HEYER Modular Operating Manual Rev 1.1 July 2007

Page 1

Modular

Anesthesia System

Operator’s Manual

Rev. 1.1 – 07/07

MODERN SOLUTIONS FOR ANESTHETICS AND INHALATION

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HEYER Modular

7.3 CMV Ventilation Mode ............................................................................................................ 37 7.3.1 CMV Ventilation Mode ..................................................................................................... 37 7.3.2 Setting Alarm Limits in CMV mode .................................................................................. 38

7.4 PVC Ventilation Mode............................................................................................................. 38 7.4.1 PCV Ventilation Mode...................................................................................................... 39 7.4.2 Setting Alarm Limits in PCV mode................................................................................... 39

8 Alarm Elimination......................................................................................................................... 40 9 Dismantling and Reassembling.................................................................................................. 41

9.1 The Patient Module................................................................................................................. 41 9.1.1 The CO2 absorber............................................................................................................ 41 9.1.2 The Bag-in-Bottle System................................................................................................ 41 9.1.3 Exchanging the Expiratory Flow Sensor.......................................................................... 41 9.1.4 Dismantling the ventilation pressure valve ...................................................................... 42 9.1.5 Replacing the control membranes ................................................................................... 42

9.2 The Valves (expirations, inspiration and emergency air valve) .............................................. 42 9.3 Installing the Vaporizers.......................................................................................................... 43 10 Cleaning ........................................................................................................................................ 43 10.1 Cleaning the housing........................................................................................................... 44 10.2 The Patient Module ............................................................................................................. 44 11 Service and Maintenance ............................................................................................................ 44 11.1 General................................................................................................................................ 44 11.2 Maintenance Work .............................................................................................................. 44

11.2.1 Maintenance work on the ventilator / patient module ...................................................... 44 11.2.2 Maintenance work by a qualified technician .................................................................... 44 11.2.3 Maintenance work after 1000 operating hours ................................................................ 45 11.2.4 Maintenance work after 2000 operating hours ................................................................ 45 11.3 Maintenance work on the vaporizer .................................................................................... 45 11.4 Other maintenance work ..................................................................................................... 45 12 Technical data .............................................................................................................................. 46 13 Warranty........................................................................................................................................ 48

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Rev. 1.1 - 07/07

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1 Details of the Manufacturer

Apparatus:

Anesthesia System HEYER Modular

Manufacturer:

HEYER Medical AG Carl-Heyer-Straße 1-3 D-56130 Bad Ems Germany

Tel.: +49 (0) 2603 / 791-3 Fax: +49 (0) 2603 / 70424

E-Mail: info@heyermedical.de Internet: http://www.heyermedical.de

Subject to alterations, issued July 2007.

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2 Description and Utilization of the Apparatus

2.1 General

2.1.1 Introduction

The HEYER Modular anesthesia system represents a flexible anesthesia workplace for implementing and monitoring inhalation anesthesia in the half-closed system and the nearly closed system for low-flow techniques with minimum gas and anesthetic agent utilization. During the development of the system special emphasis was placed on the ergonomic design and consequently the safe and easily learnable operation. Furthermore the excellent airtightness of the system ensures the economical daily high and low pressure utilization.

The standard model contains the following system components:

A. Electronic ventilator:

The processor-controlled ventilator allows constant-volume ventilation for all patient groups with a body weight of 3 kg upwards. Due to the system compliance compensation, even small tidal volumes can be precisely administered. The ventilation type CMV as the standard and PCV as the optional ventilation type as well as considerable variation options of the artificial ventilation cycle facilitate secure ventilation for complicated lung conditions. A comprehensive test and alarm management ensures the required safety for patients and prevents out-of-control operating conditions. The clear design of the user interface and the display allow the secure operation and a quick detection of the selected ventilation parameters.

B. Patient module

The circular patient absorber system is highly integrated and compacted in an aluminum block. This block is tempered to prevent the formation of condensation. It also contains a monitored emergency air valve, a fresh gas reservoir in form of a hand-held anesthesia bag and an expiratory flow sensor. All sensors are continuously monitored during operation. The sensors are automatically calibrated during the start-up of the apparatus.

C. Integrated fresh gas dosing system including vaporizer unit:

The flowmeter tube block contains all mandatory safety equipment as well as a pneumatic regulation system to maintain a

HEYER Modular

minimum oxygen concentration of 25% in the fresh gas flow (ratio system).

2.1.2 Intended purpose

The Heyer Modular anesthesia system is suitable to make available anesthetic gases and to perform automatic or spontaneous/manual ventilation with a circular system in a semi-closed system. This procedure can be used on adults as well as children. The use of an open system to anesthetize small children and newborns is possible. The Modular anesthetic system is intended for use in operating rooms in clinics and mobile doctor’s practices. It is not suitable for use in the vicinity of MRI scanners. Possible anesthetic procedures that are supported by automatic or manual artificial ventilation are:

- Full anesthetic with volatile anesthetic agents

- Full anesthetic with balanced anesthesia - Full anesthetic with intravenously applied

anesthetic agents - Partial anesthetic

2.1.3 Product improvements

HEYER Medical AG reserves the right to make changes and/or to revise devices and/or operating instructions without prior notice. These instructions deal with all the characteristics of the anesthetic system HEYER Modular according to the state of information at the time of going to print. Instructions and devices created or manufactured at a later date may already include improvements or changes not featured in earlier models.

