1 Cleaning the Device... 45 10.2 Annual Inspection ... 45 10.3 Maintenance by Authorized Service Technician... 45 10.4 Replacing the Fuse ... 46 10.5 Care and Maintenance of Reusable Tube Set ... 47 10.5.1 Cleaning the Reusable Tube Set ... 47

EN

10.5.2 10.5.3

EN

Disinfecting the Reusable Tube Set... 48 Sterilizing the Reusable Tube Set... 49

11

Annual Inspection ... 50 11.1 Electrical Safety Test... 50 11.2 Basic Function Test (in High Flow Operating Mode) ... 50 11.3 Testing the Pressure Sensors in High Flow Operating Mode... 51 11.4 Pressure Monitoring Test in High Flow Operating Mode... 52 11.5 Venting Valve Test ... 52 11.6 Max. Device Pressure Test... 53 11.7 Gas Flow Rate Test... 53

12

Electromagnetic Compatibility... 54 12.1 Impact of Mobile and Portable HF Communication Devices... 54 12.2 Electrical Connections... 54 12.3 Accessories ... 54 12.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 55 12.5 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions ... 56 12.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - for the Insufflator. 57 12.7 Recommended Safety Distances between Portable and Mobile HF Telecommunications Devices and the Insufflator... 58

13

Error and Warning Messages... 59

14

Technical Data... 61

15

Accessory List ... 62

16

Appendix ... 63 16.1 Test Log... 63 Index ... 64

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

General Safety Notes

EN

2 Exclusion of liability

General Safety Notes

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.

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. WARNING: Modifying the Synergy Insufflation FM134 is not permitted.

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.

4

General Information

3

General Information

3.1

Device Description

EN

The Synergy Insufflation FM134 serves to create a cavity by insufflating CO2 during diagnosis and/or therapeutic laparoscopy procedures. • The High Flow operating mode of the device is intended to be used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas. • The Bariatric operating mode is used for laparoscopic surgery on morbidly obese patients. The High Flow operating mode is designed explicitly for laparoscopies performed on normal weight and slightly overweight patients (BMI < 30 kg/m2). While in High Flow operating mode, the insufflator limits the pressure to max. 30 mmHg and the gas flow rate to max. 40 l/min. The device measures the pressure within the abdomen and 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. The Bariatric operating mode is used for laparoscopies performed on severely overweight adults (BMI > 30 kg/m2). While in Bariatric mode, the insufflator limits the pressure to max. 30 mmHg and the gas flow rate to the max. value listed on the equipment data label located on the back of the device. This operating mode enables the rapid insufflation of large volumes.

3.2

Intended Use and Contraindications

3.2.1

Intended Use

The Synergy Insufflation FM134 is a CO2 insufflator intended to be used during diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas.

3.2.2

Contraindications

The device may not be used to fill an abdomen with CO2 if a laparoscopy is contraindicated. The device is not suitable for hysteroscopic insufflation procedures, i.e., it may not be used to distend the uterus.

3.3

General Warnings and Precautions

3.3.1

General Warnings

Contraindications

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.

5

General 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

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! To avoid the risk of electrical shock, only use this device when connected to a properly grounded power supply network.

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 also not suitable for training physicians in the use of surgical techniques. Medical accessories and devices may be used only by physicians and medical assistants under the direction of a physician with the appropriate technical qualification.

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.

WARNING! Cleaning the device Do not sterilize the device.

6

General Information

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.

EN

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.

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! 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.

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! 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 4.3.1 Con-

7

General Information

necting a Gas Bottle).

EN

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.

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

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! 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.

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 The connected equipment must comply with the standard EN 60950 in the currently valid version. Do not connect a device to the service connection during surgery.

8

General Information

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

EN

WARNING! Increased airway pressure/compression of the vena cava When using the device on children, an increased risk of elevated airway pressure and/or compression of the vena cava (low input syndrome) exists.

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! 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! 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 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:

9

General Information

• 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! Emphysema Incorrect placement of a cannula or a trocar into subcutaneous tissue may lead to emphysema. To reduce the risk, use a low gas flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned. Long surgeries (> 200 min.), the use of many access points, duration and size of leaks at these points may also contribute to emphysema. Be sure to close leakages in trocar accesses immediately.

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.

WARNING! Automatic venting system Make sure the automatic venting system is activated (see chapter 8 Configuration Menu (Overview), page 34) when using an additional insufflation source. It is not possible to use an additional insufflation source when the automatic venting system is deactivated.

