HOME CARE

HOSPITAL

LM Flow / LM Flow 100

Instructions for Use and Technical
Description

HUMID BM / BH
High-flow device with heatable
humidifier

HOSPITAL HOME CARE DIAGNOSTICS

1
Table of Contents

Table of Contents .............................................................................02

Symbols ...............................................................................................03
Warnings .............................................................................................03
Foreword ...........................................................................................06
Intended use ...................................................................................06
Device description ...........................................................................06
System preparation .........................................................................07
Notes to the reader / Warnings ..................................................10
Control panel.....................................................................................12
Use ........................................................................................................14
Alarms ..................................................................................................19
Cleaning and maintenance...........................................................22
LM Flow disinfection instructions ..............................................23
Service and repair ...........................................................................24
Troubleshooting ...............................................................................25
Technical data ...................................................................................26
Electrical block diagram ...............................................................28
Flow Block Diagram .......................................................................28
Packing list .........................................................................................29
Appendix A Electromagnetic Compatibility ...........................29
Appendix B Order numbers .........................................................34

02
 Symbols

Degrees Celsius Litre per minute

°C L/min
Protection class II against electric shock Protection class against vertical
IPX1 water drips (dripping water)

Alarm condition Electrical level of protection, BF

Acoustic alarm switched OFF Serial number

According to RoHS Pay attention to the User Manual

According to EC directive 93/42 / EEC Pay attentiion to the safety

information

Menu open; parameter changes

Caution – hot surfaces
possible

Menu blocked; Parameter-

Heated tube
changes not possible

Warnings
• Before using this high-flow physician with recommendations
device, please read this user in the user manual.
manual carefully.
• This high-flow device may only
• Do not use this high-flow device be used with humidifiers, heated
for life support. breathing tubes, nasal cannulas
and other accessories approved
• The high-flow device generates by Löwenstein Medical. The use
a positive airway pressure during of unapproved accessories can
operation. If the high-flow shows impair the functionality of the
side effects in patients, please high-flow device or cause danger.
discontinue therapy immediately
and call a physician. • In the event of a power failure or
malfunction of the high-flow de-
• This high-flow device may only vice, remove the nasal cannulas
be used and adjusted on the and shut off the oxygen supply.
instructions of a physician.
• To ensure electromagnetic
• Do not replace the advice of the compatibility, this high-flow

03
 device must be installed, tested damage, liquid has penetrated
and used in accordance with the the high-flow device, the therapy
provisions in the accompanying gas is too hot, or if unusual nois-
documents. es can be heard.
• Portable and mobile RF commu- • If the high-flow device is used in
nications equipment can impair accordance with the specified
the electromagnetic compatibility ambient and humidity conditions,
of this high-flow device. Should the therapy gas temperature is
this happen, please contact below 43°C.
Löwenstein Medical to resolve
• The temperature and humidity of
the problem.
the therapy gas will be affected if
• This high-flow device can only be the high-flow device is operated
connected with the power cords outside of the specified ambi-
specified in this document. The ent temperature and humidity
use of unapproved accessories conditions.
and power cords to connect
• If the high-flow device is used
the high-flow device can lead
outside the specified environ-
to increased electromagnetic
mental conditions (temperature,
emissions or reduce immunity to
humidity, etc.), the performance
electromagnetic radiation.
of the high-flow device may be
• Do not place this high-flow device affected.
near other devices.
• The AC input voltage should be
If this high-flow device is to be
within ± 10% of the rated voltage.
installed in the vicinity of other
AC input voltages outside of this
devices, inspections and obser-
range can damage the high-flow
vations must be made to ensure
device.
that this high-flow device can
function normally in such a loca- • The high-flow device can be
tion. The high-flow device should disturbed if it is operated in the
be placed in a well-ventilated vicinity of electrocautery, elec-
area and not on a soft surface. trosurgery, defibrillation, X-rays
(y-rays), infrared radiation and
• Do not use the high-flow device
transient electromagnetic fields
if it is surrounded by flammable
including magnetic resonance
and / or narcotic gases.
(MRI) and radio interference.
• Do not continue to use the high-
• If the high-flow device is blocked
flow device if there is obvious
by closing the therapy tube or the

04
 air inlet, the high-flow device may
overheat or be damaged.
• If the high-flow device is connect-
ed to oxygen and the therapy
tube is blocked, this can lead to
an increased oxygen concentra-
tion.
• The ventilation openings are in
the bottom of the humidification
chamber. To avoid burns, do not
touch the underside when moving
the device.
• Do not carry the high-flow device
during operation, do not turn it
upside down or tilt it when there
is water in the water chamber.
This will prevent water from flow-
ing back into the high-flow device
and damaging it.
• When the high-flow device is not
in use, remove the plug from the
socket.
• Do not open the inside of the
high-flow device. Repairs may
only be carried out by authorised
maintenance personnel.
• For proper disposal of the
high-flow device, please contact
Löwenstein Medical.
• Note: Above are general warn-
ings and precautions. Refer
to this User Manual for more
detailed warnings, notes to the
reader, and remarks.