2.1.4 Responsibility of the operating personnel

The proper functioning of the anesthetic system HEYER Modular is only warranted if the apparatus is used and maintained n accordance with the directions provided by the manufacturer. Not observing these instructions will void any warranty claims with regard to HEYER Medical AG.

ATTENTION: Before using the apparatus, please read the operating instructions, as well as the section “General precautionary measures” and observe in particular all directions in these instructions that are titled ATTENTION or WARNING. These instructions merely describe the operation of the device. A qualified professional can find instructions regarding maintenance and repair in the SERVICE INSTRUCTIONS HEYER MODULAR.

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The device may only be operated by qualified, trained professional personnel. Prerequisite for this is the unlimited observance of these operating instructions and/or additional accompanying documents and manufacturer’s indications, as well as the adherence to the general precautionary measures listed in the following, and the briefing by authorized medical product consultants.

Additional gas monitoring is prescribed to operate the device. The following conditions must be met at a minimum (DIN EN 740):

At least the following are to be monitored: • concentration of the anesthetic gas • concentration of carbon dioxide

For these additional monitoring parameters, it must be possible to set upper and lower alarm limits. When reaching one of these upper or lower alarm limits, a visual or acoustic alarm needs to be activated.

The measuring adapter to be inserted into the circle system or patient’s tube system must be equipped with ISO cones (DIN EN 740). This is to be applied at the inspiration tube connection or ideally the Y-piece. Measurement close to the tube is recommended, however, since this makes the collection of inspiratory and expiratory gas values possible. Monitors that work using the sidestream procedure should definitely be preferred in order to complement the additionally required gas monitoring.

In case a device should not work as described in these instructions, the device in question may not be used until the fault is eliminated. The operating personnel carry the responsibility for damages and injuries whose causes can be traced back to the improper operation and/or repair/maintenance of the device by unauthorized persons.

2.1.5 Liability of the manufacturer

The HEYER Medical AG is only liable for the safety, reliability and functionality of the device if:

- the device was operated corresponding to the directions provided by the manufacturer.

- additions, new settings, changes or repairs were carried out by professionals qualified by the manufacturer.

- the device and was only operated in buildings with facilities for protective grounding in compliance with the regulations of the IEC.

2.2 General precautionary measures

2.2.1 Warning directions

Avoiding potentially dangerous situations in which an injury to the patient and/or the operating personnel cannot be excluded.

Carry out the tests listed on the checklist daily and in case of any fault that occurs do not use the system until the fault has been eliminated.

Always connect the output of the ventilation pressure valve for gas overflow with the anesthetic gas ongoing flow installation, usually installed in operating rooms.

The patient should also be observed closely by qualified professional personnel. In certain situations, life-threatening circumstances may occur that don’t necessarily trigger an alarm.

Always set the alarm limits so that the alarm is triggered before a hazardous situation occurs. Incorrectly set alarm limits may result in operating personnel not being aware of drastic changes in the patient’s condition.

In order to prevent an electric shock, the apparatus (protection class I) may only be connected to a correctly grounded mains connection (socket outlet with grounding contact).

Danger of explosion! The device may not be operated in the immediate vicinity of flammable anesthetics of other flammable substances. The use of flammable anesthetics (e.g. ether, cyclopropane) is not permitted.

Since this device is not permitted for use with flammable anesthetics (e.g. ether, cyclopropane), the use of antistatic breathing hoses and facemasks is not required (DIN EN 740).

Electric shock and fire hazard! Always switch off the apparatus and disconnect it from the mains before cleaning.

Fire hazard! The fuses (e.g. the additional sockets) may only be replaced by fuses of the same type and with the same fuse value.

Electric shock hazard! The device may only be opened by qualified or authorized professional personnel.

In case of a failure of the protective conductor the connection of the apparatus via the additional socket may lead to a discharge current exceeding the permissible values.

Ambient interference caused by electromagnetic radiation exceeding the specifications of EN 60601-1-2 can influence machine functions.

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2.2.2 Precautionary measures

Avoid situations in which the device may malfunction or be damaged.

This device may only be operated by trained professional medical personnel.

Before putting the device into service, the operating personnel must be familiar with the directions and information in these instructions and must have been briefed by a medical product consultant.

If the apparatus does not function as described, it must be examined and possibly repaired by qualified service personnel before being used again.

Treat the device with care in order to avoid damages and faults in its functionality.

