Manual
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Insufflator für die Laparoskopie Insufflator for laparoscopy Insufflateur pour la laparoscopie Insuflador para laparoscopia Insufflator for laparoskopien
Handbuch
DE FR
Manual
EN FR
Manuel
FR
Manual
ES
Håndbok
NO
Bildzeichen/Pictographs/Symboles/Pictogramas/Grafiske symboler
Bildzeichen
Pictographs
Symboles
Pictogramas
Grafiske symboler
Achtung Begleitpapiere beachten
See operating manual
Attention, lire la documentation jointe!
¡Atención! Observe la documentación adjunta
OBS, vær oppmerksom på følgeskriv
Symbol für ein Gerät des Typs BF
Symbol for type BF equipment
Symbole pour un appareil de type BF
Símbolo para un aparato del tipo BF
Symbol for apparat av type BF
Symbol für den Potentialausgleich
Symbol for potential equalization
Fiche équipotentielle
Símbolo para la conexión equipotencial
Symbol for potensialutjevning
Gehäuseschutzklasse (IP-Code)
Degrees of protection provided by enclosures (IP-Code)
Degrés de protection procurés par les enveloppes (Code IP)
Grado de protección proporcionado por los envolventes (Código IP)
IP grad hus
Wechselstrom
Alternating current
Courant alternatif
Corriente alterna
Service
Service
Service
Servicio
Bestellnummer
Order number
Référence produit
Número de pedido Bestillingsnummer
Nicht zur Wiederverwendung
Single use only
Usage unique
No reutilizable
Ikke til gjenbruk
STERILE EO
Sterilisiert mit ETO
Sterile with ETO
Stérilisés à l´ ETO
Esterilizado con ETO
Sterilisert med ETO
LOT
Chargenbezeichnung
Lot no.
Numéro de lot
Denominación de partida o lote
Chargebetegnelse
Seriennummer
Serial number
Numéro de série
Número de serie
Serienummer
Herstellungsdatum
Date of manufacture
Fecha de Date de fabrication fabricación
Produksjonsdato
Verwendbar bis
Expiration day
Date limite d'utilisation
Utilizable hasta
Kan brukes til
Stück pieces
Anzahl, Menge
Pieces, quantity
Pièces, quantité
Pieza, cantidad
Antall, mengde
QTY
Menge
Quantity
Quantité
Cantidad
Mengde
IP 40
DE
EN FR
FR FR
ES
NO
REF
Service
Bildzeichen/Pictographs/Symboles/Pictogramas/Grafiske symboler
DE
Bildzeichen
Pictographs
Symboles
Latex free
LATEX FREE
FR
ES
xx
Grafiske symboler
Sin latex
EN 134 °C 3 bar 5 min
Pictogramas
Anzahl der Autoklavierungen
Number of autoclaving cycles
Paramètres pour la stérilisation à l´autoclave
Número de esterilizaciones por autoclave
Antall autoklaveringer
Vor Nässe schützen
Do not get wet
Protéger de l'humidité
Proteger contra la humedad
Beskyttes mot væte
Haut-bas
Arriba-abajo
Oppe - Nede
Fragile
Frágil
Forsiktig glass
Marche/Arrêt
Encendido / apagado
Oben - Unten
Top-Bottom
Zerbrechlich
NO Aus
Start/Stopp
Start/ Stop
Touche Start/Stop
Tecla Start/Stop
Start/Stop
Heizung
Heater
Chauffage
Calefacción
Gassoppvarming
Abnehmend Zunehmend
Increase/decrease
Décroissant Croissant
Creciente/ decreciente
Øking/avta
Flow-Symbol
Flow symbol
Symbole débit
Simbolo de flujo
Flow-symbolet
Druck-Symbol
Pressure symbol
Symbole Pression
Simbol de presión
Trykk-symbolet
Datenaufzeichnung
Data logger
Enregistrement des données
Registro de datos
Dataregistrering
Gleichstrom
Direct current
Courant continu
Corriente continua
Likestøm
Gasausgang
Gas output
Sortie de gaz
Salida de gas
Gassutgang
Menü-Taste
Menu key
Touche Menu
Tecla menú
Menytast
Reset-Taste
Reset key
Remise à zéro
Tecla reset
Tilbakestillingstast
Anhang 17.2 Rücksendeformular
DE
Rücksendeformular / Return form Bitte füllen Sie bei Rücksendung des Gerätes dieses Formular aus Please fill out the card below and mail it back with the device Name des Eigentümers / Name of owner:
Vertriebspartner / Sales representative:
Rücksendeadresse / Address of return Straße/Hausnummer/Street:
PLZ / ZIP code:
Stadt / City:
Staat / State:
Land / Country:
Gerätetyp / Type of device:
Wichtig! / Important! Seriennummer (SN, siehe Typenschild) / Serial number (SN, see identification plate):
Beschreibung des Defektes / Description of defect:
Ansprechpartner / Name of responsible person
Unterschrift / Signature
Datum / Date
67
Contents 1 2 3 4 5
6
7 8 9
10 11
12
13 14 15
Important User Notes ... 1 Safety Notes... 3 2.1 Dangers and Risks... 4 Purpose of the Device ... 7 3.1 Device-inherent Dangers... 7 Initial Use of the Device... 13 4.1 Gas Connection ... 14 Operating the Device... 15 5.1 Front of the Device ... 15 5.2 Rear of the Device... 15 5.3 Device Setup... 16 5.4 Gas Supply Display ... 18 5.5 Preselecting the Nominal Pressure... 18 5.6 Preselecting Nominal Flow ... 19 5.7 Starting/Stopping Insufflation ... 21 5.8 Actual Pressure Display... 22 5.9 Gas Consumption Display ... 22 5.10 Insufflation Tube Connection... 23 5.11 Gas Heating ... 23 5.12 Turning Device Off... 25 Safety Functions ... 27 6.1 Automatic Venting System ... 27 6.2 Exceeding Nominal Pressure ... 27 6.3 Gas Supply Display ... 28 6.4 Warning Display Occlusion... 29 6.5 Error Message Service... 29 6.6 Power Failure ... 30 User Menu ... 31 Options... 39 8.1 Remote Control ... 39 8.2 HERMES™ Port ... 40 Function Test... 41 9.1 Testing the Device ... 41 9.2 Testing the Veress Cannula ... 42 9.3 Filling Tube System with CO2 ... 43 Use of the Device During Surgery... 45 10.1 Insufflating with Veress Cannula... 45 10.2 Insufflating with the Trocar... 45 Care and Maintenance... 47 11.1 Cleaning the Device... 47 11.2 Cleaning the Reusable Tube Set ... 47 11.3 Disinfecting the Reusable Tube Set... 47 11.4 Sterilization of Reusable Tube Set ... 48 11.5 Annual Inspection... 48 11.6 Authorized Service Technician Maintenance ... 49 11.7 Replacing the Fuse... 49 Annual Inspection ... 51 12.1 Safety Test... 51 12.2 Basic Function Test... 51 12.3 Test of the Pressure Sensors... 52 12.4 Pressure Monitoring Test ... 53 12.5 Venting Valve Test... 53 12.6 Max. Device Pressure Test... 54 12.7 Gas Flow Rate Test... 54 Technical Data... 55 Error and Warning Messages... 57 Accessory List ... 59
EN
Contents 16
EN
17 18
Electromagnetic Compatibility ... 61 16.1 Impact of Mobile and Portable RF Communication Devices ... 61 16.2 Electrical Connections... 61 16.3 Accessories ... 61 16.4 Guidelines and Manufacturer's Statement - Electromagnetic Emissions... 62 16.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity ... 62 16.6 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - for the Lapflow 40 ... 63 16.7 Recommended Safety Distances Between Portable and Mobile RF Telecommunications Devices and the Lapflow 40 ... 64 Appendix ... 65 17.1 Test Record... 65 17.2 Return Form ... 67 Index... 69
Important User Notes 1
Important User Notes
Read the manual carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. Non-observance of the manual can lead to • 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.
Reading this Manual
The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product through continued development of the product.
Subject to Technical Changes
The words DANGER, WARNING and NOTE carry special meanings and they should be read carefully. The words DANGER, WARNING and NOTE carry special meanings and they should be read carefully.