05
 Foreword
The high-flow devices of the LM Flow series are heatable high-flow devic-
es with an integrated respiratory humidifier. In order to use this high-flow
device safely and effectively, please read this user manual carefully before
use.

Intended use
This high-flow device is suitable for patients with spontaneous breathing.
For treatment, heated and humidified breathing gas with a specific flow is
provided. This high-flow device is suitable for humidification treatment and
oxygen therapy via nasal cannula, endotracheal intubation and tracheos-
tomy. This product is not for life support.

Device description

Device components
 he LM Flow series high-flow devices consist of the following
T
components:

Components and functions

LCD display Reference point of the
target dew point
Breathing gas temperature Power connection Data port
outlet

Oxygen inlet
cover Low pressure
LM Flow Air inlet
filter
Encoder
Buttons Water chamber
06
 O2 control module

LM Flow 100
Oxygen inlet, Low-/ High
pressure

LCD display Parameter display, parameter setting (only LMFlow100)

Buttons / encoders Start/stop, parameter setting

Oxygen inlet Connection to an external oxygen source

Power connection Connection to the power supply

Cover, air inlet, filter Inlet and filtering of the therapy air

Extends the functions of the device; please contact Löwen-

Data port
stein Medical for details

Breathing gas outlet Connection to the heated therapy tube

Water chamber Water supply and heating

Reference point of the

Reference point of the target dew point temperature
target dew point temperature

O2-control module Auto FiO2 control

Warning: Only connect storage media approved by Löwenstein Medical

to the data port.

System preparation

Warning: If the water chamber and heated therapy tube are not properly
installed, please do not start the high-flow device. To avoid burns, do not
touch the underside of the water chamber.

07
Installation LM Flow

Connect the nozzle To insert the water Connect the water bag
fitting to the water chamber, press the / water bottle (only
chamber. lock with the bottom when using the auto-fill
of the water chamber water chamber).
and slide the water
chamber onto the
heating plate until the
lock engages.

Check the water level Connect the heated

in the water chamber. tube system.

Connect the oxygen Connect the oxygen Connect

source to the oxygen source to the high-flow the LM flow to power.
tank (not necessary if device (not necessary
no additional oxygen is if no additional oxygen
required). is required).

08
 Installation LM Flow 100

Connect the nozzle To insert the water Connect the water bag
fitting to the water chamber, press the / water bottle.
chamber. lock with the bottom
of the water chamber
and slide the water
chamber onto the
heating plate until the
lock engages.

Check the water level Connect the heated

in the water chamber. tube system.

Connect Connect
the oxygen source the LM flow 100 to
(not necessary if no power.
additional oxygen is
required).

09
 Notes to the reader / Warnings

→ Home care water chamber

 hen using the Home care water chamber, fill clean water or medical
W
sterile water (e.g. ALLEGRA sterile water) into the water chamber. By
heating the water to 100°C before use, you reduce limescale deposits
in the water chamber. Do not fill the water chamber above the mark for
the maximum water level.
Note to the reader: The water chamber is heated during operation.

Please avoid touching the metal base of the water chamber and the
heating plate of the high-flow device.

→ Clinic water chamber (Auto-Fill)

When using the Clinic AutoFill water chamber, hang a sterile water
bag in a high position. Insert the inlet needle into the rubber stopper of
the water bag and open the ventilation opening of the bag. The Clinic
AutoFill water chamber is automatically filled with water to the intended
level.
Please use sterilised water suitable for medical purposes and not more
than 2000 ml.
After connecting the water bag, check that the water flows into the
Clinic AutoFill water chamber and is below the marking line. Replace
the clinic AutoFill water chamber in the event of problems.
Make sure that water does not leak from the Clinic AutoFill water
chamber and water bag during use. Otherwise the Clinic AutoFill water
chamber will run dry and impair the humidification effect.
To avoid damage to the Clinic AutoFill water chamber, avoid running
empty.

→ Therapy tube
Check the therapy tube and nasal cannula before connecting them and

replace them if a breakage or other damage is visible.
Do not expose uncovered skin to the heated therapy tube for a long
time to avoid skin irritation caused by the heat.
Do not run the therapy tube near a heat source (e.g. heater). Do not
cover large areas of the therapy tube. Otherwise the temperature may
rise.