Always make sure that the device is supplied with gas in a way that conforms to the technical specifications. Before operating the device, it must be properly calibrated and the corresponding device tests need to be carried out, as described in these instructions.

Should the device display any functional faults during the calibration and tests prior to operation, it may not be operated until the faults have been eliminated by a qualified professional.

After any maintenance tasks, a function test and the compliance and system tests need to be carried out before the device is put into clinical use.

Only bacteriological filters with a low flow resistance must be connected to the patient module and/or patient connection.

3 Functional Description

3.1 Anesthesia ventilator

Ventilators are described according to the principle of controlling the change over from inspiration to expiration. The HEYER Modular apparatus offers the following characteristics I the controlled ventilation mode or so-called CMV mode (Controlled Mandatory Ventilation).

- time-controlled: The timely sequence of inspiration and expiration has been specified by the ventilation frequency settings. The ration of the inspiration to the expiration time of the individual ventilation cycle is determined by the adjustable I/E ratio.

- pressure-limited: The tidal volume during a controlled ventilation is supplied during the entire period if the inspiratory flow and can be set as a ventilation

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parameter. The inspiration is, however, terminated before the tidal volume has been administered once the measured airway pressure reaches the set peak pressure alarm limit.

- constant-volume: The inspiratory flow to the patient required for a ventilation with the set parameters frequency f, tidal volume Vt and ventilation time ratio I/E, is automatically calculated by the ventilator. This inspiratory flow is generated via the drive gas for the patient module. In standard anesthesia ventilators deviations in the tidal volumes actually administered to the patient could occur due to the respective fresh gas setting and system compliance of the ventilation system. The ventilator of the HEYER Modular apparatus supplies a constant volume, as on the one hand the patient module is uncoupled from the fresh gas system. On the other hand the system compliance of the patient module is automatically taken into consideration by the ventilator when generating the breathing volume.

3.1.1 Fresh gas decoupling

During fresh gas decoupling in CMV mode, the fresh gas flow is directed into the manual ventilation bag. The manual ventilation bag thus serves as a fresh gas reservoir. This principle offers the following advantages for machine-controlled ventilation:

1. The tidal volume is completely independent from the set fresh gas flow. This ventilation is therefore referred to as constant volume ventilation.

2. The fresh gas flow can be maintained at a very low level, e.g. below 500 ml/min, depending on the patient. The manual ventilation bag serves as a fresh gas reservoir for the fresh gas administered during inspiration. The entire fresh gas volume is available during the next inspiration, i.e. not only the fresh gas stored in the reservoir but also the fresh gas supplied during expiration.

3.1.2 Constant volume provided by machine-controlled ventilation

During controlled CMV ventilation, the set tidal volume is administered irrespective of the pulmonary circumstances. In principle the ventilator drive represents a constant flow generator. The inspiratory flow of the ventilation gas is automatically adapted to the respective settings of the tidal volume Vt, the ventilation frequency rate f and the ventilation time ratio I/E.

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3.1.3 Compliance compensation

The administered tidal volume is corrected to the target value set by the user with the aid of the compliance compensation. The system compliance of each ventilation system i.e. the compliance of patient hoses and the patient module itself always leads to losses in the administered tidal volume. In the case of the HEYER Modular, a control loop can correct this volume loss as an automatic compensation function. For this purpose several ventilation cycles are required. The drive gas flow is then increased to just above the normal values, i.e. values to achieve the set ventilation volume. The correct tidal volume is, however, administered to the patient, while the slightly higher volume is absorbed by the system compliance due to the effective compliance compensation.

3.1.4 Bag-in-Bottle System

The so-called Bag-In-Bottle system is part of the patient section or circuit system. The gasconducting sections are divided from the ventilator into a primary (ventilator) and a secondary circuit (patient). The gas volume provided by the drive is not directly administered to the patient but instead compresses a bellows inside a pressure dome. As a result the ventilation gas contained in the bellows is administered to the patient. The larger the drive volume flowing into the pressure dome, the greater the tidal volume will be. Once the drive gas flow has finished the pressure compensation between the primary and secondary circuit is also ended. A distinctive plateau in the ventilation pressure curve is formed if the system does not switch over to the expiration directly after the end of the inspiratory gas flow. For this purpose the drive volume contained ion the pressure dome us maintained at a steady level for some time. The bellows are suitable for adults and children. An exchange of the bellows for different patient groups is not necessary.

3.2 Fresh gas dosing

The adjustment of the amounts of gas delivered to the patient is handled at the measuring tube block. It contains flow measurement tubes, also described as rotameters. These measuring tubes consist of a vertically aligned glass tube with a floating element inside. Since the glass tube widens toward the top, a certain flow of gas will lift the floating element to a corresponding height. Adjusting the gas flow is handled by valve spindles inside the respective measuring tubes.

