28/06/2022
USER TRAINING
BEMS/UT/001
TYPE CODE : 14-361
Ventilators, Intensive Care, Neonatal/Pediatric
(Draeger Babylog 2000)
Prepared by :
Nurhafizah
BEMS
CONTENT
1.
EQUIPMENT OVERVIEW
2.
BASIC FUNCTION (not to include clinical application)
3.
DAILY AND ROUTINE MAINTENANCE
4.
SAFETY PRECAUTIONS IN OPERATING EQUIPMENT
5.
CAUSES AND CORRECTIVE ACTIONS
6.
CLEANLINESS AND DECONTAMINATION AWARENESS
7.
MAINTENANCE REQUEST PROCEDURE
8.
POTENTIAL HAZARD
9.
AWARENESS ON VIGILANCE REPORTING
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1. EQUIPMENT
OVERVIEW
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Front
1 Rotary switch for setting the CPAP/IMV/IPPV operating mode
0 =OFF
2 Buttons for manual inspiration
3 Seat for O2 sensor housing, sealed with cap
4 Connection sleeve for pressure measuring line
5 Inspiration port
6 Expiratory valve
7 R button to reset the alarm after eliminating
the cause of the alarm
8 Button G toggles the alarm tone for 2 minutes
9 LEDs
10 Rotary knob to adjust the inspiratory O2 concentration from
21% to 100%
11 Display for ventilation frequency f and lower pressure Pmean
• For CPAP, only Pmean is displayed
12 Rotary knob for setting the upper alarm limit
13 Rotary knob for setting the lower alarm limit
14Yellow LED, lights up with IPPV/IMV
15Yellow LED, lights up during CPAP
16 Analog mechanical pressure gauge for continuous display of
inspiratory and expiratory airway pressure
17 Rotary knob for setting PEEP/CPAP
18 Knob for time settings TEX/TIMV; blue scale valid for IMV, gray
scale valid for IPPV
19 Pinsp setting knob
20 Knob for the time settings TIN
1. EQUIPMENT
OVERVIEW
Back
1 connection for O2 (NIST)
2 Connection for compressed air
(NIST)
3 Adapter compressed air from NIST to
DIN connection
4 Adapter O2 from NIST to DIN
connection
5 Electrical supply box
6 12VDC to 24VDC input jack
7 Power cord connector 1 10/120 VAC
or 220/240 VAC, optional
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2. BASIC FUNCTION
1. Insert expiratory valve
 Use sterile expiratory valve. Loosen the
knurled screws and unscrew the valve
block from the device. Tilt the valve block
90° forward
 Insert the diaphragm into the valve block.
The lettering on the membrane must be
legible.
 Place the lower left hole on the valve block
on the guide pin for the housing
connection. The lettering "Expiration"
must be legible.
 Press the valve block with the membrane
onto the housing connection. Tighten
both knurled screws
2. BASIC FUNCTION
2. Gas supply installation
 Screw the air and O2 connection hose to the
back of the Babylog 2000*.
When supplied from a central gas supply
 Plug the plug into the wall tapping points.

When supplied from bottles
 Connect the air and O2 connection hose to the
pressure reducer of the corresponding bottle.
*The compressed gases must be dust-free, oilfree and dry!
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2. BASIC FUNCTION
3. Power Supply
Internal supply - with integrated 6 V battery
External supply
Before using for the first time or after a long
period of non-use:
1 With DC voltage from the vehicle electrical
system: – via 12/24V input socket (max. 30 V
input voltage). q Plug the 12/24 V DC
connection cable into the input socket.
 Charge the battery for approx. 10 hours at
ambient temperatures above 01C.
 Plug in the mains plug or 12/24 V DC connection
cable.
With a fully charged battery, the Babylog 2000
can be operated for around 10 hours.
The operating time is reduced by reducing the
capacity of the battery as it ages and when
operated at ambient temperatures below 0°C.
2 With integrated power supply (for devices
with electrical supply box2):
The mains voltage must match the voltage
range specified on the rating plate, 100 to 240
V AC. Nameplate on the underside of the
electrical supply box.
