NEBULAE I System Operators Manual Rev H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 1: Table of Contents SECTION 1: TABLE OF CONTENTS...1 SECTION 2: DEFINITIONS AND SYMBOLS ...2 SECTION 3: DEVICE DESCRIPTION AND SAFETY FEATURES...5 SECTION 4: INDICATIONS AND CONTRAINDICATIONS...6 SECTION 5: WARNINGS AND CAUTIONS ...7 SECTION 6: UNPACKING AND INSPECTION ...14 SECTION 7: EQUIPMENT SPECIFICATIONS ...15

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SECTION 8: ELECTRICAL REQUIREMENTS ...16 SECTION 9: FRONT PANEL CONTROLS...17 SECTION 10: REAR PANEL CONTROLS ...18 SECTION 11: ASSEMBLY PRIOR TO SURGERY...19 SECTION 12: SETTING UP FOR THE PROCEDURE...20 SECTION 13: INSUFFLATOR TEST...22 SECTION 14: UNDERSTANDING PRODUCT ALERTS...23 SECTION 15A: GETTING STARTED, SET-UP INFORMATION...25 SECTION 15B: GETTING STARTED, USER SETTINGS ...26 SECTION 16A: UNDERSTANDING OPERATING MODE SCREENS ...28 SECTION 16B: UNDERSTANDING PEDIATRIC MODE OPERATION...32 SECTION 16C: UNDERSTANDING CUSTOM MODE OPERATION ...35 SECTION 17: GENERAL OPERATING INSTRUCTIONS ...36 SECTION 18: TRUE ABDOMINAL PRESSURE SENSING SYSTEM...39 SECTION 19: GAS WARMING ...40 SECTION 20: NEBULAE SMOKE EVACUATION TUBING SET...43 SECTION 21: CLEANING, STORAGE AND DISPOSAL...45 SECTION 22: SERVICE AND REPAIR ...46 SECTION 23: CONTACT INFORMATION...47 SECTION 24: ORDERING INFORMATION ...48 SECTION 25: TROUBLESHOOTING GUIDE...51 SECTION 26: GUIDANCE AND MANUFACTURER’S DECLARATION ...53 SECTION 27: PRODUCT WARRANTY...57

80-19410-1 Rev. H

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 2: Definitions and Symbols The following list are abbreviations and symbols for commonly used terms throughout this manual and on the NEBULAE I System:

TAP™ L L/minute m / ft μ

Method for monitoring patient abdomen pressure

ULPA

“Ultra-Low Penetration Air” Filtration efficiency at 0.12 μ to 99.999 % Kilopascal

Liter Per Minute (or Liters Per Minute, LPM) Meters / Feet Micron

Fahrenheit

pCO2 hPa °C Hz g ” RH

Millimeters of mercury CO2 Pounds per Square Inch Kilogram / Pounds Partial Pressure of Carbon Dioxide in the blood Carbon Dioxide partial pressure or tension Hectopascal Celsius

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kPa °F VAC mm oz mg/L NTI™

Liter (or Liters)

mmHg Gas psi kg / lbs PaCO2

Volt of Alternating Current Millimeter Ounce

Milligram Per Liter

Hertz Gram Inch Relative Humidity

Northgate Technologies, Inc.

This manual provides information for the operation of the NEBULAE I System, (also referred to in this manual as “insufflator”, "unit" or "device").

CONSULT OPERATORS MANUAL

INPUT CO2 Gas Input.

GAS WARMING

CONSULT MANUAL

Contains or Presence of Phthalates (DEHP & DBP)

GAS OUTPUT CO2 Gas Output to the patient.

TAP™ - Lit when the TAP Sensing Tubing Set is in use to measure intraabdominal pressure with separate sensing line.

BI-DIRECTIONAL INTERFACE RS-232 Data Interface.

EQUIPOTENTIALITY - Interconnection to ensure all equipment is at the same potential or earth ground.

