Laerdal LSU Serres 78 00 30 User Guide Rev A 2021

Contents Important Information Intended Use Battery Cautions

4 4 5

Overview User Interface

6 7

Assembly - LSU Serres Suction Bag System

8

Use Before Use Checklist Use After Use Checklist

9 9 9 10

Emptying Empty LSU Serres

11 11

Cleaning Clean the Cabinet

12 12

Device Test Before Device Test Checklist Device Test Indicators Run the Test

13 13 13 14

Device Test - Evaluation Evaluation of Device Test Results

16 16

Device Test - Leakages Troubleshooting for Leakages

17 17

Battery Charging Replace the Battery

18 19 20

Service and Maintenance Warranty

21 21

Troubleshooting

22

Specifications

23

Accessories and Parts

29 3

Important Information Intended Use The Laerdal Suction Unit (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. 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. Read this User Guide carefully, and become thoroughly familiar with the operation and maintenance of the LSU before using it. Read all Cautions and Warnings before using the LSU. Warnings and Cautions A Warning states a condition, hazard, or unsafe practice that can result in serious personal injury or death. A Caution states a condition, hazard, or unsafe practice that can result in minor personal injury or damage to the product. Warnings • The LSU is not suitable for use in the presence of flammable liquids or gases; there can be a danger of explosion or fire. • Not intended for use in MRI environments. • Do not use the LSU under environmental conditions that are outside the ranges specified in Specifications section. This can endanger safety and adversely affect operation of the device. • Do not block the Exhaust Outlet during use. This will lead to reduced flow and can also cause damage to the LSU. • Disconnect the LSU from external power prior to cleaning. Use a minimum amount of liquid to prevent any electrical shock hazard. • Do not immerse the LSU or allow it to stand in water or other liquids. This might damage the device, and cause electrical hazard. Cautions • Do not pump any cleaning solution or other liquids through the vacuum pump, i.e. through the Vacuum Connector. This can damage the LSU. • Use only parts and accessories supplied by Laerdal Medical or one of our authorised distributors to ensure that the LSU operates satisfactorily. • Overflow of suctioned material can damage the device. If overflow of liquid from the Canister into the pump is suspected, contact your local Laerdal Medical representative. • The LSU should only be used by persons trained in the use of medical suction equipment. 4

Important Information Battery Cautions • 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. • The LSU must be charged between each clinical use. • To maintain satisfactory operation of the battery, placing the LSU on continuous charge immediately after use and when not in use is recommended. • 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 4 hours at least once a month. • The LSU must be placed on charge for a minimum of 4 hours to reach full battery capacity. Fast charging gives approximately 80% battery capacity after 3 hours (for a new battery). Repetitive 3 hour charging is not recommended. • Fully charging the battery is recommended. Repetitive charging to a lower capacity level will reduce battery life. • Always fully charge the battery before storage. • Do not store the battery when it is discharged. • Do not store the LSU with a discharged battery. • Laerdal recommends charging a spare battery every 6 months when stored in room temperature at 25 °C (77 °F).

5

Overview

Vacuum Inlet Serres Vacuum Connector Patient Inlet Quick Reference

Suction Tube

Holder for Suction Tubing

Canister Holder Battery Door

User Interface

Release Arm

Canister

6

Serres Suction Bag with filter

Overview User Interface

Test Button Run the Device Test program

Power On Indicator • Continuously lit - LSU is switched on. • Rapid flash (approx. twice per second) Device Test in progress. • Slow flash (approx. once per second) Automatic power save mode activated; Device Test interrupted or battery discharged.

Vacuum Indicator* Actual vacuum level during operation. Each fully lit segment represents 50 mmHg. If a segment has a dim light, this represents 25 mmHg (e.g 125 mmHg is shown by 2 fully lit and 1 dimly lit segments).

External Power Indicator AC or DC power connected

Battery Status Indicator

Failure Mode Indicator Possible malfunction detected

Operating Knob On/Off switch Vacuum selector

*Pressure conversion chart mmHg

80

120

200

350

500

kPa

10.6

16.0

26.6

46.6

66.5

mBar

107

160

267

467

667

7

Assembly - LSU Serres Suction Bag System

1

2

3

4

C

B

D CLICK

A

Note Turn the operating knob to 500+ mmHg. Block the Patient Inlet with your thumb and simultaneously push the lid down. The lid is properly installed when vacuum has reached 500 mmHg. Release the Patient Inlet and make sure that the bag is fully inflated.

