PNEUMOCLEAR Type FM300 CO2 Conditioning Insufflator Instructions for Use Rev G Jan 2020

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Fragile

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Sterilized using ethylene oxide

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Authorized for Sale or use by Physician only Stryker European Representative Non-ionizing electomagnetic radiation Complies with Australian regulatory requirements Complies to IEC 60601-1 including US and Canadian deviations in their respective valid version Data transmission port (see Using Device Control instructions for detail) Only for service

Caution: Hot Air Out Quality Seal. Unbroken seal indicates the product has not been tampered with or serviced. Due date of next service

Only to be used with medical-grade CO2 Maximum supply pressure of medical-grade CO2

Table of Contents 1

Important User Notes ... 7

2

Safety Information ... 8

3

General Information ... 9 3.1 Device Description... 9 3.2 Intended Use and Contraindications ... 9 3.2.1 Intended Use ... 9 3.2.2 Contraindications ... 10 3.3 Warnings... 10 3.3.1 General Warnings CO2 Insufflation ... 10 3.3.2 Warnings Standard and High Flow/Bariatric Operating Mode... 14 3.3.3 Warnings Pediatric Operating Mode ... 16 3.3.4 Warnings Vessel Harvest Operating Mode ... 17 3.3.5 Warnings TAMIS Operation Mode ... 18 3.4 General Precautions... 19

4

Initial Device Setup ... 21 4.1 Device Setup and Connection ... 21 4.2 Front of the Device ... 22 4.3 Rear of the Device... 23 4.4 Gas Connection ... 23 4.4.1 Connecting a Gas Bottle... 24 4.4.2 Connecting to Central Gas Supply ... 25 4.5 Gas Supply ... 25 4.6 Switching Device On ... 26 4.7 Switching Device Off ... 26

5

Operating the Device - General ... 28 5.1 Monitor with Touch Screen ... 28 5.2 Insufflation Tube Sets... 28 5.3 Connecting an Insufflation Tube Set ... 29 5.4 Using Gas Heating... 30 5.5 Using the Smoke Evacuation Function... 31 5.6 Use of Insufflation Gas Humidification Function... 33 5.7 Using Device Control ... 35 5.8 Unlocking Operating Modes... 36 5.9 Displaying/Selecting Insufflation Operating Mode... 36 5.10 Setting the Nominal Pressure - All Operating Modes ... 36 5.11 Setting the Nominal Flow - All Operating Modes ... 36 5.12 Running Function Tests before Device Use... 37 5.13 Gas Consumption Display ... 39 5.14 Starting/Stopping Insufflation ... 39 5.15 Desufflation... 40

6

Operating Modes of the PNEUMOCLEAR™ Insufflator ... 41 6.1 Standard Operating Mode ... 41 6.2 High Flow/Bariatric Operating Mode ... 43 6.3 Pediatric Operating Mode ... 46 6.4 Advanced Flow Operating Mode... 48 6.5 Vessel Harvest Operating Mode... 48 6.6 TAMIS Operating Mode... 50

7

Menu (Overview) ... 51

8

Safety Functions... 53 8.1 Automatic Venting System... 53 8.2 Occlusion... 53 8.3 Contamination ... 54 8.4 Leakage Detection ... 54

9

Care and Maintenance... 55 9.1 Cleaning the Device ... 55 9.2 Maintenance Intervals ... 55 9.3 Maintenance by Authorized Service Technician... 55 9.4 Replacing the Fuse... 56

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10 Annual Inspection... 58 10.1 Electrical Safety Test ... 58 10.2 Basic Function Test (in Standard Operating Mode) ... 58 10.3 Pressure Sensor Test (Standard Operating Mode) ... 59 10.4 Pressure Monitoring Test (in Standard Operating Mode) ... 60 10.5 Venting Valve Test... 60 10.6 Maximum Device Pressure Test ... 60 10.7 Gas Flow Rate Test... 61 11 Electromagnetic compatibility ... 62 11.1 Electrical Connections ... 62 11.2 Guidance and Manufacturer's Declaration - Electromagnetic Emissions... 62 11.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 63 12 Error and Warning Messages... 65 13 Technical Data ... 67 14 Accessories ... 69 15 Warranty and Service ... 71 16 Glossary ... 72 17 Appendix ... 73 Index... 75

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Important User Notes

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Important User Notes

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Read the instructions for use 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 or service personnel, or • damages or malfunction of device and/or accessories. The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product through continued development of its products.

Subject to technical changes

Paragraphs marked with the words WARNING, CAUTION, and NOTE carry special meanings. Sections marked with these words must be given special attention.

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 party.

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

NOTE! These paragraphs contain information to clarify the instructions or provide additional useful information.

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Safety Information

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Safety Information

Federal Law (only for U.S. market)

CAUTION! Federal law restricts this device to sale by or on the order of a physician.

