PNEUMO SURE Model F114 High Flow Insufflator Instructions for Use Rev H Oct 2014

Symbols/Símbolos/Symboles/Símbolos

EN

REF

Symbols

Símbolos

Symboles

Símbolos

Refer to instruction manual

Consulte el manual de instrucciones

Consultez le manuel d’utilisation

Consulte o manual de instruções

Caution

Peligro

Danger

Perigo

Symbol for type BF equipment

Símbolo para un aparato del tipo BF

Symbole pour un appareil de type BF

Símbolo para um aparelho do tipo BF

Do not resterilize

No reesterilizar

Ne pas restériliser

Não reesterilizar

Symbol for potential equalization

Símbolo para la conexión equipotencial

Fiche équipotentielle

Sistema para a compensação do potencial

Degrees of protection provided by enclosures (IP-Code)

Grado de protección proporcionado por los envolventes (Código IP)

Degrés de protection procurés parles enveloppes (Code IP)

Classificação do grau de proteção oferecido pelas carcaças (IP)

Alternating current

Corriente alterna

Courant alternatif

Corrente alternada

Service

Servicio

Service

Assistência

Catalog number

Número de catálogo

Numéro du catalogue

Número do catálogo

Single use only

No reutilizable

Usage unique

Vedada a reutilização

Sterilized using EO

Esterilizado con EO

Stérilisés à l’EO

Esterilizado com EO

Lot number

Denominación departida o lote

Numéro de lot

Designação do lote

Serial number

Número de serie

Numéro de série

Número de série

Date of manufacture

Fecha de fabricación

Date de fabrication

Data de fabricação

Use by

Utilizable hasta

Date limite d’utilisation

Utilizável até

Pieces, quantity

Piezas, cantidad

Pièces, quantité

Número, quantidade

Quantity

Cantidad

Quantité

Quantidade

ES

FR

PT

Symbols/Símbolos/Symboles/Símbolos

Symbols

Símbolos

Symboles

Símbolos

Exit

Salida

Quitter le menu

Saída

Menu - Increase

Menú-Aumento

Menu-Croissant

Menu-Aumento

Menu - Decrease

Menú-Disminución

Menu-Décroissant

Menu-Descida

Real-Time Pressure Sensing activada

Real-Time Pressure Sensing activée

Real-Time Pressure Sensing activada

Real-Time Pressure Sensing defective or deactivated

Real-Time Pressure Sensing defectuosa o desactivada

Real-Time Pressure Sen- Real-Time Pressure Sensing défectueuse ou sing danificada o desacdésactivée tivada

House gas supply

Alimentación de gas central

Alimentation en gaz centrale

Alimentação de gás doméstico

Tank gas supply

Alimentación por botella de gas

Alimentation en gaz par bouteille

Alimentação de gás com uma botija de gás

Low gas pressure

Presión de gas baja

Pression de gaz basse

Pressão de gás baixa

Gas pressure too low

Presión de gas demasiado baja

Pression de gaz insuffisante

Pressão de gás demasiado baixa

Push to release

Presione para retirar

Appuyer pour retirer

Premir para eliminar

Do not use if package damaged

No utilizar si el envoltorio está dañado

Ne pas utiliser si l’emballage est endommagé

Não usar se a embalagem é danificada

Keep away from sunlight

Proteger de la luz solar

Protéger des rayons du soleil

Proteja da luz solar

Authorized for Sale or use by Physician only

Autorizado sólo para la venta o el uso médico

Autorisé seulement pour la vente ou l’utilisation par un médecin uniquement

Autorizado somente para a venda ou o uso médico

EN

Real-Time Pressure Sensing in progress

ES

FR

PT

Table of contents 1

Important User Notes ... 3

2

Safety Information... 4 2.1 Hazards... 5

3

Device Purpose... 7 3.1 Laparoscopy Applications ... 7 3.1.1 Using High Flow Operating Mode ... 7 3.1.2 Using Pediatric Operating Mode... 7 3.1.3 Using Bariatric Operating Mode ... 8 3.1.4 Contraindications for Laparoscopy Applications... 8 3.2 Using Vessel Harvest Operating Mode... 8 3.3 General Device-Inherent Dangers ... 8 3.3.1 Device-Inherent Dangers - Laparoscopy ... 10 3.3.2 Device-Inherent Dangers - Vessel Harvesting... 12

