Laerdal Suction Unit - Lagaay International

LSU
Laerdal Suction Unit
Cat. No. 78 00 00 - Reusable
Cat. No. 78 00 30 - Serres
Directions for Use
4
2 Intended Use
4
3 User Interface
–– 3.1 Operating Knob 5
7 Device Test
18
–– 7.1 Setup 18
–– 7.2 Run the Test
19
–– 7.3 Evaluation of Device Test Results 20
8Servicing
21
–– 3.2 Indicators 5
9 Troubleshooting21
–– 3.3 TEST-Button 6
–– 3.4 Power Sources 6
–– 3.5 Automatic Power-save Function 6
10 Accessories and Parts
4 LSU Reusable Canister System
–– 4.1 Overview 11 Specifications24
7
–– 11.1 Classification24
–– 4.2 Parts7
–– 4.3 Use 8
–– 4.4 Quick Reference
22
11
–– 11.2 General Tolerance
24
–– 11.3 Physical Characteristics
24
–– 11.4 Operation24
–– 4.5 After Use 11
–– 4.6 Decontamination of Laerdal Reusable
Canister11
–– 11.5 Power Requirements
24
–– 11.6 Enviromental Conditions
25
–– 11.7 Material Chart
25
–– 11.8 Symbols26
5 Serres Suction Bag System
–– 11.9 EMC Specifications
27
–– 5.1 Overview12
–– 5.2 Parts 12
–– 5.3 Use 13
–– 5.4 Quick Reference 15
12Limited Warranty 28
13 Addresses28
–– 5.5 After Use15
6 Cleaning and Maintenance
–– 6.1 General16
–– 6.2 Clean the Cabinet and parts
16
–– 6.3 Disinfection of reusable parts
16
–– 6.4 Charge the Battery
16
–– 6.5 External Battery Charger
17
–– 6.6 Check the Battery Quality
17
–– 6.7 Replace the Battery
17
–– 6.8 Fastening the brackets
18
–– 6.9 Release arm for Canister holder 18
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1 Cautions and Warnings
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These Directions for Use covers two
configurations of the Laerdal Suction Unit (LSU):
Reusable, Serres Suction Bag System. Unless
otherwise specified the information in this
Directions for Use applies to both configurations.
Use only accessories supplied by Laerdal Medical
or one of our authorised distributors to ensure
that the LSU operates satisfactorily.
Read these Directions for Use carefully, and
become thoroughly familiar with the operation
and maintenance of the LSU before using it.
• Only use batteries approved by Laerdal
Medical. Other batteries will have problems
related to the battery status indicator of the
LSU, the battery operation time, and safety.
1 Cautions and Warnings
• T
o maintain satisfactory operation of the
battery, it is recommended to place the LSU
on continuous charge when not in use.
Battery
The LSU should only be used by persons trained
in the use of medical suction equipment.
• T
he LSU must be placed on charge for
a minimum of 24 hours to reach full
battery capacity. The fast charging gives
approximately 80% battery capacity after
3 hours (for a new battery). Please note
that repetitive 3 hour charging is not
recommended.
The LSU is not suitable for use in the presence of
flammable liquids or gases; there can be a danger
of explosion or fire.
Do not use the LSU under environmental
conditions that are outside the ranges specified
under section 11.6. This can endanger safety and
adversely affect operation of the device.
• If it is not possible to place the LSU on
continuous charge when not in use, make
sure the battery is charged for a minimum of
24 hours at least once a month.
Do not block the Exhaust Outlet during use.
This will lead to reduced flow and can also cause
damage to the LSU.
• D
o not store the battery when it is
discharged; always fully charge the battery
before storage.
• We recommend charging a spare battery
every 6 months when stored in room
temperature at 25°C (77°F ).
Always use the Reusable version with the filter
and the Float Ball in place.
Overflow of suctioned material can damage the
device. If overflow of liquid from the Canister
into the pump is suspected, the LSU must be
returned for service (see section 8).
2 Intended Use
The LSU is a portable, electrically powered,
medical suction equipment intended for field and
transport use. It is intended for intermittent
operation to remove secretions, blood or vomit
from a patient´s airway to allow ventilation.
Disconnect the LSU from external power prior
to cleaning. Use a minimum of liquid to prevent
any electrical shock hazard.
Higher vacuum levels are generally selected for
oropharyngeal suctioning, and lower vacuum
levels are usually selected for tracheal suctioning
and the suctioning of children and infants.
Do not immerse the LSU or allow it to stand
in water or other liquids. This might damage the
device, and cause electrical hazard.
Do not pump any cleaning solution or other
liquids through the vacuum pump, i.e. through the
Vacuum Connector. This can damage the LSU.
4
continues to lit after three OFF/ON cycles and
after replacing the battery with a fully charged
battery, discontinue use and return the LSU for
service. (See section 8).
3.1 Operating Knob
The Operating Knob is a combined ON/OFF
switch and vacuum selector, located at the
bottom of the User Interface.
3.2.4 Vacuum Indicator
This green LED bargraph displays the
actual vacuum level during operation
of the LSU.
Each fully lit segment represents 50
mmHg. If a segment has a weak light,
this represents 25 mmHg (e.g 125
mmHg means 2 fully lit and 1 weakly
lit segments).
The LSU is switched ON by turning the
Operating Knob to the required setting.
Each setting indicates the maximum achievable
vacuum level for the selected position (80, 120,
200, 350, 500+ mmHg).