ELECTRICAL SHOCK HAZARD Dangerous Voltage. EU - NOT FOR GENERAL WASTE

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IP31

INGRESS PROTECTION RATING 1st numeral “3” means protected against solid foreign objects of 2.5 mm Ø and greater. 2nd numeral “1” means protection against vertically falling water drops.

MANUFACTURER DATE OF MANUFACTURE

SERIAL NUMBER

FEDERAL (US) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

HUMIDITY LIMITATION

TEMPERATURE LIMITS

CATALOG NUMBER

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

TYPE B APPLIED PART

DO NOT USE IF PACKAGE IS DAMAGED

DO NOT REUSE

USE BY

THIS PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX

DO NOT RESTERILIZE STERILE

R

STERILIZED USING IRRADIATION

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BATCH CODE

80-19410-1 Rev. H

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NEBULAE™ I System, Operator’s Manual

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Touchscreen Symbols and Buttons

1. Increment and Decrement Values: Increase or decrease Pressure and Flow-rate values. Adjustments can be made one value at a time or “key repeating and scrolling” when maintaining constant pressure when touching the symbol. Key repeating is allowed within the clinically recommended operating ranges of each operating mode. 2. Restore Factory Default: Will restore and reset the default value set by the manufacturer. 3. Return to Previous Screen: Returns the user to the screen viewed previous to the current screen in view. The user may continue to back out of each screen as long as this symbol is available. 4. Power Down Unit: Places the insufflator in a standby or off mode. The LED located in the lower left corner of the insufflator is “Blue” when in “Power Down Mode”. The user must touch the front of the screen to bring the unit out of “Power Down” mode. 5. STOP: When this symbol is depressed, the user can stop the insufflation function of the product. 6. Allow Function / START: When this symbol is depressed, the user can start the insufflation function of the product. 7. Go to Set-Up Menu: Brings the user to the Set-Up Menu screen that allows the selection and saving of insufflator function choices. 8. Store Data: Saves selected function choices. 9. Alert: When visible, this symbol indicates an alert condition. Alert conditions are described in detail in Section 14: Understanding Product Alerts of this manual. Depressing this button will temporarily silence the audible alert sound. 10. Alert Temporarily Silenced: Indicates that an audible alert has been silenced. If the alert condition is not cleared in 10 seconds, 30 seconds, or 10 minutes the alert will sound again. 11. Select Choice: Provides confirmation of the function choice selected by the user. 12. FLOW PRESET: Allows user to quickly switch from low verres flow rates to higher and maximum flow rates allowed for each operating mode. Factory default settings can be adjusted and stored based on user preference. !CAUTION! It is strongly recommended to use ‘Verres Flow Set’ mode when using a Verres needle for initial insufflation. The NEBULAE I System is designed to maximize flow rates through a Verres needle when in ‘Verres Flow Set’ mode. There is no benefit to using higher flow rates with a Verres needle. Page 4

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 3: Device Description and Safety Features DEVICE DESCRIPTION The NEBULAE I System by Northgate Technologies, Inc. (NTI™) is a device that provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures.

SAFETY FEATURES

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The following features help to ensure safe operation of the unit: ! Gas flow can be stopped at any time by touching the STOP button. ! Upon turning power on, gas flow is not initiated until the START button is touched. ! If the preset pressure is exceeded by 3 mmHg for 5 seconds, a software controlled valve will automatically relieve pressure until the preset pressure is re-attained. ! The pressure cannot be set above the default value without touching the “UP” arrow in deliberate one step increments. ! An audible alert shall sound if the pressure exceeds the pre-set pressure by 3 mmHg for 5 seconds or when the gas bottle pressure is low. ! The TAP™ feature negates the need for the Patient Tubing Set to act as a pressure monitoring line, in addition to supplying CO2 gas. This provides the patient with an uninterrupted flow of gas through the patient tubing set, with the pressure reading derived through the separate tubing set. Be sure to use a NEBULAE High-flow Insufflation Tubing Set, REF#7-510-52. If the In-Line Gas Warmer or the drive circuit is defective, or the gas temperature exceeds the specification, the WARMER ALERT indicator will turn on and the audible alert will sound.

