Stryker PneumoSure User manual

2016/09 www.stryker.com 1000-401-015 Rev. J
ES
EN
FR
PT
Instructions for
Use
Instrucciones
de uso
Instructions
d’utilisation
Instruções de
utilização
Insufflator for Laparoscopy and Vessel Harvesting

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Identificación CE conforme a la directriz 93/42/CEE
Marquage CE conforme à la directive 93/42/CEE
Distintivo CE conforme a Directiva 93/42/CEE
Type:F114/1200628/10000016403 01/2016-09/Hahn
Stryker Endoscopy
5900 Optical Court, San Jose
CA 95138 (USA)
[phone] [phone]
www.stryker.com
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ENDOSCOPY cualquier aviso, indicación u observación con respecto a posibles
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STRYKER ENDOSCOPY remercie d’avance les utilisateurs de ses produits qui lui
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avisos sobre possíveis falhas ou dúvidas deste manual.
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Produced for/Producido para/Produit pour/Produzido para:

Symbols/Símbolos/Symboles/Símbolos
EN
ES
FR
PT
Symbols Símbolos Symboles Símbolos
Refer to instruction
manual Consulte el manual de
instrucciones Consultez le manuel d’utilisation Consulte o manual de instruções
Caution Peligro Danger Perigo
Symbol for type BF
equipment
Símbolo para un aparato
del tipo BF
Symbole pour un appa-
reil de type BF Símbolo para um apare- lho do tipo BF
Do not resterilize No reesterilizar Ne pas restériliser Não reesterilizar
Symbol for potential
equalization
Símbolo para la
conexión equipotencial Fiche équipotentielle Sistema para a compen- sação do potencial
Degrees of protection
provided by enclosures
(IP-Code)
Grado de protección
proporcionado por los
envolventes (Código IP)
Degrés de protection
procurés parles enve-
loppes (Code IP)
Classificação do grau de
proteção oferecido
pelas carcaças (IP)
Alternating current Corriente alterna Courant alternatif Corrente alternada
Service Servicio Service Assistência
Catalog number Número de catálogo Numéro du catalogue Número do catálogo
Single use only No reutilizable Usage unique Vedada a reutilização
Sterilized using EO Esterilizado con EO Stérilisés à l’EO Esterilizado com EO
Lot number Denominación depar-
tida o lote Numéro de lot Designação do lote
Serial number Número de serie Numéro de série Número de série
Date of manufacture Fecha de fabricación Date de fabrication
Data de fabricação
Use by Utilizable hasta Date limite d’utilisation Utilizável até
Pieces, quantity Piezas, cantidad Pièces, quantité Número, quantidade
Quantity Cantidad Quantité Quantidade
REF

Symbols/Símbolos/Symboles/Símbolos
EN
ES
FR
PT
Not made with natural
rubber latex
Producto no producido
con látex de caucho
natural
Ce produit ne contient
pas de latex de caout-
chouc naturel
Não elaborado com
látex de borracha natu-
ral
Number of autoclaving
cycles Número de esteriliza- ciones por autoclave Paramètres pour la sté- rilisation à l’autoclave Número de esteriliza- ções em autoclave
Do not get wet Proteger contra la
humedad Protéger de l’humidité Proteger da humidade
Top-Bottom Arriba-abajo Haut-bas Em cima-Em baixo
Fragile Frágil Fragile Frágil
Waste management Gestión de residuos Élimination des déchets Eliminação
Manufacturer Fabricante Fabricant Fabricante
Start Start (Inicio) Start Start
Stop Stop (Parada) Stop Stop
On/Off On/Off (Encendido/
Apagado) On/Off (Marche /Arrêt) On/Off (Ligar/Desligar)
Gas heater OK Calefacción de gas OK Chauffage de gaz OK Aquecedor do gás OK
Gas heater error Calefacción de gas
defectuosa Erreur du chauffage de gaz Falha no aquecedor do gás
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 Representante europeo de Stryker Représentant Stryker Europe Representante Europeu da Stryker
Save Guardar Mémoriser Guardar
Symbols Símbolos Symboles Símbolos
HEATING
HEATING
EC REP