10
 To avoid interference, the therapy tube should be kept away from all
objects with electronic radiation and from electrical wires and conduc-
tors.
→ Connecting the oxygen source
LM Flow (Fig.III a)
The LM Flow high-flow device can be con-
nected to a low-pressure oxygen source
(e.g. oxygen concentrator). To do this, plug
the oxygen supply hose onto the oxygen
connector on the high-flow device (see
Figure IIIa).
III a) Oxygen connection
LM Flow 100 (Fig.III b) (Low pressure)

The LM Flow 100 high-flow device can be

connected to both a low-pressure oxygen
source (e.g. oxygen concentrator) and a
high-pressure oxygen source.
For connection to a low-pressure oxygen
source, please proceed as described under
LM Flow and Figure IIIa.
To connect to a high-pressure oxygen
source, screw the connecting nut of the
oxygen supply hose onto the thread of the III b) Oxygen connection
oxygen connection of the high-flow device (Low pressure)
(see Fig. IIIb) and tighten the connecting nut Oxygen connection
firmly (hand-tight). (High pressure)

→ How to connect to the power supply

 onnect the power cord to the power connector on the back of the
C
high-flow device and insert the power plug into the socket. The high-
flow device screen will light up indicating that the high-flow device is
being properly supplied with power.

11
 Control panel
The control panel consists of buttons and an LCD display.

LCD display

Start/stop button

Mute button
→ Buttons Encoder
Menu button

• Press this button in standby mode to start therapy. Press this

Start/Stop
button during the therapy to end therapy.

Mute • Press this button to enable or disable the acoustic alarm.

• Press this button to enter the setup menu or to exit and confirm the
Menu set menu parameters.

• The encoder has three basic functions: confirm (press), turn left,
turn right.

• In the setup menu, press the encoder to select or exit the displayed
Encoder function.
By turning left or right you select the different functions and can
then change the values or data. The data or values are applied by
pressing the encoder again.

→ LCD display
* The LCD display can be operated in Monitoring mode or Setup Menu
Mode.
* Monitoring mode : Displays the operating mode and monitors the oxy-
gen concentration, flow rate and temperature.

* Ifdevice
no input is made for approx. 5 minutes during therapy, the high-flow
darkens the LCD display. When you press any button, the LCD
display lights up again.

12
Operating status of the high- Display of the oxygen
flow device, prompts, alarm 55 concentration
information Standby %
Concentration

LM Flow
Setting the flow value
30 °C Set value of the dew
L/min Temp point temperature
Flow

Operating status of Working time Prompts,

the high-flow device Standby alarm information

LM Flow 100
Setting the flow value
30 55 °C Set value of the
L/min %
Concentration
Temp dew point
Flow temperature
Display of the oxygen
concentration

* Setup menu: Mode setting, Alarm setting, System configuration

13
 Use

→ How to connect the high-flow device

Connect the high-flow device to the mains.
→ Set parameters
Do not change the parameters without the doctor's instruction and
supervision. You can skip this chapter if the high-flow device is to
continue to operate with the last settings.
You cannot change the parameters if is displayed in the upper right
corner of the settings interface.
Only if is displayed, can you change the parameters and make
changes to the system configuration.

Parameter setting LM Flow

Press the menu button to select Set the parameters with the
the flow and temperature via the encoder.
encoder.

Set the desired oxygen concen- Press the Start/Stop button for 3
tration at the oxygen source. (Not seconds to start therapy.
applicable if no additional oxygen
is required)

Adjust the nasal cannula.

14
Parameter setting LM Flow 100

Select the parameters using the Set the required parameters(O2,

touchscreen. flow, temperature) using the
touchscreen / encoder.

Press the Start/Stop button for 3 Adjust the nasal cannula.

seconds to start therapy.

End of therapy

LM Flow: LM Flow 100:

Disconnect/shut off the Disconnect/shut off the
oxygen source. oxygen source.

Press the Start/Stop button Remove the tube system and disconnect the power.
for 3 seconds to end the
therapy and start or end
the drying mode.

15
Operating mode:
Parameter settings mode
Children • Flow: 2-25 L/min;
• Temperature: 34 °C
• O2: 21-100%

Adults • Flow: 10-80 L/min

• Temperature : 31 °C, 34°C, 37°C
• O2: 21-100%

Alarm settings:
Alarm Parameter settings Default value

O2 too high! OFF, 30% - 100% 90%

O2 too low! OFF, 21% - 25% 21%

System alarm! OFF, ON OFF

System blocked!! OFF, ON OFF

Reset alarms Resets the default values of the alarm

parameters

System configuration:

Clinical menu OFF: High-flow device can only be switched

ON and OFF. All other settings are blocked
On: All settings can be changed.

