stryker Pneumo sure User Manual

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Manuel

Manual

Insufflator for Laparoscopy and Vessel Harvesting

2011/02 www.stryker.com 1000-401-015 Rev. E

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Some of the parts and equipment referred to in this manual bear registered trademarks but are not identified as such. It should therefore not be assumed that the absence of the trademark indicates that any given designation is not subject to trademark protection.

Users of this product should not hesitate to point out to us any errors or unclarities in this manual.

pia, microfilm u otros medios y procedimientos.

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STRYKER ENDOSCOPY agradecerá a los usuarios de los productos de STRYKER ENDOSCOPY cualquier aviso, indicación u observación con respecto a posibles fallos, incongruencias o explicaciones poco claras que puedan encontrarse en el presente manual.

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Produced for/Producido parar/Produit pour/Produzido para:

Stryker Endoscopy 5900 Optical Court, San Jose CA 95138 (USA) (408) 754-2000 (800) 624-4422 www.stryker.com

Stryker European Rep-

REP

RA/QA Manager ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex France

CE marking according to directive 93/42/EEC

Identificación CE conforme a la directriz 93/42/CEE

Marquage CE conforme à la directive 93/42/CEE

EDistintivo CE conforme a Directiva 93/42/CEE

Model: F114/1200628/10000002254 04/0211/ama

Symbols/Símbolos/Symboles/Símbolos

Symbols Símbolos Symboles Símbolos

See operating manual

Symbol for type BF

equipment

Symbol for potential

equalization

Degrees of protection

provided by enclosures

(IP-Code)

Alternating current

Service

Order number Número de pedido Référence produit Refêrencia

Single use only No reutilizable Usage unique Vedada a reutilização

¡Atención! Observe la

documentación adjunta

Símbolo para un aparato

del tipo BF

Símbolo para la cone-

xión equipotencial

Grado de protección

proporcionado por los

envolventes (Código IP)

Corriente alterna Courant alternatif Corrente alternada

Servicio Service Assistência

Attention, lire la docu-

mentation jointe!

Symbole pour un appa-

reil de type BF

Fiche équipotentielle

Degrés de protection procurés parles enve-

loppes (Code IP)

Atenção, atentar aos

documentos de expe-

dição

Símbolo para um apare-

lho do tipo BF

Sistema para a compe-

sação do potencial

Classificação do grau de

proteção oferecido

pelas carcaças (IP)

Sterile with ETO Esterilizado con ETO Stérilisés à l’ETO Esterilizado com ETO

Lot no.

Serial number Número de serie Numéro de série Número de série

Date of manufacture Fecha de fabricación Date of fabrication

Expiration day Utilizable hasta Date limite d’utilisation Utilizável até

Pieces, quantity Pieza, cantidad Pièces. quantité Número, quantida

Quantitiy Cantidad Quantité Quantida

Latex free Sin latex sans latex Isento de látex

Denominación

departida o lote

Numéro de lot Designação do lote

Data de fabricação

Number of autoclaving

cycles

Número de esteriliza-

ciones por autoclave

Paramètres pour la sté-

rilisation à l’autoclave

Número de esteriliza-

ções em autoclave

Symbols/Símbolos/Symboles/Símbolos

Symbols Símbolos Symboles Símbolos

Do not get wet

Top-Bottom Arriba-abajo Haut-bas Em cima-Em baixo

Fragile Frágil Fragile Frágil

Waste management Gestión de residuos Élimination des déchets Eliminação

Produced for Producido para Produit pour Produzido para

Start Start (Inicio) Start Start

Stop Stop (Parada) Stop Stop

Proteger contra la

humedad

Protéger de l’humidité Proteger da humidade

HEATING

REP

On/Off

Gas heater Calentador del gas Chauffage du gaz Aquecedor do gás

Gas heater error

Increase Aumento Croissant Aumento

Decrease Disminución Décroissant Descida

Forward to menu Remitir al menú Expédier au menu Enviar ao menu

Back to menu Volver al menú Retour au menu Voltar ao menu

Stryker European Repre-

sentative

Save Guardar Mémoriser Guardar

On/Off (Encendido/

Apagado)

Fallo en calentador del

gas

Representante europeo

de Stryker

On/Off (Marche /Arrêt) On/Off (Ligar/Desligar)

Erreur du chauffage du

gaz

Représentant Stryker

Europe

Erro no aquecedor do

gás

Representante Europeu

da Stryker

Exit Salida Sortie Saída

Menu - Increase Menú-Aumento Menu-Croissant Menu-Aumento

Symbols/Símbolos/Symboles/Símbolos

Symbols Símbolos Symboles Símbolos

Menu - Decrease Menú-Disminución Menu-Décroissant Menu-Descida

Real-Time Pressure Sensing in progress

Real-Time Pressure Sensing defective or deacti-

vated

House gas supply

Tank gas supply

Low gas pressure Presión de gas baja Pression de gaz basse Pressão de gás baixa

Gas pressure too low

Push to release Presione para retirar Appuyer pour retirer Premir para eliminar

Do not use if package

damaged

Real-Time Pressure Sen-

sing activada

Real-Time Pressure Sen-

sing defectuosa o

desactivada

Alimentación de gas

central

Alimentación por

botella de gas

Presión de gas dema-

siasdo baja

No utilizar si el envolto-

rio está dañado

Real-Time Pressure Sen-

sing activée

Real-Time Pressure Sen-

sing défectueuse ou

désactivée

Alimentation en gaz

centrale

Alimentation en gaz par

bouteille

Pression de gaz insuffi-

sante

Ne pas utiliser si

l’emballage est endom-

magé

Real-Time Pressure Sen-

sing activada

Real-Time Pressure Sensing danificada o desac-

tivada

Alimentação de gás

doméstico

Alimentação de gás

com uma botija de gás

Pressão de gás dema-

siado baixa

Não usar se a embala-

gem é danificada

Keep away from hea Proteger contra el calor

Authorized for Sale or

use by Physician only

Autorizado sólo para la

venta o el uso médico

Protéger contre la cha-

leur

Autorisé seulement

pour la vente ou l’utili-

sation par un médecin

uniquement

Proteger de encontro ao

calor

Autorizado somente

para a venda ou o uso

médico

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................................................................................................................................................................ 32

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................................................................................................................................................................ 41

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

8.6.3 "Real-Time Pressure Sensing" functionality (RTP) ........................................................................................................... 50

8.7 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 Ope-

rating 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 ..................................................................................... 54

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......................................................................................................................................... 56

9.6.1 Insufflation with Vessel Harvest Instrument................................................................................................................... 56

9.6.2 Stop the Insufflation................................................................................................................................................................ 57

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

13.2 Basic Function Test (in High Flow Operating Mode)...................................................................................................... 78

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 USA.................................................................................................................................................... 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

1Important User Notes

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.

technical data of the supplied product through continued product development.

marked with these words must be read especially attentively.

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.

Important User Notes

Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and

Please noteThe words DANGER, WARNING, and NOTE carry special meanings. Sections

NOTE! Here you will read information about the maintenance of the device or the ac-

cessories.

Safety Information

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 o rder of a p hysici an.

Exclusion of liability The manufacturer is not liable for direct or consequential damage and the war-

ranty 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.

Authorized service technician Only an authorized service technician may perform repairs, adjustments, or al-

terations 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.

Safety Information

2.1 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 re-

sponsible 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 deter-

mine 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 anes-

thetic gases are present.

WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device your-

self. Refer servicing to qualified service personnel.

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

WARNING! Professional qualification This manual does not include descriptions or instructions for surgical proce-

dures/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

Safety Information

technical qualification.

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 EC 60601-2-18 and ISO 8600.

3 Device Purpose

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.

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 proce-

dure.

Device Purpose

Intended useThe PNEUMO SURE High Flow Insufflator serves to create a cavity by insufflating

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 mmHg 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

Children between 1 and 3 years

Children between 3 and 4 years

Children between 4 and 14 years

approx. 1-9 kg 0.1 -0.5 l/min

approx. 10-15 kg 0.5 -1.0 l/min

approx. 16-19 kg 1.0 -2.0 l/min

> 20 kg > 2.0 l/min

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).

3.1.3 Using Bariatric Operating Mode

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

) adults. While in Bariatric mode, the insufflator limits the

3.1.4 Contraindications for Laparoscopy Applications

Contraindications The device may not be used to fill an abdomen with CO2 if a laparoscopy is con-

traindicated. 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 in-

strument 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 surgi-

cal 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 switch-

ing off the device to prevent backflow of bodily fluids. Fluid may penetrate the insufflation tube whenever you change the gas bottle and/or when you stop the gas flow during the operation. If this happens, you must immediately disconnect the insufflation tube from the trocar or from the device.

WARNING! Backflow Body secretions or contaminated gas may backflow into the device through the

insufflation tube if

• a filter is not used,

• the actual pressure is higher than the nominal pressure or

• the automatic venting valve is activated.

WARNING! Gas flow A high gas flow can occur due to large leaks within the surgical system or instru-

ment. 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 hav-

ing to interrupt surgery due to a lack of insufflation gas (see chapter 4.1.1 Connecting a Gas Bottle).

Device Purpose

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 qual-

ified 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-

Device Purpose

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

WARNING! Electronic device control Do not close the valve at the trocar sleeve during surgery. The electronic control unit of the device adjusts the actual pressure as desired.

WARNING! Medically pure CO2 Make sure to use only medically pure CO2. Other gases (i.e., helium, N2O, argon),

mixtures of gases, high pressure compressed gases, gases with entrapped liquids, or polluted gases must not be used with this device.

WARNING! Service connection 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 devic-

es 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 recom-

mended 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 new-

borns or patients weighing less than 25 kg (approx. 55 US pounds).

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

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 mm Hg. Pressure values above 15 mm Hg are required for only a few cases but do increase the risk of intravasation. Never exceed the max. intra-abdominal pressure of 30 mm Hg.

Device Purpose

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 in-

sufflation. 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

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).

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 en-

tire insufflation if additional sources are used.

WARNING! Automatic venting system Make sure the automatic venting system is activated (see chapter 10 Configura-

tion 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

reaction).

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 al-

ways 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 meta-

bolic 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

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).

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.

Initial Device Startup

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 anes-

thetic gases are present.

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 power supply cable must be plugged into a properly installed safety wall plug (see DIN VDE 0107). 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 orig-

inal 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 line, type SJT, mini-

mal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 or IEC 320/CEE22. 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 liq-

uids, 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.

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 bottles with riser pipe.

Initial Device Startup

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).

Operating the Device - General

5 Operating the Device - General

5.1 Front of the Device

Fig. 5-1 Device Front

(1) ON/OFF switch (2) Touch screen display (3) Insufflation tube connection

(1) (2) (3)

Fig. 5-2 Device Rear

(4) Type plate (5) Device data plate (6) SIDNE interface (optional) (7) Data input/output (8) Connection for potential equaliza-

tion

(9) Device plug (10) Fuse holder (11) Gas supply connection

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

5.2 Rear of the Device

(4) (5) (6)

(11) (9)(10)

(7) (8)

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

Operating the Device - General

5.3 Touch screen display

(1)

(15)

(14)

(13)

Set Pressure

mm Hg

Actual Pressure

mm Hg

GAS

Mode: High Flow

Change

Mode

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).

START

0.0

Liter

(4)(2) (3) (5)

Set Flow

l/min

HEATING

Actual

(6)

(7)

(8)

l/min

(9)(10)(11)(12)

Fig. 5-3 Screen displays

(1) Continuous pressure reading dis-

play

(2) Gas supply display (3) Actual pressure display (4) Gas consumption display/func-

tion 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 dis-

play/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.

bols and acoustic signals (see chapter 11 Safety functions for gas pressure display information).

> 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.

Gas supply displaysThe status of the gas supply is monitored by the device and indicated with sym-

Gas supply with gas bottleThe following gas bottle pressures are displayed:

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.

Operating the Device - General

House gas supply The following house gas supply pressures are displayed:

House gas supply pressure OK

(green)

House gas supply pressure too low

(red)

5.4 Switch on Device

1. Connect with mains power supply.

2. Connect the gas supply to the gas connection port and open the gas supply.

(2)

(3)

(1)

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

4. After being switched on, the device performs a device check. The touch screen

depicts the company logo as well as the lines PNEUMO SURE respectively PNEUMO SURE XL ->Device check ->Device OK is visible for 3 seconds after the successful completion of the device check. In case the device check failed and error message is displayed please see chapter 15 Error and Warning Messages for advises.

5. The display depicts an insufflation operating modes overview. Unavailable operating modes are depicted in gray and cannot be selected. Press the respective function field to select the corresponding desired operating mode (e.g. High Flow).

