Heyer Modular User manual

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Modular

Anesthesia System

Operator’s Manual

Rev. 1.1 – 07/07

MODERN SOLUTIONS FOR AN ESTHETICS AND INHALATION

HEYER Modular

Table of contents

1 Details of the Manufacturer........................................................................................................... 5

2 Description and Utilization of the Apparatus.............................................................................. 6

2.1

General ..................................................................................................................................... 6

2.1.1 Introduction........................................................................................................................6

2.1.2 Intended purpose...............................................................................................................6

2.1.3 Product improvements.......................................................................................................6

2.1.4 Responsibility of the operating personnel.......................................................................... 6

2.1.5 Liability of the manufacturer............................................................................................... 7

2.2 General precautionary measures.............................................................................................. 7

2.2.1 Warning directions............................................................................................................. 7

2.2.2 Precautionary measures....................................................................................................8

3 Functional description................................................................................................................... 8

3.1 Anesthesia ventilator................................................................................................................. 8

3.1.1 Fresh gas decoupling ........................................................................................................ 8

3.1.2 Constant volume provided by machine-controlled ventilation........................................... 8

3.1.3 Compliance compensation ................................................................................................ 9

3.1.4 Bag-in-Bottle System......................................................................................................... 9

3.2 Fresh gas dosing....................................................................................................................... 9

3.3 Vaporizer Mounting Device and Vaporizer............................................................................... 9

3.4 Patient module........................................................................................................................10

3.4.1 Circuit Absorber System.................................................................................................. 10

3.4.2 CO2 absorber................................................................................................................... 10

3.4.3 Reservoir and Manual Ventilation Bag............................................................................10

3.4.4 Volume Measurement...................................................................................................... 10

3.4.5 Oxygen Measurement ..................................................................................................... 10

3.4.6 Patient module heating.................................................................................................... 10

3.5 Touch Screen Display.............................................................................................................11

3.5.1 Symbol Description..........................................................................................................11

4 Operating Elements / Device Connections................................................................................ 12

4.1 Views of Apparatus................................................................................................................. 12

4.1.1 Front view / left-hand side view ....................................................................................... 12

4.1.2 Rear view / right-hand side view......................................................................................12

4.2 Ventilation unit......................................................................................................................... 13

4.2.1 "Ventilation Mode"- selector switch..................................................................................14

4.3 Flowmeter tube block with fresh gas dosing...........................................................................14

4.4 Vaporizer Mount......................................................................................................................15

4.5 Patient module (circle system)................................................................................................ 16

4.6 IR adapter ............................................................................................................................... 17

4.7 Compressed air injector for bronchial suction (optional) ........................................................ 17

4.8 Symbols on the apparatus......................................................................................................17

5 Alarm Messages and Safety Devices......................................................................................... 18

5.1 Alarm Messages and ..............................................................................................................19

Corrective Measures..........................................................................................................................19

5.1.1 Alarm messages during the compliance test...................................................................24

5.1.2 Alarm messages during the system test.......................................................................... 26

5.1.3 Alarm messages in normal mode....................................................................................27

5.1.4 Alarm message “Technical fault”.....................................................................................31

5.2 Test of alarm functions............................................................................................................ 31

6 Start-up and functional test ........................................................................................................32

6.1 Preparing for Operation .......................................................................................................... 32

6.2 Pre-Operation Tests................................................................................................................ 32

6.2.1 Compliance test............................................................................................................... 33

6.2.2 O2 Sensor Calibration......................................................................................................33

6.2.3 Leak test fresh gas system.............................................................................................. 34

7 Operation in the Individual Functions........................................................................................ 36

7.1 Standby Mode......................................................................................................................... 36

7.1.1 The Options Window in Standby Mode...........................................................................36

7.2 “Manual/Spontaneous” ventilation mode................................................................................ 36

7.2.1 Setting Alarm Limits in “Manual/Spontaneous” mode..................................................... 36

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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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1 Details of the Manufacturer

Apparatus: Anesthesia System HEYER Modular

Manufacturer: HEYER Medical AG

Internet: http://www.heyermedical.de

Subject to alterations, issued July 2007.

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

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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

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 thes e 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

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 V

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 V

, 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 O

/AIR and/or O2/N2O is made via a change-

over switch, which opens the respective gas line to the measuring tube block. The fresh gas cannot be set with a mixture of AIR and N

O 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 O

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% O

along with the N2O in the

gas mix dosage. When raising the flow of N the required flow of O

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 CO

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 CO

parts. This is achieved with a circuit

ventilation system facilitating a re-breathing of the expiratory CO

-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 CO

absorber

The absorber serves to absorb the breathing lime. It aims to remove the CO

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.

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

Peak airway pressure in mbar

Mean airway pressure in mbar Minute volume in liters

FiO

Inspiratory oxygen concentration

CMV

CMV or PCV ventilation mode

PCV

Mute switch for acoustic alarm signals

Cursor for increase or decrease of set values

OK PLAT.

PEEP I:E f

SET

OPT.

Confirmation of entered values Plateau pressure in % of the inspiration

time Positive Expiratory End Pressure

Inspiratory to expiratory ratio Ventilation frequency Tidal volume in mL in CMV mode;

Drive gas in l/min in PCV mode Display change-over from measures

values to SET values Alarm limits setting mode

Options

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4 Operating Elements / Device

Connections

4.1 Views of apparatus

4.1.1 Front view / left-hand side view

Fig. 2 Front view

Vaporizer mount

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

compatible vaporizer

2 Flowmeter block

5-fold flowmeter block with integrated ratio system,

bypass and N20/AIR change-

over 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

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.

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.

4.3 Flowmeter tube block with fresh gas dosing

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Fig. 5 Flowmeter tube block with fresh gas dosing

4.4 Vaporizer mount

Fig. 6 Vaporizer mount

1 Flowmeter tube O

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

2 Flowmeter tube O

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 N

Owith low measuring range, for

settings from 0 to 1000 ml/min

6 Flowmeter tube N

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

7 Valve spindle for O

gas dosing

8 Valve spindle for AIR gas dosing 9 Valve spindle for N

O gas dosing

10 N

O/AIR change-over switch

This switch allows the pre-selection of the gases N 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.