Language German/English

16
 Caution:
If the high-flow device sends an alarm because the set flow value is
not reached, this may be because the nasal cannula model is not suit-
able. In this case, it must be replaced with a larger nasal cannula. It is
recommended that the NAS-1 S model be used when the flow is less
than 50 L / min or the NAC-1 M model when the flow is less than 60 L /
min.
Do not set the parameters without the instruction of your attending
physician and use this high-flow device only under the supervision of a
physician.
Incorrect alarm threshold settings can lead to false alarms.
→ Preheating
Press the Start/Stop button for 3 seconds to start the high-flow device.
The screen shows “Preheating” and the high-flow device begins to
warm up. Immediately afterwards
the displayed flow and dew point
values increase. When the set
values are reached, the display Preheating Active
value remains unchanged.
The word "Active" then appears
after warm up.
Warning:
Make sure that the high-flow device is already started when you con-
nect oxygen.
Oxygen may only be connected to the oxygen inlet of the high-flow
device itself. Make sure that the oxygen hose, air inlet cover, filter,
and power plug are properly installed. Before ending the therapy, first
shut off the oxygen source, then disconnect the oxygen hose and only
switch the high-flow device to standby mode when the oxygen con-
centration in the high-flow device has returned to the ambient level
(21 vol%).
When the high-flow device is not in use, make sure that the oxygen
source is shut off to prevent oxygen accumulation in the device.
To avoid the risk of fire, special precautions must be taken during oxy-
gen therapy. The high-flow device must not be located near sources of
fire or smoke.
The high-flow device should be installed in a well-ventilated place.
For safety reasons all ignition materials should be kept away from
oxygen and should not be stored in the same room with oxygen. “No
17
 smoking, no fire”, signs should be visibly hung.
Near medical oxygen equipment and accessories avoid sparks gener-
ated by static electricity (through friction).
→ Adjust the oxygen flow

Adjust the flow of the oxygen source and ensure that the oxygen
concentration shown on the display of the high-flow device corresponds
to the required values. The FiO2 can be controlled automatically when
using the LM Flow 100.
The oxygen concentration must be within the preset range of the alarm
parameters for the oxygen concentration, otherwise an alarm will
sound.
Note to the reader:
The gas inhaled by the patient may be below the monitored value due
to dilution by air.
→ Use
Put on the nasal cannula correctly and start the treatment.
If the external power supply is interrupted during treatment, an alarm
sounds (press the mute button to switch off the alarm). In this case, the
user must immediately shut off the oxygen source, remove the nasal
cannula, check the power supply, and do not continue to use the high-
flow device until the fault has been rectified.

→ Transport-Mode
Press and hold the mute button for 3 seconds in standby, warm up or
active mode so that the high-flow device switches to transport mode
and the hoses and water chamber are no longer in warm up mode. The
high-flow device switches back to warm up mode 20 minutes later. The
device flow remains unchanged during transport mode.
→ End of therapy
When you end therapy with the high-flow device, remove the nasal can-
nula, shut off the oxygen source first, then disconnect the oxygen hose
from the high-flow device. Press the Start/Stop button for 3 seconds.
The high-flow unit then switches to the drying mode, in which the hoses
are dried. The drying mode runs for 99 minutes. The high-flow device
then switches to standby mode. If the drying mode is to be switched off
earlier, press the Start/Stop button for at least 3 seconds.
18
 Warning:
If drying phases are too short, the tubes can be dam-
aged by the remaining moisture, which can prevent
reuse. 99
Caution: Close oxygen
At the end of the therapy, the oxygen must always
be switched off in order to avoid an accumulation of
oxygen in the high-flow device.
Warning:
99
To avoid possible damage to health, do not wear a Drying Tube
nasal cannula during the drying mode.

Alarms
The high-flow devices of the LM Flow series are
equipped with visual and acoustic alarm signals. The
visual alarm signal appears if an alarm is triggered
while using the high-flow device. The causes of alarm
signals should be eliminated as soon as possible in
order to avoid risks. !! Error !

The visual alarm signal is shown in the figure on the

right. The alarm type is explained under the symbol.
The mute button can mute the acoustic alarm for 2
minutes.
The acoustic alarm is reactivated by pressing the mute !! Error !
button again.

19
The following alarms are arranged according to internal priority:

Alarm Problem description Modus operandi

Internal alarm Problem description Turn off and turn on again. If

After commissioning, an error alarm this does not solve the problem,
displays errors in internal parts such please contact Löwenstein
as the engine, and after 5 seconds Medical.
an acoustic alarm sounds.

