Operating Instructions
17 Pages
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ARTEC Anaesthesia Machine
Operating Instructions
Status 05.99
01/7-hö
Operating Instructions Artec Table of contents
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GENERAL INFORMATION
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2
TECHNICAL DESCRIPTION
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2.1
Possible Expansion and Upgrading of the Unit
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2.2
Scope of Use and Application
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3
DESCRIPTION
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3.1
Gasmixingunit 3 and 4
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3.2
O2 – Ratiosystem
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3.3
O2-Flush
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3.4
AIR/N2O Mode Switch
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3.5
O2- supply deficiency signal
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3.6
Nitrous Oxide Block
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3.7
Vaporizer
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3.8
Gas-cylinder Supply Component
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4
TESTING UNIT FUNCTIONS
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4.1
Dosage valves of the Gas Mix Unit
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4.2
O2-Flush
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4.3
AIR / N2O Mode Switch
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GAS TYPE TEST AND TESTING SAFETY DEVICES
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5.1
Testing Gas Type
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5.2
Testing the Vaporizer / Vaporizer holding rack
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CLEANING AND CARE OF ANESTHESIA UNIT
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7
NOTES ON POTENTIAL MALFUNCTIONS
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8
TECHNICAL DATA
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9
MAINTENANCE AND SERVICING
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Operating Instructions Artec
1 General Information The „ARTEC inhalation anesthesia unit is in compliance with all current directives and regulations. During the design and development of the unit, the following regulations and standards have been taken into consideration. DIN 13 152 IEC 601/VDE/0750 VBG 62/04.69 VBG62/03.70
Inhalation Anestesia Units Electrical Safety of Medical Products Oxygen Operating Instructions for UVV Oxygen
The Medical Equipment Regulations (MedGV), and the law on technical medical working materials (MPBetreibV) stipulate that the attention of the operator must be drawn to the following: The operation of the Unit must be carried out only by qualified personnel. Exact knowledge and understanding of the Operating Instructions is a pre-conditioned for operation. Use of the equipment is solely for that as stipulated in the Operating Instructions. Inspections and servicing must be duly entered in the Logbook of the Unit. The Equipment must be inspected at regular intervals by qualified personnel only. F.Stephan GmbH stipulates a half-yearly inspection and maintenance by one of its authorized Service Technicians. Before each use of the unit, a complete function test of the unit must be carried out. In the case on medico.technical devices with electrical connection, the standards of particular VDE 0751 and IEC 601 must be closely complied with. According to these standards, such devices may only be set up and put into operation by the manufacturer or his expressedly authorized technician or dealership. Unit equipped with a pressure reducer should undergo a basic overhaul at least every 5 years for reasons of safety. An emergency ventilation system (e.g. Ambu-Bag) must always be in close proximity of the unit. F. Stephan shall assume no responsibility or liability for any damage or defects arising from non-observance of the above-mentioned information.
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Operating Instructions Artec
2 Technical Description Driven by customer requests and requirements, the ARTEC model series had been designed and developed as a compact universal version. At the same time high qualitystandards and maximum economy has been achieved. The elementary structure ensures a good overview and quick allocation and adjustment of parameters for the respective unit components. The ARTEC anesthesia unit is an inhalation anesthesia unit that is equipped with a anesthesia agent specific vaporizer for use in a semi-closed system The unit consists of a basic housing of stainless steel in which a drawer is provided. Located above that is the gas-mix unit (GME, with which the available medical gases O2, N2O and (optional) compressed air can be dosaged. The GME consists of an integrated pneumatic unit with relvant safety valves providing for N20 block and O2 deficiency signal (in compliance with DIN 13252 and the dosage unit for the above-mentioned medical gases. On the right-hand side, an anesthesia agent specific vaporizer can be mounted on special mounting racks ( one or two-fold). Located on the basic unit and depending on model, there is provided a stainless steel shelf for additional monitoring or a ventilation module with integrated monitoring (according to DIN 13252). On the reverse side of the unit there are standard connections for gas supply linea and depending on model, holding racks for reserve bottles with integrated high-pressure reducers. The unit is also equipped with four plug sockets for electrical power supply for additional monitors. These sockets are constantly supplied with current regardless of the Ventilators ON/OFF power supply status.