Please Note
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.
EN
DANGER
These paragraphs contain information concerning the intended and proper use of the device or accessory. WARNING
Here you will read information about the maintenance of the device or accessories. NOTE
1
Safety Notes 2
Safety Notes
U.S. law stipulates that this device is to be used only by a physician or under supervision of a physician.
Federal Law (only for U.S. market)
The manufacturer does not assume any liability for direct or consequential damage if • the device or the accessories are improperly used, prepared, or maintained; • the instructions and rules in the manual are not adhered to, • non-authorized persons perform repairs, adjustments, or alterations on the device or accessories; • non-authorized persons open the device;
No Liability
EN
Receiving technical documentation from the manufacturer does not authorize individuals to 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. Any violation will void the manufacturer's warranty. Authorized service technicians are only trained and certified by the manufacturer.
Authorized Service Technician
To guarantee safe operation, it is 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 to the manual instructions prior to 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 • should be double-sealed in safety foil. The manufacturer has the right to refuse carrying out repairs if the product is contaminated. Observe national waste management regulations when disposing of device and accessories.
Disposal
3
Safety Notes 2.1
EN
Dangers and Risks
WARNING
Condensation / Water Penetration Protect device from moisture. Do not use if moisture or liquid has penetrated the device.
DANGER
Original Accessories For your own safety and that of your patient, use only original accessories.
DANGER
DANGER
Factory Settings Check all user menu settings and values. Such internal standard settings are not necessarily prescribed for the doctor. The doctor is responsible for all settings that pertain to the operation performed by him/her.
Techniques and Procedures Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect.
WARNING
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 may cause errors and malfunctions and destroy the equipment.
DANGER
Not explosion-proof Electrical components are not explosion-proof. Do not use in an area where flammable gases are present.
DANGER
Risk of Electrical Shock To prevent electrical shock, do not open this device. Never open this device yourself. Refer servicing to qualified service personnel.
Replacing Fuse Replace the fuse only with a fuse of the same type and rating. DANGER
4
Safety Notes
Professional Qualification This manual does not provide a detailed description of operation techniques and is as such not suitable to introduce a beginner to this operating technique. Medical accessories and devices may be used only by physicians and medical assistants under the direction of a physician with the appropriate technical/medical qualification.
DANGER
EN
Function Test The function test must be performed prior to each surgical procedure. DANGER
Sterile Agents and Accessories Always work exclusively with sterile substances and mediums, sterile fluids and sterile accessories.
DANGER
Cleaning the Device Do not sterilize the device. WARNING
Replacement Device and Accessories In case the device or any of the accessories fail during an operation, a replacement device and replacement accessories should be kept within easy reach to be able to finish the operation using the replacement device or replacement accessory.
DANGER
Device-inherent Dangers Read the warnings specific to this device in chapter 3.1 Device-inherent Dangers, page 7.
DANGER
Device Defect If a device defect is suspected or confirmed, stop using the device until it has been checked by authorized service personnel.
DANGER
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 ISO 8600.
DANGER WARNING
5
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. The insufflator limits the pressure to max. 30 mm Hg (mm mercury column) and the gas flow rate to the highest value possible (see device data label at rear of device). The device measures the pressure within the abdomen in regular intervals and continuously compares the nominal pressure with the current actual pressure within the abdomen. The function of the device is to maintain the nominal pressure. Any overpressure within the abdomen is lowered to the preset nominal pressure by the automatic venting system. The nominal pressure cannot be reached if the nominal flow is set too low. Check for possible leaks. The device may not be used to fill an abdomen with CO2 if a laparoscopy is contraindicated. Please consult the instructional manual of your laparoscope for absolute and relative contraindications. The device is not suitable for hysteroscopic insufflations, i.e., it may not be used to distend the uterus. The gas flow may not exceed 14 l/min when performing a laparoscopy on patients weighing less than 25 kilos.
3.1
EN
Contraindications
Device-inherent Dangers
CO2 Absorption CO2 is absorbed during insufflation (intravasation). Intravasation causes the body to absorb 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 high gas flow promote CO2 absorption. The abdomen is sufficiently distended using a pressure between 10 to mm Hg. Pressure values above 15 mm Hg are required for only a few cases but do increase the risk of intravasation. Never exceed the max. intra-abdominal pressure of 30 mm Hg.