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

O or

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4.5 Patient module (circle system)

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

Outlet of the ventilation pressure valve

Here the anesthetic gas suction unit is connected.

9 Connection for expiration hose 10 Fresh gas outlet 11 O

12 CO 13 Bellows with pressure dome

bypass

The O

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 O

bypass

button, this returns to its original position and the

bypass is interrupted automatically.

absorber

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4.6 IR adapter

Fig. 8 IR adapter

4.7 Compressed air injector for bronchial suction (optional)

Fig. 9 Suction

4.8 Symbols on the apparatus

Caution! Please observe the following documentation

On / Off (connection to power supply)

IR adapter

The optical infrared interface allows the connection of computers or monitoring systems.

Compressed air injector (drive for suction unit)

Compressed air injector with vacuum display and vacuum regulating button.

Connection for vacuum hose

Connection for hose to suction glass connection “vacuum”

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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

Compliance test carried out

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

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

ATTENTION! Use Manual ventilation mode only.

System Resistance too high.

Compliance out of range.

Leak test Complete Leak rate is higher than 500 ml/min. Verify that APL is set to MAX position CO

absorber,

vaporizers locked.

Leak test Complete Leak rate is higher than 1,000 ml/min. Verify that APL Valve is set to MAX position CO

absorber,

vaporizers locked.

Cause Corrective Measures

The initial compliance test was carried out successfully.

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

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

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

The resistance of the ventilation hoses or the bacteriological filter is too high.

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

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

100.

The leak rate of the entire circuit higher than 1,000 ml/min at 40 Pa x

100.

The system is ready for operation.

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.

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

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.

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.

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Alarm message

Cause Corrective Measures

O2 Sensor Calibration Successful

O2 cell invalid. Press OK to start

O2 Calibration is OK. System is ready for the FiO2

measurement.

The O2 call either has a concentration of <21% O

, is not connected or

faulty.

Expose O connection to room air with 21% O replace.

sensor with connected cable

O2 concentration too high. Expose Sensor to room air.

The O2 call either has a concentration of <21% O

, or is faulty.

Expose O O

or replace.

sensor to room air with 21%

Press OK to start 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 set alarm limit P

max

Check the tidal volume setting, check that P

is reached, the ventilator

max

changes over to expiration and check the P

setting.

max

Peak pressure below alarm limit

FiO2 lower than O2 min The measured FiO2 value is lower

FiO2 greater than FiO2 alarm limit

Tidal volume lower than V

min

Check Vent Dial position.

Minute volume below alarm limit

The peak pressure is lower than the set alarm limit P

than the set alarm limit FiO

max

min.

The measured FiO2 value is higher than the set alarm limit FiO

max.

The measured V the set alarm limit V

value is lower than

min.

The vent dial has been in a position that is not allowed for longer than 3 sec.

The measured minute volume value is lower than the set alarm limit AMV min.

Check the tidal volume and/or plateau setting. Check the hose connections.

Verify that the O and check the O

supply is adequate

alarm setting.

Check the fresh gas composition and the O2 alarm setting.

Check the tidal volume setting and the Vt alarm setting.

Turn the vent dial to a permissible position. Select a ventilation mode and re-start ventilation.

Check the ventilation parameters and the AMV min alarm setting.

PEEP greater than P

The measured PEEP value is higher

min

than the set alarm limit P

min

Check the correct APL valve and the P

alarm setting.

min

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Alarm message

Cause Corrective Measures

PEEP greater than PEEP setting

Unable to attain target pressure. Adjust flow or I:E ratio Set APL Valve to CMP/SP position

The measured PEEP value is higher than the set PEEP value.

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.

Ambient air intake; Check Fresh Gas setting

Too high pressure or no expiration.

The room air valve in the patient module is opening.

A continuous ventilation pressure without a significant change of the pressure value is measured.

Invalid CMV parameters The set parameters require a drive

gas flow that cannot be achieved by 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

parameters cannot be realized by the ventilator.

Expiratory time too short.

Resume Ventilation

The expiration time is not sufficient to completely fill the bellows.

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

System pressurized The system is measuring too high a

pressure in the circuit.

System vented The system cannot build up any

pressure during the compliance test or fresh gas test.

Drive Gas missing; after standby then CMV

The compressed air supply that drives the ventilator has failed.

Check the correct APL valve setting.

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.

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

Set the APL valve to CMV/SP position.

Check whether the set values are correct.

Change the PCV settings.

Check the settings of I:E and ventilation frequency.

Select a ventilation mode. Resume ventilation.

Relieve the pressure in the system and close the fresh gas supply.

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

Check the compressed air supply.

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Alarm message

Cause Corrective Measures

Caution! Ventilator has stopped. Check position of mode selector switch

AC Power lost, using Battery

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

The selector switch has been in an impermissible position for more than 12 sec.

Mains voltage failure. Machine running on batteries.

About 20 min battery supply remaining.

Turn the selector switch to a permissible position. Select a ventilation mode and resume ventilation.

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

Check the mains connector.

remaining 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 Battery. Battery running low. Use Manual Ventilation

EEPROM – Error during writing.

Data exchange faulty. The data exchange between the

Pressure sensor faulty. The system h as detected a fault on

Breathing system is unlocked.

The voltage supplied by the battery is too low for machine-controlled ventilation. The display will go out within a few minutes.

Data for parameters or alarm limit settings were not correctly stored.

ventilation modules has failed.

one or both pressure sensors. The breathing system is not correctly

adapted.

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

Repeat function. Call a service technician if required.

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

Carefully push the patient module into the docking station and lock it.

Hotwire measurement invalid

The hotwire did not pass the test. It may be damaged.

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

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Alarm message

Cause Corrective Measures

System vented or drive gas missing

The system was not able to build up pressure.

Fault in CPU system The automatic test has detected a

fault in the processor system.

CPU monitor failure

The processor monitoring system has detected a fault.

Expiration valve blocked The airway pressure is not being

reduced during the expiration phase.

Fault on solenoid valve(s)

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

Check the bellows valve. The system has detected a pressure

increase. The control membranes could leak and control gas could

penetrate the system. Fault in proportional valve

The proportional valve that regulates

the tidal volumes is not working

properly.