Operating the Device - General

5.5 Connecting Insufflation Tube Set

Three different insufflation tube set types can be connected to the insufflation tube connection at the front of the device (see Fig. 5-1 Device Front, page 16, (3)).

Heated tube set with Real-Time Pressure Sensing (RTP)

High Flow tube set with Real-Time Pressure Sensing (RTP)

High Flow II tube set Disposable (single use) insufflation tube set with:

Disposable (single use) insufflation tube set with:

• Filter

• Gas heating

• Measuring tube for direct pressure measurement (RTP)

Disposable (single use) insufflation tube set with:

• Filter

• Measuring tube for direct pressure measurement (RTP)

• Filter

connection at the front of the device until it snaps firmly into place.

• A short acoustic warning signal is emitted,

• the message Tube set connected is displayed,

• a check mark is displayed.

If the tube is accidentally unlatched by pressing twice or if the tube is removed during insufflation:

• 2 long acoustic warning signal are emitted,

• the message Tube set not connected is displayed,

Connecting the tube setInsert the plug of the insufflation tube set correctly into the insufflation tube set

Set Pressure

mm Hg

Actual Pressure

mm Hg

Change

Mode

0.0

GAS

Liter

Tube set connected

START

Set Flow

Actual

l/min

Operating the Device - General

Removing the tube set Press the plug of the insufflation tube in the direction of the device. This releases

the snap-in latch and you are now able to remove the insufflation tube set.

• 2 long acoustic warning signal are emitted,

• the message Tube set not connected is displayed,

5.6 Using the Gas Heating

Connecting the gas heating Use the heating tube to insufflate lukewarm gas (37° C).

1. Switch device on.

2. Connect an insufflation tube with gas heating (Heated tube set with RealTime Pressure Sensing (RTP).

The heating module is located directly in the insufflation tube.

Fig. 5-4 Connecting the gas heating

(1) Plug for insufflation tube with gas

heating

(2) Internal heating

(1)

(3) Insufflation tube (4) Measuring tube

(2)

(4)

(3)

CAUTION! Do not subject the heater tube to direct heat (e.g., operating room lamp, en-

doscop with light source) or high room temperatures.

Gas heating display The device automatically determines whether a tube set with or without gas

Set Pressure

mm Hg

Actual Pressure

mm Hg

Set Flow

l/min

heating is connected. The display depicts a symbol and the status line reads Gas heater OK after the successful detection of the corresponding tube set.

HEATING

Mode

High Flow

0.0

Liter

GAS

Gas heater OK

STOP

HEATING

Actual

l/min

Press the START function field. The gas is automatically heated to 37 °C.

2. Stopping gas heating: Press the STOP function field. Gas heating is switched off.

3. Pull the tube set plug from the device connection.

Operating the Device - General

Gas heating ON/OFF1. The gas heating is automatically started at the START of the insufflation:

Incorrect/defective heating tubeWhen a defective heating tube set is used,

• the display depicts a crossed out symbol

HEATING

•the text line reads Gas heater defective <-> Call service,

• and an acoustic signal is emitted (3 short beeps).

Insufflation can be continued in this case, but the heating function is not available.

caused for exemple by external heat sources. If the temperature sensor measures a temperature >42°C, the status field of the display depicts Gas tempera- ture >42 °C; 3 accoustic signals are emitted in addition, the HEATING symbol is crossed out . Insufflation and the heating function are halted. After 3 seconds, the display depicts Disconnect luer lock alternating with Cool down tube until

HEATING

the insufflation is manually restarted.

WARNING! Unplug the cable of the heating tube from the device if the temperature sensor measures a gas temperature exceeding >42 °C. Hot gas in the abdomen can lead

to serious injuries.

1. Disconnect the insufflation tube from the trocar or Veress needle.

2. Press the START function field. The device insufflates without heating the gas.

3. Let hot gas escape until the tube is only warm to the touch and then reconnect the device again.

4. Continue surgery without gas heating.

Set Pressure

Actual Pressure

mm Hg

Gas heater defective

Change

Mode

mm Hg

0.0

Liter

GAS

START

HEATING

Set Flow

Actual

l/min

Gas temperature exceeds 42 °CThe device is equipped with a temperature sensor to protect against overheating,

Set Pressure

mm Hg

Actual Pressure

Cool down tube

Change

Mode

mm Hg

0.0

Liter

GAS

START

HEATING

Set Flow

Actual

l/min

and back on after approx. 10 seconds have expired. Gas heating is reactivated.

2. Should the error message be displayed again, you can continue using the device without gas heating by observing the risks for hypothermia.

3. Call an authorized service technician to check/fix the gas heating.

5.6.1 Using the direct pressure measurement function (Real-Time

Pressure Sensing RTP)

The insufflation tube sets "Heated tube set with Real-Time Pressure Sensing (RTP)" and "High Flow tube set with Real-Time Pressure Sensing (RTP)" are equipped with a sensor line which enables continuous measuring of the abdominal pressure. The insufflation line must be connected to one trocar and the measuring line (sensor line) to a second trocar. This set-up enables the PNEUMO SURE XL High Flow Insufflator to directly measure the actual abdominal pressure while in High Flow-, Pediatric- and Bariatric operating mode. The "Real-Time Pressure Sensing" is deactivated during the Vessel Harvest operating mode. The use of an insufflation tube without a second measurement/sensor line only allows the intermittent measuring of the pressure.

Insufflation is initially always started intermittently. Availability of the "Real-

Check gas heating after surgery1. Check gas heating after surgery using a different tube. Turn the device off

Pull apart at seam as much as needed

at second trocar

at insufflation trocar

Operating the Device - General

Time Pressure Sensing" functionality is checked automatically. If this is the case, the device switches to a continuous mode. This is indicated by the corresponding symbol on the display:

The symbol is removed if continuous pressure measurement is currently not possible or if insufflation is stopped.

CAUTION! A closed, obstructed or disconnected pressure sensing line will disable the real-

time pressure sensing function. In this case the device will operate in the conventional intermittent insufflation mode.

Error detection and monitoring of the "RealTime Pressure Sensing (RTP)" function

The continuous pressure measurement function is verified during the initial device self check. Should a defect within the measuring system be detected, three acoustic warning signals are emitted. The symbol is crossed out and the status line reads as follows: RTP defective / Call Service.

A detected defect within continuous pressure measurement does not generally hinder use of the device, however without the RTP function. Disconnect the measuring channel and perform the surgery in the intermittent insufflation mode. The acoustic warning on the defective RTP will be emitted with every activation/ deactivation of the insufflation as long as the pressure measurement function remains defective.

CAUTION! Do not attach a trocar to the pressure measurement / sensor line if the message "RTP defective / Call Service" is displayed. Perform surgery only in the conven-

tional intermittent insufflation mode without using the real-time pressure sensing function.

In case of a closed sensor line or with pressure on the sensor or the insufflation line during the initial device self check the real-time pressure sensing function will not be activated and the will be crossed out. Three acoustic warning signals are emitted, the status line readsas follows: RTP deactivated. The device can be operated in the conventional intermittent insufflation mode. In order to activate the RTP function the sensor line must be cleared, possible pressure released and the device rebooted by turning it off and back on.

Leakage detection with function "RealTime Pressure Sensing (RTP)"

CAUTION! When working with a tube set permitting the use of the RTP function, please

make sure that both lines are open upon activation of the device and there is pressure neither on the sensor line nor on the insufflation line. Otherwise the real-time pressure sensing function (RTP) will not be recognized and activated during the initial device self check.

In case of an occlusion or a leakage in the sensor line during insufflation the device will automatically switch from the RTP operating mode into the conventional intermittent insufflation mode.

If the system detects a leak at the RTP connection regardless of the insufflation mode:

• 2 long acoustic warning signal are emitted,

•the RTP symbol is no longer depicted,

• the message Check/change tube set is displayed,

• the usual intermittent pressure measuring is enabled again,

• the function of the occlusion detection is disabled.

5.6.2 Displaying/Selecting Insufflation Operating Mode

The device can be equipped with up to 4 procedure modes. Procedure options can be released or uploaded in different combinations depending on the order or software upgrade.

PNEUMO SURE High Flow operating mode / Pediatric operating mode PNEUMO SURE XL High Flow operating mode / Pediatric operating mode /

Bariatric operating mode / Vessel Harvest operating mode

Set Pressure

mm Hg

Operating the Device - General

Actual Pressure

mm Hg

Set Flow

l/min

1. Control or selection of the insufflation modes can be done only while insufflation is stopped. Press the function field for 2 s to change the insufflation operating mode.

2. The display depicts an insufflation operating modes overview. Unavailable operating modes are depicted in gray and cannot be selected. Press the respective function field to select the corresponding desired operating mode (e.g. Pediatric).

3. After pressing the function field for the insufflation operating mode, the display depicts the selected procedure (e.g. Pediatric operating mode). The displayed parameters correspond with the factory settings or the values set in the Configuration menu (see chapter 10.1 Configuration menu I, page 60).

5.6.3 Setting the Nominal Pressure - General

Press the function fields  or  on the display below the text line Set Pressure to set the nominal pressure.

Applies to all modes:

• The nominal pressure can be increased or decreased during insufflation or

while insufflation is stopped.

• With every touch of the pressure function field  or  the nominal pressure is

increased/reduced in steps of 1 mm Hg. When pressing the pressure function field  or  longer than 1,5 seconds, scrolling is activated but only up to the respective, application-dependent safety threshold. Once this limit has been reached, the status line depicts the message Safety limit and the actual value flashes. To allow settings above the safety threshold release the pressure function field for 2 seconds. The display switches back to the status display. Now it is possible to increase the pressure above the safety threshold but only to the next safety threshold (as far as existent) or to the maximum setting.

• The latest working settings are stored with interruption of the insufflation, but

only if the last value was below the lowest safety threshold (15 mm Hg for High

Flow and Bariatric operating mode, 12 mm Hg with Pediatric operating mode and Vessel Harvest operating mode). Otherwise the set pressure value is reset

to the lowest safety threshold upon deactivation of insufflation.

• The latest settings are reset to the values preselected in the Configuration

menu when deactivating the device or when changing into the Configuration menu or the Mode Selection menu. Upon choice of the respective working

mode the nominal settings as stored in the Configuration menu are displayed (see chapter 10.1 Configuration menu I, page 60).

(1)

(2)

Mode: High Flow

Change

Mode

START

GAS

Actual

l/min

0.0

Liter

5.6.4 Setting the Nominal Flow - General

Press the function fields  or  on the display below the text line Set Flow to set the nominal flow.

Applies to all modes:

Operating the Device - General

• The nominal flow can be increased or decreased during insufflation or while insufflation is stopped.

• With every touch of the flow function field  or  the nominal flow is increased/reduced in steps of 1 l/min. When working within the range of 0.1 to 1 l/min in Pediatric mode, the value is increased/reduced 0.1 l/min. When pressing the flow function field  or  longer than 1.5 seconds, scrolling is ac- tivated but only up to the respective, application-dependent safety threshold. Once this limit has been reached, the status line depicts the message Safety limit and the actual value flashes. To allow settings above the safety threshold release the function field for 2 seconds. The display switches back to the status display. Now it is possible to increase the flow above the safety threshold but only to the next safety threshold (as far as existent) or to the maximum setting.

• The latest working settings are stored with interruption of the insufflation, but only if the last value was below the lowest safety threshold (5l/min for Pedi- atric operating mode and 6l/min for Vessel Harvest operating mode). Other- wise the set flow value is reset to the lowest safety threshold upon deactivation of insufflation.

• The latest settings are reset to the values preselected in the Configuration menu when deactivating the device or when changing into the Configuration menu or the Mode Selection menu. Upon choice of the respective working mode the nominal settings as stored in the Configuration menu are displayed (see chapter 10 Configuration Menu (Overview), page 58).

• The flow safety thresholds can be deactivated in the Configuration menu.

5.6.5 Gas Consumption Display

The gas consumption display depicts the insufflated volume of the gas in liters since the last "resetting" of the display. The display indicates values between 0.0 liter and 9.9 liter in increments of 0.1 and between 10 liter to 999 liter in increments of 1.

Resetting the display The gas consumption display can be reset to 0.0 while insufflation is started as

well as stopped. Press the gas consumption display/function field to reset the gas consumption display.

5.6.6 Starting/Stopping Insufflation

The START or STOP function field is displayed differently depending on operating status.

Set Pressure

mm Hg

Mode: High Flow

Change

Mode

Actual Pressure

mm Hg

0.0

Liter

GAS

START

Set Flow

Actual

l/min

Start insufflation:

The START function field is displayed while insufflation is stopped. Press this field to start insufflation.

The status display depicts the selected insufflation mode (e.g. Mode: High Flow). The insufflation mode display depicts Change Mode.