2.1 Possible Expansion and Upgrading of the Unit Basic Model The ARTEC basic model is suitable for wall mounting. For such mounting, the mounting rails of the basic unit ar attached to the V2A rails. For wall mounting, exact vertical mounting of the unit must be strictly observed, otherwise inexact mounting could lead to falsh measuring results of gas flows. An adjustable distancer device provides a precise alignment of the unit. Unit Model with Mobile Stand The unit can be mounted on a mobile stand that enables and ensures variable site operation. The basic unit can be mounted on the mobile stand profile (80x30) by tightening the four mounting bolts. The mobile stand can be equipped with a stand-alone oxygen, compressed air and vacuum generator module „STAXEL“
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Operating Instructions Artec Gas Supply: The unit is designed with a central gas supply coupling connection in compliance with DIN 13253. A set of hoses is supplied with the unit for the three types of gases O2, N2O and compressed air ( if air is provided). Gas supply can either be via a central gas supply network, or via bottle supply with 10 litre bottles O2 and N2O. To ensure uninterrupted gas supply, in the event of breakdown of the central gas supply, 2 litre reserve bottles can be connected. An alternative to bottled gas supply, the ARTEC anesthesia unit offers the possiblity of a decentalized oxygen supply via the supply „outlet“. This is the „STAXEL“ that has been especially developed as an oxygen / compressed air and vacuum generator.
Ventilation Module: The ventilation module ABVA is easy to use and can eventually mounted to the basic unit later on. For this the V2A shelf is removed from the basic unit. After that the ventilation module can be mounted to the basic unit via two mounting bolts. The compressed air supply of the ventilator is created via a connection line to the basic unit.
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Operating Instructions Artec After attaching the V2A shelf, you now have a respiratory-contolled anesthesia ventilation system with the current necessary state-of-the-art monitoring system. It is strongly advised to have the installation carried out by our specially trained Stephan Service Team.
2.2 Scope of Use and Application The ARTEC is an inhalation anesthesia unit for the manual anesthesia of infants, children and adults. It can be used in conjunction with a ISO circuit system, but can also be operated with open ventilation systems. The scope of applications of the ARTEC anesthesia unit ranges from use in the practitioner’s surgery to hospital operation theatres.
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Operating Instructions Artec
3 Description 3.1 Gasmixingunit 3 and 4 02
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N 20
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6 9 1
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0, 8
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0, 6
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0, 4
4 2 1
5 4
0, 2
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O2
O
N2 O
2
02
0 FLUSH 2
The gasmixingunit serves as a dosage unit for medical gases (e.g. O2, N2O, Air). The choosen gases can mixed in a arbitary relation, but the ratio-system guarantees a O2-concentration higher then 21 % (see below). The different gases are clearly displayed with rotary buttons. To avoid mistakes, the O2-rotary button discerns from the others. A unintentional move is prevented by a protection. The dosing device makes a continuous flow enable, when opening the valves by rotation against clockwise. The O2-measuring range contains two measuring devices. This makes a fine dosage possible. The left measuring tube has a range from 0 to 2 l/min O2, the right tube has a range from 2 to 15 l/min O2. As point of observation serves the upper surface of the floating body.
N2 0
3.2 O2 – Ratiosystem A r t .N r . 1 5 0 6 1 0 7 0
02
AIR N 20
The Gasmixingunits GME 3 and GME 4 can be equipped optionally with a pneumatical system to assure at every flowrange of N2O a minimum concentration of oxygen of 25 % O2 (+/- 5%). The so called O2 - Ratiosystem avoids the delivery of pure N2O to the breathing system. Mode of operation
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0, 8
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0, 6 0, 4 0, 2
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0 FLUSH 2
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02
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AI R
AIR
N2 0
G a s mi s c h e i n h e i t G M E 4 Ar t . N r . 15 0 6 1 0 7 1
The O2 – Ratiosystem examines the O2 – Flowrate. If there is no O2 – Flow the N2O – Line is blocked. Thus it is impossible to apply pure N2O to the breathing system without opening the O2 – Valve at the GME. Only when the O2 – Valve is opened counterclockwise, a N2O – flow according the flowrate of O2 can be adjusted. The minimal achievable oxygen concentration is 25 % +/- 5%. Control of function 1. Close O2 – and N2O – Valve at the GME. 2. Open N2O – Valve to maximum ⇒ There should be no N2O – Flow 3. Open O2 – Valve counterclockwise ⇒ N2O – Flow is increasing 4. Adjust 1 l/min O2 ⇒ N2O – Flow should be 3 l/min +/- 0,2 l/min 5. Adjust 3 l/min O2 ⇒ N2O – Flow should be 9 l/min +/0,6 l/min
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Operating Instructions Artec Caution The O2 – Ratiosystem controls the O2 – concentration in the freshgas. It doesent prevent in any case a hypoxic gasmixture in the circlesystem. Please do control the inspiratory O2 – concentration by using an oxygenmonitor.
3.3 O2-Flush By pressing the O2 Flush push-button, a fast oxygen supply (approx. 50 litres per minute) is activated directly to the fresh-air outlet (not via the anesthesia vaporizer). After releasing the O2 Flush push button it must return to it original position.