The free air flow value changes along with the
increasing vacuum settings (see section 11.4 for
details). The LSU is switched OFF by resetting the
Operating Knob to “0”.
Even if the Operating Knob is in “0” position,
voltage is present on some of the internal
circuitry, when the LSU is connected to mains. To
fully remove power, pull out the Power Cord.
mmHg
kPa
mBar
3.2 Indicators
80
120
200
350
500
11
16
27
47
67
107
160
267
467
667
Pressure conversion chart
3.2.1 Power ON Indicator
3.2.5 Battery Status Indicator
This green LED has 3 modes:
This green LED bargraph has 3 functions:
• It is lit continuously while the LSU
is switched ON.
• Indicates remaining battery capacity
during operation from internal
battery
• It flashes rapidly (approx. twice per second)
during the Device Test.
• Indicates approx. achieved battery
capacity during charging.
• It flashes slowly (approx. once per second)
while the Automatic Power-save Function is
activated, if the Device Test is interrupted or
when the battery is discharged.
• Indicates which test is currently in progress
during device test
During operation from internal battery:
Indicates approx. remaining battery capacity.
During operation from internal battery and
during charging the displayed values must only be
used as indications.
Several parameters can influence them e.g.
device settings, state of battery, temperature etc.
3.2.2. External Power Indicator
This green LED is continuously lit
while external AC or DC power is
connected.
3.2.3 Failure Mode Indicator
The red LED is lit when a possible
malfunction of the LSU has been
detected. If lit, turn the LSU OFF, and then
ON again to check if the indication disappears.
Provided that the indication does not occur
again the LSU can be operated. If the Indicator
Note: Immediately after turning the LSU ON and
immediately after switching from external power
to internal battery operation, all 4 LED’s will
flash for 5 seconds before the remaining battery
capacity is displayed.
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3 User Interface (all configurations)
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Typical remaining Battery capacity
3.4 Power Sources
Accuracy is dependent upon the lifetime and
condition of the battery, as well as, the condition
of the unit. Outside variables such as temperature
may also affect accuracy.
The LSU is delivered with an AC Power Cord for
connection to AC mains and a DC Power Cord
for connection to DC mains.
The device can be operated from the internal
battery, and can be operated or charged from
one of the following external Power Sources:
Battery Capacity
Output
> 50 %
4 LEDs lit.
30 - 50%
3 LEDs lit.
20 - 30%
2 LEDs lit.
< 20%
1 LED lit.
• AC mains when used with the AC Power
Cord: 100-240 VAC (50 / 60 Hz).
• DC mains when used with the DC Power Cord: 12-28 VDC.
A Wall Bracket to hold the LSU during operation
and (optional) charging is available separately
(see section 10).
Battery Low; (min. 1 minute of operation left
based on 500+ mmHg/free flow). 1 LED flashes.
During charging: indicates approx. achieved
battery capacity.
Capacity
AC Connector Socket
Output*
< 75%
The LED’s will be lit sequentially
75 - 80%
3rd LED’s lit and 4th flashing
> 80%
4 LED’s lit.
DC Connector Socket
External power connection will cause
the External Power Indicator to be lit.
Always check that it is lit when
connecting external power or
inserting the LSU into the Wall Bracket.
*Note: If no battery is installed, the battery status
indicator will be fully lit for approx. 5 sec. until it
is turned off.
During the Device Test
Indicates which step of the test is currently in
progress or which corresponding test result is
being displayed:
LED 1 (lower LED) lit = STEP 1,
LED 2 lit = STEP 2 etc.
3.5 Automatic Power-save Function
The LSU has an Automatic Powersave Function that switches the pump
motor off.
3.3 TEST-Button
While in this mode, the Power ON Indicator will
flash slowly (approx. once per second).
This button allows you to run a
4-step user initiated Device Test
program to identify whether the
LSU is operating satisfactorily or if it needs
service (see section 7).
This function will be activated when the
Operating Knob is set to 200, 350 or 500+
mmHg and the actual vacuum level has been
continuously higher than 120 mmHg for more
than 2 minutes.
To exit the Power-save Mode and revert to
normal operation, set the Operating Knob to
any other position and then go back to required
setting.
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4 LSU Reusable Canister System
4.1 Overview
Aerosol Filter
PATIENT Inlet
Vacuum inlet
Patient Suction Tubing
Suction Catheter
Adapter
User Interface
Holder for Water
Bottle/Patient
Suction Tubing.
Canister
Water Bottle
Canister Lid
with Float Ball
Battery Door
Canister Holder
Release Arm
4.2 Parts
Canister
PATIENT Inlet
Patient Suction Tubing
Canister Lid w/Float Ball
Gasket
Angled Connector
Suction Catheter Adapter
Vacuum seal
The LSU Reusable Canister System consists of:
• A 1000 ml transparent plastic Canister.
Aerosol Filter
Connector from the VACUUM Inlet. The Float
Ball will be released and the Angled Connector
can be reattached,
• A Canister Lid w/Float Ball
• An Aerosol Filter with tubing
Note: The LSU Reusable Canister System must
not be used without the Aerosol Filter or the
Float Ball.
The Canister Lid contains a Float Ball that shuts
off the vacuum if the canister is full or the LSU
tips over. To restore the vacuum, remove the
Angled
Decontamination of reusable parts must be
performed in accordance with section 4.6.
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4.3.2 Using the LSU
The Aerosol Filter protects the LSU by
preventing aerosols from entering the Pump
Unit. It is not intended for microbiological or
for particle filtration. The Aerosol Filter is not
designed for decontamination.
