Operating Manual
48 Pages
Preview
Page 1
OPERATING MANUAL ARGON COAGULATION UNIT
Contents
Contents Scope of delivery ...6 1.
2.
Using this Operating Manual...7 1.1.
Revision index ...7
1.2.
Scope of validity ...7
1.3.
Other applicable documents ...7
1.4.
Symbols and notation ...8 Format of warning instructions ...8
1.4.2.
Hazard levels of warning instructions ...8
1.4.3.
Tips ...8
1.4.4.
Other symbols and notation...9
Safety ...10 2.1.
Intended use ...10
2.2.
General safety instructions ...11
2.3.
Personal safety instructions ...12
2.4.
2.5.
3.
1.4.1.
2.3.1.
Ambient conditions ...12
2.3.2.
Patients with pacemakers...13
2.3.3.
Patient preparation ...13
Device-related safety instructions ...14 2.4.1.
Correct connection of the argon device ...14
2.4.2.
Correct use of the argon device ...15
2.4.3.
Correct connection and use of the argon gas bottle ...16
Safe handling (general instructions) ...17 2.5.1.
Surgical environment: prevention of explosions and ignition ...17
2.5.2.
Application of the neutral electrode ...18
Description ...19 3.1.
3.2.
Controls and indicators ...19 3.1.1.
Front panel controls and indicators ...19
3.1.2.
Rear panel controls and connectors ...20
Symbols on the device ...21 3.2.1.
Rating label ...22
3.3.
Components required for operation ...22
3.4.
Operating conditions ...22
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Operating Manual
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Contents
4.
Preparation...23 4.1.
Setting up the argon device ...23
4.2.
Switching on the argon device ...25
4.3.
Connecting instruments ...26
4.4.
5.
6.
8.
Use with flexible argon probes ...26
4.3.2.
Use with rigid argon probes ...26
4.3.3.
Using a sterile filter ...27
Functional test ...28 4.4.1.
Self-test...28
4.4.2.
Cyclical test during operation ...28
Operation...28 5.1.
Activation and alarm signals ...28
5.2.
Actions in case of problems ...28
5.3.
Settings and recommended parameter values ...29
5.4.
Selection and changeover of gas bottles ...31
5.5.
Purge function ...31
5.6.
Short-form operating instructions, fault list and cabling guide ...32
5.7.
Post-surgery instructions ...32 5.7.1.
Shutting off the argon gas ...32
5.7.2.
Exchanging the gas bottle ...32
5.7.3.
Shutting off the HF unit ...32
Detecting and Correcting Faults ...33 6.1.
7.
4.3.1.
Fault list ...33
Cleaning ...35 7.1.
Cleaning of accessories ...35
7.2.
Disinfection and cleaning ...35
Maintenance and Repair ...36 8.1.
Maintenance ...36 8.1.1.
Technical safety inspection (TSI) ...36
8.2.
Repairs ...37
8.3.
Technical service ...38
9.
Storage ...38
10.
Technical Specifications ...39
4
ARC PLUS
Operating Manual
Contents
10.1.
ARC PLUS technical data ...39
11.
Accessories and Spare Parts ...42
12.
EMC...43 12.1.
13.
Guidelines and manufacturer's declaration in accordance with IEC 60601-12:2007 ...43
Disposal...46
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Scope of delivery
Scope of delivery
6
ARC PLUS
Fibre optic cables (2x 130 mm)
Extension power cable, Y-type
Connector covers
Operating manual
ARC PLUS
Operating Manual
1 Using this Operating Manual
1.
Using this Operating Manual This operating manual is part of the product. BOWA-electronic GmbH & Co. KG, referred to in the following simply as BOWA, assume no liability nor provide any warranty whatsoever for any damage or consequential damages arising from non-compliance with the operating manual.
Read the operating manual carefully and thoroughly before using this device.
Store the operating manual in a safe place throughout the service life of the device.
Keep the operating manual accessible to operating theatre personnel.
Give the operating manual to each successive owner and/or user of this device.
Always update the operating manual whenever you receive additional information from the manufacturer.
1.1.
Revision index Software version
Last revised
Valid from Version 2.0
2016/09
1.2.
Scope of validity
This operating manual applies only to the devices designated on the title page.