Symbols/Símbolos/Symboles/Símbolos
EN
ES
FR
PT
Exit Salida Quitter le menu Saída
Menu - Increase Menú-Aumento Menu-Croissant Menu-Aumento
Menu - Decrease Menú-Disminución Menu-Décroissant Menu-Descida
Real-Time Pressure
Sensing in progress Real-Time Pressure Sen- sing activada Real-Time Pressure Sen- sing activée Real-Time Pressure Sen- sing activada
Real-Time Pressure
Sensing defective or
deactivated
Real-Time Pressure Sen-
sing defectuosa o des-
activada
Real-Time Pressure Sen-
sing défectueuse ou
désactivée
Real-Time Pressure Sen-
sing danificada o desac-
tivada
House gas supply Alimentación de gas
central Alimentation en gaz centrale Alimentação de gás doméstico
Tank gas supply Alimentación por bote-
lla de gas Alimentation en gaz par bouteille Alimentação de gás com uma botija de gás
Low gas pressure Presión de gas baja Pression de gaz basse Pressão de gás baixa
Gas pressure too low Presión de gas dema-
siado baja Pression de gaz insuffi- sante Pressão de gás dema- siado baixa
Push to release Presione para retirar Appuyer pour retirer Premir para eliminar
Do not use if package
damaged No utilizar si el envolto- rio está dañado
Ne pas utiliser si
l’emballage est endom-
magé
Não usar se a embala-
gem é danificada
Keep away from sun-
light Proteger de la luz solar Protéger des rayons du soleil Proteja da luz solar
Authorized for Sale or
use by Physician only Autorizado sólo para la venta o el uso médico
Autorisé seulement
pour la vente ou l’utili-
sation par un médecin
uniquement
Autorizado somente
para a venda ou o uso
médico
Symbols Símbolos Symboles Símbolos