The choice between a setting of gas types O2/AIR and/or O2/N2O is made via a changeover switch, which opens the respective gas line to the measuring tube block. The fresh gas cannot be set with a mixture of AIR and N2O as in this case a decrease of the oxygen content to below 21% could not be avoided. Reducing the oxygen content to less than 21% is theoretically also possible when dosing the O2 and N2O gases. Such unfavorable settings are prevented by a pneumatic safety system. This mechanism, also described as the “Ratio system”, ensures a steadily present minimum content of 25% O2 along with the N2O in the gas mix dosage. When raising the flow of N2O, the required flow of O2 is also raised automatically. The fresh gas thus adjusted will be fed to the vaporizer automatically and mixed with the anesthetic there.

3.3 Vaporizer mounting device and vaporizer

The appliance contains a Selectatec® compatible vaporizer mounting device (standard configuration) for two vaporizers. The vaporizer has a chamber, which contains the anesthetic in liquid form in its lower part. A wick made of metal mesh enriches the upper part of the chamber with saturated vapors of the anesthetic. The concentration of the saturated vapor at room temperature is much higher than is clinically justifiable. A suitable mixing ratio of the gas with anesthetic with a flow of gas passing by this chamber can lead to the desired concentration. This is handled by the adjusting wheel. This adjusts the ratio of the streams of carrier gas via a bypass channel and through the vaporizer chamber in such a way that the desired concentration is attained at the vaporizer outlet. In the zero position of the vaporizer this bypass channel remains open, while the vaporizer chamber is completely closed off to the flow of gas. The anesthetic vapor concentration in the vaporizer chamber may be saturated, but the absolute content of anesthetic is still dependent on temperature. This is why there is a temperature compensation valve in the bypass channel, which in the case of vapor pressure changes caused by temperature fluctuations changes the set dilution ratio in such a way that a temperature-independent concentration output of the anesthetic is warranted.

For additional indications see: Operating instructions of the anesthetic vaporizer used.

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3.4 Patient module

3.4.1 Circuit absorber system

A circuit absorber system is a ventilation system with a CO2 absorber. This system allows anesthetics to be carried out at extremely low fresh gas settings. The ventilation gas contains various parts of rebreathing gas i.e. expiratory gas freed from CO2 parts. This is achieved with a circuit ventilation system facilitating a re-breathing of the expiratory CO2-containing gas. A circuit system with high re-breathing contents causes a reduction of the consumption of anesthetic gases. This type of system also offers an improved breathing gas conditioning. The patient module is designed as a circuit absorber system in the form of a compact aluminum block. The hose connections normally required between the ventilator and the circuit system are thus no longer needed.

3.4.2 CO2 absorber

The absorber serves to absorb the breathing lime. It aims to remove the CO2 from the expiration air. The absorption process is a chemical reaction in which carbon dioxide is bound and most of the reaction water evaporates and the lime is removed. This is why used breathing lime is dry and hard. The lime must be hermetically sealed for storage in a cool and dry place so as not to become malabsorbant.

3.4.3 Reservoir and manual ventilation bag

The reservoir consisting of a manual ventilation bag serves as an inspiratory interim storage facility for the fresh gas. The reservoir pressure during machine and spontaneous ventilation is limited to 1-2 bar by the excess / ventilation pressure valve, also known as the overflow valve. This valve serves additionally for setting the desired ventilation pressure for manual ventilation.

3.4.4 Volume measurement

Volume measurement takes place by means of measuring the flow in the expiration branch using a flow sensor, which works according to the hot-wire anemometer principle. The ventilator processors integrate this measured value with the displayed tidal and ventilation minute volumes. The tidal volume shown in the display is a purely measured value. The tidal volume displayed during machine-controlled ventilation is measured by an internal flow sensor and is not dependent on the expiratory volume measurement.

HEYER Modular

3.4.5 Oxygen measurement

Oxygen measurement is metered by a measuring cell installed on the inspiration valve. This single-cathode measuring cell, also referred to as a fuel cell, offers a longer service life compare to other oxygen cells and is less sensitive to existing anesthetic gases.

3.4.6 Patient module heating

The heating prevents the formation of condensation in the patient module and on the valve caps of the inspiration and expiration valve. The heating positively contributes to a ventilation gas conditioning. The heating mat also functions as a sealing mat and is installed between the top and bottom sections of the patient module. An electronic control integrated in the ventilator keeps the temperature of the patient module constant at approx. 36°C. An over-temperature protection protects the apparatus against overheating.

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3.5 Touch screen display

The “Touch screen” display acts as the user interface for the HEYER Modular. With the exception of the ventilation mode dial, all data input is done via light finger pressure on the touch screen. Therefore it is no problem to operate the system with moist or dirty hands. To change a value, for instance, you press the corresponding symbol of the value you wish to change. The illumination of the selected symbol will then be intensified as confirmation. You can then increase or decrease the value using the arrow symbols. To confirm the data change, press the OK button.

