Respiration unit Stephan ABV . A-U Operating Instructions

OPERATING INSTRUCTIONS Respirator ABV-A / U I

1. Attention This product is in compliance with all current directives and statutory regulations The design and construction of this device comply with the following regulations and norms: DIN EN 60601-1 (and following)

Medical electrical equipment

DIN 13252

Inhalation Anaesthesia Devices

DIN VDE 0750-211

Medical electrical equipment, partial Requirements for safety of anaesthesia machines

VBG 62/04.69

Oxygen

VBG 62/03.70

Implementing Ordinance for UW Oxygen

In compliance with the law governing technical operational devices ( Instrument Safety Act) of June 24 1968 (German Civil Code Gazette/BGBI, page 717) in the wording of Amending Act of August 13 1979 (BGBI, page 1432) in the law governing Safety of Medical Devices (MedGV) of January 14 1985 (BGBI 2. page 93) we point out that:

1. The operation ofthis device is to be carried out by duly trained personnel only. Exact knowledge

and understanding ofthe operating instructions are necessary.

2. The device may only be used for the purposes indicated in the operating instructions. 3. The device must be serviced at regular intervals by trained personnel. Such servicing must be recorded in the device logbook provided. 4. The manufacturer stipulates servicing and maintenance every six months by an authorised service technician. For this reason, a maintenance agreement must be concluded. 5. Devices equipped with pressure relief systems should, for safety reasons, undergo a general reconditioning at least every five years. 6. For medico-technical devices with electrical connections, strict compliance with VDE directives

and IEC 601 (VDE 0751) is necessary. Accordingly, these devices may

only be serviced by the manufacturer or his expressed authorised representative. 7. An emergency respirator (e.g., ambu bag) must be kept near the device. 8. Operating conditions: Power supply: Room temperature:

230 V mains voltage between 10°C and 40°C

relative humidity 90% 3

OPERATING INSTRUCTIONS Respirator ABV-A/ U I

Do not place any large heat source around or on the device. Make sure there is sufficient space around the device for ample heat dissipation. 9. Check al! functions carefully to see that they are working properly according to the checklist and operating instructions. 10. Under the above conditions the device can be used in ncontinuous operation" mode. 11. Functioning of this device can be negatively influenced by other devices being used in close proximity: such as short-wave surgery and diathermy devices, defibrillators, radiothermy, etc. The manufacturer is not liable for any damage to the machine caused by improperly operating the machine or non-compliance with the instructions mentioned above.

Manufacturer:

F. Stephan GmbH KirchstraLSe19 0-56412 Gackenbach.

Tel.:

(+49) 6439-9125-0

Fax:

(+49) 6439-9125-111

e-mail:

[email protected]

Homepage:

http://www.stephan-gmbh.com

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OPERATING INSTRUCTIONS Respirator ABV-A I U I

2.

Design and description of functions

2.1 Overview The respirator module consists of a pneumatic and an electron ic control component (respirator ABV-A / U and patient component), as weil as an electron ic pressure monitor and, as an option, monitors for oxygen concentration, anaesthetic gases and ventilation parameters. The electronics of the respirator module are supplied with mains power (230 V /50 Hz), while the pneumatic requires propellant in the form of compressed air (3 - 5 bar) The respirator is suitable for controlled anaesthesia in a semiclosed system for children and adults. The patient component can easily be disconnected and replaced by means of snap couplings for purposes of hygiene (partly autoclaveable up to 134°C).

General Description Compressed air with a line pressure of 3-5 bar must be used to supply the respirator ABV-A with a propellant. The various respiration parameters can then be set on the respirator. ~ 2

.C' __ u

1) Frequency 2) Respiratory time quotient 3) Volume 4) PEEP 5) Plateau

A sufficient flow of fresh gas must be ensured. Observation of the respiration schemes of the anaesthetic device "ARTEC" is analysed in two parts.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

2.2 Technical function during the "inspiratory phase".

Functionsscheme Inspiration Volumevalve

~

•••••••••••••••••••••••••••••••••••••

~:::::::

solenoid1.Aave

: ••••••••: :: •••••••••••.-1".11 ••••••••••••••••••••••••••

PEEp· Valve o ·12 mbar

Expirationvalve Gas exceedingvalve ( Berner)

.•

•...