EN
Table of contents
1 Important User Notes ......................................................................................................................................................... 3
2 Safety Information.............................................................................................................................................................. 4
2.1 Hazards........................................................................................................................................................................................ 5
3 Device Purpose.................................................................................................................................................................... 7
3.1 Laparoscopy Applications ...................................................................................................................................................... 7
3.1.1 Using High Flow Operating Mode....................................................................................................................................... 7
3.1.2 Using Pediatric Operating Mode.......................................................................................................................................... 7
3.1.3 Using Bariatric Operating Mode.......................................................................................................................................... 8
3.1.4 Contraindications for Laparoscopy Applications............................................................................................................. 8
3.2 Using Vessel Harvest Operating Mode............................................................................................................................... 8
3.3 General Device-Inherent Dangers ....................................................................................................................................... 8
3.3.1 Device-Inherent Dangers - Laparoscopy............................................................................................................................ 10
3.3.2 Device-Inherent Dangers - Vessel Harvesting.................................................................................................................. 12
4 Initial Device Startup .......................................................................................................................................................... 14
4.1 Gas connection ......................................................................................................................................................................... 14
4.1.1 Connecting a Gas Bottle......................................................................................................................................................... 15
4.1.2 Connecting to Central Gas Supply....................................................................................................................................... 15
5 Operating the Device - General .......................................................................................................................................... 16
5.1 Front of the Device................................................................................................................................................................... 16
5.2 Rear of the Device .................................................................................................................................................................... 16
5.3 Touch screen display................................................................................................................................................................ 17
5.4 Switch on Device ...................................................................................................................................................................... 18
5.5 Connecting Insufflation Tube Set ........................................................................................................................................ 19
5.6 Using the Gas Heating............................................................................................................................................................ 20
5.6.1 Using the direct pressure measurement function (Real-Time Pressure Sensing RTP).......................................... 21
5.6.2 Displaying/Selecting Insufflation Operating Mode ....................................................................................................... 23
5.6.3 Setting the Nominal Pressure - General ............................................................................................................................ 23
5.6.4 Setting the Nominal Flow - General ................................................................................................................................... 23
5.6.5 Gas Consumption Display...................................................................................................................................................... 24
5.6.6 Starting/Stopping Insufflation............................................................................................................................................. 24
5.6.7 Using the SIDNE Port (Optional) .......................................................................................................................................... 25
5.6.8 Turning Device Off ................................................................................................................................................................... 25
6 Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode ...................................................... 26
6.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in High Flow Operating
Mode............................................................................................................................................................................................ 26
6.2 Selecting High Flow Insufflation Mode.............................................................................................................................. 28
6.3 Presetting Nominal Pressure in High Flow Operating Mode....................................................................................... 28
6.4 Presetting Nominal Flow in High Flow Operating Mode.............................................................................................. 28
6.5 Performing the Function Test in High Flow Operating Mode...................................................................................... 29
6.5.1 Filling Tube System with CO2 ............................................................................................................................................... 31
6.6 Using the Device during Surgery ......................................................................................................................................... 31
6.6.1 Insufflating with Veress Cannula......................................................................................................................................... 31
6.6.2 Insufflating with the Trocar................................................................................................................................................... 32
6.6.3 "Real-Time Pressure Sensing" functionality (RTP) ........................................................................................................... 32
6.6.4 Stop the Insufflation................................................................................................................................................................ 33
7 Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode....................................... 34
7.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in Pediatric Operating
Mode............................................................................................................................................................................................ 34
7.2 Selecting Pediatric Operating Mode................................................................................................................................... 36
7.3 Presetting Nominal Pressure in Pediatric Operating Mode ......................................................................................... 36
7.4 Presetting Nominal Flow in Pediatric Operating Mode ................................................................................................ 37
7.5 Performing the Function Test in Pediatric Operating Mode before Using the Device during Surgery............ 38
7.5.1 Filling Tube System with CO2 ............................................................................................................................................... 40
7.6 Using the Device during Surgery ......................................................................................................................................... 40
7.6.1 Insufflating with Veress Cannula......................................................................................................................................... 40
7.6.2 Insufflating with the Trocar................................................................................................................................................... 41
7.6.3 "Real-Time Pressure Sensing" functionality (RTP) ........................................................................................................... 41
7.6.4 Stop the Insufflation................................................................................................................................................................ 42
8 Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode................................... 43
8.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in Bariatric Operating
Mode............................................................................................................................................................................................ 43
8.2 Selecting Bariatric Operating Mode.................................................................................................................................... 45
8.3 Presetting Nominal Pressure in Bariatric Operating Mode.......................................................................................... 46
8.4 Presetting Nominal Flow in Bariatric Operating Mode................................................................................................. 46
8.5 Performing the Function Test in Bariatric Operating Mode before Using the Device during Surgery ............ 47
8.5.1 Filling Tube System with CO2 ............................................................................................................................................... 48
8.6 Using the Device during Surgery ......................................................................................................................................... 49
8.6.1 Insufflating with Veress Cannula......................................................................................................................................... 49
8.6.2 Insufflating with the Trocar................................................................................................................................................... 49

EN 8.6.3 "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 ..................................................................................... 53
9.5 Performing the Function Test in Vessel Harvest Operating Mode before Using the Device during Surgery. 54
9.5.1 Filling Tube System with CO2 ............................................................................................................................................... 55
9.6 Using the Device during Surgery ......................................................................................................................................... 55
9.6.1 Insufflation with Vessel Harvest Instrument................................................................................................................... 56
9.6.2 Stop the Insufflation................................................................................................................................................................ 56
10 Configuration Menu (Overview)......................................................................................................................................... 58
10.1 Configuration menu I.............................................................................................................................................................. 60
10.1.1 Setting First Nominal Pressure............................................................................................................................................. 60
10.1.2 Setting the Venting Controls................................................................................................................................................. 61
10.1.3 Setting the Gas Supply Type.................................................................................................................................................. 62
10.1.4 Setting the Alarm Volume ..................................................................................................................................................... 63
10.2 Configuration menu II............................................................................................................................................................. 64
10.2.1 Setting the Gas Flow Rates* .................................................................................................................................................. 64
10.2.2 Setting First Nominal Gas Flow*.......................................................................................................................................... 64
10.2.3 Setting the Maximum Nominal Pressure.......................................................................................................................... 65
10.2.4 Setting the Flow Safety Limit* .............................................................................................................................................. 66
10.2.5 Setting the Warning signal: Occlusion .............................................................................................................................. 66
10.3 Utility menu............................................................................................................................................................................... 66
10.3.1 Changing Display Settings..................................................................................................................................................... 67
10.3.2 Setting the Language.............................................................................................................................................................. 67
10.3.3 Checking Software Version.................................................................................................................................................... 68
10.3.4 Upgrade XL* ............................................................................................................................................................................... 69
10.3.5 Service Menu ............................................................................................................................................................................. 69
11 Safety functions.................................................................................................................................................................. 70
12 Care and Maintenance........................................................................................................................................................ 74
12.1 Cleaning the Device................................................................................................................................................................. 74
12.2 Annual Inspection .................................................................................................................................................................... 74
12.3 Maintenance by Authorized Service Technician.............................................................................................................. 74
12.4 Replacing the Fuse ................................................................................................................................................................... 75
12.5 Care and Maintenance of Reusable Tube Set................................................................................................................... 75
12.5.1 Cleaning the Reusable Tube Set........................................................................................................................................... 76
12.5.2 Disinfecting the Reusable Tube Set..................................................................................................................................... 76
12.5.3 Sterilization of Reusable Tube Set ....................................................................................................................................... 76
13 Annual Inspection ............................................................................................................................................................... 78
13.1 Safety Test................................................................................................................................................................................... 78
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 USA4 ................................................................................................................................................. 90
17.2 Accessories for Sale Outside of the USA ............................................................................................................................ 91
18 Warranty and Service ......................................................................................................................................................... 93
19 Appendix............................................................................................................................................................................. 95
19.1 Test Log........................................................................................................................................................................................ 95
Index ................................................................................................................................................................................... 96