• Plug in the mains plug.
When both supplies are connected to the
electrical supply box 2, the electrical supply
comes from the mains before the supply from
the 12/24 V DC connection cable.
The connection of both supplies is possible and
does not cause any interference.
2. BASIC FUNCTION
4. Preparation
Use sterile hose system!
Insert the catheter connector elbow (refer picture)
1 into the "Expiration" outlet and
2 into the "Inspiration" outlet
*Attach ventilation hoses, note hose lengths.
Connect Y-piece - Adapter K, 90°
3 Slide the sterile Y-piece into the ventilation hoses.
4 Connect the bellows as a test lung to the Y-piece
with the catheter connector.
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2. BASIC FUNCTION
Connect the pressure measuring line
Use sterile pressure measuring line.
5 Plug the hose (0.3 m) onto the spout P.
6 Attach the sterile bacteria filter and position it
so that no condensate can penetrate.
 Plug the pressure measuring line (1.6 m)
onto the bacterial filter and
7 Put the rubber angle on the pressure tap on
the Y-piece.
 If necessary, shorten the hose accordingly.
Connect humidifier
 Connect the humidifier according to the
associated instructions for use.
2. BASIC FUNCTION
5. OPERATION
1 Set required oxygen concentration.
Controlled ventilation IPPV
2 Set rotary switch to IPPV operating mode.
3Yellow LED Q lights up.
4 Set the rotary knobs to "green dots", the device
now works with the parameters:
TIN = 0.8 s
TEX = 1.2 s
f
= 30 bpm
or
I : E = 1 : 1.5
• Set ventilation parameters patientPEEP = 2 mbar
specifically.
Pinsp = 20 mbar
• Connect patients.
•
Set alarm limits for pressure monitoring
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2. BASIC FUNCTION
Ventilation with plateau (Pressure limitation)
5 Knob »P insp« : Adjust according to the display on the
pressure gauge, starting with small values, until the
desired inspiratory pressure plateau is reached.
6 Knob »PEEP/CP AP« : set.
 In the ventilation pattern with a plateau, the Pinsp
setting prevents damaging pressures, e.g. if the
compliance decreases.
Ventilation without a plateau (Time limit)
1 Knob »P insp« : Set approx. 5 mbar above the
inspiratory pressure peak.
2 Knob »PEEP/CP AP« : set.
2. BASIC FUNCTION
PEEP Setting
3 Knob »PEEP/CP AP« Set to the desired value
according to the pressure gauge reading.
Ventilation with plateau:
 The effective stroke volume is reduced.
4 If necessary, increase P max.
Ventilation without plateau:
The airway pressure is increased by the amount of
the CPAP value.
 Increase Pinsp by this amount.
 Adjust upper airway pressure limit.
Conversion from TEX/ TIN to f or I : E
f and I : E can be roughly determined from TIN
and TEX using the frequency diagram:
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2. BASIC FUNCTION
Intermittent Mandatory Ventilation (IMV)
For weaning from ventilation with IPPV.
Mixed form of mechanical ventilation and spontaneous
breathing. The mechanical ventilation strokes ensure the
minimum ventilation, in between the patient can breathe
spontaneously.
The ventilation pattern of the mechanical, mandatory
breaths works as in IPPV: with and without a plateau. A
positive airway pressure can be applied for spontaneous
breathing.
The device applies a continuous flow of 8.5 L/min.
1 Turn rotary switch to IMV.
2 At the knob »TEX/TIMV« : the blue scale TIMV is now valid.
Gradually increase expiration time. The inspiration pattern
is preserved.
3 Use the rotary knob »PEEP/CPAP« to set the positive
airway pressure for the spontaneous breathing phases.
2. BASIC FUNCTION
Spontaneous breathing under positive
airway pressure (CPAP)
The device applies a continuous flow of 8.5
L/min. An adjustable end-expiratory pressure
is generated with the expiratory valve.
1 Turn rotary switch to CPAP.
2Yellow LED w lights up.
3 Use the »PEEP/CPAP« rotary knob to set the
positive airway pressure.