--------- ---. -. -. ':::I+:=' Fre-schgas

Excess Gas

To begin inspiration, the solenoid valve of the respirator opens. Via the ZGA connection, compressed air (so-called "propellantn)

flows into the patient component. The amount of in-

flowing gas is adjusted at the volume valve. Opening time of the solenoid valve is regulated by respiratory frequency and time quotient. The build-up of pressure in the Plexiglas cylinder (bottie) compresses the bellows bag. The gaseous mixture consisting of fresh gas and returned patient gas present in the bellows bag doses the expiration valve and is led to the CO2 absorber. The gas opens the inspiration valve and flows to the patient. Respiration pressure can be read both on the pressure gauge of the respirator and on the circuit system. When the respiration pressure reaches the pre-set plateau pressure limit before the end of the inspiration time, the PLATEAU valve opens, releasing propulsion gas into the open. The integrated pressure monitor allows continuous monitoring of pressures during the inspiration phase. A visual and acoustic signa I warns wh en the pre-set upper pressure limit has been exceeded.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

2.3 Technical function during the "expiratory phaseu

Functional scheme expiration Functionsscheme Expiration

... ------- ... ----------------------.--------------------

Cf==I ~

~I

CPU

... ---------". IW

1--

II

Following the inspiratory phase, the solenoid valve shuts off the flow of propulsion gas. Pressure in the lungs of the patient doses

... .- - - - - - - ~ -

-

- -

the inspiration valve and opens the expiration valve. The patient exhales into the respiration bellows which is then pressed down. At the same time, fresh gas flows into the bellows. The propellant gas being pressed out of the glas cylinder is released into the open via the solenoid valve. The excessive exhaled air is fed via the PEEP valve diaphragm. The PEEP diaphragm retains as much pressure in the system as had been pre-set on the patient component adjustable PEEP value. The reduction in respiratory pressure and the remaining positive end expiratory pressure (PEEP) are displayed on the pressure gauges of the circuit system and the respirator.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

2.4 Technical function during "manual respirationU

Functionsscheme

Manual Ventilation

Volume-

valve

PEEP - Valve 0-12 mbar

Patient component

Excess pressure

valve (Bemer) ...

Bag Exceeding

Switch over lever in .manual" position

+-=<

Freschgas

Gas

By means of the switch over lever "Man uaI I Respirator" on the patient component, the manual respiration bag is connected directly to the circuit system. Pressure build-up now develops directly via the man uaI respiration bag. CAUTION ! Pressure limitation is effected only via the excess valve (Berner valve) of the circuit system ! The PLATEAU valve ofthe patient component is disabled. Make sure the Berner valve is open after switching over to "Manual".

The PEEP and PLATEAU functions ofthe patient component are disabled. The residual pressure remaining in the circuit system can be pre-set in a range of 0 - 50 mbar via the Berner valve. Make su re that an additional connection of the scavenging system (NGA) is made to the Berner valve.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

2.5 Respirator with patient component The ABV-A / U respirator has been designed for controlled anaesthesia respiration in compliance with state-of-the-art technology. Operation of the respirator is driven by compressed air, timed and volume constant; the maximum inspiration pressure can be pre-set at the patient component The patient component is based on the "bag-in-bottle principle" with which a separation of respiratory gas from control gas is achieved. In addition, the patient component serves as a reservoir.

3

The ON/OFF switch (1) is situated at the upper left of the ).)iTEC ••• -u

.•

I front control panel. Immediately below is the volume regulation valve (2) with which the volume fJowto the patient's lungs during the inspiratory phase can be regulated. The frequency of the respiratory cycle can be varied between 6 and 60

inspirations per minute by means of the potentiometer "Frequency" (3). The ratio between inspiratory phases and expiratory phases of 1:4 to 2:1 can be pre-set using the range switch "Respiratory time quotient" (4). A pressure-proof respiratory pressure gauge shows the circuit system pressure in the range of -10 to 60 mbar. In the event of power failure, an acoustic signal is activated for at least 60 seconds. By using the switch-over lever (5) found on the patient component, either the respirator or manual respiration can be activated. The PEEP valve (6) regulates the end expiratory pressure up to a maximum of 12 mbar. The PLATEAU valve (7) achieves a constant upper limit respiratory pressure of maximum 60 mbar.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