Exclusion of liability

The manufacturer is not liable for direct or consequential damages, and the warranty becomes null and void if: • the device and/or the accessories are improperly used, transported, stored, prepared, or maintained; • the instructions and rules in the instructions for use are not adhered to; • unauthorized persons perform repairs, adjustments, or alterations on the device or accessories; • unauthorized persons open the device; • the prescribed inspection and maintenance schedules are not adhered to. The handing over of technical documents does not constitute authorization to make repairs or alterations to the device or accessories. WARNING! Modification of the devices PNEUMOCLEAR™ 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. Maintenance of the device may not be performed during the operation. NOTE! Service or maintenance work may not be carried out during surgery.

Contamination

Before shipping, decontaminate device and accessories in order to protect the service personnel. Follow the instructions listed in these instructions for use. 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

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This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. For disposal of the device and its accessories, please consult the manufacturer or an authorized disposal company, in compliance with legal or national regulations.

General Information

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General Information

3.1

Device Description

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The device PNEUMOCLEAR™ is an insufflator and serves to create a cavity through the insufflation of CO2 with a preset flow rate and pressure. The gas will be transported to the patient via a tube connected with a trocar. The insufflator limits the pressure to a maximum of 30 mmHg and the flow rate to a maximum of 50 l/min. The device can be operated in different operating modes which are intended to suit different surgical procedures and/or different patient’s physical characteristics. The following table describes the different operating modes. Operating mode

Description

Patients Population

Standard operating mode

designed for laparoscopies perused to distend the peritoneal formed on normal weight and cavity during laparoscopic proslightly obese (BMI < 30 kg/m2) cedures by insufflating CO2. patients over the age of 14.

designed for laparoscopies perused to distend the peritoneal formed on normal weight and High Flow/Bariatric operating cavity during laparoscopic proobese patients (BMI > 30 kg/m2) mode cedures by insufflating CO2. over the age of 14. Pediatric operating mode

used to distend the peritoneal designed specifically for use on cavity during laparoscopic pro- newborns, infants, and children cedures by insufflating CO2. under the age of 14.

used to distend the peritoneal designed for laparoscopies percavity during laparoscopic proformed on normal weight and Advanced Flow operating mode cedures, including but not limobese patients over the age of ited to robotic-assisted laparo14. scopies by insufflating CO2. Vessel Harvest operating mode

used to distend the cavity along the vena saphena magna and ra- designed for patients over the dial artery during an endoscopic age of 14. vessel harvesting procedure.

TAMIS operating mode

used to dilate and fill the rectum and colon by insufflating CO2 designed for patients over the during transanal minimally in- age of 14. vasive surgery.

The device measures the actual pressure in the cavity and compares it to the set nominal pressure. The function of this device is to maintain the nominal pressure. Overpressure within the cavity is lowered to the preset nominal pressure by the automatic venting system.

Essential performance

Additional optional features are available to increase user and patient comfort: 1.

Integrated gas heater to heat the insufflation gas.

2.

Suction function to evacuate surgical smoke from the cavity.

3.

Humidification of the insufflation gas.

These features become available by use of the appropriate tube sets, see Chapter Insufflation Tube Sets [} 28]. The insufflator is a pneumatic device that works through the port on the back, with central gas as well as bottled gas. It is operated via buttons and indicators or displays on the front of the device. Optionally, the device can be operated via remote access and a central device control, either by voice control or a remote touch panel.

3.2

Intended Use and Contraindications

3.2.1

Intended Use

The device PNEUMOCLEAR™ is a CO2- insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas. The operating modes Standard, High Flow/Bariatric, Pediatric and Advanced Flow of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use

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General Information

during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery.

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3.2.2

Contraindications

The device should not be used to fill a cavity with CO2 if an endoscopy is contraindicated. Please consult the manual of your endoscope for absolute and relative contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it may not be used to distend the uterus. The gas flow may not exceed 14 l/min when performing a laparoscopy on newborns or patients weighing less than 25 kg. The device may not be used for the endoscopic harvesting of vessels if this surgical application is contraindicated. Please consult the manual of the instrument for absolute and relative contraindications.

3.3

Warnings

3.3.1

General Warnings CO2 Insufflation

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

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.

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.

WARNING! Not explosion-proof The device is not explosion-proof. Do not operate the device in the vicinity of explosive anesthetic gases and not in the vicinity of oxygen-enriched environments.

WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Notify the authorized service technicians of any required repairs.

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.

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General Information

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WARNING! Replace the fuse Replace the fuse only with a fuse provided by the manufacturer (see Chapter Accessories [} 69]).

WARNING! Professional qualification The instructions for use do 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! Automatic device self-test The device self-test must be performed prior to each surgery. Because the device self-test is performed during initial start up, the unit must be power cycled (off/on) prior to each surgery.