 Set lower alarm limit
4 The displayed pressure Pmean should match
the set PEEP/CPAP.
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2. BASIC FUNCTION
6. Alarm limit
Set alarm limits for IP V/ IMV
Lower alarm limit:
1 Set the rotary knob to approx. 5 mbar above the
end-expiratory pressure.
2 Green LED P flashes at the beginning of each
inspiration = correct setting of the alarm limit.
Upper alarm limit:
3 Set the rotary knob approx. 10 mbar above the
maximum pressure Pmax.
2. BASIC FUNCTION
Set alarm limits for CPAP
With CPAP =0, monitoring of the lower alarm limit
is not possible. The device warns constantly.
Use the patient monitor to detect an apnea!
Lower alarm limit:
4 Set the rotary knob 2 to 3 mbar below the endexpiratory pressure.
Upper alarm limit:
5 Set the rotary knob approx. 10 mbar above the
maximum pressure Pmax.
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2. BASIC FUNCTION
Start inspiration manually
Possible in all operating modes
1 Set the »Pinsp« knob to the "green dot" approx. 20
mbar.
2 Set rotary knob »TIN« to "green dot" or to patientspecific value.
3 Briefly press the »Man Insp« button.
After the set inspiration time TIN (with IPPV/IMV)
has elapsed, expiration or CPAP takes place.
For a prolonged inspiration:
3 Keep the »Man Insp« button pressed for the time
of inspiration.
2. BASIC FUNCTION
After connection of the patient:
4 Set rotary switch to 0.
 Set the switch of the additional devices to 0.
 Pull out all electrical and pneumatic supply
plugs.
If the battery is to be charged, leave the
electrical supply connected.
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3. DAILY & ROUTINE
MAINTENANCE
After Use:
Disconnect breathing circuits
 Disconnect all hoses from the outlets.
 Pull the catheter connector elbow out of the
outlets.
 Remove Y-piece.
 Detach the pressure measuring line from the Ypiece and from the »P« socket.
 Pull off bacterial filter.
 Unscrew the O2 sensor housing and remove the
O2 sensor. Clean according to the relevant
instructions for use.
At the expiratory valve:
 Loosen both knurled screws, remove the valve
block and take out the diaphragm.
3. DAILY & ROUTINE
MAINTENANCE
Routine maintenance
Bacterial filter for pressure measuring line
Replace after 20 times sterilization
Diaphragm of the expiratory valve
Replace every six months
Device inspection and maintenance
Every six months by experts
Recurring safety checks
Every six months by experts
Battery pack
Replaced by experts after 2 years
Major overhaul of pressure reducers
Every 6 years by experts
Membrane keyboard
If damaged, have it replaced by experts
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1. Follow the instructions
4. SAFETY
PRECAUTIONS IN
OPERATING
EQUIPMENT
Any handling of the device requires precise knowledge of and compliance with these
instructions for use. The device is only intended for the use described.
2. Maintenance
The device must be inspected and serviced by specialists every six months (with a report).
Repairs to the device only by specialists
3. No operation in potentially explosive areas
The device is not approved for operation in potentially explosive areas
4. Monitor ventilation
Have qualified medical personnel monitor the patient during ventilation
5. Have manual ventilation equipment ready
If there is a noticeable error on the ventilator,
e.g. If, for example, the compressed gas supply fails, the life-sustaining function can no
longer be guaranteed, the patient must be ventilated immediately with an independent
ventilation device
6. Do not use mobile phones within a distance of 10 meters from the device
Cellular phones can interfere with the function of electromedical devices
5. CAUSES AND
CORRECTIVE
ACTION
Alarms
1 LED J for power supply
 Green = operation
 Red = operating voltage low alarm
2 Red LED MIX lights up in the event of a lack of gas
alarm
3 Red LED W for upper airway pressure alarm limit
4 Red LED w for airway pressure lower alarm limit for
CPAP
5 LED P for fail to cycle alarm for IPPV/IMV
 Green = inspiration phase for IMV/IPPV
 Red = fail to cycle (FTC) alarm, inspiration
phases are not recognized
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5. CAUSES AND
CORRECTIVE
ACTION
In the event of an alarm
 Alarm tone sounds, the glowing red LED indicates
the cause of the alarm.