3.4 AIR/N2O Mode Switch The Air / N2O Mode Switch is located below the rotary knobs for (AIR /N2O). This offers a pre-selection of the gases AIR or N2O. The respective dosage of the gases is effected via the regulation valve.
3.5 O2- supply deficiency signal In the event of a pressure drop in the supply system (oxygen below 2.0 to 1.5 bar) an acoustic warning alarm is activated for a duration of at least 7 seconds. An interruption is not possible).
3.6 Nitrous Oxide Block In the event of a further fall in presure of oxygen to about 1 bar,the ratio of N2O is reduced proportionately to the oxygen supply. Should there be a total fallout of oxygen, the N20 flow is set to zero. Release of N2O is then closed. The unit stand-by mode can be resumed only by setting the stipulated oxygen pressure of at least 2 bar at the network inlet.
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Operating Instructions Artec
3.7 Vaporizer On request, the ARTEC inhalation anesthesia unit can be equipped with various vaporizersystems. In the standard model, the vaporizerss come in use which are equipped with an „Interlock‘“ locking system to enable alternating operation of two vaporizers. The anesthetic agent is mounted to the selected vaporizer rack by means of a click-in mechanism. The locking lever secures the vaporizer on the holding rack. Please read the operating instructions of the respective model of vaporizer with which the ARTEC anesthesia unit is equipped.
Vaporizer holding-rack „single“
The unit is equipped with one vaporizer rack holder. Only one vaporizer can be put into operation. The vaporizer holding rack is provided with automatic closing valves. The seal between the vaporizer and the holding rack takes on the function of a gasket ring placed on the valve. Optionally, a side-rail possiblity for a second vaporizer can be provided besides the active vaporizer holding rack. Vaporizer holding rack „two-fold“ Interlock locking system: Interlock
The unit is provided with two vaporizer holding racks. Two vaporizers can be alternately used. The vaporizers are provided with locking devices that disables the vaporizer that is not in operation .
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Operating Instructions Artec
3.8 Gas-cylinder Supply Component When in the gas-cylinder operation mode, the gas is reduced from 200 or 50 bar to a working pressure of 5 bar. The cylinder pressure can be read on the pressure gauge and indicates the status of level fill of the gas bottles. The feed of the gases to the actual unit is effected via the quick-fit couplings or the DIN threaded couplings which are unmistakeably coded according to type of gas being used. IMPORTANT: When transporting, it is absolutely necessary to close the cylinder-valves.
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Operating Instructions Artec
4 Testing Unit Functions
4.1 Dosage valves of the Gas Mix Unit When closing the dosage valves make sure that the respective floating marker of the respective measuring tubes are re-set to zero. Otherwise, a leakage of the respective spindle will result that must be remedied by a service technician.
4.2 O2-Flush Before each operation of the ventilation unit check to see whether the O2 bypass valve immediately and automatically closes after releasing the push-button. Basic Setting: Dosage valve (1) on measuring tube section is closed. Conducting Test: Briefly press the bypass button. On release of the push-button it immediately return to its initial position.
4.3 AIR / N2O Mode Switch Basic Setting: O2 dosage valve closed N2O dosage valve set to 3 litres per minute AIR dosage valve set to 3 litres per minute Mode Switch in „N2O“ position Anesthesia aspiration unit connected O2 monitor calibrated and in operating mode Conducting Test: The measuring tubes for N2O must show 3 litres per minute flow, while the compressed measuring tube must indicate no flow. The O2 monitor shows approx. 0% O2 (after a brief waiting time). When switching from N2O to AIR – without changing dosage valve status – indication of floating marker of the N2O measuring tube must return to zero, while, at the same time the display of the compressed-air measuring tube must indicate 3 litres per minute. The O2 monitor shows 21% O2 as comfirmation.
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Operating Instructions Artec
5 Gas Type Test and Testing Safety Devices 5.1 Testing Gas Type: Check for proper connection of the anesthesia unit to the central gas supply system before operation of the unit. Basic Setting: Unit in operation mode Anesthesia gas aspiration unit connected O2 monitor in standby mode and calibrated. Measuring at fresh gas outlet.
Conducting the test: Oxygen ( O2): Open the O2 dosage spindle to approx. 1.5 to 2.0 litres per minute. The O2 monitor must display approx. 98 to 99 O2. Nitrous Oxide (N2O): Open the N2O dosage spindle to approx. 1.5 to 2.0 litres per minute. The O2 monitor must display 0 % O2. Compressed air (AIR) Open the AIR dosage spindle to approx. 1.5 to 2.0 litres per minute The O2 monitor must display approx. 21% O2 In the event of any deviance, the unit must undergo a service inspection!