2.6 Adjusting respirator parameters Inspiration flow chanqes on volume requlatinq valve

Principally, it is possible to vary the inspiration flow, using the volume regulating valve, to achieve a tidal volume of 0-1500 mI. Together, however, with the PLATEAU pressure distinct respiratory curves can be generated. For greater inspiratory flow, the maximum co

.D E

pressure, here limited by the PLATEAU valve, is quickly reached. Thereafter, the pressure does not change until at the end of the inspiratory phase. This PLATEAU serves to improve the alveolar exchange of gas. Volume ti sec.

flow to the patient falls, after initially reaching the PLATEAU pressure, back to "O"until it slips to negative values through the introduction of expiration. Because as much gas must flow

I sec.

back from the patient in the expiratory phase as had been led to him in the inspiratory phase, the unit area of the inspiratory flow curve must be equal to that of the expiratory

rn

flow curve .

.D E

The inspiration flow can be reduced so far that the PLATEAU pressure is reached exactly at the end of the inspiratory phase. In the case of ti sec.

renewed reduction in inspiratory flow, a respiratory curve can be realised, in which the maximum pressure reached lies below that of the PLATEAU pressure.

ti sec.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

Frequencv adiustment

The frequency, i.e., the number of

ro .c

E

inspirations per minute can be infinitely adjusted fram 6 to 60 per minute. It must be remembered, however, that in the case of increased frequency the respiratory minute

ti sec.

volume does in fact remain constant, but the tidal volume sinks. Very high frequencies can result in the maximum pressure desired not being reached and this, in turn, leads to respiration that is too flat. To prevent this occurrence, increase the inflow volume at the volume contral stem.

Respiratorv time quotient (insp:exp)

The respiratory time quotient, i.e., the ratio of inspiration time to expiration time, can be randomly varied fram 1:4 to 2:1, whereby the respiratory frequency is not influenced. Contrallimit IPPS

This respirator model allows you to carry out

ro

.c

'---' .

E

pressure-contralled respiration (IPPS), where the expiratory phase is intraduced upon reaching the pre-set maximum pressure. The Insp. zeit

,~

Insp. zeit

I-J

J~

Exsp.zelt Exsp.z€lt verkürzte

pressure limit alarm of the integrated ~j

~-

Exsp.zelt

pressure monitor is used as a pressure

Insp-zeit

contra!. The new inspiratory phase is then triggered by the pre-adjusted frequency time.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

Sensitivitv adiustment (optional. onlv for ABV-U respirators)

In order to work more effectively in the case of not completely disabled breathing or reoccurring spontaneous breathing of the

[~J

patient, we provide a respirator module "ABV-U" with an additional function for assisted-controlled respiration.

Through the inhalation efforts of the patient, a vacuum develops in ASSI~ KONTR.

the system which induces the respirator to carry out an additional completely controlled tidal volume according to the pre-set respiration parameters. If the patient's spontaneous breathing comes to a complete standstilI, respiratory frequency is reduced to the pre-set values and controlled respiration continues

automatically. The suction produced by the patient that is necessary to trigger this function can be set at a sensitivity of 0.2 to 2 mbar pressure difference using the sensitivity adjustment knob. Should possible end expiratory pressure be used, the trigger threshold automatically uses this value.

0...

t / sec. Sensitivität o - 2 mbar

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OPERATING INSTRUCTIONS Respirator ABV-A I U I

PEEP adiustment

The so-called "positive end expiratory pressure" is adjusted with the left control knob of the patient component. The purpose of increasing the pressure curve in the expiratory phase is to deny the alveoli the possibility of collapsing or even to re-expand already collapsed alveoli so that they can participate in exchange of gas once again. This PEEP can be infinitely adjusted from 0 to 12 mbar; however, a certain dependence on flow of fresh gas exist which must be considered when adjusting. The first curve runs with the

cr;

.c --E

PEEP value zero or called ZEEP

Cl

(zero end expiratory pressure), whereas the second curve depicts true PEEP.