Suppress alarm sound:
1 Press button G.
 The alarm sound is switched off for approx. 2
minutes. Yellow LED in button lights up.

When the cause of the alarm has been eliminated:
2 Press the R button.
 "Reset" is possible with FTC alarms, even if the cause
of the alarm has not yet been eliminated.
 After a delay time, the alarm is triggered again.
When the alarm sounds:
• All LEDs go out, monitoring is no longer
possible. The alarm tone cannot be
suppressed.
Then:
• Connect to external power supply via mains
cable or 12 V / 24 V DC connection cable.
The monitoring is immediately ready for use
again.
• Charge battery
In the event of a lack of gas alarm:
 Press button R, the alarm tone is switched off.
 The LED display only goes out when there is
sufficient gas supply.
In the event of an alarm from the electrical supply:
 Red LED J lights up.
 Recharge the battery.
 The battery is ready for operation for approx. 1 hour.
5. CAUSES AND
CORRECTIVE
ACTION
Error
Cause
Action taken
Red LED J lights up
Voltage supply for monitoring
functions too low:
battery discharged.
Charge the battery.
Alarm sounds,
all LEDs go out.
Battery discharged, no residual
capacity available
Charge the battery, if the alarm sounds
anyway, change the battery
Red LED lights up,
alarm sounds
Supply pressure too low.
Pressure hoses not connected.
Check which gas triggered the alarm,
make sure the pressure is greater than 3
bar.
When supplied from bottles, a
remaining operating time of approx. 40
minutes is guaranteed. To suppress the
alarm tone for longer, press the R
button
Mixer function disrupted
Red LED W lights up,
alarm sounds
Upper alarm limit Paw exceeded:
Increase in pressure in the hose
system.
Patient breathes against the device.
Check alarm limit setting.
Check hose system.
Check ventilation parameter settings
and change if necessary.
Press the R button
Red LED w lights up,
alarm sounds
Lower alarm limit Paw undershot for
17 s with CPAP.
Leak or disconnection in the tubing
system
Check alarm limit setting.
Tubing Check for tight connection.
Press the R button
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5. CAUSES AND
CORRECTIVE
ACTION
Error
No breathing possible
Condensate in the expiration hose
Expiratory tubing kinked
Exhalation valve blocked
Red LED P lights up,
alarm sounds
Fail to cycle Alarm (FTC)
6. CLEANLINESS AND
DECONTAMINATION
AWARENESS
Cause
Paw has not crossed the lower alarm
limit (FTC alarm limit) for 17 s for
IPPV or for 40 s for IMV
Paw lower than the lower alarm limit:
Leakage or disconnection in the hose
system
Paw constantly greater than the
lower alarm limit: device error
Action taken
Empty the expiratory hose
Check expiration hose, create free
passage
Check diaphragm for proper seating
Check the alarm limit setting
Hose system Check for tight
connection.
Press the R button
Call for service
Perkara ini adalah merujuk kepada:
“MASTER AGREED PROCEDURE : BEM-TS-004 (INCIDENTS, HAZARDS
AND HANDLING HAZARDOUS AND CONTAMINATED BIOMEDICAL
EQUIPMENT ) PARA 6.3 (Handling Contaminated Biomedical
equipment )”
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START
7. MAINTENANCE
REPORT
PROCEDURE
User identify faults during use
Perform Corrective
Maintenance
Decontaminate faulty
equipment
Perform performance
test/electrical safety test
Initiates a request to
Medivest
Complete work order and
assessment detail
(Emergency call must be
made via direct call to the
Medivest’s help desk )
Request number provided
to the user and generate
Corrective Maintenance
Work-Order
Authorised Personnel to
verify and close work
order
User Verify
Update record in ASIS
Respond to the request
within the specified time
frame
9.
AWARENESS
OF VIGILANCE
REPORTING
END
There is no vigilance report such as Incident
Reporting, Hazard Alert & Recall for this equipment
from manufacturer and Medical Devices Authority
(MDA) as at 2018.
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