Check tube The alarm appears if the high-flow

device does not detect a heatable Make sure the respiratory tube
respiratory tube after starting thera- is not damaged and has been
py. An acoustic alarm tone sounds connected properly. If this does
after 5 seconds. not solve the problem, replace
the tube.

Check for leakage If the high-flow device detects a Verify that the water chamber
leak, a leak alarm is displayed and is installed. Check whether
an acoustic alarm tone sounds after the therapy tube is intact and
5 seconds. properly connected.

System blocked If the device detects a blockage, an Check to see if the water cham-
alarm is displayed and after 10 sec- ber, therapy tube, or nasal can-
onds an acoustic alarm tone sounds. nula are blocked. Check whether
the air inlet of the device or the
filter are clogged.

Oxygen too low If it is detected that the oxygen con- Check that the device's oxygen
centration is below the limit value, an inlet is properly connected to the
alarm is displayed and an acoustic oxygen source. Adjust the flow
alarm tone sounds after 20s. The of the oxygen source as needed.
alarm setting range of the low FiO2
is between 21 to 25 vol% and OFF
(setting levels: 1 vol%). The default
setting is 21 vol%.

If it is recognised that the oxygen Adjust the flow of the oxygen

Oxygen too high concentration has exceeded the limit source as needed.
value of the high FiO2 alarm, an
alarm is displayed and an acoustic
alarm sounds after 20s. The range is
adjustable from 30 to 100 vol% and
OFF. The default setting is 100vol%
(setting levels: 1vol%).

Target flow If the high-flow device does not reach Check whether the water cham-
the preset flow within 10 minutes ber, the therapy tube
(± 1 minute), an alarm is displayed. or the nasal cannula are
In addition, an acoustic alarm tone clogged. Check if the fan air
sounds. inlet cover or filter are clogged.

20
 Check if the preset flow value is
too high.

Check water level If there is not enough water in the Check whether the water in the
water chamber, an alarm is displayed water chamber has evaporated
and an acoustic alarm tone sounds and the chamber has been
after 20 minutes for a flow> 20l / min damaged as a result. Make
or after 40 min for a flow <20l / min. sure there is always water in the
water chamber.

Target temperature If the device does not reach the Decrease the flow value or the
preset temperature within 30 minutes target temperature if the flow
(± 3 minutes), an alarm is displayed. of the device is too high and /
In addition, an acoustic alarm tone or the ambient temperature is
sounds. too low.

Check system If the ambient temperature is outside Do not use the device if the
the range of 16-30°C when the de- ambient temperature is not in the
vice is started, an alarm is displayed range of 16-30°C, as the preset
to check temperature will probably not be
the operating condition. In addition, reached. A sudden change in
an acoustic alarm tone sounds after ambient conditions can trigger
60s (± 6s). an alarm. Start the device at
ambient temperature and let it
run for 30 minutes. Then restart
the device.

Power failure In the operating status, after the Check that the power supply is
failure of the external power supply, properly connected and working.
an acoustic alarm tone sounds after
1s and lasts longer than 120s.

The selected alarm settings remain saved in the device, even when it is
switched off. After switching on the device, check whether the alarm sys-
tem is working properly: Remove the heatable therapy tube. You should
now see the “Check tube” alarm on the display and hear an alarm tone.
Otherwise, stop using the device and contact Löwenstein Medical.

21
 Cleaning and maintenance

The high-flow devices of the LM Flow series humidify the respiratory ther-
apy gas with water vapor. If the regular cleaning, disinfection and replace-
ment of parts are not carried out in accordance with these instructions,
there is a risk that bacteria will settle on and in the high-flow device, which
can infect the patient. The high-flow device must therefore be cleaned
thoroughly before and after each use. It must be cleaned and disinfected
when used on multiple patients.
→ Cleaning
Daily cleaning: Hoses, nasal cannula, water chamber. Connect the en-
tire tube system with nasal cannula and activate the drying mode. Once
dry, remove the water chamber and rinse with clean water.
Warning:
The water chamber and the therapy tube must not be cleaned with
cleaning agents. Use a clean, lint-free, disposable cloth (moistened
with a neutral detergent) to wipe the connector between the auto-fill
water chamber and the high-flow device.
Also check that all impurities have been removed.
The power supply of the high-flow device must be disconnected before
cleaning. Do not place the device in liquids.

22
 LM Flow disinfection instructions

Installation


Press the Start/Stop button for 3 seconds to
end the therapy and start or end the drying
mode. Remove the tube system and disconnect
the device from the power source.