3.5.1 Symbol description

Fig. 1 Touch Screen Display

Pˆ

Peak airway pressure in mbar

P

MV

Mean airway pressure in mbar Minute volume in liters

FiO2 Inspiratory oxygen concentration

CMV PCV CMV or PCV ventilation mode

Mute switch for acoustic alarm signals

Cursor for increase or decrease of set values

OK

Confirmation of entered values

PLAT. Plateau pressure in % of the inspiration

time

PEEP Positive Expiratory End Pressure

I:E

Inspiratory to expiratory ratio

f

Ventilation frequency

Tidal volume in mL in CMV mode;

Drive gas in l/min in PCV mode

SET Display change-over from measures

values to SET values

Alarm limits setting mode

OPT. Options

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4 Operating Elements / Device Connections

4.1 Views of apparatus 4.1.1 Front view / left-hand side view

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1 Vaporizer mount

Selectatec® compatible vaporizer mount for two vaporizers (As an option, a single mount for Dräger vaporizers is available.)

2 Flowmeter block

5-fold flowmeter block with integrated ratio system, O2 bypass and N20/AIR changeover switch.

3 Ventilator unit

Microprocessor-controlled ventilation unit with EL display

4 Patient module

Absorber circuit system with integrated "Bag-in-Bottle" system, active and passive valves as well as APL ventilation pressure valve

5 Oxygen sensor with

connecting cable

6 Mount for holding arm

Fig. 2 Front view

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4.1.2 Rear view / right-hand side view

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1 Mains cable Power supply cable for the connection of the apparatus to a socket with grounding contact.

2 Hook for cable winding

3 Additional sockets

Other apparatus with a maximum power consumption of 3.5 A each can be connected to 2 additional sockets.

4 fuses (resetable)

Over current triggering device 5A, 2 each for the ventilator, one for the backup battery for power supply in the event of a mains failure.

5 Reserve bottles – connections

6 Type plate with serial number

7 Fan for housing ventilation

8 Mains connection for the central

gas supply With 3 manometers for pressure monitoring

9 Mains switch

The apparatus is switched on/off via this switch and the supply of mains voltage is created. This switch stays in ON position during operation.

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Fig. 3 Rear view

4.2 Ventilation unit

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Fig. 4 Ventilator display and ventilation mode selector switch

The ventilator has a color LCD display (an EL display is optionally available. This highcontrast display allows a clear overview of the measured values and ventilator settings. A clear side read-off is possible.

4.2.1 "Ventilation Mode"- selector switch

The rotary switch for the selection of the ventilation mode has four positions:

Standby: Position for the commissioning and implementation of compliance and system tests

Manual/Spont: This position switches the ventilator to manual ventilation or spontaneous ventilation mode.

CMV child: This position switches the ventilator to CMV mode for machine-controlled ventilation of children.

CMV adult: This position switches the ventilator to CMV mode for machine-controlled ventilation of adults.

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4.3 Flowmeter tube block with fresh gas dosing

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1 Flowmeter tube O2

with low measuring range, for settings from 0 to 1000 ml/min

2 Flowmeter tube O2

with high measuring range, for settings from 1.5 to 10 l

3 Flowmeter tube AIR with low measuring range, for

settings from 0 to 1000 ml/min

4 Flowmeter tube AIR

with high measuring range, for settings from 1.5 to 10 l/min

5 Flowmeter tube N2Owith low measuring range, for

settings from 0 to 1000 ml/min

6 Flowmeter tube N2O

with high measuring range, for settings from 1.5 to 10 l/min

7 Valve spindle for O2 gas dosing

8 Valve spindle for AIR gas dosing

9 Valve spindle for N2O gas dosing

10 N2O/AIR change-over switch

This switch allows the pre-selection of the gases N2O or AIR, which can subsequently be dosed with the respective valve spindles. The previously set volume flow is retained after switching back to the same gas type.

Fig. 5 Flowmeter tube block with fresh gas dosing

4.4 Vaporizer mount

1 Valve cartridge of vaporizer mount 2 Locking device 3 Stop buffer (support) for vaporizer

Fig. 6 Vaporizer mount

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4.5 Patient module (circle system)

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Fig. 7 Patient module (circle system)

1

Emergency air valve

2

Inspiration valve

3

Ventilation pressure valve

Including rotary regulator for setting the pressure

control during manual ventilation or for setting it as an

overflow valve for CMV or spontaneous ventilation.

4

Expiration valve

5

Oxygen measuring cell

6

Connection for inspiration hose

7

Hose connection for reservoir/ manual ventilation

bag

8

Outlet of the ventilation pressure valve

Here the anesthetic gas suction unit is connected.

9

Connection for expiration hose

10 Fresh gas outlet

11 O2 bypass

The O2 bypass supplies a high flow of O2 (approx. 50 l/min) directly to the fresh gas outlet or to the patient module. When releasing the O2 bypass button, this returns to its original position and the O2 bypass is interrupted automatically.

12 CO2 absorber

13 Bellows with pressure dome

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4.6 IR adapter

1

IR adapter

The optical infrared interface allows the connection

of computers or monitoring systems.