80-19410-1 Rev. H

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 4: Indications and Contraindications Indication for Use The NEBULAE I System provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: ! ! ! !

General Laparoscopy Pediatric Laparoscopy Bariatric Laparoscopy Minimally Invasive Saphenous Vein Harvesting

Contraindications for Use

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The NEBULAE I System should be used only when minimally invasive procedures are called for and should therefore not be used for any other treatments. It is designed to function with specific minimally invasive instruments that provide passage of gas to specific body cavities and should only be used with instruments specifically designed for that purpose. It should only be used under the direct guidance of a surgeon skilled in laparoscopic and minimally invasive surgical procedures. Use of this device for body cavity distension is contraindicated whenever minimally invasive procedures are contraindicated. See operator’s manual of your laparoscope/endoscope for absolute and relative contraindications. This device is contraindicated for hysteroscopic insufflation, i.e., it must not be used for intrauterine distension. Use of the NEBULAE I System is contraindicated for use on pediatric patients weighing less than 1 kg. A distending pneumoperitoneum is contraindicated in patients unable to tolerate either decreased venous return or increased PaCO2’s.

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 5: Warnings and Cautions This section describes warning and caution information for safe operation of the NEBULAE I System. All information in this manual, and particularly in this section, should be read thoroughly and understood before using the device.

General Device Warnings !WARNING!

Prolonged intra-abdominal pressures greater than 20 mmHg should be avoided. This can cause any of the following: ! ! ! !

!WARNING! !WARNING!

!WARNING!

!WARNING! !WARNING!

!WARNING!

Excessive absorption of CO2 results from either excessive flow rate and/or excessive pressure. The abdomen can be adequately distended by pressure in the range of 15-20 mmHg. Use of pressure <20 mmHg will dramatically reduce the likelihood of intravasation of CO2 gas into open vascular channels. Also, adequate respiration helps avoid problems related to excessive or retained CO2.

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!WARNING!

Metabolic Acidosis with resultant cardiac irregularity Compromised diaphragmatic excursion resulting in decreased respiration Decreased venous return Decreased cardiac output

Infusion of CO2 can result in carbonic acid irritation of the diaphragm.

Infusion of CO2 can result in embolization. Improper placement of the insufflation instrument could cause insufflation of gas into a vessel, resulting in air or CO2 embolisms. To reduce the risk of air or CO2 embolism, perform initial insufflation at a low flow rate 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 setting and close damaged vessels at once. Air Embolism Hazard: Purge air from tubing sets and instruments with CO2 before delivering gas to the patient. Allow 0.1 Liter volume for each 6 feet (1.8 m) of tubing. After purging, press the STOP button before reconnecting the tubing. Only resume flow when the tubing is properly reconnected. Equipment is not suitable for use in the presence of a flammable anesthetic mixture, with air, with oxygen or with nitrous oxide.

Never attempt to service the device when it is connected to a power source. Hazardous voltages inside the device can cause severe electrical shock. Disconnect the power cord before servicing.

Ensure that all high-pressure gas line connections are secure before opening the gas source(s). Loose connections could separate unexpectedly with great force, causing personal injury.

!WARNING!

This device should be operated only by or under the direct supervision of a physician experienced in laparoscopic / endoscopic surgical procedures. The user should be thoroughly familiar with the operation of this device prior to use.

!WARNING!

When performing a laparoscopic procedure, always insure that you have gained access to the peritoneal cavity prior to the delivery of insufflation gas. Failure to do so may cause injury to the patient.

!WARNING!

To avoid the risk of electrical shock, connect the power cord to a properly wired grounding receptacle.

!WARNING!

Patient tubing sets are packaged sterile. Do not use if packaging is damaged.

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual Any products used with this device that are marked “Do Not Reuse”, are NOT to be re-used or re-packaged due to risk of cross-contamination. DO NOT attempt to resterilize these products due to the possibility of deterioration of component materials.

!WARNING!

