Dräger Primus User manual

Drager medical
A Drager and Siemens Company
Primus
Anaesthetic Workstation
Software 2.n
instructions for Use
Emergency Care - OR/Anesthesia - Critical Care - Perinatal Care - Home Care Because you care

How to use these Instructions for Use
In the header is the subject...
of the main chapter.
To help you find your way around quickly.
On each page...
the instructions for use
combining text with illustrations. The information is translated
directly into actions to enable the user to learn "hands-on" how
to use the workstation.
Left-hand column...
the text
provides explanations and guides the user clearly and
ergonomically with brief directions for using of the product.
Bullets indicate the steps to be followed, and if there are
several steps, numbers refer to the illustration and indicate the
sequence.
Right-hand column...
the illustration
provides a link with the text and serves as a guide to the
workstation. Points mentioned in the text are emphasized and
non-essential information is omitted.
Screen displays guide the user and confirm the steps to be
followed.
Conhgunng the default settings
Configuring the default
settings
Default settings describe those
parameters lor vonldalion, gas delivery
and monitoring, as well a6 the screen
settings with which the workstation
starts when switched on and which are
activated vía tho sofl koy «restore
detautt settings. in standby.
Changes in default settings become
active immediately.
The default sefiings can bo configured
1 standby as follows:
& Switch Primus to standby
1. Press the soft key «default config...
The operator is roquesied to enter a
fourdigt password in order to prevent
unauthorized changes to tha basic
functions. This password is allocated
whon commissioning tha workstation,
H denied, the functian can be disabled
by DrägorService or an individual
password scl
2. Seloci the succossive digits from the
line displayed using the ratary knob
and push the rotary knob to confirm
them. The password is represented
by asterisks (* * * *} below the line of
numbers.
The menu for selecting the defauk
values is displayed whon the
password has been entered
correct
The default vatucs are adoptod
automatically when the menu ts
displayed
Dispiay (example);
106 Insituctone for Use Primus SW 2.n
Instructions for Use Primus SW 2.n
0001

instructions for Use Primus SW 2.n
Table of Contents
Table of Contents
119

Table of Contents
Instructions for Use Primus SW 2.n

Instructions for Use Primus SW 2.n
Abbreviations and symbols
Abbreviations and symbols
Abbreviations
Symbols ....

Abbreviations
Abbreviations
Abbreviations
Agent
AGS
Air
APL
ATPS
BTPS
CAL
Compl.
CPAT
AO2
APPS
Des.
etCO2
Ent.
ex./exp.
FG
FLOW
Freq.
Freg.MIN
Hal.
HLM
in./insp.
in Des
in Enf
in Hal
in Iso
in Sev
Meaning
Anaesthetic gas
Anaesthesia Gas Scavenging System
Compressed air for medical use
Adjustable Pressure Limitation
Measuring conditions at ambient
temperature, current atmospheric
pressure and with saturated gas
Measuring conditions at body
temperature, current atmospheric
pressure and with saturated gas
Calibration
Compliance
Patient compliance
Difference between inspiratory and
expiratory 02
Pressure difference for pressure support
in pressure support mode
Desflurane
End-expiratory CO2 concentration
Enflurane
Expiratory
Fresh-gas
Expiratory flow
Frequency
Mandatory minimum frequency in pressure
support mode
Halothane
Mode with modified alarm response when
using a heart lung machine
Ratio of
inspiration time to expiration time
Inspiratory
Inspiratory desflurane concentration
Inspiratory enflurane concentration
Inspiratory halothane concentration
Inspiratory isoflurane concentration
Inspiratory sevoflurane concentration
Abbreviations
in CO2
in O2
INOP
Iso.
MAC
Man. Spont.
MEAN
MV
MVLEAK
MVMEAS
N20
NiBP
NTPD
O2
Pa
PAW
PEAK
PEEP
PINSP
PLAT
Pleth
PMAX
Press. Mode
Press. Supp.
PS
Sev.
SORC
SpO2
sync
TG
Meaning
Inspiratory CO2 concentration
Inspiratory O2 concentration
Inoperable
Isoflurane
Minimum Alveolar Concentration
Manual ventilation/
spontaneous breathing
Mean pressure
Expiratory minute volume
Difference between inspiratory and
expiratory minute volume
Measured minute volume
Nitrous oxide (laughing gas)
Non-invasive blood pressure
Normal temperature pressure dry
(20 °C, 1013 hPa, dry)
Oxygen
Pascal (1 mbar = Pax 100)
Airway pressure
Peak pressure
Positive end-expiratory pressure
Pressure limitation in pressure mode
Plateau pressure
Plethysmogram
Maximum pressure
Pressure mode
Pressure-controlled ventilation
Pressure support mode
Pressure-assisted ventilation
Pressure support
Sevoflurane
Sensitive Oxygen Ratio Controller
Functional O2 saturation
Synchronization
Carrier gas
Instructions for Use Primus SW 2.n

