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.
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.
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.
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,
t
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
t
ventilation frequency rate f and the ventilation
time ratio I/E.
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-
2
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
2
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
2
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
2
gas mix dosage. When raising the flow of N
the required flow of O
is also raised
2
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.
A circuit absorber system is a ventilation
system with a CO
absorber. This system
2
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
2
ventilation system facilitating a re-breathing of
the expiratory CO
-containing gas. A circuit
2
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
2
The absorber serves to absorb the breathing
lime. It aims to remove the CO
from the
2
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.
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
P
MV
Fig. 1 Touch Screen Display
ˆ
Peak airway pressure in mbar
Mean airway pressure in mbar
Minute volume in liters
FiO
Inspiratory oxygen concentration
2
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
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.
with low measuring range, for settings from 0 to 1000
ml/min
2 Flowmeter tube O
2
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
2
settings from 0 to 1000 ml/min
6 Flowmeter tube N
O
2
with high measuring range, for settings from 1.5 to 10 l/min
7 Valve spindle for O
gas dosing
2
8 Valve spindle for AIR gas dosing
9 Valve spindle for N
O gas dosing
2
10 N
O/AIR change-over switch
2
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