Pressure Reading out of tolerance.

The system has detected a fault on

one or both pressure sensors.

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

Flow Error: Use Manual Ventilation Call Service

The external flow sensor that

measures the expiration volume is

faulty.

The internal flow sensor and/or the

measurement of the generated drive

gas is not working properly.

Temp Sensor readings not available Call

The temperature sensor in the patient

module is defective. Service

Temp Sensor out of tolerance

The control system for the patient

module heating or the heating mat is

defective.

Check the drive gas supply and verify that the system is closed.

Call a service technician.

Inspect the APL valve and check the control membranes on the back of the patient module.

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

Check the control membranes.

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

Inform the service department.

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Alarm message

Cause Corrective Measures

Fan Error Check Fan Call Service

The fan for the ventilation of the

housing and the cooling of installed

Inform the service department.

modules is defective. EEPROM data not

saved!

The start-up test for the internal

circuits has detected an error.

Call a service technician.

EEPROMS are defective. System error, call a

service technician.

The ventilator has a technical defect,

machine-controlled ventilation is not

Call a service technician.

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 Meaning/Cause Alarm type

S1 System Resistance too high. The resistance of the patient

System alarm hoses or the bacteriological filters is too high.

S2 Leak rate too high. The leak rate of the patient

System alarm module including the patient hoses is greater than 100 ml/min.

S3 Compliance incorrect 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.

S4 Error while saving. Saving of data for parameter

System alarm and/or alarm limit setting was faulty.

S5 Check the bellows valves. The system has detected a

System alarm pressure increase. The bellows valves are leaking.

S6 Pressure sensors faulty. The system has detected a

System alarm fault on one or both of the double pressure sensors.

S7 Flow Error: Use Manual

Ventilation Call Service

Test of internal flow sensor indicates a defect or an

System alarm internal mis-adjustment of the

ventilator.

S8 Flow/Volume Readings not

available Replace Flow Sensor –Call Service

The external flow sensor has not measured the required flow during the test,

System alarm

calibration was not successful. Sensor may be faulty.

S9 Proportional valve def. The proportional valve of the

System alarm ventilator is defective.

S10 Flow control system def. The flow control system of the

System alarm ventilator for the breathing volume is defective.

S11 No data exchange The data exchange between

System alarm the modules of the ventilator for the control and the display representation is faulty.

S12 Fault on solenoid valve(s) 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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5.1.2

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

Alarm messages during the system 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.

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

# Alarm message Meaning/Cause Alarm type

T1 O2 cell is faulty. The O2 cell has been

correctly calibrated. Please check O test.

T2 System Resistance too high. The resistance of the

patient hoses or the bacteriological filters is too high.

T3 Leak rate greater than

300 ml/min.

T4 Compliance incorrect The compliance of the

T5 Error while saving. Saving of the data was T6 Check the bellows valves. The system has detected a

T7 No data exchange The data exchange

The leakage test for the fresh gas system has detected a leakage greater than 300 ml/min.

connected patient hoses is outside the range able to be compensated by the ventilator.

faulty. pressure increase. The

bellows valves indicate a leak, please check.

between the modules of the ventilator for the control and the display representation is faulty.

cell and repeat

System alarm

System alarm System alarm

System alarm

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5.1.3 Alarm messages in normal mode

During and after normal operation, alarm messages are displayed in the lower part of the ventilation mode window:

Tidal Volume lower than VTE

Ppeak pressure greater than alarm limit

Fig. 12 Example of an alarm message during normal mode

After each activation of CMV mode, for example, the following alarm message appears as a reminder to check the setting of the ventilation pressure valve (APL) in the lower part of the ventilator display.

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Alarm messages in normal mode (continuation)

# Alarm message Meaning/Cause Alarm type

B1 Fault in CPU system The self-testing routine of the

CPU system has detected a fault in the CPU control system.

B2 CPU monitor failure The monitoring function for

the CPU has failed.

B3 Expiration valve blocked The ventilation pressure is not

falling during expiration.

B4 Flow Error: Use Manual

Ventilation Call Service

B5 Fault in proportional valve The proportional valve for the

B6 Fault on solenoid valve(s) One or several of the solenoid

B7 Pressure sensors faulty. The system has detected a

B8 Drive gas failure The compressed air supply

B9 Ext. flow sensor faulty. The external flow sensor for

B12 A P N E A No breathing or ventilation

B13 Breathing Circuit

Disconnection

B14 PEEP greater than P

The measured PEEP value is

min

The internal flow sensor for the measurement of the generated breathing volume is not working properly.

generation of the breathing volume is not working properly.

valves for the control of the bellows valves in the patient module is/are defective.

fault on one or both of the double pressure sensors.

that generates the drive gas for the ventilator has failed.

expiratory volume measurement in the patient module is defective.

activity has been detected via the expiratory volume measurement. No adequate pressure increase measured during ventilation.

higher than the set pressure limit P

min

System alarm

Alarm for patient monitoring

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# Alarm message Meaning/Cause Alarm type B15 FiO2 lower than FiO2 min The measured FiO2 value is lower

than the set minimum oxygen

B16 Tidal volume lower than Vt

min

B17 Peak pressure greater than

alarm limit

B18 Peak pressure below alarm

limit

B19 Minute volume below alarm

limit

B20 FiO2 greater than FiO2 alarm

limit

concentration limit FiO The measured tidal volume Vt value is lower than the set limit for V The peak pressure P than the set pressure limit P The peak pressure P the set pressure limit P The breathing minute volume AMV is lower than the set limit AMV min. The measured FiO2 value is higher than the set minimum oxygen concentration limit FiO

min.

is higher

peak

max

is lower than

peak

min

max.

min.

B21 PEEP exceeded The measured PEEP value is higher

than the pre-set value.

B22 Temperature sensor defective The temperature sensor in the

Alarm for patient monitoring

Alarm for patient monitoring Alarm for patient monitoring Alarm for patient monitoring Alarm for patient monitoring Alarm for patient monitoring

Alarm for patient monitoring System alarm

patient module is defective.

B23 Fault on patient module

heating

The control system for the patient module heating or the heating mat is

System alarm

defective.

B24 Fan failure The fan for the ventilation of the

System alarm housing and the cooling of installed modules is defective.