Fig. 8 IR adapter

4.7 Compressed air injector for bronchial suction (optional)

1

Compressed air injector (drive for suction unit)

Compressed air injector with vacuum display and

vacuum regulating button.

2

Connection for vacuum hose

Connection for hose to suction glass connection

“vacuum”

Fig. 9 Suction

4.8 Symbols on the apparatus Caution! Please observe the following documentation

On / Off (connection to power supply)

IR adapter

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5 Alarm Messages and Safety Devices

The HEYER Modular anesthesia system shows alarm messages on the EL display during operation. The alarm message is displayed until the fault condition that triggered the alarm is resolved. High-priority alarms are display against a light background. Low-priority alarms are display against a dark background. The alarm indication on the display is not affected by pressing the mute button for the acoustic alarm. A bell will appear on the righthand side of the screen to indicate the acoustic alarm suppression.

In the following information all alarms able to occur during the various operating statuses are explained.

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5.1 Alarm messages and corrective measures

Alarm message

Cause

Corrective Measures

Compliance test carried The initial compliance test was

out

carried out successfully.

The system is ready for operation.

Test passed Leak rate is more than 300 ml/min. Please check breathing circuit. Press OK to continue

The initial compliance test was carried out successfully. Leak rate is between 300-600 ml/min .

The ventilator can be safely operated with an adequate fresh gas flow. If necessary repeat the compliance test in the OPTIONS menu after having tightened the cap nuts and correcting the hose connections.

Test passed Leak rate is more than 600 ml/min. Please check breathing circuit. Press OK to continue

The leak rate of the circuit and the patient hoses is greater than 600 ml/min at 40 Pa x 100.

The ventilator can be safely operated with an adequate fresh gas flow. If necessary repeat the compliance test in the OPTIONS menu after having tightened the cap nuts and correcting the hose connections.

ATTENTION! Use Manual ventilation mode only.

The compliance test was not carried out or not passed. Machinecontrolled ventilation is not possible until the compliance test has been passed.

Carry out the compliance test in the Standby/OPTIONS menu. If this is not successful, please call a service technician.

System Resistance too The resistance of the ventilation

high.

hoses or the bacteriological filter is

too high.

Renew the bacteriological filter and/or the ventilation hoses. Carry out the compliance test in the Standby/OPTIONS menu. If this is not successful, please call a service technician.

Compliance out of range.

The compliance of the connected ventilation hoses is outside the permissible range of 3.0 to 9.9 ml/mbar.

Remove the bacteriological filter and/or the ventilation hoses. Carry out the compliance test in the Standby/OPTIONS menu. If this is not successful, please call a service technician.

Leak test Complete Leak rate is higher than 500 ml/min. Verify that APL is set to MAX position CO2 absorber, vaporizers locked.

The leak rate of the entire circuit higher than 500 ml/min at 40 Pa x 100.

The ventilator can be safely operated with an adequate fresh gas flow. If necessary repeat the compliance test in the OPTIONS menu after having tightened the cap nuts and correcting the hose connections to the vaporizer and absorber.

Leak test Complete

The leak rate of the entire circuit

Leak rate is higher than higher than 1,000 ml/min at 40 Pa x

1,000 ml/min. Verify that 100.

APL Valve is set to MAX

position CO2 absorber,

vaporizers locked.

The ventilator can be safely operated with an adequate fresh gas flow. If necessary repeat the compliance test in the OPTIONS menu after having tightened the cap nuts and correcting the hose connections to the vaporizer and absorber.

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Alarm message

Cause

Corrective Measures

O2 Sensor Calibration O2 Calibration is OK. Successful

System is ready for the FiO2 measurement.

O2 cell invalid. Press OK to start

The O2 call either has a concentration Expose O2 sensor with connected cable

of <21% O2, is not connected or

connection to room air with 21% O2 or

faulty.

replace.

O2 concentration too high. Expose Sensor to room air. Press OK to start

The O2 call either has a concentration Expose O2 sensor to room air with 21%

of <21% O2, or is faulty.

O2 or replace.

A P N E A

The system is not measuring an expiratory volume of the patient.

Check the ventilation of the patient and the hose connections. The initial Apnea alarm tone can be selected between 15, 30 and 45 sec. A continuous tone sounds after 2 min Apnea.

Breathing Circuit Disconnection

No relevant pressure increase measured during ventilation.

Connect ventilation hoses.

Peak pressure greater than alarm limit

The peak pressure is higher than the Check the tidal volume setting, check

set alarm limit Pmax .

that Pmax is reached, the ventilator

changes over to expiration and check

the Pmax setting.

Peak pressure below alarm limit

The peak pressure is lower than the Check the tidal volume and/or plateau

set alarm limit Pmax .

setting. Check the hose connections.

FiO2 lower than O2 min The measured FiO2 value is lower than the set alarm limit FiO2 min.

FiO2 greater than FiO2 The measured FiO2 value is higher

alarm limit

than the set alarm limit FiO2 max.