WARNING! Gas flow limit The gas flow may not exceed 14 l/min when performing a laparoscopy on patients weighing less than 25 kg (approx. 55 US pounds).

10

General Information

3.4

Precautions

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.

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. Combining/connecting with other devices generates a medical electrical system (MES). The system configurator is responsible for compliance with the standard IEC 60601-1 / EN 60601-1 in its latest version.

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

11

Initial Device Startup

EN

4 Delivery inspection

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.

4.1

Scope of Delivery

• Device Synergy Insufflation Type FM134 • Instructions for Use • Power supply cord US, 2.5 m Returning the device

Use the original packaging material if the device has to be returned. The manufacturer is not responsible for transport damages due to insufficient or unsuitable packaging. Please make sure that all required information has been supplied: • Name of owner • Address of owner • Device type and model • Serial number of the equipment (see identification plate) • Detailed description of defect

4.2 Setting up the device

Preparing the Device

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 14 Technical Data, page 61. WARNING! Not explosion-proof The device is not explosion-proof. Do not use in an area where flammable anesthetic gases are present.

WARNING! Position the device in such a way that it is easy to operate and switch off.

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. Grounding contact

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.

Only for U.S. operators

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

12

Initial Device Startup

60320. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket. Integrate the device into the potential equalization system as specified by local safety rules and regulations.

4.3

EN Potential equalization

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 supply port or connect to a centralized CO2 gas supply.

4.3.1

Connecting a Gas Bottle

CAUTION! Always use a high-pressure tube to connect gas bottle and device.

The gas bottle must be in a vertical position. The gas bottle pressure may not exceed 80 bar or be less than 15 bar. CAUTION! Gas bottles with riser pipe can release dirt and oily fluids into the device. Do not use a gas bottle with riser pipe.

4.3.2

Connecting to Central Gas Supply

Use the following device connectors available as additional equipment to connect to a central gas supply (house supply): • 2200703 for house gas supply NIST or • 2200702 for house gas supply DISS

1. Attach the high-pressure tube to the gas connection. 2. Fasten the high-pressure tube with the nut. 3. Tighten the nut. The type of corresponding gas supply must be set in the configuration menu (see chapter 8.1.3 Setting the Gas Supply Type, page 38).

13

Initial Device Startup

4.3.3

EN

Switching Device Off

Ending operation of the insufflator safely: 1. Press the ON/OFF switch (see Fig. 5-1 Device front (1)). 2. Disconnect device from power supply by pulling the mains plug from the mains socket (see Fig. 5-2 Device rear (11)).

14

Operating the Device - General

5

Operating the Device - General

5.1

Front of the Device

EN Fig. 5-1

(1)

(2)

(3)

(4)

Device front

(1)

ON/OFF switch

(2)

Touch Screen Display

(3)

Insufflation tube connection

(4)

Gas heating connection for reusable heating tubes

(5)

Gas heating connection for disposable heating tubes

(5)

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

5.2

Rear of the Device (4)

(5)

(12)

(6)

(8) (9)

(7)

(11)

Fig. 5-2

Device rear

(4)

Type plate

(5)

Device data plate

(6)

Arthrex control bus interface

(7)

Arthrex control bus interface

(8)

Service interface

(9)

Connection for potential equalization

(10)

Fuse holder

(11)

Device mains socket

(12)

Gas supply connection

(10)

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

15

Operating the Device - General

EN

5.3 Fig. 5-3

Touch Screen Display

Screen displays

(1)

(1)

Insufflation mode selection

(2)

Insufflation mode display

(3)

Status display/error and warning messages

(17)

(4)

Menu

(16)

(5)

Increasing nominal gas flow

(6)

Nominal gas flow display

(7)

Decrease nominal gas flow

(8)

Actual gas flow display

(9)

START/STOP function field

(10)

Gas heater connected/ready

(11)

Gas supply display

(12)

Gas consumption display

(13)

Function field to reset the gas consumption display (reset button)

(14)

Decrease nominal pressure

(15)

Nominal pressure display

(16)

Increase nominal pressure

(17)

Abdominal pressure display

(2)

(3)

(4)

(5)

(15)

(6)

(14)

(7)

(13) (12) (11) (10)

(9)

(8)

The above depiction of the touch screen also shows all display and function fields.

