Heyer Narkomat+ User manual

N a r k o m a t

+

A n e s t h e s i a S y s t e m

Operator’s Manual

Rev. 3.1 – 05/09

M

OD ER N SOL UT IO NS F OR ANE ST HE TI CS A ND INH AL AT IO N

H E Y E R N a r k o m a t+

Table of Contents

Page

Table of Contents ................................................................................................................................3

Table of Figures...................................................................................................................................6

1 Details of the Manufacturer / Apparatus.......................................................................................8

2 Description and Utilization of the Apparatus................................................................................9

2.1 General.....................................................................................................................................9

2.1.1 Product improvements.................................................................................................10

2.1.2 Responsibilities of operators........................................................................................11

2.1.3 Liability of the manufacturer.........................................................................................11

2.2 General precautions ...............................................................................................................12

2.2.1 Warning notes..............................................................................................................12

2.2.2 Caution notes...............................................................................................................13

3 Functional Description................................................................................................................14

3.1 Anesthesia ventilator ..............................................................................................................14

3.1.1 Fresh gas decoupling ..................................................................................................14

3.1.2 Constant volume provided by controlled ventilation....................................................14

3.1.3 Compliance compensation ..........................................................................................15

3.1.4 Bag-in-bottle system....................................................................................................15

3.2 Fresh gas dosing ....................................................................................................................15

3.3 Vaporizer mounting device and Vaporizers............................................................................16

3.4 Patient module........................................................................................................................17

3.4.1 Circuit absorber system...............................................................................................17

3.4.2 CO2 absorber...............................................................................................................17

3.4.3 Reservoir and manual ventilation bag .........................................................................17

3.4.4 Volume measurement..................................................................................................17

3.4.5 Oxygen measurement*................................................................................................17

3.4.6 Patient module heating................................................................................................18

3.5 Gas measurement*.................................................................................................................18

4 Operating Elements / Connections for Appliances ....................................................................19

4.1 Views of apparatus .................................................................................................................19

4.1.1 Front of apparatus........................................................................................................19

4.1.2 Rear of apparatus........................................................................................................20

4.1.3 Left side of apparatus ..................................................................................................21

4.1.4 Right side of apparatus................................................................................................22

4.2 Ventilator unit..........................................................................................................................23

4.2.1 Operating panel, ventilator keyboard...........................................................................24

4.2.1.1

"Ventilation Modes"- selection switch .................................................................24

4.2.1.2

"Push to Enter" - encoder button to change and confirm settings ......................25

4.2.1.3

Operating panel keys for insp. pause and exp. pause........................................25

4.2.1.4

"Settings" - panel keys for basic set-up ..............................................................25

4.2.1.5

"Alarms" - panel keys and displays for alarms....................................................26

4.2.1.6

Vent. Settings" - panel keys for direct selection display windows ......................26

4.3 Flow meter tube block including fresh gas dosing..................................................................27

4.4 Vaporizer mounting device .....................................................................................................28

4.5 Patient module (circuit system) ..............................................................................................29

4.6 Sample gas recirculation ........................................................................................................30

4.7 Vacuum source for bronchial suction (optional) .....................................................................31

4.8 Symbols on the Unit................................................................................................................32

5 Alarm Messages and Safety Devices ........................................................................................33

5.1 Alarm messages direct after the System start........................................................................34

5.2 Alarm Messages in Standby...................................................................................................35

5.3 Compliance test alarm messages ..........................................................................................36

5.3.1 Compliance test alarm messages................................................................................36

5.4 System test alarm messages .................................................................................................38

5.5 Alarm messages during normal operation..............................................................................40

5.5.1 Alarm messages during normal operation with the integrated Gas Module * .............45

5.5.2 Alarm messages during normal operation with the optional ventilation mode PCV....47

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5.6 Technical failure alarm message............................................................................................48

6 Start-Up and Functional Test.....................................................................................................48

6.1 Preparation of apparatus ........................................................................................................48

6.2 Pre-Operation Tests ...............................................................................................................49

6.3 Sample Tube Connection (optional integrated Gas Module) .................................................50

6.4 System Start ...........................................................................................................................51

6.5 Battery Control........................................................................................................................52

6.6 Sensor Test ............................................................................................................................52

6.6.1 Compliance Test..........................................................................................................54

6.7 System Test............................................................................................................................56

6.7.1 O2 sensor calibration* .................................................................................................58

6.7.2 Leak Test Fresh Gas Delivery System........................................................................62

6.8 Gas module verification*.........................................................................................................64

7 Operation in the Individual Functions.........................................................................................71

7.1 Standby mode.........................................................................................................................72