PEEP 0 - 121mbar I ...

t / sec.

ZEEP

PLATEAU adiustment The maximum inspiratory

pressure is set using the right control knob at the patient component. The purpose of the socalled PLATEAU is to retain the inhaled gas at a constant pressure in the lungs for a short time, in order to improve the alveolar exchange of gas. In addition, the PLATEAU can be used as an upper pressure limit or security against excessive build-up of pressure. The PLATEAU value can be varied from 10 to 60 mbar. The first curve shows a low cr;

PLATEAU value, at which a

.c E --

considerable piece of the

Cl

/

PLATEAU - G,,"~

respiratory pressure curve is cut oft. The second curve requires ti sec.

higher pre-set value of the

PLATEAU, but it is visible that pressure limit has no influence on the duration of inspiration.This PLATEAU is, however, to be seen only as pressure limitation, and is in no way to function as a pressure- controlled respirator.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

Pressure monitor

The pressure monitor is an electron ic module, divided into two pressure measuring ranges for continuous monitoring of patient pressure.

1. Max. pressure The max. pressure monitor is equipped with a potentiometer, with which the maximum respiratory pressure can be infinitely adjusted from 6 to 60 mbar.

Should the patient pressure exceed the pre-set max. pressure, the pressure monitor sets off an optic and acoustic warning for the duration the limit is exceeded.

2. Minimum pressure or disconnection component

The minimum pressure range can be infinitely adjusted from 5 to 25 mbar using the potentiometer. During the respiratory phase, the minimum pressure must exceed and fall below this pre-set limit, otherwise an optic and acoustic alarm is triggered.

blinkinq red: constant exceeding of the minimum limit (PEEP too high) or constantly falling below the minimum limit value. (disconnection).

Should a disconnection exist in the respiration system that leads to a steep drop in pressure, a disconnection alarm is triggered with a 15 second delay. By pressing the membrane key "Stand-by" of the pressure monitor, the acoustic alarm can be suppressed for the duration of 2 minutes. The pressure monitor is activated via the ON switch of the respirator. It is only in operation while the respirator is switched on.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

3. MODIFICATIONS AND OPTIONS Patient component tor paediatric respiration

To enable the user to easily and quickly use the respirator tor paediatric purposes without the need ot tedious refitting, a special plexi-bottle with inner chamber has been designed. A rubber bellows designed tor paediatric respiration is inserted in the inner chamber. The plexi-bottle can be fitted in place in no time. The volume ot the paediatric system is variabie trom 0 to 400 mI.

Furthermore, it is recommended to adjust the circuit system ot the respirator to the special conditions ot paediatric anaesthetisation through the use ot a volume reducing children's hose system (Ulmer set) and removing one CO2 absorber.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

4. OPERATION CHECK

4.1 Leakage test of complete system The leakage test of the respirator

is carried out in conjunction

with that of the circuit system.

In this way leakage is checked for the entire system .

Respiration pres.gauge

~ ... ,-.. ~

Leakaoe test of ...

entire svstem:

Basic setup:

•

close flow regulator

RESPIRATOR MANUAl

JI Jni,

valve on gas .MANUAL· Swilohto

J

mixing unit

, Freschgas

•

adjust

Bag trom hese

pressure

Patient .CL"

Or

compooent remove manu;'

regulator

resp.

valve to CL •

remove mask from Y -piece

(1 ) • separate •

manual respiration

attach corrugated

bag from corrugated

hose

hose (3) to Y -piece to form closed system between circuit system and

respirator •

adjust switch lever on the patient component

from "respirator"

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to "man ua I"

OPERATING INSTRUCTIONS Respirator ABV-A/ U I

Test procedures:

• After having checked that the respiratory pressure gauge is set at zero (2) carefully open the oxygen flow regulator valve until the pressure gauge remains constant at 60 mbar.

• The amount of gas leagkage can be read on the respective measuring tube

• Should leakage be below 250 mi/min, the circuit system is sufficiently sealed for operation.

