stryker_40l_core_insufflator_user_manual_rev_c.pdf
Page 1
Manual
Manual
Manuel
Handbuch
US Version
EU Version
Insufflator for laparoscopy
lnsuflador para laparoscopia
.
lnsufflateur pour la laparoscopie
lnsufflator fur die Laparoskopie
Page 2
This manual contains information that is subjectto copyright.All
rights resewed. This manual should not be photocopied,
duplicated on microfilm or otherwise copied or distributed,
completely or in part, without the approval of STRYKER
ENDOSCOPY.
Some o f the parts and equipment referred t o in this manual bear registered
trademarks but are not identified as such. It should therefore not be assumed
that the absence ofthetrademark indicates that any given designation is not
subject t o trademark protection.
Users o f this product should not hesitate fo point out t o us any errors or
unclarities in this manual.
Copyright O STRYKER ENDOSCOPY
Ce manuel contient des informations proteg6espar la legislation
des droits de propriQ6 et des droits dlauteur.Tous droits sont
proteges. IIest interdit de reproduire ou de distribuer ce manuel
- que ce soit integralement ou partiellement par photocopie,
microfilm ou autres procedes de reproduction sans I'autorisation
ecrite expresse de I'entreprise STRYKER ENDOSCOPY.
En raison du perfectionnement permanent de nos produits, nous nous
resewons le droit de prodder a des modifications techniques sans avis
prealable. II se peut que les fonctionnalites ou que le design des produits
different partiellement de la description figurant dans le manuel. Pourde plus
amples informations concernant ce produit ou d'autres produits, n'hesitez pas
a nous contacter.
Les designations qui representent en meme temps des marques deposees
n'ont pas 3 6 specifiquement caracterisbes. L'absence du logotype ne peut en
aucun casfaire supposer que la designation represente une marque non
deposee. De la mCme maniere, cela n'indique pas la presencede brevets ou de
modeles deposes.
STRYKER ENDOSCOPY remercie d'avance les utilisateurs de ses produitsqui lui
fourniront des informations eu egard ides errata possibles ou 9 des
imprecisions susceptibles d'ctre contenus dans ce bresent manuel.
Copyright@STRYKER ENDOSCOPY
Este manual contiene informaciones protegidas por el derecho
de propiedad (copyright), que forma parte de 10s derechos de
autor. Todos 10s derechos estan protegidos. Sin autorizacidn por
escrito de STRYKER ENDOSCOPY, este manual no podr6 ser ni
total n i parcialmente reproducido ni divulgado por medio de
fotocopia, microfilm u otros medias y procedimie~tos.
Debido al desarrollo constante de nuestros productos, nos rese~amosel
derecho a llevar a cabo modificacionestecnicas sin aviso previo.El
funcionamientoy el diseiio podr6n diferir parcialmentede la dcscripcion en el
manual. Rogamos establezcan contact0 con nosotros, si desean adquirir m6s
informacion sobre este o cualquier otro producto.
Las denominaciones que son, a su vez, marcas registradas, no han sido
identificadas especialmente.Lafalta de la identiicacibn con marca no implica
que el product0 en cuestion no posea marca comercial alguna. Asimismo, no
pueden sacarse conclusionesdel presente manual, sobre la existencia o
inexistencia de patentes n i modelos de utilidad.
STRYKER ENDOSCOPYagradecera a 10s usuarios de 10s productos de STRYKER
ENDOSCOPY cualquier aviso, indicacidn u obsewaci6n con respecto a posibles
fallos, incongruencias o explicaciones poco claras que puedan encontrarse en
el presente manual.
Copyright O STRYKER ENDOSCOPY
Dieses Handbuch enthalt eigentumsrechtlich geschutzte
Informationen, die dem Urheberrecht unterliegen. Alle Rechte
sind geschutzt. Ohne ausdruckliche, schriftliche Cenehmigung
von STRYKER ENDOSCOPY darf dieses Handbuch weder
vollstandig noch in Auszugen durch Photokopie. Mikrofilm oder
andere Verfahren vewielfaltigt oder verbreitet werden.
Durch die stiandige Weiterentwicklung unserer Produkte behalten wir uns
technische iinderungen ohne Ankijndigungvor. Funktion oder Design konnen
teilweise von der Beschreibungi m Handbuch abweichen. Bitte kontaktieren
Sie uns, um weitere lnformationen zu diesem oder anderen Produkten zu
erhalten.