7.1.1 Standby mode menu window.......................................................................................73

7.1.2 Standby mode graphics window..................................................................................77

7.1.3 Standby mode options window....................................................................................78

7.1.4 Standby mode screen saver function..........................................................................79

7.2 Control Panel Keys in the Ventilation Modes CMV / (S)CMV / PCV * Adult / Child...............80

7.2.1 Menu-Window in the Ventilation Modes CMV / (S)CMV / PCV * Adult / Child............80

7.2.2 Graphic Window in the Ventilation Modes CMV / (S)CMV / PCV * Adult / Child ........81

7.2.3 Options Window in the Ventilation Modes CMV / (S)CMV / PCV * Adult / Child.........82

7.2.4 Automatic Anesthetic Agent and Agent Mixture Identification * ..................................83

7.2.5 Panel Key VT/V in the Ventilation Modes CMV / (S)CMV Adult / Child ......................85

7.2.6 Panel Key VT/V in the Ventilation Mode PCV Adult / Child.........................................86

7.2.7 Panel Key f in the Ventilation Modes CMV / (S)CMV / PCV Adult / Child...................87

7.2.8 Panel Key I:E in the Ventilation Modes CMV / (S)CMV / PCV Adult / Child................88

7.2.9 Panel Key PEEP in the Ventilation Modes CMV / (S)CMV / PCV Adult / Child ..........89

7.3 “Manual/spontaneous” ventilation mode.................................................................................90

7.3.1 “Manual/spontaneous” ventilation mode......................................................................90

7.3.1.1

Alarm limit setting in “manual/spontaneous” mode.............................................94

7.4 Controlled Ventilation Mode....................................................................................................98

7.4.1 CMV adult ventilation mode.........................................................................................99

7.4.1.1

Parameter Settings in CMV Adult Mode...........................................................104

7.4.1.2

Alarm limits setting in CMV adult mode............................................................105

7.4.1.3

Alarm limits setting in CMV child mode.............................................................108

7.5 Ventilation mode (S)CMV .....................................................................................................109

7.5.1 Ventilation mode (S)CMV ..........................................................................................110

7.5.1.1

Changing parameter settings in (S)CMV adult mode .......................................115

7.5.1.2

Alarm limits setting in (S)CMV adult mode .......................................................116

7.5.1.3

Alarm limits setting in (S)CMV child mode........................................................119

7.6 Ventilation mode PCV...........................................................................................................120

7.6.1 PCV adult ventilation mode .......................................................................................121

7.6.1.1

Changing graphic settings in PCV Adult mode.................................................126

7.6.1.2

Alarm limits setting in PCV adult mode.............................................................127

7.6.1.3

Alarm limits setting in PCV child mode.............................................................130

8 Dismantling and Reassembling................................................................................................131

8.1 Patient module......................................................................................................................131

8.1.1 CO2 absorber canister ...............................................................................................131

8.1.2 Bag-in-bottle system..................................................................................................131

8.1.3 Replacing the expiratory flow sensor.........................................................................133

8.1.4 Dismantling the ventilation pressure valve (APL)......................................................133

8.1.5 Replacing the diaphragm valves................................................................................135

8.1.6 Valves (emergency air, inspiration, and expiration valve).........................................137

8.2 Connecting and disconnecting of the vaporizers..................................................................137

9 Cleaning ...................................................................................................................................138

9.1 Cleaning and sterilizing the apparatus .................................................................................138

9.1.1 Cleaning the housing.................................................................................................138

9.2 Patient module......................................................................................................................138

9.2.1 Sterilizing the patient module.....................................................................................138

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10 Preventive Maintenance and Servicing................................................................................139

10.1

General...........................................................................................................................139

10.1.1 Preventive Maintenance by a qualified technician.....................................................139

10.1.1.1 6 Month Service Interval ...................................................................................139

10.1.1.2 12 Month Service Interval .................................................................................140

10.1.1.3 36 Month Service Interval .................................................................................141

10.2

Servicing the Vaporizer..................................................................................................141

10.3

Other Servicing...............................................................................................................141

11 Specifications........................................................................................................................142

12 Warranty ...............................................................................................................................146

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V

Table of Figures

Fig. 1 Front view of the apparatus......................................................................................................................... 19

Fig. 2 Rear of the apparatus.................................................................................................................................. 20

Fig. 3 Left side view on the apparatus................................................................................................................... 21

Fig. 4 Right side view on the apparatus................................................................................................................. 22

Fig. 5 Ventilator display and airway pressure gauge ............................................................................................. 23

Fig. 6 Operating panel, ventilator keyboard........................................................................................................... 24

Fig. 7 Flow meter block including fresh gas dosing............................................................................................... 27

Fig. 8 Vaporizer mounting device.......................................................................................................................... 28

Fig. 9 Patient module (circuit system).................................................................................................................... 29

Fig. 10 Sample gas recirculation and .................................................................................................................... 30

Fig. 11 Vacuum source.......................................................................................................................................... 31

Fig. 12 Example of an alarm message during the booting procedure.................................................................... 34

Fig. 13 Example of an alarm message during the booting procedure.................................................................... 35

Fig. 14 Example of a sensor test alarm message.................................................................................................. 36

Fig. 15 Example of a system test alarm message................................................................................................. 38

Fig. 16 Example of an alarm message during normal operation............................................................................ 40

Fig. 17 “Major Technical Failure” alarm message.................................................................................................. 48

Fig. 18 First display message during system start................................................................................................. 51

Fig. 19 Second display message during system start............................................................................................ 51

Fig. 20 Display before sensor test......................................................................................................................... 52

Fig. 21 Display after the sensor test....................................................................................................................... 53

Fig. 22 Display prior to the compliance test........................................................................................................... 54

Fig. 23 Display after the compliance test as extended information........................................................................ 55