Start insufflation by pressing the START function field.

Activated insufflation:

The status line depicts Insufflation and the name of the selected insufflation mode (e.g. Insufflation: High Flow or Veress insufflation).

The frames around the insufflation mode display and the actual gas flow (menu access) are hidden. This signals that these function fields are inactive during this state.

The insufflation mode display depicts the selected mode (e. g. Mode: High Flow).

Stop insufflation:

The STOP function field is displayed while insufflation is active.

Stop insufflation by pressing the STOP function field.

The status line depicts Insufflation stopped followed by the selected mode (e.g. Insufflation: High Flow) alternating with Push to release. The insufflation mode display depicts Change Mode.

In case the tube set connection is lost, the insufflation stops and the display depicts Insufflation stopped ->Mode: High Flow <->Tube not connected.

Operating the Device - General

The device depicts the same message if a tube set has not been connected or has not been inserted correctly and the START function field has been pressed. In this case the insufflation will not be started. Please insert a tube set or check the tube set connection.

5.6.7 Using the SIDNE Port (Optional)

The SIDNE Port allows connection to the SIDNE control system. When connected, all of the functions and settings of the insufflator can be:

• controlled with SIDNE voice and pendant commands; and

• displayed on the SIDNE video overlay and pendant.

The physician(s) and support personnel must be thoroughly familiar with the setup and operation of the SIDNE. Please refer to the SIDNE documentation for the proper setup, use and troubleshooting. When SIDNE is connected and active, the functions and settings of the insufflator may simultaneously be adjusted using the buttons on the front panel and the SIDNE.

5.6.8 Turning Device Off

Use the ON/OFF switch to turn the device off. The device is turned off.

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

6 Using and Controlling the PNEUMO SURE High Flow Insuf-

flator in High Flow Mode

Intended use The PNEUMO SURE High Flow Insufflator serves to create a cavity by insufflating

CO2 during diagnostics and/or therapeutical laparoscopy. High Flow operating mode is designed explicitly for laparoscopies performed on normal weight and slightly obese (BMI < 30 kg/m 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 either continuously or at short intervals and constantly 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.

Contraindications The device may not be used to fill an abdomen with CO2 if a laparoscopy is con-

The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos.

) patients over the age of 14. While in High Flow

6.1 Device-Specific Dangers when Using the PNEUMO SURE High

Flow Insufflator in High Flow Operating Mode

WARNING! Idiosyncratic reactions Patients with sickle cell anemia or pulmonary insufficiency may have a higher

risk of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reaction).

WARNING! CO2 absorption CO2 is absorbed during insufflation (intravasation). This means the body absorbs part of the CO2 gas used for insufflation. CO2 concentrations in the blood or re-

spiratory 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 mm Hg. Pressure values above 15 mm Hg are required for only a few cases but do increase the risk of intravasation. Never exceed the max. intra-abdominal pressure of 30 mm Hg.

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 in-

sufflation. Hypothermia during insufflation can cause heart and cardiovascular

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

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

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 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 en-

tire insufflation if additional sources are used.

WARNING! Please read the general risks and dangers information in chapter 2.1 Hazards,

page 5 and chapter 3.3 General Device-Inherent Dangers, page 8.

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

(1)

Set Pressure

mm Hg

Mode: High Flow

Change

Mode

(2)

Actual Pressure

mm Hg

0.0

Liter

GAS

START

Set Flow

Actual

l/min

6.2 Selecting High Flow Insufflation Mode

1. Selection of the insufflation mode can be done only while insufflation is

stopped. If High Flow operating mode is not yet set and displayed, press the function field Change Mode for 2 seconds to get the insufflation mode overview.

2. The display depicts the different insufflation operating modes that can be ac-

tivated. Select the desired insufflation operating mode by pressing the High Flow function field. *Inactive operating modes are displayed in gray.

3. The procedure profile is depicted on the display. The displayed parameters

correspond with the factory settings or the values set in the Configuration menu (see chapter 10.1 Configuration menu I, page 60).

l/min

Set Pressure

mm Hg

Mode: High Flow

Change

Mode

Actual Pressure

mm Hg

0.0

Liter

GAS

START

Set Flow

Actual

l/min

6.3 Presetting Nominal Pressure in High Flow Operating Mode

The nominal pressure can be set during insufflation or while insufflation is stopped. Values may range from 1 to max. 30 mm Hg or the value set in the Configuration menu.

Increasing/decreasing nominal pressure:

Briefly press the  or  function field to increase or decrease the pressure. Keeping the  or  function field depressed longer than 1.5 seconds activates scrolling in increments of 1.

Safety limit:

When increasing the nominal pressure, the status line of the display depicts Safety limit when reaching a value of 15 mm Hg. The nominal pressure 15 mm Hg is

a threshold value. This is where the recommended range for the intra-abdominal pressure ends. Pressing the nominal pressure function field again does not increase the pressure any further. Release the function field for 2 seconds. Now you can set a value up to 30 mm Hg.

CAUTION! Exceeding this safety limit is to be decided by and the responsibility of the user/ operator.

6.4 Presetting Nominal Flow in High Flow Operating Mode

The nominal flow can be set during insufflation or while insufflation is stopped.

1. Briefly press the  or  function field to increase or decrease the flow. The

nominal flow can be increased from 1 to max. 40 l/min.

• Briefly press the corresponding field to set values in increments of 1.

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

• Keeping the  or  function field pressed longer than 1.5 seconds activates scrolling through the gas flow rates 3, 20, 40 l/min or 40, 20, 3 l/min.

2. The preset values of the Configuration menu can be changed individually (see chapter 10.1 Configuration menu I, page 60). Select a nominal gas flow between 1-40 l/min. The preset value is indicated in the nominal gas flow display. The values for the nominal gas flow refer to a device without connected tube, filter, or instrument. Tube, filter, and instrument can reduce the gas flow.

The device monitors the gas flow in two different operating modes depicted in the status line with the following messages:

• Veress insufflation (1-5 l/min)

• Insufflation: High Flow (6-40 l/min)

Veress insufflation operating mode:

Veress insufflation is a gentle type of insufflation so that the actual pressure

does not exceed the preset pressure even in case of small volumes. To minimize the risks in case of a faulty incision, the manufacturer recommends using Veress

insufflation to start a procedure (filling abdomen with CO2).

CAUTION! Please note that the automatic venting system is not active during Veress insuf-

flation mode.

Set Pressure

mm Hg

Mode: High Flow

Change

Mode

Actual Pressure

mm Hg

0.0

Liter

GAS

START

Set Flow

Actual

l/min

Insufflation: High Flow

While Insufflation: High Flow any pressure loss due to leaks can be quickly equalized. The APC Technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. In case of large volumes, the actual pressure does not exceed the nominal pressure (see chapter 11 Safety functions, page 70).

Start the device by pressing the START function field.

With a nominal flow setting of < 6 l/min Veress insufflation is displayed. Above 5l/min Insufflation: High Flow) is displayed.

Stop the device by pressing the STOP function field.

NOTE! Tube, filter, and instrument can reduce the gas flow.

6.5 Performing the Function Test in High Flow Operating Mode

Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

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

PreparationSterilize reusable instruments and tubing before surgery to prevent infections.

WARNING! The function test must be performed prior to each surgical procedure.

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

Testing the device

Fig. 6-1 Layout for testing the device

(1) ON/OFF switch (2) Nominal pressure display (3) START/STOP function field (4) Gas consumption display (5) Nominal flow display (6) Insufflation tube set (7) Stopcock (valve) (8) Veress cannula

1. The device is switched off, no tube set is connected.

2. Make sure the gas supply is connected and open.

3. Use the ON/OFF switch (1) to turn the device on. The device conducts a device check.

4. Select High Insufflation operating mode in the insufflation mode selection.

5. Connect an original insufflation tube set (6) to the device.

6. Attach the insufflation tube to the Veress cannula (8).

7. Attach the stopcock (valve) to the Veress cannula (7).

8. If the gas consumption display function field does depict a value, press the (4) function field to reset the display to 0.

9. Select the nominal pressure 15 mm Hg (2) and the gas flow 3 l/min (5).

10. Start insufflation: Press the START function field (3).

11. The display status line depicts Occlusion after max. 4 seconds.

12. Stop insufflation: Press the STOP function field (3).

(1) (2) (3) (4) (5) (6)

(8)

(7)

WARNING! If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If

this happens, use steps 13 to 15 outlined below to locate the leak.

13. Repeat items 7 to 11 without Veress cannula and with closed tube end. The previously connected Veress cannula has a leak if gas consumption is now below 0.4 l.

14. Repeat items 8 to 12 without Veress cannula and without tube if another leak becomes apparent. Close the end of the insufflation tube connection for this test. If the gas consumption is then below 0.4 l, the previously used tube set has a leak.

15. If another leak is detected, this leak is then directly within the device. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

WARNING! Never work with a leaky insufflation tube, accessory, and/or device. This can lead to an incorrect measurement of the actual pressure values, which can cause

an uncontrolled pressure increase in the abdomen.

Testing gas heating functionality The functionality of the gas heating is indicated by displaying the gas heating

symbol on the display when using the "Heated tube set with RTP for Pneumo

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

Sure".

1. Connect the corresponding tube set ("Heated with Real-Time Pressure Sensing" or "High Flow with Real-Time Pressure Sensing").

2. Insufflation is initially always started intermittently. Availability of the "RealTime Pressure Sensing" functionality is checked automatically. If this is the case, the device switches to a continuous mode. This is indicated by the corresponding symbol on the display.

6.5.1 Filling Tube System with CO2

At least 1 l of CO2 has to be let out from the system before every surgery while the tube is connected and the end of the tube is open. This will expel any air within the tube system and the device.

1. Start insufflation: Press the START function field. Wait until the gas consumption display shows 1.0 Liter.

2. Stop insufflation: Press the STOP function field.

3. Press the gas consumption display field to reset the gas consumption display to 0.0 Liter. This ensures the gas consumption is correctly displayed during surgery.

The function test is complete. The device is tested and ready to be used for surgery.

"Real-Time Pressure Sensing" functionality (RTP)

WARNING! Do not use this device if a defect is suspected or detected during the function check. This also applies to obvious defects, especially defects on the power plug

and power cable.

6.6 Using the Device during Surgery

WARNING! The function test must be performed prior to each surgery.

CAUTION! The venting system is automatically triggered (not during Veress mode and not

if the venting valve has been deactivated in the Configuration menu) if the measured actual pressure exceeds the set nominal pressure during insufflation. The device interrupts insufflation and releases gas until the actual pressure has dropped below the set nominal value.

1. The device is turned on.

2. An insufflation tube set is connected.

6.6.1 Insufflating with Veress Cannula

Using the device during surgery

On delivery from the factory, following values are set for High Flow operating mode:

• a gas flow value of 3 l/min and

• Veress insufflation for insufflation through the Veress cannula.

CAUTION! Up to 5 l/min Veress insufflation is set automatically. Please note that the automatic venting system is not active during Veress insufflation operating mode

(the venting valve is switched off automatically). The gas transport through the

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

device is also specifically customized for use with a Veress cannula.

WARNING! This manual does not include instructions for the safe use of the Veress cannula. Only when you have ensured endoscopically that an aeroperitoneum can be gen-

erated, should a gas flow of more than 3 l/min and a pressure of more than 10 mm Hg be selected. Insert the Veress cannula into the abdomen. Check to see if the Veress cannula is correctly positioned in the abdomen.

1. Attach the insufflation tube to the Veress cannula.

2. Select the desired nominal pressure and nominal gas flow.

3. Start insufflation: Press the START function field.

Check the actual pressure display and the gas consumption display.

6.6.2 Insufflating with the Trocar

1. Insert the trocar into the abdomen.

2. Connect the Luer Lock connection of the insufflation tube to the trocar.

3. Make sure the trocar is correctly positioned in the abdomen. Then select the desired pressure and desired gas flow as intraoperative conditions.

4. The actual pressure display shows the current measured value for insufflation. As soon as this value approximates the selected nominal value, the gas flow is automatically minimized. The gas consumption display shows the volume of gas consumed.

5. Check how the patient's body reacts to the selected pressure and gas flow rate. Compare the abdominal filling rate to the selected nominal pressure. You can change the nominal gas flow and the nominal pressure during surgery without interrupting the insufflation process.

6.6.3 "Real-Time Pressure Sensing" functionality (RTP)

To use the "Real-Time Pressure Sensing" (RTP) please use a tube set with measuring line. The Luer Lock connection of the measuring tube has to be connected to another trocar placed during the surgery. This enables the continuous measuring of the pressure (see 5.5 Connecting Insufflation Tube Set, page 19 and 5.6.1 Using the direct pressure measurement function (Real-Time Pressure Sensing RTP), page 21).

