User Manual MRI 508
User Manual MRI 508
Ins tr uc ti o ns f o r U s e
Table of Contents
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.1 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.4 Operator setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.5 Manufacturer's liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.6 Built-in safety features in the Dameca MRI 508 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2. SAFETY PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.1 Explosion hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.2 Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.3 Machine malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.1.4 Occupational hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3. FUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.1 Anesthesia Gas Scavenging System (AGSS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.1.1 External breathing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4. OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.2.1 Integrated breathing system (IBS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.2.2 Replacing the CO2 absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.2.3 External breathing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.2.4 Patient flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.5 O2 fuel-cell sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.3 Function test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.3.1 FULL self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.3.2 L C self-test, leakage and compliance test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.3.3 R otameter box with minoxyguard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.4 A ir/N2O selector valve (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.5 O2 monitor test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.6 E xpired minute volume Low/High alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.7 A irway pressure High alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.8 M ains power failure alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.3.9 T est of reserve gas cylinders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.3.10 Patient suction test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.3.11 Vaporizer test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.3.12 A uxiliary O2 test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.4 Operation of the ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.4.2 Stop automatic ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
4.4.3 Default ventilator settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5. MEASUREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1 Volume measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1.1 Accuracy of volume measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.2 Pressure measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.3 Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.4 O2% Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6. USER MENUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.1 Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.1.1 Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.1.2 Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.1.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.1.4 Self-test data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.1.5 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.2 Alarm menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.3 Menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6.3.1 Main Menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
7. ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
7.1 Ventilator alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
7.1.1 Airway pressure High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
7.1.2 System pressure High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
7.1.3 Disconnection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.1.4 Drive gas Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.1.5 Battery Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.1.6 System pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.1.7 Pressure limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.1.8 Fresh gas flow too High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.1.9 Insp. O2% High/Low (only if an external O2 fuel-cell sensor is installed) . . . . . . . . . . . . . . . . . . . 54
7.1.10 Exp. MV High/Low (only if a volume monitor is installed) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.1.11 Mains power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.1.12 System fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.1.13 TV too High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.1.14 PSV Backup mode is switching to PCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7.1.15 Required Insp. pressure is too Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7.1.16 Required Insp. pressure is too High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7.1.17 Required Insp. pressure too close to High-press. alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Blank page
1. Introduction
This manual is related to ventilator software version The machine can be equipped with various additio-
2.8. nal equipment such as:
The anesthesia machine, model Dameca MRI 508, is • Active scavenging system
suitable for most types of inhalation anesthesia. O2 • Transfusion stand
and N2O or O2 and Air can be administered, and an- • Arm for patient monitor
esthesia vaporizer(s) can be connected to a back • Pin-index yokes for 4 L gas cylinders
bar. Gases can be supplied from a centralized supply
The machine is designed to accommodate accesso-
or cylinders. There is no difference in machine per-
ries and additional rails, holders, and so on.
formance when gases are supplied from cylinders.
If the absorber is replaced during use, two absorber • Continuous flow: 2–80 L/min
valves automatically close to prevent gas loss from • Max. Peak flow: 120 L/min
the breathing system.
No matter which mode is used, the set tidal volume, The following features can be installed when the
respiratory rate, I:E rate and inspiratory pause are anesthesia machine is manufactured:
controlled to ensure that the inspiratory flow re-
mains in the range 2-80 L/min. • Integrated patient suction
• Auxiliary fresh gas outlet and integrated auxiliary
Inspiratory flow = Tidal volume x Resp. Rate x O2 flow meter
((I+E)/I) x (100/(100-Insp. pause)) • Auxiliary gas outlets for O2, Air or VAC
• Active AGSS suction
The breathing system has an expiratory and inspira- • PSV available or not
tory resistance of: • PRVT available or not
The following parameters can be configured by the
Resistance 60 L/min 30 L/min 5 L/min super user after the anesthesia machine has been
manufactured:
Expiratory 4.5 2.0 0.3
(x100 Pa) (x100 Pa) (x100 Pa)
• Ventilator volume setting based on tidal volume
Inspiratory 4.5 2.0 0.3 or minute volume
(x100 Pa) (x100 Pa) (x100 Pa) • SIMV available or not
• The O2 monitoring based on an external fuel-cell
sensor can be activated or deactivated
1.4 Operator setup • The volume monitoring can be activated or deac-
tivated
The Dameca MRI 508 can be setup as the operator
If volume monitoring is activated, the measure-
wishes.
ment can be configured in one of two ways:
MINOXYGUARD
The N2O cuts off if the O2 supply fails.
VAPORIZER RAIL
Back bar for one or two vaporizers. The back bar for
two vaporizers has an interlock system to ensure
that only one vaporizer can be opened at a time.
Flow marker
O2 flush
AIR pipeline
Integrated
Fresh gas breathing Patient
Rotameter system
switch
unit
(option)
N2O pipeline
Vaporizer
11
INSTRUCTIONS FOR USE
Blank page
2. Safety precautions
Read this manual carefully and familiarize yourself with • Bacteria filters used with this machine must comply
the machine before using it. with EN 13328-1 or a similar standard.
• The machine must only be connected to properly • A patient monitor connected to the breathing system
grounded hospital-grade electrical outlets. could cause leakage, even if the monitor is in standby
mode.
• Prior to servicing, cleaning or disinfecting, unplug the
power cord from the electric outlet. Allow the • The AGS system must always be activated when the
machine to dry completely before reconnecting the machine is in use.
power cord to the electric outlet.
• Serious personal injury and property damage has re-
• Spilled fluids can cause electrical shock. sulted from the use of steel gas cylinders in close
proximity to MRI devices.
• Ensure that all cables are intact and in good condition
before connecting the machine to a patient. • No add-ons, removals or changes should be made to
this machine unless so authorized by Philips.
• This machine must not be used in an environment
that exceeds the EMC levels stated in the EN60601- • Do not place magnetic items on the machine, as they
1-2 standard. will pose a danger in an MRI environment!
• Compressed gas cylinders, cylinder valves, cylinder quency diathermy equipment and are therefore not
regulators, other assemblies included with cylinders recommended for use with this machine.
or any other equipment used to supply compressed
• Once the patient is under anesthesia or connected to
gases shall not be present in the same room as an
the ventilator, the patient should be monitored by
MRI device, unless proven to be non-magnetic and/or
qualified personnel. Some machine malfunctions re-
tested and deemed suitable for use in an MRI envi-
quire immediate action.
ronment.
• When using the ventilator, alternative patient ventila-
2.1.1 Explosion hazard tion equipment must always be available.
• Do not use oil or grease lubricant with this machine. • When operating the machine, an alternative O2 gas
This also applies to silicon-based lubricant and non- supply must always be available.
combustible oils and grease. Only PTFE-based, O2
• Use only the anesthetic agent for which the vaporizer is
compatible lubricants can be used (e.g., Philips special
calibrated. Use of the wrong anesthetic agent in the va-
lubricant, product no. 36825).
porizer may be fatal to the patient.
• Do not use flammable anesthetic gases, such as ether
• If using a reusable CO2 absorber, note the following
or cyclopropane, with this machine. Use only anes-
concerning replacement of the soda lime absorber:
thetic agents that comply with the EN740 or similar
Absorber soda lime is caustic and can produce burns
standard with this machine.
in the respiratory tract if inhaled. Use breathing pro-
• Combustible materials that could be found near pa- tection equipment to prevent inhalation of soda lime
tients should be avoided in the area where O2 is being dust.
administered. This includes: hair oils, oil-based lubri-
• Do not begin any test procedure with a patient con-
cants, skin lotions, facial tissues, clothing and linen,
nected to the machine. Test procedures are designed
rubber and plastic articles, suction tubing, alcohols
to ensure safe and correct machine performance. Test
and acetone.
procedures should not be bypassed unless the pa-
tient's condition requires immediate use of the ma-
2.1.2 Patient safety chine.
• Do not use the machine for clinical procedures until
• The O2 concentration in the breathing system can dif-
ensuring the entire system is operating correctly.
fer significantly from the O2 concentration in the fresh
• The machine should always be used with a separate gas.
monitor for O2, anesthetic agent and CO2 concentra-
• When using soda lime in absorbers, always follow the
tions. This monitor must comply with the relevant
manufacturer's instructions.
standards under the EU council directive on medical
devices. • Use of different anesthetic agents in the machine may
result in the presence of residual agents (ppm) within
• If volume monitoring is not installed, the machine
the machine (vaporizer back bar, etc.). These residuals
should always be used with a separate monitor for ex-
can be minimized by setting a high fresh gas flow for
pired volume. This monitor must comply with the rel-
an extended period of time.
evant standards specified in the EU council directive
on medical devices.
Warning
• Before use, check all hose connections and ensure The use of 100% O2 can cause retinal fibroplasia in
that the machine is working correctly. Pay special at- neonatal patients.
tention to the breathing system and O-rings to ensure
that there are no loose connections or leaks in the
breathing system.
Warning
When 100% O2 from the auxiliary O2 flow meter
• Antistatic or electrically conducting breathing hoses gets in contact with some types of facial creams it
and masks can cause burns if used with High-fre- can ignite.
• Precautions should be taken to prevent cross infec- • The maximum torque on the table side rails is 20 Nm.
tions between patients. See section 8 regarding main-
• The maximum torque on the table side rails is 20 Nm.
tenance and cleaning.
• Vaporizers used for Fluothane, Halothane or other anes-
Note thetic agents containing Tymol or other stabilizers must
The auxiliary O2 flow meter (optional) bypasses the be emptied every second week and the drained agent
MPL valve. Thus, pressure from the flow meter may must be destroyed.
exceed the pressure from the fresh gas outlet.
• Vaporizer calibration should be regularly checked with a
suitable gas indicator (refractometer or similar).
• If the patient is connected to the anesthesia machine
in a volume controlled ventilation mode, and at- • This machine should be serviced at least once a year by
tempts a large spontaneous breath around the same a qualified technician.
time as a mandatory breath, it is possible for the pa-
• Vaporizers should be serviced at an authorized service
tient to create a high negative airway pressure. If the
center in accordance with the manufacturer's directions.
negative airway pressure is below -7.5 cmH20 (hPa),
the NPL valve of the anesthesia machine will open, • Use only original Philips hoses and accessories; other
but due to the resistance of the flow and the time hoses and accessories may cause malfunction if they do
taken to reach the patient, the airway pressure may not have the same dimensions or materials.
decrease further. The negative pressure however is
• Use only original Philips O-rings; other O-rings may
not sustained. If the patient is breathing spontane-
cause problems if they do not have the same dimensions
ously, and if the machine is installed with support
or are not made of the same materials.
ventilation modes, VSV or PSV could be considered.
• The reserve cylinder valves must be closed when the
2.1.3 Machine malfunction machine is using the central gas supply. The pressure in
the reserve cylinders may be higher than the central gas
• If the machine does not perform as described, it
supply pressure; thus, the cylinders could be depleted.
should not be used until the malfunction has been
corrected by a qualified technician. • When the machine is not in use disconnect it from the
power supply and central gas supply to prevent pollu-
2.1.4 Occupational hazard tion.
• Do not use the machine in insufficiently ventilated ar- • The anesthesia device should not be used next to other
eas. Use AGS systems to prevent elevated levels of an- devices, unless those devices are compatible with IEC
esthetic gases in the operation rooms. Make sure that 60601-1-2. In the event the anesthesia machine is used
the ball in the flow marker is visible. next to other electrical devices, it is recommended that
the user verify that the performance is not affected.
Humidity limitation
10%
Protective ground
Temperature limitation
50°C
Equipotentiality 0°C
This way up
ON/OFF
Manufacturer 1
Stacking limit by number
250 kg max
Warnings Batteries
Cautions
Gauss level maximum - 1000 Gauss
Note
General symbol for recovery/recyclable Gauss level maximum for gas cylinders -
1000 Gauss
Gaus level maximum for the power sup-
Class ply box - 100 Gauss
3. Function
12
11 13
10 14
15
9 16
17
8 18
7 19
Integrated 6
breathing 20
5
system 4
21
3
22
2
23
1 1
Fig. 3-1 Anesthesia machine model Dameca MRI 508 front view
7
8
6
5
9
4
10
3
11
2
12
1 1
Fig. 3-2 Anesthesia machine model Dameca MRI 508 rear view
1 2 3 4 5 6 7
9 8
Warning
Fig. 3-5 Flow marker If an external breathing system is used, it must have
its own open reservoir integrated into the AGSS sy-
stem. Otherwise, the auxiliary AGSS connection cre-
Note ates subatmospheric pressure in the breathing sy-
The AGSS flow marker only works with the breath- stem, which can be dangerous to the patient.
ing system. If an external breathing system is used
instead, it must be equipped with its own indicator When the external breathing system is no longer
of correct AGSS flow. needed with the machine, the plug must be placed
into the auxiliary AGSS connector (30 mm female
connector).
4. Operation
Scanner
Note
Before using the machine for the first time, the elec-
trical safety must be tested in accordance with EN
60601-1, and all patient-related parts must be 1000 Gauss line
cleaned.
Note
Scanner table
Before connecting the machine to a patient, per-
form the function test described in section 4.3.
Note
Before connecting the machine to the power supply,
check that the voltage rating on the machine's TYPE
label (on the rear of the machine) is the same as the
°
voltage of the power supply. 25°<
α <90
4.1 Installation
Before the machine is put in use, the following test Warning
must be performed: The power supply box must be properly secured.
1. Mark the 1000 Gauss line on the floor. Place the 2. S tart the machine on a test lung, with the venti-
machine in the MR scanner room, and connect lator activated.
to the power supply and pressurized gases.
3. P
lace a test object (calibration test object) into
The machine must be placed to the right side of the MR scanner.
the scanner table for the patient, and the angle
between the front of the anesthesia machine 4. O
bserve if the machine is operating normally,
and the scanner table must be 25-90O. and whether the images from the MR scanner
are influenced by the machine.
The wheels of the machine should always be
placed on the outside of the 1000 Gauss line. 5. If this test indicates normal function of the ma-
chine and of the MR scanner, means must be
Place the ventilator power supply box as far from provided to assure that the user does not place
the MR scanner as possible. The power supply box the machine closer to the MR scanner, e.g. by
should always be placed on the outside of the marking on the floor.
100 Gauss line.
6. If this test indicates abnormal function of the
machine or the MR scanner, then the distance
Warning between the scanner and the machine must be
The power supply box must never be placed on the
increased, and the test should be performed
machine, when the machine is in the MR scanner
again.
room.
Warning
When the machine is placed in the MR scanner
room, the brakes must be activated.
Warning
The ventilator power supply box must be placed as
1
far from the MR scanner as possible. The box is only
intended for magnetic fields up to 100 Gauss.
2
3
Warning 4
All accessories and parts placed on the machine
5
must be MRI compatible.
6
4.2 Setup
• Connect the machine to the power supply.
• Connect the machine to the gas supply 1. Assemble the breathing system (see section 8),
(300-600 kPa), vacuum (optional) and AGSS. connect it to the base (1) and lock it in place with
the handle (2).
• Activate the AGSS flow and check that the yellow
ball in the flow marker (3 in fig. 3-1) is visible. The
2. Connect the i-SORB CO2 absorber (3) to the
AGSS flow can be generated by either the ma-
breathing system by placing it into the bracket
chine (optional) or by one of the hospital's AGSS
underneath the base and lifting it upward by the
units. If the AGSS flow is generated by the ma-
handle until the lock clicks.
chine, activate it by pressing the red/green pin
above the flow marker (3 in fig. 3-1).
Warning
If using i-SORB disposable absorbers with the ma-
chine, first remove the seal from the
absorber before placing it into the breathing system.
Note
If the i-SORB CO2 absorber has been removed for
more than 30 sec. the following message will be dis-
played on the screen:
"Absorber disconnected".
Remove seal on
PRESS new absorber
CLICK
(disposable ver-
sion)
Caution
Remove the red protection seal from the new ab-
sorber and place it on the old absorber before di-
scarding.
Note
When used up, the disposable CO2 absorber can be
discarded as other hospital waste.
Whispa
May 11 10:28
Caution Superusers or technicians can use the Service menu
The ventilator cannot be used when the fresh gas to define the default value for the placement of the
ENT Adult
switch is set to "Aux Outlet," and Sensor
if the user at- Compl.flow30 mL/cmH2O
sensor.
tempts to do so, a "system pressure high" alarm will
P (cmH2O)start and the patient will not be ventilated. Alarm
If the flow sensor is placed at the Y-piece, the sen-
sor must be mounted with the PATIENT port facing
30
the patient.
4.2.4 Patient flow sensor
The machine can be equipped with a volume moni-
Peak
• If the TV Insp. value on the ventilator display says
tor which uses a flow sensor. "OFF"20when the ventilator is in STBY mode, the
flow sensor should be placed on the expiratory
Then the ventilator display will appear as follows: Plateau
side, on the breathing system.
• If the 19
TV Insp. value on the ventilator display
Two different types of flow sensors are used:
reads a value when the ventilator is in STBY
A pediatric flow sensor is used for patients with a
mode,PEEP
the flow sensor must be placed at the
Y-piece, between patient and Y-piece.
tidal volume between 20 and 300 mL (Insp./Exp. 3
flow 2-35 L/min).
Note
4 8 12 16 20A bacteria
T (sec)
filter must always be placed between the
patient and the flow sensor.
Patient port
Warning Note
During the FULL self-test all alarms are disabled.
The patient must not be connected to the machine
when powering up or during the function test.
Test sequences
The machine powers up, carries out an initial self-
Startup
test of internal functions, and performs test se-
quence 1. This takes approximately 25 sec.
Display: "Do you want to perform FULL TEST ?
Yes/No"
Note "Patient must NOT be connected"
If the machine is equipped with an O2 monitor "Select Yes or No and press to continue."
which uses an external fuel-cell sensor, this monitor
will not be working until approximately 30 sec. after • Change between Yes and No by turning the con-
activating the main switch. trol dial, then press to select.
• Selecting Yes launches the FULL self-test.
When the initial self-test has been successfully com- • Selecting No bypasses the FULL self-test. This
pleted, the ventilator is in Standby mode and the should only be used in an emergency.
FULL self-test can be performed.
Even after the FULL self-test has been launched, the
operator can cancel it by pressing the "Main Screen
4.3.1 FULL self-test key" field (7 in fig. 3-3). The following text is then dis-
played:
During a FULL self-test, machine function, compli-
ance, and leakage are tested. Display: "Do you want to bypass self-test ? Yes/No"
"Only bypass in case of an emergency"
Compliance and leakage measurements include the "Select Yes or No and press to continue."
breathing system, including the hoses and Y-piece.
• Change between Yes and No by turning the con-
When the ON/OFF switch on the front panel is trol dial, then press to select.
pressed to the ON position, the machine automati- • Selecting Yes bypasses the FULL self-test. This
cally performs test sequence 1 to verify the correct should only be used in an emergency.
operation of necessary components. Next, test • Selecting No causes the FULL self-test to resume.
sequence 2 is performed.
TEST SEQUENCE 6 – L EAKAGE BAG/VENT VALVE, 1. T he APL valve should be adjusted as desired by
EXP. VALVE AND PEEP VALVE the operator.
Display: "Set APL valve at pat. circuit to SP." 2. If the machine is set up with a volume monitor,
"Close vaporizer" the operator must use the Spirometry menu to
"Then remove Y-piece from occlusion" define the type of sensor (adult or pediatric) to
"Press to continue" use.
• S et the APL valve at pat. circuit 3. Pressing the control dial puts the machine in
to SP and close vaporizer. STBY mode, and all user settings are reset to de-
• Remove the Y-piece from the fault values.
occlusion.
• Press the control dial to confirm. 4. Next, the manual part of the self-test should be
performed as described in sections 4.2.3 to 4.2.12.
Display: "Valve check running"
When a 30 cmH2O pressure is reached on the out- 4.3.2 LC self-test, leakage and
side of the bellows of the bag-in-bottle, with the
BAG/VENT valve in BAG position, the leakage from
compliance test
the BAG/VENT valve and the expiration and PEEP
The leakage and compliance (LC) test can be used to
valves inside the ventilator is checked based on the
measure leakage and compliance when parts of the
pressure drop during time.
breathing system are changed between two patients
(e.g., hoses and respiration bags).
If the leakage is too high, the following error mes-
sage is displayed on the screen:
During the LC self-test, system compliance is meas-
ured, and leakage is checked.
Display: "Leakage in BiB too High"
"Check BiB and change-over valve"
The compliance and leakage test includes the
"Press to repeat test"
breathing system, including hoses and the Y-piece.
Pressing the control dial restarts the leakage test for
the BAG/VENT valve, the expiration valve, the PEEP
When the operator selects the LC self-test (a sub-
valve inside the ventilator, and the APL valve.
menu of the Setup Menu), the following test se-
quences are performed.
TEST SEQUENCE 7 - TEST COMPLETED
2. Set the fresh gas flow to 10 L/min Air and wait 4. Set the "Airway pressure High" alarm to the
until the displayed O2% reading stabilizes. Check same value as before (above Peak pressure) and
that the reading shows 20–22% O2. If not, recali- check that the alarm stops.
brate the O2 fuel-cell sensor as described in sec-
tion 6.1.6.
4.3.8 Mains power failure alarm
3. Set the fresh gas flow to 10 L/min O2 and wait 1. Attach a test lung to the Y-piece and start the
until the displayed O2% reading stabilizes. Check ventilator.
that the reading shows 98–102% O2. If not, re-
calibrate the O2 fuel-cell sensor as described in 2. Disconnect the 230 V power supply to the ma-
section 6.1.6. chine, and check that the "Mains power failure"
alarm triggers and that machine continues to
operate.
4.3.6 Expired minute volume
Low/High alarm 3. Reconnect the 230 V power supply to the machine.
If the machine is set up with a volume monitor us-
ing a flow sensor (see section 4.1.5), the following 4.3.9 Test of reserve gas cylin-
test must be performed:
ders
1. A
ttach a test lung to the Y-piece and start the If the machine is set up with reserve O2 or N2O cyl-
ventilator in VCV mode. inders, the following test must be performed:
2. Wait about 1 minute and read the expired min- 1. Disconnect the O2 and N2O supply to the ma-
ute volume on the display. chine and open the reserve gas cylinders.
3. Check that this corresponds with the set minute 2. Open the valves of the reserve O2 and N2O cylin-
volume (Tidal volume x Respiration rate). ders.
4. C
heck that the Insp. and Exp. valves in the 3. Set the Air/N2O selector valve (16 in fig. 3-1) to
breath-ing system move during inspiration/expi- N2O.
ration.
4. Close O2 and N2O flow regulator knobs (9 in fig.
3-1).
4.3.7 Airway pressure High
alarm 5. Read the pressure in the reserve cylinders on the
manometers on the rear of the machine.
1. Attach a test lung to the Y-piece and start the
ventilator.
6. Check for sufficient cylinder pressure (the pres-
sure of the cylinders must never be below
2. Read the displayed Peak pressure and set the
10 bar).
High-pressure alarm 5 cmH2O lower than the
Peak pressure.
7. Close the reserve cylinders.
3. Check that the "Airway pressure High" alarm
8. Observe the pressure gauges for at least one
triggers and that the Peak pressure is limited by
minute. The pressure must not decrease.
the new alarm setting.
9. Reconnect the central gas supply to the machine. 3. Close the flow meter regulator (clockwise) and
check that the flow meter reduces to zero.
4.3.10 Patient suction test
If the machine is equipped with patient suction, the
4.2.13 Test of auxiliary fresh gas
following test must be performed: outlet
If the machine is equipped with an auxiliary fresh
1. Fully open the regulator of the suction unit and
gas outlet, set the switch to On
occlude the suction hose.
Block the outlet with a finger and push the O2 flush
2. S tart the suction by activating the ON/OFF
for two seconds to test the Maximum Pressure Limi-
switch, and check that the vacuum gauge indi-
ting (MPL) valve's pop-of function.
cates a vacuum of at least -0.7 bar.
Set the switch to "Circle system" and check that the
3. Set the suction unit regulator to the desired vac-
message disappears.
uum. Turn off the suction unit with the ON/OFF
switch, and reopen the suction hose.
4.2.14 Daily test completed
4.3.11 Vaporizer test 1. Press
"Cancel Alarms" to clear old alarm mes-
sages from the display.
If the machine is equipped with a vaporizer, the fol-
lowing test must be performed:
Caution
1. Check that the vaporizer(s) is(are) correctly at- After the function test is completed, check that all
tached to the machine. alarm settings are suitable for the patient before
connecting the machine to the patient.
2. For each vaporizer, check that the vaporizer
knob(s) can freely turn throughout the full regu-
lation range and can be locked in the "0" posi-
tion.
Note
Consult the vaporizer user manual.
When the self-test is completed, the machine is in The ventilator constantly adjusts the inspiratory
STBY mode ready for automatic ventilation of the flow to deliver the set tidal volume to the patient in-
patient, following adjustment of the ventilation pa- dependently of the breathing system’s compliance
rameters. and the actual fresh gas flow.
The following parameters can be set while the ma- VCV is also known as "CMV" or "IMV".
chine status is in STBY or VENT.
Note
A. Ventilation modes If the patient is connected to the anesthesia ma-
chine in a volume controlled ventilation mode, and
During automatic ventilation, the following ventila-
attempts a large spontaneous breath around the
tion modes are available:
same time as a mandatory breath, it is possible for
the patient to create a high negative airway pres-
VCV Volume Controlled Ventilation
sure. If the negative airway pressure is below -7.5
SIMV Synchronized Intermittent
cmH20 (hPa), the NPL valve of the anesthesia ma-
(Mandatory Ventilation
chine will open, but due to the resistance of the
PCV Pressure Controlled Ventilation
flow and the time taken to reach the patient, the
PSV Pressure Supported Ventilation (optional)
airway pressure may decrease further. The negative
PRVT Pressure Regulated Volume Target
pressure however is not sustained. If the patient is
(optional)
breathing spontaneously, and if the machine is in-
stalled with support ventilation modes, VSV or PSV
VCV mode could be considered.
In VCV mode, the ventilator gives the set tidal vol-
ume pressure to the patient using a constant inspir-
atory flow.
SIMV mode
In SIMV mode, the patient can trigger a VCV inspira-
tion during the expiration phase by causing the
breathing system pressure to decrease. In the
"Setup menu", the operator can define the size of
pressure drop needed to trigger a VCV inspiration.
The decrease in pressure is in relation to set PEEP.
The time interval in which the patient can trigger When the operator reduces the respiration rate in
an inspiration is called the "trigger window." The SIMV mode to force the patient’s spontaneous
ventilator calculates this trigger window when it breathing during wake-up, the trigger window is
shifts to SIMV mode to equal one cycle (inspira- maintained at the end of the expiration phase.
tion + expiration).
F or patient safety, the patient cannot trigger a Therefore, the trigger window is prohibited from
new inspiration while the ventilator is delivering entering the inspiratory phase plus a following
an inspiration or just after completion of the period of 200 msec. The patient can only trigger
inspiration. one inspiration per trigger window.
Tggeriäg is
Triggering is never
never possible
possible during
during
insp.time
Insp. time + + 200msec.
200 msec.
INSPIRATION
When the patient begins an inspiration and the in-
PRVT mode
spiratory flow at the Y-piece (measured by the flow In PRVT mode, the ventilator gives a precise inspira-
sensor) is Higher than the set "Insp. trig." the venti- tory pressure to the patient using a decelerating in-
lator initiates an inspiration in order to reach the set spiratory flow. The ventilator continuously adjusts
"Support pressure". Once this "Support Press." is this flow in the same manner as in PCV mode. The
reached, the ventilator maintains the pressure difference between PCV and PRVT mode is that, in
throughout the remainder of the inspiratory phase. PRVT mode, the ventilator automatically adjusts the
inspiratory pressure for each inspiration in order to
EXPIRATION deliver the set tidal volume to the patient.
The inspiration stops and expiration begins when
the following conditions prevail: The ventilator automatically adjusts the inspiratory
flow to maintain a difference of less than 10% be-
1. The measured pressure in the breathing system tween the set tidal volume and the expired tidal
is Higher than the High-pressure alarm limit (the volume (measured by the flow sensor in the breath-
same function as in the other ventilation modes). ing system).
2. The duration of the inspiration exceeds 2.5 sec. When PRVT mode is selected, the inspiratory flow
(if the flow sensor is set to "Adult") or 1.5 sec. (if for the first three inspirations is the same as in VCV
the flow sensor is set to "Ped."). mode, with an inspiratory pause of 20% in order to
measure patient compliance. This compliance value
3. The inspiratory flow at the Y-piece (measured by is used to calculate the inspiratory pressure needed
the flow sensor) is lower than the set "Exp. trig." to deliver the set tidal volume to the patient.
"Exp. trig." is set as a percentage of the maxi-
mum flow measured during inspiration. For the fourth inspiration, the inspiratory flow is as
in PCV mode, and the inspiratory pressure is based
VENTILATION BACKUP on both the set tidal volume and the measured pa-
If the patient does not trigger an inspiration before tient compliance.
the "PSV backup" period has ended, a "PSV backup
mode is, switching to PCV" alarm triggers (see sec- From the 5th inspiration onward, the ventilator au-
tion 7.6), and the ventilator automatically switches tomatically adjusts the inspiratory flow by compar-
to PCV mode. ing the set tidal volume with the measured expired
tidal volume.
The alarm disappears by pressing "Cancel Alarms".
If the ventilator detects that an inspiratory pressure Press the Vent. Mode key and select the desired
of less than 4 cmH2O is needed to reach the set tidal mode with the control dial (14 in fig. 3-1)
volume, the inspiratory pressure sets to 4 cmH2O
and triggers an alarm: Press the control dial to confirm the selected mode.
"Required Insp. pressure is too Low" (see section 7). The ventilation mode will not change until the con-
trol dial is pressed.
If the ventilator detects that an inspiratory pressure
of more than 67 cmH2O is needed to reach the set
tidal volume, the inspiratory pressure sets to 67
B. Tidal volume/minute volume
cmH2O and triggers an alarm: (active in VCV or SIMV modes only)
"Required Insp. pressure is too High" (see section 7).
The tidal volume/minute volume delivered by the
ventilator in VCV or SIMV mode is automatically
If the ventilator detects that the required inspiratory
compensated for the compliance of the breathing
pressure to reach the set tidal volume is within 5
system and for the fresh gas flow.
cmH2O of the set High-pressure alarm limit, the in-
spiratory pressure resets to the High-pressure alarm
TV,patient = TV,ventilator + TV,fresh gas -
limit minus 5 cmH2O and triggers an alarm:
TV,compliance
"Required Insp. pressure too close to High
press. alarm" (see section 7).
During automatic ventilation in VCV or SIMV mode
the ventilator automatically calculates the correct
If the set inspiratory pressure cannot be obtained
inspiratory flow to give the patient the desired tidal
during inspiration, a "Pressure limit" alarm is trig-
volume/minute volume, independent of other ven-
gered (see section 7).
tilator settings (respiration rate, I:E ratio, inspiratory
pause, etc.) and of the compliance and fresh gas
Caution flow.
If the expired tidal volume measured during PRVT
ventilation is Low compared with the set tidal vol- Press the "Tidal volume/Minute volume" key and
ume, the ventilator automatically increases the in- select the desired tidal volume/minute volume with
spiratory pressure to within 5 cmH2O of the airway the control dial (14 in fig. 3-1).
pressure High alarm limit.
Thus, while in PRVT mode, it is particularly impor- Press the control dial to confirm the selected tidal
tant to set an airway-pressure-High alarm limit to a volume/minute volume. The tidal volume/minute
value suitable for the patient. volume will not change until the control dial is
pressed.
Note The Service menu can be edited to define whether
PRVT mode is an option that can be installed by ei-
the set volume is to be the tidal volume or minute
ther Philips or an authorized technician.
volume. This setting can only be changed by a supe-
ruser or service technician.
Note
PRVT mode is only available if the flow sensor is pla- (Minute volume = Tidal volume x Resp. Rate)
ced at the Y-piece or at the EXP cone on the
breathing system.
1. Press on the "Resp. rate" field and set the de- If PEEP is set to "OFF", the PEEP in the breathing
sired respiration rate using the control dial (14 in system will be approximately 3 cmH2O (depending
fig. 3-1). on the fresh gas flow) due to the bag-in-bottle.
2. Press the control dial to confirm the set respira- 1. Press on the PEEP field and set the PEEP using
tion rate. The respiration rate will not change un- the control dial (14 in fig. 3-1).
til the control dial is pressed.
2. Press the control dial to confirm the set PEEP.
D. I:E ratio (active in all modes) PEEP will not change until the control dial is
Definition: The ratio between the inspiration time pressed.
and expiration time.
Adjust the APL valve (6 in fig. 3-1) in order to limit Ventilation VCV VCV, SIMV, PCV
the airway pressure during manual ventilation. mode
Tidal volume/ 500 mL/6.0 L 20-1500 mL/
Note Minute volume 0.2-60.0 L
The APL valve is for manual ventilation only.
Respiration 12 resp./min 4-80 resp./min
rate
I:E ratio 1:2 3:1 - 1:9.9
PEEP OFF OFF, 4-20
cmH2O
Inspiratory 17 cmH2O 4-67 cmH2O
pressure
Inspiratory 0% 0-70%
pause
High-pressure 30 cmH2O 10-80 cmH2O
alarm
SIMV trigger -3.0 cmH2O -0.5 to -10.0
point cmH2O
PSV support 7 cmH2O 4-50 cmH2O
pressure
PSV Insp. 3 L/min 1-10 L/min
trigger flow
PSV Exp. 40 % 10-80%
trigger flow
PSV backup 30 sec. 10-40 sec.
periods
ENT 5.
P (cmH O)
2
Measurements
Adult Sensor Compl. 30 mL/cmH2O
Alarm
The ventilator of the Dameca MRI 508 performs a The High and Low alarm limits for the expired min-
number of measurements, depending on the config-
30
ute volume are shown on the screen to the right of
uration of the ventilator. the actual expired minute volume values.
Peak
20 inspired and expired tidal volume for
The measured
5.1 Volume measure- each respiration are shown as "TV Insp./Exp." in mL.
Plateau
When the ventilator is set to automatic ventilation
ments and the ventilation mode is VCV or SIMV, the in-
19volume is not displayed, as the inspired
spired tidal
Measurement of the expired minute volume as well tidal volume is controlled by the ventilator based on
as the inspired/expired tidal volume can be dis- PEEP
the ventilator settings.
played on the screen if the machine is equipped 3
with a flow sensor (see section 4.2.4).
5.1.1 Accuracy of volume mea-
4 8 12 16 20 Tsurements
(sec)
The patient flow sensor used for measuring expired
O 2% Insp. OFF Vent. Mode
minute volume and inspired/expired tidal volume
TV Exp. 480
measures the actual inspiration/expiration flow in
real-time.
OFF
30 22 MVExp. 4.
8.0
8 4.0 PCV
The ventilator then integrates this real-time flow
during time, in order for the volume measurement
to be shown on the display.
If the flow sensor is placed at the Y-piece, the in- Therefore the accuracy of the measured minute vol-
spired tidal volume will also be measured, and a spi- ume and tidal volume depends upon the actual gas
rometry curve (pressure-volume) can be shown on concentrations.
the display.
Note
A superuser or technician can use the Service menu
to define the default setting for the placement of
the flow sensor.
I:E 30
ments PEEP 10
5.3 Compliance
The calculated compliance is displayed next to the
curve in mL/cmH2O.
6.1.2 Graph
When "Graph" is selected, a submenu will appear
6.1.3 Setup
on the display with the following settings: When setup is selected, a sub-menu will appear on
the display, with the following settings:
• Type (only if it is defined in the Service menu
that flow sensor is placed at the Y-piece) • O2% calibration
• T-scale • Set time
In this menu the settings for the respiration graph Selecting "O2% calibration" allows the user to cali-
shown on the display can be defined. brate the external O2 fuel-cell sensor.
If O2% calibration is activated, the sensor will be cal- 6.1.4 Self-test data
ibrated, by following these sequences:
Selecting "Self-test data" activates a submenu with
A. P
lace the O2 fuel-cell sensor on the breathing information about the latest self-test results.
system, including patient hoses.
Open fresh gas flow 10 L/min. Air, other gases • Last test type
closed. • Last test time
The Y-piece must be open to ambient Air. • Leakage in Vent. system
As an alternative, place O2 fuel-cell sensor in am- • Compliance in Vent. system
bient Air. Press the control dial (14 in fig. 3-1) to
confirm. 6.1.5 Service
Pressing "Service" opens a submenu "PASSWORD"
B. N
ow waiting for stable O2 percentage. When the
on the display with the following settings:
O2 percentage has stabilized, the next step of the
calibration procedure will be started.
• Part 1
• Part 2
C. C
lose Air fresh gas flow, open fresh gas flow 10 L/
• Part 3
min O2. O2 fuel-cell sensor must be placed on the
breathing system, including patient hoses. Press Enter the superuser password, in order to be able to
the control dial (14 in fig. 3-1) to confirm. change the configuration of the ventilator.
D. N
ow waiting for stable O2 percentage.
When the O2 percentage has stabilized, the next
step of the calibration procedure will be started.
E. P
ress the control dial (14 in fig. 3-1) to save the
calibration.
Press the "Cancel Alarms" field in order not to
save the calibration.
6.2 Alarm menu Activate the setting by pressing the control dial
(14 in fig. 3-1).
When pressing the "Alarm Menu" key (5 in fig. 3-3),
The alarm settings can be changed immediately, by
the Alarm Menu appears in right side of the display.
turning the control dial, and press to confirm.
Select a setting by turning and pressing the control
The new setting does not take effect until the con-
dial (14 in fig. 3-1).
trol dial is pressed.
The following alarm settings can be accessed in the
alarm menu: Warning
The alarms should be set according to the patient's
• High Press needs and not be set to extreme values.
• High O2% (only if O2 monitor with external fuel-
cell sensor is activated in the Service menu)
• Low O2% (only if O2 monitor with external fuel-
cell sensor is activated in the Service menu)
• High MV Exp. (only if flow sensor is activated in
the Service menu)
• Low MV Exp. (only if flow sensor is activated in
the Service menu)
Actual selection is highlighted.
Type Time-Press *
T-scale Press-Volume
T-scale
10
20 *
30
60
Previous Menu
Main Screen
Main Menu
Spirometry
Graph
SIMV trigger: -X (cmH2O)
PSV Insp. trig: X (L/min)
PSV Exp. trig: X (%)
PSV backup: X (sec)
Insp. Pres: X (cmH2O)
Setup Setup O2 Sensor Cal
Selftest Data Confirm
Service O2 % Calib.
Set time Yes *
No
CAUTION:
Main Screen Ventilator will go
Software version: to stby-mode if
calibration is
activated
Set Time
Year YY:
Month MM:
Date DD:
Hour HH:
Minute MM:
Previous menu
Main Screen
Main Screen
Software version:
Password
Part1
Part2
Part3
Alarm Menu
Main Screen
7. Alarms
The ventilator of the Dameca MRI 508 anesthesia 7.1.1 Airway pressure High
machine has a built-in alarm system for all the mea-
sured parameters, as well as for the safe function of The "Airway pressure High" alarm triggers when the
the ventilator. measured pressure in the breathing system exceeds
the High-pressure alarm limit.
All alarms are both audible and displayed. For most
of the alarms, the alarm sound can be disabled for When the airway pressure reaches the High-pressure
120 sec. by pressing the "Cancel Alarms" field alarm limit, the ventilator automatically switches to
(6 in fig. 3-3). If an audible alarm is disabled, a yellow expiration in consideration of patient safety.
light beside the Cancel Alarms key will be shown.
CORRECTIVE ACTION
Whenever an alarm is started, the LED next to the The "Airway pressure High" alarm terminates when
"Cancel Alarms" field will flash on the display. there is an automatic respiration without the airway
pressure reaching the High-pressure alarm limit.
When an alarm ends, the LED will stop flashing. The
alarm message will remain displayed in the alarm
field until the operator confirms the alarm by press-
Note
The "Airway pressure High" alarm is active during
ing the "Cancel Alarms key".
automatic ventilation only.
CORRECTIVE ACTION
7.1.4 Drive gas Low If the bellows is full and the alarm does not stop af-
The "Drive gas Low" alarm triggers if the dynamic ter about 10 sec., check the breathing system, espe-
pressure to the ventilator is less than 2.5 bar. cially the open/close functioning of the yellow valve
flaps in the one-way valves.
CORRECTIVE ACTION
Check that the Air supply is connected to the ma-
chine.
7.1.7 Pressure limit
The "Pressure limit" alarm triggers if the max. air-
way pressure during PCV ventilation is lower than
7.1.5 Battery Low the set inspiratory pressure.
The "Battery Low" alarm triggers if the capacity of
the built-in ventilator battery is too low to ensure CORRECTIVE ACTION
proper performance in case of mains power failure. This could be caused by a full bellows in the bag-in-
bottle. Check that the breathing system, hoses, tub-
If the battery capacity is too low to power the venti- ing, etc. are properly connected.
lator, a "Closing down" message is displayed, and
the machine automatically enters into MAN status.
7.1.8 Fresh gas flow too High
The ventilator will also shut down within approxi- The "Fresh gas flow too High" alarm triggers if the
mately 20 sec. to avoid discharging the battery set fresh gas flow is too high for the ventilator set-
completely. tings in VCV or SIMV mode, according to the follow-
ing formula:
CORRECTIVE ACTION
Connect the machine to the electrical outlet and Ventilator inspiratory flow – Fresh gas flow
turn on the machine to recharge the ventilator bat- <2 L/min.
tery.
The alarm triggers in order to ensure that the tidal
The machine cannot be used until the battery is volume given to the patient does not exceed the set
charged to a safe level. tidal volume.
CORRECTIVE ACTION
Note Increase the set tidal volume or lower the fresh gas
flow to turn off the alarm.
CORRECTIVE ACTION
Consider increasing the tidal volume or respiration
rate, or choose another ventilation mode.
CORRECTIVE ACTION
Check for occlusion in patient hoses, tubing, etc.
8.2 Cleaning
8.3 Cleaning the Dameca
8.2.1 Washing machine MRI 508
Only use a washing machine constructed to clean
Wipe the machine's outer surfaces with a cloth moi-
instruments and anesthesia equipment. The wa-
stened with a mild detergent or Isopropyl alcohol.
shing cycle and detergent must be appropriate for
Afterward, dry the machine with a clean, dry cloth.
cleaning plastic and rubber goods. The cleaning pro-
cedure must conclude with a clean water rinse, heat
disinfection, and drying. Caution
Avoid abrasive or caustic cleaners, as they can dam-
age the machine. Avoid organic liquids, such as Ace-
Note tone, Turpentine, and Thinners.
The detergent should have a pH final dissolution of
7 to 10.
8.4 Cleaning the inte-
8.2.2 Chemical disinfection
Follow the manufacturer's instructions carefully. The
grated breathing
disinfectant should be suitable for the component
being disinfected.
system (IBS)
Prior to cleaning, the breathing system should be
The components should not be exposed to the dis-
disassembled as described in section 8.4.5.
infectant longer than necessary.
8.4.1 Routine cleaning is labeled B. The tool (11) may be used to help
remove the valves.
All components in the breathing system can be
6. Remove the changeover valve (10) marked A.
washed in a washing machine and tolerate chemical
The tool (11) may be used to help remove the
disinfectants and autoclaving according to directions.
valve.
8.4.2 F ollowing an infected The breathing system can now be cleaned and disin-
fected (see section 8.2).
patient
Place all breathing system components into a liquid
disinfectant. Afterward, clean all components in
8.4.4 After cleaning
compliance with instructions for routine cleaning. Check that all components are thoroughly dry, un-
damaged, and correctly connected.
8.4.3 D
isassembling
Fig. 8-1 Breathing system (IBS) overview
Note
Some disinfectants that contain Phenol and
Aldehyde components can be absorbed and accu-
mulate in plastic and rubber goods following re-
peated disinfection.
1
2 Warning
3 Be careful when rinsing; the components' recesses
may hold hot water when taken from the washing
4
5
machine.
10 6
8 9
11
DRYING
After washing, all the components can be dried in a Fig. 8-2 Integrated breathing system (IBS) overview
hot-air cabinet or at room temperature for approxi-
mately 12 hours.
8.4.6 Assembling
1. Mount the Insp. and Exp. valves (7) with the
groove in the valve body fitting over the pin in
the breathing system body. Ensure that the
valves are fully inserted by pushing on the valve
bracket. Inspect the valve flaps for visible dam-
age. If a valve flap is damaged, the whole valve
must be replaced. Do not touch the valve flaps
with your fingers.
2 Bellows
3
3 Cap for Ispill valve
4
4 Spill valve membrane
5
5 APL valve
6 Valve dromes
7 Yellow valve flaps 7
8 C-valve for the absorber 10 6
ABSORBENTS
Following absorbents can be used: Sofnolime, Me-
disorb, Prosorb, Soda lime, LimePak, Agasorb, Sefa-
sorb, CarboLime, Chemosorb, Vitalime, and Vent
6. Remove the absorber seal(8) before mounting.
iSorb.
7. Clean the surfaces of the absorber to ensure re-
sidual granules or dust are removed.
8. Lubricate the absorber ports(7) using a thin
layer of oxygen compatible grease.
9. The i-SORB reusable absorber is now ready to
be mounted onto the integrated breathing sy-
stem (IBS).
Note
Make sure that the locking ring is correctly positio-
ned before use.
8.9 Disposable
Description 12NC Part number
i-SORB disposable absorber (box of 8 pcs.(11044)) . . . . . . . . . . . . . . . . . . . . . . . . . . 989803185691 (11044-08)
i-SORB reuseable absorber (box of 1 pc.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 989803185701 (11048)
Filter for reusable absorber (box of 40 pcs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 989803185711 (11040-40)
Adult flow sensor for Philips anaesthetic machines (25 pcs). . . . . . . . . . . . . . . . . . 989803191191 (42632-342)
Paediatric flow sensor for Philips anaesthetic machines (25 pcs) . . . . . . . . . . . . . . 989803191151 (42632-243)
Note
Cleaning and disposal of accessories should be done as prescribed in the instruction for use accompayning
the individual accessory.
9. Technical data
All flow and volume measurements are based on STPD conditions (Standard Temperature Pressure Dry).
9.1 General
Dimensions
Height 1510 mm
Width 760 mm (incl. Integrated breathing system (IBS))
Depth 670 mm
Weight Approximately 110 kg (depending on configuration)
MRI compatibility Max. magnetic field: 1000 Gauss
Electrical
Class I
Type B
Power supply voltage 100/115/230 volt 50/60 Hz
Power consumption 80 VA
Battery capacity 1.5 Ah (ventilator)
Battery backup time Approximately 90 min (only by mains power failure)
Battery type Pb rechargeable
Battery charge time Approximately 12 hours
Note There is no difference in performance when the machine is battery powered.
9.2 Gases
Note All gases and anesthetic agents must comply with the European Pharmacopoeia.
Central gas supply
Inlet pressure 4-6 (x 100 kPa) for O2, Air and N2O
Reserve gas supply (optional)
Pin-index yokes for 4 L ONLY MRI COMPATIBLE
cylinders (O2 and N2O) Gas cylinders must be used
Manometers
Central gas supply (optional) 0-10 (x 100 kPa) for O2, Air and N2O
Gas cylinder 0-315 (x 100 kPa) for O2
0-100 (x 100 kPa) for N2O
9.4 Ventilator
Drive gas (Air)
Pressure Min. 3.0 (x 100 kPa) at 80 L/min
Max. consumption (Peak flow) 120 L/min
Mean consumption Max. 80 L/min at 2.8 (x 100 kPa)
Pressure range
Pressure limitation (P. lim max.) 90 (x 100 Pa) (mechanical, pressure limitation value)
Max. adjustable working pressure 80 (x 100 Pa)
High-pressure alarm 10 to 80 (x 100 Pa)
Min. expiration pressure (P. lim min) +1 (x 100 Pa)
Cycling pressure 1 to 80 (x 100 Pa)
NPL valve opening pressure -5 to -7.5 cmH20 (hPa) at a flow rate of 3.5 to 4.5 L/min.
Note Negative pressure is only possible if the patient is exclusively breathing spontaneously.
Set parameters
Tidal volume 20 to 1500 mL
Accuracy (VCV and SIMV mode) 20 to 250 mL: ±10%, min. 10 mL
250 to 1500 mL: ±5%, min. 25 mL
Minute volume 0.2 to 60.0 L/min
Resp. rate 4 to 80 resp./min
Accuracy ±5%
I:E ratio 3:1 to 1:9.9
PEEP OFF, 4 to 20 (x 100 Pa)
Inspiratory pressure 4 to 67 (x 100 Pa)
Inspiratory pause 0 to 70%
Ventilation mode (controlled) VCV, SIMV, PCV, PSV, PRVT (optional)
SIMV settings
SIMV trigger point -0.5 to -10.0 (x 100 Pa)
PSV settings
Support pressure 4 to 50 (x 100 Pa)
Inspiratory trigger 1 to 10 L/min
Expiratory trigger 10 to 80%
PSV backup 10 to 40 sec.
Test mode LC TEST, FULL TEST
9.6 Environment
Storage temperature -20OC to +50OC (optional O2 fuel-cell sensor: 0OC to +50OC)
Working temperature 10OC to 40OC
Relative humidity 10 to 90% RH (non-condensing)
Storage pressure 63 kPa to 106 kPa
Working pressure 960 to 1060 (x 100 Pa)
9.7 Standards
Dameca MRI 508 complies with the following standards
Software EN 60601-1-4
EMC EN 55011; Group 1, Class B
Electrical safety EN 60601-1
Function safety EN ISO 10524-1, EN ISO 5359, EN 740, EN 837-1, EN 980,
EN ISO 5356-1
O2 fuel-cell sensor (optional) EN ISO 19054, EN ISO 21647, EN ISO 15002
Classification according to EN 60601-1
Class I equipment Type of protection against electrical shock
Type B equipment Degree of protection against electrical shock
Continuous operation Mode of operation
Classification according to Directive 93/42EEC concerning medical equipment
The anesthesia machine, Model Dameca MRI 508, is classified as IIb.
M R
Machine malfunction 15 Relative humidity 67
Magnetic field 22 Replacing the CO2 absorber 24
Maintenance 56 Required Insp. pressure is too high 55
Maintenance and cleaning 56 Reserve gas supply 63
Manometers 63 Respiration rate 65
Manufacturer's liability 10 Resp. Rate 39
Measured parameters 66 Rotameter tubes 64
Measured TV too high 54 Rotameter unit 7
Menu structure 49
S
Minoxyguard 10, 64
Safety precautions 13
Minute volume 38
Self-test data 47
MRI Compatibility 63
Set parameters 65
MRI Compatible 7
Set-up 22
MR scanner and room 21
SIMV mode 35
N SIMV settings 65
NPL valve 10, 15, 65 SIMV trigger point 40
Spirometry 45
O
Start automatic ventilation 41
O2% calibration 47
Storage pressure 67
O2 flush valve 64
Support Pressure 40
O2 fuel-cell sensor kit; part no. 10967-85 26
Symbols 16
O2 sensor lifetime 66
System and valves 28
Occlude Y-piece 28
System fail 54
Occupational hazard 15
System pressure 53
Operator set-up 9
T
P
Test of reserve gas cylinders 33
Patient safety 14
Test sequence 5 – Leakage, BAG 29
Patient-suction test 33
Tidal volume 38
Patient volume sensor 25
Time-Pressure curve 46
PCV mode 36
TV too High 54
Pediatric volume sensor 25
PEEP 39 V
Power failure alarm 33 Vaporizer 33
Pressure limit 53 Vaporizer test 33
Pressure range 65 VCV mode 34
Pressure-Volume loop 46 Ventilation modes 34
PRVT mode 37 Ventilator alarms 52
PSV Backup mode activated 55 Ventilator battery low 53
PSV mode 37 Ventilator display and controls 19
PSV settings 41, 65 Volume monitor (optional) 66
W
Warnings 13
Working pressure 67
Working temperature 67