Flow 50 Instructions for Use Ver 2.0

Bildzeichen/Symbols/Symboles/Símbolos/Simboli

de Symbols

Beschreibung

Description

Description

Descripción

Descrizione

Gebrauchsanweisung befolgen (weißes Bild auf blauem Grund)

Follow instructions for use (white image on a blue background)

Lire les instructions d‘utilisation (en blanc sur fond bleu)

Observar las instrucciones de uso (imagen blanca sobre fondo azul)

Consultare le istruzioni per l'uso (immagine bianca su sfondo blu)

Gefahr

Warning

Danger

Peligro

Pericolo

Gebrauchsanweisung beachten

Consult instructions for use

Observer le mode d’emploi

Tener en cuenta las instrucciones de uso

Rispettare le istruzioni per l’uso

Medizinprodukt

Medical Device

Dispositif médical

Producto sanitario

Dispositivo medico

Gerät des Typs CF

Type CF applied part

Appareil de type CF

Aparato del tipo CF

Apparecchio mod. CF

Gerät der Klasse II

Class II equipment

Équipement de classe II

Equipo de clase II

Apparecchio di classe II

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fr

es

it Potentialausgleich

Equipotentiality

Fiche équipotentielle

Conexión equipotencial

Collegamento equipotenziale

Gehäuseschutzklasse (IP-Code)

Degrees of protection provided by enclosures (IP-Code)

Degrés de protection procurés parles enveloppes ( Code IP)

Grado de protección proporcionado por los envolventes (Código IP)

Grado di protezioni degli involucri (Codice IP)

Wechselstrom

Alternating current

Courant alternatif

Corriente alterna

Corrente alternata

Service

Service

Service

Servicio técnico

Servizio

Bestellnummer

Catalogue number

Numéro d’article

Número de pedido

Numero di ordinazione

Nicht resterilisieren

Do not resterilize

Ne pas restériliser

No reesterilizar

Non risterilizzare

Nicht wiederverwenden

Do not reuse

Ne pas réutiliser

No reutilizable

Non riutilizzabile

Sterilisiert mit Ethylenoxid

Sterilized using ethylene oxide

Stérilisés à l'oxyde d'éthylène

Esterilizado por óxido de etileno

Sterilizzato con ossido di etilene

Nicht steril

Non sterile

Non stérile

No estéril

Non sterile

Chargenbezeichnung

Batch code

Codes de lot

Código de lote

Designazione lotto

Seriennummer

Serial number

Numéro de série

Número de serie

Numero di serie

Herstellungsdatum (JJJJ-MM-TT)

Date of manufacture (YYYY-MM-DD)

Date de fabrication (AAAA-MM-JJ)

Fecha de fabricación (AAAA-MM-DD)

Data di fabbricazione (AAAA-MM-GG)

Verwendbar bis (JJJJ-MM-TT)

Use by date (YYYY-MM-DD)

Utilisable jusqu’à (AAAA-MM-JJ)

Fecha de caducidad (AAAA-MM-DD)

Da utilizzarsi entro (AAAA-MM-GG)

Table of contents 1

Important User Notes ... 3

2

Safety Information... 4

3

General Information ... 5 3.1 Device Description ... 5 3.2 Intended Use and Contraindications ... 5 3.2.1 Intended Use... 5 3.2.2 Contraindications ... 5 3.3 Warnings ... 6 3.3.1 General CO2 Insufflation Warnings... 6 3.3.2 Warnings Standard and Bariatric Indications... 10 3.3.3 Warnings Pediatric Indication ... 12 3.3.4 Warnings Vessel Harvesting Mode (Cardiac Indication)... 13 3.3.5 Warnings Fieldflooding Mode (Cardiac Indication)... 14 3.4 General Precautions ... 14

4

Initial Device Set-up... 16 4.1 Scope of Delivery ... 16 4.2 Device Setup and Connection... 17 4.3 Front of Device ... 18 4.4 Rear of the Device ... 19 4.5 Gas Connection... 19 4.5.1 Connecting a Gas Bottle... 20 4.5.2 Connecting to Central Gas Supply... 21 4.6 Gas Supply ... 22 4.7 Switching Device On... 22 4.8 Switching Device Off ... 23 4.9 Demo Mode... 23