1.3.
ARC PLUS
Other applicable documents Comply with other applicable documents mentioned in the appendix or in the other sections.
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1 Using this Operating Manual
1.4.
Symbols and notation
1.4.1.
Format of warning instructions
ATTENTION Nature, source and consequences of the hazard (risk of personal injury)
Measures for avoiding the risk
NOTE Nature, source and consequences of the hazard (risk of property damage)
1.4.2.
Measures for avoiding the risk
Hazard levels of warning instructions Symbol
1.4.3.
Hazard level
Probability of occurrence
Consequences of non-compliance
DANGER
Immediate risk
Death or serious injuries
WARNING
Possible risk
Death or serious injuries
CAUTION
Possible risk
Minor injuries
NOTE
Possible risk
Property damage
Tips
Tips and additional information for easier working
8
ARC PLUS
Operating Manual
1 Using this Operating Manual
1.4.4.
Other symbols and notation Symbol or notation
Meaning
Prerequisite for an activity
Activity with one step
1.
Activity with several steps in strict sequence
2. 3.
Result of preceding activity
List (first level)
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List (second level)
Emphasis
Emphasis
..., see Section “xxx”, page xxx
Cross reference
... Purge button 3
Numbers in bold face (e.g. 3) refer to marked items on photos of the device
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2 Safety
2.
Safety 2.1.
Intended use Argon plasma coagulation is particularly suitable for the thermal coagulation of tissue surfaces for haemostasis of surface bleeding on parenchymatous organs and for devitalising tissues, among other uses. The key advantages of this method are: Application does not involve contact, so there is no adhesion of tissue or other material to the electrodes leading to degradation of effectiveness (in contrast to conventional electrosurgery). The maximum penetration depth of the coagulation effect is 3 mm, and it is evenly distributed over the coagulated surface. This reduces the risk of penetration of thin-walled structures. Smoke generation is significantly reduced, which particularly in endoscopic applications improves visibility and leads to shorter surgery times. Carbonisation of tissue is avoided, which facilities better wound healing. With the aid of suitable electrodes, argon-assisted cutting is also possible. The main advantage of this is reduced smoke formation. The ARC PLUS argon device is used in combination with the ARC 200 (900-200), ARC 250 (900-250), ARC 300e (900-301), ARC 303 (900-303), ARC 300 (900-300) or ARC 350 (900-350) HF generator for cutting and coagulation in open and endoscopic surgery. The following are suitable application areas:
General surgery
Gynaecology
Casualty surgery
Plastic and reconstructive surgery
Gastroenterology
Laparoscopy
Thorascopy
Bronchoscopy
The argon coagulation unit should not be used if, in the opinion of an experienced physician or according to current professional literature, such use would endanger the patient, due for example to the general condition of the patient, or if other contra-indications are present. Trimming stents with argon coagulation is contraindicated. BOWA presumes that the argon and HF devices are operated under the supervision of qualified or authorised personnel. The surgeon and the medical staff must be trained in the fundamental principles, rules for use and risks of HF surgery and must be familiar with these in order to safely and reliably avoid putting patients, staff and equipment at risk. Contact your BOWA dealer if there is a need for training or training documents.
Any other use is neither intended nor proper and must be effectively prevented.
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2 Safety
When setting up the argon device, ensure easy access to the power cable so it can be disconnected from the device. (IEC 60601-1:2012; Ch. 7.9.2.7).
2.2.
General safety instructions
Observe the instructions on electromagnetic compatibility (see Section “EMC”, page 43).
Always connect the HF device to a mains power system with a protective earth lead in order to prevent electric shock.
NOTE The ARC PLUS device may only be operated with ARC 200 (900-200), ARC 250 (900-250), ARC 300e (900-301), ARC 303 (900-303), ARC 300 (900300) or ARC 350 (900-350).
Additional devices connected to electrical medical devices must satisfy relevant IEC or ISO standards (e.g. IEC 60950 for data processing devices). Furthermore, all configurations must comply with the standard requirements for medical systems (see IEC 60601-1-1 or Section 16 of the third edition of IEC 60601-1, as relevant). Anyone who connects additional devices to medical electrical devices is perforce a system configurator and therefore responsible for meeting standardised system requirements. Please note that local laws prevail over the aforementioned standard requirements. In case of questions, please contact your local dealer or service centre (see Section “Technical service”, page 38).