Note: The LSU must be operated and
transported in the upright position to prevent
overflow of suctioned material.
It is recommended that the Aerosol Filter be
replaced after each use or at least once every
shift. If the LSU is used on patients in areas where
cross contamination is not an issue, the Aerosol
Filter should be replaced at least once a month.
It is recommended always to have extra Aerosol
Filters with the LSU in case one has to be
discarded. If the Aerosol Filter becomes wet, it
should be replaced immediately or as soon as
possible after use.
1 Unwind the Patient Suction Tubing
2 Set the Operating Knob to the required
vacuum level. The LSU will automatically be
switched ON and start to operate.
The green Power ON Indicator is lit
continuously while the LSU is switched ON.
4.3 Use
Note: Read all the Cautions and Warnings listed
in section 1 thoroughly before you use the LSU.
The parts are color coded to help re-assembly
after cleaning.
3 When suction is complete, set the Operating
Knob to “0”
4.3.3 Emptying the Canister
4.3.1 Check list
Note: To prevent damage and keep the LSU in
good working order; empty the canister when
3/4 full. Check the filter after each use.
• Check that no parts are missing and that all
parts are clean.
• If you decide to operate the LSU from
external power, connect to either external AC
or DC power as described in section 3.4.
If you decide to operate the LSU from internal
battery, check that the battery is installed.
If the filter is broken so liquid penetrates the
membrane, the pump will be contaminated, and
the LSU must be returned for service (see
section 8).
• Check that the Patient Suction Tubing is
securely connected to the PATIENT Inlet on
the Canister Lid; and the Aerosol filter is
securely fastened in the LSU and the lid.
When liquid reaches the top of the Canister, the
LSU will stop suctioning. To continue suctioning,
empty canister and replace the filter.
Overflow of suctioned material can damage the
device.
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5 Clean the LSU according to section 6.2 and
its reusable parts according to section 4.6.
4.3.4 Assembly of the Reusable Canister System
1 Place the yellow Gasket in the Lid, make sure
that the gasket is placed flat in the Lid and
not twisted.
1 Disconnect the Filter Tubing from the blue
Vacuum Inlet (see section 4.2 regarding
handling instructions for the Aerosol Filter).
2 If the Float Ball has been removed, hold the
lid upside down and snap the ball into place
as shown.
Note: Never use the LSU without the Float Ball.
2 To release the Canister Holder, press down the
Release Arm while sliding the Holder towards
you. Remove the Canister from the Holder.
3 Secure the Lid to the Canister by turning it
clockwise until it is securely fastened.
3 Release the Patient Suction Tubing (if
applicable).
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4 Safely dispose of the contents of the Canister
according to local protocols.
To remove the Canister, proceed as follows:
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4 Connect the Suction Catheter Adapter to
the Patient Tube.
8 Insert the Canister in the canister holder and
slide it into the LSU.
5 Connect the Angled Connector to the Patient
Tube.
9 Connect the yellow Angled Connector to the
yellow Vacuum Seal
6 Mount the yellow Vacuum Seal in the centre
hole of the Lid and push it into place.
10 Connect the Angled Connector on the Patient
tubing to the PATIENT Inlet on the canister Lid.
7 Connect the Aerosol Filter (blue ring) to the
blue Vacuum Inlet on the LSU. (Color code:
Blue on Blue)
11 Perform the Device Test according to section 7.
12Wind the Patient Tubing on the Patient
Tubing Holder.
13 Place the LSU on charge (see section 6.4)
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Note: Connect tubing according to color code:
Blue on Blue & Yellow on Yellow.
6.
4.4 Reusable Canister System
1.
Quick reference
The assembly of the tubing is
illustrated on the right side of the
LSU. 1 Connect the blue Aerosol filter
to the blue Vacuum Inlet.
4.
7.
2.
3.
8.
5.
4.6.2 Preparation
• Remove and empty the Canister according
to section 4.3.
2 Connect the yellow angled
connector to the yellow
Vacuum Seal.
• Disassemble the Canister into separate parts
as indicated in the picture above.
3 Connect the Patient Tubing to
the Patient inlet.
• The Float Ball on the reusable canister can
be snapped out of the lid.
4.5 After Use
4.6.3 Rinsing
• Rinse all parts under cold running water.
• When suction is complete, set Operating
Knob to ”0” and inspect all parts for damage
or excessive wear. Replace parts if necessary.
• Immerse in warm water (30-40°C).
4.6.4 Cleaning
• Clean the LSU and its reusable parts
according to section 6.2
• Immerse all parts in hot water (60-70°C)
containing a mild detergent (see section 6.3).
• Perform the Device Test according to section
7.
• Thoroughly clean all surfaces, use a brush
where possible.
• Place the LSU on charge (see section 6.4).
• Rinse in warm water and allow to dry.
4.6 Decontamination of Laerdal Reusable Canister
• Inspect all parts to be visibly clean and dry.
4.6.1 Parts to be Decontaminated
Note: Thorough rinsing and cleaning are very
important steps prior to disinfection.
After Each Use:
1 Canister Lid
2 Float Ball
3 Gasket.
4 Vacuum Seal
5 Angled Connectors
6 Canister
7 Patient Suction Tubing
8 Suction Catheter Adapter.
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5. Serres Suction Bag system
5.1 Overview
Serres Vacuum Connector
PATIENT Inlet
Vacuum Inlet
Suction Tube
User Interface
Serres Suction
Bag with filter
Canister
Holder for
Suction Tubing
Canister Holder
Release Arm
Battery Door
5.2 Parts
Reusable Parts
Disposable Parts
Parts to be cleaned or replaced regulary:
• Canister
• Suction bag with filter
• Serres Vacuum Connector
• Serres Suction Tube
Serres Suction Tube
Suction Bag with Filter
Canister
Serres Vacuum
Connector
The Serres Suction Bag system contains a
hydrophilic filter that shuts off the vacuum if the
canister is full or the LSU tips over.