Remove the tube system with the water cham-

ber and insert the filter and the green cap as
shown in the figure.

Connect the red hose to the breathing gas
outlet and the ozone disinfection device to the
open connection.

Press the ozone disinfection device button to

start disinfection. The disinfection ends auto-
matically after 35 minutes.

 
To complete disinfection, remove the filter and
disconnect the therapy tube and the ozone
disinfection device from the high-flow device.
Do not use the device for at least one hour after
disinfection.

23
 Warning:

Disconnect the oxygen supply from the high-flow device during the
disinfection process.
Before connecting the ozone disinfection device, the high-flow device
must be disconnected from the mains. When the ozone disinfection de-
vice is in operation, no one should be in the same room for a long time.

→ Replacement of the accessories

In clinical use:
Replace the nasal cannula, the heated therapy tube and the autofill wa-
ter chamber every 2 weeks or whenever you change patients. Replace
the air inlet filter every 2 months or after 1000 hours of operation.
In non-clinical use:
Replace the nasal cannula, the heated therapy tube and the autofill
water chamber every 8 weeks or whenever you change patients. The
home care water chamber can be reused for up to one year. Before
each use, however, check whether damage and / or leaks are visible
and replace the water chamber in the event of damage or after 1 year
at the latest. Replace the air inlet filter every 2 months or after 1000
hours of operation.

Service and repair

• If the high-flow device fails, contact Löwenstein Medical.

• To ensure long-term use of the high-flow device, the user must follow its
safety, cleaning and disinfection guidelines.
• For proper disposal of the high-flow device, please contact Löwenstein
Medical.
• The service life of the high-flow device is 10 years.
• See the label for production date information.
• For more about the guarantee: see the guarantee card.

24
 Troubleshooting

Error Root cause analysis Troubleshooting

Insufficient flow • Air inlet filter or outlet port blocked. • Replace the air inlet filter,
• Respiratory tube leaking or damaged. clear the outlet opening from
• Water chamber not installed or the blockage.
damaged. • Replace the nasal cannula or
• Respiratory tube connection the respiratory tube.
defective. • Wear the nasal cannula ac-
• Tube used not compatible. cording to the manufacturer's
instructions.
• Check that the connection is
correct and reliable.
• Only use devices recom-
mended and provided by
Löwenstein Medical.
• Contact Löwenstein Medical.

Excessive noise • Incorrect installation. • Check that the hoses are

properly connected
• Check whether the respiratory
tube is leaking.
• Check that the connection
between the water chamber
and the high-flow device is
working correctly.
• Contact Löwenstein Medical.

Internal error or • Tubes not or incorrectly connected. • Check that the connection
device does not • Nasal cannula or respiratory tube between the high-flow device
work leaking. and the power supply is
• The motor of the high-flow device correct.
has failed or there is another internal • Contact Löwenstein Medical.
technical problem.

Dry and / or irritated • Inflammation • If necessary, adjust the tem-

upper and / or lower • Dry air perature setting to your needs
airways or consult a physician.
• Check the water level in the
water chamber.

Redness or • Headband too tight. • Loosen the headband.

inflammation in the • The nasal cannula model is not • Consult a physician if
contact area of the suitable for the patient. necessary.
nasal cannula • The patient is allergic to the material
of the nasal cannula model.

25
Water in the • The high-flow device has fallen into • End the therapy immediately
high-flow device water or water has penetrated the and contact Löwenstein
interior of the high-flow device. Medical to have the high-flow
device repaired

Technical data

Target condensation temperature 31°C, 34°C, 37°C

Flow 10-80 L/min, (Mode: adults), 31°C, 34°C, 37°C

2-25 L/min, (Mode: children), 34°C

Max. oxygen supply 80L/min

Noise level <20dBA at 10 L/min

Dimensions 300x197x165mm (LM Flow)

358x197x165mm (LM Flow 100)

Weight 2.0Kg(LM Flow), 2.5Kg(LM Flow 100)

High-flow device outlet > 33 mg/L (2-60L/min, 37°C)

> 10 mg/L (2~80L/min, 34°C)
> 10 mg/L (2~60L/min, 31°C)

Maximum temperature of the trans- 43°C

ported gas

Preheating time 10 minutes to 31°C, 30 minutes to 37°C,

(Auto-Fill-water chamber (clinic), flow 35 L/min,
Initial temperature 23±2°C)

Max. capacity of the water chamber ≤ 90ml Auto-Fill-water chamber (clinic)