NOTE Impairment of other devices. Electromagnetic interference fields are generated during normal use of the argon device.
Ensure that no electronic devices that may be impaired by electromagnetic fields are placed in the vicinity of the argon and HF devices.
The following measures are advisable:
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Place sensitive devices in a separate location.
Use separate mains power circuits.
Keep HF cables as short as reasonably possible.
Do not route HF cables and camera cables next to each other.
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2 Safety
Argon gas
Ensure that only argon gas with purity grade 4.8 or better is used.
All connected instruments must be purged with argon gas before use.
Close the gas bottle(s) after every use. Refill gas bottle in accordance with applicable national standards.
2.3. Personal safety instructions 2.3.1.
Ambient conditions Do not operate the HF device in the immediate vicinity of the patient. Observe the minimum distances recommended by BOWA, as shown in the following figure.
Figure 2-1:
12
Patient environment
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2 Safety
2.3.2.
Patients with pacemakers
Malfunction or destruction of the pacemaker can endanger the life of the patient or result in irreversible injuries to the patient.
In the case of patients with pacemakers, consult the cardiologist before carrying out HF surgery. This applies in particular to surgery in the thorax region.
Observe the corresponding instructions in the operating manual for the HF device.
Attach the HF neutral electrode close to the operating field.
Set the demand pacemaker to a fixed frequency.
Ensure that the pacemaker does not come into contact with the HF electrode.
Keep a fully operational defibrillator within reach.
Carry out a postoperative pacemaker check.
2.3.3.
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Patient preparation
To avoid emphysemas, do not insert the electrodes into tissue or open vessels, or apply them directly to tissue or open vessels.
Always keep the distal end of the electrode visible during surgery.
Due to the monopolar operating mode, the HF current flows through the patient’s body to the neutral electrode. For this reason, always ensure that no thermal damage occurs to nearby tissue structures with a tendency to increased local current density.
In the case of gastrointestinal surgery, the endogenous gases must be securely removed by purging before and during surgery.
Position the patient so that the patient is not touching any metal parts that are grounded or have considerable capacitance relative to ground (e.g. operating table brackets). If necessary, place anti-static towels between the patient and the bedding.
Ensure that the patient does not touch any wet towels or bedding.
Avoid skin-to-skin contact.
Place anti-static towels between areas of heavy sweating and skin-to-skin contact on the patient's trunk.
Ensure a suitable support surface in order to prevent pressure necrosis.
Drain urine via a catheter.
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2 Safety
2.4. Device-related safety instructions Devices manufactured by BOWA are developed in accordance with the current state of technology and generally accepted safety rules. Despite this, risks to the life and health of the user or other parties and/or damage to the device and other objects can occur.
Use only accessories approved by BOWA; see Section “Accessories and Spare Parts”, page 42.
Use the device only if it is free from technical defects and in good working order and only for the intended purpose, always remaining aware of safety requirements and risks while complying with this operating manual.
Have malfunctions that can adversely affect safety (e.g. deviations from the permissible operating conditions) repaired without delay.
Wipe down the HF device only with cleaning agents and disinfectants that are nationally approved for surface cleaning. See Section “Disinfection and cleaning”, page 35.
Never immerse the device in water or cleaning agents.
Never use automatic equipment to disinfect the device.
Immediately drain any fluid that may have penetrated the device.
If the argon device has previously been stored or transported at temperatures below +10 C or at a relative humidity over 75%, it will take approximately three hours to adjust to room temperature.
2.4.1.
Correct connection of the argon device
The HF voltages present during electrosurgery can cause interference to imaging devices. This interference can be largely eliminated by suitable grounding and screening.
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Always ground the argon and HF devices via the equipotential bonding terminals (e.g. to the equipotential rail of the equipment trolley). Connect the equipotential rail of the equipment trolley to the equipotential rail of the operating theatre, This will minimise interference to other electronic devices from the argon and HF devices.
Do not place any equipment other than the ARC 200 (900-200), ARC 250 (900-250), ARC 300e (900-301), ARC 303 (900-303), ARC 300 (900-300) or ARC 350 (900-350) HF generator on top of the argon device.