CAUTION! Make sure the stopcock (valve) of the trocar is fully opened and that both tube connections are connected to different trocars.

6.6.4 Stop the Insufflation

1. Press the STOP function field. The following values are displayed:

• Gas consumption display: last measured value

• Actual pressure: current measured value

• Actual gas flow: 0 l/min

• Nominal pressure: last set value In case of exceeding the safety limit, the

nominal pressure value will be reset to the safety limit value.

• Nominal gas flow: last set value The status field of the display depicts Insufflation stopped followed by Mode:

High Flow alternating with Push to release.

2. Remove the tube set from the device. Observe applicable hygiene regulations when disposing of the tube set.

CAUTION! If the tube set remains connected to the device, there is the danger that leftover

Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode

fluid in the tube or the instruments will be sucked into the device.

3. Close the gas supply.

4. Use the ON/OFF switch to turn the device off.

NOTE! Observe applicable hygiene regulations when disposing of the tube set.

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

7 Using and Controlling the PNEUMO SURE High Flow Insuf-

flator in Pediatric Operating Mode

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. 20mm Hg and the gas flow rate to max. 20l/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 All children < 25 kg < 14.0 l/min

Contraindications The device may not be used to fill an abdomen with CO2 if a laparoscopy is con-

The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos.

7.1 Device-Specific Dangers when Using the PNEUMO SURE High

Flow Insufflator in Pediatric Operating Mode

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

for the endoscopic vessel harvesting procedure.

WARNING! Gas flow limit The gas flow may not exceed 14 l/min when performing a laparoscopy on new-

borns or patients weighing less than 25 kg (approx. 55 US pounds).

WARNING! Recommended work settings The flow values listed above for laparoscopic procedures performed on new-

borns, infants, and children are only suggested values. The selection of the suitable flow and pressure values is solely the responsibility of the attending physician. However, adhering to the values listed above ensures an optimal performance of the Pediatrich operating mode of the insufflator.

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

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

WARNING! Increased airway pressure When laparoscopic procedures are performed on children, the increased intra-

abdominal pressure also increases the risk for higher airway pressures. Always strictly monitor respiration and airway function when performing laparoscopic procedures on children younger than 12 years of age.

WARNING! Compression of the vena cava When insufflating the abdomen of a child with medical CO2, an increased risk of

compressing the vena cava exists. This risk can be reduced by monitoring the systolic and diastolic blood pressure during the entire surgery.

WARNING! Haemodynamic stability 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 haemodynamic system. It is recommended to increase the breathing rate of the patient and to work with low flow values and pressure values not exceeding 12 mm Hg. The patient' circulatory system should be monitored at all times.

WARNING! Hypothermia The insufflation gas flow usually drops significantly after the target pressure has

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

WARNING! Device-inherent dangers Please read the general risks and dangers information in chapter 2.1 Hazards,

page 5 and chapter 3.3 General Device-Inherent Dangers, page 8.

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

(1)

(2)

7.2 Selecting Pediatric Operating Mode

1. Selection of the insufflation mode can be done only while insufflation is stopped. If Pediatric operating mode is not yet set and displayed, press the function field Change Mode for 2 seconds to get the insufflation mode overview.

2. The display depicts an insufflation modes overview. Select the desired insufflation operating mode by pressing the Pediatric function field.

3. The procedure profile is depicted on the display. The displayed parameters correspond with the factory settings or the values set in the Configuration menu (see chapter 10 Configuration Menu (Overview), page 58).

7.3 Presetting Nominal Pressure in Pediatric Operating Mode

The nominal pressure can be set during insufflation or while insufflation is stopped. Values may range from 1 to max. 20 mm Hg or the value set in the Configuration menu.

Increasing/decreasing nominal pressure:

Briefly press the  or  function field to increase or decrease the pressure. Keeping the  or  function field depressed longer than 1.5 seconds activates scrolling in increments of 1.

Select a nominal pressure value between 1 and 20 mm Hg. The preset value is indicated in the nominal pressure display.

Safety limit:

When increasing the nominal pressure, the status line of the display depicts Safety limit starting at 12 mm Hg and the nominal value flashes.

The nominal pressure value 12 mm Hg is a limit value and should not be exceeded for newborns if at all possible. Pressing the nominal pressure  function field again does not increase the pressure any further.

CAUTION! Exceeding this safety limit is to be decided by and the responsibility of the user/

operator.

Release the function field at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 15 mm Hg. The nominal pressure 15 mm Hg is a limit value. This is where the recommended range for

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

the intra-abdominal pressure ends. Pressing the nominal pressure ºfunction field again does not increase the pressure any further. The status line of the display depicts Safety limit and the nominal value flashes.

Release the function field at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 20 mm Hg.

7.4 Presetting Nominal Flow in Pediatric Operating Mode

The nominal flow can be set during insufflation or while insufflation is stopped.

Reducing nominal gas flow:

Press the nominal gas flow function field  to reduce the nominal gas flow. The nominal gas flow is decreased in the range of

• 0.1 l/min to 2 l/min in increments of 0.1 l/min.

• 2 l/min to 20 l/min in increments of 1 l/min.

Keeping the  function field depressed longer than 1.5 seconds activates scrolling.

• In the range of 0.1...2 l/min, rounding down to 1 or 0.1 l/min is applied.

• In the range of 2...20 l/min in increments of 1.

The nominal flow can be set during insufflation or while insufflation is stopped.

Set Pressure

mm Hg

Change

Mode

Actual Pressure

mm Hg

283

Liter

GAS

Safety limit

START

Set Flow

0.1

Actual

l/min

Increasing nominal gas flow:

Press the nominal gas flow function field  to increase the nominal gas flow. The nominal gas flow is increased in the range of

• 0.1 l/min to 2 l/min in increments of 0.1 l/min.

• 2 l/min to 20 l/min in increments of 1 l/min.

Keeping the  function field depressed longer than 1.5 seconds activates scrolling.

• In the range of 0.1 l/min...<2 l/min, rounding up to 1 or 2 l/min is applied.

• Then in one-step increments down to 20 l/min.

Safety limit:

When increasing the nominal flow, the status line of the display depicts Safety limit starting at 5 l/min and the nominal value flashes. (This safety limit can be

activated or deactivated in the Configuration menu).

Release the function field to increase the nominal gas flow further. The display switches back to the nominal value setting after 2 seconds. Now you can set a value of up to 20 l/min.

WARNING! Exceeding this safety limit is to be decided by and the responsibility of the user/

operator.

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

Veress insufflation operating mode:

The device monitors the gas flow in two different operating modes:

• Veress insufflation (≤ 1 l/min)

• Insufflation: Pediatric (> 1 l/min)

Veress insufflation Veress insufflation is intended for the gentle development of a pneumoperitone-

um. The nominal gas flow emitted by the device in this case is very low (in the range of 0.1 l/min to 1 l/min).

To minimize the risks in case of a faulty incision, the manufacturer recommends using Veress insufflation to start a procedure (filling abdomen with CO2).

Start the device by pressing the START function field.

CAUTION! Please note that the automatic venting system is only active during the Veress

insufflation mode if "In Veress insufflation ON" has been set in the configuration menu (only possible in Pediatric operating mode, see chapter 10 Configuration Menu (Overview), page 58).

Venting system "In Veress insufflation OFF"

With a nominal flow setting of ≤ 1 l/min, Veress insufflation is displayed in the status line after pressing the Start/Stop switch.

Above 1 l/min, Insufflation: Pediatric is displayed.

Venting system "In Veress insufflation ON"

With this setting, after pressing the START function field Insufflation: Pediatric is displayed, even if the nominal flow is set to ≤ 1 l/min.

Insufflation: Pediatric While Insufflation: Pediatric any pressure loss due to leaks can be quickly equal-

ized. The APC Technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure.

NOTE! Tube, filter and instrument can reduce the gas flow.

7.5 Performing the Function Test in Pediatric Operating Mode be-

fore Using the Device during Surgery

Preparation Sterilize reusable instruments and tubing before surgery to prevent infections.

Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

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

WARNING! The function test must be performed prior to each surgical procedure.

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

(1) (2) (3) (4) (5) (6)

(8)

(7)

1. The device is switched off, no tube set is connected.

2. Make sure the gas supply is connected and open.

3. Use the ON/OFF switch (1) to turn the device on. The device conducts a device check.

4. Select Pediatric operating mode in the insufflation mode selection.

5. Connect an original insufflation tube set (6) to the device.

6. Attach the insufflation tube to the Veress cannula (8).

7. Attach the stopcock (valve) (7) to the Veress cannula.

8. If the gas consumption display function field does depict a value, press the

(4) function field to reset the display to 0.

9. Select the nominal pressure 8 mm Hg (2) and the gas flow 2 l/min (5).

10. Start insufflation: Press the START function field (3).

11. Insufflate for approx. 30 s. The display status line depicts Occlusion after max. 4 seconds.

12. Stop insufflation: Press the STOP function field (3).

Testing the device

Fig. 7-1 Layout for testing the device

(1) ON/OFF switch (2) Nominal pressure display (3) START/STOP function field (4) Gas consumption display (5) Nominal flow display (6) Insufflation tube set (7) Stopcock (valve) (8) Veress cannula

WARNING! If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If this happens, use steps 13 to 15 outlined below to locate the leak.

13. Repeat items 7 to 11 without Veress cannula and with closed tube end. The previously connected Veress cannula has a leak if gas consumption is now below 0.4 l.

WARNING! Never work with a leaky insufflation tube, accessory, and/or device. This can

lead to an incorrect measurement of the actual pressure values, which can cause an uncontrolled pressure increase in the abdomen.

Testing gas heating functionalityThe functionality of the gas heating is indicated by displaying the gas heating

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

symbol on the display when using the "Heated tube set with RTP for Pneumo Sure".

"Real-Time Pressure Sensing" functionality (RTP)

1. Connect the corresponding tube set ("Heated with Real-Time Pressure Sensing" or "High Flow with Real-Time Pressure Sensing").

7.5.1 Filling Tube System with CO2

At least 1 l of CO2 has to be let out from the system before every surgery while the tube is connected and the end of the tube is open. This will expel any air within the tube system and the device.

1. Start insufflation: Press the START function field. Wait until the gas consumption display shows 1.0 Liter.

2. Stop insufflation: Press the STOP function field.

3. Press the gas consumption display field to reset the gas consumption display to 0.0 Liter. This ensures the gas consumption is correctly displayed during surgery.

The function test is complete. The device is tested and ready to be used for surgery.

WARNING! Do not use this device if a defect is suspected or detected during the function

check. This also applies to obvious defects, especially defects on the power plug and power cable.

Using the device during surgery

7.6 Using the Device during Surgery

WARNING! The function test must be performed prior to each surgery.

CAUTION! The venting system is automatically triggered (not during Veress mode and not

1. The device is turned on.

2. An insufflation tube set is connected.

7.6.1 Insufflating with Veress Cannula

On delivery from the factory, following values are set for Pediatric operating mode:

• a gas flow value of 0.1 l/min and

• Veress insufflation for insufflation through the Veress cannula.

CAUTION! Please note that with flow values up to 1 l/min the Veress insufflation operating

mode is automatically activated (the venting valve is switched off). The gas

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

transport is also specifically customized for use with a Veress cannula.

WARNING! This manual does not include instructions for the safe use of the Veress cannula. Only when you have ensured endoscopically that an aeroperitoneum can be gen-

erated, should a gas flow of more than 3 l/min and a pressure of more than 10 mm Hg be selected (see corresponding setting for children, chapter 3.1.2 Using Pediatric Operating Mode, page 7). Insert the Veress cannula into the abdomen. Check to see if the Veress cannula is correctly positioned in the abdomen.

1. Attach the insufflation tube to the Veress cannula.

2. Select the desired nominal pressure and nominal gas flow.

3. Start insufflation: Press the START function field.

Check the actual pressure display and the gas consumption display.

7.6.2 Insufflating with the Trocar

1. Insert the trocar into the abdomen.

2. Connect the Luer Lock connection of the insufflation tube to the trocar.

3. Make sure the trocar is correctly positioned in the abdomen. Then select the desired pressure and desired gas flow as intraoperative conditions.

7.6.3 "Real-Time Pressure Sensing" functionality (RTP)

CAUTION! Make sure the stopcock (valve) of the trocar is fully opened and that both tube

connections are connected to different trocars.

7.6.4 Stop the Insufflation

1. Press the STOP function field. The following values are displayed:

• Gas consumption display: last measured value

• Actual pressure: current measured value

• Actual gas flow: 0 l/min

• Nominal pressure: last set value In case of exceeding the safety limit, the

nominal pressure value will be reset to the lowest safety limit value.