Verify that the O2 supply is adequate and check the O2 alarm setting.

Check the fresh gas composition and the O2 alarm setting.

Tidal volume lower than The measured Vt value is lower than Check the tidal volume setting and the

Vt min

the set alarm limit Vt min.

Vt alarm setting.

Check Vent Dial position.

The vent dial has been in a position Turn the vent dial to a permissible

that is not allowed for longer than 3 position. Select a ventilation mode and

sec.

re-start ventilation.

Minute volume below alarm limit

The measured minute volume value Check the ventilation parameters and is lower than the set alarm limit AMV the AMV min alarm setting. min.

PEEP greater than Pmin The measured PEEP value is higher Check the correct APL valve and the

than the set alarm limit Pmin.

Pmin alarm setting.

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Alarm message

Cause

Corrective Measures

PEEP greater than PEEP setting

The measured PEEP value is higher Check the correct APL valve setting. than the set PEEP value.

Unable to attain target pressure. Adjust flow or I:E ratio

Set APL Valve to CMP/SP position

The inspiration time is too short and/or the drive gas flow is too low.

Reminder for the user that the APL valve must always be in CMV/SP position for machine-controlled ventilation. This message appears when the measured PEEP value is higher than the set PEEP value.

Check the settings of I:E, frequency and drive gas flow.

Set the APL valve to CMV/SP position if this is not already the case.

Ambient air intake;

The room air valve in the patient

Check Fresh Gas setting module is opening.

Check whether the fresh gas flow is adequate and the patient is spontaneously breathing.

Too high pressure or no A continuous ventilation pressure

expiration.

without a significant change of the

pressure value is measured.

Set the APL valve to CMV/SP position.

Invalid CMV parameters The set parameters require a drive Check whether the set values are gas flow that cannot be achieved by correct. the ventilator. The AMV must not exceed 20 l/min and the inspiratory flow must not be higher than 75 l/min.

PCV Setting not valid.

The combination of the set ventilation Change the PCV settings. parameters cannot be realized by the ventilator.

Expiratory time too short.

The expiration time is not sufficient to Check the settings of I:E and ventilation

completely fill the bellows.

frequency.

Resume Ventilation

Ventilation can be resumed after having stopped due to lack a drive gas.

Select a ventilation mode. Resume ventilation.

System pressurized

The system is measuring too high a Relieve the pressure in the system and

pressure in the circuit.

close the fresh gas supply.

System vented

The system cannot build up any pressure during the compliance test or fresh gas test.

Check whether the O2 cell and ventilation hoses are correctly connected. If necessary set the APL valve to maximum position.

Drive Gas missing; after The compressed air supply that

standby then CMV

drives the ventilator has failed.

Check the compressed air supply.

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Alarm message

Cause

Corrective Measures

Caution! Ventilator has The selector switch has been in an Turn the selector switch to a permissible

stopped. Check position impermissible position for more than position. Select a ventilation mode and

of mode selector switch 12 sec.

resume ventilation.

AC Power lost, using Battery

Mains voltage failure. Machine running on batteries.

Check the mains connector. Call a service technician if required.

AC Power lost, using Battery 30 min. (to 10 min) remaining

About 20 min battery supply remaining.

Check the mains connector.

AC Power lost, using Battery 5 min remaining

About 5 min battery supply remaining.

Machine-controlled ventilation will end in approx. 5 minutes. The display will remain until the battery is fully discharged. The patient can be manually ventilated as long as compressed air is available.

AC Power lost, using The voltage supplied by the battery is Check the mains connector. Call a

Battery. Battery running too low for machine-controlled

service technician if required.

low. Use Manual

ventilation. The display will go out

Ventilation

within a few minutes.

EEPROM – Error during Data for parameters or alarm limit

writing.

settings were not correctly stored.

Repeat function. Call a service technician if required.

Data exchange faulty. The data exchange between the ventilation modules has failed.

Repeat function. Restart the machine. Call a service technician if required.

Pressure sensor faulty. The system has detected a fault on Repeat function. Restart the machine.

one or both pressure sensors.

Call a service technician if required.

Breathing system is unlocked.

The breathing system is not correctly Carefully push the patient module into

adapted.

the docking station and lock it.

Hotwire measurement The hotwire did not pass the test. It Repeat function. Restart the machine.

invalid

may be damaged.

Call a service technician if necessary.

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HEYER Modular

Alarm message

Cause

Corrective Measures

System vented or drive The system was not able to build up Check the drive gas supply and verify

gas missing

pressure.

that the system is closed.

Fault in CPU system

The automatic test has detected a Call a service technician. fault in the processor system.

CPU monitor failure

The processor monitoring system has Call a service technician. detected a fault.

Expiration valve blocked The airway pressure is not being Inspect the APL valve and check the reduced during the expiration phase. control membranes on the back of the patient module.

Fault on solenoid valve(s)

One or more solenoid valve(s) has/have failed.