8

Use Before Use Checklist • Check that no parts are missing and that all parts are clean. • To operate the LSU from an external power source, connect to either external AC or DC power. To operate the LSU from the internal battery, check that the battery is installed. • Run Device Test. • 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: block patient inlet and turn on the LSU. Vacuum will build up when all parts are assembled correctly. • Attach appropriate suction catheter if necessary. (Not supplied by Laerdal Medical).

Use

1

1. Unwind the Suction Tubing. Set the Operating Knob to the required vacuum level. The LSU will switch on and start to operate. The Power On Indicator lights up during operating.

2

2. When suction is complete, set the Operating Knob to “0” to turn off.

9

Use Caution Even if the Operating Knob is set to “0”, voltage is present on some of the internal circuitry when the LSU is connected to external power. Disconnect from the mains to fully remove power. Note The LSU has an automatic power save mode which switches the pump motor off. While in this mode, the Power On Indicator will flash slowly (approx. once per second). Power save mode is 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 power save mode and revert to normal operation, set the Operating Knob to any other position and then go back to required setting.

After Use Checklist

• Inspect all parts of the LSU for damage and excessive wear. Replace parts if necessary. • Clean the LSU cabinet. Clean and disinfect reusable parts. See Cleaning section. • LSU Serres: The Serres Vacuum Connector should be replaced regularly. Place an unopened Serres Suction Tube on the side of the LSU. • Perform Device Test. See Device Test section. • Place the LSU on charge. Note 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.

10

Emptying Empty LSU Serres

1

When liquid reaches approximately 1000 ml, the LSU will not suction any more. If overflow of liquid from the bag into the pump is suspected, contact Laerdal Service. See Service and Maintenance section.

3

2

A

B

4

C

5

Safely dispose of the Serres Suction bag and suction tube according to local protocols. 11

Cleaning Parts to be cleaned or replaced regularly: Serres Canister Serres Vacuum Connector The disposable parts must be replaced after each use. Clean the Serres canister if needed according to manufacturer’s instructions for use. 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.

Clean the Cabinet Use a minimum amount 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 in the Material Chart, 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.

12

Device Test The Device Test is a user initiated test program to identify whether the LSU operates satisfactorily or if it needs service. If the device is not in frequent use (i.e. less than once a month), the Device Test should be performed both on a monthly basis and after each Cleaning and Assembly process. The program runs 4 different tests: 1. Occlusions - Blockages in the Suction System, including canister and tubing. 2. Vacuum efficacy - How much vacuum builds up in the Pump System within 3 seconds. 3. Maximum vacuum level - The maximum achievable vacuum level of the LSU within 10 seconds. 4. Leakages - Air leakages in the Pump System, including canister and tubing.

Before Device Test Checklist:

• Ensure the LSU is correctly assembled and the Patient Suction Tubing is unwound. • The Suction Catheter Adapter is removed from its holder (if applicable). • Ensure the battery is not being charged (the device is not connected to AC/DC power source). 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.

Device Test Indicators Test result indication

Running Test 3 Testing the maximum achievable vacuum level of the LSU

Running Test 4 Testing for air leakages in the Pump System

Running Test 2 Testing the vacuum build-up efficacy of the Pump System

Running Test 1 Testing for occlusions in the Suction System

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Device Test Run the Test

1

2

1

2

1. Press and hold the Test Button while turning the Operating Knob to 500+ 3 mmHg.

2. Hold the Test Button in for 2 seconds.

4

4

3

3. The test will start immediately. During test mode, the Power On Indicator will flash rapidly.

4. When LED 2 lights up, block the Patient Suction Tubing with your thumb.

14

Device Test

5

5. Keep the tubing blocked while LED 2, 3 and 4 light up. Release the tubing when LED 1 lights up again.

Notes If the tubing is not blocked within 2 minutes, the test will be interrupted.During interrupted device test, the Power On Indicator will flash slowly. • To restart the test, set the Operating Knob to “0” and start over again. • To evaluate test results, do not tun off the LSU after running Device Test. •

15

Device Test - Evaluation Evaluation of Device Test Results

After the test is completed, the Vacuum Indicator will display the results. Press the Test Button to scroll through the results of each test to display the results.

Test No.

Test result indication

Test 1 Occlusions

Action if test failed • •

Check possible blockages (e.g. twisted tubing, blocked filter, blocked filter in the liner) and run the Device. Test again. If the High Efficiency Filtration Kit is installed the pass limit is 150mmHg.