To restore the vacuum, replace the Suction bag:
The disposable parts must be replaced after each
use.
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Note: The LSU should be operated and
transported in the upright position to prevent
overflow of suctioned material.
Clean the Serres Vacuum Connector by wiping
with a damp cloth or a sponge. Do not autoclave
or attempt to disassemble.
1 Unwrap the Serres Suction Tube.
2 Connect the Serres Suction Tube to the
Patient inlet on the canister lid.
5.3 Use
Note: Read all the cautions and warnings listed in
section 1 thoroughly before you use the LSU.
5.3.1 Check list
• Check that no parts are missing and that all
parts are clean.
• If you decide to operate the LSU from
external power, connect to either external
AC or DC power as described in section 3.4.
If you decide to operate the LSU from
internal battery, check that the battery is
installed and charged.
3 Attach appropriate suction catheter if
necessary. Not supplied by Laerdal Medical.
4 Set the Operating Knob to the required
vacuum level and the LSU will automatically
be switched on and start to operate.
The green power ON Indicator is lit
continuously while the LSU is switched on.
• Check that the Serres Vacuum Connector is
properly connected to the LSU and to the
canister
Check that the lid of the canister is properly sealed:
5 When suctioning is complete, set the
Operating Knob to “0”.
1 Block patient inlet and turn on the LSU.
5.3.3 Empty the canister
Note: It is recommended to replace the Suction
Bag when it is ¾ full.
When liquid reaches approximately 1000 ml,
the LSU will not suction any more liquid. If
overflow of liquid from the bag into the pump is
suspected, the LSU must be returned to service
(see section 8).
2 Vacuum will build up when all parts are
assembled correctly.
Overflow of suctioned material can damage the
LSU.
Disconnect Serres Suction tube. Safely dispose
of the Serres suction tube according to local
protocols.
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5.3.2 Using the LSU
The reusable canister must be cleaned if needed
according to manufacturer’s instructions for use.
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1 Plug Patient Inlet with plug provided on the
lid. Disconnect the Serres Vacuum Connector
from the canister.
5.3.4 Assembly of the Serres Suction Bag system
2 Press the release arm while sliding the holder
towards you to loosen or completely remove
canister.
2 Partially insert the canister holder into the
LSU.
1 Place the canister in a canister holder in an
upright position.
3 Unfold the Suction Bag and place inside the
canister. Suction bag has to be installed into
equal size canister
3 Remove suction bag from canister
4 Safely dispose of the Serres Suction bag
according to local protocols.
5 Clean the LSU if needed according to section
6.2.
6 Clean the Serres canister if needed according
manufacturers instructions for use.
Note: Clean the Serres Vacuum Connector by
wiping with a damp cloth or a sponge.
Do not autoclave or attempt to disassemble.
The Serres Vacuum Connector should be
replaced regularly.
4 Insert the Serres Vacuum Connector into the
LSU Vacuum Inlet.
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10 Turn off the LSU.
6 Insert the opposite side of the Serres Vacuum
Connector into the canister.
11 Fasten the Suction Tubing on the Suction
Tubing Holder
12 Place the LSU on charge (see section 6.4)
5.4 Serres Suction Bag System
Quick Reference
Correct assembly of the tubing
is illustrated on the right side of
the LSU.
7 Turn the operating knob to 500+ mmHg.
8 Close the Patient inlet with your finger and
simultaneously push the middle of the lid
down. The lid is properly installed when
vacuum has reached 500 mmHg.
5.5 After Use
1 Inspect all parts of the LSU for damage and
excessive wear.
Replace parts if necessary.
The Serres Vacuum Connector should be
replaced regularly.
2 Place an unopened Serres Suction Tube on
the side of the LSU.
3 Perform Device Test according to section 7.
9 Release the patient inlet and make sure that
the bag is fully inflated.
4 Place the LSU on charge see section 6.4.
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5 Fully insert canister holder into the LSU.
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6. Maintenance
6.4 Charge the Battery
6.1 General
The internal rechargeable battery can be charged
directly from external AC or DC power as
described in section 3.4. No external charger is
needed. To charge the battery, proceed as follows:
• Make sure the maintenance instructions
under “After Use” are followed.
• If the device is not in frequent use (i.e. less
than once a month), the Device Test (see
section 7) should be performed both on a
monthly basis and after each use.
1 Make sure the Operating Knob is set to “0”. Connect either external AC or DC power to the LSU and charging will start automatically.
2 During charging the Battery Status Indicator
will indicate approx. achieved battery capacity
(see section 3.2.5 for details).
6.2 Clean the Cabinet and parts
Warning: Disconnect the LSU from external
power prior to cleaning.
3 The LSU should be placed on charge for a
minimum of 24 hours to reach full battery
capacity. The fast charging gives approx. 80%
capacity after 3 hours (for a new battery).
Repetitive charging for only 3 hours is not
recommended.
Use a minimum of liquid to prevent any electrical
shock hazard. Do not immerse the LSU or allow
it to stand in water or other liquids. This can
damage the device, and cause electrical shock
resulting in injury to persons.