4

Initial Device Startup ... 14 4.1 Gas connection ... 14 4.1.1 Connecting a Gas Bottle... 15 4.1.2 Connecting to Central Gas Supply... 15

5

Operating the Device - General ... 16 5.1 Front of the Device... 16 5.2 Rear of the Device ... 16 5.3 Touch screen display... 17 5.4 Switch on Device ... 18 5.5 Connecting Insufflation Tube Set ... 19 5.6 Using the Gas Heating... 20 5.6.1 Using the direct pressure measurement function (Real-Time Pressure Sensing RTP)... 21 5.6.2 Displaying/Selecting Insufflation Operating Mode ... 23 5.6.3 Setting the Nominal Pressure - General ... 23 5.6.4 Setting the Nominal Flow - General ... 23 5.6.5 Gas Consumption Display... 24 5.6.6 Starting/Stopping Insufflation... 24 5.6.7 Using the SIDNE Port (Optional) ... 25 5.6.8 Turning Device Off ... 25

6

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode ... 26 6.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in High Flow Operating Mode ... 26 6.2 Selecting High Flow Insufflation Mode... 28 6.3 Presetting Nominal Pressure in High Flow Operating Mode... 28 6.4 Presetting Nominal Flow in High Flow Operating Mode... 28 6.5 Performing the Function Test in High Flow Operating Mode... 29 6.5.1 Filling Tube System with CO2 ... 31 6.6 Using the Device during Surgery ... 31 6.6.1 Insufflating with Veress Cannula... 31 6.6.2 Insufflating with the Trocar... 32 6.6.3 "Real-Time Pressure Sensing" functionality (RTP) ... 32 6.6.4 Stop the Insufflation... 33

7

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode ... 34 7.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode ... 34 7.2 Selecting Pediatric Operating Mode ... 36 7.3 Presetting Nominal Pressure in Pediatric Operating Mode ... 36 7.4 Presetting Nominal Flow in Pediatric Operating Mode ... 37 7.5 Performing the Function Test in Pediatric Operating Mode before Using the Device during Surgery... 38 7.5.1 Filling Tube System with CO2 ... 40 7.6 Using the Device during Surgery ... 40 7.6.1 Insufflating with Veress Cannula... 40 7.6.2 Insufflating with the Trocar... 41 7.6.3 "Real-Time Pressure Sensing" functionality (RTP) ... 41 7.6.4 Stop the Insufflation... 42

8

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode... 43 8.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in Bariatric Operating Mode ... 43 8.2 Selecting Bariatric Operating Mode... 45 8.3 Presetting Nominal Pressure in Bariatric Operating Mode... 46 8.4 Presetting Nominal Flow in Bariatric Operating Mode... 46 8.5 Performing the Function Test in Bariatric Operating Mode before Using the Device during Surgery ... 47 8.5.1 Filling Tube System with CO2 ... 48 8.6 Using the Device during Surgery ... 49 8.6.1 Insufflating with Veress Cannula... 49 8.6.2 Insufflating with the Trocar... 49

EN

8.6.3 8.7

EN

"Real-Time Pressure Sensing" functionality (RTP) ... 50 Stop the Insufflation... 50

9

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode... 51 9.1 Device-Specific Dangers when Using the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode ... 51 9.2 Selecting Vessel Harvest Operating Mode... 52 9.3 Presetting Nominal Pressure in Vessel Harvest Operating Mode ... 53 9.4 Presetting Nominal Flow in Vessel Harvest Operating Mode ... 53 9.5 Performing the Function Test in Vessel Harvest Operating Mode before Using the Device during Surgery. 54 9.5.1 Filling Tube System with CO2 ... 55 9.6 Using the Device during Surgery ... 55 9.6.1 Insufflation with Vessel Harvest Instrument ... 56 9.6.2 Stop the Insufflation... 56

10

Configuration Menu (Overview)... 58 10.1 Configuration menu I... 60 10.1.1 Setting First Nominal Pressure... 60 10.1.2 Setting the Venting Controls... 61 10.1.3 Setting the Gas Supply Type... 62 10.1.4 Setting the Alarm Volume ... 63 10.2 Configuration menu II... 64 10.2.1 Setting the Gas Flow Rates* ... 64 10.2.2 Setting First Nominal Gas Flow* ... 64 10.2.3 Setting the Maximum Nominal Pressure... 65 10.2.4 Setting the Flow Safety Limit* ... 66 10.2.5 Setting the Warning signal: Occlusion ... 66 10.3 Utility menu ... 66 10.3.1 Changing Display Settings... 67 10.3.2 Setting the Language ... 67 10.3.3 Checking Software Version... 68 10.3.4 Upgrade XL* ... 69 10.3.5 Service Menu ... 69