Abbreviations
TIP : TINSP
TINSP
TSLOPE
UPS
VAC
Vent.
Vol.
Vol. Mode
VT
ZV
Meaning
Ratio of
inspiratory pause time
to inspiration time
Inspiration time
Rise
time
Uninterruptible power supply
Vacuum (e.g. for secretion aspiration)
Ventilation symbols
Volumeter
Volume mode
Volume-controlled ventilation
Tidai volume
Piped medical gas supply for O2, N20,
AIR and vacuum
Instructions tor Use Primus SW 2.n
Abbreviations

Symbols
Symbols
Symbol
CE È
回
KAKS
KA
Seg
eda
Meaning Symbol
Conformité Européenne Fa
Directive 93/42/EC
on Medical Products >
Suppress alarm tone for 2 minutes, a
change priority of technical alarms and 3
acknowledge them ©
Call up standard screen È
P MX us
Call up basic screens in succession €
Standby/operation switch
Pulse rate
Fresh-gas flowing
Action in progress
Upper and lower alarm limits
Upper alarm limit only
Lower alarm limit only
Alarm tone suppressed for 2 minutes
Alarm monitoring inactive
Alarm limits disabled
Upper alarm limit disabled
Lower alarm limit disabled
Alarm limit disabled
4-digit password entered
Protection class type B (body)
Protection class type BF (body floating)
Connection for equipotential bonding
Note
Close menu,
return to preceding menu
Non-rebreathing system
at external gas outlet
Available operating time with
uninterruptible power supply UPS
Manual ventilation
Meaning
Automatic ventilation
Connector for piped medical gas supply
(ZV)
Backup gas cylinder
Rotary knob
UL test mark
Plug system for Vapor units
Instructions for Use Primus SW 2.n

Instructions for Use Primus SW 2.n
For your safety and that of your patients
For your safety and that of your patients
For your safety and that of your patients .................................
Safety precautions

For your safety and that of your patients
For your safety and that of your
patients
Strictly follow the Instructions for Use
Any use of the apparatus requires full understanding and strict
observation of these instructions.
The apparatus may only be used for the purposes specified
here.
Maintenance
The apparatus must be inspected and serviced every
6 months by trained service personnel.
Repair and general overhaul of the apparatus may only be
carried out by trained service personnel.
We recommend that a service contract be obtained with
DragerService and that all repairs also be carried out by them.
Only authentic Drager spare parts may be used for
maintenance.
Observe chapter "Maintenance intervals”.
Accessories
Only the accessories listed in the enclosed list of accessories
("Primus" equipment series 86 03 522, Rev. 09 or higher) may
be used.
Note: Even accessories designed to be reused after cleaning
have a limited life. Due to a number of factors connected with
handling and preparation, disinfectant residues can attack the
material more intensely during autoclaving; increased wear
can occur and service life can be markedly shortened. Such
parts should be replaced when external signs of wear become
apparent, such as cracks, deformation, discoloration, peeling,
etc.
Not for use in areas of explosion hazard
This apparatus is neither approved nor certified for use in
areas where combustible or explosive gas mixtures are likely to
occur.
Safe connection with other electrical equipment
Electrical connections to equipment which is not listed in
these Instructions for Use should only be made following
consultations with the respective manufacturers or an expert.
10
Liability for proper function or damage
The liability for the proper function of the apparatus is
irrevocably transferred to the owner or operator to the extent
that the apparatus is serviced or repaired by personnel not
employed or authorized by DragerService or if the apparatus is
used in a manner not conforming to its intended use.
Drager cannot be held responsible for damage caused by
non-compliance with the recommendations given above.
The warranty and liability provisions of the terms of sale and
delivery of Drager are likewise not modified by the
recommendations given above.
Drager Medical AG & Co. KGaA
Instructions for Use Primus SW 2.n