≤ 500ml Home care water chamber

Noise level of the 45dB (A) ( 1 m distance)

acoustic alarm

Power supply 220VAC±22V, 50Hz±1 Hz

Fuse F1 : 0451 005.(5N125V fast fracture) LAC1,

LAC2: MEF F3.15A250V

26
Oxygen measuring range 21%-100%, with an accuracy of ±3%

Classification Product class according to EC Directive 93/42/

EEC: lla; device class Type II BF Model Pro-
tection against water IPX1 Dripping water
Operating mode: continuous operation. Do not use the
device in an environment with air, oxygen or nitrous oxide,
or other gases mixed with flammable anaesthetic gases.
Air pressure: 700 - 1060 kPa.
Operating temperature: 16°C - 28°C

Operating humidity: 10 - 95%, without condensation

Environmental conditions Temperature during storage and transport: -20°C - 60°C
Humidity during storage and transport: 10 - 95% without
condensation

27
 Electrical block diagram

Control panel
(displays and buttons)

220 L
Detection of
Power supply Main control panel flow and
Switch on/OFF
oxygen concentration

220 N

Ventilator

Flow Block Diagram

Fresh air/medical oxygen

Inlet filtration Ventilator

User

High-flow device

Therapy Detection of the

Nasal cannula Water chamber
tube oxygen concentration

28
 Packing list

Item Description Units Quantity

01 High-flow device Piece 1

02 Water chamber Set 1

03 Heatable therapy tube Piece 1

04 Nasal cannula Piece 1

05 Power cord Piece 1

06 Oxygen hose set (optional) Set 1

07 Oxygen hose Piece 1

08 Mounting screw (optional) Piece 3

09 filter Piece 5

10 Guarantee card Piece 1

11 Quality card Set 1

12 Operating Instructions Piece 1

13 User manual Piece 1

14 Carrier bag Piece 1

15 Device stand (optional) Set 1

Appendix A Electromagnetic Compatibility

Guidelines and manufacturer's declaration on electromagnetic emissions:

The high-flow device is intended for use in the electromagnetic environ-
ment described below. The buyer and the user should ensure that the
high-flow device is in the electromagnetic environment described.

29
 lmmunity test Conformity Electromagnetic
environment - guidelines

RF emission Group I The high-flow device used

GB 4824 RF energy only for its internal function.
Therefore, the high-flow device has very low
RF emission Type B RF emissions and other electronic devices in
GB 4824 the vicinity are very unlikely to be disturbed.

Harmonious emission Type A The high-flow device is suitable for use in all
facilities, including in residential buildings with
Flow variation / a direct connection to a public low-voltage
Flash emission GB17625.2 OK network for residential buildings.

Guidelines and manufacturer's declaration on electromagnetic emissions:

The high-flow device is intended for use in the electromagnetic environ-
ment described below. The buyer and the user should ensure that the
high-flow device is in such an electromagnetic environment.

lmmunity test IEC60601 Compliance level Electromagnetic Envi-

Test level ronment - Guidelines

Electrostatic dis- ±6kV contact ±6kV contact discharge The floor should be
charge GB/T17626.2 discharge ±8kV ±8kV air discharge made of wood, concrete
air discharge or ceramic tiles. If the
floor is covered with
synthetic material, the
relative humidity should
be at least 30%

Fast electrical tran- ±2kV for power ±2kV to power line The power supply should
sient disturbances line be suitable for use in
GB/T17626 ±1 kV for inlet / Not applicable typical business or hos-
outlet line pital environments.

Overvoltage ±1 kV, ±1 kV conductor to The power supply should

GB/T17626.5 conductor to conductor be suitable for use in
conductor typical business or hos-
±2kV, conduc- Not applicable pital environments.
tor to ground

30
 Voltage dips, short <5% of the <5% of the mains The power supply of
interruptions and mains voltage voltage, the networks should
voltage fluctuations Lasts 0.5 Lasts 0.5 cycle 40% of be suitable for use in
GB/T17626.11 cycles at 40% the mains voltage typical business or
of the mains Lasts 5 cycles 70% of hospital environments. It
voltage. Lasts the mains voltage is recommended to use
5 cycles at Lasts 25 cycles <5% of an uninterruptible power
70% of the the mains voltage supply or batteries if the
mains voltage Lasts 5S cycles user requires continuous
and voltage operation of the high-
fluctuations flow device during a
Lasts 25 cycles power interruption.
<5% Ute
Lasts 5S
cycles

GB/T17626.8 3A/m 3A/m The power frequency

magnetic field should
exhibit typical charac-
teristics of the power
frequency magnetic field
in a typical business or
hospital environment..
Note to the reader: Ute refers to the mains voltage before the test voltage is applied.