B25 AC Power lost, using Battery The mains voltage supply has failed,

System alarm the apparatus is running on power supply form the installed battery.

B26 Too high pressure or no

expiration

A continuous ventilation pressure without a significant change of the

System alarm pressure value is measured.

B27 Power supply failure The power supply from the battery is

System alarm no longer given and will fail shortly.

B28 Ambient air intake; Check

Fresh Gas setting

The emergency valve in the patient module is opening, please check the

System alarm fresh gas setting and increase the

fresh gas flow if necessary.

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# Alarm message Meaning/Cause Alarm type B30 Set APL Valve to CMP/SP

position

Reminder that the ventilation pressure valve (APL) must

System alarm

also be switched to CMV/SP position after activating CMV mode.

B31 f min not reached The measured breathing

Alarm for patient monitoring frequency f falls below the set limit for f min.

B32 f max exceeded The measured breathing

Alarm for patient monitoring frequency f exceeds the set limit for f max.

B33 Invalid CMV parameters The set parameters for

System alarm ventilation in CMV mode give an inspiratory flow that can no longer be achieved by the machine. A minute volume of > 20 L/min, and/or an inspiratory flow of > 80 L/min are considered as the limit values here.

B57 P

lower than selected

peak

plateau

The peak pressure P

peak

achieved in PC mode does

Patient alarm not reach the set plateau

pressure. Check the PCV parameters and increase the set inspiratory flow if necessary.

B58 PCV set values not possible The inspiratory flow set in

Patient alarm PCV mode cannot be generated in combination with the parameters for frequency and I/E ratio. Please check the parameter settings.

B59 Expiratory time too short. The remaining expiratory time

Patient alarm in PCV mode to too short with the set parameters. Check the parameter settings for frequency and I/E ratio.

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5.1.4 Alarm message “Technical fault” # Alarm message Meaning/Cause Alarm type

H01 Technical fault The ventilator indicates a

System alarm serious technical fault and stops machine-controlled ventilation in CMV mode.

This alarm is not displayed in the other used alarm windows of the various displays. This fault is displayed in a window of its own due to its exceptionally high priority level.

Fig. 13 Alarm message “Technical fault”

5.2 Test of alarm functions

APNEA: Please switch the selector switch for

ventilation mode to Manual/Spontaneous position and wait for 30 seconds without carrying out any ventilation action. After this time the alarm message “APNEA“ must appear on the screen.

P>P

: Please switch the selector switch for

max

ventilation mode to CMV position. Connect the apparatus to a test lung and sect the ventilation parameters and alarm settings such that the airway pressure will reach the upper alarm limits. Make sure that the inspiration phase is no active and check the alarm message ”P greater than P after 3 ventilation cycles.

FiO2>O2

: Expose the O2 measuring cell to

min

the ambient air and select a O

“ on the screen

max

-min value

higher than 25%. After 3 ventilation cycles the alarm message “FiO

2>O2 min

“ must appear on

the screen.

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6 Start-up and Functional Test

6.1 Preparing for operation

1. Install the apparatus in such a way that the operating panel at the font of the apparatus is within easy reach and the flow measuring tubes can be easily read.

2. When the apparatus has been installed in the correct position, engage the brakes on the front rollers to prevent accidental movement.

3. Connect the gas connection lines to the gas connections near the rear of the unit. Check that the pressure of the gas supply complies with the specifications of the apparatus. Connect the gas supply by plugging the connectors into the gas supply sockets. Ensure that the connectors are not in the park position.

4. Plug the mains cable into a grounded socket. Switch on the power supply using the mains switch at the rear side of the apparatus.

5. Wait until the ventilator display requests the compliance test. If the patient module should not yet be connected to the apparatus, remove the transportation cover if necessary and push the patient module into the mount. After pushing in the patient module as far as it will go, lock it in by turning the lever on the underside of the swivel mechanism.

6. Next equip the patient module with the ”Bag-In-Bottle” system, consisting of the bellows and the patient dome. Attach the CO

absorber. Connect the set of hoses for

the anesthesia gas scavenging to the outlet of the overflow/ventilation pressure valve. Create the connection to the anesthetic gas suction unit.

7. Connect the manual ventilation bag to the corresponding hose on the patient module. Connect the patient hose set to the inspiratory and expiratory connections.

2. Start the compliance test on the apparatus. Follow the instructions on the ventilator display.

3. Carry out the leak test and the O2 calibration. Instructions on these procedures also appear on the ventilator display.

4. Ensure that a suitable independent device for manual ventilation (e.g. ambulatory bag) is available at or near the apparatus.

5. If required, start the additional monitoring for CO

and anesthesia gases and if

available for the ECG and check their function according to the respective operating instructions. The gas return line from monitors operating according to the sidestream procedure should be connected to the connection at the rear side labeled measuring gas return.

6.2 Pre-operative tests

The tests and examinations described below must be carried out before each system start. They are also listed on the check list on the apparatus.

1. Install and lock the vaporizers to be used on the device.

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6.2.1 Compliance test

When the automatic self-test of the system has been completed, the following display appears for the performance of the compliance test.

details on the determined system compliance and leakage of the patient module.

Fig. 14 Display before the compliance test

Follow the instructions on the ventilator display and activate by pressing the OK button on the touch screen display.

The system now checks and calibrates all sensors such as e.g. the expiratory flow sensor and the pressure sensors. Also the internal sensors of the ventilator drive and the active components such as pneumatics control valves are checked during the compliance test.

The patient module, patient connection hoses, the Y-piece etc. are also tested for leaks. Furthermore the system compliance to which in particular also the patient hoses contribute is detected during the compliance test.

During the compliance test a display message confirms that the test is running and a bar indicates its progress.

Fig. 15 Display during the compliance test

After the successful compliance test, information on the result is displayed with the message “Compliance Test Passed” including

Fig. 16 Display after the compliance test

If the patient tubes were exchanged against others with different hose compliance, the test should be repeated.

6.2.2 O

Sensor calibration

The following display appears upon the start of the O

sensor calibration.

Fig. 17 Display 1 for O2 sensor calibration

Pull the O

measuring cell out of the mount of

the inspiration valve. Connect the cell to the calibration adapter next to the patient module. Then start cell calibration.