• Nominal gas flow: last set value In case of exceeding the safety limit, the

nominal flow value will be reset to the safety limit value (only if activated).

The status field of the display depicts Insufflation stopped followed by Mode: Pediatric alternating with Push to release.

2. Remove the tube set from the device. Observe applicable hygiene regulations

Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode

when disposing of the tube set.

CAUTION! If the tube set remains connected to the device, there is the danger that leftover

fluid in the tube or the instruments will be sucked into the device.

3. Close the gas supply.

4. Use the ON/OFF switch to turn the device off.

NOTE! Observe applicable hygiene regulations when disposing of the tube set.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

8 Using and Controlling the PNEUMO SURE XL High Flow In-

sufflator in Bariatric Operating Mode

weight (BMI>30kg/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.

The gas flow may not exceed 14 l/min when performing a laparoscopy on infants or patients weighing less than 25 kilos.

Intended useBariatric operating mode is used for laparoscopies performed on severely over-

ContraindicationsThe device may not be used to fill an abdomen with CO2 if a laparoscopy is con-

8.1 Device-Specific Dangers when Using the PNEUMO SURE High

Flow Insufflator in Bariatric Operating Mode

WARNING! Altered Respiratory Physiology Always monitor the patient's respiratory functions during the entire surgery. The

larger body mass supported by the thoracic cage and the larger amount of fat in the abdominal cavity may reduce the elasticity of the thoracic wall. In addition, the increased intra-abdominal pressure secondary to insufflation may alter the normal physiological lung parameters thus resulting in a reduction of the functional lung volume. Shallow, rapid breathing is symptomatic of this condition. Even modest physical stress causes a tremendous increased demand for oxygen, which stands in contrast to the ineffective respiratory musculature that requires more oxygen because it must overcome the reduced elasticity of the thoracic cage. The functional capacity of the lungs is small and even moderate stress can lead to respiratory failure.

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! 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

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

WARNING! CO2 supersaturation To avoid generating CO2 supersaturation, an increased level of respiratory activ-

ity is required. An overweight patient's oxygen demand and carbon dioxide production are greater and increase faster under physical stress than do those of patients with normal body weight.

WARNING! Heart and cardiovascular insufficiency Constantly monitor all heart and cardiovascular parameter during surgery since

morbidly obese patients have an increased risk of heart and cardiovascular insufficiencies.

WARNING! Metabolic and cardiac reactions Insufflating CO2 may result in metabolic acidosis. This can lead to cardiac irreg-

ularities 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

• High gas flow due to large leaks

• Long surgeries

• Use of cold (not preheated) irrigation and infusion solutions

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).

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

WARNING! Embolism Improper placement of the insufflation instrument could cause insufflation of

WARNING! Additional insufflation sources The use of additional insufflation sources increases the intra-abdominal pres-

sure. Continuously monitor intra-abdominal pressure over the course of the entire insufflation if additional sources are used.

WARNING! Device-inherent dangers Please read the general risks and dangers information in chapter 2.1 Hazards,

page 5 and chapter 3.3 General Device-Inherent Dangers, page 8.

8.2 Selecting Bariatric Operating Mode

1. Selection of the insufflation mode can be done only while insufflation is stopped. If Bariatric operating mode is not yet set and displayed, press the function field Change Mode for 2 seconds to get the insufflation mode overview.

2. The display depicts an insufflation modes overview. Select the desired insufflation operating mode by pressing the Bariatric function field. *Inactive operating modes are displayed in gray.

3. The procedure profile is depicted on the display. The displayed parameters correspond with the factory settings or the values set in the Configuration menu (see chapter 10.1 Configuration menu I, page 60).

(1)

(2)

Set Pressure

mm Hg

Mode: High Flow

Change

Mode

Actual Pressure

mm Hg

0.0

Liter

GAS

START

Set Flow

Actual

l/min

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

8.3 Presetting Nominal Pressure in Bariatric Operating Mode

The nominal pressure can be set during insufflation or while insufflation is stopped. Values may range from 1 to max. 30 mm Hg or the value set in the Configuration menu.

Increasing/decreasing nominal pressure:

Briefly press the  or  function field to increase or decrease the pressure. Keeping the  or  function field depressed longer than 1.5 seconds activates scrolling in increments of 1.

Safety limit:

When increasing the nominal pressure, the status line of the display depicts Safety limit starting at 15 mm Hg and the nominal value flashes. The nominal pres-

sure 15 mm Hg is a threshold value. This is where the recommended range for the intra-abdominal pressure ends. Pressing the nominal pressure  function field again does not increase the pressure any further. Release the function field at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 30 mm Hg.

CAUTION! Exceeding this safety limit is to be decided by and the responsibility of the user/

operator.

8.4 Presetting Nominal Flow in Bariatric Operating Mode

The nominal flow can be increased or decreased during insufflation or while insufflation is stopped.

1. Briefly press the  or  function field to increase or decrease the flow. The

nominal flow can be increased from 1 to max. 45 l/min.

• Briefly press the corresponding field to set values in increments of 1.

• Keeping the  or  function field pressed longer than 1.5 seconds activates scrolling through the gas flow rates 5, 25, 45 l/min or 45, 25, 5 l/min.

2. The preset values of the Configuration menu can be changed individually (see chapter 10.1 Configuration menu I, page 60). Select a nominal gas flow between 1-45 l/min. The preset value is indicated in the nominal gas flow display. The values for the nominal gas flow refer to a device without connected tube, filter, or instrument. Tube, filter, and instrument can reduce the gas flow.

The device monitors the gas flow in two different operating modes:

• Veress insufflation (1-5 l/min)

• Insufflation: Bariatric (6-45 l/min)

Veress insufflation operating mode:

Veress insufflation is a gentle type of insufflation so that the actual pressure

does not exceed the preset pressure even in case of small volumes. To minimize the risks in case of a faulty incision, the manufacturer recommends using Veress

insufflation to start a procedure (filling abdomen with CO2).

WARNING! Please note that the automatic venting system is not active during Veress insuf-

flation mode.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

Insufflation: Bariatric

While Insufflation: Bariatric any pressure loss due to leaks can be quickly equalized. The APC Technology (Advanced Pressure Control) enables raising the actual pressure gently to the level of the nominal pressure. In case of large volumes, the actual pressure does not exceed the nominal pressure (see chapter 11 Safety functions, page 70).

Start the device by pressing the START function field.

With a nominal flow setting of < 6 l/min Veress insufflation is displayed. Above 5l/min Insufflation: Bariatric is displayed.

Stop the device by pressing the STOP function field.

NOTE! Tube, filter and instrument can reduce the gas flow.

8.5 Performing the Function Test in Bariatric Operating Mode before Using the Device during Surgery

Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

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

WARNING! The function test must be performed prior to each surgical procedure.

(1) (2) (3) (4) (5) (6)

PreparationSterilize reusable instruments and tubing before surgery to prevent infections.

Testing the device

Fig. 8-1 Layout for testing the device

(1) ON/OFF switch (2) Nominal pressure display (3) START/STOP function field (4) Gas consumption display (5) Nominal flow display (6) Insufflation tube set (7) Stopcock (valve) (8) Veress cannula

(8)

(7)

1. The device is switched off, no tube set is connected.

2. Make sure the gas supply is connected and open.

3. Use the ON/OFF switch (1) to turn the device on. The device conducts a de-

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

vice check.

4. Select Bariatric operating mode in the insufflation mode selection.

5. Connect an original insufflation tube set (6) to the device.

6. Attach the insufflation tube to the Veress cannula (8).

7. Attach the stopcock (valve) (7) to the Veress cannula.

8. If the gas consumption display function field does depict a value, press the

(4) function field to reset the display to 0.

9. Select the nominal pressure 15 mm Hg (2) and the gas flow 5 l/min (5).

10. Start insufflation: Press the START function field (3).

11. Insufflate for approx. 30 s. The display status line depicts Occlusion after max.

4 seconds.

12. Stop insufflation: Press the STOP function field (3).

WARNING! If the actual gas consumption is higher than 0.4 l, there is a leak in the system. If

this happens, use steps 13 to 15 outlined below to locate the leak.

13. Repeat items 7 to 11 without Veress cannula and with closed tube end. The previously connected Veress cannula has a leak if gas consumption is now below 0.4 l.

WARNING! Never work with a leaky insufflation tube, accessory, and/or device. This can lead to an incorrect measurement of the actual pressure values, which can cause

an uncontrolled pressure increase in the abdomen.

Testing gas heating functionality The functionality of the gas heating is indicated by displaying the gas heating

symbol on the display when using the "Heated tube set with RTP for Pneumo Sure".

"Real-Time Pressure Sensing" functionality (RTP)

1. Connect the corresponding tube set ("Heated with Real-Time Pressure Sensing" or "High Flow with Real-Time Pressure Sensing").

8.5.1 Filling Tube System with CO2

At least 1 l of CO2 has to be let out from the system before every surgery while the tube is connected and the end of the tube is open. This will expel any air within the tube system and the device.

1. Start insufflation: Press the START function field. Wait until the gas consumption display shows 1.0 Liter.

2. Stop insufflation: Press the STOP function field.

3. Press the gas consumption display field to reset the gas consumption display to 0.0 Liter. This ensures the gas consumption is correctly displayed during surgery.

The function test is complete. The device is tested and ready to be used for surgery.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

WARNING! Do not use this device if a defect is suspected or detected during the function

check. This also applies to obvious defects, especially defects on the power plug and power cable.

8.6 Using the Device during Surgery

WARNING! The function test must be performed prior to each surgery.

CAUTION! The venting system is automatically triggered (not during Veress mode and not

1. The device is turned on.

2. An insufflation tube set is connected.

Using the device during surgery

8.6.1 Insufflating with Veress Cannula

On delivery from the factory, following values are set for Bariatric operating mode:

• a gas flow value of 5 l/min and

• Veress insufflation for insufflation through the Veress cannula.

CAUTION! Please note that with flow values up to 5 l/min the Veress insufflation operating mode is automatically activated (the venting valve is switched off). The gas

transport is also specifically customized for use with a Veress cannula.

WARNING! This manual does not include instructions for the safe use of the Veress cannula.

Only when you have ensured endoscopically that an aeroperitoneum can be generated, should a gas flow of more than 3 l/min and a pressure of more than 10 mm Hg be selected. Insert the Veress cannula into the abdomen. Check to see if the Veress cannula is correctly positioned in the abdomen.

1. Attach the insufflation tube to the Veress cannula.

2. Select the desired nominal pressure and nominal gas flow.

3. Start insufflation: Press the START function field.

Check the actual pressure display and the gas consumption display.

8.6.2 Insufflating with the Trocar

1. Insert the trocar into the abdomen.

2. Connect the Luer Lock connection of the insufflation tube to the trocar.

3. Make sure the trocar is correctly positioned in the abdomen. Then select the desired pressure and desired gas flow as intraoperative conditions.

5. Check how the patient's body reacts to the selected pressure and gas flow

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode

rate. Compare the abdominal filling rate to the selected nominal pressure. You can change the nominal gas flow and the nominal pressure during surgery without interrupting the insufflation process. The Luer Lock connection of the measuring tube can be connected to another trocar that also inserted when using a tube set with measuring line. This enables the continuous measuring of the pressure.

8.6.3 "Real-Time Pressure Sensing" functionality (RTP)

CAUTION! Make sure the stopcock (valve) of the trocar is fully opened and that both tube

connections are connected to different trocars.

8.7 Stop the Insufflation

1. Press the STOP function field. The following values are displayed:

• Gas consumption display: last measured value

• Actual pressure: current measured value

• Actual gas flow: 0 l/min

• Nominal pressure: last set value In case of exceeding the safety limit, the nominal pressure value will be reset to the safety limit value.

• Nominal gas flow: last set value

The status field of the display depicts Insufflation stopped followed by Mode: Bariatric alternating with Push to release.

2. Remove the tube set from the device. Observe applicable hygiene regulations when disposing of the tube set.

CAUTION! If the tube set remains connected to the device, there is the danger that leftover

fluid in the tube or the instruments will be sucked into the device.

3. Close the gas supply.

4. Use the ON/OFF switch to turn the device off.

NOTE! Observe applicable hygiene regulations when disposing of the tube set.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

9 Using and Controlling the PNEUMO SURE XL High Flow In-

sufflator in Vessel Harvest Operating Mode

medical-grade CO2 when harvesting vessels (veins and arteries) during a minimally invasive procedure within the scope of heart bypass surgery. While in Ves- sel 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.

cal application is contraindicated. Please consult the manual of that instrument for additional information and special application indications.

9.1 Device-Specific Dangers when Using the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

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

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

the used instrument is intended for CO2 insufflation.