Guidelines and manufacturer's declaration on electromagnetic emissions:

The high-flow device is intended for use in the electromagnetic environ-
ment specified below. The buyer and user should ensure that it is used in
such an electromagnetic environment.

lmmunity test IEC60601 Compliance Electromagnetic

Test level level Environment - Guidelines

RF line 3V (effective 3V The distance for the use

GB/T17626.6 value) 150kHz-80MHz of portable and mobile RF
150kHz-80M Hz communications equipment
should be no less than the
recommended distance from
any part of the high-flow device,
including power cords. This
distance should be calculated
using the following formula: d =
1.2 P, which corresponds to the
transmitter frequency.

RF line 3V/m 3V/m d=1.2 80MHz-800MHz d=1.2

GB/T17626.3 80MHz-2.5GHz 80MHz-2.5GHz 800MHz-2.5GHz

31
RF line
GB/T17626.3: 3V/m
80MHz-2.5GHz: 3V/m
80MHz-800MHz: d= 1.2P
80MHz-2.5GHz: d= 1.2 P
With the following meaning:
P - the maximum output power of the transmitter specified by the manu-
facturer, unit: W;
d - recommended distance, unit: m;
The field strength of fixed RF transmitters must be determined by measur-
ing "a" of the electromagnetic field and should be lower than the compli-
ance level for each frequency range. Interference may occur in the vicinity
of equipment marked with the following symbol.
Note 1: For the frequencies 80 MHz and 800 MHz, the formula of the
higher frequency band is used.
Note 2: These guidelines do not apply in all cases. Electromagnetic prop-
agation is adversely affected by absorption and reflection from buildings,
objects and human bodies.
(a) For fixed transmitters, such as base stations of mobile phones (cellu-
lar/cordless phones) and ground mobile radio, amateur radio, AM and FM
radio and television broadcasting, the field strength can theoretically not
be predicted accurately. In order to correctly assess the electromagnetic
environment of fixed RF transmitters, the measurement of the electro-
magnetic field should be considered. If the measured field strength of the
high-flow device is greater than the RF compliance level specified above,
the therapeutic device should be observed to verify normal operation. If
normal operation is not possible, additional measures may be required,
e.g. readjusting the direction or location of the high-flow device.
(b) Within the entire frequency range from 150 kHz to 80 MHz, the field
strengths should be less than 3 V/ m 1 .
Recommended distance between portable and mobile RF communica-
tions equipment and high-flow equipment:
The high-flow device is intended for use in an electromagnetic environ-
ment with controlled radio frequency interference. Depending on the
maximum output power rating of communications equipment, the buyer
or user can help prevent electromagnetic interference by maintaining the

32
following minimum recommended distance between portable and mobile
RF communications equipment (transmitters) and the high-flow device.

Distance of the transmission frequency in meters (m)

Max. output power
in Watt (W) 150kHz-80MHz 80 MHz-800MHz 80MHz-2.5GHz
d = 1.2 d = 1.2 d = 2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.79 3.79 7.27

100 12 12 23

For the maximum output power of transmitters not listed in the table
above, the recommended distance d in meters (m) can be determined us-
ing the formula in the corresponding column for the transmitter frequency.
Thereby, P is the maximum output power in watts (w) of the transmitter as
specified by the manufacturer.
Note 1: For the frequencies 80 MHz and 800 MHz, the formula of the
higher frequency band is used.
Note 2: These guidelines do not apply in all cases. Electromagnetic prop-
agation is adversely affected by absorption and reflection from buildings,
objects and human bodies.

33
Appendix B Order numbers

Figure Name Item no.

LM Flow 302010004

LM Flow 100 302010003

lmhfc2001
lmhfc2002
Löwenstein Medical lmhfc2003
high-flow Cannulas lmhfc2004
lmhfc2005
lmhfc2006

Tracheostoma 303030007
Adapter

Disinfection device 303030010

Disinfection kit 303030011

34
Heated therapy tube 313030017

Set of heated therapy

tube & Autofill water 303030017
chamber

Home care water 303040002

chamber

Handle water 501010141

chamber

Air inlet filter 5011500017

(5 pieces per pack)

Trolley 402300020

LM Flow / LM Flow
100 Instructions for gba10440de2005
use and technical
description
35
 Prolinx GmbH
EC REP
Brehmstr.56, 40239 Düsseldorf Germany
T: +49-2131 4051968-0

Shenyang RMS Medical Tech Co.,Ltd

No. 21, Gaoke Road, Hunnan New District, Shenyang, China

Import and Distribution: Löwenstein Medical

Arzbacher Straße 80, 56130 Bad Ems, Deutschland
T: +49 2603 9600-0 - F: +49 2603 9600-50
info@hul.de - www.hul.de

36