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STRYKER ENDOSCOPY ist Anwendern von STRYKER ENDOSCOPY-Produkten
dankbar fiir jeden Hinweis auf mogliche Fehler oder Unklarheiten dieses
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Copyright O STRYKER ENDOSCOPY
Manufacturer/Fabricante/ Fabricant/Hersteller
-
Stryker
Endoscopy
5900 optical Court
CA95138
-
CE marking according t o Directive 93142lEEC
Identificacibn CE conforme a la directriz 931421CEE
Marquage CE conforme ila directive 931421CEE
CE- Kennzeichnung gemaR Richtlinie 931421CEE
Modell Model01 Seriel Baureihe
Regulatory Manager, Stryker France
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, FRANCE
FllZ~MIOIZ01-5199-DI1205lama
Page 3
1 Pictographs 1 Pictogramas I Syrnboles 1 Bildreichen /
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operating
manual
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Observe la
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documentation
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Simbolo para un
aparato del tip0 BF
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Symbole pour un
appareil de type BF
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Symbol for type BF
equipment
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Degrees of protec- I Grado de protec- 1 Degres de protecprovided by
c~onproporcionado tion procures par
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equalization
enclosures (IP-Code)
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Gehauseschutzklasse (IP-Code)
Service
Order number
N h e r o de pedido
R6firence produit
Bestellnummer
Single useonly
1
No reutilizable
Esterilizadocon
ETO
1
Denominacibn
departida o lote
Serial number
Pieces, quantity
Latex free
Numberof
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Sterilises iI'ETO
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Nlimero de serie
NumCro de serie
Seriennummer
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STERILE EO sterile vnth ETO
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beachten
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Numero de
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Page 4
1
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tf
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a
Pictographs
get wet
Top-Bottom
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1
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Proteger contra la
humedad
Arriba-abajo
1
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Proteger de
l'humiditl
Haut - bas
1
1
Bildzeichhen
Vor Nasse
schiitzen
Oben - Unten
I.
Fragile
Frigil
Fragile
Heater
Calefacci6n
Chauffage
Heizung
IncreaselDecrease
iE$iE:e
Croissan t l
decroissant
Zunehmendl
abnehmend
Connectorsignal input
Entrada para seiiales
Entreede signaux
Eingangfur Signale
signal output
Connector-
I
Salida para seiiales
I
Sortie de signaux
Zerbrechlich
1
p,usgawfur "gna-
Direct current
Corriente continua
Courant continu
Cleichstrom
Gas output
Salida degas
Sortie de gaz
Gasausgang
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1
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Manufacturer
Stryker European
Representative
1
Fabricante
Representante
europeo de Stryker
(
Fabricant
Representant
Stryker Europe
I
1
Hersteller
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...................................................................................................................................................
..........................................................................................................................................................
....................................................................................................................................................
Important User Notes
1
Safety Instructions
3
2.1
Dangers and Risks .........................................................................................................................................................................4
Purpose of the Device
7
3.1
Device-inherent Dangers ............................................................................................................................................................8
Manufacturer's Notice: Device Versions ................................................................................................................................
12
3.2
Initial Use of the Device
13
4.1
Gas Connection ..............................................................................................................................................................................1 4
Operating the Device
15
5.1
Front of the Device ........................................................................................................................................................................15
5.2
Display ..............................................................................................................................................................................................15
5.3
Rear of the Device .......................................................................................................................................................................16
5.4
Device Setup ................................................................................................................................................................................... 16
5.4.1 High Flow Application ..................................................................................................................................................................17
5.4.2 Low Flow Application (optional) ...............................................................................................................................................17
5.5
Gas Supply Display ........................................................................................................................................................................18
5.6
Presetting Nominal FlowINominal Pressure with High Flow Application ................................................................... 18
5.6.1 Presetting Nominal Pressure with High Flow Application ................................................................................................ 18
5.6.2 Preselecting Nominal Flow with High Flow Application ................................................................................................... 19
5.7
PreselectingNominal Flow/Nominal Pressure with Low Flow Application ................................................................. 2 1
5.7.1 PreselectingNominal Pressure with Low Flow Application .............................................................................................. 22
5.7.2 Preselecting Nominal Flow with Low Flow Application .....................................................................................................23
5.8
StartIStop Key .................................................................................................................................................................................