Repeat the compliance test in standby mode. If the problem still exists, please call a service technician.

Check the bellows valve. The system has detected a pressure Check the control membranes.

increase. The control membranes

could leak and control gas could

penetrate the system.

Fault in proportional The proportional valve that regulates Carry out the compliance test in the

valve

the tidal volumes is not working

Standby/OPTIONS menu. If this is not

properly.

successful, please call a service

technician.

Pressure Reading out of The system has detected a fault on

tolerance.

one or both pressure sensors.

Carry out the compliance test in the Standby/OPTIONS menu. If this is not successful, please call a service technician.

Flow/Volume Readings not available Replace Flow Sensor –Call Service

The external flow sensor that measures the expiration volume is faulty.

Carry out the compliance test in the Standby/OPTIONS menu. If this is not successful, please call a service technician.

Flow Error: Use Manual Ventilation Call Service

The internal flow sensor and/or the measurement of the generated drive gas is not working properly.

Carry out the compliance test in the Standby/OPTIONS menu. If this is not successful, please call a service technician.

Temp Sensor readings not available Call Service

The temperature sensor in the patient Carry out the compliance test in the

module is defective.

Standby/OPTIONS menu. If this is not

successful, please call a service

technician.

Temp Sensor out of tolerance

The control system for the patient Inform the service department. module heating or the heating mat is defective.

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Alarm message Fan Error Check Fan Call Service

EEPROM data not saved!

System error, call a service technician.

Cause

Corrective Measures

The fan for the ventilation of the

Inform the service department.

housing and the cooling of installed

modules is defective.

The start-up test for the internal circuits has detected an error. EEPROMS are defective.

Call a service technician.

The ventilator has a technical defect, Call a service technician. machine-controlled ventilation is not possible.

5.1.1 Alarm messages during the compliance test

During and after the system test, alarm messages are displayed in the lower part of the system test window:

Fig. 10 Example of an alarm message during the compliance test

If the system is error-locked due to a sensor fault, only use the apparatus in an emergency for manual ventilation and inform the technical service department in the case of repeated failure of the compliance test.

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Alarm messages during the compliance test (continuation)

# Alarm message S1 System Resistance too high. S2 Leak rate too high.

S3 Compliance incorrect

S4 Error while saving. S5 Check the bellows valves. S6 Pressure sensors faulty. S7 Flow Error: Use Manual

Ventilation Call Service S8 Flow/Volume Readings not

available Replace Flow Sensor –Call Service

S9 Proportional valve def. S10 Flow control system def. S11 No data exchange

S12 Fault on solenoid valve(s)

Meaning/Cause

Alarm type

The resistance of the patient System alarm

hoses or the bacteriological

filters is too high.

The leak rate of the patient System alarm

module including the patient

hoses is greater than 100

ml/min.

The compliance of the

System alarm

connected patient hoses is

outside the range able to be

compensated by the ventilator

of 3.0 to 9.9 ml/mbar.

Saving of data for parameter System alarm

and/or alarm limit setting was

faulty.

The system has detected a System alarm

pressure increase. The

bellows valves are leaking.

The system has detected a System alarm

fault on one or both of the

double pressure sensors.

Test of internal flow sensor System alarm

indicates a defect or an

internal mis-adjustment of the

ventilator.

The external flow sensor has System alarm

not measured the required

flow during the test,

calibration was not

successful. Sensor may be

faulty.

The proportional valve of the System alarm

ventilator is defective.

The flow control system of the System alarm

ventilator for the breathing

volume is defective.

The data exchange between System alarm

the modules of the ventilator

for the control and the display

representation is faulty.

One or several of the solenoid System alarm

valves for the control of the

bellows valves in the patient

module is/are defective.

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Page 26

5.1.2 Alarm messages during the system test

During and after the system test, alarm messages are displayed in the lower part of the system test window:

HEYER Modular

Fig. 11 Example of an alarm message during the compliance test

If the total leakage of the system exceeds 300 ml/min at 40 mbar, this message is displayed in the bottom part of the system test window, for example.

#

Alarm message

Meaning/Cause

Alarm type

T1

O2 cell is faulty.

The O2 cell has been

System alarm

correctly calibrated. Please

check O2 cell and repeat test.

T2

System Resistance too high.

The resistance of the

System alarm

patient hoses or the

bacteriological filters is too

high.

T3

Leak rate greater than

The leakage test for the

System alarm

300 ml/min.

fresh gas system has

detected a leakage greater

than 300 ml/min.

T4

Compliance incorrect

The compliance of the

System alarm

connected patient hoses is

outside the range able to be

compensated by the

ventilator.

T5

Error while saving.

Saving of the data was

System alarm

faulty.

T6

Check the bellows valves.

The system has detected a System alarm

pressure increase. The

bellows valves indicate a

leak, please check.

T7

No data exchange

The data exchange

System alarm

between the modules of the

ventilator for the control and

the display representation

is faulty.

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