• Use a cloth or sponge that is dampened with
a mild detergent (hand dishwashing liquid or
similar) to clean the external surfaces of the
LSU. Use a detergent that is compatible with
the materials listed under section 11.7, and
follow the detergent manufacturer´s
instructions.
• Use a cloth or sponge dampened with water
and wipe the surfaces again.
• Dry the surfaces using a clean cloth or a
paper towel.
6.3 Disinfection of reusable parts
To disinfect the parts, the following methods are recommended:
Method
Temperature / Concentration
Contact Time
Post-treatment
Glutaraldehyde
Room temperature / Conc.: 2% 60 minutes
Rinse all parts warm water.
Allow to dry.
Sodium Hypochlorite
(not cleared for use in
the US)
Room temperature / Conc.: 0.5% 20 minutes
Rinse all parts warm water.
Allow to dry.
Virkon
Room temperature / Conc.: 1% 10 minutes
Rinse all parts warm water.
Allow to dry.
Steam autoclaving
Autoclave at max. 121° C
Allow parts to cool.
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60 minutes
If poor battery quality is suspected, charge the battery for a minimum of 24 hours and then
perform the following test without connection to
external power:
• Run the Device Test and
LED 4
then let the LSU operate
LED 3
continuously at 500+
LED 2
mmHg setting and free
LED 1
air flow for 20 minutes.
• It is recommended to always fully charge the
battery. Repetitive charging to a lower
capacity level will reduce battery life.
• If it is not possible to place the LSU on
continuous charge when not in use, make
sure the battery is charged for a minimum of
24 hours at least once a month.
• If the LSU stops before
completing the 20
minutes, the battery should be discarded.
• D
o not store the battery when it is
discharged. Always fully charge the battery
before storage.
6.7 Replace the Battery
• D
o not store the LSU with a discharged
battery.
Note: Use only batteries recommended by
Laerdal Medical.
• T
he recommended ambient temperature for
charging is from 15°C to 25°C.
1 Open the Battery Door.
• The battery will not be charged when the
LSU is in operation.
2 To remove the battery, push and move it
slightly to the left and then release.
• If no battery is installed, the battery status
indicator will be fully lit for approx. 5 sec.
until it is turned off.
3 Withdraw the battery from the LSU.*
4 To insert a battery, push it fully in and then to
the right to lock it.
• Replace the battery when it does not pass
the Battery Quality Check (see section 6.6
for details) or after 3 years, whichever comes
first.
5 Close the Battery Door.
6 After inserting the battery, place the LSU
on charge unless a fully charged battery is
inserted.
• A completely discharged battery cannot be
charged by the LSU and must be replaced.
• We recommend charging a spare battery
every 6 months when stored in room
temperature at 25°C (77°F ).
*When you discard the battery, dispose of safely
in accordance with local protocols for sealed lead
acid or Nickel Metal Hydride (NiMH) batteries.
6.5 External Battery Charger
The LSU battery can also be charged
in an optional External Battery Charger.
See section 10.
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6.6 Check the Battery Quality
Note:
• To maintain satisfactory operation of the
battery, it is recommended to place the LSU
on continuous charge immediately after use
and when not in use.
English
7 Device test
6.8 Fastening brackets
The fastening bracket is used to hold the LSU in
the optional wall bracket. Inspect the fastening
brackets for wear and tear regularly.
Replace if worn. See section 10.
The Device test is a user initiated test program
for all models which can identify whether the
LSU operates satisfactorily or if the LSU needs
service.
The program runs 4 different tests:
1 It tests for occlusions in the Suction System
(including canister and tubing).
Fastening
brackets
2 It tests the vacuum build-up efficacy of the
Pump System (How much vacuum is built up
within 3 seconds).
6.9 Release arm for Canister holder
3 It tests the maximum achievable vacuum
level of the LSU (reaches this level within 10
seconds).
An extra release arm for the canister holder can
be attached. See section 10.
4 It tests if there are air leakages in the Pump System (including canister and tubing).
7.1 Setup
Before the test can be performed make sure that:
• The Patient Suction Tubing is unwound and
not blocked or bent.
• The Suction Catheter Adapter is removed
from its holder (if applicable).
• The canister lid, T-bar, angled connector and
tubing are securely fastened.
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4 Release the tubing when LED 1 comes on
again.
Note: If you need to interrupt the test and revert
to normal operation, turn the Operating Knob
to another position and then select the required
setting.
1 Press and hold the TEST-Button while setting
the Operating Knob to 500+ mmHg.
5 Evaluate the test results (See section 7.3)
6 After evaluating the test results turn the
Operating Knob to “0” to exit the Device Test.
Note: To indicate that the LSU is in test mode,
the Power ON Indicator will flash rapidly (approx.
twice per second) until you exit the test program.
* If the tubing is not occluded within 2 minutes,
the test will be interrupted and the Power ON
Indicator will start to flash slowly (approx. once
per second). To restart the test, set the Operating
Knop to “0” and start over again.
Note: Do not release the TEST-Button until min.
2 seconds after the Operating Knob has been set
to 500+ mmHg. The test will start immediately
2 As soon as LED 2 from the bottom of the
Battery Status Indicator comes on (takes
approx. one second), fully block the Patient
Suction Tubing.*
3 Keep the tubing blocked while LED 2 , 3 and
4 lights up.
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7.2 Run the Test
English
7.3 Evaluation of Device Test Results
After the test is completed, the Vacuum Indicator will automatically display the first result (blockage). To
display the other results press the TEST-Button once for each test. If you continue pressing the button after
the 4th test result has been displayed, the earlier results will be repeated (Test 1,2,3,4,1,etc.). To exit the
test program, set the Operating Knob to another position.