Safety precautions"
The workstation may only be used under the permanent
supervision of qualified medical personnel so that
assistance can be provided immediately in the event of any
malfunctions.
Explosive anaesthetics, such as ether or cyclopropane,
must not be used due to the risk of fire.
Primus must not be used with nuclear spin tomography
(MRT, NMR, NMI).
Operation of the workstation may be impaired and the
patient endangered.
Drugs or other substances based on inflammable
solvents, such as alcohol, must not be introduced into the
patient system.
Risk of fire.
Adequate ventilation must be ensured if highly
inflammable substances are used for disinfection.
Mobile radio telephones must not be used within
10 metres of the workstation.
Mobile telephones may interfere with the operation of
electrical and electronic medical equipment and endanger
the patient!**
The application of a wail or ceiling mounting support is
designated for buildings, not for mobile facilities such as
ambulances, helicopters ar ships.
Always keep a manual ventilator at hand.
If ventilation of the patient is no longer assured due to an
obvious fault in the equipment, the patient must immediately
be ventilated with a separate emergency ventilator.
Do not use conductive breathing hoses or face masks.
They may cause burns during HF surgery.
* Additional precautions can be found in the respective chapters.
** Drager medical equipment fulfils the interference resistance
requirements according to the product-specific standards or
EN 60601-1-2 (IEC 60601-1-2). However, depending on the design
of the mobile phone and circumstances of use, field strengths may
occur in the immediate environment of a mobile phone that exceed
the limits of the above standards and therefore cause interference.
Instructions for Use Primus SW 2.n
For your safety and that of your patients
11

12
Instructions for Use Primus SW 2.n
ищи
iz

Instructions for Use Primus SW 2.n
Intended use
Utilizind 1 に に ーー に ーー に に に トト トー トト に トト トト レト トレ ト て トト トト し し し し ト て て て て て て て レト K eens 14
Ventilattonmodes ............................. elele 14
The following measured values are displayed ............................... 14
The following parameters are displayed as curves ........................... 14
The following are displayed as bar graphs.................................. 14
Monitornd ーー に に に に トー トー トト トト に ーーー トト トト トト トー トト トト トト レト トー て トト トト て ーー トー トー て ーー ここ 14
13

Intended use
Intended use
Primus Anaesthetic Workstation for adults, children and
neonates with automatic and manual ventilation, as well as
spontaneous breathing with or without pressure support.
Utilizing
— inhalation anaesthesia in rebreathing systems
— Inhalation anaesthesia in semi-closed to virtually closed
systems with "low flow" and "minimal flow" techniques
(for minimal gas and anaesthetic agent consumption)
ー Inhalation anaesthesia in non+ebreathing systems, with a
separate fresh-gas outlet for connecting of the Bain system
or Magill system, for example,
with a fresh-gas flow of 0.2 to 18 L/min.
Ventilation modes
ー Volume-controiled ventilation in volume mode.
With activation of: synchronization,
pressure support (optional)
ー Pressure-controlled ventilation in pressure mode
With activation of: synchronization,
pressure support (optional)
— Manual ventilation (Man.)
— Spontaneous breathing (Spont.)
ー Pressure-assisted spontaneous breathing in pressure
support mode (optional)
The following measured values are displayed
— Peak pressure PPEAK, mean pressure PMEAN,
plateau pressure PPLAT and PEEP
— Expiratory minute volume MV,
difference between inspiratory and expiratory minute
volume MVLEAK,
patient compliance CPAT,
tidal volume VT,
breathing rate Freq.
— Inspiratory and expiratory concentrations of O2, N20,
anaesthetic gas and CO2
ー AO2:
difference between inspiratory and expiratory
O2 concentration
Optional:
— Functional oxygen saturation (SpO2) and pulse rate
The following parameters are displayed as curves
— Airway pressure PAW
— Inspiratory and expiratory flow
ー Inspiratory and expiratory concentrations of O2, CO2 and
anaesthetic gas
14
Optional:
— Plethysmogram
— p-V loops and V-flow loops
The following are displayed as bar graphs
Inspiratory, expiratory and leakage tidal volume
Volumeter
— Pressure
— Econometer for indicating fresh-gas utilisation (optional)
Trends showing the measured values over time and a logbook
are also available.
Monitoring
by means of adjustable alarm limits which can automatically be
adapted to the momentary ventilation situation.
With monitoring for
— Airway pressure PAW
ー Expiratory minute volume MV
— Apnoea |
— Inspiratory and expiratory anaesthetic gas concentration |
— Detection of anaesthetic gas mixtures (simultaneous
detection of up to two anaesthetic agents)
— Inspiratory O2 and N2O concentrations
ー Inspiratory and expiratory CO2 concentrations
— Special alarm response in HLM mode
Optional:
— Oxygen saturation
— Pulse rate
instructions for Use Primus SW 2.n