Intended useVessel Harvest operating mode is designed for the controlled insufflation of

ContraindicationsThe device may not be used for the endoscopic harvesting of vessels if this surgi-

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

reaction).

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 ves-

sel harvesting - it is especially important to remember the existing risk of metabolic acidosis when insufflating with CO2. This can lead to cardiac irregularities

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

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

(1)

WARNING! Device-inherent dangers Please read the general risks and dangers information in chapter 2.1 Hazards, page 5 and chapter 3.3 General Device-Inherent Dangers, page 8.

9.2 Selecting Vessel Harvest Operating Mode

1. Selection of the insufflation mode can be done only while insufflation is stopped. If Vessel Harvest operating mode is not yet set and displayed, press the function field Change Mode for 2 seconds to get the insufflation mode overview.

2. The display depicts an insufflation modes overview. Select the desired insufflation operating mode by pressing the Vessel Harvest function field.

(2)

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

9.3 Presetting Nominal Pressure in Vessel Harvest Operating Mode

The nominal pressure can be set during insufflation or while insufflation is stopped. Values may range from 1 to max. 20 mm Hg or the value set in the Con- figuration menu.

Increasing/decreasing nominal pressure:

Briefly press the  or  function field to increase or decrease the pressure. Keeping the  or  function field depressed longer than 1.5 seconds activates scrolling in increments of 1.

Safety limit:

When increasing the nominal pressure, the status line of the display depicts Safety limit starting at 12 mm Hg and the nominal value flashes.

The nominal pressure value 12 mm Hg is a limit value and should not be exceeded when performing vessel harvesting surgery. Pressing the nominal pressure  function field again does not increase the pressure any further.

CAUTION! Exceeding this safety limit is to be decided by and the responsibility of the user/

operator.

Release the function field at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 15 mm Hg.

The Safety limit message is re-displayed in the status line starting at 15 mm Hg and the nominal value flashes.

The nominal pressure value 15 mm Hg is a limit value and should not be exceeded when performing vessel harvesting surgery. Pressing the nominal pressure  function field again does not increase the pressure any further.

CAUTION! Exceeding this safety limit is to be decided by and the responsibility of the user/ operator.

Release the function field at that point. The display switches back to the nominal value setting after 2 seconds. Now you can set a value up to 20 mm Hg.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

9.4 Presetting Nominal Flow in Vessel Harvest Operating Mode

The nominal flow can be set during insufflation or while insufflation is stopped.

Increasing nominal gas flow:

• Press the function field  to increase gas flow. The nominal flow can be in-

creased from 1 to max. 10 l/min.

• Briefly press the corresponding function field to set values in increments of 0.5

for a range from 1 to 5 l/min.

• Set values in increments of 1 for a range from 5 to 10 l/min.

• Keeping the  or  function field pressed longer than 1.5 seconds activates

scrolling through the gas flow rates 1, 4, 10 l/min (in the Configuration menu).

Reducing nominal gas flow:

Briefly press the nominal gas flow function field  to reduce the nominal gas flow.

Safety limit:

The safety limit can be activated or deactivated in the Configuration menu.

When increasing the nominal flow, the status line of the display depicts Safety limit starting at 6 l/min and the nominal value flashes.

Release the function field to increase the nominal gas flow further. The display switches back to the nominal value setting after 2 seconds. Now you can set a value of up to 10 l/min.

CAUTION! Exceeding this safety limit is to be decided by and the responsibility of the user/

operator.

9.5 Performing the Function Test in Vessel Harvest Operating Mode

before Using the Device during Surgery

Preparation Sterilize reusable instruments and tubing before surgery to prevent infections.

Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.

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

WARNING! The function test must be performed prior to each surgical procedure.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

(1) (2) (3) (4) (5) (6)

(7)

1. The device is switched off, no tube set is connected.

2. Make sure the gas supply is connected and open.

3. Use the ON/OFF switch (1) to turn the device on. The device conducts a device check.

4. Select Vessel Harvest operating mode in the insufflation mode selection.

5. Connect an original insufflation tube set High Flow 2 (6) to the device.

6. Press the function field for the gas consumption display (4) to set the display to 0 Liter.

7. Select the nominal pressure 10 mm Hg (2) and the gas flow 1 l/min (5).

8. Close the end of the tube (Luer Lock) (7).

9. Start insufflation: Press the START function field (3).

10. Insufflate for approx. 30 s. The display status line depicts Occlusion after max. 4 seconds.

11. Stop insufflation: Press the STOP function field (3).

Testing the device

Fig. 9-1 Layout for testing the device

(1) ON/OFF switch (2) Nominal pressure display (3) START/STOP function field (4) Gas consumption display (5) Nominal flow display (6) Insufflation tube set (7) Luer Lock connection

WARNING! If the actual gas consumption is higher than 0.4 l, there is a leak in the system.

12. Replace the tube set and repeat the test from step 6 to step 11.

13. If another leak is detected, this leak is then directly within the device. Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

WARNING! Never work with a leaky insufflation tube, accessory, and/or device. This can lead to an incorrect measurement of the actual pressure values, which can cause

an uncontrolled pressure increase in the abdomen.

symbol on the display when using the "Heated tube set with RTP for Pneumo Sure".

9.5.1 Filling Tube System with CO2

At least 1 l of CO2 has to be let out from the system before every surgery while the tube is connected and the end of the tube is open. This will expel any air within the tube system and the device.

Testing gas heating functionalityThe functionality of the gas heating is indicated by displaying the gas heating

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

1. Start insufflation: Press the START function field. Wait until the gas consumption display shows 1.0 Liter.

2. Stop insufflation: Press the STOP function field.

3. Press the gas consumption display field to reset the gas consumption display to 0.0 Liter. This ensures the gas consumption is correctly displayed during surgery.

The function test is complete. The device is tested and ready to be used for surgery.

WARNING! Do not use this device if a defect is suspected or detected during the function

check. This also applies to obvious defects, especially defects on the power plug and power cable.

9.6 Using the Device during Surgery

Using the device during surgery

WARNING! The function test must be performed prior to each surgery.

CAUTION! The venting system is automatically triggered (only if activated in the Configu-

ration menu) if the measured actual pressure exceeds the set nominal pressure during insufflation. The device interrupts insufflation and releases gas until the actual pressure has dropped below the set nominal value.

1. The device is turned on.

2. An insufflation tube set is connected.

9.6.1 Insufflation with Vessel Harvest Instrument

Set the Vessel Harvest operating mode in the Configuration menu for an endoscopic vessel harvesting procedure If the device was switched off during a vessel harvesting procedure, the display depicts Vessel Harvest after restarting the de- vice indicating that the device is already using the Vessel Harvest mode.

CAUTION! Before you use the insufflator for a vessel harvesting procedure, make sure to

read the manual of your endoscopic instrument to check whether the instrument can be used in conjunction with CO2.

1. Connect the special vessel harvesting instrument with the insufflation tube. Use a manufacturer's recommended instrument to harvest vessels.

2. Select the necessary nominal pressure and nominal gas flow.

3. Connect the Luer Lock connection of the insufflation tube to the vessel harvesting instrument.

4. Select the desired pressure and desired gas flow as intraoperative conditions.

5. Start insufflation: Press the START function field. Check the actual pressure display and the gas consumption display.

6. The actual pressure display shows the current measured value for insufflation. As soon as this value approximates the selected nominal value, the gas flow is automatically minimized. The gas consumption display shows the volume of gas consumed.

7. Check how the patient's body reacts to the selected pressure and gas flow rate. You can change the nominal gas flow and the nominal pressure during surgery without interrupting the insufflation process.

Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Vessel Harvest Operating Mode

9.6.2 Stop the Insufflation

1. Press the STOP function field. The following values are displayed:

• Gas consumption display: last measured value

• Actual pressure: current measured value

• Actual gas flow: 0 l/min

• Nominal pressure: last set value In case of exceeding the safety limit, the nominal pressure value will be reset to the safety limit value.

• Nominal gas flow: last set value In case of exceeding the safety limit, the nominal flow value will be reset to the safety limit value (only if activated).

The status field of the display depicts Insufflation stopped followed by Mode: Vessel Harvest alternating with Push to release.

2. Remove the tube set from the device. Observe applicable hygiene regulations when disposing of the tube set.

CAUTION! If the tube set remains connected to the device, there is the danger that leftover

fluid in the tube or the instruments will be sucked into the device.

3. Close the gas supply.

4. Use the ON/OFF switch to turn the device off.

NOTE! Observe applicable hygiene regulations when disposing of the tube set.

NOTE! Insufflation with "Real-Time Pressure Sensing" (RTP) is not available in the Vessel Harvest operating mode.

Configuration Menu (Overview)

10 Configuration Menu (Overview)

Configuration menu Device parameters are changed with the configuration menu. The following is an

overview and a subsequent detail depiction (factory settings = bold, italics).

Configuration menu I

Menu level ↔ 1. Submenu level 2. Submenu level 3. Submenu level First nominal

pressure

↑↓

Venting controls↑↓↔ Venting valve status ↔ High Flow:*

High Flow: 15 mm Hg (setting range 115 mm Hg)

Bariatric: 15 mm Hg (setting range 115 mm Hg)

Vessel Harvest 10 mm Hg (setting range 112 mm Hg)

Pediatric: 8 mm Hg (setting range 112 mm Hg)

With veress insufflation OFF

Venting system OFF

↔ Bariatric:*

↔ Venting pressure limit ↔ 2 mm Hg, 3 mm Hg, 4 mm Hg, 5 mm Hg ↔ Venting response time ↔ 2 s, 3 s, 4 s, 5 s

Gas supply

↑↓

Alarm volume↑↓↔ Level 1

*Inactive menu items are displayed in gray.

↔ House gas

Gas bottle

Level 2

Level 3

With veress insufflation OFF

Venting system OFF

↔ Vessel Harvest:*

Venting system ON

Venting system OFF

↔ Pediatric:*

With veress insufflation ON

With veress insufflation OFF

Venting system OFF

Configuration menu II

Configuration Menu (Overview)

Menu level 1. Submenu level 2. Submenu level 3. Submenu

Gas flow rate*↑↓↔ High Flow:

Rate 1= 3 l/min (range 1-20)

Rate 2= 20 l/min (range rate 1-40)

Rate 3= 40 l/min (range rate 2-40)

Venting controls

↑↓

First nominal gas flow

Max. nominal pressure

↑↓

Flow safety limit

Warning signal Occlusion

↑↓

*Inactive menu items are displayed in gray.

↔ Bariatric:

Rate 1= 5 l/min (range 1-20)

Rate 2= 25 l/min (range rate 1-45)

Rate 3= 45 l/min (range rate 2-45)

↔ Vessel Harvest:

Rate 1= 1 l/min (range 1-10)

Rate 2= 4 l/min (range rate 1-10)

Rate 3= 10 l/min (range rate 2-10)

↔ Pediatric:

0.1 l/min (setting range 0.1-1 l/min)

↔ High Flow: 30 mm Hg (setting range 5-30 mm Hg)

Bariatric: 30 mm Hg (setting range 5-30 mm Hg)

Vessel Harvest: 20 mm Hg (setting range 520 mm Hg)

Pediatric: 20 mm Hg (setting range 5-20 mm Hg)

↔↔Limit ON

Limit OFF

↔ Vessel Harvest: Signal ON, Signal OFF

Bariatric: Signal ON, Signal OFF

Pediatric: Signal ON, Signal OFF

High Flow: Signal ON, Signal OFF

level

Menu item Gas Flow Rates is inactive in Pediatric mode.

Menu item First Nominal Gas Flow is active exclusively in Pediatric mode.

Menu item Flow Safety Limit is active only in Pediatric operating mode and Vessel Harvest operating mode.

Configuration Menu (Overview)

Utility menu

Menu level ↔ 1. Submenu level 2. Submenu level 3. Submenu level Display setting

Dimmer

-75%, -50%, -25%

↑↓

Dimmer sensor

Activated

OFF

Language

↑↓

↔ english

français

deutsch

español

português

↔ nederlands

norsk

suomi

greek

svenska

↔ polski

românã

simplified chinese

korean

japanese

italiano

dansk

Program version↑↓↔

Upgrade XL Upgrade from version Pneumo Sure to Pneumo Sure XL Service Access only for service technicians

*Inactive menu items are displayed in gray.

10.1 Configuration menu I

Functions of the configuration menu While insufflation is stopped, press the Actual gas flow function field for 2 sec-

onds to access the Configuration menu I

Depiction/functions in configuration menu

Tap the "arrow forward" function field to access the next menu on the same level.

Set Pressure

mm Hg

Mode: High Flow

Change

Mode

Actual Pressure

mm Hg

0.0

Liter

GAS

START

Set Flow

Actual

l/min

(1)

Tap the "arrow backward" function field to access the previous menu on the same level without saving set- tings or to access the previous menu of the next higher menu level.