Test No.
The program
has tested for
Battery
indicator
Test result indication
Action if test failed
Test 1
Blockage in the LED #1 lit up
Suction System
(including
canister and
tubing)
Test Passed <100 mmHg Check possible blockages (e.g.
twisted tubing, blocked filter,
blocked filter in the liner) and
run the Device.Test again.
If the High Efiiciency Filtration
FAIL
Kit is installed the pass limit is
100 mmHg
150mmHg
PASS
Test 2
The vacuum
LED #2 lit up
build-up
efficacy of the
Pump System
(How much
vacuum is built
up within 3
seconds)
Test Passed >300 mmHg Check Connectors, Tubes and
Canister Lid for leakage* or
damage.
Check exhaust outlet for
PASS
occlusion and run the Device
300 mmHg
Test again
FAIL
Test 3
The maximum
achievable
vacuum level
of the LSU
(reaches this
level within 10
seconds)
LED #3 lit up
Test Passed >500 mmHg Check Connectors, Tubes and
Canister Lid for leakage* or
PASS
damage.
500 mmHg
Check exhaust outlet for
FAIL
occlusion and run the Device
Test again
Test 4
Air leakages
in the Pump
System
(including
canister and
tubing)
LED #4 lit up
Test Passed >450 mmHg Check Connectors, Tubes and
Canister Lid for leakage* or
PASS
damage and run the Device
450 mmHg
Test again
FAIL
* If it is not obvious where the system is leaking; go step by step through the connections. Start by disconnecting
the Vacuum Tube at the Canister and run the Device Test (blocking the tube). Reconnect the tube and
disconnecting the patient tube, run device test (block the PATIENT inlet on the Canister). Continue with other
connections until the leakage is identified.
Note: If the LSU does not pass one or more of the steps in this test after suggested actions are taken, the
device might need to be returned for service (see the Troubleshooting guide).
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8. Servicing
There are no user serviceable parts inside the cabinet. Do not open cabinet.
Please note that wear and tear parts of the pump mechanism should be changed every third year.
Refer servicing to personnel qualified by Laerdal Medical, or to Laerdal Medical or one of its authorised
distributors.
9. Trouble Shooting
Fault
Condition
Action
The LSU does not
operate with the AC
or DC Power Cord
connected.
External Power Indicator is
not lit when the Operating
Knob is set to “0”.
Check power cord connections and the
external AC or DC power source.
External Power Indicator is lit.
The LSU must be returned for service (see
section 8).
The LSU cannot be
operated from the
internal battery.
Power ON Indicator is OFF.
OR
All the lights in the front panel
flash on and off repeatedly.
Check that battery is installed.
The LSU operates,
but little or no suction
available.
Vacuum Seal blocked by float
ball.
Unplug the Vacuum Seal to release the
vacuum
Canister full.
Remove and replace the Canister (see
section 4.3, 5.3)
Poor vacuum connection
between Pump Unit and
Canister.
Install the Vacuum Connector
Tubing correctly.
Patient Suction Tubing twisted
or blocked.
Replace the filter or liner if the filter is
blocked Untwist the Patient Suction
Tubing and/or clear blockage
or replace the tubing.
(Serres) Lid is not properly
sealed
Seal lid using vacuum, not force. See section
5.3.4
Battery is not charged.
Check power cord connections and that
battery is installed
Battery Status Indicator
is not ON.
Place the LSU on charge.
If still faulty after charging completed,
remove and replace the battery (see
section 6.7).
Vacuum Indicator
Tube(s) is kinked or twisted
indicates more than 100
mmHg with free air flow
Straighten / untwist the tube(s).
The LSU does not
charge with the AC
or DC power cord
connected
Check power cord connections
and the external AC- or DC-power source.
The LSU must be returned for service (see
section 8).
A flat battery cannot be recharged
The external Power indicator
is not lit.