Fig. 24 Display after the compliance test as pass/fail information ......................................................................... 55

Fig. 25 System test selection display..................................................................................................................... 56

Fig. 26 Display of system test selection sub-menu................................................................................................ 57

Fig. 27 First display message of O2 sensor calibration.......................................................................................... 58

Fig. 28 Second display message of O2 sensor calibration..................................................................................... 59

Fig. 29 Third display message of O2 sensor calibration......................................................................................... 60

Fig. 30 Fourth display message of O2 sensor calibration....................................................................................... 61

Fig. 31 Display prior to the fresh gas system leak test .......................................................................................... 62

Fig. 32 Display after the Leak Test Fresh Gas Delivery System............................................................................ 63

Fig. 33 Display of the gas module verification ....................................................................................................... 64

Fig. 34 Connection of the tube system to the verification gas bottle...................................................................... 65

Fig. 35 Display No. 1 for gas measurement verification ........................................................................................ 65

Fig. 36 Display No. 2 for gas measurement verification ........................................................................................ 66

Fig. 37 Display No. 3 for gas measurement verification ........................................................................................ 67

Fig. 38 Display No. 4 for gas measurement verification ........................................................................................ 68

Fig. 39 Display No. 5 for gas measurement verification ........................................................................................ 69

Fig. 40 Display No. 6 for gas measurement verification ........................................................................................ 70

Fig. 41 Control panel ............................................................................................................................................. 71

Fig. 42 Standby mode display ............................................................................................................................... 72

Fig. 43 Standby mode menu window..................................................................................................................... 73

Fig. 44 "Set time" within the menu window............................................................................................................ 74

Fig. 45 "Load/save personal alarm limits" within the menu window....................................................................... 75

Fig. 46 "System test options“ within the menu window.......................................................................................... 76

Fig. 47 Standby mode graphic settings window..................................................................................................... 77

Fig. 48 Stand-by mode options display.................................................................................................................. 78

Fig. 49 Screen saver ............................................................................................................................................. 79

Fig. 50 Menu-Window in the ventilation mode CMV-Adult..................................................................................... 80

Fig. 51 Graphic-Window in the ventilation mode CMV-Adult................................................................................. 81

Fig. 52 Options-Window in the ventilation mode CMV-Adult ................................................................................. 82

Fig. 53 Vt adjustment in the ventilation mode CMV Adult...................................................................................... 85

Fig. 54

Fig. 55 Rate adjustment in the ventilation mode CMV Adult.................................................................................. 87

Fig. 56 I:E adjustment in the ventilation mode CMV Adult..................................................................................... 88

Fig. 57 PEEP adjustment in the ventilation mode CMV Adult................................................................................ 89

Fig. 58 "Manual/spontaneous settings" display 1 .................................................................................................. 90

Fig. 59 "Manual/spontaneous settings" display 2 .................................................................................................. 91

Fig. 60 "Manual/spontaneous settings" display 3 .................................................................................................. 92

Fig. 61 Ventilation pressure valve (APL) in CMV/SP setting.................................................................................. 93

Fig. 62 Ventilation pressure valve (APL) in 20 cmH2O setting.............................................................................. 93

Fig. 63 Alarm limits 1 in the Manual/spontaneous ventilation mode...................................................................... 94

Fig. 64 Display “Alarm limits 2 in the Manual/spontaneous ventilation mode”....................................................... 95

Fig. 65 Alarm limits in manual/spontaneous mode................................................................................................ 96

&

adjustment in the ventilation mode PCV Adult....................................................................................... 86

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Fig. 66 Graphics window in manual/spontaneous ventilation mode ...................................................................... 97

Fig. 67 Display “ventilation mode adult”................................................................................................................. 99

Fig. 68 "CMV-Settings / Adult" display................................................................................................................. 100

Fig. 69"Start in CMV adult" ventilation mode display........................................................................................... 102

Fig. 70" CMV adult" ventilation mode display...................................................................................................... 103

Fig. 71 "Parameter setting during the CMV adult" ventilation mode display........................................................ 104

Fig. 72 Display “Alarm limits 1 in the CMV Adult ventilation mode ...................................................................... 105

Fig. 73 Display “Alarm limits 2 in the CMV Adult ventilation mode” ..................................................................... 106

Fig. 74 Alarm limits in the CMV Adult ventilation mode ....................................................................................... 107

Fig. 75 Alarm limits in the CMV Child ventilation mode ....................................................................................... 108

Fig. 76 Display “ventilation mode adult”............................................................................................................... 110

Fig. 77 "(S)CMV-Settings / Adult" display............................................................................................................ 111

Fig. 78 "(S)CMV adult" ventilation mode display 1 .............................................................................................. 113

Fig. 79 "(S)CMV adult" ventilation mode display 2 .............................................................................................. 114

Fig. 80"Parameter setting during the (S)CMV adult" ventilation mode display .................................................... 115

Fig. 81 "Alarm Settings" ventilation mode (S)CMV adult ..................................................................................... 116

Fig. 82 Display “Alarm limits 2 in the (S)CMV Adult ventilation mode” ................................................................ 117

Fig. 83 Alarm limits in the (S)CMV Child ventilation mode................................................................................... 118