25
5.9
Actual Pressure Display ...............................................................................................................................................................
26
5.10 Gas Consumption Display ........................................................................................................................................................... 26
26
5.11 lnsufflation Tube Connection ....................................................................................................................................................
26
5.12 Gas Heating .....................................................................................................................................................................................
5.13 Switching Device Off ....................................................................................................................................................................28
Safety Functions
29
User Menu
33
43
Options
8.1
Video Messaging (Superposition) .............................................................................................................................................43
Function Test
45
9.1
Testing the Device .........................................................................................................................................................................
45
9.2
Testingthe Veress Cannula ........................................................................................................................................................
46
9.3
Fill Tube System with CO2 ..........................................................................................................................................................47
Use of the Device During Surgery
49
10.1 lnsufflating with Veress Cannula .............................................................................................................................................
49
10.2 lnsufflating with the Trocar .......................................................................................................................................................49
Care and Maintenance
51
11.1 Cleaning the Device ......................................................................................................................................................................
51
11.2 Cleaning of the Reusable Tubing Set .......................................................................................................................................5 1
11.3 Disinfecting the Reusable Tube Set ........................................................................................................................................ 51
52
11.4 Sterilization of Reusable Tube Set ............................................................................................................................................
11.5 Annual Inspection .........................................................................................................................................................................52
11.6 Maintenance Carried out by Authorized Service Technician ...........................................................................................52
11.7 Replacingthe Fuse ........................................................................................................................................................................53
Annual inspection
55
12.1 Safety Test .......................................................................................................................................................................................55
12.2 Basic Function Test (in High Flow Mode) ...............................................................................................................................55
12.3 Test of the Pressure Sensors ...................................................................................................................................................... 56
12.4 Pressure Monitoring Test ............................................................................................................................................................57
12.5 Venting Valve Test ........................................................................................................................................................................57
12.6 Max. Device Pressure Test ..........................................................................................................................................................58
12.7 Gas Flow Rate Test .......................................................................................................................................................................58
Technical Data
59
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.......................................................................................................................................................................
...........................................................................................................................................................................
..................................................................................................................................................................
..................................................................................................................................
....................................................................................................................................................
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................................................................................................................................................................
Page 6
Contents
14
15
16
17
*W
......................................................................................................................................
Electromagnetic Compatibility
61
14.1 Impact of Mobile and Portable RF Communication Devices ............................................................................................ 6 1
61
14.2 Electrical Connections ..................................................................................................................................................................
61
14.3 Accessories ......................................................................................................................................................................................
14.4 Guidelines and Manufacturer's Statement - Electromagnetic Emissions .................................................................... 62
14.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity ........................................... 62
14.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity 40L Core lnsufflator .....................................................................................................................................................................
63
14.7 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and
the 40L Core lnsufflator ..............................................................................................................................................................
64
Accessories
65
15.1 Accessories for 40L Core lnsufflator with Integrated Low Flow, Mode US ................................................................... 65
15.2 Accessories for 40L Core Insufflator with Integrated Low Flow, Mode EU ................................................................... 65
15.3 Remote Control (only for EU Version) .....................................................................................................................................66
Error and Warning Messages
69
Appendix
71
17.1 Test Record .....................................................................................................................................................................................7 1
73
17.2 Return Form ................................................... ................................................................................................................................
......................................................................................................................................................................
........................................................................................................................................
........................................................................................................................................................................
Page 7
s
t
*
Important User Notes
Important User Notes
1
Read the manual carefully and become familiar with the operation and function
of the device and the accessories before using either for surgical procedures.
Noncompliance with the manual may lead
Readingthis Manual
t o life-threatening injuries of the patient,
t o severe injuries of the surgical team, nursing staff or service personnel, or
t o damage or malfunction of device andlor accessories.
The manufacturer reserves the right to modify the appearance, graphics, and
technical data of the product through continued development of the product.
Subject toTechnical Changes
Paragraphs with the words DANCER, WARNING, and NOTE carry special
meanings and should be read attentively.
-
-
-
- -
-
-
- -
- -
The safety and/or health of the patient, user, or a third party is at risk. Comply
with this warning to avoid injury to the patient, user, or third party.