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

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.

CAUTION! Cleaning the Device Do not sterilize the device.

WARNING! Obvious defects Never use the device if it has suspected or confirmed defects, especially if these involve the power plugs or the mains power supply connection cables. In this case have the device repaired by authorized service personnel.

WARNING! Positioning the patient Positioning the patient lower than the device can prevent body fluids from leaking into the tube set. 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.

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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 can flow counter to the insufflation direction and block the insufflation filter, if • 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 procedures should be performed with a gas flow of 4 to 10 l/min. An even lower gas flow is recommended for diagnostic purposes.

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 Gas Connection [} 23]).

WARNING! Gas supply Maintain adequate gas supply at all times.

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.

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WARNING! Insufflation of CO2 The insufflation of CO2 should be done carefully and while monitoring the patient's response. The user, particularly the anesthetist, should be informed about possible cardiovascular and respiratory problems of the patient and monitor these intra-operatively.

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

WARNING! Fill the tube set with CO2 For the safety of the patient please fill the tube set with CO2 gas prior to beginning the insufflation by activating the insufflation for a few seconds and then turning it off again before introducing the insufflation instrument to the cavity and beginning the surgery.

WARNING! Lowest gas flow and pressure Depending on age and health condition of the patient, the smallest possible gas flow and pressure for establishing the pneumoperitoneum should be selected. It is not recommended to exceed insufflation pressures of 15 mmHg in colo-rectal procedures.

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

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 cannula sleeve during surgery. The electronic control unit of the device adjusts the actual pressure as desired.

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3.3.2

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Warnings Standard and High Flow/Bariatric Operating Mode

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 a part 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 maximum 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. Therefore, you must always monitor the patient's body temperature during the entire insufflation process. Make especially sure that the following, hypothermia-fostering, surgical conditions are avoided as best as possible: • High gas flow due to large leaks • Long surgeries • Use of irrigation and infusion solutions that are not preheated to body temperature.

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WARNING! Dehydration Insufflation can lead to dehydration of the tissue, especially if the surgery time is prolonged. This can lead to damage of peritoneal cell structures within the tissue. Insufflation, especially with unconditioned gas, is associated with post-operative pain. Long surgeries and large leaks increase the risk of dehydration especially at the insertion points of the trocars. The use of humidified and prewarmed gas can reduce risks associated with tissue dehydration.

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! Subcutaneous 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 initial insufflation and ensure that the insufflation instrument is correctly positioned. Long surgeries, 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! Subcutaneous emphysema When puncturing the thicker abdominal wall of morbidly obese patients with the Veress cannula or the trocar, carefully monitor the correct position of the instrument in the abdomen.

WARNING! Additional insufflation sources/automatic venting system Make sure the automatic venting system is activated (see Chapter Menu (Overview) [} 51]). 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! Altered Respiratory Physiology Always monitor the patient's respiratory functions during the entire surgery. The larger body mass supported by the thoracic cage and the larger amount of fat in the abdominal cavity may reduce the elasticity of the thoracic wall. In addition, the increased intra-abdominal pressure secondary to insufflation may alter the normal physiological lung parameters thus resulting in a reduction of the functional lung volume. Shallow, rapid breathing is symptomatic of this condition. Even modest physical stress causes a tremendous increased demand for oxygen, which stands in contrast to the ineffective respiratory musculature that requires more oxygen because it must overcome the reduced elasticity of the thoracic cage. The functional capacity of the lungs is small and even moderate stress can lead to respiratory failure.

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WARNING! CO2 supersaturation To avoid generating CO2 supersaturation, an increased level of respiratory activity is required. An overweight patient's oxygen demand and carbon dioxide production are greater and increase faster under physical stress than do those of patients with normal body weight.

WARNING! Heart and cardiovascular insufficiency Constantly monitor all heart and cardiovascular parameters during surgery since morbidly obese patients have an increased risk of heart and cardiovascular insufficiencies.

3.3.3

Warnings Pediatric Operating Mode

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

WARNING! Recommended work settings The flow values listed for laparoscopic procedures performed on newborns, infants, and children are only suggested values. The selection of the suitable flow and pressure values is solely the responsibility of the attending physician.

WARNING! Pneumolabium/pneumoscrotum Children are at risk of a pneumolabium or pneumoscrotum.

WARNING! Procedures with children Only those who are specially trained and qualified for procedures with children or endoscopic vessel harvesting procedures may use this device for these purposes.

WARNING! Increased airway pressure When laparoscopic procedures are performed on children, the increased intra-abdominal pressure also increases the risk for higher airway pressures. Always strictly monitor respiration and airway function when performing laparoscopic procedures on children younger than 12 years of age.

WARNING! Compression of the vena cava When insufflating the abdomen of a child with medical CO2, an increased risk of compressing the vena cava exists. This risk can be reduced by monitoring the systolic and diastolic blood pressure during the entire surgery.