This device contains pressure relief mechanisms. A sterile 0.12 micron hydrophobic filter must be used in the tubing set to prevent unit contamination and patient cross contamination.

!WARNING!

Be sure to use a sterile, single use filtered tubing set to prevent contamination and transmission of disease. DO NOT REUSE DISPOSABLE TUBING SETS OR FILTERS.

!WARNING!

Always maintain a clear and unobstructed flow path for the insufflation gas. Verify that the disposable tubing set is not kinked or occluded in any way prior to and during the surgical procedure. Failure to do so may cause injury to the patient.

!WARNING!

The In-Line Gas Warmer is shipped NON-STERILE. It must be disassembled and sterilized before using. All components, including the pre-attached cable, are suitable for sterilization according to the instructions contained in this instruction sheet.

!WARNING!

!WARNING! !WARNING! !WARNING!

!WARNING!

!WARNING! !WARNING!

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!WARNING!

The In-Line Gas Warmer is supplied as a re-useable accessory. Examine the device carefully for any damage before every use. Do not use if there is any physical degradation of the Warmer, or fraying or other damage to the cable or connector which could cause an electrical shock to the user or patient. After autoclaving the In-Line Gas Warmer, allow it to cool down before use to avoid risk of burn to the operator or patient.

To avoid risk of burns, do not plug the In-Line Warmer into the control unit without the end-cap and sheath properly attached.

At flow rates greater than 20 L/minute the In-Line Warmer may not be able to warm the CO2 gas to body temperature. Subsequently, there is no greater risk to the patient. It would be as if there were no warmer at all. A 0.12 micron hydrophobic filter must be used in the tubing set between the insufflator and the In-Line Warmer to prevent unit contamination and patient crosscontamination. To protect the insufflation unit, a 0.12 micron hydrophobic filter should be used in the patient tubing and TAP™ tubing sets. Idiosyncratic reactions: In patients with sickle cell disease or pulmonary insufficiency, use of these devices may pose increased risks of metabolic imbalance related to excessive CO2 absorption.

!WARNING!

Use of dry CO2 in contact with body tissues could result in a drying effect resulting in dehydration. 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). Evaporation of moisture from the tissues could also result in a cooling effect leading to patient hypothermia.

!WARNING!

To avoid inaccurate distension pressures, verify proper connection of tubing before using the unit. If tubing must be disconnected at any time (for example, switching from a verres needle to a trocar), press the STOP button prior to reconnecting the tubing, and only resume flow when the tubing is properly reconnected.

!WARNING!

Improper placement of the verres needle or cavity pressures higher than recommended could lead to subcutaneous emphysema.

!WARNING!

If a sudden loss or decrease to the pneumoperitoneum / intra-abdominal pressure should occur, check to see that the insufflator is powered up and operating properly.

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual Do not allow fluids to enter the device, as damage can result.

!WARNING!

CO2 absorption: CO2 is absorbed (intravasation) during insufflation. Intravasation causes the body to absorb part of the CO2 gas used for insufflation. CO2 concentration in the blood or respiratory systems 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 the 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!

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

!WARNING!

!WARNING!

!WARNING!

!WARNING!

!WARNING!

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!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 process if additional sources are used. 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. 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 cylinder 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. 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 pressure relief valve is activated.

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 application should be carried out with a gas flow rate of 4-10 L/minute. An even lower gas flow rate is recommended for diagnostic purposes. It is recommended to perform endoscopies with the lowest gas flow rate possible.

!WARNING!

To minimize the risk of over-pressure, initial pneumoperitoneum should be established using a flow rate of 5LPM or less (even when using a trocar instead of a verres needle). Use of higher flow rates during initial insufflation increases the risk of over-pressure.

!WARNING!

Fatigue symptoms: When there is a high level of CO2 used during the procedure, you should make sure to supply the operating area with a sufficient amount of fresh air, since increasing CO2 levels in the air can cause medical personnel to suffer fatigue symptoms, an inability to concentrate, unconsciousness or even death.