11

Safety functions ... 70

12

Care and Maintenance... 74 12.1 Cleaning the Device... 74 12.2 Annual Inspection ... 74 12.3 Maintenance by Authorized Service Technician... 74 12.4 Replacing the Fuse ... 75 12.5 Care and Maintenance of Reusable Tube Set ... 75 12.5.1 Cleaning the Reusable Tube Set ... 76 12.5.2 Disinfecting the Reusable Tube Set... 76 12.5.3 Sterilization of Reusable Tube Set ... 76

13

Annual Inspection ... 78 13.1 Safety Test... 78 Basic Function Test (in High Flow Operating Mode) ... 78 13.2 13.3 Testing the Pressure Sensors in High Flow Operating Mode... 79 13.4 Pressure Monitoring Test in High Flow Operating Mode... 80 13.5 Venting Valve Test ... 80 13.6 Max. Device Pressure Test... 81 13.7 Gas Flow Rate Test... 81

14

Electromagnetic compatibility ... 82 14.1 Impact of Mobile and Portable HF Communication Devices... 82 14.2 Electrical Connections... 82 14.3 Accessories ... 82 14.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity... 83 14.5 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions ... 84 14.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - PNEUMO SURE High Flow Insufflator ... 85 14.7 Recommended Safety Distances Between Portable and Mobile HF Telecommunications Devices and the PNEUMO SURE High Flow Insufflator... 86

15

Error and Warning Messages... 87

16

Technical Data... 89

17

Accessories for PNEUMO SURE High Flow Insufflator... 90 17.1 Accessories for Sale in USA4 ... 90 17.2 Accessories for Sale Outside of the USA ... 91

18

Warranty and Service ... 93

19

Appendix ... 95 19.1 Test Log... 95 Index ... 96

Important User Notes

1

Important User Notes

EN

Read the manual carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing staff or service personnel, or • to damage or malfunction of device and/or accessories. The manufacturer reserves the right to modify the appearance, graphics, and technical data of the supplied product through continued product development.

Subject to technical changes

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

Please note

WARNING! The safety and/or health of the patient, user, or a third party are at risk. Comply with this warning to avoid injury to the patient, user, or third parties.

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

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

3

Safety Information

EN

2

Safety Information

Federal Law (only for U.S. market)

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

Exclusion of liability

The manufacturer is not liable for direct or consequential damage and the warranty is null and void if: • the device and/or the accessories are improperly used, prepared, or maintained, • the instructions and rules in the manual are not adhered to, • non-authorized persons perform repairs, adjustments, or alterations on or to the device or accessories, • non-authorized persons open the device, • the prescribed inspection and maintenance schedules are not adhered to. Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations on or to the device or accessories. Caution: No modification of this equipment is allowed.

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

Safety Information

2.1

EN

Hazards

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

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

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

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.

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

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

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

WARNING! To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth.

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

5

Safety Information

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.

EN

WARNING! Function test The function 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.

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 easy reach to be able to finish the operation with the replacement components.

WARNING! Device-inherent dangers Read the warnings specific to this device in chapter 3.3 General Device-Inherent Dangers.

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

CAUTION! Endoscope The device may only be connected with endoscopes designed for and featuring the technical specification permitting such a combined use. Any utilized endoscopes must comply with the most recent versions of IEC 60601-2-18 and ISO 8600.

6

Device Purpose

3

Device Purpose

The PNEUMO SURE High Flow Insufflator serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutical laparoscopy. High Flow operating mode, Pediatric operating mode, and Bariatric operating mode of the device are used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas. Pediatric operating mode is designed specifically for use on newborns, infants, and children. Vessel Harvest operating mode is used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

EN

Intended use

Two alternative configurations are provided: 1. PNEUMO SURE High Flow Insufflator contains the applications High Flow operating mode -> Insufflation for adults and the Pediatric operating mode -> Insufflation for infants and children. 2. PNEUMO SURE XL High Flow Insufflator contains the applications High Flow operating mode -> Insufflation for adults and the Pediatric operating mode -> Insufflation for infants and children, Bariatric operating mode -> Insufflation for morbidly obese patients, Vessel Harvest operating mode -> Insufflation for Vessel Harvesting procedure. The PNEUMO SURE XL configuration is available directly or via software upgrade. High Flow operating mode, Pediatric operating mode, and Bariatric operating mode of the device are used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas. Bariatric operating mode is used for laparoscopic surgery on morbidly obese patients. Vessel Harvesting operating mode is used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