Attention: The cell must be exposed to the ambient air long enough otherwise incorrect calibration may be the result.

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During calibration of the O2 sensor, a display appears providing information on the progress of the calibration process.

6.2.3 Leak test fresh gas system

To carry out a leak test for the entire fresh gas system, select the “Fresh gas test” button on the display.

Fig. 18 Display 2 for O2 sensor calibration

The result of the O

sensor calibration is then

displayed as follows:

Fig. 19 Display 3 for O2 sensor calibration

Remove the O

measuring cell from the

calibration adapter and re-insert it in the inspiration valve mount. This completes the calibration of the O

sensor.

Fig. 20 Display before the leak test for the fresh gas system

Follow the instructions on the ventilator display. Connect the patient hoses and the hose of the manual ventilation device, i.e. of the reservoir/manual ventilation bag, to the Ypiece. Set the ventilation pressure valve (APL) to max position and start the fresh gas test by activating the Ok screen button.

Apart from the leak test for the fresh gas system on the patient module, patient connection hoses, Y-piece etc., the tightness of the measuring tube block, vaporizer mount, and/or activated vaporizer, absorber, manual ventilation hose and ventilation pressure valve is tested.

During the leak test on the fresh gas system, a display appears on the screen to confirm that this test is being carried out.

Fig. 21 Display during the leak test for the fresh gas system

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The following message appears on the display after the successful leak test on the fresh gas system:

Fig. 22 Display after the leak test for the fresh gas system

Return the patient module hoses to their normal condition and re-connect the reservoir/manual ventilation bag to its hose. Return the ventilation pressure valve back to CMV/SP position. This completes the leak test on the fresh gas system.

Exit the window by pressing the “OK” screen button.

After carrying out the compliance and system test and after observing the test points on the check list, the ventilator is now ready for operation. The standby window for normal mode then appears. In the following section 7 "Operation in the Individual Functions" this display is described in section 7.1 "Standby Mode".

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7 Operation in the Individual

Functions

The preparation and operation of the system up to readiness for operation on standby mode is described in section “6 Start-up and Functional" and its sub-items. The following sections describe how to operate the system in the various ventilation modes, in standby mode and in the operating modes.

7.1 Standby mode

Standby mode is the waiting mode before and between the ventilation cycles. The system automatically goes to this mode after starting. The following display appears on the screen:

temperature of the heated patient module. The volume of the alarm messages can be preselected here using the arrow keys. You can close the window again by pressing the symbol “OPT“ on the touch screen.

7.2 “Manual/Spontaneous” ventilation mode

Fig. 25 Setting CMV/SP of the ventilation pressure valve for spontaneous ventilation

Return the ventilation pressure valve (APL) to

Fig. 23 Display in Standby mode

The ventilator display provides information on the status of the system tests.

7.1.1 The options window in standby mode

The “Options window“ can also be opened by pressing the symbol “OPT“ on the touch screen.

CMV/SP position for spontaneous ventilation.

Fig. 26 Setting the ventilation pressure for manual ventilation e.g., to 20 mbar

For manual ventilation the ventilation pressure valve must be set to a corresponding value (e.g. 20 mbar) and the patient is to be

Fig. 24 Standby-Modus Options Window

ventilated using the manual ventilation bag (reservoir).

The window informs about the overall operating hours and the measured

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7.2.1 Setting alarm limits in “Manual/Spontaneous” mode

The setting of alarm limits takes place in “Manual/Spontaneous” ventilation mode by a single press on the “Limits” button on the operating panel.

The graphic presentation then opens up a window "Alarm settings" and indicates the alarm limits.

Fig. 27 Display of alarm limits in manual/spontaneous ventilation mode

The individual alarms have the following meanings:

Apnea Time delay in seconds between

FiO FiO Vol. Volume of alarm tone

the occurrence of the Apnea and the issuance of the first alarm.

max Limit for max. FiO2 value in %

min Limit for min. FiO2 value in %

Display of adjustable alarm limits in manual/spontaneous ventilation mode

Parameter Basic setting for

Basic setting Increment Adjustable values

ON/OFF option O2 high 100 [%] 5 [%] 30 – 100 [%] O2 low ON (always) 18 [%] 2 [%] 18 – 90 [%]

7.3 CMV ventilation mode

For controlled ventilation, the HEYER Modular anesthesia system offers two ventilation modes; for adults and children, selectable via the selector switch on the operator panel. The difference between these modes lies in the

7.3.1 CMV ventilation mode

Se the operator panel selection switch to "Child" for the machine-controlled ventilation of children and to “Adult“ for the ventilation of adults.

variously adjustable ventilation parameters and alarm limits for these patient groups.

Select the ventilation mode depending on the ventilation requirements of the patient. Different bellows are not necessary for the ventilation of adults and children. The hose systems and filters used, however, should be adapted to the patient group.

Fig. 28 Start window for CMV ventilation mode

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During CMV ventilation mode the display shows the measured pressure, volume, ventilation rate as well as the oxygen concentration values.

The measured values are displayed below the real-time graphic diagram.

The graphic presentation then opens up a window "Alarm settings" and indicates the respective alarm parameters in pairs above one another.

When the button SET is pressed the set parameters are shown inversely. They disappear after approx. 5 seconds or by pressing the "SET " button again. The measured values can be directly selected in order to change the setting parameters. The display changes over to the target value. This is displayed inversely and can be changed using the arrow keys. The OK button must be pressed to adopt the parameter changes. If no change is made within 5 seconds, the display will switch back to the measured value and the changed setting will not be adopted.

Fig. 30 Alarm settings in CMV ventilation mode

The individual alarms have the following meanings:

Vt min Limit for minimum tidal volume P max Maximum pressure limit (highest

O2 max Limit for maximum FiO2 AMV min Limit for minimum minute volume

pressure limit)

P min Minimum pressure limit (Lowest

pressure limit)

Fig. 29 Display CMV ventilation mode

The individual alarms have the following meanings:

Airway pressure in mbar

Average pressure in mbar MV Minute volume in l FiO2 Inspiratory O2 concentration in

% Vt/

Drive gas flow in l/min

f Ventilation frequency in 1/min I:E Inspiratory to expiratory ratio PEEP Positive Expiratory End Pressure in

mbar

Plat Plateau pressure in mbar

O2 min Limit for minimum FiO2

If the measured values are within the area marked white, no alarm message will be generated. Through direct selection of the alarm messages in bold print, these can be changed. After selection of an alarm limit value, this value is highlighted and can be changed using the arrow keys. To adopt the setting it must be confirmed by pressing OK. After confirmation the screen changes back to real-time graphic display.