Always keep a filled CO2 cylinder on hand ready for replacement. This avoids having to interrupt surgery due to a lack of insufflation gas. Printed on: 03 Dec 2020, 04:25:17 pm; Printed by: TGATTO. 80-19410-1 Rev. H Page 9 !WARNING!

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual !WARNING!

This product contains the Phthalate DEHP which is considered to possibly be carcinogenic, mutagenic or toxic to reproduction. Through scientific data and past use of medical products containing DEHP, it has been determined as insignificant and of no risk to the patient. The physician shall determine if use of this product on children or pregnant or nursing women is beneficial and outweighs any potential risks.

!WARNING!

In the unlikely event of a loss of power to the insufflator, turn off the stopcock located on the luer connection port of the trocar sleeve. Turning off the stopcock will help to prevent a rapid loss of the patient’s pneumoperitoneum through the insufflation tubing that is connected to the luer connection port.

!WARNING!

Close proximity of trocar tips may impede measurement of the abdominal pressure which may result in excessive abdominal pressure or make it impossible to maintain the selected abdominal pressure.

!WARNING!

!WARNING!

!WARNING!

!WARNING!

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Device Warnings – Bariatric Mode

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.

Subcutaneous Emphysema: When puncturing the thicker abdominal wall of morbidly obese patients with the Verres needle or the trocar, carefully monitor the correct position of the instrument in the abdomen. 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. 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.

Device Warnings – Pediatric Mode !WARNING!

Pediatric patients are at risk for pneumoscrotum and pneumolabium during laparoscopic surgical procedures.

!WARNING!

Pediatric Patient ages, weights and associated flow rate are approximations and recommendations only. The laparoscopic surgeon skilled in pediatric laparoscopic surgical procedures must decide the optimal pressure and flow rate best suited for the pediatric patient.

!WARNING!

Because pediatric patients are particularly susceptible to hypercapnia, continuous end tidal CO2 monitoring is recommended.

!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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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual !WARNING!

Hemodynamic instability: A laparoscopy performed on children younger than 12 years of age can result in the phenomenon of the increased CO2 content in the blood and with that to problems of the hemodynamic system. It is recommended to ensure good ventilation at all times and to work with low flow values and pressure values not exceeding 15 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/minute. When operating on children younger than 12, a gas flow of more than 1 L/minute poses an increased risk of hypothermia for

!WARNING!

!WARNING!

!WARNING!

!WARNING!

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the patient. Corresponding measures to prevent hypothermia include the use of blankets or pre-warmed gas. The patient’s body temperature has to be monitored at all times during surgery. Abdominal insufflation may be poorly tolerated in [pediatric] patients with either chronic lung disease and baseline elevated pCO2’s, as well as patients with congenital heart lesions placing them at risk from situations in which venous return may become impaired. Please be sure to have an anesthesiologist skilled in pediatric anesthesiology associated with laparoscopic procedures when using the insufflator in the pediatric mode setting. Failure to do so may cause injury to the patient. Use of higher intra-abdominal pressures during laparoscopic procedures may pose a risk for airway restrictions. Respiration and airway function should be carefully monitored when performing laparoscopic procedures on children under the age of 12 years. Do not exceed a flow rate greater than 15 L/minute on pediatric patients weighing less than 24 kilos or 53 pounds.

Device Warnings – Vessel Harvest Mode !WARNING!

An accidental pneumoperitoneum can occur during a Vein Harvest procedure. Care must be taken to avoid perforating the groin area resulting in an unintentional pneumoperitoneum.

Device Warnings – Custom Mode !WARNING!

Custom Mode should not be used for Pediatric or Vessel Harvest Procedures.

General Device Cautions !CAUTION!

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

!CAUTION!

USE ONLY NORTHGATE APPROVED ACCESSORIES that have been designed and tested with the NEBULAE I System to provide maximum patient safety and product performance. Approved accessories are listed in Section 23: Ordering Information of this manual.

!CAUTION!

To reduce the likelihood of potential over-pressure situations, use the TAPTM feature and the associated TAP Sensing Tubing Set as often as possible. DO NOT use any other tubing set for this purpose as it may directly affect the pressure monitoring results.