5

Operating the Device - General ... 24 5.1 Monitor with Touch Screen ... 24 5.2 Insufflation Tube Sets ... 24 5.3 Connecting an Insufflation Tube Set ... 25 5.4 Gas Heating... 25 5.5 Using the Smoke Evacuation Function ... 27 5.5.1 Replacing the Smoke Evacuation Filter Cassette ... 28 5.5.2 Replacing the Disposable Smoke Evacuation Tube Set ... 29 5.6 Displaying/Selecting Insufflation Indication... 29 5.7 Setting the Nominal Pressure - All Indications Except Fieldflooding ... 30 5.8 Setting the Nominal Gas Flow Rate - All Indications ... 30 5.8.1 Veress Insufflation ... 31 5.8.2 Highflow Insufflation... 31 5.8.3 Profiles... 31 5.9 Function Test before Device Use ... 32 5.10 Gas Consumption Display... 33 5.11 Starting/Stopping Insufflation... 33

6

Indications of the Flow 50 Insufflator ... 34 6.1 Standard Indication ... 34 6.2 Bariatric Indication ... 36 6.3 Pediatric Indication... 38 6.4 Cardiac Indication ... 40 6.4.1 Fieldflooding ... 40 6.4.2 Vessel Harvesting ... 41

7

Menu ... 43 7.1 Profiles... 44 7.1.1 Creating Profiles ... 44 7.1.2 Change Profile ... 44 7.1.3 Delete Profile ... 44 7.2 Indication Setting... 45 7.2.1 Insufflation... 45 7.2.2 Smoke Evacuation... 45 7.3 System ... 45 7.4 Service... 46 7.5 Protocol ... 46 7.6 User Menu (Overview) ... 46

8

Safety Functions... 50 8.1 Automatic Venting System... 50 8.2 Occlusion ... 50 8.3 Contamination ... 51 8.4 Leakage Detection... 51 8.5 Gas Heating - Overtemperature ... 51

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1

9

Care and Maintenance... 52 9.1 Cleaning the Device PG150 ... 52 9.2 Maintenance Intervals... 52 9.3 Maintenance Carried out by Authorized Service Technician ... 52 9.4 Replacing the Fuse ... 53 9.5 Care and Maintenance of Reusable Tube Sets PG014 ... 54 9.5.1 Cleaning and Disinfecting PG014... 55 9.5.2 Sterilization of Reusable Tube Sets PG014... 57 9.6 Cleaning and Disinfection of the Foot Control PG124... 58

10

Annual Inspection ... 59 10.1 Electrical Safety Test... 59 10.2 Basic Function Test (in Standard Indication) ... 59 10.3 Pressure Sensor Test (in Standard Indication and Veress Mode) ... 60 10.4 Pressure Monitoring Test (in Standard Indication and Veress Mode) ... 60 10.5 Venting Valve Test ... 61 10.6 Device Maximum Pressure Test ... 61 10.7 Gas Flow Rate Test... 61

11

Electromagnetic Compatibility... 62 11.1 Impact of Mobile and Portable HF Communication Devices... 62 11.2 Electrical Connections... 62 11.3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 63 11.4 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 64 11.5 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Flow 50... 65

12

Error and Warning Messages... 66

13

Technical Data... 68 13.1 Technical Data PG150 ... 68 13.2 Technical Data Foot Control ... 70

14

Accessories ... 71

15

Glossary... 72

16

Appendix ... 73 16.1 Test Log... 73

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Index ... 74

2

Important User Notes

1

Important User Notes

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 staff or service personnel, or • to damage or malfunction of device and/or accessories.

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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

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

Please note

WARNING! Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

CAUTION! Indicates a possible threat of material damage. If not avoided, the product may be damaged.

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

3

Safety Information

2 Exclusion of liability

Safety Information

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, 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 schedule is not adhered to.

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The handing over of technical documents does not constitute authorization to make repairs or alterations to the device or accessories. WARNING: Modifying the device Flow 50 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.

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.