Fig. 84 Alarm limits in the (S)CMV Child ventilation mode................................................................................... 119

Fig. 85 Display “ventilation mode adult”............................................................................................................... 121

Fig. 86 "PCV -Settings / Adult" display ................................................................................................................ 122

Fig. 87 "Start in PCV adult" ventilation mode display .......................................................................................... 124

Fig. 88 "PCV adult" ventilation mode display....................................................................................................... 125

Fig. 89 "Parameter setting during the PCV adult" ventilation mode display......................................................... 126

Fig. 90 Display “Alarm limits 1 in the PCV adult ventilation mode”...................................................................... 127

Fig. 91 Display “Alarm limits 2 in the PCV adult ventilation mode”...................................................................... 128

Fig. 92 Alarm limits in the PCV adult ventilation mode ........................................................................................ 129

Fig. 93 Alarm limits in the PCV Child ventilation mode........................................................................................ 130

Fig. 94 Dismantling of the patient module, front view .......................................................................................... 132

Fig. 95 Dismantling of the patient module, top view ............................................................................................ 134

Fig. 96 Dismantling of the valve bodies............................................................................................................... 136

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1 Details of the Manufacturer / Apparatus

Apparatus: Anesthesia system HEYER NARKOMAT

Manufacturer: HEYER Medical AG
Carl-Heyer-Strasse 1-3

56130 Bad Ems
Germany

Tel: ++49 2603 / 791-3
Fax: ++49 2603 / 70424

E-Mail: [e-mail]

Software version: Display driver software: 3.0

Ventilator software: 2.5.n

+

Certificate-No.: 04 207-1743/98

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2 Description and Utilization of the Apparatus

2.1 General

Introduction

The HEYER NARKOMAT+ 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, a secure and easy operation. Furthermore the excellent air-tightness of the
system ensures the economical daily high and low pressure utilization.

The standard model contains the following system components:

A. Electronic ventilator

The process-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, the
(S)CMV and PCV as optional ventilation modes, as well as various forms of ventilation and
considerable variation options of the artificial ventilation cycle, facilitate a secure ventilation
even 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. The patient module

The circular patient absorber system is highly integrated and compacted in an aluminum
block. The block is tempered to prevent the formation of condensation. The block also
contains an emergency air valve, a fresh gas reservoir in form of a hand-held anesthesia bag
and an expiratory flow sensor. A motor drive connects the module to the basic apparatus. 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 flow meter tube block contains all mandatory safety equipment as well as a pneumatic
control system to maintain a minimum oxygen concentration of 25% in the fresh-gas flow
(ratio system).

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D. Integrated gas measurement
CO2

The continuous CO2 measurement is graphically shown as a capnogramm. The end
expiratory and inspiratory CO2 measurement will be shown as a numerical value. The CO2
values can be displayed in Vol% or mmHg.

N2O

The nitrous oxide measurement is similar to the CO2 measurement and will be shown in Vol%
in the form of numerical values.

O2

The display of the oxygen measurement is based on the same principles as the measurement
of CO2 and N2O and will be shown in Vol% in the form of numerical values.

Anesthesia gas

The gas module is equipped with an automatic anesthetic agent and anesthetic agent mixture
identification. The apparatus measures the agents Halothane, Isoflurane, Enflurane,
Desflurane and Sevoflurane. The display of the Anesthesia gas measurement is based on the
same principles as the measurement of CO2, N2O and O2 .

MAC

The displayed Minimal Alveolar Concentration is calculated according to the following
formula:

EtAA[%] EtN20[%]
MAC (AA) = ------------ + ------------­ xAA 100

AA = Anesthetic agent
Et = End expiratory concentration
x = Alveolar concentration of the Anesthetic agent for MAC =1 at 100% O2 and
patient age of 40 years.

2.1.1 Product improvements

HEYER MEDICAL AG retains the right to carry out modifications or to update the apparatus
and/or operating instructions without prior notification. These Operating Instructions explain all
features of the HEYER NARKOMAT+ anesthesia system and are correct at going to print.
Instructions and models produced at a later stage may already contain improvements or
modifications that were not included in previous models.

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2.1.2 Responsibilities of operators

The correct functioning of the HEYER NARKOMAT+ anesthesia system can only be
guaranteed if the apparatus is operated and serviced in accordance with the information
provided by the manufacturer. The non-compliance with this information voids all guarantee
claims against HEYER MEDICAL AG.

NOTE: Before using the apparatus please study the Operating Instructions as well as the
section "General precautions", observing all information contained in these Operating
Instructions that are highlighted with CAUTION or WARNING. These Operating Instructions
only describe the operation of the apparatus. Information about service and repair by qualified
trained personnel are contained in the HEYER NARKOMAT+ SERVICE INSTRUCTIONS.

The apparatus may only be operated by qualified and trained skilled personnel. All operators
must fully observe these Operating Instructions or relevant additional documentation and
information provided by the manufacturer. They must also comply with the general
precautions detailed below and must be trained by authorized medical product consultants.