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Operating Instructions Artec
5.2
Testing the O2 deficiency signal / nitrous oxide block:
Basic Setting: Unit in operation mode Anesthesia aspirator device connected All dosage valve spindles opened to 3 litres per minute AIR / N2O Mode Switch in N2O position Conducting test: remove angle plug for O2 from circuit the oxygen flow must continuously decrease at apprix. 2.0 to 1.5 bar circuit pressure the O2 deficiency signal is activated When pressure further decreases to approx. 1 bar, the nitrous oxide block is activated and the N2O flow sinks parallel to the oxygen flow, until for a fully empty system both volumen flows fall to zero. By re-connecting the O2 angle plug, the oxygen supply is re-established. Interruption of the N2O feed line. The N2O flow sinks to zero. In the event of deviations of the description above, please inform customer service.
5.2 Testing the Vaporizer / Vaporizer holding rack The anesthesia agent vaporizer is to be check for its proper function before using the unit. Basic Setting: Unit set in operation mode Anesthesia agent vaporizer filled and ready for operation Conducting the test: Vaporizer: Check adjusting and locking device for proper functioning Check level status display for damage Check adapter for safety support for damage Check vaporizer locking lever
Condition of Vaporizer: Check sealing valve for leakage Inspect sealing gasket for exterior damage
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Operating Instructions Artec
6 Cleaning and Care of Anesthesia Unit The anesthesia unit is to undergo a thorough cleaning at appropriate intervals; whereby servicing measures must also be conducted that will prolong the service life of the machine. After removing the vaporizer, the unit can be wiped clean using a common detergent agent. It is highly recommended to follow this up by using a dry cloth to remove any moisture and thus limiting any danger of corrosion. Special attention should be given to the O-rings located at the vaporizer holding rack. These are to be carefully removed, cleaned and replaced in a dry condition. Should these rings show damage of any type, they are to be replaced by new O-rings.
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Operating Instructions Artec
7 Notes on Potential Malfunctions Error Possible Cause(s) Floating marker of the Measuring tube is dirty measuring tubes do not return to zero Dosage valve leakage
Remedy Clean measuring tube Loosen rotary knob and reset (Service)
When using Mode Switch Mode switch valve is not Replace mode switch valve AIR/N2O switch, the properly sealed. (customer service) selected gas is not activated (indicated via O2 monitor) Oxygen concentration too Leakage in oxygen dosage Loosen rotary knob and rehigh valve set (customer service) Flush Valve does not close Replacement of Flush properly Valve by customer service O2 deficiency signal constantly activated
is Supply pressure too low
Valve is defect
Set pressure reducer of the bottle supply higher Have customer replace valve
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serve
Operating Instructions Artec
8 Technical Data Inhalation Anesthesia Unit MPG-Class 2b, Model Registration Number: 11 / M-01491 Typ: B Protection Class: 1 U: 230 V AC P: 80 VA (with ventilator) Dimensions (with Ventilator ABVA) Width: 500 mm Height: 1350 mm Depth: 630 mm Dimensions (without Ventilator ABVA) Width: 500 mm Height: 1240 mm Depth: 630 mm Connections (threaded) for Gas Types: O 2: M 12 x 1 AIR: M 20 x 1.5 N2O: M 14 x 1 Fresh Gas: M 16 x 1.5 Circuit pressure 5 bar +/- 0.5 bar Measuring range for measuring hoses: O2 (fine) : 0 to 2 litres per minute (roughly) : 2 to 15 litres per minute AIR N2O
: :
0 to 15 litres per minute 0 to 15 litres per minute
Precision of Measuring tubes: +/- 10% of the respective end scale value. For integrated micro measuring range +/- 10% of the measuring endscale value (under standard conditions 20ºC and 1.013 bar)
O2 deficiency signal: Trigger pressure: Duration of acoustic warning signal
2.8 bar 7 seconds
N2O Block: Trigger pressure:
2.0 bar
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Operating Instructions Artec
9 Maintenance and Servicing Medico-technical products and required to undergo at regular intervals inspection and servicing in compliance with MedGV (Medical Equipment Regulations). Such inspections and servicing are to be carried out by authorized personnel only (Service Staff) of the Supplier.
Periodic Maintenance is genenally semi-yearly. Safety Technical Inspections Recommended Scope: 1. Visual check of necessary identification markings and Exterior detected damage 2. Check for completeness of Unit 3. Check proper functioning and alarm functioning 4. Measure earthing resistance, replacement unit ground contact and the insulation resistance in comliance with VDE 0751 Part 1/12.84 The Maintenance Agreement ensures the best guarantee, and provides semi-annual inspections with automatic replacement of parts subject to wear. Should maintenance and servicing of the unit be carried out by unqualified and unauthorized persons, the Manufacturer cannot be held reliable for the safe and proper functioning of the unit.
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