Instructions for Use Primus SW 2.n
Operating concept
Screenergonomics............................ lala. 16
Selecting/setting ventilation parameters ................................... 18
Selecting/setting monitoring functions. ..................,................. 19
Screen layout ο erre rear ease ων εν ον ερ ων 21
Three basic screensformonitoring.................... 4... 5.21.1111 21
Colour concept νο νν κενο чин ον ων εν ων 29
Horizontalsoftkeys........................... 0 00 еее анна 22
Verical soft keys し し し に ー に に に に に に に に ーーー に に に トー トー に トト トト トト トレ トト レト ーー レレ て トレ ー ト ーー ニー ニーー 23
Parameter bar......oooooooooncc ячеек 23
15

Operating concept
Operating concept
Screen ergonomics
All the settings required for
— Gas measurement
Fresh-gas delivery
Ventilation
— Monitoring
are entered on the system screen using
the appropriate keys and the rotary
knob.
The keys are grouped in function fields:
Top left-hand field
for gas measurement
Bottom left-hand field
for fresh-gas delivery
Top right-hand field
for monitoring
Bottom right-hand field
for ventilation
16
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Instructions for Use Primus SW 2.n
0002

The main functions for anaesthesia, e.g.
selecting of N20 or AIR, or selecting of
ventilation modes, can be selected
directly by keys with permanently
defined functions ("hard keys"):
1 Left-hand block:
The »N20« or »Air« keys are used to
selectthe gas to be mixed with O2 for
the fresh-gas mix.
2 Righthand block:
The »Man. Spont.«, »Vol. Mode«,
»Press. Mode« or »Press. Supp.«
(optional) keys are used to select the
ventilation made, or » 에 « (optional
external fresh-gas outlet).
These function keys are located in the
bottom row of the contro! panel:
Left-hand block for setting the fresh-gas
delivery.
Right-hand black for ventilation.
Complementary "soft keys" with variable
functions are provided at the bottom
edge of the screen, above each group of
hard keys. These soft keys are used to
set the fresh-gas delivery parameters
and ventilation parameters.
3 Left-hand block:
The keys for setting the O2
concentration and fresh-gas flow.
4 Right-hand block:
The keys for setting the parameters
for the relevant ventilation mode.
The example shows the parameters
for volume-controlled ventilation,
These soft keys have different functions,
depending on the operating status or
ventilation mode.
Current parameter values are displayed
in the soft key field.
Instructions for Use Primus SW 2.n
14 Jun 2005
15.05
Operating concept
17
0003
0004

Operating concept
In a prominent position at the bottom
right-hand side:
The "turn-and-push" rotary knob is the
main operating control of the device and
has the following functions in all setting
operations:
1 Select/set = turn
2 Confirm = push
— to confirm the selected carrier gas or
a ventilation mode
— tosetand confirm the parameters for
fresh-gas and ventilation modes
— to set and confirm the monitoring
functions.
Beside the rotary knob:
The standby key (©). for switching
from operation to the standby mode.
3 Press standby key Ol and confirm
by pushing the rotary knob.
Selecting/ setting ventilation
parameters
Example: PEEP ventilation parameters
4 Push the soft key »PEEP«.
5 Select the PEEP value = turn the
rotary knob.
6 Confirm the PEEP value = push the
rotary knob.
18
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Instructions for Use Primus SW 2.n
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1 The keys for the various monitoring
functions and configurations are
located on the right-hand side of the
screen.
These keys also have different functions
= soft keys, depending on the
monitoring screen required.
Selecting/ setting monitoring
functions
For example, to change the lower alarm
limit of the end-expiratory CO2
concentration.
2 Press the »alarm limits« soft key.
The »alarm limits« menu is displayed
on the screen.
© Select the alarm limit value =
turn the rotary knob.
Confirm the selection =
push the rotary knob.
Set the alarm limit value =
turn the rotary knob.
Confirm the new alarm limit =
push the rotary knob.
Instructions for Use Primus SW 2.n
Operating concept
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Operating concept
Exit the »Alarm limits« menu:
1. Confirm the » r—> « symbol to exit
the menu = push the rotary knob
or
2 Press the AO). key.
The function keys for standard functions
are located on the right-hand side of the
control panel.
2). Suppress the acoustic alarm for
2 minutes or change the priority
of technical alarms and
acknowledge them
©. Select the screen
AS Back to standard screen
20
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Instructions for Use Primus SW 2.n
0007