These paragraphs contain information concerning the intended and proper use
of the device or accessory.
A
DANGER
a
WARNING
Here you will read informationabout the maintenance of the device or accessories.
El
NOTE
Page 8
Important User Notes
stw-
iI
Left Blank on Purpose
1'
Page 9
Safety Instructions
2
Safety Instructions
U.S. federal law restricts use of this device by or on the order of a physician.
U.S. Federal Law (Only for U.S. Market)
The manufacturer does not assume any liability for direct or consequential
damage if:
No Liability
the device orthe 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 the
device or accessories;
non-authorizedpersons open the device;
the prescribed inspection and maintenance schedule is not adhered to.
1
1
4
1
I
Receiving technical documentation from the manufacturer does not authorize
individuals t o perform repairs, adjustments, or alterations on the device or
accessories/peripherals.
Only an authorized service technician may perform repairs, adjustments, or
alterations on the device or accessories and use the service menu. Authorized
service technicians are only trained and certified by the manufacturer.
Authorized Service Technician
To guarantee safe operation, it i s absolutely necessary to carry out proper care
and maintenance of the device and accessories. For the protection of the patient
and the operating team, check that the device is complete and functional before
each use.
Care and Maintenance
New products as well as repaired products must be prepared and tested
according t o the manual instructions priorto use.
For the protection of the service personnel and to maintain safety during
transportation, all devices and accessory parts that are sent in to be repaired
must be prepared for shipment as described in the manual.
Contamination
If this is not possible,
the product must be clearly marked with a contamination warning and
double-sealed in safety foil.
The manufacturer has the right t o refuse carrying out repairs if the product is
contaminated.
This symbol indicates that the waste of electrical and electronicequipment must
not be disposed as unsorted municipal waste and must be collected separately.
Please contact the manufacturer or other authorized disposal company to
decommissionyour equipment.
Waste Management
Page 10
S
t
-
Safety Instructions
2.1
A
A
A
DANGER
Dangers and Risks
Condensation/Water Penetration
Protect device from moisture. Do not use if moistureor liquid has penetratedthe device.
Original Accessories
For your own safety and that of your patient, use only original accessories.
DANGER
DANGER
A
DANGER
A
A
A
A
DANGER
DANGER
DANGER
DANGER
Factory Settings
Check all user menu settings and values (cf. chapter 7 User Menu, page 33). Such
internal standard settings are not necessarily prescribedfor the doctor. The doctor i s responsible for all settings that pertain to the operation performed by
him/her.
Technique and Procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this device is indicated. The physician must determine the specific technique and procedurethat will accomplish the desired clinical effect.
Available Mains Voltage
Check to make sure that the available mains voltage matches the data listed on
the label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and destroy the equipment.
Not Explosion-Proof
Electrical components are not explosion-proof. Do not use in an area where flammable gases are present.
Risk of Electrical Shock
To prevent electrical shock, do not open this device. Never open this device yourself. Refer servicingto qualified service personnel.
ReplacingFuse
Replace the fuse only with a fuse of the same type and rating.
Page 11
St-
Professional Qualification
This manual does not include descriptions or instructions for surgical proceduresltechniques. It i s also not intendedt o introduceto or train physiciansin the
use of surgical techniques. Medical accessories and devices may be used only by
physicians and medical assistants under the direction of a physicianwith the appropriate technicallmedical qualification. Only specially trained and qualified
personnel may use this device on children.
Safety Instructions
A
DANGER
Function Test
The function test must be performed prior to each operation.
I
DANGER
Sterile Substances and Accessories
Always work exclusively with sterile substances and mediums, sterile gas, and
sterile accessories.
Cleaning the Device
Do not sterilize the device.
A
A
A
DANGER
DANGER
Replacement Device and Accessories
In case the device or any of the accessories fail during an operation, a replacement device and replacementaccessoriesshould be kept within easy reach to be
able to finish the operation using the replacement device or replacement accessory.
Device-inherent Dangers
Read the warnings specific to this device in chapter 3 Purpose of the Device, page 7.
DANGER
A
A
A
DANCER
Device Defect
If a device defect is suspected or confirmed, stop using the device until it has
been checked by authorized service personnel.