7.3.2 Setting alarm limits in CMV mode

The window for alarm limits is opened by pressing the symbol "Alarm settings".

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7.4 PVC ventilation mode

The HEYER Modular anesthes ia system offers the ventilation modes PCV Child and Adult for controlled ventilation.

With this Pressure Controlled Ventilation (pressure-limited ventilation) a pr imarily pr e-set maximum inspiratory pressure is maintained. The change to expiration is time-controlled as opposed to pressure-controlled ventilation. Apart from the inspiration time and the preselected pressure limit, the tidal volume depends on the flow and the pulmonary resistance values. The advantage is the avoidance of high pressure peaks, so that it is mainly used in pediatrics but also increasingly to ventilate adults e.g. in cases of severe lung failure or ling leakage.

7.4.1 PCV ventilation mode

Se the operator panel selection switch to "Child" for the machine-controlled ventilation of children and to “Adult“ for the ventilation of adults.

In the display the required ventilation mode “PCV” can be selected by lightly pressing the CMV/PCV symbol.

Fig. 31 Start window for PCV ventilation mode

During PCV ventilation mode the display shows the measured pressure, volume, ventilation rate as well as the oxygen concentration values.

The measured values are displayed below the real-time graphic diagram.

pressed to adopt the parameter changes. If no change is made within 5 seconds, the display will switch back to the measured value and the changed setting will not be adopted.

Fig. 32 Display PCV ventilation mode

The individual alarms have the following meanings:

Airway pressure in mbar

Average pressure in mbar MV Minute volume in l FiO2 Inspiratory O2 concentration in %

Vt/

Drive gas flow in l/min

f Ventilation frequency in 1/min I:E Inspiratory to expiratory ratio PEEP Positive Expiratory End Pressure in

mbar

Plat Plateau pressure in mbar

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7.4.2 Setting alarm limits in PCV mode

The setting of alarm limits is made by pressing the symbol "Alarm settings" on the display.

The graphic presentation then opens up a window "Alarm settings" and indicates the respective alarm parameters in pairs above one another.

8 Alarm Elimination

By pressing the alarm suppression key on the operating panel, all acoustic alarms are muted for a period of 2 minutes at the most.

Pressing this button a second time cancels thus mute command before the time expires.

The mute command is not active in case of the alarm message "Failure battery supply"!

Fig. 33 Alarm settings in PCV ventilation mode

The individual alarms have the following meanings:

Vt min Limit for minimum tidal volume P max Maximum pressure limit (highest

O2 max Limit for maximum FiO2 AMV min Limit for minimum minute volume

pressure limit)

P min Minimum pressure limit (Lowest

pressure limit)

O2 min Limit for minimum FiO2

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9 Dismantling and Reassembling

9.1 The patient module

In order to dismantle the patient module, the CO

absorber and the Bag-in-Bottle system

must be released. The patient module is carefully pulled out of the mount of the apparatus, after having previously turned the locking lever on the underside of the connecting block.

Note: The expiratory flow sensor can be changed and/or replaced without disassembling the top section of the patient module.

9.1.1 The CO

To release the CO2 absorber from the patient module, the unit must be turned anti-clockwise and unscrewed together with the connecting pipe. Now the lime can be removed from the absorber.

Fill up with fresh lime up to approx. 4 cm below the edge of the absorber. Ensure that the mesh plate in the absorber is present and that there is no lime inside the connecting pipe.

Used lime changes its color. Replace the lime when about 2/3 of the absorber contents have changed color.

The discoloration of the lime disappears after a while if it is not used. If used again, the discoloration returns at a reduced level. Therefore, the decision to replace the lime should take place after a long period of use, e.g. at the end of each second workday.

Attention: After changing the lime, please carry out a leak test of the fresh gas system.

9.1.2 The Bag-in-Bottle system

The patient dome of the Bag-in-Bottle system is screwed out of the bayonet fitting clockwise. It can now be pulled out from below.

The bellows can be pulled off the connection cone.

absorber

Fig. 34 Disassembly of the patient module, view from the front

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9.1.3 Exchanging the expiratory flow sensor

To replace the flow sensor (3) the expiration valve body must be removed (1).

- For this purpose, remove the fixing screw

(4) on the front and pull the valve body out of the cover.

- The flow sensor can now be carefully

removed and replaced after releasing the plug-in connection.

- Slide the plug-in connection and supply

line back into the recess in the bottom section.

- The flow sensor with sealing mats (2) is

carefully placed into the recess with the larger connection facing down.

- The expiration valve is placed back into the

cover and secured on the front side by means of the screw

Attention: After replacing the flow sensor, please carry out a leak test of the fresh gas system.

9.1.4 Dismantling the ventilation pressure valve

- To dismantle the ventilation pressure valve

the cap nut must be unscrewed. The top section can now be removed.

- The membrane can now be removed from

the bottom section and replaced if required.

- The membrane is re-inserted into the

bottom section with the metal plate facing upwards.

- The top section of the ventilation pressure

valve is re-attached and screwed down using the cap nut.

Attention: The spring in the top section of the ventilation pressure valve must not be loaded. After removing the top section from the bottom section, put the top section aside and avoid any exceptional loading of the spring.

9.1.5 Replacing the control membranes

- To replace the control membranes (2) on

the rear side of the patient module, the connecting element (1) is screwed off first.

- The control membrane can be removed

from the patient module using your fingers.

- Assembly takes place in reverse order.

- When reassembling, please make sure that the control membrane is installed in the patient module with the flat sealing side first.

Fig. 35 Disassembly of the patient module, view from the top

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9.2 The valves (expirations, inspiration and emergency air valve)

- To dismantle the vales, the coupling ring (1)

must be unscrewed from the valve body (7, 8, 9). The valve cover (2) can now be removed.

