TMT Life Control MV112 User manual

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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KT-731030-3 Revision Date/No: 02.10.2020/5
Disposable Mechanical Ventilator Instructions for Use with document code KT-731030-3 is valid for the
devices in Table.1 below.
Reference
Code
Device Description
Accessories
HME Filter
Catheter
Mount
Oxygen Mixer
Manometer
Profix ®
Fixing
Device
Weight
Pneumatic Visual
Mixport
O2Mixer
MV112
Life Control ®
Mechanical
Ventilator
√
√
√
√
90gr
MXH112
Life Control ®Mix
Mechanical
Ventilator with
Mixport and HME
filter
√
√
√
√
145gr
MX112
Life Control ® Mix
Mechanical
Ventilator with
Mixport
√
√
√
123gr
MREST
Life Control ®Rest
Mechanical
Ventilator with
Restport and HME
filter
√
√
√
√
123gr
MREST112
Life Control ®Rest
Mechanical
Ventilator with
Restport
√
√
√
105gr
Table.1 Device Models

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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KT-731030-3 Revision Date/No: 02.10.2020/5
Please read these instructions for use carefully before using this device.
PLEASE DO NOT USE THE DEVICE WITHOUT READING THE INSTRUCTIONS MANUAL
THIS DEVICE IS USED BY TRAINED MEDICAL PERSONNEL IN CPR APPLICATIONS.
This device is intended for use under Emergency, Open Field Environment use and "CONTINUOUS USER SUPERVISION" in normal use.
The patient should not be left alone while the device is operating
The device must be disposed of in accordance with The Medical Waste Rules
An Oxygen supply is required to operate the Life Control® branded Disposable Mechanical Ventilator. The device will not operate without
a compressed air supply. Without an air supply with a pressure range of 1-5 bar or air supply with a flow rate of 6-40 L / min, the device
will not operate. The diaphragm valve inside the device does not operate without oxygen pressure.
This instructions for use;
1. What is the Life Control ®; what is it used for?
2. What should be considered before using?
3. What is important information about Life Control ®?
4. How to use Life Control ®?
5. What are the Life Control ®indications?
6. What are the Life Control ® contraindications?
7. What are the measures, risks and advantages?
8. Operational features
9. Component summary information
10. Manufacturer information
1. What is the Life Control®; what is it used for
Life Control ®is a single-use, air-pressure operated mechanical ventilator (resuscitator)
To provide active respiratory support for patients who have stopped breathing
2. What should be considered before using
This device can operate in 10-50 cmH2O (± 5 cmH2O) pressure range
Factory set of the device is 25-30 cmH2O pressure.
For intubated cases it is recommended to provide 35cmH2O pressure. In intubated cases, pressure should
be increased because the airway lengthens and shrinks.
Life Control ® IS A DISPOSABLE DEVICE AND IS NOT USED FOR THE SECOND TIME.
Disassembling and washing its parts, disinfecting with different solutions, displacing parts for the use of
second time, causing all values in use to change and may cause harm to the patient.
Any section on the LİFE CONTROL ® or OXYGEN line must not be lubricated in any way. The contact of
pure oxygen with oil causes flammable, caustic and explosive causes.
Please note that the device has intensive Oxygen (O2) during operation. Do not approach with smoking,
fire or any other substances which react with O2.
The overpressure valve will be activated at , ≥ 55-60 cmH2O.
The device does not require any maintenance or calibration. Do not interfere in the means of technical
repair and maintenance of the device for any reason. You may cause unwanted results.
Check the robustness of the Oxygen Connection Hose in the package.
Manometer
Catheter mount /
HME Filter (Patient
Connection)
Frequency
adjustment
screw
Safety valve
O2
connection
Part*
Pressure
adjustment
screw
Device
Body
* Life Control® Mix and Life Control®
ReSt models have an oxygen
blending mixer in the O2connection.