!CAUTION!

Allow the In-Line Gas Warmer to cool down after autoclaving and before using, or a false over-temperature alert condition will be registered and the warmer will not operate.

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual The In-Line Gas Warmer should be covered and stored in a cool, dry location. Care should be taken to avoid rough handling, jarring, or dropping the unit.

!CAUTION!

Allow the In-Line Gas Warmer to cool down after use before disassembling.

!CAUTION!

This device is designed to function with specific laparoscopic / endoscopic instruments which provide passage of gas into specific body cavities and should be used only with instruments specifically designed for that purpose.

!CAUTION!

Be sure to inspect the insufflator and any accessories for proper operation before each use. If the unit is found to be defective or damaged, it should be returned to the manufacturer or qualified service personnel for inspection and repair.

!CAUTION!

The unit’s cabinet should not be opened except by a qualified service person. Tampering by unqualified persons can damage the unit.

!CAUTION!

Be sure to use only “Medical Grade” CO2 for all procedures requiring the use of the insufflator.

!CAUTION!

!CAUTION! !CAUTION!

!CAUTION! !CAUTION!

!CAUTION!

!CAUTION! !CAUTION!

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!CAUTION!

Do not use the insufflator in an MRI (Magnetic Resonance Imaging) environment as strong electromagnetic fields could potentially damage the product and cause personal injury. If Electromagnetic Interference is suspected, consider moving the device to a different location or increasing the distance between this device and other devices. Always be sure to check for CO2 leaks in the disposable tubing and fittings prior to using the insufflator. If a leak is detected, discard the tubing set and replace it with a new set.

Do not use the insufflator or accessories if you suspect that gas may be leaking from these products.

As with any precision instrument, periodic calibration of the unit is recommended on an annual basis or on a more frequent basis if conditions require. The manufacturer recommends an annual inspection and calibration of this product by a qualified service center. If at any time the unit performs erratically or provides otherwise abnormal operation, remove the unit from service and have it repaired.

If the proper gas supply source is not selected, Low CO2 gas alert will not be notified in timely manner

When using this device, the best protection against over-pressurization at the operative site is to use direct pressure monitoring (via the TAP™ Sensing Tubing Set).

!CAUTION!

In case of emergency, disconnect the device from the supply mains by unplugging the power cord.

CAUTION!

The insufflation unit could experience potential loss in operational performance if not used with approved accessories. Approved accessories are listed in Section 23: Ordering Information of this manual.

!CAUTION!

The insufflation unit could experience potential loss in operational performance if not used with approved accessories.

!CAUTION!

The specification of the fuses in the device must correspond with the fuse rating on the identification plate.

!CAUTION!

This product has no user serviceable parts. Do not remove the cover or attempt to do any repairs yourself.

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual !CAUTION!

It is strongly recommended to use ‘Verres Flow Set’ mode when using a Verres needle for initial insufflation. The insufflator is designed to maximize flow rates through a Verres needle when in ‘Verres Flow Set’ mode. There is no benefit to using higher flow rates with a Verres needle.

!CAUTION!

Never connect the NEBULAE Smoke Evacuation Tubing Set and the High-flow Insufflation Tubing Set to the same trocar.

!CAUTION!

Never connect the NEBULAE Smoke Evacuation Tubing Set and the TAP Sensing Tubing Set to the same trocar.

Device Cautions – Pediatric Mode Given the susceptibility of the pediatric population to small changes in pressure, direct pressure monitoring (via the TAP Sensing Tubing Set) is recommended when using Pediatric Mode.

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!CAUTION!

80-19410-1 Rev. H

Printed on: 03 Dec 2020, 04:25:17 pm; Printed by: TGATTO. Uncontrolled when printed.