HF voltages are present during argon-assisted electrosurgery. Orderly insulation of all probes, electrodes, wiring and cables with respect to the HF generation being used must therefore be verified before each use.
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2 Safety
Connection to the AC mains
Connect the device directly to the AC mains.
Caution: To avoid the risk of electric shock, always connect the device to a supply network with a protective earth lead.
If the ARC PLUS forms part of a medical electrical system, the requirements in Section 16 of IEC 60601-1:2005 must be observed.
If a medical electrical system is formed with the ARC PLUS by use of a multiple socket-outlet as a separate unit, a warning must be present to indicate that this multiple socket-outlet may not be placed on the floor.
Avoid using multiple socket-outlets.
Do not use any additional multiple socket-outlets or extension cables.
Always ensure that the installation conforms to the allowable limits for leakage current and protective earth lead resistance. These limits may be exceeded if several devices (medical and non-medical) are connected to a multiple socket-outlet. The totality of devices connected to a multiple socket-outlet form a system and must be regarded as a unit.
If a multiple socket-outlet is powered from an isolation transformer, ensure that no part of the system is at the same time powered from the regular supply mains, as otherwise galvanic isolation will no longer be present.
If a multiple socket-outlet not powered from an isolation transformer is used, connections to devices used for medical purposes must only be possible with the aid of a tool.
2.4.2.
Correct use of the argon device
Endoscopic use In laparoscopic surgery the argon entering the body cavity increases the abdominal insufflation pressure (CO2), unless a suitable arrangement to compensate for the pressure rise is provided.
We recommend using an insufflator with pressure monitoring.
To prevent potential damage to the camera optics, do not aim the argon plasma jet at the camera chip.
For patient protection, avoid touching the patient and any of the following parts at the same time:
ARC PLUS
exposed contacts of plug-and-socket connectors;
contacts of fuse holders that are accessible during fuse replacement;
contacts of lamp sockets that are accessible when the lamp is removed;
parts inside an access cover, o
which can be opened without using tools or
o
where a tool is necessary but the use instructions instruct any
o
operator who is not a member of maintenance staff to open the cover concerned.
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2 Safety
2.4.3.
Correct connection and use of the argon gas bottle
Observe the safety instructions of the gas supplier. Only personnel trained to deal with pressurised gas containers may handle these containers.
Always transport gas bottles with the valve protector fitted, and avoid exerting force on the bottle and the pressure reducer.
Observe the use instructions for the pressure reducer that is used.
The maximum permissible inlet pressure at the device for operation from bottled gas is 4.5 bar.
Use only argon with purity grade 4.8 or better.
Protect the bottle against heating from external sources, such as open flames or radiators.
Use only pressure reducers approved by BOWA.
Ref. 900-901 900-902 900-903 900-904
Designation Pressure reducer for ARC PLUS, DIN no. 6 Pressure reducer for ARC PLUS, DIN no. 10 Pressure reducer for ARC PLUS, CGA 580 Pressure reducer for ARC PLUS, BS 341 no. 3
Do not use damaged gas bottles.
Uncontrolled outflow of argon gas, if it reaches sufficient concentration in the atmosphere, can lead to oxygen deficiency and the associated consequences for the organism. For this reason, always check connections for leaks if you hear a persistent hissing sound.
Do not use leaky gas bottles, pressure reducers or pressurised gas lines.
Do not apply any lubricants to the pressure reducer, and do not use any tools for assembly.
Up to two gas bottles can be connected using pressure reducers. Gas bottle connector
Pressure gauge
Quick-release coupling on end of hose
Figure 2-2:
16
Pressure reducer
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Operating Manual
2 Safety
2.5. Safe handling (general instructions)
Before each use of the device, check to ensure that it is functioning properly and is in good working order.
Observe the instructions for use with regard to standards; see Section “Hazard levels of warning instructions”, page 8.
Always observe and obey the acoustic signals or fault indications of the HF device and argon device system during use; see Section “Fault list”, page 33.
The device and accessories may be operated and used only by persons who have the necessary training, knowledge and experience.
Regularly inspect accessories, particularly electrode cables and endoscopic accessories, for damage to the insulation.