Disposal

4

The product must be prepared by the operator for disposal. When disposing or recycling the product or its components, make sure to comply with national rules and regulations at all times! A product labeled with this symbol must be disposed separately according to local rules about the waste collection of electrical and electronic devices. The disposal is carried out free by the manufacturer if within the European Union. Please contact your local B. Braun/Aesculap representative or distributor for additional information about the disposal of your product; see chapter 9 Care and Maintenance.

General Information

3

General Information

3.1

Device Description

The device Flow 50 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 maximum 30 mmHg (mm mercury column) and the flow rate to maximum 50 l/min. The device measures the actual pressure in the cavity and compares it with the set nominal pressure. The function of this device is to maintain the nominal pressure. Any overpressure within the cavity is lowered to the preset nominal pressure by the automatic venting system.

en Essential performance

The user and patient comfort can be increased by additional accessories: 1. Tube set with integrated gas heating to heat the insufflation gas. 2. Tube set with evacuation function to remove surgical smoke from the cavity. These functions are available when using the appropriate tubing sets; see chapter 5.2 Insufflation Tube Sets. 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.

3.2

Intended Use and Contraindications

NOTE! The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

For indications, see Intended use.

3.2.1

Intended Use

The device Flow 50 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 indications Standard, Bariatric and Pediatric of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric indication is indicated for pediatric laparoscopic procedures. Vessel Harvesting is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The Fieldflooding is indicated for use in open and endoscopically assisted cardiac surgery to displace ambient air from the surgical site.

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 insufflation procedures, i.e., it may not be used to distend the uterus.

5

General Information

3.3

Warnings

3.3.1

General CO2 Insufflation Warnings

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

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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. Refer servicing to qualified service technician.

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.

WARNING! Professional qualification This manual does not include descriptions or instructions for surgical procedures/techniques. It is also not suitable for training physicians in the use of surgical techniques. Medical accessories and devices may be used only by physicians and medical assistants under the direction of a physician with the appropriate technical qualification.

WARNING! 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.

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General Information

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

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WARNING! Reprocessing of sterile disposable products Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! Do not reprocess the product.

WARNING! Replacement device and accessories In case the device or any of the accessories fail during surgery, a replacement device and replacement accessories should be kept within close proximity to be able to finish the operation with the replacement components.

WARNING! Cleaning the device Do not sterilize the device.

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

WARNING! Positioning the patient Always position the patient lower than the device to prevent body fluids from leaking into the insufflation tube. Actual pressure may increase and fluid may penetrate the insufflation tube if the patient is repositioned during surgery. If this occurs, immediately disconnect the insufflation tube. When the patient is repositioned onto his or her side, internal tissue may block the insufflation channel. Always insufflate through the elevated side of the patient.

WARNING! Removing the insufflation tube Always disconnect the insufflation tube after each 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.

7

General Information

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.

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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 4.5.1 Connecting a Gas Bottle).

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.

WARNING! 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.

8

General Information

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.

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

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

WARNING! Visual inspection of the filter cassette Before the operation, perform a visual inspection of the filter cassette. Damaged filter cassette may not be used.

WARNING! Visual inspection Before the operation, perform a visual inspection of the insufflator and accessories. Damaged components may not be used.

WARNING! Check for damage Check all products used for the operation for damage before surgery. Replace them if necessary.

9

General Information

WARNING! Delay to operation, stress to patient/surgeons If you do not replace the smoke evacuation filter cassette, the smoke evacuation performance will (consequently) be insufficient, delaying the operation and stressing the patient/surgeon. Stop suction and replace smoke evacuation filter cassette if filter is exhausted.

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WARNING! Disposal Comply with hygiene rules and regulations when disposing of tube sets or smoke evacuation filter cassettes.

3.3.2

Warnings Standard and Bariatric Indications

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 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

10

General Information

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.

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

WARNING! Embolism/insufflation of internal organs Improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value. CO2 embolisms can also be caused by a high intra-abdominal pressure. Avoid high-pressure settings and close damaged blood vessels at once.

WARNING! 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 first 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 7 Menu). 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.

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General Information

3.3.3

Warnings Pediatric Indication

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).

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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! Only specially trained and qualified personnel may use this device on children.

WARNING! Increased airway pressure When laparoscopic procedures are performed on children, the increased intraabdominal 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.

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 pre-

12

General Information

warmed gas. The patient's body temperature has to be monitored at all times during surgery.