Tap the (SAVE) function field to save settings. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level.

Press the (EXIT) function field to exit the menu or return to the work screen.

10.1.1 Setting First Nominal Pressure

Operating mode Factory setting Range

Bariatric 15 mm Hg 1-15 mm Hg High Flow 15 mm Hg 1-15 mm Hg Vessel Harvest 10 mm Hg 1-12 mm Hg Pediatric 8 mm Hg 1-12 mm Hg

In the configuration menu I, press the First nominal pressure function field to access the setting.

The display switches to the First nominal pressure menu.

Press the function field  or  to set the First nominal pressure.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

10.1.2 Setting the Venting Controls

In the configuration menu I, press the Venting controls function field to access the venting system selection.

Configuration Menu (Overview)

(2)

(1)

(3)

The display switches to the Venting controls selection menu.

Operating

Factory setting Range

mode

Bariatric With veress insufflation OFF With veress insufflation OFF,

Venting system OFF

High Flow With veress insufflation OFF With veress insufflation OFF,

Venting system OFF

Vessel Harvest Venting system OFF Venting system ON,

Venting system OFF

Pediatric With veress insufflation ON With Veress insufflation ON,

For example, tap the Venting valve status function field.

With Veress insufflation OFF,

Venting system OFF

Setting the venting valve statusFactory Settings

The display switches to the Venting valve status selection menu.

With Veress Insufflation ON is only selectable while in Pediatric operating mode

and is otherwise depicted in gray.

Venting system ON is only selectable while in Vessel Harvest mode and is otherwise depicted in gray.

Configuration Menu (Overview)

(2)

(1)

(3)

For example, press the Venting system OFF function field.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without sav-

ing,

3. or press (EXIT) to return to the work screen without saving.

Setting the venting pressure limit of the venting valve

(2)

(1)

(3)

Setting the venting system response time Factory setting = 3 s (for all operating modes)

Factory setting = 3 mm Hg (for all operating modes)

For example, press the Venting pressure limit function field.

The display switches to the Pressure limit selection menu.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without sav-

ing,

3. or press (EXIT) to return to the work screen without saving.

For example, press the Venting response time function field.

(2)

(1)

(3)

The display switches to the Venting response time selection menu.

For example, press the 4 s function field.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without sav-

ing,

3. or press (EXIT) to return to the work screen without saving.

10.1.3 Setting the Gas Supply Type

Use this menu to select the type of connected gas supply.

Select House Gas if you are working with a house gas supply (use the corresponding house gas device adapter available as an additional accessory). The gas supply

indicators and displays are described in Chapter 11 Safety functions, page 70. If house gas supply has been selected but bottled gas (pressure >15 bar) is connected to the device, the gas supply display automatically switches accordingly.

Select Bottle if you want to work with a gas bottle. The gas supply indicators and displays are described in Chapter 11 Safety functions, page 70. It is not possible to operate the device if Bottle gas is set and a house gas supply is actually connected.

Factory setting = House gas

In the configuration menu I, press the Gas supply function field to access the gas supply selection menu.

The display switches to the Gas supply selection menu.

You now have the opportunity to

Configuration Menu (Overview)

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

10.1.4 Setting the Alarm Volume

Factory setting = Level 3

In the configuration menu, press the Alarm volume function field to access the volume selection.

The display switches to the Alarm volume selection menu. The selection/setting applies to all operating modes.

For example, press the Level 2 function field to lower the volume.

(2)

(1)

(3)

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

(2)

(1)

(3)

Configuration Menu (Overview)

10.2 Configuration menu II

Configuration menu II While insufflation is stopped, press the Actual function field for 2 seconds to ac-

cess the Configuration menu. In the Configuration menu I, press the ⇒ to access the Configuration menu II.

10.2.1 Setting the Gas Flow Rates*

Rate Operating mode Factory setting Range

Rate 1 Bariatric

High Flow

Vessel Harvest

Pediatric

Rate 2 Bariatric

High Flow

Vessel Harvest

Pediatric

Rate 3 Bariatric

High Flow

Vessel Harvest

Pediatric

5 l/min

3 l/min

1 l/min

Not available

25 l/min

20 l/min

4 l/min

Not available

45 l/min

40 l/min

10 l/min

Not available

1 -20 l/min

1 -10 l/min

Rate 1 -45 l/min

Rate 1 -40 l/min

Rate 1 -10 l/min

Rate 2 -45 l/min

Rate 2 -40 l/min

Rate 2 -10 l/min

(2)

(1)

(3)

*Inactive with Pediatric mode

In the configuration menu II, press the Gas flow rates function field to access the selection menu.

The display switches to the gas supply selection menu.

For example, press the function field (Rate 1: 3 l/min) to set gas flow rate 1.

The display switches to the setting menu for gas flow rate 1.

Press the function field  or  to specify the value.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without sav-

ing,

3. or press (EXIT) to return to the work screen without saving.

10.2.2 Setting First Nominal Gas Flow*

*Selectable only in Pediatric mode

In the Configuration menu I, press the ⇒ to access the Configuration menu II.

In the configuration menu II, tap the First nominal gas flow function field to access the setting.

Factory setting: 0.1 l/min (0.1-1 l/min selectable)

The display switches to the First nominal gas flow menu.

Press the function field  or  to set the First nominal gas flow.

You now have the opportunity to

Configuration Menu (Overview)

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

10.2.3 Setting the Maximum Nominal Pressure

Operating mode Factory setting Range

Bariatric 30 mm Hg 5-30 mm Hg High Flow 30 mm Hg 5-30 mm Hg Vessel Harvest 20 mm Hg 5-20 mm Hg Pediatric 20 mm Hg 5-20 mm Hg

In the Configuration menu I, press the ⇒ to access the Configuration menu II.

The display changes to the Configuration menu II.

In the configuration menu, press the Maximum nominal pressure function field.

The display switches to the Maximum nominal pressure selection menu.

(2)

(1)

(3)

Press the function field  or  to specify the value.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

(2)

(1)

(3)

Configuration Menu (Overview)

(2)

(1)

(3)

10.2.4 Setting the Flow Safety Limit*

Factory setting = Limit OFF

*selectable only in Pediatric operating mode and Vessel Harvest operating mode.

In the Configuration menu I, press the ⇒ to access the Configuration menu II.

In the configuration menu II, press the Flow safety limit function field to access the setting. (Only selectable while in Vessel Harvest or Pediatric operating mode; otherwise depicted in gray - if set, valid for both modes)

The display switches to the Flow safety limit selection menu.

For example, press the Limit ON function field.

You now have the opportunity to

• save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

•press the ⇐ function field to return to the previous menu level without saving,

• or press (EXIT) to return to the work screen without saving.

10.2.5 Setting the Warning signal: Occlusion

(2)

(1)

(3)

Factory Settings

Operating mode Factory setting

Bariatric Signal ON High Flow Signal ON Vessel Harvest Signal OFF Pediatric Signal ON

In the Configuration menu I, press the ⇒ to access the Configuration menu II.

The display changes to the Configuration menu II.

In the configuration menu II, press the Warning signal: Occlusion function field to access the selection menu.

The display switches to the Warning signal: Occlusion selection menu.

For example, press the Signal OFF function field.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without sav-

ing,

3. or press (EXIT) to return to the work screen without saving.

10.3 Utility menu

Utility menu While insufflation is stopped, press the Actual function field for 2 seconds to ac-

cess the Configuration menu. In the Configuration menu I, press the ⇒ function field to access the Configuration menu II and there press the ⇒ function field

again to access the Utility menu.

10.3.1 Changing Display Settings

Factory setting

Dimmer -75% Dimmer sensor Activated

In the Utility menu, press the Display setting function field to access the selection menu.

The display switches to the Display setting selection menu.

For example, press the Dimmer function field.

The display switches to the Dimmer selection menu.

Press the respective function field to set the dimming level (-75%/-50%/-25%).

Configuration Menu (Overview)

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

The display switches to the Display setting selection menu.

For example, press the Dimmer sensor function field.

The display switches to the Dimmer sensor selection menu.

For example, press the OFF function field.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display depicts (SAVED) for 2 seconds. After saving you return automatically to the previous level,

2. press the ⇐ function field to return to the previous menu level without saving,

3. or press (EXIT) to return to the work screen without saving.

(2)

(1)

(3)

(2)

(1)

10.3.2 Setting the Language

While insufflation is stopped, press the Actual function field for 2 seconds to access the Configuration menu. In the Configuration menu I, press the ⇒ function field to access the Configuration menu II and there press the ⇒ function field again to access the Utility menu.

Factory setting = english

In the Utility menu, press the Language function field to access the language selection screen.

(3)

Configuration Menu (Overview)

(2)

(1)

(3)

The following languages are available:

1. Submenu level 2. Submenu level 3. Submenu level

english nederlands polski français norsk românã deutsch suomi simplified chinese español greek korean português svenska japanese italiano dansk

Press the english function field to select english as the display language, for example.

You now have the opportunity to

1. save the selected value by pressing the (SAVE) function field. The display de-

picts (SAVED) for 2 seconds. After saving you return automatically to the previous level.

2. press the ⇐ function field to return to the previous menu level without sav-

ing,

3. or press (EXIT) to return to the work screen without saving.

(2)

10.3.3 Checking Software Version

In the Utility menu, press the Software version function field to open the corresponding window.

The display depicts the Software version.

You now have the opportunity to

(1)

1. press the ⇐ function field to return to the previous menu level without sav-

ing,

2. or press (EXIT) to return to the work screen without saving.

Configuration Menu (Overview)

10.3.4 Upgrade XL*

*Only selectable for Pneumo Sure devices, inactive with Pneumo Sure XL devices

In the Configuration menu I and II press the ⇒ to access the Utility menu.

The display changes to the Utility menu.

In the Utility menu, press the Upgrade XL function field.

Press the function field  or  to specify the first digit of the activation code.

Save the first set digit by pressing the (SAVE) function field.

Press the function field  or  to specify the next digit of the activation code.

Save the set digit by pressing the (SAVE) function field.

Repeat this process until you have the complete activation code.

You now have the opportunity to

1. press the ⇐ function field to return to the previous menu level without saving,

2. or press (EXIT) to return to the work screen without saving.

(1)

(2)

10.3.5 Service Menu

Access to the service menu is restricted for trained and authorized service personnel. Please consult the service manual for further information.

Safety functions

11 Safety functions

Automatic venting system The device is equipped with an automatic venting system.

When the insufflator detects an overpressure it automatically activates the venting system. The venting system releases gas from the abdomen or from the vessel until the set nominal value has been reached again.

The function "Automatic venting system" can be activated/deactivated in the Configuration menu.

CAUTION! Please note that the automatic venting system is only active during the Veress insufflation mode if "In Veress insufflation ON" has been set in the configuration

menu (only possible in Pediatric operating mode, see chapter 7 Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode, page 34).

WARNING! The venting rate of the automatic venting system is limited. Always monitor the

actual pressure when using additional insufflation sources.

Insufflation source The manufacturer advises against using additional, non-pressure controlled in-

sufflation sources during minimally invasive surgical procedures.

The self-inflating property of lasers cooled with CO2 and argon beamers can lead to values exceeding the recommended and safe pressure rating.

Exceeding nominal pressure After 2 to 5 seconds (depending on the setting in the Configuration menu), the

display depicts Venting system active when the nominal pressure has been exceeded by 2-5 mm Hg.

Exceeding nominal pressure for more than 5seconds

If the overpressure cannot be reduced by the automatic venting system within 5 seconds, the display depicts Overpressure followed by Venting system active. An acoustic alarm is emitted.

Nominal pressure limit 30 mm Hg / 20 mm Hg

Once the nominal pressure limit has been reached/exceeded (High Flow/Bariatric -> 30 mm Hg or Pediatric/Vessel Harvest -> 20 mm Hg), the display depicts the message Overpressure. A warning signal is emitted at the same time.

Safety functions

If the actual pressure reaches /exceeds nominal pressure +4 mm Hg longer than 3 seconds, the display depicts Overpressure.

bols and acoustic signals.

> 50 bar

40 - 50 bar

30 - 40 bar

In case of deactivated venting system or during Veress insufflation

mm Hg

Mode

Actual Pressure

mm Hg

283

Liter

GAS

Overpressure

STOP

Set Flow

Actual

l/min

Set Pressure

High Flow

Gas supply displaysThe status of the gas supply is monitored by the device and indicated with sym-

Gas supply with gas bottleThe following gas bottle pressures are displayed:

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.

House gas supply pressure OK

(green)

House gas supply pressure too low

(red)

sion is depicted. An audible warning signal is emitted. Actual pressure and actual flow displays show 0.