• Should leakage exceed 250 mi/min, the following points are to be checked:

=> tightness of connection

union

=> tightness of threaded couplings

=> gaskets and o-rings

=> damage to corrugated

hose

=> damage to o-rings of the patient component connection

(firmly mounted under the

repirator)

Should unacceptable leakage still exist after a second test, notify technical support.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

4.2 PEEP (postive end expiratory pressure) Basic setup:

- circuit system in operation mode - on circuit system switch excess valve to CL (closed) position - remove mask trom Y-piece - calibrate respiratory pressure gauge on respirator - connect Y-piece to test lunge - switch lever on patient component to respirator Test Procedure:

- adjustment ot oxygen or compressed air flow ot 5 I/min - adjust PEEP valve to "max.". PEEP value at respiratory pressure gauge must rise to 12 +/2 mbar within a tew seconds. - adjust PEEP valve to "min.". PEEP value at respiratory pressure gauge must taU again to 0 mbar - tolerance +/-1 mbar - notify technical support it deviations trom these values are observed.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

4.3 PLA TEAU (upper pressure limit) Basic setup:

- circuit system in operation mode - on circuit system switch excess valve to CL (closed) position - remove mask from Y-piece - connect Y-piece to test lunge - switch lever on patient component to respirator - calibrate respiratory pressure gauge on respirator - adjust PEEP valve to "min" - adjust PLATEAU valve to "max" and switch respirator on - open volume valve completely - adjust respiratory frequency to 10/min - set respiratory ratio to 2:1 - adjust on gas mixing unit dosage of fresh gas to 5 I/min. Test Procedure

-

In the inspiration phase the respiratory pressure must register 60 mbar at the respiratory pressure gauge

- Tolerance: +5 mb mbar ~

- When adjusting down the PLATEAU during the inspiration phase, the pressure is to continuously drop to approx. 10 mbar (tolerance: +5 mbar)

4.4 Respirator function - Turn on mains power switch on the respirator module - Switch on respirator's operating switch - The key of the operating switch must illuminate green showing readiness for operation -

If key is not lit green, disconnect the power plug and check fuses, and if necessary replace.

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

Power tailure alarm ot the respirator

- Turn on operating switch ot the respirator - After one minute switch off the power switch ot the respirator module - An audio warning signal wil! sound at the same time

4.5 Pressure monitor Basic setup:

- Circuit system in operation mode '--...--

- connect Y-piece to test lunge - switch lever on patient component to "respirator" - turn excess valve to "CL" - adjust tresh gas to approx. 3 - 5 I/min. - switch on respirator Test Procedure

- adjust potentiometer to 30 mbar tor "max. pressure limit alarm" - adjust potentiometer to 10 mbar tor "min. pressure limit alarm" - set "PLATEAU" pressure at approx ,,40 mbar" - an optic and acoustic warning signal must result tor the duration ot exceeding the "upper limit pressure alarm - set "upper limit pressure alarm" at ,,60 mbar" - disconnect corrugated hose trom circuit system - after 15 seconds, at the latest, the pushbuUon wil! blink red and an acoustic signal is activated - activate "stand-by" pushbuUon -

alarm must be suppressed tor 2 minutes

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OPERATING INSTRUCTIONS Respirator ABV-A / U I

5. Cleaning the respirator

5.1 Patient component

D 5.1.1 Disassembly

[]

[J

-

Loosen knurled thumb screw (1)

-

Pull out patient component

- According to sketch pull off clamps (2) forwards and laterally unhook - Remove plexiglass cylinder (3) - Remove bellows (4) and o-ring (5)

5.1.2 Cleaning Apart from the patient component's basic unit, all components are to undergo a preliminary cleaning or preliminary disinfection according to the following procedure. The components (rubber parts as weil) are put in a disinfectant. After elapse of the recommended time (manufacturer's recommended time) for effective disinfection, the parts are to be thoroughly rinsed with clear water. It is recommeded to thoroughly dry the components to prevent corrosion and the growth of bacteria. Rubber parts are not to be cleaned with hard objects.

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