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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In Life Control® Mix and Life Control®ReSt model mechanical ventilators, make sure that the oxygen
mixing mixer is at the desired concentration. (50% -100%).
If the device used is Life Control®Mix with reference code MXH112 and MX112;
Make sure the cap on the mixport is tightly closed.
If you are going to make a standard single air supply connection on the mixport, make sure that you make
the connection to the exposed main air supply port and not to the top port.
If you are going to make a dual connection with MixPort (Main Input = Air Supply - Top Input = Oxygen
Supply), make sure that the orange switch is at the 100% position to achieve Manual Oxygen concentrate.
3. What is important information about Life Control ®
3.1 Verify the cmH2O pressure values with the manometer while the device is running.
3.2 For all interventions, ensure that the airway is clean and open. Intraoral, excretion, vomit, glass fracture,
tooth fractures etc. foreign and unwanted substances should be cleaned
3.3 The values read through the pressure gauge are approximate values.
3.4 In the case of masks, ensure that the mask air bag is properly sealed. If necessary, inflate the airbag
3.5 If necessary, you can open the aspiration port on the catheter mount and aspirate without ventilation
3.6 An audible vibration sound (disturbing) or the non-rhythm (vibrate) operation of the cmH2O manometer
while the device is running may be a sign of blockage in the airway.
3.7 If vomit or discharge from the patient has come to the filter and has damaged the filter, do not waste
time with cleaning the device. In such a case, follow the steps below;
Remove the catheter mount, remove the filter and change it.
Connect the catheter mount to the cmH2O manometer if the filter will not be installed
All this operations should be done within 20 seconds. Dispose of dirty filter according to medical waste
regulations.
3.8 This device can be used in patients over 10 kg
3.9 When the device continues at normal rhythm, suddenly switching to semi-rhythm (unusual frequency) in
ventilation or frequency cycle stop in ventilation while air flow is in progress, means that high risk of lung
damage or single lung failure. Intervene with observing and listening with a stethoscope
3.10 Modifying or tampering with any part of the device will void all warranties and terminates the
manufacturer's responsibility
4. How to use Life Control ®
For the device models of Life Control®ReSt and MV112;
4.1 Life Control ®is in the package. Open the packaging, the oxygen connection hose is connected to the
device, connect the other end to the oxygen source.
4.2 Set desired flow (Q), adjust PIP pressure dial to obtain desired inspiratory time (tinsp) to attain tidal
volume (TV = Q x tinsp see Tidal Volume Table 1). The gas flow, patient’s lung compliance, and PIP settings
LİFE CONTROL ® the inspiratory time and tidal volume. Then adjust rate dial to obtain desired breathing
rate.
Flow
(L/dk)
Inspiration Time (sec)
0.5
1
1.5
2
2.5
3
15
125
250
375
500
625
750
20
167
333
500
667
833
1000
25
208
417
625
833
1042
1250
30
250
500
750
1000
1250
1500
35
292
583
875
1167
1458
1750
40
333
667
1000
1333
1667
2000
Table.2 Estimated Tidal Volume (mL) Delivered at Various Flow (L/min) and Inspiratory Time (seconds)

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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4.3 Confirm the pressure values with the cmH2O manometer. Manometer scales showing the pressure values
and the color definition are as follows;
Visual.1 Manometer Scale
4.4 In intubated cases, connect the catheter mount directly to the intubation tube. In the case of mask use,
training on "mask ventilation" techniques is required.
4.5 With both forms of ventilation, intraoral foreign objects should be cleaned before ventilation (if there is
any).
4.6 When ventilation starts, check the respiration
numbers in indexed to time.
4.7 To achieve a particularly low frequency, you
must lower the flow with the flowmeter. Low
flows can be obtained by reducing the pressure
by a "manometer with a pressure adjuster
valve (adjust screw)" that is connected to the
oxygen supply.
4.8 When adjusting the frequency adjust screw by
turning clockwise (slower), the frequency may
stop due to Life Control® led adjustment. Turn
the frequency adjustment knob clockwise
(faster) until it comes to the stable frequency
to regain the pressure cycle
4.9 To confirm whether chest movements are
inspiratory and expiratory compatible and that
ventilation continues smoothly, can confirm it
by following with the eye with and hearing with
the stethoscope.
4.10 If the patient vomits: Please read the 3. What is
important information about Life Control ®
/Item 3.7.
4.11 When Life Control® is connected to a 50 PSIG
gas supply, it will automatically deliver oxygen
at 40 L/min (667 mL/sec). The ideal pressure for
operating the device is between 1-5 bar (~14-72
psi).
4.12 When Life Control® is connected to an oxygen
source with an adjustable flow Life Control®, it
can operate comfortably within a pressure
range of 10-50 cmH2O(±5 cmH2O) and a flow
rate of 6 l/min - 40 l/min.
4.13 When Life Control ® is taken from horizontal to
vertical position or from vertical position to
horizontal position, the pressure of cmH2O may