Endoscope
The device may only be connected to endoscopes designed for use with the device for the intended medical procedure. The endoscopes must comply with the
most recent versions of IEC 60601-2-18 and I S 0 8600.
DANGER
DANGER
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Safety Instructions
Left Blank on Purpose
6
I
Page 13
Purpose of the Device
3
Purpose of the Device
The device serves to insufflate CO2 into the abdomen during a diagnostic or
therapeutic laparoscopy. Please consult the instructional manual of your
laparoscope for additional information and special application indications.
Intended Use
The insufflator has two operating options.
The High Flow application limits the pressure to max. 30 mm Hg (mm mercury
column) and the gas flow to max. 40 Ilmin.
High FlowApplication
The device measures the pressure within the abdomen in short intervals and
continuously compares the nominal with the actual abdominal pressure. The
function of the device is to maintain the nominal or set point pressure. Any
overpressure within the abdomen is lowered to the preset nominal pressure by
the automaticventing system.
The Low Flow application limits the pressure to max. 20 mm Hg (mm mercury
column) and the gas flowto max. 20 Ilmin.
Low Flow Application
The Low Flow application is specially designed for use on newborns, infants, and
children.
When used on children, it is recommended to control and adjust the device and
the nominal flow based on the following factors:
Age Group
Weight
Flow Range
Children youngerthan 1 year
approx. 1-9kg
0.1 -0.5Ilmin
Children between 1 to 3 years
approx. 10-15kg
0.5 -1.0Ilmin
Children between 3 to 4years
approx. 16-19kg
1.0 -2.0Ilmin
Children between 4to 14years
2 20 kg
> 2.0 l/min
The nominal pressure cannot be reached if the nominalflow is set too low. Check
for possible leaks.
1
Due t o the special operating method used during the Low Flow application
(optional), the speed of equalizing the leak is slower than when using the High
Flow application (lower effective flow in Low Flow application).
I
I
i
The device may not be used to fill an abdomen with CO2 if a laparoscopy i s
contraindicated. Please consult the instructional manual of your laparoscope for
absolute and relative contraindications.
i
I
I
I
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 Ilmin when performinga laparoscopy on infants
or patients weighing less than 25 kg.
Contraindications
Page 14
Purpose of the Device
3.1
DANGER
Gas Flow Limit
The gas flow may not exceed 14 I/min when performinga laparoscopy on infants
or patients weighing less than 25 kilos.
-
A
A
Device-inherentDangers
-
-
-
-
-
-
-
-
-
-
Pneumolabium/Pneumoscrotum
Children are at risk of a pneumolabium or pneumoscrotum.
DANGER
DANGER
A
DANGER
A
A
DANGER
DANGER
A
DANGER
Increased Airway Pressure/Compression of the Vena Cava
When using the Low Flow application on children, an increased risk of high airway pressure and/or compression of the vena cava (low input syndrome) exists.
Positioningthe Patient
Always position the patient lower than the device to prevent body fluids from
leaking into the device. Intra-abdominal pressure can be increased and fluid can
penetratethe insufflation tube if the patient is repositionedduring surgery. If this
occurs, immediately disconnect the insufflation tube at the trocar. When the patient i s placed on an angle, shifting of internal tissue may block the insufflation
channel. Always insufflatethrough the elevated side of the patient.
Idiosyncratic Reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive C 0 2 absorption (idiosyncratic
reaction).
-
-
CO2 Absorption
CO2 is absorbed during insufflation (intravasation). lntravasation causes the
body to absorb part of the CO2 gas used for insufflation. CO2 concentrationsin
the blood or respiratory system that are too high can lead todeath 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
breathingwell. Sufficient respirationcan help avoid or limit problems with CO2.
High pressure or high gas flow promote CO2 absorption.
Metabolic and Cardiac Reactions
A pressureof more than 20 mm Hg can result in metabolic acidosis. This can lead
to cardiac irregularities and the following symptoms :
Reduced respiration with restricted diaphram function
Reduction of venous reflux
Reduced cardiac output
Metabolic acidosis
Page 15
stryker'
Hypothermia/Monitoring Body Temperature
The gas flow can lead to a lowering of the patient's body temperature during insufflation. This in turn can cause heart and cardiovascular problems. Always
monitor the patient's body temperature during the entire insufflation. Make especially sure that the following, hypothermia promoting, operation conditions
are avoided as best as possible:
*High gas flow due to large leaks
Long surgeries
U s e of cold (not preheated) irrigation and infusion solutions.