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10. Accessories and Parts
Cat. No. Description
78 00 00 LSU w/Reusable Canister
78 00 30 LSU w/ Serres Suction Bag System
(Label on back side of cabinet: REF 78 00 xx)
Reusable
78 12 00 Aerosol Filter for LSU Reusable
Canister
77 04 10 Suction Tubing 150 cm w/o tip
65 01 13 Suction Catheter adapter, pkg. 10
78 40 00 LSU Reusable Canister
78 10 06 Angled Connectors, pkg. 10
78 10 02 Float Ball, pkg. 10
78 40 07 Vacuum Seal
78 40 08 Gasket
78 04 30 LSU Reusable Canister Holder
78 04 00
78 12 00
77 04 10
65 01 13
78 10 60
78 10 02
78 40 07
78 40 08
78 40 30
Serres
57 151 Serres Suction Bag
(1000 ml, Blue)
58 23 181 Serres Suction Tube
(non-sterile CH25) 180 cm
78 12 06 Serres Vacuum Connector
78 04 12 Disposable patient tubing 180cm
57 300 Serres Canister
(1000ml, Transparent)
57 301 Serres Canister (1000ml, Blue)
78 04 51 Serres Canister Holder
58 23 181
78 04 12
78 12 06
Serres pre 2014
57 300
78 12 04 Serres Vacuum Connector Tubing
78 12 03 Serres High Efficiency Filtration Kit
78 04 50 Serres Canister Holder
57 301
57 151
Serres pre 2014
78 12 04
78 12 03
78 04 51
78 04 50
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English
All versions
78 03 00 xx Directions for Use
(xx indicates local language configuration)
78 04 33 Strap for Tubing
78 04 32 Release Arm
78 02 00 DC-Power Cord
78 02 10 AC-Power Cord US
78 02 20 AC-Power Cord EU
78 02 30 AC-Power Cord UK
78 08 00 LSU Battery - NiMH
78 04 00 LSU Battery - Lead Acid
78 04 36 Fasten bracket left/right
78 04 35 Holder for water bottle
79 35 00 Water Container
79 35 00
78 04 32
78 02 10
78 04 35
78 04 33
78 02 00
78 02 20
78 02 30
78 04 00
78 08 00
78 04 36
Accessories (all versions)
78 20 00
78 26 00
78 26 10
78 26 20
78 26 30
78 26 40
78 23 00
78 24 00
78 04 40
Carrying Bag (full covering)
Wall Bracket w/DC-Power Cord
Wall Bracket w/AC-Power Cord US
Wall Bracket w/AC-Power Cord EU
Wall Bracket w/AC-Power Cord UK
Wall Bracket wo/ Power Cord
Shoulder Strap
Side Pouch
External Charger kit
78 23 00
78 20 00
78 04 40
78 26 10
78 26 20
78 26 30
78 26 40
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78 24 00
English
11. Specifications
Approx noise levels (free air flow) at different
settings:
11.1 Classification
Electrically powered medical suction equipment
for field and transport use, according to
ISO10079-1
High vacuum/high flow.
Not suitable for use in the presence of flammable
liquids or gases.
Internally powered/class ll equipment type BF,
according to IEC 60601-1
The degree of protection provided by the chassis
is according to IP34D:
• Protected against solid foreign objects of
2,5 mm Ø and greater
mmHg
80
120
200
350
500+
dBA
48
48
51
53
56
Vacuum - Max.: > 500 mmHg (67 kPa).
Vacuum - Range: 80 - 500+ mmHg (11 - 67 kPa).
Vacuum Indicator accuracy: ±5% of full scale.
11.4.1 Operation with High Efficiency Filtration
Kit
The flow and operation time of the LSU will be
reduced when the Vacuum Connector Tubing is
replaced with a High Efficiency Filtration Kit.
• Protected against splashing water
The LSU with High Efficiency Filtration Kit
installed is in accordance with ISO 10079-1.
• Protected against access with a wire
11.2 General tolerance
Overall tolerance ±5%
The filter has an efficiency of 99.97% down to a
particle size of 0.3 μm.
11.3 Physical Characteristics
11.5 Power Requirements
Size: 315 mm (12,4 in) x 330 mm (13 in) x 160
mm (6,3 in), (h x w x d)
Weight: 4kg (8,9 lbs) (including battery NiMH)
Canister Capacity: 1000 ml
Canister graduation
accuracy: ±5% of full scale
Patient Suction Tubing
(non-sterile) Cat.No 770410: 8 mm (0.315 in.)
inside diameter x 1.5 m (59 in.) length
Operating/charging AC:** 100-240 VAC +10%/15%, 50-60 Hz +/- 3 Hz (100-240 VAC),
Operating/charging DC:** 12-28 VDC +/-10%.
Battery: 12 VDC 2 Ah, NiMH, rechargeable, 12
VDC 2 Ah, Sealed Lead - Acid, rechargeable
Charging Time: 3 hours for approx. 80% battery
capacity, 24 hours for fully charged.
Fuses: The LSU has no fuses to be replaced by
the user (see section 9).
11.4 Operation
** The external AC power source must be able
to deliver a current of min. 1A and the external
DC power source min. 6A, if not the LSU may
switch to battery operation.
Approx. free air flow at different settings:
mmHg
80
120
200
350
500+
l/min
12
16
20
23
>25
Approx. battery operation time (free air flow) at
different settings (±10%):
mmHg
min
80
120
200
350
500+
3h20
2h20
1h30
1h
45
24
• Side Pouch: PVC coated Polyester
Operating/Charging Temperature:
0° C (32°F) to + 40° C (104° F).
• Shoulder Strap: POM + Polyester
• Wallbracket: Aluminium + Steel + PA with
fibers Aerosol Filter, LSU Reusable Canister:
PVC + ABS Styrene-Butadiene Copolymer
(SBC)
Recommended Charging Temperature:
15°C (59°F) to + 25°C (77°F ).
• Float Ball, LSU Reusable Canister: PP
Long term Storage Temperature:
0° C (32°F) to + 40° C (104° F).
• Vacuum Plug, LSU Reusable Canister: Silicone
• Serres Canister: PC
• The angle connector of the canister: TPE
Max. 24 hour Storage Temperature:
-30° C (-22°F) to + 70° C (158° F).
• Serres Canister Holder: PP
• Serres Suction Bag: PE + PP
Humidity (Operating & Storage):
5 - 95% RH non-condensing
11.7.1 Dismantling/Disposal
When discarding the LSU, we
recommend it be dismantled and
discarded according to local protocol.
Dismantle the LSU by unscrewing the screws
on the back side of the LSU, remove the
components and sort according to the table in
11.7.
11.7 Material Chart
• Cabinet front: Poly Cabonate/Acrylonitrile
Butadiene Styrene (PC/ABS)
• Protector for front: Styrene Ethylene Betyl
Styrene (SEBS)
• Cabinet back: PC/ABS
• Cabinet base w/Protector: PC/ABS + SEBS
The cleaned LSU can also be delivered to
your local Laerdal Medical representative for
dismantling/disposal. Laerdal Medical AS will not
charge any fee for the dismantling; Sender is
reponsible for the cost of the shipment.