3.1

Laparoscopy Applications

3.1.1

Using High Flow Operating Mode

High Flow operating mode is designed explicitly for laparoscopies performed on normal weight and slightly obese (BMI < 30 kg/m2) patients over the age of 14. While in High Flow operating mode, the insufflator limits the pressure to max. 30 mm Hg 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 the device is to maintain the nominal pressure. Any overpressure within the abdomen is lowered to the preset nominal pressure by the automatic venting system.

3.1.2

Using Pediatric Operating Mode

Pediatric operating mode is designed specifically for use on newborns, infants, and children. While in Pediatric operating mode, the insufflator limits the pressure to max. 20 mm Hg and the gas flow rate to max. 20 l/min. When used on children, the device should be set depending on the selected nominal flow and the age and weight of the treated child as outlined in the table below:

Age Group

Weight

Flow Range

Children younger than 1 year

approx. 1-9 kg

0.1 -0.5 l/min

Children between 1 and 3 years

approx. 10-15 kg

0.5 -1.0 l/min

Children between 3 and 4 years

approx. 16-19 kg

1.0 -2.0 l/min

Children between 4 and 14 years

> 20 kg

> 2.0 l/min

7

Device Purpose

If the nominal flow is set too low, the nominal pressure cannot be reached. Check for possible leaks. Due to the special operating method used during the Pediatric application, the speed of equalizing the leak is slower than when using the High Flow application (lower effective flow in the Pediatric application).

EN

3.1.3

Using Bariatric Operating Mode

Bariatric operating mode is used for laparoscopies performed on severely overweight (BMI > 30 kg/m2) adults. While in Bariatric mode, the insufflator limits the pressure to max. 30 mm Hg and the gas flow to max. 45 l/min. This operating mode delivers rapid insufflation of large volumes.

3.1.4 Contraindications

Contraindications for Laparoscopy Applications

The device may not be used to fill an abdomen with CO2 if a laparoscopy is contraindicated. Please consult the manual of your laparoscope for absolute and relative contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it may not be used to distend the uterus. The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos.

3.2

Using Vessel Harvest Operating Mode

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

Vessel Harvest operating mode is designed for the controlled insufflation of medical-grade CO2 when harvesting vessels (veins and arteries) during a minimally invasive procedure within the scope of heart bypass surgery. While in Vessel Harvest operating mode, the insufflator limits the pressure to max. 20 mm Hg and the gas flow rate to max. 10 l/min. Surgery to harvest vessels requires the use of a special instrument. Contraindications

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

General Device-Inherent Dangers

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.

8

Device Purpose

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.

EN

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 4.1.1 Connecting a Gas Bottle).

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 con-

9

Device Purpose

nected to instruments which are intended for intra-abdominal CO2 insufflation.

EN

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

CAUTION! Electrical Interference (See chapter 14 Electromagnetic compatibility). Electrical interference with other devices or instruments was practically eliminated when developing this devices and none was detected during testing. However, if you still detect or suspect such interference, please follow these suggestions: • Move this, the other or both devices to a different location • Increase distance between used devices • Consult an electro-medical expert

WARNING! Peripheral devices Additional peripheral equipment connected to interfaces of the medical monitor has to meet the requirements of the following specifications: IEC 60601-2-18 / EN 60601-2-18 for endoscopic devices and IEC 60601-1 / EN 60601-1 for electrical medical devices. All configurations have to comply with IEC 60601-1 / EN 60601-1 specifications. Whoever connects additional equipment to signal output or signal input is considered the system configurator and as such is responsible for complying with requirements of the standard IEC 60601-1 / EN 60601-1.

3.3.1

Device-Inherent Dangers - Laparoscopy

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

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 (approx. 55 US pounds).

10

Device Purpose

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

EN

WARNING! Increased airway pressure/compression of the vena cava When using the pediatric application of the device on children, an increased risk of high 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: • High gas flow due to large leaks • Long surgeries • Use of cold (not preheated) irrigation and infusion solutions

11

Device Purpose

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).

EN

WARNING! Embolism 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 settings and close damaged blood vessels at once.