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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KT-731030-3 Revision Date/No: 02.10.2020/5
Additional
Inspiratory
Valve
vary from 1-3 by the increasing or decreasing spring strength of the diaphragm.
4.14 Oxygen (O2) mixer on Life Control® (Mix and ReSt models) can be converted to 50% (± 10%) or 100% (>
85%) oxygen transfer according to the oxygen concentration requirement.
On Life Control®Mix / MXH112 and MX112 reference code devices:
Implementation steps from 3.1 to 3.14 are valid. In addition, the Mixport oxygen mixing port optionally
has two connection ports. The following should be considered when using these connections.
Mixport Standard Single Air Source Connection: When the mixport is operated with a single air source at a
100% concentration, the orange switch is turned and if the 50% mode is switched on, there will be
changes in frequency due to the change of air flow rate and may require re-frequency adjustment. While
the Mixport is operating in 50% mode, high cmH2O settings may create the need to increase the flow
rate.
Two Air Source Connections with MixPort: Open the cap on the MixPort and connect the oxygen supply
here.
When connecting the dual oxygen concentration control with MixPort, Mixport orange switch should be
in 100% mode.
It is possible to capture concentrations in the range of 21% to 85% by controlling the mixing ratio of the
oxygen that is connected to the second connection point of the MixPort with the flowmeter or
manometer connected to the oxygen source.
Manual oxygen concentration can be adjusted with the second connection port on the MixPort.
While the pressure required for the operation of the device to the Life Control®Mix source entry point is
provided using the air source (21%), a 100% oxygen source is connected to the second connection port on
the MixPort. While the air source provides an oxygen concentration of about 21%, a 100% oxygen source
connected to the MixPort is increased in the desired amount to provide an oxygen mixture to the air
source connected to the device. Thus, all oxygen concentrations are obtained on the LifeControl Mix with
MixPort at Min 21% to Max 85% (eg = 35%, 42%, 76.3%).
Fixing The Device To The Patient
There is a male fixing pin in the center of the round (circular) polyurethane foam stabilizer
On the Life Control® body, there is female version of the male pin on the foam
Connect the male pin on the foam with the female and hear the "click". Remove the transparent polyester on
the foam bottom surface and adhere to the appropriate area on the patient.
5. What are the Life Control®indications
Patients in need of emergency, short term, constant flow, pressure cycled ventilatory support
Patients unable to maintain an adequate acid-base status during unassisted ventilation
6. What are the Life Control® contraindications
Patients requiring greater than 60 cmH2O PIP
Patients below 10 kg body weight
7. What are the measures, risks and advantages
7.1 Measures
The patient should be monitored continuously by a medical personnel with "CPR training" when
connected to the device. The patient should not be left alone.
Life Control® is a resuscitation management system and is not an
automatic ventilation system to leave the patient on its own.
The extra inspiration valve on the Life Control® should never be
switched off-closed or clogged, as the patient may request additional air.
Positive End Expiratory Pressure (PEEP) is programmed into the device
and is equal to 1/5 of the PIP value and is between 2 and 10 cmH2O (±1
cmH2O).