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 6: Unpacking and Inspection Proper care and maintenance are critical for safe operation of sophisticated medical equipment. We recommend careful inspection of all equipment upon receipt and prior to each use as a safeguard against possible injury to patient or operator. To avoid inadvertent damage, study this manual thoroughly before handling, assembling, testing, using or cleaning the insufflator unit. Examine the shipping carton and instrument for signs of damage. Any breakage or other apparent damage should be noted, the evidence retained, and the carrier or shipping agency notified. Verify that the shipping carton contains the items listed below:

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a) NEBULAE I System, Insufflator b) Operator’s Manual c) Power Cord

See the complete list of available insufflator accessories on pages 48-50.

Notify NTI Customer Service at 1(800) 348-0424 immediately if any damage or discrepancies are noted.

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 7: Equipment Specifications The NEBULAE I System is indicated for use as a means of providing CO2 for cavity distension during minimally invasive surgical procedures. The NEBULAE I System is not intended for use to distend the uterus.

Specifications Insufflator:

Size:

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Weight: Control Panel: Gas Flow Limit: Operating Modes:

12” wide x 6” high x 12” deep; (305 x 153 x 305 mm) 11.5 lb (4.3 kg) Full Color, Digital Touch Screen. Adjustable from 0-50 L/minute. General Laparoscopic, Bariatric, Pediatric, Custom, Vessel Harvest. ± 5 %, ± 1 LPM Operating mode dependent. Electronically controlled relief of displayed pressure at 3 mmHg above the preset value. Audible alert when the abdomen pressure is more than 3 mmHg above the preset level for 5 seconds. ±3% Flow start or stop. Cylinder tank, or Central wall supply. To 2200 psi “E” cylinder; See Section 8 on House Gas

Flow Display Accuracy: Pressure Adjustment: Pressure Relief Valve:

Pressure Display Accuracy: Operating Modes: Gas Inlet: Gas Input Pressure:

Tubing Sets: (Sold Separately) High-flow Insufflation Tubing Set: TAP™ Sensing Tubing Set:

High-flow Smoke Evacuation Tubing Set:

High-flow insufflation tubing set with a 0.12 μ, ULPA hydrophobic filter; 10 ft in length True abdominal pressure sensing tubing set with a 0.12 μ, ULPA hydrophobic filter; 10 ft in length High-flow smoke evacuation tubing set with a 0.12 μ, ULPA hydrophobic filter; 15 ft in length

In-Line CO2 Gas Warmer: (Sold Separately) Size: 3.44” long X 1.00” diameter (87.4 X 25.4 mm); 9’ 8” (3 m) Weight: 4.68 oz (133 g) Gas Temperature: 95 – 106 °F (35 – 41 ∀C), non-adjustable Power: 24 Watts

80-19410-1 Rev. H

Printed on: 03 Dec 2020, 04:25:17 pm; Printed by: TGATTO. Uncontrolled when printed.

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 8: Electrical Requirements 100 to 240 VAC nominal line voltage; 50/60 Hz (line voltage can vary by ±10 % from nominal)

Power:

100 watts maximum double fusing with removable power cord

Standards:

IEC 60601-1:2005 IEC 60601-1 Amd.2 Ed. 2.0 b:1995 IEC 60601-1-2:2014 IEC 60601-1-6 (IEC 62366) CSA C22.2 No. 601.1 EN 60601-1, EN 60601-1-2:2015 IEC 62304:2006 Medical Device Directive (MDD) 93/42/EEC

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Input Voltage:

EQUIPMENT CLASSIFICATION: NEBULAE I System, Insufflator In-Line Warmer

Class I Type B Applied Part, IP31 Class I Type B Applied Part

ENVIRONMENTAL REQUIREMENTS: Operating:

Ambient Temperature Relative Humidity Pressure

50 – 104 °F (10 – 40 °C). 30 – 70 % non-condensing 700 hPa – 1060 hPa

Transit & Storage:

Ambient Temperature Relative Humidity Pressure

-13 – 158 °F (-25 – 70 °C) 15 – 90 % non-condensing 500 hPa – 1060 hPa

House CO2 Gas:

Inlet CO2 Gas Pressure Greater than 45 psi (Higher Inlet CO2 gas pressure would allow the device to operate at MAX flow.)