Do not place any instruments on the patient or on the devices.
Avoid unintentional activation.
Avoid direct contact with the patient.
Avoid indirect contact through electrically conductive objects or wet cloths.
Temporarily place HF instruments not currently being used use in a beaker or in a dry area of the preparation trolley.
Always adjust the acoustic activation signal for good audibility.
Ensure that no instruments are being cleaned when AUTOSTART is activated.
Do not use needle electrodes as ECG electrodes.
Wear suitable gloves during surgery.
Always set the output power of the HF device as low as possible.
Use a central gas supply network where possible. The argon gas purity grades specified by BOWA and the maximum inlet pressure specifications must be observed.
The maximum permissible inlet pressure at the device for operation from a central gas supply network is 6.0 bar. The corresponding option must be present on the argon device.
2.5.1.
Surgical environment: prevention of explosions and ignition
Argon itself is not flammable, but the high temperature of the plasma can ignite other flammable materials and gases.
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For this reason, always purge endangered intestinal sections with argon or CO2 gas before activating the HF current.
Do not use the argon device in areas where there is a risk of explosion.
Do not use any flammable or explosive liquids.
Stop using the argon device if any display components fail.
Avoid using ignitable anaesthetics and gases which support combustion (e.g. nitrous oxide or oxygen) during surgery in regions such as the head or thorax.
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2 Safety
Use only non-flammable cleaning agents, disinfectants and solvents (for adhesives). If you use flammable cleaning agents, disinfectants or solvents, ensure that they have fully evaporated before using the HF surgical equipment.
Ensure that no flammable liquids collect beneath the patient or in body cavities (e.g. the vagina). Suction and/or purge body cavities before activating the device.
Wipe off all liquids before using the HF device.
Ensure that no endogenous gases are present that could ignite.
Ensure that all materials saturated with oxygen (e.g. cotton or gauze) are kept far enough away from the HF environment that they cannot ignite.
Always check oxygen lines for leaks.
If the output power is not sufficient with the customary settings, first ensure that:
the neutral electrode is correctly attached;
the working electrodes are clean;
the connectors are properly connected
before selecting a higher output power.
2.5.2.
Do not use the device if even the smallest irregularity is present.
Application of the neutral electrode Observe the instructions for use of the neutral electrode in the operating instructions of the HF device and the instructions on the packaging of the neutral electrode.
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Operating Manual
3 Description
3.
Description 3.1.
Controls and indicators
3.1.1.
Front panel controls and indicators
2
14
12
5
13
1 15
4
3
7
6
8
9
10
11
16
On/Off switch and
Up/Down buttons for adjusting the gas flow for cutting Gas flow indicator "Cutting" in l/min
and
Up/Down buttons for adjusting the gas flow for coagulation Gas flow indicator "Coagulation" in l/min Selector switch for gas bottle 1 Level indicator for gas bottle 1 Selector switch for gas bottle 2 Level indicator for gas bottle 2 Symbol for gas bottle 1 Symbol for gas bottle 2 Fault indicator / output error Purge button Luer Lock gas connector; for argon instruments only
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3 Description
3.1.2.
Rear panel controls and connectors
26
25 19
20
21
22
23
24
Fibre optic signal output connector Fibre optic signal input connector Bleed stub for pressure reducer connection hose Connector for pressure reducer (gas bottle 1) Connector for pressure reducer (gas bottle 2) Equipotential bonding pin Socket for mains plug
Use the following connections only for service and training purposes: UART communication interface
The USB connector can be used to perform software updates. The maximum voltage at the SIP/SOP ports is 15 VDC.
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3 Description
3.2. Symbols on the device Symbol
Designation Purge button Fault indicator Connector for gas bottle 1 Connector for gas bottle 2 Bleed stub for pressure reducer Fibre optic signal output Fibre optic signal input Equipotential bonding Fuse Alternating current HF energy in the range of 9 kHz to 400 GHz is used when the HF device is activated. This energy generates electromagnetic radiation. Labelling of electrical and electronic devices in accordance with Directive 2002/96/EC (WEEE); see "Disposal" Manufacturer Date of manufacture Observe operating instructions On/Off switch
IP 21
Protection Class Catalogue number Serial number CE-marking with number of notified body UART communication interface
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