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WARNING! Haemodynamic stability A laparoscopy performed on children younger than 12 years of age may result in problems of the haemodynamic system due to the CO2 content in the blood. It is recommended to increase the breathing rate of the patient and to work with low flow values and pressure values not exceeding 12 mmHg. The patient's circulatory system should be monitored at all times.

WARNING! Hypothermia The insufflation gas flow usually drops significantly after the target pressure has been reached and it is then only required to maintain the abdominal pressure. However, leaks within the abdomen or the instrument can lead to a constant gas flow of above 1 l/min. When operating on children younger than 12, a gas flow of more than 1 l/min poses an increased risk of hypothermia for the patient. Corresponding measures to prevent hypothermia include the use of blankets or prewarmed gas. The patient's body temperature has to be monitored at all times during surgery.

WARNING! Children with cardiovascular problems Laparoscopy with CO2 should not be performed on children with cardiovascular problems.

WARNING! Hypercapnia Because pediatric patients are especially susceptible to hypercapnia, it is recommended to establish an end-tidal CO2 monitoring routine.

3.3.4

Warnings Vessel Harvest Operating Mode

WARNING! CO2 absorption Due to the special surgical procedures - start of the heart bypass operation, and the endoscopic removal of the vessel - special care has to be taken as CO2 is always absorbed through the tissue of the patient 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.

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

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WARNING! Dehydration Insufflation can lead to dehydration of the tissue, especially if the surgery time is prolonged. This can lead to damage of peritoneal cell structures within the tissue. Insufflation, especially with unconditioned gas, is associated with post-operative pain. Long surgeries and large leaks increase the risk of dehydration especially at the insertion points of the trocars. The use of humidified and prewarmed gas can reduce risks associated with tissue dehydration.

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! Procedures with children Only those who are specially trained and qualified for procedures with children or endoscopic vessel harvesting procedures may use this device for these purposes.

WARNING! Instrument used for CO2 insufflation Before using the insufflator to endoscopically harvest vessels, please check whether the instrument used is intended for CO2 insufflation.

WARNING! Pneumoperitoneum When a vessel is harvested from the leg of a patient with a perforated groin, it is possible for CO2 to reach the abdomen and cause a pneumoperitoneum. Make sure the abdomen does not fill with CO2 during surgery.

3.3.5

Warnings TAMIS Operation Mode

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. Pressure values above 15 mmHg are required for only a few cases but do increase the risk of intravasation. It is recommended not to exceed insufflation pressures of 15mmHg during transanal minimally invasive surgery.

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WARNING! Lowest gas flow and pressure Depending on age and health condition of the patient, the smallest possible gas flow and pressure for establishing the cavity should be selected. It is not recommended to exceed insufflation pressures of 15 mmHg in transanal minimally invasive surgery procedures.

3.4

General Precautions

CAUTION! Continuous operation After 24 hours of continuous operation, a device self-test must be carried out. Switch device off and on again.

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 EC 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 Electromagnetic compatibility [} 62]). Care was taken during the development and testing of this device that electrical interference of or from other devices or instruments was practically eliminated. 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

CAUTION! Use of other accessories, other transducers and cables The use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM (see Chapter Glossary) as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.

CAUTION! ME Device in Rack The ME device may not be used when stacked or stored directly adjacent to or with other devices. If it should be necessary to operate the device close to stacked with other devices, the ME device or ME system should be monitored to ensure it works properly as configured.

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CAUTION! Service connection Service connection is reserved for service tasks . 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.

CAUTION! 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.

CAUTION! Mains Power Cable Any power cables employed by the user that are not provided by the manufacturer must meet the safety requirements of the national standards in the respective current valid version.

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Initial Device Setup

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Initial Device Setup

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The operation of the device PNEUMOCLEAR™ is reserved for medical staff with the relevant professional qualifications trained to use the device.

NOTE! Locations The device may be used only in the hospital or operating rooms. Always check all parts and optional accessories of the device immediately after receiving the shipment. The manufacturer only considers 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

Please keep the original 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

4.1

Device Setup and Connection

Place the device on a flat surface free of vibration located in a dry environment. The ambient conditions must meet the requirements mentioned in Chapter Technical Data [} 67].

Setting up

CAUTION! ME systems The medical electrical (ME) device is suitable for integration in ME equipment systems (see Chapter Glossary). Operation of the ME device in vicinity of non-ME devices may result in voiding the intended use of the ME device.

CAUTION! Device setup Device should be positioned outside of the sterile area in such a way that • it can be easily disconnected, • it is easy to use and switch off and on, • it allows an easy monitoring of the display values, device functions, and access to the control elements.

CAUTION! Ventilation of the device • Avoid device overheating. • Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm).

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