Important User Notes
3
EN
1ImportantUserNotes
Read the manual carefully and become familiar with the operation and function
of the device and the accessories before use during surgical procedures. Non-ob-
servance 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.
Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and
technical data of the supplied product through continued product development.
Please noteThe words WARNING, CAUTION, and NOTE carry special meanings. Sections
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.
NOTE!
Here you will read information about the maintenance of the device or the ac-
cessories.

4
Safety Information
EN 2 Safety Information
Federal Law (only for U.S. market) U.S. federal law restricts use of this device to use by or on the order of a physician.
Exclusion of liability The manufacturer is not liable for direct or consequential damage and the war-
ranty is null and void if:
• the device and/or the accessories are improperly used, prepared, or main-
tained,
• the instructions and rules in the manual are not adhered to,
• non-authorized persons perform repairs, adjustments, or alterations on or to
the device or accessories,
• non-authorized persons open the device,
• the prescribed inspection and maintenance schedules are not adhered to.
Receipt of technical documentation from the manufacturer does not authorize
individuals to perform repairs, adjustments, or alterations on or to the device or
accessories.
Caution: No modification of this equipment is allowed.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or 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 protec-
tion 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 pos-
sible,
• 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
5
EN
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 clin-
ical 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!
To avoid risk of electrical shock, this equipment must only be connected to a sup-
ply mains with protective earth.
WARNING!
Replacing fuse
Replace the fuse only with a fuse of the same type and rating.

6
Safety Information
EN 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 sur-
gical techniques. Medical accessories and devices may be used only by physicians
and medical assistants under the direction of a physician with the appropriate
technical qualification.
WARNING!
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 de-
vice 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 appropri-
ate 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 endo-
scopes must comply with the most recent versions of IEC 60601-2-18 and
ISO 8600.

Device Purpose
7
EN
3 Device Purpose
Intended useThe PNEUMO SURE High Flow Insufflator serves to create a cavity by insufflating
CO2 during diagnostics and/or therapeutical laparoscopy. High Flow operating
mode, Pediatric operating mode, and Bariatric operating mode of the device are
used in conjunction with a laparoscope to fill and distend a peritoneal cavity with
gas. Pediatric operating mode is designed specifically for use on newborns, in-
fants, 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.
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 pres-
sure. The function of the device is to maintain the nominal pressure. Any over-
pressure 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 pres-
sure to max. 20 mm Hg and the gas flow rate to max. 20 l/min. When used on
children, the device should be set depending on the selected nominal flow and
the age and weight of the treated child as outlined in the table below:
Age Group Weight Flow Range
Children younger than 1
year approx. 1-9 kg 0.1 -0.5 l/min
Children between 1 and
3 years approx. 10-15 kg 0.5 -1.0 l/min
Children between 3 and
4 years approx. 16-19 kg 1.0 -2.0 l/min
Children between 4 and
14 years > 20 kg > 2.0 l/min

8
Device Purpose
EN 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 over-
weight (BMI > 30 kg/m2) adults. While in Bariatric mode, the insufflator limits the
pressure to max. 30 mm Hg and the gas flow to max. 45 l/min. This operating
mode delivers rapid insufflation of large volumes.
3.1.4 Contraindications 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 rel-
ative 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 mini-
mally 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 re-
quires 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 chan-
nel. 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.