Metabolic and Cardiac Reactions A pressure of 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.
DANGER
DANGER
7
Purpose of the Device
DANGER
Idiosyncratic Reactions Patients with sickle cell anemia or pulmonary insufficiency may have a higher risk of metabolic imbalance related to excessive CO2 absorption (idiosyncratic reaction).
EN
DANGER
DANGER
DANGER
DANGER
DANGER
8
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 • use of cold (not preheated) irrigation and infusion solutions. The risk for hypothermia can be significantly reduced with the use of gas pre-warmed to body temperature.
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).
Embolism Improper placement of the insufflation instrument could cause insufflation of gas into a vessel, resulting in air or CO2 embolisms. To reduce the risk of air or CO2 embolism, perform initial insufflation at a low flow rate and ensure that the insufflation instrument is correctly positioned. Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value. CO2 embolisms can also be caused by a high intra-abdominal pressure. Avoid high pressure settings and close damaged blood vessels at once.
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. Surgical procedures should be performed with a gas flow of 4 to 10 l/min. An even lower gas flow is recommended for diagnostic purposes.
Keep Filled CO2 Bottle on Hand Always keep a filled CO2 bottle on hand ready for replacement. This avoids having to interrupt surgery due to a lack of insufflation gas (cf. chapter 14 Error and Warning Messages, page 57).
Purpose of the Device
Automatic Venting System The automatic venting system has a limited venting rate. Whenever you use additional insufflation sources, you should constantly monitor the intra-abdominal pressure.
DANGER
EN Additional Insufflation Sources The use of additional insufflation sources increases the intra-abdominal pressure. Continuously monitor intra-abdominal pressure over the course of the entire insufflation if additional sources are used.
Contamination Do not use device and/or accessories if signs of a contamination are detected. Make sure the device/accessories can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.
Filter Use a new/sterile filter for each patient. You must work with a 0.2 µm two-way (retention rate 99.99%) hydrophobic filter between the patient and the device. This should prevent bodily fluids from entering the device and also prevents impurities from possibly entering into the patient’s body. Reduced flow capacity should be considered when using a hydrophobic filter.
DANGER
DANGER
DANGER
Contaminated Filter Exchange a contaminated filter immediately during surgery to ensure an unhindered gas flow.
DANGER
Connecting the Tube The tube outlet may only be connected to instruments which are intended for intra-abdominal CO2-insufflation.
DANGER
Positioning the 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 penetrate the insufflation tube if the patient is repositioned during surgery. If this occurs, immediately disconnect the insufflation tube at the trocar. When the patient is placed on an angle, shifting of internal tissue may block the insufflation channel. Always insufflate through the elevated side of the patient.
DANGER
9
Purpose of the Device
DANGER
EN
DANGER
DANGER
Disconnecting the Insufflation Tube Always disconnect the insufflation tube after ending the operation 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 immediately disconnect the insufflation tube from the trocar.
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.
DANGER
Fatigue Symptoms When there is a high level of CO2 consumption, you should make sure to supply the operating area with enough fresh air, since an increasing CO2 level in the air can cause the medical personnel to suffer fatigue symptoms, an inability to concentrate, unconsciousness, or even death.
DANGER
Medically Pure CO2 Make sure to use only medically pure CO2. Other gases (i. e., helium, argon), mixtures of gases, high pressure compressed gases, gases with entrapped liquids, or solid contaminants may not be used with this device.
DANGER
DANGER
10
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.
Service Connection Connected devices have to comply with the standard EN 60950. Devices may not be connected to the service connection during the surgical procedure.
Electromagnetic Interference (cf. Chapter 16 Electromagnetic Compatibility, page 61) Electromagnetic interference with other devices or instruments was practically eliminated when developing this devices and none was detected during testing. However, if you still detect or suspect such interference, please follow these suggestions: • move this device to a different location or move the other device, • increase distances between all used devices, • consult an electromedicine expert.