The risk for hypothermia can be significantly reduced with the use of gas
pre-warmedto body temperature.
Dehydration
lnsufflation 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).
Embolism
Improper placement of the insufflation instrument could cause insufflation of
gas into a vessel, resulting in air or C 0 2 embolisms. To reduce the risk of air or
COZ embolism, perform initial insufflation at a low flow rate and ensure that the
insufflation instrument i s correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressurevalue. CO2 embolisms can also be caused by a high intra-abdominal
pressure. Avoid high pressure settings and close damaged blood vessels at once.
Additional lnsufflation Sources
The use of additional insufflation sources increases the intra-abdominal pressure. Continuously monitor intra-abdominal pressure over the course of the entire insufflation if additional sources are used.
Disconnecting the lnsufflation Tube
Always disconnect the insufflation tube after ending surgery and before switching off the device to prevent backflow of bodily fluids. Fluid may penetrate the
insufflation tube whenever you change the gas cylinder and/or when you stop
the gas flow during the operation. If this happens, you must immediatelydisconnect the insufflation tube from the trocar or from the device.
Backflow
Body secretion or contaminated gas can result in a backflow into the device, if
*a filter is not used,
*the actual pressure is higher than the nominal pressure or
*the automatic venting valve is activated.
Purpose of the Device
A
DANGER
A
DANGER
A
DANGER
A
A
DANGER
DANGER
A
DANGER
Page 16
SImkeP
Purpose of the Device
A
DANGER
A
A
A
DANGER
DANCER
DANGER
A
A
DANCER
DANGER
Gas Flow
A high gas flow can be due to large leaks within the surgical system or instrument. This can result in an 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. It i s recommended to perform laparoscopies with the lowest gas flow possible.
Keep Filled C02 Bottle on Hand
Always keep a filled CO2 bottle on hand ready for replacement. This avoids having to interrupt surgery due to a lack of insufflation gas (cf. chapter 16 Error and
Warning Messages, page 69).
Contamination
Do not use device andlor accessories if signs of a contamination are detected.
Make sure the devicelaccessoriescan no longer be operated until a qualified service technician conducts the appropriate tests and repairs.
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 C02 level in the air
can cause the medical personnel to suffer fatigue symptoms, an inability to concentrate, unconsciousness, or even death.
Automatic Venting System
The automatic venting system has a limited venting rate. Whenever you use additional insufflationsources, you should constantly monitor the intra-abdominal
pressure.
Filter
Use a newlsterile filter for each patient.
You must work with a 0.2 pm two-way (retention rate 99.99 %) hydrophobic filter between patient and device. This should prevent bodily fluids from entering
the device and also prevents impuritiesfrom possibly entering into the patient's
body. Reducedflow capacity should be considered when using a hydrophobic filter.
-
A
A
DANGER
DANGER
-
-
ContaminatedFilter
Exchange a contaminated filter immediately during surgery to ensure an unhindered gas flow.
Connecting the Tube
The tube outlet may only be connected to instruments which are intended for intra-abdominal CO2-insufflation.
Page 17
Purpose of the Device
Electronic Device Control
The valve located at the trocar sleeve may not be closed intraoperatively. The
electronic control unit of the device adjusts the intra-abdominal pressure as desired.
I
Medically Pure C02
Make sure t o use only medically pure CO2. Other gases (i. e., helium, NzO, argon), mixtures of gases, high pressure compressed gases, gases with entrapped
liquids, or polluted gases may not be used with this device.
Service Connection
Connected devices have t o comply with the standard EN 60950. Devices may not
be connected t o the service connection during the surgical procedure.
Electromagnetic Interference (cf. chapter 14 Electromagnetic Compatibility,
Page 61)
Electromagneticinterferencewith other devices or instrumentswas practicallyeliminated when developingthis devices and none was detected during testing. However, if you still detect or suspect such interference, please follow these suggestions:
*move this device to a different location or move the other device,
*increase distances between all used devices,
*consult an electromedicineexpert.