Device Purpose
9
EN
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 endan-
ger the patient. In case of a disrupted gas flow, you should therefore inspect
device, tube, and instruments immediately. Surgical applications should be car-
ried 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 Con-
necting a Gas Bottle).
WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected.
Make sure the device or/and accessories can no longer be operated until a qual-
ified service technician conducts the appropriate tests and repairs.
WARNING!
Fatigue symptoms
When there is a high level of CO2consumption, you should make sure to supply
the operating area with enough fresh air, since an increasing CO2level in the air
can cause the medical personnel to suffer fatigue symptoms, an inability to con-
centrate, 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-

10
Device Purpose
EN nected to instruments which are intended for intra-abdominal CO2insufflation.
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 liq-
uids, 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 oth-
er 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 electri-
cal medical devices. All configurations have to comply with IEC 60601-1 / EN
60601-1 specifications. Whoever connects additional equipment to signal out-
put or signal input is considered the system configurator and as such is responsi-
ble 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).

Device Purpose
11
EN
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 syn-
drome) exists.
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive CO2absorption (idiosyncratic
reaction).
WARNING!
CO2absorption
CO2is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO2gas used for insufflation. CO2concentrations 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 pres-
sure or a high gas flow promotes CO2absorption. The abdomen is sufficiently
distended using a pressure between 10 to 15 mmHg. Pressure values above
15 mmHg are required for only a few cases but do increase the risk of intravasa-
tion. Never exceed the max. intra-abdominal pressure of 30 mmHg.
WARNING!
Metabolic and cardiac reactions
Insufflating CO2may result in metabolic acidosis. This can lead to cardiac irregu-
larities 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 follow-
ing, 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

12
Device Purpose
EN WARNING!
Dehydration
Insufflation can lead to dehydration of the tissue. This can result in organ tissue
damage and cardiovascular reactions of the patient. Long surgeries and large
leaks increase the risk of dehydration (especially at the insertion points of the
trocars or when changing instruments).
WARNING!
Embolism
Improper placement of the insufflation instrument could cause insufflation of
gas into a vessel, resulting in air or CO2embolisms. To reduce the risk of air or
CO2embolism, perform initial insufflation at a low flow rate and ensure that the
insufflation instrument is correctly positioned. Check the position of the insuf-
flation instrument immediately if the actual pressure rapidly reaches the nomi-
nal pressure value. CO2embolisms 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 pres-
sure. 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 addi-
tional 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 CO2absorption (idiosyncratic

Device Purpose
13
EN
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 (intravasa-
tion). 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 absorp-
tion.
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 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
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 insuf-
flation instrument immediately if the actual pressure rapidly reaches the nomi-
nal 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.

14
Initial Device Startup
EN 4 Initial Device Startup
Delivery inspection Always check all parts and accessories of the device immediately after receiving
the shipment. The manufacturer considers only replacement claims that have
been immediately submitted or reported to a sales representative or an autho-
rized 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.
WARNING!
Position the device such that it is easy to operate and disconnect.
Mains connection
CAUTION!
Check to make sure the available mains voltage matches the data listed on the
type label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and may destroy the device.
Make sure the connection data and technical specifications of the power supply
comply with DIN VDE or national requirements. The mains connection cable may
be plugged only into a properly installed, grounded safety wall socket (shock-
proof socket) (see DIN VDE 0100-710). Read the device label located in rear of de-
vice (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 be-
tween the mains wall socket and the non-heating device plug located in the rear
of the device.
Only for U.S. operators Only use a certified (UL-listed), removable mains connection cable, type SJT, min-
imal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 or IEC
60320. Grounding will only be reliable if the equipment is connected to a corre-
sponding 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 con-
nection or connect to centralized CO2 gas supply.