Gas supply displays

The status of the gas supply is monitored by the device and indicated with symbols and acoustic signals (see chapter 9 Safety Functions for gas pressure display information).

Gas supply with gas bottle

The following gas bottle pressures are displayed: > 50 bar

40 - 50 bar

30 - 40 bar

15 - 30 bar; Three acoustics warning signals (beeps) can be heard and the message "Change gas bottle" is displayed. User is advised to prepare for changing the gas bottle. < 15 bar; Three warning signals can be heard and the message "Check gas supply" is displayed. Immediately replace the gas bottle.

If the gas cylinder pressure keeps falling, warnings will appear to remind the user to replace the gas bottle immediately. At < 5 bar and again at 0 bar, 5 beeps will sound and the display depicts "Check Gas Supply." Insufflation stops at 0 bar. House gas supply

16

The following house gas supply pressures are displayed:

Operating the Device - General

EN

House gas supply pressure OK (green) House gas supply pressure too low (red)

5.4

Switching the Device On

1. Connect the device with the mains power. 2. Connect the gas supply to the gas connection port and open the gas supply. (2) (1)

3. Press the ON/OFF switch. The device turns on.

(3) 4. The device performs a device check after being switched on. The company logo is displayed on the touch screen for 3 seconds after the successful device test as well as the lines Synergy Insufflation -> Device Test -> Device OK. In case the device check fails and an error message is displayed, please see chapter 13 Error and Warning Messages for additional information.

5. The display depicts an insufflation operating modes overview. Press the respective function field to select the corresponding desired operating mode (e.g., High Flow).

5.4.1

Insufflation Tube Connection

1. Always connect a hydrophobic filter to the silicone tube or use the PVC tube set with filter. 2. Connect the insufflation tube to the insufflation tube connection and to the Veress cannula/trocar. ISO 5356-1 connection A male ISO connector is located at the device (ISO-M). Connect the female ISO connector (ISO-F) of the filter or tube firmly with the ISO-M connector.

17

Operating the Device - General

EN

5.4.2

Gas Heater

Use the gas heater and the heating tube to insufflate lukewarm gas (37 °C). Connect insufflation tube and heater plug as depicted in Fig. 5-4 Connect gas heater, page 18. CAUTION! Do not subject the heater tube to direct heat (e.g., heating blanket) or high room temperatures.

Fig. 5-4

Connect gas heater

(1)

Insufflation tube

(2)

Gas heater connection for disposable heating tube

(2)

(1)

Connect gas heater

1. Connect the filter and the heating tube. 2. Connect the plug of the heater tube with the appropriate gas heating connection. NOTE! A mix-up cannot occur because of the different shapes of gas heater connections for disposable or reusable heating tubes.

Once the heating tube has been connected, the status bar (3) displays Heater OK message for 3 seconds. The reusable gas heating tube is automatically preheated to 33°C if insufflation is switched off. Gas heater ON/OFF

Start gas heating: Press the Start/Stop key. The gas is automatically heated. The gas is automatically heated to 37°C in approx. 10 minutes.

Gas heating error

The message Heater defect - Call service (3) is displayed for 2 seconds in case of a function defect of the gas heater (e.g., cable flawed or broken, loose plug). Check gas heating using a different tube. Should the error message be displayed again, you can continue using the device without gas heating by observing the risks for hypothermia. Check gas heating after surgery using a different tube. If the message Heater defect -> Call service persists, call an authorized service technician to check the device.

Gas temperature exceeds 42°C

The status bar (3) depicts the following displays in case of excess temperature: Temperature > 42 °C (for 3 s) ->Unplug heater ->(after removing plug) Cool down heater (for 2 s).

18

Operating the Device - General

WARNING! If the temperature sensor measures a gas temperature > 42° C, unplug the heating plug from the device. Hot gas in the abdomen can lead to serious injuries.

EN

A warning signal is audible. Gas heating and insufflation are deactivated. 1. 2. 3. 4. 5. 6.

Disconnect the insufflation tube from the trocar or Veress needle. Unplug the plug for the gas heating from the device. Press the Start/Stop key. The device insufflates without heating the gas. Let hot gas escape until the tube is only warm to the touch. Continue operation without connecting gas heating. Check gas heating after surgery using a different tube. Turn device off and on again. Gas heating is reactivated. 7. Should the error message be displayed again, you can continue using the device without gas heating by observing the risks for hypothermia. 8. Call an authorized service technician to check the gas heating.

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