- The O-ring (3) and the metal basket (5) in

the expiration and/or inspiration valve can now be removed. The valve plate (6) can be removed. Assembly takes place in reverse order.

- The membrane of the emergency air valve

(4) can be taken out of the valve body after removal of the coupling ring (1) and the valve cover (2). Assembly takes place in reverse order.

The O-rings (10) of the valve bodies must be replaced if necessary after dismantling of the valve bodies from the top section of the patient module.

Fig. 36 Dismantling the valves

9.3 Installing the vaporizers

- To install the vaporizers on the apparatus, they must be carefully placed in a horizontal position on the vaporizer mount.

- Check that the vaporizer is correctly

positioned and lock it.

Warning: Only vaporizers with an Interlock system may be used with this apparatus. The interlock system prevents both vaporizers from being activated at the same time.

Attention: After changing the vaporizers, please carry out a leak test on the fresh gas system.

Attention: To fill up and empty the vaporizer, remove it from the apparatus and set it on a suitable surface.

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10 Cleaning

WARNING:

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

10.1 Cleaning the housing

The apparatus housing can be cleaned with a cloth that has been previously moistened in a mild liquid cleaning agent. To avoid abrasion on the housing the cloth must be moistened before cleaning. If additional cleaning is necessary please use a conventional agent for surface disinfection.

ATTENTION:

Only use a little cleaning agent. Excess fluid can penetrate the interior of the apparatus and cause damage.

10.2 The patient module

The patient module can only be autoclaved up to max. 134°C. For this, remove the Bag-inBottle system and the absorber. The connecting element of the left control membrane (expiration valve membrane) and the membrane must be removed from the patient module. Also the connection element of the right control membrane (decoupling valve membrane) and the membrane.

ATTENTION:

The patient dome of the Bag-in-Bottle system cannot be autoclaved! It does not come into contact with ventilation gas. In case of soiling, the patient dome must be cleaned with water ands a liquid cleaning agent. Disinfection can take place using a conventional surface disinfectant, but please do not use alcohol.

The bellows can also be autoclaved at 134°C, as well as the CO are preferred as regards the service life of the materials of the bellows and/or seals on the absorber.

For autoclaving the ventilation pressure valve (APLP) should be dismantled by unscrewing the top section. Please autoclave the APL top section and the membrane as individual elements with the patient module.

absorber. However, 121°C

11 Service and Maintenance

11.1 General

In order to guarantee fault-free operation of the apparatus, the following maintenance work should be carried out at the specified intervals.

NOTE:

After completion of the maintenance work the pre-operative tests for the ventilation unit and the corresponding calibrations must be carried out. The appliance must not be used again for patients without these final tests/calibrations. Please compare the respective sections of these instructions.

11.2 Maintenance work

11.2.1 Maintenance work on the ventilator /

Maintenance work as required:

- Cleaning, wipe disinfection of the basic

- Sterilization of the patient module

- Sterilization of the CO

- Sterilization of the bellows

- Replacement of the external flow sensor

- Replacement of the control membranes

ATTENTION:

The patient module and all components coming into contact with the ventilation gas must be sterilized at least once a day. If bacteria filters are continuously used, the sterilization interval for patient modules can be extended to once a week.

patient module

apparatus and the operating panels

absorber

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11.2.2 Maintenance work by a qualified technician

Testing of electrical safety acc. to IEC 6011:

- Measurement of the ground conductor

resistance

- Measurement of the leakage current of the

apparatus

- Measurement of the insulation resistance

Visual check and functional test:

- Check for the presence of the check list and

operating instructions.

- Check of the apparatus and accessories for

external damage and completeness

- Check of all ground conductors

- Test of the apparatus acc. to the check list

- Test of all alarm functions and the

pneumatic safety equipment

11.2.3 Maintenance work after 6 Month

- Replacement of the O-ring (art.-no. 323-

0147) and the flat seal (art.-no.980-1170) of the absorber

- Replacement of the O-ring (art.-no. 323-

0147) of the patient dome

- Replacement of the O-rings at the valve

cartridges of the vaporizer holder (art.-no. 049-3110)

- Functional test of the ventilation pressure

valve

- Performance of a compliance and system

test

- Performance of a manual leak test

- Check of intake filters O

, AIR and N2O

- Check of reserve bottle pressure reducer, if

present

- Test of pneumatic safety equipment:

Laughing gas lock, O

shortage signal

- Concentration test ratio system

- Heating function test

- Check of holding arm joint settings

Attention: After all maintenance work, carry out a preoperative check before clinical use is considered.

11.2.4 Maintenance work after 12 Month Maintenance work after 6 Month and in

addition:

- Check of internal hose connections

- Replacement of the O-rings of the gas connectors at the connection block (art.-no. 49-3052)

- Replacement of the valve plates (art.-no. 610-3156)

- Replacement of the control membranes (3 x art.-no. 440-0021)

- Replacement of sealing sets for valve bodies (3 x art.-no. 323-0313)

- Replacement of the ventilation pressure valve membrane (art.-no. 323-0310)

- Replacement of the O-rings on the ventilation pressure valve (art.-no. 323-

0272)

- Carrying out of the service software, calibration of the measuring modules for pressure, flow, internal flow

- Checking and if necessary setting of the internal HP and LP pressure reducers

- Check of solenoid valves MV1 to MV4

Attention:

After all maintenance work, carry out a preoperative check before clinical use is considered.

11.3 Maintenance work on the

vaporizer

The maintenance work can be found in the operating and service instructions for the anesthetic vaporizers used.

11.4 Other maintenance work

The service department will carry out other maintenance work on the gas preparation unit, fresh gas dosing system etc. For details and an exact description of the listed work, please refer to the service instructions for the HEYER Modular.