The apparatus may only be operated with an additional gas monitoring if a gas monitoring is
not included. The following conditions must be fulfilled (DIN 13 252):

At least the:

- anesthesia-gas concentration and

- the carbon dioxide concentration
must be monitored.
Upper and lower alarm limits must be set for these monitoring parameters. Upon reaching

one of these upper or lower alarm limits, an optical and acoustic alarm must be triggered.
The measuring adapter to be installed in the circular system or patient hose system must

contain ISO cones (DIN 13 252). These must be applied to the inspiration hose connection or
ideally to the Y piece. Measuring close to the tube is, however, recommended as this allows
the recording of the inspiratory and expiratory gas values. Monitors using the side-stream
procedure should be clearly preferred as a supplement to the additionally required gas
monitoring.

Any apparatus not functioning as described in these Operating Instructions must not be used
until the fault has been removed. The operators are responsible for any damage or injuries
caused by the incorrect operation or repair/servicing of the apparatus by unauthorized
personnel.

2.1.3 Liability of the manufacturer

HEYER MEDICAL AG shall only be liable for the safety, reliability and functionality of the
apparatus, if:

- the apparatus was operated in accordance with the information issued by the manufacturer;

- extensions, new adjustments, modifications or repairs have been carried out by an expert

authorized by the manufacturer;

- the apparatus was only operated in buildings containing grounding facilities according to the

IEC regulations.

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2.2 General precautions

2.2.1 Warning notes

NOTE: A warning note points out potentially dangerous situations which may cause injuries to
the patient or operating personnel.

Carry out the daily checks specified on the checklist and do not operate the system in case of
a fault until the fault has been repaired.

If possible, always connect the output of the ventilation pressure valve (APL) to the anesthetic
gas removal line, usually installed in the operating theatre.

The patient should furthermore be visually monitored by qualified personnel. In certain
situations, life-threatening circumstances may occur which may not necessarily trigger an
alarm.

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

Always check that the displayed ventilation pressure value lies within an acceptable range
before activating the "Set Pmin/Pmax automatically" function, automatically setting new alarm
limits.

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).

Explosion hazard! The apparatus may not be operated near flammable anesthetic agents or
other flammable substances. No flammable anesthetic agents (i.e. ether, cyclopropane) may
be used.

As the apparatus may not be used with inflammable anesthetic agents (i.e. ether,
cyclopropane), no antistatic ventilation hoses or face masks are required (DIN VDE750, part

214).
Electric shock and fire hazard! Always switch off the apparatus and disconnect from mains

before cleaning.
Fire hazard! Fuses (i.e. additional sockets) may only be replaced by fuses of the same type

and with the same fuse value.
Electric shock hazard! The apparatus may only be opened by qualified or authorized experts.
The connection of apparatus via the additional socket may, in case of a failure of the

protective conductor, lead to a discharge current exceeding the permissible values.
Electromagnetic radiation disturbances exceeding the values of EN 60601-1-2, can affect the

function of the machine.

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2.2.2 Caution notes

NOTE: A CAUTION note refers to a situation which may cause damage or the incorrect
function of the apparatus.

This apparatus may only be operated by trained, skilled medical staff.
Before starting the apparatus, the operating personnel must be familiar with the notes and

information contained in these Operating Instructions and must have been trained by a
medical product consultant.

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

Handle the apparatus with care to prevent damage or functional faults.
Ensure that the gas supply of the apparatus always complies with the technical specification.
Before the operation, the apparatus must be correctly calibrated and/or the respective

apparatus tests, as described in the Operating Instructions, must be carried out.
If the apparatus should show faults during the initial calibration or testing, the apparatus may

not be operated until the fault has been repaired by a qualified expert.
After servicing, a functional test and a sensor and system test must be carried out before

clinical use.
Only bacteriological filters with a low flow resistance must be connected to the patient module

and/or the patient connection.
* After the unit has been switched on, a warming period of 4 minutes is necessary to ensure

an exact measurement of the anesthesia gas values. The other breathing gas values are
within the ISO specifications after 1 min

* Only use the recommended pressure controller when doing the gas verification. A to high or
to low calibration gas flow can lead to faulty result.

* Use only the original tube system as measuring tube.
* The gas measurement tube system at the monitor must be connected before putting the

apparatus into use or changing the flow rate. Otherwise the apparatus might falsely detect a
tube blockage.

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3 Functional Description

3.1 Anesthesia ventilator

Ventilators are described according to the principle of controlling the change over from
inspiration to expiration. The NARKOMAT+ apparatus offers the following characteristics in

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 ratio of the inspiration to the expiration time of the individual
ventilation cycle is determined by the adjustable I/E ratio.

pressure limitation:

The tidal volume during controlled ventilation is supplied during the entire period of the
inspiratory flow and can be set as 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 ventilation with the set parameters, frequency f,
tidal volume T. Vol. 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 to the tidal volume actually supplied to the patient could
occur due to the respective fresh gas setting and system compliance of the ventilation

system. The ventilator of the NARKOMAT+ apparatus supplies in each setting a constant
volume. The patient module containing the bellows is decoupled from the fresh gas, and the
system compliance of the patient module is automatically taken into consideration by the
ventilator when generating the tidal volume.

3.1.1 Fresh gas decoupling

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

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

2. The fresh gas flow can be maintained at a very low level, i.e. below 500 ml/min,
depending on the patient. The manual ventilation bag serves as a reservoir for the
fresh gas administered during the 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 the expiration period.