• Battery door: SEBS
• Connector retainer for battery:
• Poly Oxy Methylene (POM)
• Operating Knob: POM
• Rotor for Operating Knob: PC/ABS
• Manifold for vacuum: POM
• Canister Holder: PP
• Handle w/Protector: PC/ABS + SEBS
• Manifold for exhaust: POM
• Strap for patient suction tubing: SEBS
• Canister Holder Release Arm: POM
• User Interface: Polyester
• Vacuum Connector: Silicone
• Suction Catheter Adapter: PC
• Suction Catheter Adapter Holder: PC
• LSU Reusable Canister: PC - HT
• Lid w/Floater Valve Cylinder,
• Gasket for Lid, LSU Reusable Canister:
Silicone
• Full covering Carrying Bag: PVC coated
Polyester
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11.6 Environmental Conditions
English
11.8 Symbols
!
This product complies with the
following ANSI/UL and CSA standards
(Direct Current).
CSA Standards:
CAN/CSA-C22.2 No:0-M91
General Requirements – Canadian Electrical
Code, part II
(Alternating Current).
3
Class II Equipment, according to
IEC 60601-1
CAN/CSA-C22.2 No:601.1-M90
Medical Electrical Equipment Part I: General
Requirements for Safety
3N
Type BF applied part, according to
IEC 60601-1
IP34D
The degree of protection provided by the chassis according to IP34D
CAN/CSA-C22.2 No:601.1S1-94
Supplement No 1-94 to CAN/CSA-C22.2 No.
601.1-M90 – Medical Electrical Equipment – Part
1: General Requirements for Safety US Standards:
UL Standard No:2601.1
Medical Electrical Equipment
This product is in compliance with
the essential requirements of MDD 93/42/EEC as amended by Council Directive 2007/47/EC
Warning: Parts of this product are designed for single patient use only. Do not re-use. Re-use will lead to
increased risk of cross contamination, degradation of performance and/or device malfunction.
Laerdal Medical is not responsible for N
any consequences of re-use
MEDICAL ELECTRICAL EQUIPMENT needs
special precautions regarding EMC and needs
to be installed and put into service according to
the EMC provided in this section. Portable and
mobile RF communication equipment can affect
MEDICAL ELECTRICAL EQUIPMENT.
Warning:
MEDICAL ELECTRICAL EQUIPMENT should
not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary,
the MEDICAL ELECTRICAL EQUIPMENT should
be observed to verify normal operation in the
configuration in which it will be used.
Date of production.
!
11.9 EMC Specifications
See Directions for Use.
Maximum cable length, AC Power cord: 1.5 meters
Maximum cable length, DC Power cord: 1.5 meters
Unique product type identification
Warning:
The use of accessories, transducers and cables
other than those specified, with exception of
transducers and cables sold by Laerdal Medical
as replacement parts for internal components,
may result in increased emission or decreased
immunity of the LSU.
3
3N
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Guidance and manufacturer’s declaration – electromagnetic immunity
The Laerdal Suction Unit (LSU) is intended for use in the electromagnetic environment specified below. The customer
or the user of the LSU should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic
tile. If floors are covered with
synthetic material,
the relative humidity should be
at least 30%.
Electrical fast
transient/burst.
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge IEC 61000-4-5
± 1 kV differential mode
± 2kV common mode
± 1 kV differential mode
± 2kV common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines.
IEC 61000-4-11
< 5% UT
(> 95% dip in UT) for 0,5
cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 sec.
< 5% UT
(> 95% dip in UT) for 0,5
cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 sec.
Mains power quality should be
that of a typical
commercial or hospital
environment.
Power Frequency
(50Hz/60Hz) magnetic
field. IEC 61000-4-8
3A/m
3A/m
NOTE: UT is the AC mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Laerdal Suction Unit (LSU) is intended for use in the electromagnetic environment specified below. The customer
or the user of the LSU should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 test level
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The LSU uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The LSU is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public lowvoltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
27
English
Guidance and manufacturer’s declaration – electromagnetic immunity
The Laerdal Suction Unit (LSU) is intended for use in the electromagnetic environment specified below. The customer
or the user of the LSU should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 test level
Compliance level Electromagnetic environment - guidance
Conducted RF
IEC/EN 61000-4-6
3 Vrms
150 kHz to 80
MHz
3 Vrms
Radiated RF
IEC/EN 61000-4-3
3 V/m
80 MHz to 2,5
GHz
10 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the LSU, including cables, than
the recommended separation distance
calculated from the equation applicable to
frequency of the transmitter.
Recommended separation distance
d=1.2 •P
d=0.35•P 80 MHz to 800 MHz
d=0.7•P 800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should
be considered. If the measured field strength in the location in which the LSU is used exceeds the applicable RF
compliance level above, the LSU should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the LSU.
b. Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
12 Limited Warranty
13 Addresses
The LSU comes with a five (5) year limited
warranty*. See the enclosed “Laerdal Global
Warranty” for terms and conditions.
The warranty is also available at www.laerdal.com
Manufacturer:
Laerdal Medical AS
Tanke Svilandsgate 30
P.O.Box 377
4002 Stavanger
Norway
* Excluding the canister, tubing systems and
battery
Distribution:
For World Wide distribution,
see Global Warranty or
www.laerdal.com
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8179 Rev I
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