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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If the device is used with an oxygen cylinder, the operating time of the device can be adjusted by the
oxygen flow rate so that the oxygen in the tube is sufficient to reach the hospital.
The average working time of a 625-liter fully charged oxygen cylinder is calculated as follows;
Adjusted Flow
Rate
Liter/minute
15
20
25
30
35
40
Average
Working Time
Minute
40
30
25
22
18
16
7.2 Risks
Re-use of a single-use device may put the patient at risk.
Failure to follow the patient's respiratory rate while the device is being used.
Leaving the patient alone when using the device.
Failure to follow the oxygen level in the patient's blood.
Chemical and physical properties are not taken into consideration in the selection of materials used in gas
transmission.
The use of materials that can be drained from the materials during the use of the device can create health
risks to the patient.
Sharp or pointy edges that can be found on the device and the materials used in gas transmission, can
cause harm to patients, users and third parties.
Possibility of finding toxic effects of materials reacting with gases.
The user cannot observe the device mechanism.
The parts of the device are not fully compatible.
When the device is contaminated with exudates or vomit during use, it takes more than 20 seconds to
clean and return to normal operation.
Missing and / or insufficient information on label and the instructions for use of the device
Biological contamination of the device due to environmental factors
Inadequate ventilation formation due to a non-fit oxygen mask
7.3 Advantages
The device is disposable, so there is no risk of cross-contamination.
It is light and easy to use.
The device can be used as a transport ventilator.
The device is used for resuscitation and short-term ventilation support.
It can be used safely with MR.
Device detects spontaneous breathing.
The device allows cardiac massage during ventilation.
The device can be operated in 1:1 to 1:3 I/E range.
The device is PEEP sensitive.
Ventilation pressure can be monitored where it reaches the patient.
Offers 50% - 100% oxygen transfer option for Life Control ® Mix and Life Control ® ReSt models.
8. Operational features
Patient Weight
: 10 kg and above
Number of breaths per minute
: 10 –60
I/E Ratio
: 1/1 –1/3
Adjustable Peak Pressure Range
: 10 - 50 cm H2O (±5 cmH2O)
PEEP Value (1/5 of PIP)
: 2 - 10 cmH2O (±1 cmH2O)
Can Operate in Flow Range of
: 6 –40 liters / minute
Dead Space
: 4 +/- 3 ml
Pressure Safety Valve Audible Alarm
: ≥ 55-60 cmH2O

INSTRUCTION FOR USE
LIFE CONTROL®
DISPOSABLE MECHANICAL VENTILATOR
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KT-731030-3 Revision Date/No: 02.10.2020/5
Inspiratory Resistance
: 3 ± 1 cmH2O / liter/second
Expiratory Resistance
: 3 ± 1 cmH2O / liter/second
Operating Environment Temperature
: -18 °C / +50 °C
Storage Environment Temperature
: -40 °C - +60 °C
Pressure Input Range
: 1 –5 bar
Oxygen Connection
: DISS Gas connection
Patient Connector
: Corresponding to connector Male Ø22mm - Female Ø15mm
connector
Device Dimensions
: 18 x 10 x 6 cm
Oxygen Concentration
: %50 - %100
Manometer Accuracy
: ±3cmH2O below 15cmH2O
±5cmH2O above 15cmH2O
9. Component summary information
Mechanical Ventilator is a pressure-operated device that is categorized as a non-sterile disposable device.
The HME filter included in the device is made of material with a 99.997% retaining property
The pressure gauge in the device shows the pressure values in 10 units increments (except 40-60 cmH2O).
(Visual.1)
The fixing apparatus FlexiFix® included in the package, which has direct contact with the patient and which
ensures that the Life Control® Mechanical Ventilator device remains on the patient during transportation, is
made of adhesive medical foam material.
The length of the catheter mount included in the package is 15 cm.
The length of the oxygen hose included in the package is 3 m.
10. Manufacturer information
TMT TIBBİ MEDİKAL MALZ. SAN. TİC. AŞ.
Fatih Mah.1188 Sok.No14 PK 35414 Sarnıç, Gaziemir – İzmir / Türkiye (Tel: + 90 232 278 15 93;
Fax: + 90 232 279 32 08)
Warehouse Address:
Fatih Mah. 1188 Sok. No: 12/A PK:35414 Sarnıç, Gaziemir – İzmir / Türkiye
Emergo Europe:
Prinsessegracht 20, 2514 AP The Hague, The Netherlands.
Devices belonging to the Life Control®brand are not manufactured from human blood or human plasma using human or animal
tissue cells.
Devices belonging to the Life Control® brand do not contain phthalates.
Devices belonging to the Life Control®brand are drug-free and not supplied with the drug.
Devices belonging to the Life Control® brand are not manufactured from substances in the carcinogenic, mutagenic or toxic
(CMR) category.
IPX4
IPX4 is the International Protection code, which shows that the device is protected from splashing water
from any angle. The device protection code of the Life Control® Mechanical Ventilator device according
to ISO 60529 standard is IPX4.
Consult instructions
for use
Keep dry
Do not re-use
Humidity limitation
Electronic instruction for
use (eIFU)
Keep away from
sunlight
Use-by date
Temperature limit
Batch code
Non-sterile
Serial Number
Do not use if
package is damaged
Does not contain DEHP.