3.1.2 Constant volume provided by controlled ventilation

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

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3.1.3 Compliance compensation

The administered tidal volume is corrected to the set 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, always leads to losses in the

administered tidal volume. The NARKOMAT+´s automatic compensation of the system
compliance can correct this volume loss with the aid of a control loop. For this purpose
several ventilation cycles are required with the drive gas flow being slightly increased above
the normal values, i.e. the values for achieving the set ventilation volume. The correct tidal
volume is, however, administered to the patient, whilst 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. An increased drive volume,
flowing into the pressure dome, also increases the tidal volume. Once the drive-gas flow has
finished, also the pressure compensation between the primary and secondary circuit is
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 in the pressure dome is maintained at a steady level for some
time. The Bellow is suitable for adults and children. An exchange of the bellows for different
patient groups is not necessary.

3.2 Fresh gas dosing

The set-up of the gas quantities administered to the patient is carried out on a measuring tube
block. This block contains measuring tubes that are also referred to as rotameters. These
measuring tubes consist of a vertical glass tube, containing a suspended body. As the glass
tubes expand towards the top, a certain gas flow lifts the suspended body to a respective
height. The gas flow is adjusted via valve spindles, located below the individual measuring
tube.
The setting of the O2/AIR or O2/N2O is selected with the 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 N2O as, in this case, a decrease of the
oxygen content to below 21% could not be avoided.
The decrease of the oxygen content to below 21% is in theory also possible with O2 and N2O
gas dosing. Such unfavorable settings are, however, prevented by a pneumatic safety
system. This system, which is also referred to as RATIO system ensures the continuous
existence of a minimum O2 content of 25% in the dosed gas mixed with N2O. In case of an
increase of the N2O flow, the required O2 flow is also automatically increased. The thus set
fresh gas is then fed over a vaporizer, where it is mixed with anesthetic agent.

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3.3 Vaporizer mounting device and Vaporizers

The apparatus contains a Selectatec compatible vaporizer
accommodating two vaporizers. The vaporizer contains two chambers, with the bottom
section containing the liquid anesthetic agent. Via a woven metal wick, the top section of the
chamber is enriched with saturated anesthetic agent steam. The concentration of the
saturated steam at ambient temperatures is considerably higher than that acceptable for
clinical purposes. The desired concentration is achieved by a suitable mixing ratio of the gas
and anesthetic agent with a gas flow that is passed around this chamber. This is achieved
with the aid of the setting wheel. For this purpose, the ratio of the flows of the carrier gas is
adjusted by a bypass channel and the vaporizer channel in such a way, that the chosen
concentration is achieved at the vaporizer outlet. In the zero position of the vaporizer, this
bypass channel remains open whilst the vaporizer chamber is completely closed for the gas
flow.
Although the anesthetic agent steam concentration of the vaporizer chamber is saturated, the
absolute anesthetic agent content depends, however, on the temperature. Consequently, the
bypass channel contains a temperature compensation valve which in case of changes in the
steam pressure caused by temperature fluctuations, changes the set dilution ratio in such a
way that the anesthetic agent concentration issued is no longer dependant on the
temperature.
For further information see:
Instructions of the respective anesthetic agent vaporizer.

mounting device

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3.4 Patient module

3.4.1 Circuit absorber system

The circuit absorber system consists of a ventilation system with CO2 absorber. This system
allows anesthetics to be carried out at extreme low fresh gas settings. The ventilation gas
contains various parts of re-breathing gas, i.e. expiratory gas freed from CO2 parts. This is
achieved with a circuit ventilation system, facilitating a re-breathing of the expiratory CO2­containing gas. A circuit system with high re-breathing contents causes a reduction of the
consumption of anesthetic agents. This system also offers an improved breathing gas
conditioning. The patient module is designed as a circuit absorber system in the form of a
compact aluminum block. The hose connections normally required between the ventilator and
the circuit system are thus no longer needed.

3.4.2 CO2 absorber

The absorber serves to absorb the soda lime and aims to remove the CO2 from the expiration
air. The absorption process is a chemical reaction in which carbon dioxide is bound, most of
the reaction water evaporates and the calcium is removed. Consequently the spent soda lime
is dry and hard. The soda lime must be stored hermetically sealed, cool and dry in order not
to become malabsorbant.

3.4.3 Reservoir and manual ventilation bag

The reservoir consisting of a manual ventilation bag provides an inspiratory interim store for
the fresh gas. The reservoir pressure during machine and spontaneous breathing is limited to
1-2 cmH2O. During manual breathing, this valve also allows the manual adjusting of the
desired ventilation pressure.

3.4.4 Volume measurement

Volume measurement is carried out by using a flow meter, operating according to the hot-wire
anemometer principle, to measure the flow in the expiration branch. The ventilator processors
integrate this measured value with the displayed tidal and ventilation minute volume. The tidal
volume shown in the display is a measured value. The tidal volume displayed during
controlled ventilation is measured by an internal flow sensor and is not dependent on the
expiratory volume measurement.