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12 Technical data

General data:

Dimensions Height: 1350 mm Width: 900 mm Depth: 800 mm Weight: approx. 135 kg (without vaporizer)

Electrical connection data:

Mains supply: 230 V+/-10% / 50Hz Power consumption, connected load: 15 A

of these, additional sockets: 10 A (maximum) Power input: 210 VA Battery supply: approx. 30 minutes, battery capacity 6.5 Ah Battery charging time: max. 7 hours if the apparatus is running. Additional sockets: 2 pc. (each protected with 2 x 5 AT fuse )

Electrical safety: Apparatus protection class I, type of protection IP21 Apparatus type BF

Pneumatic connection data:

Centr. Gas supply (CGS) O

AIR: 2.8 - 6 bar N2O: 2.8 - 6 bar

Ambient conditions:

Storage temperature: -5 - 50°C Working temperature: +10 - 35°C

Humidity (relative humidity): Storage: 15 - 95 %, non-condensing Work: 15 - 95 %, non-condensing

Fresh gas dosing: 6-fold measuring tube block Standard measuring tubes: O

N AIR: 0.1 - 1 / 1.5 - 10 l/min

Ratio system: integrated (at least 25 vol.% O

Mount for anesthetic vaporizer: "Selectatec"-compatible, dual holder

Patient module /circuit system:

Internal volume: approx. 2.5l Absorber volume: approx. 1.4l Absorber system: Conventional filling Patient module connection: Mechanical, manual Condensate block: Heated patient module (36 +/- 2°C) Preparation: autoclavable at 134°C System compliance: automatically compensated Fresh gas decoupling: automatic during inspiration, thus enabling constant-volume ventilation

Mark of conformity: EC Type Test Certificate acc. to 93/42/EEC Annex III Identification: 0 0044

: 2.8 - 6 bar

: 0.05 - 1 / 1.5 - 10 l/min

O: 0.1 - 1 / 1.5 - 10 l/min

in fresh gas)

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Patient module materials:

Housing: : Aluminum Ventilation bag: Silicone Hoses: Silicone Valve plate: Silicone Valve plate holder: Silicone Bellows valves: Silicone Heating mat: Silicone Absorber container: Polysulfon Absorber inserts: Chrome-plated metal

Ventilation unit:

Ventilator control: time-controlled, pressure-limited, constant-volume Ventilation types: Manual ventilation, spontaneous v entilation, CM child, CM adult Tidal volume: 20 - 1400 ml (+/- 5%),

CMV child: 20 - 400 ml, CMV adult :300 - 1400 ml

Ventilation frequency: 4 - 60 I/min CMV child: 10 - 60 I/min CMV adult: 4 - 30 I/min

Ventilation minute volume: max. 20 l/min I:E ratio: 1:1; 1:1,5; 1:2, 1:3; inverses I:E ratio 2:1 and 3:1

Insp. pause: max. 5 sec Exp. pause: max. 30 sec Plateau (end insp.): 20 % or 30% of insp. time PEEP: 0 - 20 +/- 2 mbar Maximum insp. pressure: 80 mbar Manual overpressure valve: 4 - 60 mbar Compliance test: automatic Leak tests: Circuit system, automatic after confirmation

Fresh gas system, automatic after confirmation Oxygen monitor: Type: Fuel cell

FiO Pressure monitor: Real-time graphics

Numerical pressure values for: PEEP, P Flow monitor: Real-time graphics

Numerical values for: Tidal volume, breathing rate, minute volume

Tolerances for measured values:

Pressure: +/- 5 % of the measured value

Volume: Adults +/- 10 % of the measured value Child +/- 10 % of the measured value

Measuring tubes: +/- 3 % of the scale value

display 0- 100 Vol% O2

, P

peak

mean

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13 Warranty

Warranty declaration by HEYER Medical AG

In addition to the legal warranty acc. to HBG §377, HEYER MEDICAL AG shall grant a warranty of 12 months for the purchase of a new apparatus from the HEYER product range. The warranty period begins with the date of invoice and is subject to the following conditions:

1. Within the warrant y period we will eliminate free of c harge an y defec ts or damages on the device that are shown to be caused by a manufacturing or material error. The warranty does not include easily breakable part s, e.g. glass or consumable parts.

2. Warranty services can only claimed upon submission of a delivery note (bill of delivery or invoice); the type and method of damage remedy (repair or replacement) shall be at the discretion of HEYER ME DICAL AG. Warranty services do not result in an extension of the warranty period, nor do they entail a new warranty being granted. There is no independent warranty period for installed spare parts.

3. Excluded from the warranty are: Damages caused by improper use, operating errors, mechanical stress or nonobservance of the operating instructions, as well as damages caused by force majeure or by extraordinary environmental conditions.

4. Warranty services may only be claimed if proof is submitted to confirm that all service and maintenance work has been carried out by authorized staff.

5. The warranty includes all faults that impair a faultless functioning of the device on the basis of technical defects of individual components. The warranty obligation can only be recognized by us if the device has been used properly and according to its intended use and no repair attempts have been undertaken by the client himself or by third parties. The warranty claim does not include faults caused by mechanical damages or if the device is being operated with accessories originating from third parties.

6. The warranty is also void if changes, alterations or repairs are made to the device by persons not authorized to do this.

7. The warranty claim only applies to customers of HEYER MEDICAL AG; it cannot be transferred to third parties.

8. The rejected device is to be shipped back to our plant postage free. In case of a request by our customer service department, the costs for shipping to the plant are to be initially generally borne by the customer. After successful repair, we will send the device back freight collect. If HEYER MEDICAL AG confirms the existence of a warranty claim, the customer will receive reimbursement for the costs of delivery and/or transport of the apparatus. Repair parts that do not fall under the warranty claim will be billed by us. The shipping of the device to us always counts as a complete assignment to eliminate all faults and/or replace missing parts, unless the customer expressly excludes partial services. Additional claims to transfer or reduce and replace damages of any kind in particular also of damages not incurred on the object of delivery itself are excluded.

Our service address: HEYER Medical AG Carl-Heyer-Straße 1-3 D-56130 Bad Ems Tel.: (02603)791-3 Fax: (02603)70 424

Subject to technical changes! Rev. No.: 1.1 dated 07.2007

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Notes:

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Carl-Heyer-Str. 1/3 D-56130 Bad Ems - Germany Tel.: +49 (0) 2603 / 791-3 Fax: +49 (0) 2603 / 70424 E-Mail: info@heyermedical.de www.HeyerMedical.de

Heyer Modular User manual

Specifications and Main Features

Frequently Asked Questions

User Manual