Test Passed <100 mmHg Test 2 – Vacuum efficacy

•

Check Connectors, Tubes and Canister Lid for leakage* or damage. Check exhaust outlet for occlusion and run the Device Test again.

Test Passed >300 mmHg

•

Test 3 – Maximum vacuum

Test Passed >500 mmHg

•

Test 4 - Leakages

Test Passed >450 mmHg

Check Connectors, Tubes and Canister Lid for leakage* or damage and run the Device Test again.

•

Check Connectors, Tubes and Canister Lid for leakage* or damage. Check exhaust outlet for occlusion and run the Device Test again.

After evaluating the test results turn the Operating Knob to “0” to exit the Device Test. 16

Device Test - Leakages Troubleshooting for Leakages

If the device test has failed, check whether the system is leaking. Run the Device Test again blocking different parts in turn, until you find the failure.

1

2

Test by blocking the Pump System Run the Device Test whilst blocking the outlet. If the device passes the test, there are no leakages in the Pump System.

Test by blocking the Patient Tubing Inlet Run the Device Test whilst blocking the Patient Tubing inlet on the Canister. If the device passes the test, there are no leakages in the Canister.

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).

17

Battery The LSU can be operated from the internal battery, and can be operated or charged from one of the following external power sources: 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. The LSU battery can also be charged in an optional External Battery Charger. A Wall Bracket to hold the LSU during operation and (optional) charging is available separately. See Accessories and Parts for more information.

Battery Status Indicator

This Battery Status Indicator has 3 functions: • During operation from internal battery: indicates approximate remaining battery capacity. • During charging: indicates approximate achieved battery capacity. • During device testing: indicates which device test is in progress. If no battery is installed, the battery status indicator will be fully lit for approx. 5 sec. until it is turned off. Note During operation from internal battery and during charging, the displayed values must only be used as indications.

Battery Capacity Capacity

Output

< 75%

The LEDs will be lit sequentially

75 - 80%

3rd LEDs lit and 4th flashing

> 80%

4 LEDs lit

Immediately after turning the LSU on or switching from external power to internal battery operation, all 4 LEDs will flash for 5 seconds before the remaining battery capacity is displayed. Due to the nature of voltage based battery capacity measurement, the battery status indication may differ from unit to unit. Each battery may vary in voltage versus remaining capacity, thus allowing for variability in the reading. Other outside variables such as temperature may also affect accuracy. The indicator is targeted to show battery capacity as indicated below. The graph shows how the accuracy of the indication can vary. 4 LEDs 3 LEDs 2 LEDs 1 LED

time

Caution If the LSU or the NiMH battery has been stored at low temperatures (< 12 °C / < 54 °F), the LSU may indicate lower remaining battery capacity than actual when first switched on. This is due to the nature of NiMH batteries. The battery indicator may flash on one LED, which normally indicates Battery Low. The LED may continue to flash until the LSU temperature is above 12 °C / 54 °F and the LSU is switched off and on again. The low battery indication in this instance is not a correct indication of the residual battery capacity. 18

Battery Charge the Battery

The internal rechargeable battery can be charged directly from external AC or DC power. 1. 2. 3.

Ensure the Operating Knob is set to “0”. Connect either external AC or DC power to the LSU and charging will start automatically. During charging, the Battery Status Indicator will indicate approximate achieved battery capacity. Minimum charging time for full charge is 4 hours.

A completely discharged battery cannot be charged by the LSU and must be replaced. If LSU battery is kept on constant charge, perform device test at least once a month to exercise battery. • • •

Cautions Do not perform the Device Test during battery charging. The recommended ambient temperature for charging is from 15°C to 25°C. The battery will not be charged when the LSU is in operation.

Check the Battery Quality

If poor battery quality is suspected, charge the battery for a minimum of 4 hours and then perform the following test. Do not connect to external power. 1. 2. 3.

Run the Device Test. Let the LSU operate continuously at 500+ mmHg setting and free air flow for 20 minutes. If the LSU stops before completing the 20 minutes, the battery should be discarded.

Caution Replace the battery when it does not pass the Battery Quality Check or after 3 years, whichever comes first.

19

Battery Replace the Battery

1

2

CLICK

3

4

5

6

CLICK

Caution Use only batteries recommended by Laerdal Medical. When you discard the battery, dispose of safely in accordance with local protocols for Nickel Metal Hydride (NiMH) batteries. 20

Service and Maintenance Service

There are no user serviceable parts inside the cabinet. Do not open the LSU Cabinet. 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.

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.

Warranty

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. * Excluding the canister, tubing systems and battery

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