House gas supplyThe following house gas supply pressures are displayed:

Warning message "Occlusion"When tube, Veress cannula, or trocar experience a temporary blockage, Occlu-

The acoustic message (warning signal) can be activated/deactivated in the configuration menu. In Pediatric mode < 1 l/min the warning signal is deactivated.

tamination is displayed and 3 warning signals are emitted.

Message is repeated with each START/STOP.

Error message "Contamination"When fluid has penetrated the device via the insufflation tube connection, Con-

Safety functions

It is possible to conclude the current surgery with this device. Insufflation is not possible after turning the device off and back on using the ON/OFF key. This is to prevent cross-contamination.

Contamination/Call service The display depicts Contamination alternating with Call service if you are switch-

ing on an already contaminated device. The device can no longer be used. The contaminated device has to be clearly marked as contaminated and sealed in two separate protective layers of safety foil. Make sure the device can no longer be used until a qualified service technician conducts the appropriate tests and repairs.

Error message when starting with defective venting valve

CAUTION! The venting valve is no longer available to reduce high pressures after a problem with the venting valve has been detected.

Error detection and monitoring of the "RealTime Pressure Sensing (RTP)" function

With each START/STOP, a 3x warning signal and the message Venting valve defective are repeated.

It is still possible to use the device but pay special attention to the pressure values while this error persists. A service technician should check/repair the device after the completed surgery.

The function of the continuous pressure measurement is verified during the device check and while the device is operated.

If the device self-test yields an error of the continuous pressure measuring, the crossed out symbol for the continuous pressure measuring then depicted in the display and the status line reads RTP defective followed by Call service. Three warning signals can be heard. Message is repeated with each START/STOP. Surgery can be continued but without the continuous pressure measurement. Do not connect the measuring line of the RTP system with a trocar.

After surgery is finished, call a service technician to repair the device.

CAUTION! The measuring line of the RTP system may not be connected to an open trocar if

the error message "RTP defective," "Call service" is displayed. Remove the measuring line since a connected line may result in an unintended slow pressure increase within the abdomen.

The continuous pressure measurement can be activated only if the automatic device check is concluded successfully when switching on the device. If one or both tubes are occluded during the device check and/or pressure is applied, the symbol is depicted crossed out and the status line reads as follows: RTP deacti- vated. Three warning signals can be heard. Message is repeated with each START/STOP. Surgery can be continued but without the continuous pressure measurement.

NOTE! Please make sure that neither of the two tubes is connected to a trocar or closed

off during a device check. The continuous pressure measurement cannot be activated otherwise.

for an extended time period, the device will function as it does when it is being restarted.

If a device malfunction occurs that prohibits any further use of the device or diminished its safety, the display depicts only

Text message - >Call service

The following text messages may be displayed:

• Contamination

• Electronic defective

• Sensor defective

• Venting valve defective

• Calibration error

• Temperature error

Safety functions

Power failureIf the power fails for less than 1 second, all settings are retained. If the power fails

Make sure the device can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

Care and Maintenance

12 Care and Maintenance

Special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories.

12.1 Cleaning the Device

1. Use the On/Off key to turn the device off.

2. Remove the power cable.

3. Wipe the surface of the device with a soft cloth moistened with the surface disinfectant (for example Meliseptol® rapid). The concentration of the used disinfectant depends on the information provided by the manufacturer of the disinfectant. Make sure moisture does not enter the device.

NOTE! Do not sterilize the device.

12.2 Annual Inspection

Manufacturer's specifications The manufacturer stipulates that qualified personnel or hospital technicians

must regularly test the device to assess its functionality and technical safety. This inspection has to be carried out once a year. The tests are described in chapter 12 Care and Maintenance.

Regular inspections will assist in early detection of possible malfunctions. This helps preserve the device and increases its safety and service life.

12.3 Maintenance by Authorized Service Technician

Two-year maintenance interval An authorized service technician has to inspect and service the device at appro-

priate intervals to ensure the safety and functionality of the unit. The minimum service interval is two years, depending on frequency and duration of use. If the service interval is not maintained, the manufacturer does not assume any liability for the functional safety of the device.

A sticker located on the rear panel of the device will remind you of the latest date for the next service or maintenance check.

Authorized service technicians are only trained and certified by the manufacturer.

Authorized trained personnel All of the service tasks, such as changes, modifications, repairs, calibrations, etc.

may be carried out only by the manufacturer or manufacturer-approved trained and skilled technicians.

Unauthorized personnel The manufacturer is not liable for the operational safety of the device if unau-

thorized persons conduct this maintenance or any other service tasks.

Liability Unauthorized opening of the device and repairs performed by unauthorized per-

sonnel or third parties and/or changes or modifications release the manufacturer of any liability concerning the operational safety of the device.

Technical documents Receiving technical documentation from the manufacturer does not authorize

individuals to perform repairs, adjustments, or alterations on the device or accessories/peripherals.

Certification Ask the service technician for a certificate after he or she has inspected the unit

or performed any service tasks. This certificate lists the type and scope of the service as well as the date and name of the servicing company together wit the signature of the service technician.

12.4 Replacing the Fuse

CAUTION! Before replacing the fuse, check the values of the fuse to be inserted acc. to chapter 16 Technical Data, page 89.

The fuse may be defective and is in need of replacement if:

• displays and LEDs do not light up,

• the device does not function.

Check to make sure

• the main power supply cable is properly connected to the power supply input and to a safety socket,

• the house power supply fuse is functioning.

WARNING! Unplug the power cable from the device before checking the fuse.

The device does not have to be opened to replace the fuse.

Care and Maintenance

1. Switch device off.

2. Disconnect device from power supply.

3. Remove power connection cable from mains socket.

4. The fuse holder is located to the left of the mains socket. Remove fuse holder

as depicted in Fig. 12-1 .

5. A Undo the latch of the fuse holder with a small screwdriver.

6. B Remove the fuse holder.

7. C Check fuses.

8. Insert a new fuse. Use only the specified type of fuse (see chapter 16 Techni-

cal Data, page 89).

9. Insert the fuse holder until it can be heard snapping into place.

10. Use the power cable to reconnect the shockproof safety socket with the rear

mains socket.

Fig. 12-1 Opening the fuse holder

12.5 Care and Maintenance of Reusable Tube Set

The device can be used with reusable tube set with gas heating validated for this purpose. Please observe the following notices when using a reusable tube set.

Care and Maintenance

12.5.1 Cleaning the Reusable Tube Set

1. Dismantle the tubing set.

2. Wash the parts carefully under running water.

3. Clean and rinse the parts with demineralized water.

4. Let all parts drip off and dry them with a sterilized soft cloth.

Notes about the Veress cannula 1. Before cleaning: Dismantle the Veress cannula (unscrew the insertion cannu-

la from the insufflation cannula with stopcock open).

2. Wash the parts carefully under running cold and warm water.

3. Clean the inner chamber of the Veress cannula with a cleaning pistol.

4. For disinfection, open the stopcock at the Veress cannula.

12.5.2 Disinfecting the Reusable Tube Set

WARNING! Disinfection of the tube and instruments is insufficient to achieve a sterility of SAL 10-6. Further sterilization is absolutely required after the disinfecting pro-

cess.

CAUTION! Do not place the plug of the reusable gas heating tube into the disinfectant so-

lution. Should this happen once, ensure that the plug is thoroughly dried prior to sterilization.

1. Only a thoroughly cleaned tube set may be disinfected.

2. Place all tube set components into a disinfectant. The concentration and the application duration of the disinfectant depends on the information provided by the manufacturer of the disinfectant. The tube set can be damaged if the concentration is too high.

WARNING! Do not leave tube set or other silicone parts in the solution for more than

30 minutes. Silicon absorbs various disinfectants and thus can be damaged when sterilized with steam.

3. Place the individual parts into the disinfection solution. Do not stack parts.

4. Remove the parts from the solution using forceps with a soft edge.

5. Remaining disinfection solution should be rinsed off with sterile water under sterile conditions.

6. Dry all parts with a sterile cloth and wrap each part in a separate sterile cloth.

7. Assemble all components before sterilization.

8. Place the tube set in a sterile container if stored for a longer period of time.

12.5.3 Sterilization of Reusable Tube Set

The maximum number of sterilization cycles for the tube set is determined by the manufacturer (see tube packaging). Never exceed the number of uses indicated by the manufacturer.

WARNING! Use the tear-off tabs attached to the tube set to keep track of the number of ster-

ilization cycles. The tube set may not be sterilized after the last tab has been removed.

WARNING! Always check the reusable tube set for signs of deterioration before use and after sterilization. Never use a tube set which shows signs of deterioration, including

cracking, brittleness, or signs of perforation.

autoclave. Please follow the instruction manual of the autoclave you are using.

The manufacturer recommends autoclaving as follows:

134 °C / 3 bar / 5 min

follow your gas sterilizer's instruction manual for proper use when using gas sterilization.

Care and Maintenance

Autoclave sterilizationOnly clean, dry, disinfected, and assembled tube sets should be sterilized in an

Gas sterilizationOnly clean, dry, disinfected, and assembled tube sets should be sterilized. Please

Gamma ray sterilizationDo not perform gamma ray sterilization.

Annual Inspection

13 Annual Inspection

Measured values and tolerances Each test conducted has to be documented with date and signature on the test

log.

The following measuring tools and resources were used by the manufacturer to determine the listed measurements and tolerances:

Manometer Range 0-100 mm Hg, error class 1.6 Syringe 60 ml Silicone tube 8 x 2 mm T adapter 8-8-8 mm Veress cannula length 100 mm

opening diameter 1.4 mm,

inner cannula diameter 1.6 mm

An authorized service technician must check the device if the specified parameters and tolerances are exceeded.

13.1 Safety Test

1. Perform a visual inspection. Make sure that

• the fuse corresponds with the specifications indicated by the manufactur-

er,

• labels and stickers on device are legible,

• the mechanical condition of the device allows for its safe use,

• the device is clean to ensure proper and safe functionality.

2. Measure leakage currents according to IEC 60601-1 / EN 60601-1.

3. Measure protective conductor resistance according to IEC 60601-1 / EN 60601-1. The protective conductor resistance is measured while device is connected to the power supply. The max. value is 0.2 Ω.

4. Measure the insulation resistance with 500-700 V DC. The min. value is 50 MΩ The electric strength with high voltage cannot be measured.

As an alternative, perform safety test according to IEC 62353 / EN 62353.

13.2 Basic Function Test (in High Flow Operating Mode)

1. Remove insufflation tube from device.

2. Use the On/Off switch to turn the device on. The device conducts a device check. A short signal can be heard. Set to High Flow operating mode.

3. The factory default settings are 15 mm Hg for the nominal pressure and 3 l/ min for the nominal flow.

4. The following values are displayed: Nominal pressure 15* [mm Hg] Nominal gas flow 3* [l/min] Actual pressure 0 [mm Hg] Gas consumption 0.0 [l] *These values correspond with the factory setting. If values in the configura-

tion menu were changed, these changed values are displayed.

5. Start insufflation: Press the START function field. The following values are displayed:

Actual pressure 0 [mm Hg] Veress insufflation is displayed. Streaming gas can be heard at the insuffla-

tion tube.

6. Select the max. nominal gas flow. The following values are displayed: Nominal gas flow max. value [l/min] Actual pressure 0 [mm Hg] Insufflation: High Flow is displayed. Streaming gas can be heard at the insuf-

flation tube.

7. Stop insufflation: Press the STOP function field.

The following values are displayed: Actual pressure 0.0 [mm Hg] Gas consumption >0.0 [l]

8. Press the gas volume function field. Gas consumption >0.0 [l]

The basic function test of the device is complete.

13.3 Testing the Pressure Sensors in High Flow Operating Mode

(1)

mm Hg

Annual Inspection

(2)(3)(4)

1. Set to High Flow operating mode.

2. Select a nominal gas flow rate of 1.0 l/min. Do not press the START/STOP function field.

CAUTION! Never use the syringe to extract gas from the device.

3. Connect a manometer (1) and an air-filled syringe (4) to the insufflation tube connection (3)/adapter (2).

4. Use the syringe to generate a pressure of at least 10 mm Hg, which registers on the manometer.

Actual pressure display: 10 ±2 [mm Hg]

5. Use the syringe to generate a pressure of at least 20 mm Hg, which registers on the manometer.

Actual pressure display: 20 ±2 [mm Hg]

6. Use the syringe to generate a pressure of at least 30 mm Hg, which registers on the manometer.

Actual pressure display: 30 ±2 [mm Hg]

Annual Inspection

13.4 Pressure Monitoring Test in High Flow Operating Mode

stryker Pneumo sure User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual