NORTH AMERICAN DRÄGER OxyLog User manual

Oxylog
Emergency Ventilator
Technical Documentation
Copyright by Dräger Medical AG & Co. KGaA, Lübeck, Federal Republic of Germany.
Copying is prohibited for commercial purposes.
Attention is to be paid to the Operating Manual.
This technical documentation does not replace the Operating Manual.
Safety Regulations: Reference is hereby made to the observance of the relevant safety provisions, such as in Ger­many the Medical Equipment Ordinance (Medizingeräteverordnung), the Pressure Container Ordinance (Druckbehälterverordnung), the Technical Rules for Pressurised Gases (Techni­sche Regeln Druckgase) or the Occupational Health and Safety Provisions (Unfallverhü­tungsvorschriften).
Insofar as reference is made to laws, regulations or standards, these are based on the legal system of the Federal Republic of Germany.
Follow your local laws and regulations.
Contents
General
1 About This Service Manual 4
1.1 Definitions .........................................................................................................................5
2 For Your Safety and that of Your Patients 7
2.1 Strictly follows the Instructions for Use ......................................................................7
2.2 Maintenance .....................................................................................................................7
2.3 Accessories ......................................................................................................................7
2.4 Liability for proper function or damage .......................................................................7
3 Intended use 8
3.1 Oxylog with spontaneous breathing attachment (option) .......................................8
4 Inspection intervals 9
5 Checking readiness for use 10
5.1 Checking ventilation frequency ................................................................................. 10
5.2 Checking safety valve .................................................................................................. 10
5.3 Checking minute volume and compressed-gas supply .........................................11
6 Technical data 12
6.1 Materials used ................................................................................................................14
6.2 Dimensions and weights ..............................................................................................14
6.3 Oxylog with spontaneous breathing attachment ....................................................14
7 Cleaning/disinfection/sterilisation 15
7.1 Cleaning ......................................................................................................................... 15
7.2 Disinfection .................................................................................................................... 16
For internal use only. Copyright reserved.
GBK5503140IECIVZ.fm
7.3 Sterilisation .....................................................................................................................17
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Contents
8 Prior to renewed use with patient 17
Functional Description
1 Gas supply 18
2 Pneumatic control 19
2.1 Oxylog ............................................................................................................................. 19
2.2 Oxylog Samsomatik ..................................................................................................... 20
Test List
1 Test Equipment 29
2 Checking general condition 30
3 Checking O
pressure reducer 30
2
4 Functional test 31
4.1 Checking I:E ratio ..........................................................................................................31
4.2 Checking frequency setting ........................................................................................31
4.3 Checking O
concentration ....................................................................................... 32
2
4.4 Checking minute-volume flow setting ...................................................................... 33
4.5 Checking safety valve .................................................................................................. 34
4.6 Checking ventilation pressure gauge ...................................................................... 34
5 Put functional device at the customer’s disposal. 35
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6 Test performed 35
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Contents
Fault-Cause-Remedy
1 Fault - Cause - Remedy 36
Changes
1 Type of Changes 37
Appendix
1 Abbreviations 38
2 Spare parts list Oxylog / Oxylog Samsomatic 39
For internal use only. Copyright reserved.
GBK5503140IECIVZ.fm
5503.140 Oxylog 04.97 Contents Page III
General
1 About This Service Manual
This service manual conforms with the International Standard IEC 601-1.
This service manual does not replace the Instruction for Use.
Read through each step in every procedure thoroughly before beginning any test. Always use the proper tools and specified test equipment. If you deviate from the instructions and/or recommendations in this service manual, you may cause the equipment to operate improperly or unsafely, or damage the equipment itself.
Use only genuine spare parts manufactured or sold by Dräger Medical AG & Co. KGaA as listed in the spare parts list.
The test list of this service manual does not replace inspections and servicing by DrägerMedical AG & Co. KGaA.
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1.1 Definitions
DANGER:
DANGER indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
WARNING:
WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION:
CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. CAUTION is also used to alert against unsafe practices.
J
NOTICE:
NOTICE is used to provide information that can help avoid damaging the product or property as a result of misuse.
IMPORTANT:
IMPORTANT is used to provide additional information, operating tips or maintenance suggestions.
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Inspection = examination of actual condition
Service = measures to maintain specified condition
Repair = measures to restore specified condition
Maintenance = inspection, service, and repair, where necessary
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2 For Your Safety and that of Your Patients
2.1 Strictly follows the Instructions for Use
Any use of the apparatus requires full understanding and strict observation of these instructions. The apparatus is only to be used for purposes specified here.
2.2 Maintenance
The apparatus must be inspected and serviced regulary by trained service personnel at 2 years intervals (and a record kept).
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 DrägerService® and that all repairs also be carried out by them. Only authentic Dräger spare parts may be used for maintenance.
Observe chapter “Maintenance Intervals”.
2.3 Accessories
Do not use accessory parts other than those in the order list.
2.4 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 DrägerService® or if the apparatus is used in a manner not conforming to its intended use.
Dräger Medical AG & Co. KGaA cannot be held responsible for damage caused by non­compliance with the recommendations given above. The warranty and liabililty provisions of the terms of sale and delivery of Dräger Medical AG & Co. KGaA are likewise not modified by the recommendations given above.
Dräger Medical AG & Co. KGaA
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3 Intended use
The Oxylog is a ventilator for the controlled, time-cycled ventilation with constant volume of infants as of a body weight of 5 kg and adults.
The unit is envisaged for mobile use in rescue operations, for transportation to a hospital in rescue vehicles or by helicopter, for moving patients to a different hospital by road or air, for ventilation of emergency admissions and for in-hospital transfer of patients receiving ventilation, e.g. from operating theatre to intensive-care ward.
3.1 Oxylog with spontaneous breathing attachment (option)
Oxylog with spontaneous breathing attachment for time-cycled, constant-volume ventilation and spontaneous breathing in a toxic atmosphere.
The Oxylog with spontaneous breathing attachment consists of the following:
• Oxylog with no Air Mix switch with demand regulator connected in parallel
• Ventilation valve with expiratory non-return valve
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4 Inspection intervals
IMPORTANT:
Before being serviced or sent in for repair, the unit (or the appropriate components) must be cleaned and disinfected in line with hospital regulations and the instructions given in this documentation.
Inspection intervals (Oxylog)
Inspection Every 6 months by specially trained personnel
Inspection intervals (Oxylog Samsomatik)
Inspection Every 2 years by specially trained personnel
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5 Checking readiness for use
• Readiness for use is always to be checked after unit upkeep. The unit must be fully assembled before being tested.
• Performance of the tests is to be recorded in the logbook.
5.1 Checking ventilation frequency
• Make the following settings on the Oxylog:
Pneum. main switch I (on) MV 3 L/min Ventilation frequency 15 min Switch No Air Mix
• Seal off ventilation valve at patient connection.
• Use stopwatch to measure time t for 10 full cycles.
-1
• Determine ventilation frequency f as follows:
f = –––––– min
-1
The Oxylog should switch at a ventilation frequency of between 13 and 17 min.-1.
5.2 Checking safety valve
• Retain the same unit settings.
• Seal off ventilation valve at patient connection.
The max. ventilation pressure should be 50 - 80 mbar.
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5.3 Checking minute volume and compressed-gas supply
• Insert catheter connector (size 5) in patient connection of ventilation valve.
• Use the following table to check the max. inspiration pressure on the airway pressure gauge.
MV Airway pressure
7L/min 4 - 8mbar
15 L/min 15 - 24 mbar
20 L/min 28 - 38 mbar
The Oxylog should switch at regular intervals from inspiration to expiration.
The setting MV = 20 L/min. provides an indirect check on proper operating conditions (min. 2 bar with 60 L/min. on Oxylog).
• Remove catheter connector (size 5) from patient connection.
The unit is ready for operation.
60
t/10
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6 Technical data
Operating principle Flow chopper Control Time-cycled, volume-constant Ventilation frequency 10 - 35 min
I:E ratio 1:1,5 ±10% Minute volume (MV) 2 - 20 L/min ±15%, infinitely variable
O2 concentration of ventilation gas using O2 as drive:
-1
±20%, infinitely variable
Switch set to Air Mix 55 Vol.% O
MV < 7 L/min, O
±10% (with MV > 7 L/min), with
2
concentration increases
2
up to 80 vol.%
Switch set to No Air Mix 100 vol.% O
2
Safety valve:
Opening pressure 50 mbar to 80 mbar Airway pressure reading Pressure gauge -10 to +80 mbar ±2,5% of
full scale value
Drive gas O
or air
2
Quality Dry, oil/dust-free, from central supply or
compressed-gas cylinders
Pressure at device inlet min. 2, max. 6 bar with a flow rate
of 60 L/min
Gas consumption:
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Control approx. 0,8 L/min MV (Air Mix) approx. 50% of set MV MV (No Air Mix) approx. 100% of set MV Typical operating time
(No Air Mix)
5503.140 Oxylog 04.97 General Page 12
With 3L cylinder/200 bar, MV = 10 L/min 54 min
Pneumatic main switch I−0 Patient system Comprises 1.1 m silicone hose and
ventilation valve Compressible volume approx. 0,3 mL/mbar Inspiration resistance 3 mbar/L/s Expiration resistance 3 mbar/L/s Dead-space volume approx. 12 mL
Ambient conditions - operation:
Temperature 5 °C to +50 °C
Humidity 0 to 100% relative humidity Ambient pressure 600 to 1200 mbar Vibration Tested as per MIL STD 810 C 514.2-III, curve
M (helicopter) In toxic atmosphere Switch set to No Air Mix, controlled ventilation
in the case of apnoea.
CAUTION:
Danger of poisoning! In the event of ongoing or resumed spontaneous breathing, toxic air is drawn in with the Oxylog, which can result in poisoning. For ventilation in a toxic atmosphere, use is to be made of the special Oxylog with spontaneous breathing attachment.
Ambient conditions - storage:
Temperature −20 °C to +70 °C Humidity 0 to 100% relative humidity Ambient pressure 600 to 1200 mbar
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6.1 Materials used
Oxylog housing Oxylog Impact-proof ABS
(acrylonitrile-butadiene-styrene) Ventilation hose Silicone rubber
Ventilation valve: Housing PSU (polysulfone) Control diaphragm Silicone rubber
6.2 Dimensions and weights
Dimensions (W x H xD) 200 x 80 x 200 mm Weight approx. 2 kg
6.3 Oxylog with spontaneous breathing attachment
Spontaneous breathing attachment:
Opening pressure Opening pressure 0 to 4 mbar Max. output 100 L/min at −7 mbar
Oxylog:
No Air Mix switch Ambient air is not sucked in
+30
Pressure limitation valve 50 Ventilation valve With additional expiratory non-return valve
mbar
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7 Cleaning/disinfection/sterilisation
• Always clean and disinfect Oxylog after ventilation.
7.1 Cleaning
• Strip down Oxylog.
• Disassemble ventilation valve into its component parts.
IMPORTANT:
Do not remove red non-return valve from yellow control valve.
• Clean disassembled components in warm running water or in water containing detergent.
• Thoroughly rinse components in running water and then dry them off.
The component parts can also be washed in the Dräger Purfactor“, which ensures that the material is disinfected and dried.
• Wipe over the surface of the unit with a soft cloth soaked in detergent.
NOTICE:
J
Material damage! Petroleum, ether or similar solvents may damage the plastic housing of the unit. Never use petroleum, ether or the like for cleaning purposes.
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7.2 Disinfection
7.2.1 Use of liquid disinfectant
• Disinfect the cleaned and dried components of the patient system in a cold disinfectant solution.
• Thoroughly rinse the components in water and then dry them off.
7.2.2 Disinfection by wiping
• Wipe over the surface of the Oxylog with liquid disinfectant.
Dräger Medical AG & Co. KGaA recommends consulting the "List of officially tested and approved disinfectants and disinfection methods" as well as the current list of disinfection procedures checked in line with the "Guidelines for testing chemical disinfectants" and deemed suitable by the German Hygiene and Microbiology Association.
7.2. 3 Disinfection in Dräger Aseptor
• Disinfect the cleaned and dried components of the patient system and the Oxylog in line with the Dräger Aseptor“ instructions for use.
NOTICE:
J
Material damage! Parts made of silicone rubber may be damaged in the Dräger Aseptor Aseptor
®
®
. Never disinfect ventilation hose and masks in the Dräger
.
®
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7.3 Sterilisation
• Sterilise the following in superheated steam at 134°C:
Cleaned and dried components of patient system
Component parts of ventilation valve
Ventilation hose
• Plastic and rubber mouldings are always to be disassembled for sterilisation purposes.
NOTICE:
J
Equipment damage! Moisture ingresses into the unit on sterilising it in an autoclave or immersing it in a disinfection bath. This can lead to damage. Never sterilise Oxylog in an autoclave or immerse it in disinfectant solution.
8 Prior to renewed use with patient
• Assemble unit.
• Check that unit is ready for operation.
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Functional Description
1 Gas supply
The gas is either supplied from a central gas supply system (CS) or from a gas cylinder with pressure reducer.
Operation of the Oxylog ventilator requires a pressure of between 2 and 6 bar (O2 or com­pressed air) with a flow rate of 60 L/min.
NOTICE:
J
Equipment damage! Dust, oil and moisture may impair the function of the unit or damage it. Make exclusive use of dry medical gases which are free from dust and oil.
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2 Pneumatic control
2.1 Oxylog
4
1
23
13
5
17
ABC
EFGH
Abb. 1: Block diagram of Oxylog
14
15
7
6
8
16
9
D
K
12
10
L
18
11
1 Gas connection 15 Vessel 2 Filter 16 Intake 3 Pressure reducer 17 Metering unit 4 On/off switch 18 Ventilation valve 5 Distributor O A Amplifier relay 6 AMV adjuster B Amplifier relay 7 Air Mix/No Air Mix switch C Amplifier relay 8 Metering unit D Amplifier relay 9 Injector E Amplifier relay 10 Relief valve F Amplifier relay 11 Vent valve G Amplifier relay 12 Pressure gauge H Amplifier relay 13 Frequency adjuster K Amplifier relay 14 Vessel L 3/2-way valve
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2.2 Oxylog Samsomatik
Microswitches 1 - 6 are grouped on an interconnection plate (pneumatic plate).
The internal connections in the block obviate the need for interconnection of the individual microswitches with hoses. The microswitches are held in position in the block by a clamp. Microswitches 2 and 5 were specially selected for their switching properties (switching pres­sure).
Microswitches
Clamp
3651 42
Abb. 2: Interconnection plate
Block
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A1
F2
VD
F1
DR
FD
S1
S2
9
WV1
MV
1
V1
2
D2
D3
3
D1
WV2
I
SV
PA
DM
BV
SS
EV
456
V2
Abb. 3: Block diagram of Oxylog (Samsomatik)
A Gas connection I Injector F1 Filter DM Pressure gauge F2 Filter PA Patient outlet DR Pressure regulator SS Silicone hose S1 On/off switch BV Ventilation valve S2 Air-Mix/No Air Mix switch EV Vent valve MV Minute volume valve V1 Vessel 1 WV1 3/2-way valve V2 Vessel 2 WV2 3/2-way valve 1 Microswitch VD Pre-metering unit 2 Microswitch D1 Metering unit 3 Microswitch
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D2 Metering unit 4 Microswitch D3 Metering unit 5 Microswitch FD Frequency valve 6 Microswitch SV Safety valve 9 Microswitch
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5503.140 Oxylog 04/97 Functional Description Seite 21
2.2.1 Unit switched off
Oxygen or compressed air flows via the connection A through the filter F1 to the pressure regulator DR, which provides a constant gas pressure of 1.5 bar. This pressure is applied to the on/off switch S1, to the distributor O and to the 3/2-way valve WV1.
S1
F1
A
F2
VD
DR
123
FD
4
WV1
MV
V1
D2
D3
V2
S2
D1
65
WV2
I
9
DM
SV
PA
BV
SS
EV
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Abb. 4: Gas supply (unit switched off)
2.2.2 No Air Mix switch setting
The distributor applies the gas to all points marked O. This switches the time cycling to expi­ration, the 3/2-way valve WV1 is disabled and the 3/2-way valve WV2 is set to No Air Mix.
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2.2.3 Unit switched on
After switching on the switch S1, gas flows to the distributor O and from there through the fil­ter F2, the pre-metering unit VD and the frequency valve FD to the time-cycling microswitches 1 and 4. At the same time, gas is routed to the microswitches 2 and 3.
S1
F1
DR
MV
A
F2
VD
WV1
1
V1
2
3
FD
4
V2
5
6
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Abb. 5: Gas supply (unit switched on)
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2.2.4 Inspiration
Microswitch 4 causes the vessel V2 to be filled as far as the switching point of microswitch 5. Microswitch 5 is vented. Microswitch 6 is also vented and its output thus depressurised (expi­ration signal blocked).
Microswitch 3 causes the inspiration signal to be passed to the 3/2-way valve WV1, to the vent valve EV and to the microswitch 6. Vent valve EV is closed.
The 3/2-way valve WV1 opens. The gas applied flows through the minute volume valve MV, the metering unit D1, the 3/2-way valve WV2 and the injector I to the patient.
S2
9
WV1
MV
D1
WV2
DM
V1
SV
I
23
PA
SS
BV
EV
5
6
Abb. 6: Inspiration
The minute volume valve MV operates on the pressure regulator principle. The setting governs the flow. The output capacity of injector I is the same in both switch settings (Air Mix/No Air Mix).
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2.2.5 Air Mix switch setting
In the Air Mix switch setting, gas flows through the switch S2 to the 3/2-way valve WV2 and to the microswitch 9. Microswitch 9 switches to ventilation.
The 3/2-way valve WV2 switches over; the intake to injector I switches to ambient air.
S2
9
D1
DM
WV2
I
Abb. 7: Air Mix switch setting
SV
PA
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2.2.6 Expiration
As soon as the reversing pressure is attained at microswitch 2 (delayed by filling time of ves­sel V1), microswitch 2 switches to venting and thus causes microswitch 3 to be vented as well. The expiration signal is passed to the microswitches 3, 4 and 5 and at the same time to the 3/2-way valve WV1. Microswitches 3, 4 and 5 switch over. The 3/2-way valve WV1 is reversed and the flow of gas to the patient is blocked. The vent valve EV relieves the tubing system (unit tubing from 3/2-way valve WV1 and patient hose to ventilation valve). The patient can exhale to the atmosphere through the ventilation valve BV.
S1
F1
A
F2
VD
DR
1
FD
4
WV1
MV
V1
D2
D3
V2
S2
9
D1
PA
DM
BV
SS
EV
WV2
SV
I
2
5
3
6
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Abb. 8: Expiration
At the same time, microswitch 4 fills the vessel V2 as far as the switching point of micro­switch 5. Switching to inspiration then takes place.
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2.2.7 Pressure limitation
To protect the patient, a max. ventilation pressure of 80 mbar is set on the safety valve SV.
WV2
SV
I
Abb. 9: Pressure limitation
DM
PA
BV
SS
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Test List
Oxylog
Serial no.:
Installation site:
—————————
—————————
Folder no.: 5503
Revision:
11.95
GBK5503140TL1.fm 19.04.99
Copyright reserved. Reproduction allowed for non-commercial purposes only.
This Test List does not replace inspections and servicing by Dräger Medical AG & Co. KGaA
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