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 10 Configuration Menu (Overview), page 58) when using Pediatric application and an additional insufflation source. It is not possible to use an additional insufflation source when the automatic venting system is deactivated.

WARNING! Only specially trained and qualified personnel may use this device on children or for the endoscopic vessel harvesting procedure.

3.3.2

Device-Inherent Dangers - Vessel Harvesting

WARNING! Before using the insufflator to endoscopic harvest vessels, please check whether the used instrument 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.

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

12

Device Purpose

reaction).

EN

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 Due to the special surgical conditions - start of the heart bypass surgery and vessel harvesting - it is especially important to remember the existing risk of metabolic acidosis when insufflating with CO2. 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! 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 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 pressure. Avoid high-pressure settings and close damaged blood vessels at once.

WARNING! Only specially trained and qualified personnel may use this device on children or for the endoscopic vessel harvesting procedure.

13

Initial Device Startup

EN

4

Initial Device Startup

Delivery inspection

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.

Setting up 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 16 Technical Data, page 89. 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 such that it is easy to operate and disconnect.

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 60320. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.

Potential equalization

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

4.1

Gas connection

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

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

14

Initial Device Startup

EN

CO2

4.1.1

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.

4.1.2

Connecting to Central Gas Supply

Use the following device connectors available as additional equipment to connect to a central gas supply (house supply): • 0620-040-003 for NIST house gas supply or • 0620-040-002 for DISS house gas supply.

1. Attach the high-pressure tube to the gas connection. 2. Fix 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 10.1.3 Setting the Gas Supply Type, page 62).

15

Operating the Device - General

EN Fig. 5-1

5

Operating the Device - General

5.1

Front of the Device

Device Front

(1)

ON/OFF switch

(2)

Touch screen display

(3)

Insufflation tube connection

(1)

(2)

(3)

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

5.2 Fig. 5-2

Rear of the Device

Device Rear

(4)

Type plate

(5)

Device data plate

(6)

SIDNE interface (optional)

(7)

Data input/output

(8)

Connection for potential equalization

(9)

Device plug

(10)

Fuse holder

(11)

Gas supply connection

(4)

(5)

(6)

(7)

(8)

CO2

(11)

(10) (9)

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

16

Operating the Device - General

EN

Touch screen display (1)

(15)

(2)

(4)

Fig. 5-3

(5)

Actual Pressure

Set Flow

mm Hg

mm Hg

l/min

15

0

Set Pressure

GAS

(14)

(3)

(13)

0.0

Liter

3

HEATING

5.3

(7)

(8)

Mode: High Flow Change Mode

(12)

(11)

START

(10)

(6)

Actual

0 l/min (9)

The above depiction of the touch screen also shows all display and function fields. Field (9) serves as actual flow display (depicted without frame while insufflating) and also as menu function field (depicted with frame). Field (12) serves as insufflation operating mode display (depicted without frame while insufflating) and also as control field for selecting the insufflation operating mode (depicted with frame).

Screen displays

(1)

Continuous pressure reading display

(2)

Gas supply display

(3)

Actual pressure display

(4)

Gas consumption display/function field for reset

(5)

Gas heating connected/ready

(6)

Increasing nominal gas flow

(7)

Nominal gas flow display

(8)

Decreasing nominal gas flow

(9)

Actual gas flow display/ menu function field

(10)

START/STOP function field

(11)

Status display/error and warning messages

(12)

Insufflation operating mode display/selecting insufflation operating mode

(13)

Decreasing nominal pressure

(14)

Nominal pressure display

(15)

Increasing nominal pressure

Press the function field (9) or (12) depicted with frame and hold for 2 seconds to trigger functions or set values. Additional explanations for individual elements are presented in the subsequent respective control element descriptions. The status of the gas supply is monitored by the device and indicated with symbols and acoustic signals (see chapter 11 Safety functions for gas pressure display information).

Gas supply displays

The following gas bottle pressures are displayed:

Gas supply with gas bottle

> 50 bar

40 - 50 bar

30 - 40 bar

15 - 30 bar; Three warning signals can be heard and the message "Change gas tank" is displayed. User is advised to obtain a replacement tank. < 15 bar; Three warning signals can be heard and the message "Check gas supply" is displayed. Replace gas tank immediately.

If gas supply pressure declines further, there are warnings to remind the user to replace the gas tank immediately. Five warning signals can be heard and the message "Check gas supply" is displayed at < 5 bar and again at 0 bar. Insufflation stops at 0 bar.

17