Purpose of the Device
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 60601-1 for electrical medical devices. All configurations have to comply with EN 60601-1-1 specifications. A person connecting additional devices to the signal IN or OUT sockets is considered to be a system configurator and as such responsible for adherence with the EN 60601-1-1 standard.
DANGER
EN
11
Initial Use of the Device 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 to a sales representative or an authorized service company.
Checking Delivered Device
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. 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
Returning the Device
Place the device on a level surface in a dry environment. The ambient temperature has to range from 10 °C to 40 °C; the relative humidity has to be between 30% and 75%.
Setup
EN
Electrical components are not explosion-proof. Do not use in an area where flammable gases are present. DANGER
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.
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 located in rear of device to determine the operating voltage of the device. The power supply has to be grounded. Use the original power cable to plug into the wall socket on one side and the rear of the device jack on the other.
Ground
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. Grounding will only be reliable if the equipment is connected to a corresponding hospital grade socket.
Only for US Operators
Integrate the device into the potential equalization system according to local safety rules and regulations.
Equipotential Bonding
13
Initial Use of the Device 4.1
Gas Connection
Always use medical grade CO2. Never use any other type of gas. DANGER
EN
Use a high-pressure tube to connect a CO2 gas bottle to the rear gas inlet connection or connect to centralized CO2 gas supply.
Gas Bottle Always use a high-pressure tube to connect gas bottle and device. WARNING
The gas bottle has to be in a vertical position. The gas bottle pressure may not exceed 80 bar.
Gas bottles with riser pipe can release dirt and oily fluids into the device. Do not use a gas bottle with riser pipe. WARNING
Gas Connection*
1. Connect the high pressure tube to the gas connection. 2. Fix the high pressure tube with the nut. 3. Tighten the nut. *The device has to be equipped with a corresponding gas connector to be connected with a central gas supply. If necessary, the device has to be retrofitted by a service technician or the manufacturer.
Central Gas Supply
Set option in user menu to Gas supply -> House gas (cf. Chapter 7 User Menu, page 31) Connect the high-pressure tube with the gas connection of the device first and then with the connection of the central gas supply.
WARNING
14
Operating the Device 5
Operating the Device
5.1
Front of the Device
Fig. 5-1-1 Front of Device
(1) (2) (3) (4) (5) (6)
(7)
(8)
(9)
(20) (19) (18) (17) (16) (15) (14) (13) (12) (11) (10)
5.2
Rear of the Device (1)
(2)
(9)
(8)
(1)
Start/stop key
(2)
LED Operation
(3)
Nominal pressure display [mm Hg]
(4)
Actual pressure display [mm Hg]
(5)
Status Display/Error & Warning Messages
(6)
Gas consumption display [l]
(7)
Nominal gas flow display [l/min]
(8)
Actual gas flow display [l/min]
(9)
Gas heater connection
(10)
Insufflation tube connection
(11)
Increase nominal gas flow (K)
(12)
Decrease nominal gas flow (L)
(13)
Reset key
(14)
Menu key
(15)
Increase nominal pressure (K)
(16)
Decrease nominal pressure (L)
(17)
LED Standby
(18)
ON/OFF Key
(19)
LED Mains voltage
(20)
Gas supply display
EN
Fig. 5-2-1 Rear of the Device (3)
(4)
(7)
(5)
(1)
Type plate
(2)
Device data plate
(3)
Service interface
(4)
Connection for equipotential bonding
(5)
Cover
(6)
Device plug
(7)
Fuse holder
(8)
HERMES Device interface
(9)
Gas connection
(6)
15
Operating the Device 5.3
Device Setup
1. Connect the gas supply to the gas connection port. 2. Open the gas supply line. 3. Connect the power cable. The device is automatically switched on and performs a self-test for approx. 15 seconds. 4. The power switch LED is illuminated in green. 5. The display shows Device check and all LEDs remain illuminated until the end of the self-test. All segments of the actual value displays are illuminated.
EN
888
The display depicts Device OK -> Select values.
• Three warning signals can be heard.
16
888
Operating the Device After the self-test has concluded, the display depicts Select values.
0
EN
0
10
3
After 3 seconds the display changes to Start ?
0
0
10
3
The device test concluded successfully. The device is operational.
17