3.4.5 Oxygen measurement*

The oxygen is metered by a measuring cell installed on the inspiration valve. This single­cathode measuring cell, also referred to as fuel cell, offers a longer life compared to other
oxygen cells and is less sensitive to existing anesthetic gases.

*not valid with the apparatus option with integrated gas module

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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 section of the patient module. An electronic control integrated in the
ventilator, keeps the temperature of the patient module constant at an approx. 36°C. An over­temperature protection protects the apparatus against overheating.

3.5 Gas measurement*

The measurement of the single gases in the breathing gas is based on the principle that
different gases absorb a different wavelength of infrared light. A pump inside the apparatus
continuously sucks a breathing gas probe out of the respiratory circulation into the
measurement chamber via a sampling line which is included with the gas module. This gas
probe flows through the measurement chamber where the absorption of the different wave
lengths of infrared light is measured. Based on these measurements, a microprocessor
calculates the concentration of CO2, N2O and anesthesia gas.

The measurement of oxygen is done with a paramagnetic oxygen sensor. This principle of
measurement is based on the paramagnetic characteristics of the oxygen molecule, through
which the oxygen concentration can be measured magnetically.

* only valid with the apparatus option with integrated gas module

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4 Operating Elements / Connections for Appliances

4.1 Views of apparatus

4.1.1 Front of apparatus

Fig. 1 Front view of the apparatus

1 Vaporizer mount

Selectatec* compatible
vap. mount for
connection of 2
vaporizers.

2 Flow meter block

6-fold flow meter block
with integrated Ratio­system, O2-Bypass
and N20/AIR change
over switch.

3 Ventilator unit

Microprocessor
controlled ventilator
with TFT-display.

4 Control panel

Control panel with
keys, selector switch
and encoder (rotary
switch).

5 Patient module

Absorber circuit system
with integrated bag-in­bottle system, active
and passive valves,
such as APL-valve.

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4.1.2 Rear of apparatus

Fig. 2 Rear of the apparatus

1 Mains cable

Voltage supply cable for
connecting the apparatus
to a socket with
grounding contact.

2 Cable hooks
3 Sockets

Additional devices
can be connected.

4 Circuit breakers

One 5A circuit breakers
for the ventilator unit ,
one 5A circuit breaker for
the battery and one 10A
(or two 5A) circuit breaker
for the convenient
receptacles

5 Cylinder jokes

Pin-index or DGAI
cylinder jokes, one for
N2O, one for O2.

6 Serial number
7 Fan

A fan provides ventilation
of the housing and
cooling of the integral
components.

8 Pipeline supply
connections

Connections for O2, AIR
and N2O from central gas
supply. Three pipeline
pressure gauges inform
about supply pressure.

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4.1.3 Left side of apparatus

Fig. 3 Left side view on the apparatus

1 Holder for patient arm

2 Oxygen-sensor with
cable*

3 Patient module

4 Suction stand with
glasses (option)

5 Water trap with gas
measurement inlet**

* Only valid without the
option gas module

**Only valid with the
option gas module

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4.1.4 Right side of apparatus

1 Machine operation
checklist

The checklist informs
about several tests which
have to be carried out in
the start-up procedure.

2 Mains switch

With this switch, the
apparatus is switched
on/off and the mains
connection is activated.
During the operation, the
switch remains in the ON
position.

3 Rail mount 25 x 10

Fig. 4 Right side view on the apparatus

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4.2 Ventilator unit

1

2

3

Fig. 5 Ventilator display and airway pressure gauge

1 Ventilator display

The ventilator uses a
color TFT display. This
display is high in contrast,
clearly visible also from
the side view and
provides all measured
values and settings of the
ventilator.

2 Airway pressure
gauge

Shows the airway
pressure on a pressure
gauge within a range of

-20 to 80 cmH2O.

3 Cylinder pressure
gauges

Shows the cylinder
pressure for each
cylinder on a pressure
gauge within a range of
0 to 315 kPa x 100 (315
bar).

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4.2.1 Operating panel, ventilator keyboard

Fig. 6 Operating panel, ventilator keyboard

4.2.1.1 "Ventilation Modes"- selection switch

This switch for the selection of ventilation modes has four positions:
Standby: Position for starting and implementing sensor and system tests.
Manual/spont.: In this position the ventilator is switched to the manual or

spontaneous ventilation mode.

Child (20-400 ml): In this position, the ventilator is switched to the mode for the

controlled ventilation of children.

Adult (300-1400 ml): In this position the ventilator is switched to the mode for the controlled

ventilation of adults.

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4.2.1.2 "Push to Enter" - encoder button to change and confirm settings

With this encoder button the different parameter windows can be selected in the display. By
turning the button anti-clockwise or clockwise, the respective windows or selection buttons in
the display are selected. By pushing the direct selection button, functions or further windows
may be selected or opened. Rotary ventilator set-up buttons shown on the display, are also
operated by the direct selection button. The respective parameters are increased in clockwise
direction and decreased in anti-clockwise direction.

In case of changes, the changed settings or selections are confirmed and stored once
the button is pressed.

4.2.1.3 Operating panel keys for insp. pause and exp. pause

Insp. Pause: Upon pressing this key in the CMV mode, the green LED flashes and an

inspiratory pause of up to 5 sec. is inserted at the end of the next inspiration.
In order to terminate the pause early, the key may be pressed a second time,
after which the inspiratory pause is terminated.