-
-
A
A
A
A
DANGER
DANGER
DANGER
DANGER
-
Peripheral Devices
Additional equipment connected to the interfaces of the device have to meet the
following specifications:
EN 60601-2-18 for endoscopic devices and EN 60601-1for electrical medical devices. All configurations have t o comply with EN 60601-1-1specifications.
A person connecting additional devices to the signal IN or OUT sockets is considered to be a system configurator and as such responsible for adherencewith the
EN 60601-1-1 standard.
A
DANGER
.
Page 18
-
Purpose of the Device
3.2
Manufacturer's Notice: Device Versions
0620-040-511
SIDNE
EN, NL, FR, DE
0620-040-512
SIDNE
EN, NO, SV, DA, FI
0620-040-513
SIDNE
EN, ES, IT, PT, EL
Page 19
Initial Use of the Device
Strykw
4
Initial Use of the Device
Always check all parts and accessories of the device immediately after receiving
the shipment. Inspect for external damage as well. The manufacturer considers
only replacement claims that have been immediately submitted or reported t o a
sales representative or an authorized service company.
Input Control
If it becomes necessary to return the device, use of the original packaging is
required. The manufacturer does not take responsibility for damage that has
occurred during transportation if the damage was caused by inadequate
transport packaging.
Returningthe Device
Please fill out the return form enclosed at the end of the manual. Enclose the
manual with the device.
Please make sure that all required information has been supplied:
Name of owner
Address of owner
Device type
Serial number (see identification plate)
Description of defect
Place the device on a level surface i n a dry environment. The ambient
temperature has t o range from 10"C t o 40 "C; the relative humidity has t o be
between 30% and 75%.
Setup
A
Electricalcomponentsare not explosion-proof. Do not use in an area where flammable gases are present.
DANCER
Power Supply
Check to make sure that the available mains voltage matches the data listed on
the label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and destroy the equipment.
a
WARNING
Make sure the connection data and technical specifications of the power supply
comply with DIN VDE or national requirements. The power cord may be plugged
only into a properly installed safety wall plug (see DIN VDE 0107). Read the device
label (device data plate) located in rear of device t o determine the operating
voltage of the device.
The power supply has t o be grounded. Use the original power cable to plug into
the wall socket on one side and the rear device jack on the other.
Protective Contact
Use only an approved detachable power supply cable, type SJT, minimum 18
AWG, 3 conductors, one end configured for NEMA 5-15, other end for IEC
320/CEE22.
Onlyfor US Operators
Grounding will only be reliable if the equipment is connected t o a corresponding
hospital grade socket.
Integrate the device into the potential equalization system according t o local
safety rules and regulations.
Equipotential Bonding
Page 20
-
Initial Use of the Device
4.1
A
DANGER
Gas Connection
Always use medical grade CO2. Never use any other type of gas.
Use a high-pressure tube to connect a C02 gas bottle t o the rear gas inlet
connedion or conned t o centralized C02 gas supply.
Gas Bottle
a
WARNING
8
Always use a high-pressuretube t o connect gas bottle and device.
The gas bottle has t o be in a vertical position.
1
Gas bottles with riser pipe can release dirt and oily fluids into the device.
Do not use a gas bottle with riser pipe.
I
WARNING
Gas Connection
II
The gas bottle pressure may not exceed 80 bar.
I
1. Connect the high pressure tube t o the gas connedion.
2. Fix the high pressure t u be with the nut.
3. Tighten the nut.
Page 21
Operating the Device
5
Operating the Device
5.1
Front of the Device
Fig. 5.1.1 Front of the Device
Startlstop key
a
a
a
Gas heater connection
@
lnsufflation tube connection
a
lncreasing nominal gas flow
Display
Reducing nominal gas flow
a
Gas consumption reset key
@
Menu key
lncreasing nominal pressure
5.2
(lo)
Reducing nominal pressure
(11)
IRsensor
(12)
ONIOFF key
Display
Fig. 5.2.1
I
lnsufflation stopped
- 15mrnHg1
0.01
I
I
I- I
pin
I
Display
Status display1Error & warning messages
a
a
Actual pressure
a
Actual flow
@
Nominal gas flow
a
Gas consumption
Gassupply
a
Nominal pressure
Page 22
Operating the Device
Fig. 5.3.1
a
Rear of the Device
Type plate
@
Device data plate
StPYkeF
5.3
RearoftheDevice
5.4
Device Setup
SIDNE Interface
(optional)
Data inputloutput
a
Connection for
equipotential bonding
Sockets for VIDEO RGBICSCC
OUT Signal (optional)
a
Socket for VIDEO S-VHS
OUT Signal (optional)
Sockets for the VIDEO RGBICSCC
IN Signal (optional)
@
Socket for the VIDEO S-VHS
IN Signal (optional)
(10)
Device plug
(11)
Fuse holder
(12)