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

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

3.3.4

Warnings Vessel Harvesting Mode (Cardiac Indication)

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

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

WARNING! Embolism/insufflation of internal organs Improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in air or CO2 embolisms. To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value. CO2 embolisms can also be caused by a high intra-abdominal pressure.

13

General Information

Avoid high-pressure settings and close damaged blood vessels at once.

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

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WARNING! 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 Fieldflooding Mode (Cardiac Indication)

WARNING! A gas flow of 10 l/min should not be used longer than up to 30 seconds.

WARNING! When using accessories not specified in the user manual, make sure the CO2 is not directly applied to soft tissue focuses.

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 IEC 60601-2-18 and ISO 8600. Combining/connecting with other devices generates a medical electrical system (MES). The system configurator is responsible for compliance with the standard IEC 60601-1 / EN 60601-1 in its latest version.

CAUTION! Electrical Interference (See Chapter 11 Electromagnetic Compatibility). Care was taken during the development and testing of this device that electrical interference from this device or other devices or instruments was practically eliminated. However, if you still

14

General Information

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

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CAUTION! Replace the fuse Before replacing the fuse, make sure the values of the fuse to be inserted are in accordance with Chapter 13 Technical Data. Only use a fuse provided by the manufacturer (see Chapter 14 Accessories).

CAUTION! Service connection Access to the service menu is restricted to authorized service personnel.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! 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.

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 15 Glossary) as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.

CAUTION! In case of serious incident Please report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the State in which the user and/or patient is established.

15

Initial Device Set-up

4

Initial Device Set-up

The operation of the device Flow 50 is reserved for persons with the relevant professional qualifications and trained to use the device. NOTE! Locations The device is only to be used in a professional facility healthcare environment.

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4.1

Scope of Delivery

• PG150 Insufflator Flow 50 • TA014996 Instructions for use Delivery inspection

Always check all parts and optional 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.

Returning the device

Use the original packaging material if a device has to be returned. The manufacturer is not responsible for transport damages due to insufficient or unsuitable shipping 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 device (see type plate) • Detailed description of defect Technical service address: Aesculap Technical Service Am Aesculap-Platz D-78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 14-939 E- Mail: [email protected] Please contact the address above for additional service addresses.

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Initial Device Set-up

4.2

Device Setup and Connection

Place the device on a flat surface free of vibration located in a dry environment. The ambient temperature and humidity must meet the requirements mentioned in Chapter 13.1 Technical Data PG150.

Setting up

WARNING! ME System (Medical Electrical System) Use only parts and/or devices from ME systems (see Chapter 15 Glossary) in patient environments in compliance with the standard IEC60601-1 in the respective currently valid version.

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CAUTION! ME Device in Rack If it should be necessary to operate the device close to stacked with other devices, the ME device or ME system (see chapter 15 Glossary) should be monitored to ensure it works properly as configured.

CAUTION! ME systems The medical electrical (ME) device is suitable for integration in ME equipment systems (see Chapter 15 Glossary). Operation of the ME device in vicinity of nonME devices may result in voiding the intended use of the ME device.

CAUTION! Equipment should be positioned such that power cord can be easily disconnected.

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).

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

CAUTION! Place the device outside the sterile field.

CAUTION! User position To avoid a malfunction, the user must be positioned correctly • within a display viewing angle of ±50° to operate the device • up to 2 m from the device front for monitoring the actual values

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Initial Device Set-up

Mains connection

en

Ensure the connection data and 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 0100710). Read the device label located in rear of device (type plate) to determine the operating voltage of the device. CAUTION! Check to make sure the available mains voltage matches the data listed on the label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy 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.

Potential equalization

The equipotential bonding is used as a protective measure against the failure of the protective conductor according to requirements of IEC 60601-1 in the respectively valid version. The installation must be according to the relevant local safety regulations.

4.3 Fig. 4-1

Front of Device

Device front

(1)

ON/OFF switch

(2)

Monitor with touch screen

(3)

Foot control connection

(4)

Gas heater connection

(5)

Cassette for Smoke evacuation

(6)

Connection for insufflation tube set

(7)

Eject button

(1)

(2)

(3)

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

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

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