Exp. Pause: Upon pressing this key in the CMV mode, the green LED flashes and an

expiratory pause of up to 30 sec. is inserted at the end of the next expiratory.
In order to terminate the pause early, the key may be pressed a second time,
after which the expiratory pause is terminated.

4.2.1.4 "Settings" - panel keys for basic set-up

Menu: This key opens a ventilator display window menu in all ventilation modes and

the standby position. The time and temperature of the patient module are
displayed. The alarm level of the acoustic alarms can be set and the alarm
limits for three personal settings may be stored or loaded. The test option
system display key opens another window in which comprehensive or brief
information may be selected for the result of the compliance test.

Graphics: This key opens a ventilator display graphic window in all ventilation modes

and the standby position. The time axis of the real-time ventilation pressure
and expiratory flow graphics to be displayed can be set to 16, 24 or 32
seconds.

Options This key opens a ventilator display graphic window in all ventilation modes

and the standby position. Here the anesthesia gas, the sample flow and the
displayed CO2 unit can be set. *
In the standby mode the patient module can be unlocked and the gas
measurement can be verified. *

*Only valid with option gas module

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V

V

4.2.1.5 "Alarms" - panel keys and displays for alarms

This key opens a display window in the manual/spontaneous, CMV,

(S)CMV or PCV ventilation modes for setting all available alarm limits.
The respective alarm limits can then be changed to the new settings.
By pressing the limits key a second time, an additional alarm window is
opened with additional adjustable alarm settings. By pressing the limits
key a third time the window is closed and the changed alarm limits are
stored.

This key switches off the sound of the acoustic alarms for a maximum

of 2 minutes. By pressing the key again, the sound is activated again
before the end of the 2 minute period.

4.2.1.6 Vent. Settings" - panel keys for direct selection display windows

For the respective parameters a smaller window is opened for a new setting or the alteration
of existing settings. With the aid of the encoder button, the current parameter setting can be
changed with a rotary display button. The changed setting is confirmed and stored by
pressing the encoder. Or the display window is closed by depressing the key again or
automatically after about 5 sec.

•

VT/

: In the CMV ventilation mode this key opens a display window for

setting the tidal volume VT.

•

In the PCV ventilation mode this key opens a display window

setting the maximum inspiratory flow.

f: This key opens a Rate display window in the CMV ventilation mode for

setting the ventilation frequency Rate.

I:E: This key opens an I:E display window in the CMV ventilation mode for

setting the ventilation time ratio I:E from inspiration to expiration time.

PEEP: This key opens a PEEP display window in the CMV ventilation mode

allowing a PEEP setting.

for

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4.3 Flow meter tube block including fresh gas dosing

Fig. 7 Flow meter block including fresh gas dosing

1 Flow meter tube O
2 Flow meter tube O
3 Flow meter tube AIR

with a low measuring range for settings between 0 to 1000 ml/min

2

with a high measuring range for settings between 1,5 and 10 l/min

2

with a low measuring range for settings between 0 to 1000

ml/min

4 Flow meter tube AIR

with a high measuring range for settings between 1,5 and 10

l/min

5 Flow meter tube N2O

with a low measuring range for settings between 0 to 1000

ml/min

6 Flow meter tube N2O

with a high measuring range for settings between 1,5 is 10 l/min

7 Valve spindle for O2 gas dosing
8 Valve spindle for AIR gas dosing
9 Valve spindle for N2O gas dosing
10 O2 bypass

The O2 bypass supplies a high O2 flow (approx. 50 l/min) directly to the fresh gas outlet or

into the patient module. Upon releasing the bypass key, the key returns to its original
position and the O2 bypass is automatically interrupted.

11 N2O/AIR change-over switch

This switch allows the pre-selection of N2O or AIR, which can then be dosed with the

respective valve spindles. The previously set volume flow is retained after switching back
to the same gas type.

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4.4 Vaporizer mounting device

Fig. 8 Vaporizer mounting device

1 Fixing knob for patient arm
2 Valve cartridge of vaporizer mount
3 Locking device
4 Stopping face

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4.5 Patient module (circuit system)

Fig. 9 Patient module (circuit system)

1 Emergency air valve
2 Inspiration valve
3 Oxygen sensor*

(fuel cell)

4 Ventilation pressure valve (APL valve): Including rotary regulator for setting the

pressure control during manual ventilation or for setting it as a 2 cmH2O release valve
during CMV or spontaneous ventilation.

5 Expiration valve
6 Hose connection branch
7 Outlet of ventilation pressure valve

(APL-valve):

The anesthetics gas scavenging system is connected to this point.

8 Hose connection for inspiration branch
9 Hose connection for reservoir/manual ventilation bag
10 Bellows including bellows dome
11 CO

absorber canister

2

*only the apparatus option without the gas module

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4.6 Sample gas recirculation

Fig. 10 Sample gas recirculation

1 Sample gas recirculation connector*

The gas return line from external monitors operating according to the side stream
procedure are connected to the "Sample gas recirculation" adapter at the rear side. The
sample gas is putted back to the reservoir bag by this adapter.

* only the apparatus option without the gas module

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