Gas connection
1. Connect the gas supply t o the gas connection port.
2. Open the gas supply line.
3. Press the ONIOFF key. The device switches on.
Device check
I
The device now conducts a self-test. Device ok followed by Select values appears
in the display.
a
WARNING
The corresponding display is depicted after switching the device on again depending whether the device was last operated i n the High Flow or Low Flow
mode. Use the user menu option "Application" (cf. 7 User Menu, page 33) to
switch between Low Flow or High Flow application.
Page 23
Operating the Device
5.4.1
High Flow Application
Ifthe device was switched off while in High Flow mode,thefollowing is displayed
after the self-test has concluded after switching the device back on:
Oik
lnsufflation stopped
OmmHg
1
15mrn~g
0.01
3- I
min
The display Device Check in the status line is replaced with the display
Device OK->Select values followed by the display lnsufflation stopped.
The device test concluded successfully. The device is operational.
5.4.2
Low Flow Application (optional)
If the device was switched off while in Low Flow mode, the following is displayed
during the self-test Low Flow Application
Application: Low Flow
Device check
The display Device Check in the status line is replaced with the display
Device OK-Select values followed by the display lnsufflation stopped.
With activated Low Flow mode, the displayed logo NEONATAL indicates that the
device is still in Low Flow mode.
OmmHa
Oiik
lnsufflation stopped
8mmHg
B",*
81
0.01
1
Omliiiiii
I
The device test concluded successfully. The device is operational.
Page 24
Operating the Device
5.5
Gas Supply with Gas Bottle
Gas Supply Display
The following gas bottle pressures are displayed:
> 40 bar
1
1
House Gas Supply
1
uI
B2
1
15-40 bar
< 15 bar
The following house gas supply pressures are displayed:
I
House gas supply pressure
OK
House gas supply pressure
too low
The status o f the house gas supply cannot be evaluated until after insufflation
has started due t o technical reasons. The display will show Check Gas Supply
after approx. 5 seconds if the gas supply is insufficient.
The gas supply display depicts the lower display (House gas supply too low).
Once insufflation has stopped, the gas supply indicator returns t o the upper
display (House gas supply pressure OK).
5.6
Presetting Nominal Flow/Nominal Pressure with High Flow Application
5.6.1
PresettingNominal Pressure with High Flow Application
PRESET PRESSURE
00
This setting is possible in standby mode and during operation o f t h e device.
Press the A key once t o activate setting the values in increments o f 1.
Keeping the A key depressed longer than 1.5 seconds activates scrolling i n
increments o f 1.
Page 25
StrYkF
Operating the Device
Press the V key to reduce the nominal pressure.
Decreasing Nominal Pressure
Press the A key to increase the nominal pressure.
Increasing Nominal Pressure
Select a nominal pressure between 1- 30 mm Hg. The preset value i s indicated in
the nominal pressure display.
A safety limit message is displayed starting with 15 mm Hg.
Safety limit
15mm Hg
1
I
PRESET PRESSURE
00
The nominal pressure of "15 mm Hg" is a threshold value. This is where the
recommended range for the intra-abdominal pressure ends. Pressing the
nominal pressure A key again does not increase the pressure any further.
Release the key 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.
Exceeding this safety limit is to be decided by and the responsibility of the usedoperator.
a
WARNING
5.6.2
PreselectingNominal Flow with High Flow Application
I
3-mln
This setting is possible in standby mode and during operation of the device.
Keeping the A I V key depressed allows you to adjust 3 levels for the nominal gas
flow. Factory setting:
Level 3 llmin
2. Level 20 llmin
3. Level 40 llmin
1.
The preset values of the user menu can be customized as well.
Seleda nominal gas flow between 1-40 I/min.The preset value is indicated in the
nominal gas flow display.