Note: If necessary, the unit may be isolated from supply mains by disconnecting the power cord from the Power Entry Module.

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

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Section 9: Front Panel Controls

1. LCD Display Screen: With the rear power switch in the “ON” position, touch screen to turn unit “ON”. The LCD screen clearly displays the complete range of treatment choices and settings.

2. Front Panel LED Display: The LED is “Blue” when power is applied, but the unit is “OFF”. The LED is “Green” when the unit is “ON” and the front panel screen is “Active”.

3. Gas Warmer: 8 pin Connection Port. 4. TAP™: System for monitoring abdominal pressure. 5. CO2 Gas Output Port: Allows for connecting the filtered, sterile, single use patient tubing sets.

80-19410-1 Rev. H

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NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

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Section 10: Rear Panel Controls

1. CO2 Gas inlet connection port: For connecting an E-cylinder using a high pressure hose and yoke assembly, or a high pressure hose to an appropriate central supply connector.

2. Grounded Power Cord Connection: A detachable, hospital grade power cord can be connected to the device. The detachable feature makes it easy when removing the unit and transporting it away from the cart.

3. Main Power Switch and Fuse Container: Two, 2 Amp, 250V~ time delay, replaceable fuses are contained within this plastic enclosure.

4. Potential Compensator Plug: Connection used to interconnect other instruments to ensure that they are at the same potential or earth ground.

5. RS-232 Connection: Data interface. NOTE: Refer to Page 2 of this manual for definitions of symbols that appear on the rear panel.

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80-19410-1 Rev. H

NOR-SPEC-IFU-0063 - MANUAL OPER NEBULAE I 50L Rev. H Effective 19 Dec 2019

NEBULAE™ I System, Operator’s Manual

Section 11: Assembly Prior to Surgery The insufflator should be inspected upon receipt and before each use. Damaged equipment should be removed from service and returned to NTI for repair or replacement. Before each use, the following procedures or inspections should be performed: Insufflator Preparation

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1. Install the insufflator on a flat surface away from potential sources of spraying or leaking liquids. 2. Visually inspect the insufflator for outward signs of damage. Damaged equipment should be removed from service and returned to NTI for repair or replacement. 3. Be sure to position the device in a way that the power supply cord is within reach. 4. Be sure to place the insufflator at a position elevated higher than the patient to avoid any fluid backflow to the unit.

Electrical Connections

The nominal AC line voltage is 100 to 240 VAC and the AC line frequency is 50 Hz to 60 Hz. The AC line voltage should not drop below 90 VAC or exceed 264 VAC. There are no switches or other AC line configuration requirements. 1. Connect the Power Cord to the AC Power Connection on the back of the insufflator. 2. Inspect the electrical connections. Do not use if inspection reveals any damage.

House CO2 Gas Preparation 1.

For optimal performance in House Gas mode, ensure that house gas pressure is greater than 45 psi. Higher Inlet CO2 gas pressure would allow the device to operate at MAX flow.

CO2 Hose Connections

For CO2 Gas Cylinders 1. 2.

Attach the CO2 Yoke of the CO2 High Pressure Hose to the CO2 Supply Tank. Tighten with the Yoke Attachment Screw. Remove the cap from the CO2 High Pressure Hose threaded end and from the CO2 Input on back of insufflator. Attach the threaded end of CO2 high-pressure Hose to the CO2 Input. Carefully tighten the hose connection with a wrench.

For House CO2 Gas 3.

For centrally supplied, House CO2 Gas, use an appropriate central supply connector hose.

!CAUTION!

Be sure to inspect the NEBULAE I System, insufflator and any accessories for proper operation before each use. If the unit is found to be defective or damaged, it should be returned to the manufacturer or qualified service personnel for inspection and repair.

!CAUTION!

If at any time the unit performs erratically or provides otherwise abnormal operation, remove the unit from service and have it repaired.

80-19410-1 Rev. H

Printed on: 03 Dec 2020, 04:25:17 pm; Printed by: TGATTO. Uncontrolled when printed.

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